Satoshi Ikeda1,2, Hiroshige Yoshioka3,4, Toshihiko Kaneda5, Toshihide Yokoyama1, Takashi Niwa1, Naoyuki Sone1, Tadashi Ishida1, Mitsunori Morita1, Hiromi Tomioka6, Chihito Komaki7, Masataka Hirabayashi8, Yoshinori Hasegawa9, Tetsuo Noguchi10, Yasutaka Nakano11, Chikara Sakaguchi12, Kenichi Yoshimura13, Toyohiro Hirai14. 1. Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan. 2. Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Yokohama, Japan. 3. Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan, hgyoshioka@gmail.com. 4. Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan, hgyoshioka@gmail.com. 5. Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan. 6. Department of Respiratory Medicine, Kobe City Medical Center West Hospital, Kobe, Japan. 7. Department of Respiratory Medicine, Matsunami General Hospital, Gifu, Japan. 8. Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan. 9. Department of Respiratory Medicine, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan. 10. Department of Respiratory Medicine, Nagahama City Hospital, Nagahama, Japan. 11. Division of Respiratory Medicine, Department of Internal Medicine, Otsu, Japan. 12. Department of Pulmonary Medicine, Rakuwakai Otowa Hospital, Kyoto, Japan. 13. Innovative Clinical Research Center, Kanazawa University Hospital, Kanazawa, Japan. 14. Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
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.
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.