Clinical Research Papers:
A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01)
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Abstract
Hye Ryun Kim1,*, Joung Soon Jang2,*, Jong-Mu Sun3, Myung-Ju Ahn3, Dong-Wan Kim4, Inkyung Jung5, Ki Hyeong Lee6, Joo-Hang Kim1, Dae Ho Lee7, Sang-We Kim7 and Byoung Chul Cho1
1 Department of Internal Medicine, Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea
2 Department of Internal Medicine, Chung-Ang University, College of Medicine, Seoul, Korea
3 Department of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
4 Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea
5 Department of Biostatistics and Medical Informatics, Yonsei University College of Medicine, Seoul, Korea
6 Department of Internal Medicine, Chungbuk National University, College of Medicine, Cheongju, Korea
7 Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
* These authors have contributed equally to this study as first authors
Correspondence to:
Sang-We Kim, email:
Byoung Chul Cho, email:
Keywords: non-small cell lung cancer, epidermal growth factor receptor, nimotuzumab, gefitinib
Received: May 24, 2016 Accepted: October 26, 2016 Published: November 03, 2016
Abstract
We aimed to evaluate the efficacy of dual inhibition of epidermal growth factor receptor (EGFR) with nimotuzumab (EGFR monoclonal antibody) plus gefitinib (EGFR-tyrosine kinase inhibitor) in advanced non-small cell lung cancer (NSCLC) after platinum-based chemotherapy. An open label, randomized, phase II trial was conducted at 6 centers; 160 patients were randomized (1:1) to either gefitinib alone or nimotuzumab (200 mg, i.v. weekly) plus gefitinib (250 mg p.o. daily) until disease progression or intolerable toxicity. The primary endpoint was progression-free survival (PFS) at 3 months. Of the total 160 enrolled patients, 155 (77: gefitinib, 78: nimotuzumab plus gefitinib) received at least one dose and could be evaluated for efficacy and toxicity. The majority had adenocarcinoma (65.2%) and ECOG performance status of 0 to 1 (83.5%). The median follow-up was 22.1 months, and the PFS rate at 3 months was 48.1% in gefitinib and 37.2% in nimotuzumab plus gefitinib (P = not significant, NS). The median PFS and OS were 2.8 and 13.2 months in gefitinib and 2.0 and 14.0 months in nimotuzumab plus gefitinib. Combined treatment was not associated with superior PFS to gefitinib alone in patients with EGFR mutation (13.5 vs. 10.2 months in gefitinib alone, P=NS) or those with wild-type EGFR (0.9 vs. 2.0 months in gefitinib alone, P=NS). Combined treatment did not increase EGFR inhibition-related adverse events with manageable toxicities. The dual inhibition of EGFR with nimotuzumab plus gefitinib was not associated with better outcomes than gefitinib alone as a second-line treatment of advanced NSCLC (NCT01498562).
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PII: 13056