培美曲塞联合卡铂一线化疗后继续培美曲塞维持治疗老年晚期非鳞非小细胞肺癌的II期研究
A phase II study of pemetrexed plus carboplatin followed by maintenance pemetrexed as first-line chemotherapy for elderly patients with advanced non-squamous non-small cell lung cancer.
作者信息
Tamiya Motohiro, Tamiya Akihiro, Kaneda Hiroyasu, Nakagawa Kazuhiko, Yoh Kiyotaka, Goto Koichi, Okamoto Hiroaki, Shimokawa Tsuneo, Abe Tetsuya, Tanaka Hiroshi, Daga Haruko, Takeda Koji, Hirashima Tomonori, Atagi Shinji
机构信息
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases, Osaka, Japan.
Department of Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, 1180 Nakgasone-cho, Kita-ku, Sakai City, Osaka, 591-8555, Japan.
出版信息
Med Oncol. 2016 Jan;33(1):2. doi: 10.1007/s12032-015-0715-7. Epub 2015 Nov 24.
A phase I study recommended carboplatin (CBDCA, area under the curve = 5) plus pemetrexed (PEM, 500 mg/m(2)) for elderly patients (≥75-years old) with non-squamous non-small cell lung cancer (NSCLC). PEM maintenance therapy was well tolerated. We conducted a multicenter phase II trial to evaluate the efficacy and safety of this regimen in elderly patients with NSCLC. Four courses of CBDCA plus PEM, followed by PEM, were administered. The primary endpoint was the 1-year overall survival (OS) rate, and the secondary endpoints were OS, progression-free survival (PFS), response rate (RR), and safety. Thirty-four patients (median age, 77 years) were enrolled between June 2012 and May 2013. The median observation time was 22.7 months. The primary endpoint of the 1-year OS rate was 58.0 % (95 % confidence interval (CI) 42.9-78.4 %), and RR and disease control rate were 41.2 and 85.3 %, respectively. Fourteen patients had partial responses, 15 had stable disease, 4 had disease progression, and 1 was not evaluated. The maintenance therapy rate was 58.8 %. The median PFS was 5.7 months (95 % CI 3.9-8.9 months), and median OS was 20.5 months (95 % CI 10.0-infinity months). Grade ≥3 hematological adverse events included leucopenia (23.5 % of patients), neutropenia (55.9 %), anemia (35.3 %), and thrombocytopenia (20.6 %). Grade ≥3 non-hematological adverse events included febrile neutropenia (8.8 %), elevated aminotransferases (5.9 %), infection (23.5 %), and anorexia/fatigue (5.9 %). Four patients had interstitial lung diseases (ILD) and one died due to ILD. CBDCA plus PEM, followed by PEM, was effective and reasonably tolerated in chemotherapy-naïve elderly patients with non-squamous NSCLC. Clinical Trial Registration This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry (Trial Number UMIN 000004810).
一项I期研究推荐卡铂（CBDCA，曲线下面积=5）联合培美曲塞（PEM，500mg/m²）用于老年（≥75岁）非鳞状非小细胞肺癌（NSCLC）患者。培美曲塞维持治疗耐受性良好。我们开展了一项多中心II期试验，以评估该方案在老年NSCLC患者中的疗效和安全性。给予4个疗程的CBDCA联合PEM，随后进行培美曲塞维持治疗。主要终点为1年总生存率（OS），次要终点为OS、无进展生存期（PFS）、缓解率（RR）和安全性。2012年6月至2013年5月期间共纳入34例患者（中位年龄77岁）。中位观察时间为22.7个月。1年OS率这一主要终点为58.0%（95%置信区间（CI）42.9 - 78.4%），RR和疾病控制率分别为41.2%和85.3%。14例患者部分缓解，15例病情稳定，4例疾病进展，1例未评估。维持治疗率为58.8%。中位PFS为5.7个月（95%CI 3.9 - 8.9个月），中位OS为20.5个月（95%CI 10.0 - 无穷大个月）。≥3级血液学不良事件包括白细胞减少（23.5%的患者）、中性粒细胞减少（55.9%）、贫血（35.3%）和血小板减少（20.6%）。≥3级非血液学不良事件包括发热性中性粒细胞减少（8.8%）、转氨酶升高（5.9%）、感染（23.5%）和厌食/疲劳（5.9%）。4例患者发生间质性肺疾病（ILD），1例因ILD死亡。CBDCA联合PEM，随后进行培美曲塞维持治疗，对于未接受过化疗的老年非鳞状NSCLC患者有效且耐受性尚可。临床试验注册 本试验已在大学医院医学信息网络临床试验注册中心注册（试验编号UMIN 000004810）。
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