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Clinical Response (clinical + response)
Kinds of Clinical Response Terms modified by Clinical Response Selected AbstractsA Prospective Study of p53 Expression and Its Correlation With Clinical Response of Radiotherapy in Nasopharyngeal Carcinoma,THE LARYNGOSCOPE, Issue 1 2001Kuen-Yao Ho MD Abstract Objectives/Hypothesis Nasopharyngeal carcinoma (NPC) is a common malignant neoplasm of the head and neck that occurs in people in the southeastern Asian area, including Taiwan. The significant association of p53 expression in NPC suggested that p53 overexpression seemed to occur at an early stage in the development of NPC. Alterations of p53 status were probably the most commonly encountered in head and neck carcinomas, and there was extensive evidence that p53 status might determine tumor response to therapy. Ionizing radiation was studied extensively for the relationship between its damaging effect and p53 status in human cancer cells. Study Design This study was carried out to investigate whether there was any correlation between overexpression of p53 protein and locoregional tumor response in patients with NPC treated with 7000 cGy of radiotherapy. Methods Sixty-eight patients (50 males, 18 females) with NPC who were diagnosed and treated with radiotherapy were studied prospectively. Before they had received a radiation dose of 7000 cGy in 35 fractions, five fractions a week, p53 status from a nasopharyngeal biopsy was studied using immunohistochemical staining (IHC). Results The locoregional response rate of primary tumor was analyzed statistically. Forty-seven patients (69.1%) showed positive p53 staining in their tumors. There were 5 positive stains in 6 squamous cell carcinomas (SCC; 83.3%), 34 positive in 53 non-keratinizing carcinomas (NKC; 64.2%), and 8 positive in 9 undifferentiated carcinomas (UC; 88.9%). The mean ages for patients with three different histopathologies were 48.5, 46.1, and 61.1 years. There were 8 patients (7 positive stains, 1 negative stain) with residual tumor after radiotherapy and all were NKC (6 males, 2 females). Therefore, the clinical response rate of primary tumor was 85.1% in positive p53 immunostaining (40 of 47 cases), 95.2% in those with no immunostaining (20 of 21 cases); the former was poorer in locoregional tumor response than the latter, but there was no significant difference (P >.05, ,2 test). Conclusions We conclude that there is no statistically significant correlation in locoregional response of primary tumor between p53 overexpression and radiotherapy in patients with NPC (P >.05, Fisher exact test). [source] Treatment of Parthenium dermatitis with methotrexateCONTACT DERMATITIS, Issue 2 2007Vinod K. Sharma Patients with parthenium dermatitis are often unresponsive to topical steroids, and immunosuppressive agents may be necessary to reduce their need for systemic corticosteroids. We evaluated the efficacy of methotrexate in parthenium dermatitis. Sixteen patients unresponsive to topical treatment were included after baseline investigations, and treated with oral methotrexate (15 mg/week). Clinical response was monitored using a dermatitis area and severity index (DASI). Seven patients completed ,6 months' follow-up, and their mean DASI fell to 5, 2.7 and 2.1 at the end of 1, 3 and 6 months respectively, from a baseline score of 10. Only 3/7 patients required oral prednisolone in the initial 2,4 weeks. Side effects were minor, being mainly folliculitis and furuncles. Methotrexate may hence be a useful alternative for patients with severe parthenium dermatitis. [source] Quality of life in 1000 patients with early relapsing,remitting multiple sclerosisEUROPEAN JOURNAL OF NEUROLOGY, Issue 6 2009N. Putzki Background and purpose:, To examine the quality of life (QoL) in a large cohort of untreated patients with relapsing,remitting multiple sclerosis (RRMS) and to investigate the impact of intramuscular (IM) interferon beta-1a (IFNß-1a) treatment. Methods:, Prospective, observational, open-label, multicentre study conducted in Germany. Untreated patients with RRMS who initiated treatment with IM IFNß-1a were included and followed for 12 months. QoL was measured using the EQ-5D questionnaire. Clinical response was assessed by relapse rate and disability (Expanded Disability Status Scale; EDSS). Results:, A total of 1157 patients were included [mean age 37.6 years, median disease duration 13 months, mean relapse rate 1.7 (95%CI: 1.58,1.73), median EDSS score 2.0]. Relapse rate was reduced to 0.6 at 12 months (95%CI: 0.51,0.69, P < 0.0001). EDSS did not change significantly. At baseline, QoL was considerably lower in MS patients compared with the general German population, but was improved after treatment initiation [utilities of EQ-5D: 0.77 (95%CI: 0.75,0.78) vs. 0.75 (95%CI: 0.74,0.76) at baseline, 95%CI for difference: 0.01,0.03, P = 0.0046]. Higher disease activity and inability to work were negative predictors of QoL. 14.7% of patients were incapable of working for MS-related reasons. Conclusions:, Quality of life is considerably impaired in early stages of MS. Treatment initiation with IM IFNß attenuates MS disease activity and improves QoL. Inability to work early during the disease is a major challenge for the social security systems. [source] Fontolizumab in moderate to severe Crohn's disease: A phase 2, randomized, double-blind, placebo-controlled, multiple-dose studyINFLAMMATORY BOWEL DISEASES, Issue 2 2010Walter Reinisch MD Abstract Background: The safety and efficacy of fontolizumab, a humanized anti-interferon gamma antibody, was investigated in patients with Crohn's disease (CD). Elevated gut mucosal levels of interferon gamma, a key cytokine involved in the inflammatory process of CD, are associated with disease symptoms. Methods: A total of 201 patients with Crohn's Disease Activity Index (CDAI) scores between 250 and 450 were randomized to receive an initial intravenous dose of 1.0 or 4.0 mg/kg fontolizumab or placebo, followed by up to 3 subcutaneous doses of 0.1 or 1.0 mg/kg fontolizumab or placebo every 4 weeks. Clinical response at day 29, the primary efficacy endpoint, was defined as a decrease in the CDAI of at least 100 points from baseline levels. Results: Of 201 patients, 135 (67%) completed the study. Day 29 response rates were similar in all treatment groups (31%,38%). At subsequent timepoints a significantly greater proportion of patients in the 1.0 mg/kg intravenous / 1.0 mg/kg subcutaneous fontolizumab group had clinical response and significantly greater improvement in the CDAI score compared with patients who received placebo. All fontolizumab groups had significant improvement in C-reactive protein levels. The overall frequency of adverse events was similar in all groups (58%,75%); most events were related to exacerbation of CD. There was a low frequency (5.2%) of neutralizing antibodies to fontolizumab. Conclusions: Although a strong clinical response to fontolizumab was not observed, significant decreases in C-reactive protein levels suggest a biological effect. Fontolizumab was well tolerated, and further studies to assess its efficacy are warranted. Inflamm Bowel Dis 2009 [source] Efficacy of infliximab in refractory pouchitis and Crohn's disease-related complications of the pouch: A Belgian case seriesINFLAMMATORY BOWEL DISEASES, Issue 2 2010Marc Ferrante MD Abstract Background: Up to 25% of inflammatory bowel disease (IBD) patients undergoing surgery with an ileal pouch,anal anastomosis (IPAA) will develop chronic pouchitis not responding to antibiotics. In case reports, thiopurine analogs and infliximab (IFX) have been proposed as effective therapy in this setting. We analyzed the long-term efficacy of IFX in Belgian patients with refractory pouch complications. Methods: We identified 28 IPAA patients who received IFX for refractory luminal inflammation (pouchitis and/or pre-pouch ileitis, n = 25) and/or pouch fistula (n = 7). Patients with elements of Crohn's disease after review of the colectomy specimen were excluded. Clinical response was defined as complete in case of cessation of diarrhea, blood loss, and abdominal pain, and as partial in case of marked clinical improvement. Fistula response was defined as complete in case of cessation and as partial in case of reduction of fistula drainage. Results: Eighty-two percent of patients were concomitantly treated with immunomodulatory agents. At week 10 following start of IFX, 88% of patients with refractory luminal inflammation showed clinical response (14 partial, 8 complete), while 6 patients (86%) showed fistula response (3 partial, 3 complete). The mPDAI dropped significantly from 9.0 (interquartile range [IQR] 8.0,10.0) to 4.5 (3.0,7.0) points (P < 0.001). After a median follow-up of 20 (7,36) months, 56% showed sustained clinical response while 3 out of 7 fistula patients showed sustained fistula response. Five patients needed permanent ileostomy. Conclusions: In this series, IFX was effective long-term in IPAA patients with refractory luminal inflammation and pouch fistula. These results warrant a prospective multicenter randomized controlled trial. Inflamm Bowel Dis 2009 [source] Infliximab treatment for Crohn's disease: One-year experience in a Dutch Academic HospitalINFLAMMATORY BOWEL DISEASES, Issue 2 2002Dr. Daan W. Hommes Abstract The aim of this study was to report the 1-year clinical experience with infliximab treatment for Crohn's disease (CD) in the Netherlands. All 73 CD patients receiving infliximab infusions were prospectively followed during 1 year after the drugs' registration in the Netherlands. Clinical response and adverse events were assessed for both active luminal disease as well as fistulous disease. A total of 212 infusions were administered to 57 patients with active luminal CD and 16 patients with fistulous CD. The mean duration between infusions was 60 days. In 17% of patients, adverse events were recorded, of which one was serious. The response rate was 81% in active luminal CD and 87% in fistulous disease. Response rates were highest in patients receiving concomitant methotrexate as maintenance therapy. Steroids could successfully be tapered off in 73% of responding luminal CD patients and 100% of responding CD patients with fistulae. Eleven patients showed a loss of response to continuous infliximab readministration. Our clinical experience with infliximab for active luminal and fistulous CD showed that the administration is safe, effective, and has high steroid-sparing efficacy. Higher response rates were seen with methotrexate as concomitant medication. [source] An open-label pilot study using thioguanine as a therapeutic alternative in Crohn's disease patients resistant to 6-mercaptopurine therapyINFLAMMATORY BOWEL DISEASES, Issue 3 2001Dr. Marla C. Dubinsky Abstract Background and Aims A substantial number of patients with inflammatory bowel disease (IBD) fail to achieve a complete clinical response with 6-mercaptopurine (6-MP) and azathioprine (AZA). Inability to achieve therapeutic 6-thioguanine nucleotide (6-TGN) levels due to the preferential overproduction of 6-methylmercaptopurine ribonucleotides (6-MMPR) upon dose escalation characterizes a newly described subgroup of IBD patients resistant to 6-MP/AZA therapy. Treatment with 6-thioguanine (6-TG), a related thiopurine, which forms 6-TGNs more directly may be beneficial in such patients. This pilot study evaluated the safety, tolerance, and efficacy of 6-TG in the subgroup of Crohn's disease (CD) patients failing to attain adequate disease control with traditional 6-MP/AZA therapy. Methods Ten CD patients with preferential 6-MMPR production upon 6-MP/AZA dose escalation were enrolled in an open-label pilot study. Seven of 10 patients had experienced dose-related 6-MP toxicities. Results Seventy percent of the patients (7 of 10) responded or were in remission at week 16. Clinical response was evident by week 4 in most. 6-TGN levels were nine-fold higher with 6-TG treatment than with 6-MP, whereas 6-MMPR levels were undetectable. No patient developed a recurrence of hepatic or hematological toxicity. Conclusions 6-TG was a safer and more efficacious thiopurine in this subgroup of IBD patients resistant to 6-MP therapy. Larger controlled trials are warranted to further evaluate both the short-and long-term safety and efficacy in this subgroup of patients as well as a broader spectrum of IBD patients. [source] Efficacy of aromatherapy (Lavandula angustifolia) as an intervention for agitated behaviours in Chinese older persons with dementia: a cross-over randomized trialINTERNATIONAL JOURNAL OF GERIATRIC PSYCHIATRY, Issue 5 2007Pamela Wan-ki Lin Abstract Background Agitated behaviours among persons with dementia are distressing to both patients and their caregivers. As pharmacological interventions may be limited by their potentially adverse effects, the use of complementary therapies for treatment of agitation has become more popular and aromatherapy is the fastest growing one. Objectives This study investigates the effectiveness of lavandula angustifolia (lavender) in treating agitated behaviours of demented people in Hong Kong. Methods It was a cross-over randomized trial. Seventy Chinese older adults with dementia were recruited; half were randomly assigned to the active group (lavender inhalation) for three weeks and then switched to control group (sunflower inhalation) for another three weeks; the other half did the opposite. Clinical response was evaluated using the Chinese versions of Cohen-Mansfield Agitation Inventory (CCMAI) and Neuropsychiatric Inventory (CNPI). Results The mean CCMAI total scores decreased from 24.68 to 17.77(t,=,10.79, df,=,69, p,<,0.001). The CNPI scores changed from 63.17 (SD,=,17.81) to 58.77 (SD,=,16.74) (t,=,14.59, df,=,69, p,<,0.001) after receiving Treatment A (Lavandula Angustifolia). There were no period and sequential effects noted. Conclusion In summary, lavender is effective as an adjunctive therapy in alleviating agitated behaviours in Chinese patients with dementia. In a patient population particularly vulnerable to side effects of psychotropic medications, aromatherapy using lavender may offer an alternative option. Copyright © 2007 John Wiley & Sons, Ltd. [source] Clinical experience with infliximab among Filipino patients with rheumatic diseasesINTERNATIONAL JOURNAL OF RHEUMATIC DISEASES, Issue 2 2006Sandra V. NAVARRA Abstract Aim:, To describe the clinical experience with infliximab among Filipino patients with rheumatic diseases, specifically disease indications, dose regimens, clinical response, and adverse events. Methods:, We reviewed the data on Filipino patients who were given infliximab by rheumatologists for a rheumatic disease indication. The case report form included demographic profile, underlying rheumatic disease, comorbidities, concurrent medications, dose and frequency of infliximab, physicians' assessment of clinical response, and adverse events. The frequency of doses, intervals between doses, and discontinuation status were recorded. Results:, Included were 64 patients (35 females), with a mean age of 44 years. Most (41%) had rheumatoid arthritis, followed by psoriasis/psoriatic arthritis (31.2%) and ankylosing spondylitis (17.2%). Average disease duration from diagnosis to initiation of infliximab therapy was 7.6 years ± 6.7 SD. Among 35 patients, the interval between maintenance infusions ranged from 6 to 13.6 weeks, with a mean of 8.27 weeks. Clinical response was good to excellent in more than 80% of patients. Discontinuation rate was 10.9% and 28.1% at 3 and 12 months, respectively. Infusion-related adverse events were mild and transient, and 14 (21.8%) cases of infection resolved with appropriate therapy. Infliximab was temporarily withheld in five (7.8%) patients with active tuberculosis. Summary:, These findings substantiate the superior clinical efficacy of infliximab and manageable adverse events among Filipinos with rheumatic diseases. It also demonstrates dose regimens in clinical practice in a third world setting with limited resources. [source] The efficacy and safety of a third anti-TNF monoclonal antibody in Crohn's disease after failure of two other anti-TNF antibodiesALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 1 2010M. ALLEZ Summary Background, Adalimumab (ADA) and certolizumab pegol (CZP) have demonstrated efficacy in Crohn's disease (CD) patients previously treated with infliximab (IFX). Aim, To assess the efficacy and tolerability of a third anti-TNF in CD after failure of and/or intolerance to two different anti-TNF antibodies. Methods, Crohn's disease patients who received ADA or CZP after loss of response and/or intolerance to two anti-TNF agent were included in this retrospective study. Data were collected using a standardized questionnaire. Clinical response, duration, safety and reasons for discontinuation were assessed. Results, Sixty-seven patients treated with CZP (n = 40) or ADA (n = 27) were included. A clinical response was observed in 41 (61%) at week 6 and 34 patients (51%) at week 20. The probability of remaining under treatment at 3 months, 6 months and 9 months was 68%, 60% and 45%, respectively. At the end of follow-up, the third anti-TNF had been stopped in 36 patients for intolerance (n = 13), or failure (n = 23). Two deaths were observed. Conclusions, The treatment with a third anti-TNF (CZP or ADA) agent of CD patients, who have experienced loss of response and/or intolerance to two anti-TNF antibodies, has favourable short-term and long-term efficacy. It is an option to be considered in patients with no other therapeutic options. [source] Efficacy of methotrexate in Crohn's disease and ulcerative colitis patients unresponsive or intolerant to azathioprine,/mercaptopurineALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2009M. WAHED Summary Background, Despite the wide use of azathioprine/mercaptopurine (AZA/MP) therapy in the management of both Crohn's disease (CD) and ulcerative colitis (UC), approximately 20% of patients cannot tolerate the drugs and 30% do not respond. Aim, To examine the efficacy and safety profile of methotrexate (MTX) in patients with CD or UC who are either intolerant or non-responsive to AZA/MP. Methods, A total of 131 patients with IBD treated with MTX were identified. Retrospective data were obtained by case note review. Clinical response (defined as steroid withdrawal, normalization of previously raised CRP or physician's clinical assessment of improvement) was assessed at 6 months. Results, Clinical response in Crohn's disease occurred in 18 of 29 patients (62%) refractory to AZA/MP and 42 of 70 patients (60%) intolerant to AZA/MP, with no difference between the groups (P = 1.0). In UC, clinical response was seen in 7 of 9 (78%) patients refractory to AZA/MP and 15 of 23 (65%) intolerant to thiopurines. MTX was well tolerated in a majority of individuals. Conclusions, Methotrexate appears effective in both CD and UC patients who fail to respond to or are intolerant to AZA/MP therapy. [source] Clinical trial: benefits and risks of immunomodulators and maintenance infliximab for IBD-subgroup analyses across four randomized trialsALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 3 2009G. R. LICHTENSTEIN Summary Background, Benefits and risks of concomitant immunomodulators and maintenance infliximab in inflammatory bowel disease (IBD) patients have not been adequately evaluated. Aim, To assess the effect of concomitant immunomodulator and infliximab maintenance therapy using data from four prospective, randomized Phase 3 trials in IBD patients. Methods, Overall, 1383 patients from ACCENT I and ACCENT II [luminal and fistulizing Crohn's disease trials] and ACT 1 and ACT 2 [ulcerative colitis trials] were analysed. Patients were treated with placebo or infliximab 5 or 10 mg/kg at weeks 0, 2 and 6 followed by every-8-week maintenance therapy. Clinical response, clinical remission, fistula response, complete fistula response, infection and infusion reaction rates; serum infliximab concentrations and immunogenicity were summarized by baseline concomitant immunomodulator subgroup (use or non-use). Results, Overall, almost 40% of evaluated IBD patients received concomitant immunomodulators. Efficacy, infection, and serious infection rates were generally similar in patients who received maintenance therapy with or without concomitant immunomodulators. There were no consistent differences in serum infliximab concentrations with or without immunomodulators in patients who received scheduled maintenance therapy. Concomitant immunomodulators reduced infusion reactions and immunogenicity. Conclusion, Concomitant immunomodulators did not improve efficacy or pharmacokinetics in IBD patients who received maintenance infliximab. [source] Early changes in rectal nitric oxide and mucosal inflammatory mediators in Crohn's colitis in response to infliximab treatmentALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 8 2007T. LJUNG SUMMARY Background Treatment with tumor necrosis factor-, monoclonal antibody (infliximab) reduces clinical activity and intestinal inflammation in Crohn's disease. Aim To study the time-course of the effects of infliximab with reference to mucosal cytokine and inducible nitric oxide synthase expression. Methods Thirty-two patients with Crohn's disease were treated with single dose infliximab (5 mg/kg). Disease activity was assessed days 1, 3, 7 and 28 using Harvey,Bradshaw index. Rectal nitric oxide levels were determined and rectal biopsies collected before treatment, 1 h after infusion and on days 3, 7 and 28. Immunohistochemical staining against inducible nitric oxide synthase, tumor necrosis factor-,, interleukin-1, and interferon-, were performed. Results Clinical response was seen in 14 patients with down-regulation of global immunohistochemistry expression, reaching nadir day 3. Rectal nitric oxide was increased at baseline (3578 ± 1199 parts per billion, ppb) compared with controls (89 ± 13 ppb) (P < 0.001). In patients with clinical response, rectal nitric oxide decreased from 3926 ± 1687 ppb to 1050 ± 428 ppb day 28 (P < 0.05). Conclusions Down-regulation of mucosal inflammatory mediators occurs after infliximab. Rectal nitric oxide levels parallel down-regulation of inducible nitric oxide synthase, tumor necrosis factor-,, interleukin-1, and interferon-, and may serve as a quantitative biomarker of intestinal inflammation. [source] Infliximab regulates lamina propria T lymphocytes in patients with Crohn's diseaseALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 2006O. WATANABE Summary Background and Aims The immune system is a major determinant of the pathophysiological inflammation, which may lead to gastrointestinal mucosal injury in patients with Crohn's disease. Cytokines such as tumour necrosis factor-alpha are well-known mediators of the immune system, and treatment with a chimeric anti-tumour necrosis factor-alpha antibody (infliximab) has been shown to be highly effective in patients with Crohn's disease. Recent evidence indicates that infliximab induces apoptosis in lamina propria T lymphocytes in these patients. To better understand the mechanisms of infliximab's effect on gastrointestinal inflammation, we investigated changes in the serum level of cytokines after treatment in these patients, and the effect of infliximab in inducing the apoptosis of T lymphocytes. Methods Thirteen patients with Crohn's disease were treated with infliximab at a dosage of 5-mg/kg body weight. Clinical response was evaluated using the Crohn's Disease Activity Index, and serum soluble interleukin-2 receptor, interleukin-6, tumour necrosis factor-alpha levels were analysed by enzyme-linked immunosorbent assay at 0 and 2 weeks after treatment. Apoptosis of peripheral and lamina propria T lymphocytes after culture with infliximab was detected by flow cytometry. Results Crohn's Disease Activity Index decreased in 12 of 13 patients, and serum soluble interleukin-2 receptor, interleukin-6 and tumour necrosis factor-alpha levels decreased in most patients after treatment with infliximab. Tumour necrosis factor-alpha level before treatment in the six patients in whom Crohn's Disease Activity Index decreased by more than 70 was <5 ng/mL. Infliximab induced the apoptosis of lamina propria but not of peripheral T lymphocytes. Conclusion These findings suggest that a low level of serum tumour necrosis factor-alpha is an indicator for infliximab treatment. The induction of apoptosis of lamina propria T lymphocytes by infliximab may be an important mechanism of its anti-inflammatory effect in patients with Crohn's disease. [source] Clinical response of patients with sickle cell anemia to cromolyn sodium nasal sprayAMERICAN JOURNAL OF HEMATOLOGY, Issue 11 2006Mehran Karimi Abstract Sickle cell anemia is the most common heritable hematological disease affecting humans. Although hydroxyurea is the most commonly used antisickling agent, several previous studies suggest that cromolyn sodium also prevents sickling when administered acutely. However, no previous studies have evaluated the safety or efficacy of prolonged administration of cromolyn to patients with sickle cell anemia. The purpose of this study, therefore, was to test the hypothesis that prolonged administration of cromolyn alone or in combination with hydroxyurea would decrease the incidence of pain crises and/or alter the chronic pain seen in patients with this disease. In this crossover, single-blind, in vivo and in vitro study, 17 patients with sickle cell disease were studied. Each patient had to fill out a standard pain chart. Every 3 months the patients' medications changed in the following manner: The first 3 months the patients used cromolyn sodium nasal spray; the second 3 months they received placebo nasal spray; the third 3 months they received cromolyn sodium nasal spray and hydroxyurea capsule; and the last 3 months they received hydroxyurea capsule and placebo nasal spray. The least pain was felt with the mixture of hydroxyurea capsule and cromolyn sodium nasal inhaler. Furthermore, with the other combinations of medications, there were no significant statistical changes in the number of sickled red blood cells. Every combination used in this survey had positive effects on decreasing the pain. cromolyn sodium nasal spray is significantly efficient in decreasing sickle cell crisis as well as pain intensity in patients with sickle cell anemia. Am. J. Hematol., 2006. © 2006 Wiley-Liss, Inc. [source] Role of Computed Tomography Imaging in Predicting Response of Nasopharyngeal Carcinoma to Definitive Radiation TherapyTHE LARYNGOSCOPE, Issue 12 2006Xuejun Ma MD Abstract Purpose: The purpose of this study was to investigate the role of posttreatment computed tomography (CT) scans in assessing response of nasopharyngeal carcinoma (NPC) to definitive radiotherapy. Material and Methods: Between March 1999 and October 2003, a total of 132 consecutive patients with newly diagnosed NPC were studied. Sixty-one patients with AJCC stage I or II NPC were treated with radiation only; 71 patients with stage III or IV disease but no evidence of distant metastasis were treated with concurrent chemoradiotherapy. All patients received CT scans of the head and neck, nasopharyngoscopy, and biopsies of primary sites at 4 to 6 months after completion of radiotherapy. Clinical response of the primary tumor as determined by comparison of pre- and posttreatment CT scans was correlated to pathology results. Results: The median follow-up time for all patients was 25 months (range, 9,40 months). Radiologic progression was seen in five patients, stable disease in 18 patients, and radiographic partial (rPR) and complete responses (rCR) were seen in 67 and 42 patients, respectively, at 4 to 6 months of follow up. Biopsies of the nasopharynx were positive in six patients. For patients with rCR, two patients (4.8%) had positive biopsies. Four patients with residual disease (rPR, stable, or progressive disease) after treatment had positive biopsies. The positive and negative predictive values, sensitivity, and specificity of CT scans in evaluating the NPC response to radiotherapy were 0.04, 0.95, 0.67, and 0.32, respectively. Conclusions: Pathologic CR for nasopharyngeal carcinoma is usually evident at 4 to 6 months after definitive radiotherapy; however, there is no correlation between pathologic and radiographic response. Although longer follow up is required to define the relationship between radiographic and pathologic responses with respect to disease control, we find CT scan at 4 to 6 months after radiotherapy to be neither sensitive nor specific in predicting the response of primary NPC to radiotherapy. [source] Overexpression of synoviolin in peripheral blood and synoviocytes from rheumatoid arthritis patients and continued elevation in nonresponders to infliximab treatmentARTHRITIS & RHEUMATISM, Issue 7 2006Myew-Ling Toh Objective Synoviolin is a novel E3 ubiquitin ligase that has been implicated in the pathogenesis of rheumatoid arthritis (RA). The purpose of this study was to examine the expression and regulation of synoviolin by tumor necrosis factor , (TNF,), both in vivo and in vitro. Methods A total of 54 RA patients and 23 healthy control subjects were analyzed before, 4 hours after the first infusion, and at week 22 of infliximab treatment. Clinical response was assessed by the American College of Rheumatology criteria for 20% improvement and the Disease Activity Score in 28 joints (DAS28) at 6 months. Synoviolin messenger RNA expression was measured by real-time reverse transcription,polymerase chain reaction in peripheral blood (PB) and fibroblast-like synoviocytes (FLS) and with and without TNF, or interleukin-1, (IL-1,) stimulation. Results Synoviolin expression was increased in whole PB obtained from RA patients as compared with that from healthy controls and was significantly reduced early and late after infliximab treatment in responders, but in not nonresponders. Reduction in synoviolin expression was associated with reduced levels of markers of disease activity, including C-reactive protein levels. Nonresponders to infliximab therapy had significantly higher synoviolin expression at baseline as compared with responders, and this elevation persisted despite infliximab therapy. PB CD14+ monocytes expressed increased synoviolin levels compared with CD3+ lymphocytes, and TNF, or IL-1, induced a further increase in expression in CD3+ cells. TNF, or IL-1, induced sustained synoviolin expression in RA FLS. Conclusion Elevated PB levels of synoviolin were identified in circulating PB mononuclear cells and were associated with nonresponse to infliximab treatment. Sustained up-regulation of synoviolin by IL-1, and TNF, may contribute to prolonged survival of immune cells and dysregulated FLS proliferation, leading to RA chronicity. [source] Comparison of etanercept and methotrexate, alone and combined, in the treatment of rheumatoid arthritis: Two-year clinical and radiographic results from the TEMPO study, a double-blind, randomized trialARTHRITIS & RHEUMATISM, Issue 4 2006Désirée van der Heijde Objective To evaluate the efficacy, including radiographic changes, and safety of etanercept and methotrexate (MTX), used in combination and alone, in patients with rheumatoid arthritis (RA) in whom previous treatment with a disease-modifying antirheumatic drug other than MTX had failed. Methods Patients with RA were treated with etanercept (25 mg subcutaneously twice weekly), oral MTX (up to 20 mg weekly), or combination therapy with etanercept plus MTX through a second year, in a double-blinded manner. Clinical response was assessed using American College of Rheumatology (ACR) criteria and the Disease Activity Score (DAS), in a modified intent-to-treat analysis with the last observation carried forward (LOCF) and in a population of completers. Radiographs of the hands, wrists, and forefeet were scored for erosions and joint space narrowing at annual intervals. Results A total of 503 of 686 patients continued into year 2 of the study. During the 2 years, significantly fewer patients receiving combination therapy withdrew from the study (29% of the combination therapy group, 39% of the etanercept group, and 48% of the MTX group). Both the LOCF and the completer analyses yielded similar results. The ACR 20% improvement (ACR20), ACR50, and ACR70 responses and the remission rates (based on a DAS of <1.6) were significantly higher with combination therapy than with either monotherapy (P < 0.01). Similarly, improvement in disability (based on the Health Assessment Questionnaire) was greater with combination therapy (P < 0.01). The combination therapy group showed significantly less radiographic progression than did either group receiving monotherapy (P < 0.05); moreover, radiographic progression was significantly lower in the etanercept group compared with the MTX group (P < 0.05). For the second consecutive year, overall disease progression in the combination therapy group was negative, with the 95% confidence interval less than zero. Adverse events were similar in the 3 treatment groups. Conclusion Etanercept in combination with MTX reduced disease activity, slowed radiographic progression, and improved function more effectively than did either monotherapy over a 2-year period. No increase in toxicity was associated with combination treatment with etanercept plus MTX. [source] Phase II study of neoadjuvant chemotherapy and extended surgery for locally advanced gastric cancer,BRITISH JOURNAL OF SURGERY (NOW INCLUDES EUROPEAN JOURNAL OF SURGERY), Issue 9 2009T. Yoshikawa Background: Locally advanced gastric cancer with extensive lymph node metastasis is usually considered unresectable and so treated by chemotherapy. This trial explored the safety and efficacy of preoperative chemotherapy followed by extended surgery in the management of locally advanced gastric adenocarcinoma. Methods: Patients with gastric cancer with extensive lymph node metastasis received two or three 28-day cycles of induction chemotherapy with irinotecan (70 mg/m2 on days 1 and 15) and cisplatin (80 mg/m2 on day 1), and then underwent gastrectomy with curative intent with D2 plus para-aortic lymphadenectomy. Primary endpoints were 3-year overall survival and incidence of treatment-related death. Results: The study was terminated because of three treatment-related deaths when 55 patients had been enrolled (mortality rate above 5 per cent). Two deaths were due to myelosuppression and one to postoperative complications. Clinical response and R0 resection rates were 55 and 65 per cent respectively. The pathological response rate was 15 per cent. Median overall survival was 14·6 months and the 3-year survival rate 27 per cent. Conclusion: This multimodal treatment of locally advanced gastric cancer provides reasonable 3-year survival compared with historical data, but at a considerable cost in terms of morbidity and mortality. Copyright © 2009 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. [source] A nonreplicating adenoviral vector that contains the wild-type p53 transgene combined with chemotherapy for primary breast cancerCANCER, Issue 5 2006Safety, biologic activity of a novel gene-therapy approach, efficacy Abstract BACKGROUND. Primary systemic therapy (PST) is the standard approach to the management of patients with locally advanced breast cancer (LABC). The authors hypothesized that the intratumoral administration of a nonreplicating adenoviral vector (Ad5) that contains the human wild-type p53, AdCMV- p53, combined with chemotherapy, could increase the efficacy of PST as measured by pathologic complete response. METHODS. In a prospective, open-label, Phase II trial, 13 patients with LABC were treated with 6 3-week cycles of PST, which consisted of intratumoral injections of Ad5CMV- p53 for 2 consecutive days plus docetaxel and doxorubicin followed by surgery. p53 status was determined at baseline and was assessed immediately after the first injection (up to 48 hours). Clinical response was assessed by clinical and radiologic methods. RESULTS. The trial was terminated early, because none of the patients achieved a pathologic complete response. The median age was 56 years (range, 39,71 years), and the median tumor size was 8 cm (range, 5,11 cm). Eight patients (73%) had a p53 mutation. Serial biopsies showed an increase in p53 messenger RNA (mRNA) and p21WAF1/Cip1 mRNA. All 12 evaluable patients achieved an objective clinical response. The surgical specimens revealed scattered tumor cells with extensive tumor-infiltrate leukocytes (predominantly T-lymphocytes). At a median follow-up of 37 months (range, 30,41 months), 4 patients (30%) developed systemic recurrence, and 2 patients died. The estimate breast cancer-specific survival rate at 3 years was 84% (95% confidence interval, 65.7,100%). There was no increase in systemic toxicity. CONCLUSIONS. Ad5CMV- p53 combined with PST is safe, active, and associated with local immunomodulatory effects. The promising clinical activity of this combination deserves further investigation in randomized studies. Cancer 2006. © 2006 American Cancer Society. [source] Vinblastine, bleomycin, and methotrexate chemotherapy plus irradiation for patients with early-stage, favorable Hodgkin lymphomaCANCER, Issue 11 2003The experience of the Gruppo Italiano Studio Linfomi Abstract BACKGROUND The acknowledged effectiveness of vinblastine, bleomycin, and methotrexate (VBM) chemotherapy in patients with early-stage Hodgkin lymphoma has been associated with conflicting toxicity reports. METHODS One hundred forty-three patients were evaluated clinically and had favorable Stage IA or IIA Hodgkin lymphoma. Ninety-three patients were treated with the standard VBM schedule combined with extended-field radiotherapy (EF-RT), leaving the choice of the therapeutic sequence free. Fifty subsequent patients were treated with a slightly modified VBM schedule (VbMp) combined with RT limited to involved fields (IF-RT) and delivered only after the end of chemotherapy. In the VbMp schedule, intervals between cycles were 21 days instead of 28 days, bleomycin doses were reduced, small doses of prednisone were given orally, and the interval before RT was prolonged. RESULTS Clinical response was complete in 96% of patients who were treated with VBM plus EF-RT and in 94% of patients who were treated with VbMp plus IF-RT. Recurrence rates were nearly identical (12% and 11%, respectively) over necessarily different follow-up (91 months and 33 months, respectively). Hematologic toxicity was tolerable in both trials, and pulmonary side effects were moderate in the first trial and negligible in the second. On the whole, treatment was tolerated better when RT followed chemotherapy. CONCLUSIONS The VBM regimen was confirmed to be effective in patients with early-stage Hodgkin lymphoma. Administration of all cycles before RT improved tolerance; pulmonary toxicity probably is mitigated further by reduced bleomycin doses, mild prednisone therapy, and a more prolonged resting interval before RT. A slightly higher recurrence rate was expectable in the VBM plus IF-RT trial despite the actual intensification of vinblastine and methotrexate. Cancer 2003. © 2003 American Cancer Society. [source] Evaluating budesonide efficacy in nasal polyposis and predicting the resistance to treatmentCLINICAL & EXPERIMENTAL ALLERGY, Issue 1 2009F. C. P. Valera Summary Background Cell resistance to glucocorticoids is a major problem in the treatment of nasal polyposis (NP). Objectives The objectives of this study were to observe the effect of budesonide on the expression of IL-1,, TNF-,, granulocyte macrophage-colony stimulating factor, intercellular adhesion molecule (ICAM)-1, basic fibroblast growth factor, eotaxin-2, glucocorticoid receptor (GR)-,, GR-,, c-Fos and p65 in nasal polyps and to correlate their expression to clinical response. Methods Biopsies from nasal polyps were obtained from 20 patients before and after treatment with topical budesonide. Clinical response to treatment was monitored by a questionnaire and nasal endoscopy. The mRNA levels of the studied genes were measured by real-time quantitative (RQ)-PCR. Results There was a significant decrease in the expression of TNF-, (P<0.05), eotaxin-2 (P<0.05) and p65 (P<0.05) in NP after treatment. Poor responders to glucocorticoids showed higher expression of IL-1, (3.74 vs. 0.14; P<0.005), ICAM-1 (1.91 vs. 0.29; P<0.05) and p65 (0.70 vs. 0.16; P<0.05) before treatment. Following treatment, IL-1, (4.18 vs. 0.42; P<0.005) and GR-, (0.95 vs. 0.28; P<0.05) mRNA expression was higher in this group. Conclusion Topical budesonide reduced the expression of TNF-,, eotaxin-2 and p65. Poor responders to topical budesonide exhibit higher levels of IL-1,, ICAM-1 and nuclear factor (NF)-,B at diagnosis and higher expression of both IL-1, and GR-, after treatment. These results emphasize the anti-inflammatory action of topical budesonide at the molecular level and its importance in the treatment of NP. Nevertheless, IL-1,, ICAM-1 and NF-,B may be associated with primary resistance to glucocorticoids in NP, whereas higher expression of GR-, in poor responders only after glucocorticoid treatment may represent a secondary drug resistance mechanism in this disease. [source] Predicting 5-fluorouracil chemosensitivity of liver metastases from colorectal cancer using primary tumor specimens: Three-gene expression model predicts clinical responseINTERNATIONAL JOURNAL OF CANCER, Issue 2 2006Ryusei Matsuyama Abstract We identified genes related to 5-fluorouracil (5-FU) sensitivity in colorectal cancer and utilized these genes for predicting the 5-FU sensitivity of liver metastases. Eighty-one candidate genes involved in 5-FU resistance in gastric and colon cancer cell lines were previously identified using a cDNA microarray. In this study, the mRNA expression levels of these 81 selected genes and the genes of 5-FU-related enzymes, including thymidylate synthase (TS), dihydropyrimidine dehydrogenase (DPD) and orotate phosphoribosyltransferase (OPRT), were measured using real-time quantitative RT-PCR assays of surgically resected materials from primary colorectal tumors in 22 patients. Clinical responses were estimated by evaluating the effects of 5-FU-based hepatic artery injection (HAI) chemotherapy for synchronous liver metastases. Four genes (TNFRSF1B, SLC35F5, NAG-1 and OPRT) had significantly different expression profiles in 5-FU-nonresponding and responding tumors (p < 0.05). A "Response Index" system using three genes (TNFRSF1B, SLC35F5 and OPRT) was then developed using a discriminate analysis; the results were well correlated with the individual chemosensitivities. Among the 11 cases with positive scores in our response index, 9 achieved a reduction in their liver metastases after 5-FU-based chemotherapy, whereas only 1 of the 11 cases with negative scores responded well to chemotherapy. Our "Response Index" system, consisting of TNFRSF1B, SLC35F5 and OPRT, has great potential for predicting the efficacy of 5-FU-based chemotherapy against liver metastases from colorectal cancer. © 2006 Wiley-Liss, Inc. [source] Dendritic cell immunotherapy for patients with metastatic renal cell carcinoma: University of Tokyo experienceINTERNATIONAL JOURNAL OF UROLOGY, Issue 6 2002Takeshi Azuma Abstract Background : Dendritic cells (DC) are the most potent antigen-presenting cells and induce host antitumor immunity through the T-cell response. A clinical study of immunotherapy using cultured DC loaded with tumor antigen, for patients with metastatic renal cell carcinoma (RCC) was performed. Methods : Dendritic cells were generated by culturing monocytes from peripheral blood for 7 days in the presence of granulocyte,macrophage colony-stimulating factor and interleukin-4. On day 6 the DC were pulsed with lysate from autologous tumor as the antigen and with keyhole limpet hemocyanin (KLH) as immunomodulator. The patients were given four doses of lysate-pulsed DC by intradermal injection with a 2-week interval between doses. Clinical effect and immune response were, respectively, evaluated by radiological examination and delayed-type hypersensitivity (DTH) test. Results : Three patients were enrolled and the immunotherapy was well tolerated without significant toxicity. The vaccination induced a positive DTH reaction to tumor lysate in two patients and to KLH in all patients. Clinical responses consisted of one case of no change and two cases of progression of disease. However, we did not see a significant reduction of tumor volume in any case. Conclusion : Dendritic cell vaccination can safely induce an immunological response against RCC. Further trials are needed to fully evaluate its efficacy. [source] Management of nonresponse to rituximab in rheumatoid arthritis: Predictors and outcome of re-treatmentARTHRITIS & RHEUMATISM, Issue 5 2010E. M. Vital Objective A proportion of patients with rheumatoid arthritis (RA) have disease that fails to respond to an initial cycle of rituximab. Using highly sensitive flow cytometry (HSFC), it has been shown that most patients who do not exhibit a response, as measured using the European League Against Rheumatism (EULAR) criteria, have persistent circulating B cell levels at week 2 after initial treatment with rituximab. This study was undertaken to examine whether an additional cycle of rituximab would improve B cell depletion and clinical response in patients whose disease did not respond to the initial cycle. Methods Patients with RA (n = 158) were treated with a first cycle of rituximab (2 infusions of 1 gm each). Clinical responses were assessed using EULAR criteria, and patients were categorized as either first-cycle responders or first-cycle nonresponders. Baseline characteristics of first-cycle nonresponders (n = 38) and first-cycle responders (n = 65) with complete data were compared. First-cycle nonresponders (n = 25) were treated with a second cycle of rituximab at least 6 months after the first cycle. HSFC was performed at baseline, immediately prior to the second infusion (week 2), 1 month after the second infusion (week 6), and then every 3 months for each cycle of rituximab. Complete B cell depletion was defined as being <0.0001 × 109 cells/liter. Results At baseline, the number of preplasma cells was significantly higher in first-cycle nonresponders than in first-cycle responders (P = 0.003). Following the first infusion of the first cycle of rituximab, only 9% of first-cycle nonresponders (3 of 34) exhibited complete depletion of B-lineage cells, compared with 37% of first-cycle responders (22 of 59) (P = 0.007). Following the first infusion of the second cycle of rituximab, 38% of first-cycle nonresponders exhibited complete depletion. Twenty-six weeks after the second cycle, there was a significant improvement in the Disease Activity Score in 28 joints, with 72% of patients exhibiting a EULAR response. Conclusion RA patients whose disease did not respond to an initial cycle of rituximab have higher circulating preplasma cell numbers at baseline and incomplete depletion. Our findings indicate that an additional cycle of rituximab administered prior to total B cell repopulation enhances B cell depletion and clinical responses. [source] Clinical responses to tumor necrosis factor , antagonists do not show a bimodal distribution: Data from the Stockholm Tumor Necrosis Factor , Followup RegistryARTHRITIS & RHEUMATISM, Issue 6 2003Ronald F. van Vollenhoven Objective To study the distribution of clinical responses to treatment with the tumor necrosis factor , (TNF,) antagonists etanercept and infliximab, and in particular, to determine whether there is a biologically meaningful distinction between responders and nonresponders. Methods Among patients in the Stockholm TNF, Followup Registry, we analyzed the clinical responses to etanercept and infliximab, using the American College of Rheumatology (ACR) core set of outcome measures. For each parameter, the absolute change (value at baseline , current value) and the percentage change ([absolute change]/[value at baseline] × 100) from baseline were calculated. The results were plotted as histograms and inspected visually, and the distributions were statistically compared with computer-generated normal distributions. Results Absolute and relative changes in outcomes on the ACR core set of measures in 406 patients receiving etanercept or infliximab were studied. All but a few of these analyses yielded normal or somewhat skewed distributions. The statistical analyses did not detect any non-normal distributions, and visually, the distributions did not appear to be bimodal. Conclusion The clinical response to TNF, blockade displays a normal or skewed, but not bimodal, distribution. The frequently encountered perception that a clear distinction can be made between responders and nonresponders is not borne out. These relatively straightforward findings imply that the biologic mechanisms determining responsiveness to TNF, blockade are multifactorial and may also have important implications for regulatory guidelines pertaining to treatment with these biologic agents. [source] Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trialDEPRESSION AND ANXIETY, Issue 1 2010Rosaly F.B. Campanini MSc. Abstract Background: Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Methods: Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. Results: Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. Conclusions: IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials. Depression and Anxiety, 2010. © 2009 Wiley-Liss, Inc. [source] Fractionated Laser Skin Resurfacing Treatment Complications: A ReviewDERMATOLOGIC SURGERY, Issue 3 2010ANDREI I. METELITSA MD BACKGROUND Fractional photothermolysis represents a new modality of laser skin resurfacing that was developed to provide a successful clinical response while minimizing postoperative recovery and limiting treatment complications. OBJECTIVES To review all of the reported complications that develop as a result of fractional ablative and nonablative laser skin resurfacing. METHODS A literature review was based on a MEDLINE search (1998,2009) for English-language articles related to laser treatment complications and fractional skin resurfacing. Articles presenting the highest level of evidence and the most recent reports were preferentially selected. RESULTS Complications with fractional laser skin resurfacing represent a full spectrum of severity and can be longlasting. In general, a greater likelihood of developing post-treatment complications is seen in sensitive cutaneous areas and in patients with intrinsically darker skin phototypes or predisposing medical risk factors. CONCLUSIONS Although the overall rate of complications associated with fractional laser skin resurfacing is much lower than with traditional ablative techniques, recent reports suggest that serious complications can develop. An appreciation of all of the complications associated with fractional laser skin resurfacing is important, especially given that many of them can be potentially prevented. The authors have indicated no significant interest with commercial supporters. [source] Treatment of Lentigo Maligna with Imiquimod before Staged ExcisionDERMATOLOGIC SURGERY, Issue 2 2008MURRAY A. COTTER MD BACKGROUND Imiquimod 5% cream has demonstrated effectiveness in the treatment of lentigo maligna (LM) in several small studies. None of the studies to date have included posttreatment surgical removal to confirm negative histologic margins. OBJECTIVE The aim of this retrospective analysis was to assess the efficacy of topical imiquimod in LM by circumferentially examining vertically oriented sections from a geometrically designed "picture frame" margin as well as bread-loafed sections of the central portion after staged excisions of imiquimod-treated lesions of LM. METHODS Forty patients with biopsy-confirmed LM were treated five times a week for 3 months with 5% imiquimod cream before staged excision. Tazarotene 0.1% gel was added when no clinical signs of erythema developed with imiquimod alone after 1 month (10 patients). After the course of topical therapy, patients were assessed for clinical and complete histologic clearance after staged excision. RESULTS A total of 33 of 40 patients had a complete clinical response as determined by the absence of remaining clinical lesion on physical examination. Upon histologic review, 30 of 40 patients had no evidence of LM whereas 10 of 40 harbored residual disease. One patient was found to have histologic evidence of invasion after completing the topical protocol. After a mean follow-up of 18 months (range, 12,34 months) and after complete surgical excision of the treatment site, none of the imiquimod-treated patients had evidence of recurrence. CONCLUSIONS Imiquimod appears to be an effective adjunctive treatment for LM but does not qualify as a replacement therapy for surgery. [source] Imiquimod Treatment of Superficial and Nodular Basal Cell Carcinoma: 12-Week Open-Label TrialDERMATOLOGIC SURGERY, Issue 3 2005Ketty Peris MD Background Imiquimod is an immune response modifier shown to be effective in basal cell carcinoma (BCC). Objective To evaluate the efficacy, tolerability, and response durability of imiquimod 5% cream in selected patients with superficial and/or nodular BCCs. Methods Seventy-five superficial and 19 nodular BCCs in 49 patients were treated with imiquimod once daily three times a week for up to 12 weeks. Results Of the 49 enrolled patients, 1 discontinued the study and 1 was lost to follow-up. After 12 weeks of treatment, a complete response occurred in 70 of 75 (93.3%) superficial BCCs and a partial response in 4 of 75 (5.3%) superficial BCCs. Ten of 19 (52.6%) nodular BCCs cleared after 12 weeks, whereas 7 (36.8%) showed partial remission. Adverse side effects were limited to local skin reactions. Recurrence was observed in 2 of 70 (2.9%) successfully treated superficial BCCs 6 and 8 months after treatment discontinuation. No recurrence was detected in 68 of 70 (97.1%) superficial BCCs and in 10 successfully treated nodular BCCs after 12 to 34 months of follow-up (mean 23 months). Conclusions In our patient population, treatment of superficial BCCs with topical imiquimod for 12 weeks produced an excellent clinical response overall, with complete remission maintained after a mean of 23 months. KETTY PERIS, MD, ELENA CAMPIONE, MD, TAMARA MICANTONIO, MD, GEORGIANA CLARE MARULLI, MD, MARIA CONCETTA FARGNOLI, MD, AND SERGIO CHIMENTI, MD, HAVE INDICATED NO SIGNIFICANT INTEREST WITH COMMERCIAL SUPPORTERS. [source] | ||||||||||||||||||||||||||||||||||