Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer

被引：86

作者：

Kenmotsu, Hirotsugu ^{[1
]}

Yamamoto, Nobuyuki ^{[2
]}

Yamanaka, Takeharu ^{[1
,3
]}

Yoshiya, Katsuo ^{[4
]}

Takahashi, Toshiaki ^{[1
]}

Ueno, Tsuyoshi ^{[5
]}

Goto, Koichi ^{[6
]}

Daga, Haruko ^{[7
]}

Ikeda, Norihiko ^{[8
]}

Sugio, Kenji ^{[9
]}

Seto, Takashi ^{[10
]}

Toyooka, Shinichi ^{[11
]}

Date, Hiroshi ^{[12
]}

Mitsudomi, Tetsuya ^{[13
]}

Okamoto, Isamu ^{[14
]}

Yokoi, Kohei ^{[15
]}

Saka, Hideo ^{[16
]}

Okamoto, Hiroaki ^{[17
]}

Takiguchi, Yuichi ^{[18
]}

Tsuboi, Masahiro ^{[19
]}

机构：

[1] Shizuoka Canc Ctr, Div Thorac Oncol, 1007 Shimonagakubo, Nagaizumi, Shizuoka 4118777, Japan

[2] Wakayama Med Univ, Internal Med 3, Wakayama, Japan

[3] Yokohama City Univ, Sch Med, Dept Biostat, Yokohama, Kanagawa, Japan

[4] Niigata Canc Ctr Hosp, Dept Chest Surg, Niigata, Japan

[5] Natl Hosp Org, Shikoku Canc Ctr, Dept Thorac Surg, Matsuyama, Ehime, Japan

[6] Natl Canc Ctr Hosp East, Dept Thorac Oncol, Kashiwa, Chiba, Japan

[7] Osaka City Gen Hosp, Dept Med Oncol, Osaka, Japan

[8] Tokyo Med Univ, Dept Surg, Tokyo, Japan

[9] Oita Univ, Dept Thorac & Breast Surg, Oita, Japan

[10] Natl Hosp Org Kyushu Canc Ctr, Dept Thorac Oncol, Fukuoka, Japan

[11] Okayama Univ, Dept Gen Thorac Surg Breast & Endocrinol Surg, Okayama, Japan

[12] Kyoto Univ, Dept Thorac Surg, Grad Sch Med, Kyoto, Japan

[13] Kindai Univ, Fac Med, Dept Surg, Div Thorac Surg, Osaka, Japan

[14] Kyushu Univ, Res Inst Dis Chest, Grad Sch Med Sci, Fukuoka, Japan

[15] Nagoya Univ, Dept Thorac Surg, Grad Sch Med, Nagoya, Aichi, Japan

[16] Natl Hosp Org Nagoya Med Ctr, Dept Resp Med, Nagoya, Aichi, Japan

[17] Yokohama Municipal Citizens Hosp, Dept Resp Med, Yokohama, Kanagawa, Japan

[18] Chiba Univ Hosp, Dept Med Oncol, Chiba, Japan

[19] Natl Canc Ctr Hosp East, Div Thorac Surg, Kashiwa, Chiba, Japan

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2020年 / 38卷 / 19期

关键词：

NSCLC ADJUVANT CHEMOTHERAPY; GEMCITABINE; CARBOPLATIN; REFINEMENT; TRIAL; IB;

D O I：

10.1200/JCO.19.02674

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PURPOSE To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan. Patients with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomly assigned to receive either pemetrexed (500 mg/m(2), day 1) plus cisplatin (75 mg/m(2), day 1) or vinorelbine (25 mg/m(2), days 1 and 8) plus cisplatin (80 mg/m(2), day 1) with stratification by sex, age, pathologic stage, EGFR mutation, and institution. These treatments were planned to be given every 3 weeks for 4 cycles. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients. RESULT Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin). Of 784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR-sensitive mutations. At a median follow-up of 45.2 months, median recurrence-free survival was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a hazard ratio of 0.98 (95% CI, 0.81 to 1.20; 1-sided P=.474). Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively). One treatment-related death occurred in each arm. CONCLUSION Although this study failed to show the superiority of pemetrexed plus cisplatin for patients with resected nonsquamous NSCLC, this regimen showed a better tolerability as adjuvant chemotherapy. (C) 2020 by American Society of Clinical Oncology.

引用

页码：2187 / +

页数：12

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