Phase I and II Trials of Vinorelbine With Carboplatin for Patients 75 Years of Age or Older With Previously Untreated Non-Small-Cell Lung Cancer

作者：Takatani Hiroshi; Nakamura Yoichi^*; Nagashima Seiji; Soda Hiroshi; Kinoshita Akitoshi; Fukuda Minoru; Fukuda Masaaki; Soejima Yoshifumi; Kasai Takashi; Nakatomi Katsumi; Iida Tetsuya; Oka Mikio; Tsukamoto Kazuhiro; Kohno Shigeru

来源：Clinical Lung Cancer, 2012, 13(5): 347-351.

DOI：10.1016/j.cllc.2011.11.007

• Carboplatin
• Elderly patients
• Non-small-cell lung cancer
• Vinorelbine

We conducted clinical trials to evaluate the safety and efficacy of vinorelbine and carboplatin for patients aged %26gt;= 75 years and with advanced non-small-cell lung cancer. The use of 20 mg/m(2) vinorelbine on days 1 and 8 followed by carboplatin with an area under the curve of 4 mg/mL/min on day 1 every 4 weeks was warranted for such patients. Background: The safety and efficacy of platinum-based combination chemotherapy for elderly patients with advanced non-small-cell lung cancer (NSCLC) remains unclear. We conducted phase I and phase II trials of a combination of vinorelbine and carboplatin for patients %26gt;= 75 years of age and with advanced NSCLC. Patients and Methods: Previously untreated patients (%26gt;= 75 years of age) with stage IIIB or IV NSCLC were enrolled. Based on a 4-week cycle, vinorelbine was given on days 1 and 8, and carboplatin was given on day 1. Dose-limiting toxicity was defined as grade 4 hematologic toxicity that lasted 4 days or more, febrile neutropenia; grade 3 or worse nonhematologic toxicities; or the omission of vinorelbine administration on day 8 in the first cycle. Results: Thirteen patients were enrolled in phase I. dose-limiting toxicity was grade 4 neutropenia that lasted 4 days or more, observed in 2 of 4 patients at level 4. Phase II study used the dose of level 3 (20 mg/m(2) vinorelbine, area under the curve of 4 mg/mL/min carboplatin). Forty-two patients were enrolled. The response rate was 14.6% of 41 assessable patients (95% CI, 3.8-25.4). The median time to progression was 98 days ( 95% CI, 61-135 days), and the median survival time was 366 days (95% CI, 321-411 days). All toxicities were mild and manageable. Conclusion: Use of 20 mg/m(2) vinorelbine on days 1 and 8, followed by carboplatin area under the curve of 4 mg/mL/min on day 1 every 4 weeks warrants a phase III study for elderly patients with advanced NSCLC.

• 出版日期2012-9