Home About us Contact
|
Home About us Contact | ||
|
|
||
Grade 3 Toxicity (grade 3 + toxicity)
Selected AbstractsPercutaneous radiofrequency ablation of painful osseous metastasesCANCER, Issue 4 2010A multicenter American College of Radiology Imaging Network trial Abstract BACKGROUND: The study was conducted to determine whether radiofrequency ablation (RFA) can safely reduce pain from osseous metastatic disease. METHODS: The single-arm prospective trial included patients with a single painful bone metastasis with unremitting pain with a score >50 on a pain scale of 0-100. Percutaneous computed tomography-guided RFA of the bone metastasis to temperatures >60°C was performed. Endpoints were the toxicity and pain effects of RFA before and at 2 weeks, 1 month, and 3 months after RFA. RESULTS: Fifty-five patients completed RFA. Grade 3 toxicities occurred in 3 of 55 (5%) patients. RFA reduced pain at 1 and 3 months for all pain assessment measures. The average increase in pain relief from pre-RFA to 1-month follow-up is 26.3 (95% confidence interval [CI], 17.7-34.9; P < .0001), and the increase from pre-RFA to 3-month follow-up is 16.38 (95% CI, 3.4-29.4; P = .02). The average decrease in pain intensity from pre-RFA to 1-month follow-up was 26.9 (P < .0001) and 14.2 for 3-month follow-up (P = .02). The odds of lower pain severity at 1-month follow-up were 14.0 (95% CI, 2.3-25.7; P < .0001) times higher than at pre-RFA, and the odds at 3-month follow-up were 8.0 (95% CI, 0.9-15.2; P < .001) times higher than at pre-RFA. The average increase in mood from pre-RFA to 1-month follow-up was 19.9 (P < .0001) and 14.9 to 3-month follow-up (P = .005). CONCLUSIONS: This cooperative group trial strongly suggests that RFA can safely palliate pain from bone metastases. Cancer 2010. © 2010 American Cancer Society [source] Phase II trial of neoadjuvant docetaxel and gefitinib followed by radical prostatectomy in patients with high-risk, locally advanced prostate cancerCANCER, Issue 4 2009Jacqueline Vuky MD Abstract BACKGROUND: Prostate cancer trials investigating neoadjuvant hormonal therapy, followed by surgery, have demonstrated that elimination of all tumor cells from the primary site is rare. The authors report a phase 2 trial assessing the efficacy and toxicity of docetaxel and gefitinib in patients with high-risk localized prostate cancer as neoadjuvant therapy before radical prostatectomy (RP). METHODS: Thirty-one patients with high-risk prostate cancer were treated with docetaxel and gefitinib for 2 months before RP. All patients met the criteria of clinical stage T2b-3 or serum prostate-specific antigen (PSA) level >20 ng/mL, or Gleason score of 8 to 10. The primary endpoint was pathologic complete response. Secondary objectives included clinical response. When available, endorectal coil magnetic resonance imaging (eMRI) was performed as part of clinical response evaluation. Immunohistochemical staining of epidermal growth factor receptor and HER-2/neu was performed on prechemotherapy and postchemotherapy prostate tissue. RESULTS: The median age of the patients was 60 years, the median pretreatment PSA level was 7.43 ng/mL, and the median Gleason score was 8. Clinical staging prior to treatment consisted of: T1 in 4 patients, T2 in 17 patients, and T3 in 10 patients. One patient with enlarged pelvic adenopathy and T4 disease did not undergo RP. Thirty patients received all scheduled therapies including RP. Grade 3 toxicities included asymptomatic liver function test elevation in 4 (13%) patients, diarrhea in 1 (3%) patient, and fatigue in 1 (3%) patient. One patient experienced grade 4 toxicity with elevated alanine aminotransferase. RP specimen pathology demonstrated residual carcinoma in all cases. Twenty-nine (94%) patients achieved a clinical partial response, including 35% of patients who demonstrated radiographic improvement on eMRI. CONCLUSIONS: No pathologic complete response was noted in 31 patients treated with docetaxel and gefitinib. This combination was well tolerated, and did not result in increased surgical morbidity. Cancer 2009. © 2009 American Cancer Society. [source] A phase II trial of arsenic trioxide in patients with metastatic melanomaCANCER, Issue 8 2005Kevin B. Kim M.D. Abstract BACKGROUND Arsenic trioxide induces growth inhibition and apoptosis in human melanoma cell lines. Therefore, a Phase II trial was conducted to evaluate the efficacy and toxicity of single-agent arsenic trioxide in patients with Stage IV melanoma. METHODS Twenty patients, 10 with metastatic melanoma of cutaneous origin and 10 with metastatic melanoma of choroidal origin, received arsenic trioxide 0.25 mg/kg/day for 5 days, followed by a maintenance dose of 0.35 mg/kg/day twice a week. All patients with melanoma of cutaneous origin and four patients with melanoma of choroidal origin had received prior therapy. RESULTS Single-agent arsenic trioxide did not induce clinical response in this patient population. Eight patients (five with melanoma of cutaneous origin, and three with melanoma of choroidal origin) had disease stabilization for at least six weeks. The median overall survival duration for patients with melanoma of cutaneous origin was 7.9 months, and that of patients with melanoma of choroidal origin has not been reached at a median follow-up duration of 11.8 months. Grade 3 toxicity included neutropenia, fatigue, abdominal pain, and arthralgia. Grade 4 toxicity did not occur. CONCLUSIONS Single-agent arsenic trioxide was generally well tolerated; however, no tumor regression was observed in this patient population. Future clinical trials should evaluate arsenic trioxide in combination with other anticancer drugs that may improve its clinical activity in melanoma. Cancer 2005. © 2005 American Cancer Society. [source] Weekly 5-fluorouracil plus cisplatin for concurrent chemoradiotherapy in patients with locally advanced head and neck cancerHEAD & NECK: JOURNAL FOR THE SCIENCES & SPECIALTIES OF THE HEAD AND NECK, Issue 2 2010Young Joo Lee MD Abstract Background. In locally advanced head and neck cancer, concurrent chemoradiotherapy (CRT) with combined 5-fluorouracil (5-FU) and cisplatin has increased acute toxicities as well as survival. Once-weekly chemotherapeutic administration schedule may reduce severe toxicities. Thus, we investigated CRT using weekly administration of 5-FU,cisplatin in locally advanced head and neck cancer. Methods. In a single-arm, phase II study, CRT included radiation (70.0 Gy/35 fr) and weekly 5-FU (750 mg/m2) and cisplatin (20 mg/m2). Results. Thirty-two patients completed planned radiation. Thirteen (41%) achieved complete response, and 16 (50%) partial response. Twelve patients (38%) experienced acute grade 3 toxicities. Grade 3 mucositis, which was the most common toxicity, developed in 5 (16%) patients. The survival rates at 1 and 2 years were 81% and 76%, respectively. The progression-free survival rates at 1 and 2 years were 69% and 66%, respectively. Conclusions. We demonstrated weekly 5-FU-cisplatin with conventional radiotherapy was efficacious and feasible with high compliance rate in locally advanced head and neck cancer. © 2009 Wiley Periodicals, Inc. Head Neck, 2010 [source] Combined treatment with pegylated interferon,,-2a and dacarbazine in patients with advanced metastatic melanomaCANCER, Issue 6 2008A phase 2 study Abstract BACKGROUND. Dacarbazine (DTIC) and pegylated interferon (IFN),,-2a have both demonstrated some efficacy as single agents in metastatic melanoma. To the authors' knowledge, the current study is the first to test a combination of these 2 agents in a phase 2 trial. METHODS. Twenty,eight patients with stage IV melanoma without brain metastases were treated with DTIC (at a dose of 850 mg/m2 every 3 weeks) combined with weekly pegylated IFN,,-2a at a dose of 180 ,g. The study was initiated to evaluate the efficacy and tolerability of the combination. The primary study endpoint was objective response. RESULTS. Twenty,five patients were evaluable for response. Two patients (8.0%) achieved a complete response that continued for >480 days and 746 days, respectively. Four patients (16.0%) demonstrated a partial response, and another patient experienced stable disease. Six of 7 nonprogressive patients had either not received treatment or had not developed disease progression during adjuvant IFN treatment for stage II/III disease. The median duration of response was 236 days, the median progression-free survival was 56 days, and the overall survival time was 403 days. Few grade 3 toxicities and only 1 grade 4 toxicity were observed (according to National Cancer Institute Common Toxicity Criteria). CONCLUSIONS. The combination of DTIC and pegylated IFN,,-2a was found to be well tolerated in patients with metastatic melanoma. The response rate of 24%, including 2 long-lasting complete responses, is encouraging, but must be confirmed in larger trials. Cancer 2008. © 2008 American Cancer Society. [source] Immunization with a P53 synthetic long peptide vaccine induces P53-specific immune responses in ovarian cancer patients, a phase II trial,INTERNATIONAL JOURNAL OF CANCER, Issue 9 2009Ninke Leffers Abstract The prognosis of ovarian cancer, the primary cause of death from gynecological malignancies, has only modestly improved over the last decades. Immunotherapy is one of the new treatment modalities explored for this disease. To investigate safety, tolerability, immunogenicity and obtain an impression of clinical activity of a p53 synthetic long peptide (p53-SLP) vaccine, twenty patients with recurrent elevation of CA-125 were included, eighteen of whom were immunized 4 times with 10 overlapping p53-SLP in Montanide ISA51. The first 5 patients were extensively monitored for toxicity, but showed no , grade 3 toxicity, thus accrual was continued. Overall, toxicity was limited to grade 1 and 2, mostly locoregional, inflammatory reactions. IFN-, producing p53-specific T-cell responses were induced in all patients who received all 4 immunizations as measured by IFN-, ELISPOT. An IFN-, secretion assay showed that vaccine-induced p53-specific T-cells were CD4+, produced both Th1 and Th2 cytokines as analyzed by cytokine bead array. Notably, Th2 cytokines dominated the p53-specific response. P53-specific T-cells were present in a biopsy of the last immunization site of at least 9/17 (53%) patients, reflecting the migratory capacity of p53-specific T-cells. As best clinical response, stable disease evaluated by CA-125 levels and CT-scans, was observed in 2/20 (10%) patients, but no relationship was found with vaccine-induced immunity. This study shows that the p53-SLP vaccine is safe, well tolerated and induces p53-specific T-cell responses in ovarian cancer patients. Upcoming trials will focus on improving T helper-1 polarization and clinical efficacy. © 2009 UICC [source] Intra-arterial therapy with cisplatin suspension in lipiodol and 5-fluorouracil for hepatocellular carcinoma with portal vein tumour thrombosisALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 4 2010H. Nagamatsu Aliment Pharmacol Ther 2010; 32: 543,550 Summary Background, Portal vein tumour thrombosis is a negative prognostic factor for hepatocellular carcinoma (HCC). Aim, To assess the efficacy of cisplatin in lipiodol emulsion combined with 5-fluorouracil (5-FU) for patients with HCC and portal vein tumour thrombosis. Methods, The study subjects were 51 patients with the above-specified criteria who received injection of cisplatin suspension in lipiodol emulsion followed by intra-arterial infusion of 5-FU. The primary objective was to determine tumour response to the treatment, while the secondary objectives were safety and tolerability. Independent factors for survival were also assessed. Results, Ten patients had complete response and 34 patients had partial response (response rate, 86.3%). The median survival for all 51 patients was 33 months, while that for 10 complete response patients and 21 patients who showed disappearance of HCC following additional therapies was 39 months. The single factor that significantly influenced survival was therapeutic effect. Treatment was well tolerated and severe toxicity was infrequent, with only grade 3 toxicity (thrombocytopenia) in one patient. Conclusions, The present study demonstrated the efficacy of hepatic arterial infusion chemotherapy using cisplatin-lipiodol emulsion and 5-FU without serious adverse effects in patients with unresectable HCC and portal vein tumour thrombosis. [source] Efficacy and toxicity of reirradiation using intensity-modulated radiotherapy for recurrent or second primary head and neck cancerCANCER, Issue 20 2010David J. Sher MD Abstract BACKGROUND: Patients with locally recurrent squamous cell cancer of the head and neck (SCCHN) are reported to have a poor prognosis and limited therapeutic options. Optimal management is selectively applied and morbid. Both surgical resection and chemoradiotherapy are reported to result in median survivals of approximately 12 months. Intensity-modulated radiotherapy (IMRT) is a highly conformal approach for delivering RT. This study reported the experience of the Dana-Farber Cancer Institute (DFCI) with IMRT-based chemoradiotherapy with or without surgery for locally recurrent SCCHN. METHODS: The current study was a retrospective study of all patients treated at DFCI who were diagnosed with nonmetastatic second primary or recurrent SCCHN and who received reirradiation based on IMRT. The primary endpoint was overall survival (OS), and secondary endpoints were locoregional (LRC) and distant control and acute and chronic toxicity. RESULTS: Thirty-five patients were treated from August 2004 until December 2008. Recurrent disease was treated in the oral cavity (4 patients), larynx/hypopharynx (13 patients), oropharynx (7 patients), nasopharynx (2 patients), and neck (9 patients). The median radiation dose was 60 Gray (Gy), and all patients received concurrent chemotherapy. The median follow-up was 2.3 years. The 2-year actuarial OS and LRC rates were 48% and 67%, respectively. Approximately 91% and 46%, respectively, of all patients developed at least 1 acute and late grade 3 toxicity. Four (11%) late deaths occurred in patients with no evidence of disease (2 aspiration events, 1 oropharyngeal hemorrhage, and 1 infectious death). CONCLUSIONS: Aggressive chemoradiotherapy with IMRT was found to be feasible and resulted in favorable survival outcomes in comparison with published reports. Acute and late toxicities were substantial. The apparently improved LRC appears to carry a significant risk of developing late complications. Cancer 2010. © 2010 American Cancer Society. [source] | ||||||||||