A phase II study of carboplatin,pemetrexed, and bevacizumab followed by erlotinib and bevacizumab maintenance for non-squamous non-small cell lung cancer with wild-type <Emphasis Type="Italic">EGFR</Emphasis> (HOT1101) |
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Authors: | Taichi Takashina Hajime Asahina Satoshi Oizumi Noriyuki Yamada Masao Harada Kei Takamura Hiroshi Yokouchi Toshiyuki Harada Osamu Honjo Takahiro Ogi Naoto Morikawa Ichiro Kinoshita Ryoichi Honda Kosuke Nakano Kenya Kanazawa Toraji Amano Hirotoshi Dosaka-Akita Hiroshi Isobe Masaharu Nishimura Hokkaido Lung Cancer Clinical Study Group |
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Institution: | 1.Department of Respiratory Medicine,Iwamizawa Municipal General Hospital,Iwamizawa,Japan;2.First Department of Medicine,Hokkaido University Hospital,Sapporo,Japan;3.Department of Respiratory Medicine,National Hospital Organization Hokkaido Cancer Center,Sapporo,Japan;4.Department of Respiratory Medicine,Obihiro-Kosei General Hospital,Obihiro,Japan;5.Department of Pulmonary Medicine,Fukushima Medical University School of Medicine,Fukushima,Japan;6.Center for Respiratory Diseases,JCHO Hokkaido Hospital,Sapporo,Japan;7.Department of Respiratory Medicine,Sapporo-Kosei General Hospital,Sapporo,Japan;8.Division of Pulmonary Medicine, Allergy, and Rheumatology,Iwate Medical University School of Medicine,Morioka,Japan;9.Department of Medical Oncology, Faculty of Medicine and Graduate School of Medicine,Hokkaido University,Sapporo,Japan;10.Department of Respiratory Medicine,Sapporo Higashi Tokushukai Hospital,Sapporo,Japan;11.Clinical Research and Medical Innovation Center,Hokkaido University Hospital,Sapporo,Japan;12.Department of Medical Oncology,KKR Sapporo Medical Center,Sapporo,Japan |
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Abstract: | BackgroundThis study evaluated the efficacy and safety of switch maintenance erlotinib and bevacizumab after induction therapy with carboplatin/pemetrexed/bevacizumab for non-squamous non-small cell lung cancer (NSCLC) with wild-type EGFR.MethodsEnrolled patients had treatment-naïve, advanced non-squamous NSCLC with wild-type EGFR. Carboplatin area under the curve (AUC) 5.0], pemetrexed (500 mg/m2) and bevacizumab (15 mg/kg) were administered on day 1 every 3 weeks for 4–6 cycles. Maintenance therapy with erlotinib (150 mg/body) on day 1 through 21 plus bevacizumab on day 1 every 3 weeks was continued until disease progression or unacceptable toxicity. The primary endpoint was 6-month progression-free survival (PFS); secondary endpoints included overall survival (OS), overall response rate (ORR), toxicity, and quality of life (QOL).ResultsFifty-one patients were enrolled between September 2011 and June 2014. The median number of cycles for induction and maintenance therapy was 4 (range 1–6) and 4 (range 1–20). Twenty-nine patients (58%) received maintenance therapy. The 6-month PFS rate was 59.5% 95% confidence interval (CI) 45.0–72.6%]. The ORR was 48.0% (95% CI 34.8–61.5%), and disease control rate was 86.0% (95% CI 73.8–93.0%). The median PFS and OS were 6.5 months (95% CI 5.8–7.2 months) and 21.4 months (95% CI 15.9–26.9 months), respectively. Although grades ≥?3 adverse events were observed in 33 patients (66.0%), most were hematologic; there was no febrile neutropenia. QOL was maintained throughout treatment.ConclusionsCarboplatin/pemetrexed/bevacizumab followed by erlotinib and bevacizumab maintenance showed modest efficacy and was well tolerated in non-squamous NSCLC patients with wild-type EGFR.Trial registrationUMIN000005872. |
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