TY - JOUR
T1 - A Multicenter Randomized Controlled Study of Paclitaxel plus Carboplatin versus Oral Uracil-Tegafur as the Adjuvant Chemotherapy in Resected Non–Small Cell Lung Cancer
AU - Toyooka, Shinichi
AU - Okumura, Norihito
AU - Nakamura, Hiroshige
AU - Nakata, Masao
AU - Yamashita, Motohiro
AU - Tada, Hirohito
AU - Kajiwara, Shinsuke
AU - Watanabe, Naoki
AU - Okada, Morihito
AU - Sakamoto, Junichi
AU - Aoe, Motoi
AU - Sou, Junichi
AU - Miyoshi, Shinichiro
AU - Hotta, Katsuyuki
AU - Matsuo, Keitaro
AU - Date, Hiroshi
N1 - Funding Information:
This investigator-initiated trial was supported in part by a grant from Bristol-Myers Squibb and Taiho Pharmaceutical and further supported, in part, by a nonprofit organization, Epidemiological and Clinical Research Information Network. Bristol-Myers Squibb and Taiho Pharmaceutical had no role in the design and conduct of the study or in collection, analysis, or interpretation of the results. We thank all 40 hospitals and institutions for their participation and cooperation (see Supplementary Table 3 ).
Funding Information:
Disclosure: Drs. Toyooka, Okumura, and Date have received honoraria from Taiho Pharmaceutical. Dr. Sakamoto has received honoraria from Tsumura and Chugai Pharmaceutical. Dr. Okada has received fees for speakers bureau participation from Taiho Pharmaceutical and Bristol-Myers Squibb. Dr. Sakamoto has received consulting fees from Takeda Pharmaceutical. Dr. Hotta has received personal fees from AstraZeneca, Ono Pharmaceutical, Boehringer Ingelheim, Nihon Kayaku, Taiho Pharmaceutical, Chugai Pharmaceutical, Novartis, Bristol-Myers Squibb, Eli Lilly Japan, and MSD, and the institute with which he is affiliated has received research funding from Bristol-Myers Squibb, AstraZeneca, Ono Pharmaceutical, Boehringer Ingelheim, Chugai Pharmaceutical, Astellas, Novartis, Eli Lilly Japan, and MSD. The institutes with which Drs. Toyooka, Okada, and Date are affiliated have received research funding from Taiho Pharmaceutical. The institute with which Dr. Okada is affiliated has received research funding from Bristol-Myers Squibb. The remaining authors declare no conflict of interest.
Publisher Copyright:
© 2018 International Association for the Study of Lung Cancer
PY - 2018/5
Y1 - 2018/5
N2 - Introduction: We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC. Methods: In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m 2 ) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m 2 ) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively. Results: Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63–76] in arm A versus 73% (95% CI: 66–78) in arm B (hazard ratio = 0.92, 95% CI: 0.55–1.41, p = 0.69). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63–1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [p < 0.0001 in both]). Conclusions: As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810).
AB - Introduction: We conducted a randomized controlled study to compare the survival benefit of paclitaxel plus carboplatin and oral uracil-tegafur (UFT) as adjuvant chemotherapy in resected NSCLC. Methods: In an open-label multicenter trial, patients with pathological stage IB to IIIA NSCLC were randomized into a group receiving paclitaxel (175 mg/m 2 ) plus carboplatin (area under the curve 5) every 3 weeks for four cycles (arm A) or a group receiving orally administered UFT (250 mg/m 2 ) daily for 2 years (arm B). The primary and secondary end points were overall survival and relapse-free survival and toxicity, respectively. Results: Between November 2004 and November 2010, 402 patients from 40 institutions were included (201 in each arm). The median follow-up period was 6.5 years. The 5-year overall survival rate was 70% (95% confidential interval [CI]: 63–76] in arm A versus 73% (95% CI: 66–78) in arm B (hazard ratio = 0.92, 95% CI: 0.55–1.41, p = 0.69). There was no significant difference in the 5-year relapse-free survival rate between arms A and B (56% versus 57% [hazard ratio = 0.92, 95% CI: 0.63–1.34, p = 0.50]). Toxicities were well tolerated and there was no treatment-related death. Toxicities of any grade or grade 4 were significantly more frequent in the paclitaxel plus carboplatin group (95.7% and 22.1%, respectively) than in the UFT group (76.5% and 1.0%, respectively [p < 0.0001 in both]). Conclusions: As adjuvant chemotherapy, paclitaxel plus carboplatin was no better than UFT in terms of survival among patients with stage IB to IIIA NSCLC tumors who underwent complete resection (UMIN000000810).
KW - Non–small cell lung cancer
KW - adjuvant chemotherapy
KW - carboplatin
KW - paclitaxel
KW - uracil-tegafur
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U2 - 10.1016/j.jtho.2018.02.015
DO - 10.1016/j.jtho.2018.02.015
M3 - Article
C2 - 29505900
AN - SCOPUS:85046097823
SN - 1556-0864
VL - 13
SP - 699
EP - 706
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 5
ER -
