Paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a phase II trial.

Johnson DH, Paul DM, Hande KR, Shyr Y, Blanke C, Murphy B, Lewis M, De Vore RF
J Clin Oncol. 1996 14 (7): 2054-60

PMID: 8683236 · DOI:10.1200/JCO.1996.14.7.2054

PURPOSE - Studies conducted by the Eastern Cooperative Oncology Group (ECOG) indicate both paclitaxel and carboplatin are associated with an improvement in 1-year survival in patients with stage IV non-small-cell lung cancer (NSCLC). Based on these findings, a phase II trial of these agents in combination was conducted in patients with advanced NSCLC.

PATIENTS AND METHODS - Eligibility included previously untreated stage IIIB or IV NSCLC patients with a good performance status (PS). Paclitaxel (135 or 175 mg/m2) was administered by 24-hour infusion on day 1, followed by a 1-hour infusion of carboplatin on day 2 (300 mg/m2 or dosed to an area under the concentration-time curve [AUC] of 6 mg/mL.min). Treatment was repeated every 28 days for a total of six cycles. Hematopoietic growth factors were not routinely used.

RESULTS - Among 51 eligible patients, there were no complete and 14 partial responses, for an overall response rate of 27% (95% confidence interval [CI], 17% to 41%). The median progression-free survival time was 23.8 weeks (range, 12.1 to 73.9) and median survival time, 38 weeks. The survival rate at 1 year was 32%. Grade 3 or 4 granulocytopenia and thrombocytopenia were observed in 47% and 3%, respectively, of the 184 treatment cycles administered. The most common nonhematologic toxicities included nausea and emesis, neuropathy, and arthralgia/myalgia.

CONCLUSION - Paclitaxel plus carboplatin is a moderately active regimen in patients with advanced NSCLC and warrants comparison with existing cisplatin-based regimens in a prospective randomized trial. The toxicities of this regimen are well tolerated in patients with a good PS.

MeSH Terms (12)

Adult Aged Antineoplastic Combined Chemotherapy Protocols Carboplatin Carcinoma, Non-Small-Cell Lung Female Humans Lung Neoplasms Male Middle Aged Paclitaxel Survival Rate

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