Watanabe Kana, Toi Yukihiro, Nakamura Atsushi, Chiba Ryosuke, Akiyama Masachika, Sakakibara-Konishi Jun, Tanaka Hisashi, Yoshimura Naruo, Miyauchi Eisaku, Nakagawa Taku, Igusa Ryotaro, Minemura Hiroyuki, Mori Yoshiaki, Fujimoto Keisuke, Matsushita Haruo, Takahashi Fumiaki, Fukuhara Tatsuro, Inoue Akira, Sugawara Shunichi, Maemondo Makoto
Department of Respiratory Medicine, Miyagi Cancer Center, Natori, Japan.
Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Transl Lung Cancer Res. 2021 Feb;10(2):712-722. doi: 10.21037/tlcr-20-721.
The optimal regimen for concurrent chemoradiotherapy (CCRT) of locally advanced non-squamous non-small cell lung cancer (NSCLC) was not definitive. We conducted randomized phase II study, NJLCG0601, and chemoradiotherapy with uracil/tegafur (UFT) and cisplatin achieved promising efficacy without severe toxicities. Here, we evaluated between this regimen and pemetrexed plus cisplatin in chemoradiotherapy for stage III non-squamous NSCLC.
Patients with inoperable stage III non-squamous NSCLC were randomly assigned in a 1:1 ratio to UFT 400 mg/m on days 1-14 and 29-42, and cisplatin 80 mg/m on days 8 and 36 (UP), or cisplatin 75 mg/m and pemetrexed 500 mg/m on days 1, 22, and 43 (PP). Involved-field radiotherapy (IFRT) underwent from day 1 to a total dose of 66 Gy in 33 fractions. Consolidation chemotherapy after CCRT was prohibited for this study. The primary endpoint was defined as 2-year overall survival (OS). This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN000003948).
From November 2010 to June 2017, 86 patients were entered from 11 institutions. Median follow-up was 54 months. Of the 85 eligible patients, the 2-year OS rate was 78.6% (95% CI, 62.8-88.3%) in UP and 85.5% (95% CI, 70.5-93.2%) in PP. Median PFS and OS was 12.3 and 64.2 months in UP, 26.2 months and not reached in PP, respectively. Grade 3/4 febrile neutropenia was more frequent in the UP group (14.0% 2.0%).
Both UP and PP with IFRT achieved the expected 2-year OS. PP engendered more favorable OS and PFS compared to UP in terms.
局部晚期非鳞状非小细胞肺癌（NSCLC）同步放化疗（CCRT）的最佳方案尚无定论。我们开展了一项随机II期研究（NJLCG0601），结果显示，尿嘧啶/替加氟（UFT）联合顺铂的放化疗疗效良好且毒性不严重。在此，我们比较了该方案与培美曲塞联合顺铂用于III期非鳞状NSCLC放化疗的效果。
无法手术的III期非鳞状NSCLC患者按1:1比例随机分组，一组在第1 - 14天和第29 - 42天接受UFT 400 mg/m²和顺铂80 mg/m²（第8天和第36天）（UP组），另一组在第1、22和43天接受顺铂75 mg/m²和培美曲塞500 mg/m²（PP组）。从第1天开始进行累及野放疗（IFRT），总剂量66 Gy，分33次。本研究禁止CCRT后进行巩固化疗。主要终点定义为2年总生存期（OS）。该试验已在大学医院医学信息网络临床试验注册中心注册（UMIN000003948）。
2010年11月至2017年6月，来自11家机构的86例患者入组。中位随访时间为54个月。85例符合条件的患者中，UP组2年OS率为78.6%（95%CI，62.8 - 88.3%），PP组为85.5%（95%CI，70.5 - 93.2%）。UP组的中位无进展生存期（PFS）和OS分别为12.3个月和64.2个月，PP组分别为26.2个月和未达到。UP组3/4级发热性中性粒细胞减少更为常见（14.0%对2.0%）。
UP方案和PP方案联合IFRT均达到了预期的2年OS。PP方案在OS和PFS方面比UP方案更具优势。
