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Complete Clinical Response (complete + clinical_response)
Selected AbstractsRelationship of clinical and pathologic response to neoadjuvant chemotherapy and outcome of locally advanced breast cancer,JOURNAL OF SURGICAL ONCOLOGY, Issue 1 2002Csaba Gajdos MD Abstract Background and Objectives Neoadjuvant chemotherapy in locally advanced breast cancers produces histologically evaluable changes and frequently reduces the size of the primary tumor. Local clinical response to neoadjuvant chemotherapy may correlate with response of distant metastases. Therefore, clinical or pathological factors, which predict or assess response to treatment, may predict outcome after consideration for initial extent of disease. Methods To identify pretreatment characteristics of locally advanced breast cancers which predict clinical and pathologic response to neoadjuvant chemotherapy as well as survival and to assess the utility of postoperative histologic changes, we retrospectively studied one hundred forty-four patients with locally advanced breast cancer treated with neoadjuvant chemotherapy between January 1975 and July 1996. Patients were identified through pathology records of the Mount Sinai Medical Center and via one of the author's clinical databases. Pathologic and clinical responses to neoadjuvant chemotherapy were correlated with survival. Stepwise logistic regression was used to identify variables most significantly related to clinical response and pathologic axillary lymph node involvement. Results Complete clinical response with no palpable tumor was noted in 7/86 patients (8%) and complete pathologic response was achieved in 18/138 patients (13%). Both clinical (P,=,0.038) and pathologic response (P,=,0.011) were related to tumor size at the time of diagnosis: smaller tumors were more likely to respond to chemotherapy than larger tumors. Histologic evidence of chemotherapeutic effect, i.e., cytoplasmic vacuolization, change in the number of mitoses and localized fibrosis in lymph nodes did not correlate with clinical or pathologically measured response. Clinical and pathologic response was not associated with age, histology, differentiation, or type of chemotherapy. No residual tumor was found in the axillary nodes of 27% (37) of the patients. Age and complete pathologic response were the only variables significantly related to pathologic nodal status. Eighty-four percent of the 61 patients under 50 years of age had nodal involvement compared to 65% of older patients (P,=,0.014). Fifty percent of complete pathologic responders had positive axillary lymph nodes compared to 76% of patients who did not have a complete pathologic response (P,=,0.020). Distant disease-free (P,=,0.039) and overall survival (P,=,0.035) were related to the number of involved axillary lymph nodes. After consideration for pathologic lymph node status, no other variable was significantly related to distant disease-free or overall survival in multivariate analysis. No variable was significantly related to local disease-free survival. Age, clinical tumor size, clinical lymph node status, clinical response, type of chemotherapy, histology, differentiation, chemotherapy effects on primary tumor and lymph nodes, decline in the number of mitoses, and degree of fibrosis in nodes were not predictive of distant recurrence or overall survival. Conclusions This study of patients treated with neoadjuvant chemotherapy for locally advanced breast cancers found little evidence that measurable clinical or pathologic changes attributable to chemotherapy predicted survival. Axillary lymph node status, associated with young age, was the most important prognostic indicator in these patients. J. Surg. Oncol. 2002;80:4,11. © 2002 Wiley-Liss, Inc. [source] Administration of adalimumab in the treatment of Crohn's disease of the ileal pouchALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2009B. SHEN Summary Background, Crohn's disease (CD) of the pouch can develop in patients with ileal pouch-anal anastomosis (IPAA). Scant data are available on the treatment of this disease entity. Aim, To evaluate efficacy and safety of adalimumab in treating CD of the ileal pouch. Methods, From June 2007 to June 2008, 17 IPAA patients with inflammatory (n = 10), fibrostenotic (n = 2) or fistulizing (n = 5) CD of the pouch treated with adalimumab were evaluated. Inclusion criteria were CD of the pouch who failed medical therapy and were otherwise qualified for permanent pouch diversion or excision. All qualified patients received the standard dosing regimen of subcutaneous injection adalimumab (160 mg at week 0, 80 mg at week 1, and 40 mg every other week thereafter). Complete clinical response was defined as resolution of symptoms. Partial clinical response was defined as improvement in symptoms. Endoscopic inflammation before and after therapy was recorded, using the Pouchitis Disease Activity Index (PDAI) endoscopy subscores. Results, The median age was 36 years with 12 patients (70.6%) being male. At 4 weeks, seven patients (41.2%) had a complete symptom response and 6 (35.3%) had a partial response. There was also a significant improvement in the PDAI endoscopy subscores at week 4 (P < 0.05). At the last follow-up (median of 8 weeks), eight patients (47.1%) had a complete symptom response and 4 (23.5%) had a partial response. Four patients (23.6%) developed adverse effects. Three patients (17.7%) eventually had pouch failure after failing to respond to adalimumab therapy. Conclusion, Adalimumab appeared to be well-tolerated and efficacious in treating CD of the pouch in this open-labelled induction study. [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] 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] External Beam Radiation Followed by Planned Neck Dissection and Brachytherapy for Base of Tongue Squamous Cell Carcinoma,THE LARYNGOSCOPE, Issue 10 2000David M. Kaylie MD Abstract Background Surgical resection of tongue base cancer can leave the patient with significant functional deficits. Other therapies, such as external beam radiation followed by neck dissection and radiation implants, have shown equal tumor control with good functional outcome. Methods Between March 1991 and July 1999, 12 patients at Oregon Health Sciences University, the Portland Veterans Administration Medical Center and West Virginia University School of Medicine Hospital were treated with external beam radiation followed by neck dissection and Ir192 implants. Two patients had T1 disease, two had T2, five patients had T3 tumors, and three had T4 tumors. Six had N2a necks, three had N2b necks, and three had N2c. Follow-up ranged from 13 months to 8 years. Results After external beam radiation, five patients had complete response and seven had partial response in the neck without complications. One patient underwent a unilateral radical neck dissection, eight had unilateral selective neck dissections involving levels I to IV, and three had dissections involving levels I to III. One of the five patients who had a complete clinical response in the neck had pathologically positive nodes. One patient had a pulmonary embolus that was treated and had no permanent sequelae. There were three complications from brachytherapy. Two patients had soft tissue necrosis at the primary site and one patient had radionecrosis of the mandible. All healed without further therapy. One patient had persistent disease and underwent a partial glossectomy but died of local disease. Distant metastasis developed in two patients. All others show no evidence of disease and are able to eat a normal diet by mouth. Conclusion This combination of therapies should be considered when treating tongue base cancer. [source] Successful Treatment of T-cell Post-Transplant Lymphoproliferative Disorder with the Retinoid Analog BexaroteneAMERICAN JOURNAL OF TRANSPLANTATION, Issue 8 2005Donald E. Tsai T-cell post-transplant lymphoproliferative disorder (PTLD) is a rare life threatening complication of organ transplantation. It is usually resistant to treatment with reduction in immunosuppression or chemotherapy and carries a poor prognosis. We report on a combined kidney and pancreas transplant patient with Epstein,Barr virus (EBV) positive T-cell PTLD that had recurred after chemotherapy and reduction in immunosuppression. The patient was successfully treated with bexarotene, a novel synthetic retinoid analog, achieving a complete clinical response. Bexarotene may be a promising treatment for T-cell PTLD. [source] Efficacy and tolerability of rituximab with or without PEGylated interferon alfa-2b plus ribavirin in severe hepatitis C virus,related vasculitis: A long-term followup study of thirty-two patientsARTHRITIS & RHEUMATISM, Issue 8 2009Benjamin Terrier Objective To report on the long-term followup of a cohort of patients with hepatitis C virus (HCV),related vasculitis treated with rituximab with or without PEGylated interferon alfa-2b (PEG,IFN alfa-2b) plus ribavirin. Methods The study group comprised 32 HCV RNA,positive patients with HCV-related vasculitis: 20 patients were treated with rituximab and PEG,IFN alfa-2b (9 of whom had not previously received antiviral treatment and 11 of whom had experienced disease resistance to or relapse with antiviral treatment), and 12 antiviral-intolerant patients were treated with rituximab alone. Results Treatment with rituximab and PEG,IFN alfa-2b plus ribavirin induced a complete clinical response and a partial clinical response in 80% and 15% of patients, respectively, a complete immunologic response and a partial immunologic response in 67% and 33% of patients, respectively, and a sustained virologic response in 55% of patients. Treatment with rituximab alone induced a complete clinical response and a partial clinical response in 58% and 9% of patients, respectively, and a complete immunologic response and a partial immunologic response in 46% and 36% of patients, respectively. B cell depletion was achieved in 96% of patients, and B cell recovery began after a median delay of 12 months. After a mean ± SD followup period of 23 ± 12 months, 22% of patients experienced a clinical relapse, and 34% of patients experienced an immunologic relapse. All relapses were associated with the absence of virologic control, and 78% of relapses were associated with B cell recovery. Six patients were re-treated with rituximab. All 6 of these patients had a complete clinical response, 50% had a complete immunologic response, and 50% had a partial immunologic response. Rituximab was well tolerated overall. Conclusion Rituximab is an effective treatment of severe and/or refractory HCV-related vasculitis. Relapses were consistently associated with the absence of virologic control. The clinical and immunologic efficacy of rituximab after repeated infusion appeared to be the same as that observed after induction therapy. [source] Neoadjuvant chemo-radiotherapy and rectal cancer: can the UK watch and wait with Brazil?COLORECTAL DISEASE, Issue 1 2010S. M. Nyasavajjala Abstract Objecive, It has recently been reported that up to one-third of patients with nonmetastatic distal rectal cancer managed with neoadjuvant chemoradiation therapy (CRT) had a complete clinical response (cCR) to treatment. In the selected cases, this has been used as the sole treatment. The aim of this study was to determine the frequency of complete pathological response for patients receiving CRT in one centre in the UK. Method, Patients receiving 6 weeks of neoadjuvant CRT were identified using the two cancer audit databases in two different tertiary hospitals from January 2002 to November 2007. Pathology was reviewed and the histopathological response of the resected specimen to CRT was evaluated using the Mandard classification (1 = complete response, 5 = no response) Results, One hundred and thirty-two consecutive patients [median age 61 (range 44,86) years, 90 men] with nonmetastatic locally advanced rectal cancer received neoadjuvant chemo radiotherapy between 2002 and 2007 followed by resection of the tumour. Data were available from 129 patients. Mandard classification Number of patients 1 13 2 14 3 31 4 47 5 24 Conclusion, Only 13 out of 132 (10%) of patients had a complete pathological response. This is one-third of the cCR previously reported. Nonsurgical therapy for rectal cancer using the Habr-Gama treatment algorithm may only be effective in a very small proportion of patients with rectal cancer in the UK and nonoperative treatment would not be recommended. [source] Long-term oral tacrolimus therapy in refractory to infliximab fistulizing Crohn's disease.INFLAMMATORY BOWEL DISEASES, Issue 1 2005A Pilot Study Abstract Aims: To evaluate efficacy and safety of oral tacrolimus in cases of fistulizing Crohn's disease (FCD), which is refractory to conventional therapy including infliximab. Methods: Patients with fistulas, previously and unsuccessfully treated with all conventional therapy (i.e., antibiotics, azathioprine, or 6-mercaptopurine and infliximab), were enrolled in a prospective, uncontrolled, open-label study of long-term treatment with oral tacrolimus (0.05 mg/kg every12 h). The evaluation of the clinical response was complemented by use of the perianal Crohn's disease activity index (PCDAI) and magnetic resonance imaging-based score (MRS) with determined periodicity. Results: Ten patients were included in the study (enterocutaneous fistula, 3 patients; perianal fistula, 4 patients; rectovaginal fistula, 3 patients) with 6 to 24 months of follow-up. Five patients were steroid-dependent, and 4 patients needed maintenance treatment with immunosuppressant agents. Four patients (40%) achieved complete clinical responses, which were verified by PCDAI and MRS. Five patients (50%) achieved partial responses (i.e., important decreases in fistula drainage, size, discomfort, and PCDAI/MRS values). Decreases in both the PCDAI and MRS were statistically significant (P < 0.05). All steroid-dependent patients stopped therapy with prednisone, and concomitant immunosuppressive therapy was tapered. The response was maintained, and no new flare-up of the disease was observed. Only mild adverse events were detected (1 patient withdrew from treatment due to headache), and no case of nephrotoxicity or diabetes was detected. One patient had received no benefit from therapy after 6 months. Conclusions: Oral tacrolimus could be an effective and safe treatment for patients with FCD, even if there has been no response to infliximab treatment. Randomized studies are needed to compare oral tacrolimus with infliximab in terms of efficacy, safety, and costs. [source] | ||||||||||