Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2019 ASCO Annual Meeting but not presented at the Meeting, can be found online only.
Randomized phase 3 study of maintenance therapy with S-1 plus best supportive care (BSC) versus BSC alone after induction therapy with carboplatin plus S-1 for advanced or relapsed squamous cell lung carcinoma (WJOG7512L).
Metastatic Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Metastatic
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr e20531)
Author(s): Kaoru Tanaka, Satoshi Morita, Masahiko Ando, Takuma Yokoyama, Atsushi Nakamura, Hiroshige Yoshioka, Takashi Ishiguro, Satoru Miura, Ryo Toyozawa, Tetsuya Oguri, Haruko Daga, Ryo Ko, Akihiro Bessho, Motoko Tachihara, Yasuo Iwamoto, Katsuya Hirano, Yoichi Nakanishi, Kazuhiko Nakagawa, Nobuyuki Yamamoto, Isamu Okamoto; Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan; Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan; Data Coordinating Center, Department of Advanced Medicine, Nagoya University Hospital, Nagoya, Japan; Department of Respiratory Medicine, Kyorin University School of Medicine, Tokyo, Japan; Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan; Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan; Division of Respiratory Medicine and Oncology, Gifu Municipal Hospital, Gifu, Japan; Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan; Department of Thoracic Oncology, National Kyushu Cancer Center, Fukuoka, Japan; Department of Education and Research Center for Community Medicine, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan; Department of Clinical Oncology, Osaka City General Hospital, Osaka, Japan; Department of Respiratory Medicine, Juntendo University, Graduate School of Medicine, Tokyo, Japan; Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan; Divisions of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan; Department of Medical Oncology, Hiroshima City Hospital, Hiroshima, Japan; Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan; Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan; Kindai University Hospital, Osaka, Japan; Third Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan
Background: Our previous phase 3 study established carboplatin plus the oral fluorinated pyrimidine formulation S-1 as a standard option for first-line treatment of advanced non–small cell lung cancer (NSCLC) (J Clin Oncol 2010; 28:5240). The importance of maintenance therapy for patients with advanced squamous NSCLC has been unknown, however. Methods: WJOG7512L was designed as a randomized phase 3 study to evaluate whether maintenance therapy with S-1 improves clinical outcome after induction therapy with carboplatin plus S-1 in such patients. Before randomization, patients received carboplatin (AUC of 5 on day 1 every 3 weeks) plus S-1 (40 mg/m2 twice per day on days 1 to 14 every 3 weeks) as induction therapy. Those who did not progress after four cycles of induction therapy were randomized to receive either S-1 plus best supportive care (BSC) or BSC alone. The primary objective was to confirm the superiority of S-1 plus BSC with regard to progression-free survival. Results: Of the 365 patients enrolled, 347 participated in the induction phase and 131 of these individuals were randomized to receive S-1 plus BSC (n = 67) or BSC alone (n = 64). Baseline demographics and clinical characteristics of the subjects, including the response to induction therapy, were well balanced. Patients receiving S-1 plus BSC showed a significantly reduced risk of disease progression compared with those receiving BSC alone (hazard ratio [HR], 0.548; 95% confidence interval [CI], 0.374–0.802; P = 0.0019). Median overall survival from randomization did not differ significantly between the two arms: 17.8 months for BSC alone and 16.7 months for S-1 plus BSC (HR, 0.890; 95% CI, 0.583–1.357). Time to deterioration in quality of life also showed no significant difference (P = 0.8754 for FACT-TOI, P = 0.9016 for FACT-LCS). The incidence of adverse events during maintenance therapy was low, with neutropenia, anemia, and thrombocytopenia of grade 3 or 4 each occurring in ~1% to 4% of patients. Conclusions: Maintenance with S-1 plus BSC is an effective and well-tolerated treatment option for patients with advanced squamous NSCLC. Clinical trial information: UMIN000010396.