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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 EGFR (HOT1101)

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Title: 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 EGFR (HOT1101)
Authors: Takashina, Taichi Browse this author
Asahina, Hajime Browse this author
Oizumi, Satoshi Browse this author →KAKEN DB
Yamada, Noriyuki Browse this author
Harada, Masao Browse this author
Takamura, Kei Browse this author
Yokouchi, Hiroshi Browse this author
Harada, Toshiyuki Browse this author
Honjo, Osamu Browse this author
Ogi, Takahiro Browse this author
Morikawa, Naoto Browse this author
Kinoshita, Ichiro Browse this author →KAKEN DB
Honda, Ryoichi Browse this author
Nakano, Kosuke Browse this author
Kanazawa, Kenya Browse this author
Amano, Toraji Browse this author
Dosaka-Akita, Hirotoshi Browse this author →KAKEN DB
Isobe, Hiroshi Browse this author →KAKEN DB
Nishimura, Masaharu Browse this author →KAKEN DB
Keywords: Maintenance therapy
Non-small cell lung cancer
Issue Date: Dec-2018
Publisher: Springer
Journal Title: International journal of clinical oncology
Volume: 23
Issue: 6
Start Page: 1060
End Page: 1069
Publisher DOI: 10.1007/s10147-018-1318-z
PMID: 30027464
Abstract: Background: This 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. Methods: Enrolled patients had treatment-naive, 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). Results: Fifty-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. Conclusions: Carboplatin/pemetrexed/bevacizumab followed by erlotinib and bevacizumab maintenance showed modest efficacy and was well tolerated in non-squamous NSCLC patients with wild-type EGFR.
Rights: This is a post-peer-review, pre-copyedit version of an article published in International Journal of Clinical Oncology. The final authenticated version is available online at:
Type: article (author version)
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 朝比奈 肇

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