A phase II study of biweekly paclitaxel and carboplatin in elderly patients with advanced non-small cell lung cancer

作者：Soejima Kenzo^*; Naoki Katsuhiko; Ishioka Kota; Nakamura Morio; Nakatani Michie; Kawada Ichiro; Watanabe Hideo; Nakachi Ichiro; Yasuda Hiroyuki; Satomi Ryosuke; Nakayama Sohei; Yoda Satoshi; Ikemura Sinnosuke; Terai Hideki; Sato Takashi; Ohgino Keiko; Arai Daisuke; Tani Tetsuo; Kuroda Aoi; Nishino Makoto; Betsuyaku Tomoko

来源：Cancer Chemotherapy and Pharmacology, 2015, 75(3): 513-519.

DOI：10.1007/s00280-014-2673-8

• Non-small cell lung cancer
• Elderly
• Paclitaxel
• Carboplatin
• Phase II trial

The number of elderly patients with advanced non-small cell lung cancer (NSCLC) is increasing. Although several studies have suggested the benefit of chemotherapy with a platinum doublet for elderly patients with advanced NSCLC, this treatment is still controversial in this age group. To evaluate the efficacy and tolerability of combination chemotherapy with biweekly paclitaxel and carboplatin for elderly patients with advanced NSCLC, we conducted a multicenter, non-randomized, open label, phase II trial.
We recruited patients aged a parts per thousand yen70 years with clinical stage IIIB and IV NSCLC and ECOG performance status (PS) of 0-2. Patients received paclitaxel (90 mg/m(2)) and carboplatin (AUC = 2.5) on day 1 and 15, every 4 weeks. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety.
Sixty-five patients (median age 79 years; range 70-87 years) were enrolled. Forty-nine patients were men, and 48 were stage IV. The PS was 0, 1, and 2 in 28, 33, and 4 patients, respectively. The histological type of NSCLC was non-squamous in 69.3 % and squamous cell carcinoma in 30.7 % of patients. The median number of treatment cycles was 3 (range 1-6). The response rate was 29.4 % (95 % CI 18.7-43.0), and the disease control rate was 78.0 % (95 % CI 64.8-87.2). Median PFS and OS were 3.8 months (95 % CI 1.9-5.3) and 17.3 months (95 % CI 10.4-25.1), respectively. The most common grade 3 or 4 toxicities were neutropenia (27 %), leukopenia (15 %), infection (10 %), and anemia (8 %).
The combination of biweekly paclitaxel and carboplatin was effective and well tolerated in elderly patients with advanced NSCLC.

• 出版日期2015-3