Oncology
Clinical Study
A Phase II Study of Cisplatin Plus Gemcitabine followed by Maintenance Gemcitabine for Advanced Squamous Non-Small-Cell Lung Cancer: Kyoto Thoracic Oncology Research Group 1302Ikeda S.a,b · Yoshioka H.a,c · Kaneda T.c · Yokoyama T.a · Niwa T.a · Sone N.a · Ishida T.a · Morita M.a · Tomioka H.d · Komaki C.e · Hirabayashi M.f · Hasegawa Y.g · Noguchi T.h · Nakano Y.i · Sakaguchi C.j · Yoshimura K.k · Hirai T.laDepartment of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan
bDepartment of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan cDepartment of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan dDepartment of Respiratory Medicine, Kobe City Medical Center West Hospital, Kobe, Japan eDepartment of Respiratory Medicine, Matsunami General Hospital, Gifu, Japan fDepartment of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan gDepartment of Respiratory Medicine, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan hDepartment of Respiratory Medicine, Nagahama City Hospital, Nagahama, Japan iDivision of Respiratory Medicine, Department of Internal Medicine, Otsu, Japan jDepartment of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan kInnovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan lDepartment of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan |
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Article / Publication Details
Received: June 12, 2019
Accepted: July 07, 2019
Published online: August 14, 2019
Issue release date: December 2019
Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 4
ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)
For additional information: https://www.karger.com/OCL
Abstract
Background: There has been no study so far on gemcitabine continuous maintenance therapy targeting only squamous non-small-cell lung cancer (NSCLC) patients. This study aimed to assess the efficacy and safety of cisplatin plus gemcitabine followed by maintenance gemcitabine for chemotherapy- naïve Japanese patients with advanced squamous NSCLC. Methods: The patients received 4 cycles of gemcitabine (1,000 mg/m2, days 1 and 8) and cisplatin (80 mg/m2, day 1) every 3 weeks, followed by gemcitabine alone as maintenance therapy every 3 weeks until disease progression or unacceptable toxicity. The primary end point of the study was progression-free survival (PFS) from the date of registration. Results: From May 2013 to October 2018, 26 patients were enrolled, and 25 patients received ≥1 cycle of planned treatment. Eighteen patients (69.2%) received 4 cycles of cisplatin plus gemcitabine, and 16 patients (61.5%) received ≥1 cycle of maintenance gemcitabine. The median PFS from the date of registration was 5.3 months (95% CI 2.9–7.3 months). In 16 patients who received ≥1 cycle of maintenance gemcitabine, the median PFS from the date of maintenance gemcitabine initiation was 3.8 months (95% CI 2.3–5.2 months). Their median overall survival from the date of registration was 11.9 months (95% CI 7.5–26.5 months). During the maintenance therapy, adverse events (AEs) were mostly Common Terminology Criteria for AE grade 1. Conclusions: While this trial did not meet the primary endpoint, the sufficient efficacy and feasibility of gemcitabine maintenance therapy were suggested.
© 2019 S. Karger AG, Basel
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Article / Publication Details
Received: June 12, 2019
Accepted: July 07, 2019
Published online: August 14, 2019
Issue release date: December 2019
Number of Print Pages: 7
Number of Figures: 2
Number of Tables: 4
ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)
For additional information: https://www.karger.com/OCL
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