- 作者：Hiroshi Takatani ; Yoichi Nakamura ; Seiji Nagashima ; Hiroshi Soda ; Akitoshi Kinoshita ; Minoru Fukuda ; Masaaki Fukuda ; Yoshifumi Soejima ; Takashi Kasai ; Katsumi Nakatomi ; Tetsuya Iida ; Mikio Oka ; Kazuhiro Tsukamoto ; Shigeru Kohno
- 关键词：Carboplatin ; Elderly patients ; Non&ndash ; small-cell lung cancer ; Vinorelbine
- 刊名：Clinical Lung Cancer
- 出版年：2012
- 出版时间：September, 2012
- 年：2012
- 卷：13
- 期：5
- 页码：347-351
- 全文大小：231 K
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 ¡Ý75 years of age and with advanced NSCLC.Patients and Methods
Previously untreated patients (¡Ý75 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/m2 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/m2 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.