TY - JOUR
T1 - 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
AU - Kenmotsu, Hirotsugu
AU - Yamamoto, Nobuyuki
AU - Yamanaka, Takeharu
AU - Yoshiya, Katsuo
AU - Takahashi, Toshiaki
AU - Ueno, Tsuyoshi
AU - Goto, Koichi
AU - Daga, Haruko
AU - Ikeda, Norihiko
AU - Sugio, Kenji
AU - Seto, Takashi
AU - Toyooka, Shinichi
AU - Date, Hiroshi
AU - Mitsudomi, Tetsuya
AU - Okamoto, Isamu
AU - Yokoi, Kohei
AU - Saka, Hideo
AU - Okamoto, Hiroaki
AU - Takiguchi, Yuichi
AU - Tsuboi, Masahiro
N1 - Funding Information:
Supported by Shinichiro Nakamura, Seiko Tanaka, and other staff members of the West Japan Oncology Group Data Center (data management) and Pharma-Valley Center (study management) and by the Japan Agency for Medical Research and Development (Grant No. 16lk0201005h0005). Pemetrexed for this study was provided by Eli Lilly (Kobe, Japan). We thank the patients, their families, and the JIPANG investigators who participated in this study. We thank Clare Cox, PhD, from Edanz Group for editing a draft of this article. JIPANG is an intergroup study among 7 clinical study groups in Japan: the Lung Oncology Group, Setouchi Lung Cancer Group, Japan Multinational Trial Organization, West Japan Oncology Group, Central Japan Lung Study Group, Tokyo Cooperative Oncology Group, and Thoracic Oncology Research Group.
Funding Information:
Supported by Shinichiro Nakamura, Seiko Tanaka, and other staff members of the West Japan Oncology Group Data Center (data management) and Pharma-Valley Center (study management) and by the Japan Agency for Medical Research and Development (Grant No.
Publisher Copyright:
Copyright © 2020 American Society of Clinical Oncology. All rights reserved..
PY - 2020/5/14
Y1 - 2020/5/14
N2 - 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/m2, day 1) plus cisplatin (75 mg/m2, day 1) or vinorelbine (25 mg/m2, days 1 and 8) plus cisplatin (80 mg/m2, 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 5 .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.
AB - 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/m2, day 1) plus cisplatin (75 mg/m2, day 1) or vinorelbine (25 mg/m2, days 1 and 8) plus cisplatin (80 mg/m2, 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 5 .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.
UR - http://www.scopus.com/inward/record.url?scp=85087320825&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85087320825&partnerID=8YFLogxK
U2 - 10.1200/JCO.19.02674
DO - 10.1200/JCO.19.02674
M3 - Article
C2 - 32407216
AN - SCOPUS:85087320825
SN - 0732-183X
VL - 38
SP - 2187
EP - 2196
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 19
ER -
