Favorable survival observed after carboplatin, paclitaxel, and concurrent accelerated hyperfractionated radiotherapy for treatment of locally advanced head and neck carcinoma.

PURPOSE: Several trials have demonstrated the superiority of simultaneous chemoradiotherapy compared with radiation alone for patients with locally advanced head and neck cancers. However, the optimal regimen remains to be defined. This study assessed the safety and activity of combined carboplatin (C), paclitaxel (P), and twice-daily radiotherapy (RT) in a community based, multicenter, phase II trial. MATERIALS AND METHODS: Eligible patients (N = 52) had ECOG PS 0-2 and previously untreated, stage III or IV (M0), unresectable, squamous cell cancers of the head and neck. Treatment consisted of 6 weekly courses of C (AUC = 1), P (40 mg/m(2)/1-h) and twice-daily radiation (120 cGy BID; total dose of 6,960 cGy). Subsequently, patients with N2/N3 disease were permitted neck dissection. RESULTS: Median follow-up was 61 months. Sixty-seven percent (67%) of patients had stage IV (M0) disease at baseline. Fifty-five percent (55%) of treated patients experienced NCI Grade 3-4 dysphagia, stomatitis, or mucositis; 80% had > or = Grade 3 toxicity of any organ system. Median weight loss was 7.1 lbs; 35% of patients experienced 10% or more weight loss. Of 43 patients evaluable for response, responses were: 29 CR (67%), 7 PR (16%), 1 MR (2%), 4 SD (9%), and 2 PD (5%); the overall response rate (CR+PR) was 84%. For the entire cohort of 52 patients, the estimated overall survival at 36 months was 60%; progression-free survival was 50%. CONCLUSIONS: We conclude that weekly C + P and concurrent twice-daily hyperfractionated radiotherapy is tolerated and highly active in patients with unresectable, locally advanced squamous cell carcinoma of the head and neck.

Results of a phase II study of weekly paclitaxel plus carboplatin in patients with extensive small-cell lung cancer with Eastern Cooperative Oncology Group Performance Status of 2, or age > or = 70 years.

PURPOSE: To determine the 1-year survival, response rate (RR), time to progression (TTP), and safety of weekly paclitaxel plus carboplatin (PC) in patients with extensive small-cell lung cancer (ESCLC) with an Eastern Cooperative Performance Status performance status (PS) of 2 or an age > or = 70 years. PATIENTS AND METHODS: Patients were treated with PC (paclitaxel 80 mg/m(2) and carboplatin area under the curve = 2) by intravenous infusion on days 1, 8, and 15 of every 4-week cycle for up to six cycles. RESULTS: Between July 2000 and December 2001, 77 eligible patients (50.6% were male, 97.4% were white, 44.2% had PS of 2, with median age of 74 years) with ESCLC were enrolled. Among the 66 patients who were assessable for response, 25 responded to treatment (one complete response and 24 partial responses), for an objective RR of 38%. There were eight cases of stable disease (12.1%) and 33 cases of progressive disease (50%). The median survival was 7.2 months (range, < 1 to 24.4 months), and the estimated 1-year survival rate was 30%. The median TTP was 3.5 months (range, < 1 to 21.2 months), and the estimated 1-year progression-free survival rate was 8%. The median duration of response was 4.5 months (range, 1.6 to 17.5 months). One death (sepsis) was possibly related to the study drugs. Grades 3 and 4 toxicities experienced by > or = 5% of patients included neutropenia (22.1%), fatigue (8.6%), anemia (5.2%), and nausea/vomiting (5.2%). CONCLUSION: This regimen produced relatively few toxicities (only two of the 66 assessable patients received fewer than two cycles because of toxicity), and both the median and 1-year survival were similar to other regimens. This regimen may be a preferable treatment choice for patients with ESCLC who have a poor PS or who are aged > or = 70 years.