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
Division of Pulmonary Medicine, Department of Medicine, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan,
Cancer Chemother Pharmacol. 2015 Mar;75(3):513-9. doi: 10.1007/s00280-014-2673-8. Epub 2015 Jan 7.
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 ≥70 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.
老年晚期非小细胞肺癌（NSCLC）患者数量正在增加。尽管多项研究表明铂类双联化疗对老年晚期NSCLC患者有益，但该治疗在这个年龄组中仍存在争议。为了评估每两周一次的紫杉醇和卡铂联合化疗对老年晚期NSCLC患者的疗效和耐受性，我们开展了一项多中心、非随机、开放标签的II期试验。
我们招募年龄≥70岁、临床分期为IIIB期和IV期NSCLC且东部肿瘤协作组（ECOG）体能状态（PS）为0 - 2的患者。患者在第1天和第15天接受紫杉醇（90mg/m²）和卡铂（AUC = 2.5）治疗，每4周重复一次。主要终点为总缓解率（ORR），次要终点为无进展生存期（PFS）、总生存期（OS）和安全性。
共纳入65例患者（中位年龄79岁；范围70 - 87岁）。49例为男性，48例为IV期。PS为0、1和2的患者分别有28例、33例和4例。NSCLC的组织学类型中，非鳞状细胞癌占69.3%，鳞状细胞癌占30.7%。中位治疗周期数为3（范围1 - 6）。缓解率为29.4%（95%CI 18.7 - 43.0），疾病控制率为78.0%（95%CI 64.8 - 87.2）。中位PFS和OS分别为3.8个月（95%CI 1.9 - 5.3）和17.3个月（95%CI 10.4 - 25.1）。最常见的3级或4级毒性反应为中性粒细胞减少（27%）、白细胞减少（15%）、感染（10%）和贫血（8%）。
每两周一次的紫杉醇和卡铂联合化疗对老年晚期NSCLC患者有效且耐受性良好。
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