TY - JOUR
T1 - Phase 2 Study of Nimotuzumab in Combination With Concurrent Chemoradiotherapy in Patients With Locally Advanced Non–Small-Cell Lung Cancer
AU - Yamamoto, Nobuyuki
AU - Harada, Hideyuki
AU - Okamoto, Isamu
AU - Masuda, Noriyuki
AU - Hayakawa, Kazushige
AU - Satouchi, Miyako
AU - Soejima, Toshinori
AU - Nishio, Makoto
AU - Kozuka, Takuyo
AU - Takeda, Koji
AU - Tanaka, Masahiro
AU - Seto, Takashi
AU - Sasaki, Tomonari
AU - Tsubouchi, Hiroshi
AU - Kakurai, Yasuyuki
AU - Nishimura, Yasumasa
AU - Nakagawa, Kazuhiko
N1 - Funding Information:
N.Y. received personal fees from Daiichi Sankyo relevant to the present work; outside the submitted work: grants and personal fees from MSD, Eli Lilly, Chugai Pharmaceutical, and Nippon Boehringer Ingelheim; and personal fees from AstraZeneca, Ono Pharmaceutical, Novartis Pharma, Pfizer, and Bristol-Myers Squibb. H.H. received personal fees from Daiichi Sankyo relevant to the present work; outside the submitted work: personal fees from Daiichi Sankyo, AstraZeneca, Brainlab, and Chugai Pharmaceutical; and grants from the Japan Agency for Medical Research and Development, and The National Cancer Center Research and Development Fund. I.O. received grants and personal fees from AstraZeneca, Taiho Pharmaceutical, Nippon Boehringer Ingelheim, Ono Pharmaceutical, MSD Oncology, Eli Lilly, Bristol-Myers Squibb, and Chugai Pharmaceutical; grants from Astellas Pharma and Novartis Pharma; and personal fees from Pfizer outside the submitted work. M.S. received grants and personal fees from Chugai Pharmaceutical, Eli Lilly, Pfizer, AstraZeneca, Nippon Boehringer Ingelheim, Bristol-Myers Squibb, Ono Pharmaceutical, Novartis Pharm, and MSD; grants from Astellas Pharma and Takeda Pharmaceutical; and personal fees from Taiho Pharmaceutical relevant to the present work. M.N. received grants and personal fees from Ono Pharmaceutical, Bristol-Myers Squibb, Pfizer, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, AstraZeneca, Nippon Boehringer Ingelheim, MSD, and Novartis Pharma; grants from Astellas Pharma; and personal fees from Daiichi Sankyo and Merck Serono outside the submitted work. T.K. received research funding from Daiichi Sankyo relevant to the present work. K.T. received a grant from Daiichi Sankyo relevant to the present work; outside the submitted work: grants and personal fees from Nippon Boehringer Ingelheim, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Ono Pharmaceutical, and Pfizer; grants from AbbVie, Astellas Pharma, Merck Serono, and MSD; and personal fees from AstraZeneca, Daiichi Sankyo, Kyowa Kirin, Novartis Pharma, and Taiho Pharmaceutical. M.T. received personal fees from Daiichi Sankyo relevant to the present work; outside the submitted work: grant from Japan Agency for Medical Research and Development. T.S. received a grant from Daiichi Sankyo relevant to the present work. Outside the submitted work: grants and personal fees from Astellas Pharma, AstraZeneca, Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly, Kissei Pharmaceutical, MSD, Nippon Boehringer Ingelheim, Pfizer, and Yakult Honsha; grants from Bayer Yakuhin, Eisai, Merck Serono, Novartis Pharma, and Verastem; and personal fees from Bristol-Myers Squibb, Kyowa Kirin, Mochida Pharmaceutical, Nippon Kayaku, Ono Pharmaceutical, Roche Singapore, Sanofi, Showa Yakuhin, Taiho Pharmaceutical, and Takeda Pharmaceutical. K.N. received grants and personal fees from AstraZeneca, MSD, Chugai Pharmaceutical, Eli Lilly, Taiho Pharmaceutical, Ono Pharmaceutical, Nippon Boehringer Ingelheim, Bristol-Myers Squibb, and Pfizer; and grants from Daiichi Sankyo and Takeda Pharmaceutical relevant to the present work; outside the submitted work: grants and personal fees from Astellas Pharma, Novartis Pharma, and Kyowa Kirin; grants from A2 Healthcare Corp, inVentiv Health Japan, AbbVie, Quintiles, ICON Japan, EP-CRSU, Gritstone Oncology, Linical, Eisai, Parexel International, EPS International, Yakult Honsha, Otsuka Pharmaceutical, AC Medical, Merck Serono, EPS Associates, Japan Clinical Research Operations, PPD-SNBL, and Covance; and personal fees from SymBio Pharmaceuticals, EPS Holdings, Showa Yakuhin Kako, Ayumi Pharmaceutical Corporation, and Kissei Pharmaceutical. H.T. and Y.K. are employees of Daiichi Sankyo. The other authors have stated that they have no conflict of interest.
Publisher Copyright:
© 2020 The Author(s)
PY - 2021/3
Y1 - 2021/3
N2 - Background: We evaluated the tolerability and efficacy of nimotuzumab, a humanized IgG1 monoclonal anti–epidermal growth factor receptor antibody, with concurrent chemoradiotherapy in patients with unresectable locally advanced non–small-cell lung cancer. Patients and Methods: In this multicenter, single-arm, open-label, phase 2 trial conducted in Japan (JapicCTI-090825), patients received thoracic radiotherapy (60 Gy, 2 Gy per fraction, 6 weeks) and four 4-week cycles of chemotherapy (day 1, cisplatin 80 mg/m2; days 1 and 8, vinorelbine 20 mg/m2). Nimotuzumab 200 mg was administrated weekly for 16 weeks. The primary endpoint was treatment completion rate, defined as the percentage of patients completing 60 Gy of radiotherapy within 8 weeks, 2 cycles of chemotherapy, and at least 75% of the required nimotuzumab dose during the initial 2-cycle concurrent chemoradiotherapy period. Results: Of 40 patients enrolled, 39 received the study treatment, which was well tolerated, with a completion rate of 87.2%. Thirty-eight patients completed 60 Gy of radiotherapy within 8 weeks. Infusion reaction, grade 3 or higher rash, grade 3 or higher radiation pneumonitis, or grade 4 or higher nonhematologic toxicity were not observed. The objective response rate was 69.2%. The median progression-free survival (PFS) and 5-year PFS rate were 508 days and 29.0%, respectively. The 5-year PFS rate in patients with non–squamous cell carcinoma (n = 23) was 13.7% and in patients with squamous cell carcinoma (n = 16) was 50.0%. The 5-year overall survival rate was 58.4%. Conclusion: Addition of nimotuzumab to the concurrent chemoradiotherapy regimen was well tolerated and showed potential for treating patients with locally advanced non–small-cell lung cancer, particularly squamous cell carcinoma.
AB - Background: We evaluated the tolerability and efficacy of nimotuzumab, a humanized IgG1 monoclonal anti–epidermal growth factor receptor antibody, with concurrent chemoradiotherapy in patients with unresectable locally advanced non–small-cell lung cancer. Patients and Methods: In this multicenter, single-arm, open-label, phase 2 trial conducted in Japan (JapicCTI-090825), patients received thoracic radiotherapy (60 Gy, 2 Gy per fraction, 6 weeks) and four 4-week cycles of chemotherapy (day 1, cisplatin 80 mg/m2; days 1 and 8, vinorelbine 20 mg/m2). Nimotuzumab 200 mg was administrated weekly for 16 weeks. The primary endpoint was treatment completion rate, defined as the percentage of patients completing 60 Gy of radiotherapy within 8 weeks, 2 cycles of chemotherapy, and at least 75% of the required nimotuzumab dose during the initial 2-cycle concurrent chemoradiotherapy period. Results: Of 40 patients enrolled, 39 received the study treatment, which was well tolerated, with a completion rate of 87.2%. Thirty-eight patients completed 60 Gy of radiotherapy within 8 weeks. Infusion reaction, grade 3 or higher rash, grade 3 or higher radiation pneumonitis, or grade 4 or higher nonhematologic toxicity were not observed. The objective response rate was 69.2%. The median progression-free survival (PFS) and 5-year PFS rate were 508 days and 29.0%, respectively. The 5-year PFS rate in patients with non–squamous cell carcinoma (n = 23) was 13.7% and in patients with squamous cell carcinoma (n = 16) was 50.0%. The 5-year overall survival rate was 58.4%. Conclusion: Addition of nimotuzumab to the concurrent chemoradiotherapy regimen was well tolerated and showed potential for treating patients with locally advanced non–small-cell lung cancer, particularly squamous cell carcinoma.
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UR - http://www.scopus.com/inward/citedby.url?scp=85100018157&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2020.12.012
DO - 10.1016/j.cllc.2020.12.012
M3 - Article
C2 - 33518480
AN - SCOPUS:85100018157
VL - 22
SP - 134
EP - 141
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
SN - 1525-7304
IS - 2
ER -