Tokujiro Yano1, Motoharu Hamatake2, Shoji Tokunaga3, Tatsuro Okamoto4, Koji Yamazaki5, Takashi Miura6, Takeshi Nagayasu7, Masami Sato8, Seiichi Fukuyama9, Kenji Sugio10. 1. Department of General Thoracic Surgery, National Hospital Organization Beppu Medical Center, 1473 Uchikamado, Beppu, 874-0011, Japan. yano.tokujiro.ej@mail.hosp.go.jp. 2. Department of Thoracic Surgery, Kitakyushu Municipal Medical Center, Kitakyushu, Japan. 3. Medical Information Center, Kyushu University Hospital, Fukuoka, Japan. 4. Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan. 5. Department of Thoracic Surgery and Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan. 6. Department of Thoracic Surgery, Oita City Medical Association's Almeida Hospital, Oita, Japan. 7. Department of Surgical Oncology, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan. 8. Department of Thoracic Surgery, Kagoshima University, Kagoshima, Japan. 9. Department of General Thoracic Surgery, National Hospital Organization Beppu Medical Center, 1473 Uchikamado, Beppu, 874-0011, Japan. 10. Department of Thoracic and Breast Surgery, Faculty of Medicine, Oita University, Yufu, Japan.
Abstract
BACKGROUND: To examine the effects of postoperative adjuvant chemotherapy for elderly (≥ 75 years of age) patients with completely resected non-small cell lung cancer (NSCLC), we conducted a multi-institutional and prospective observational study. METHODS: Patients were recruited between January 2014 and December 2017, and assigned to two cohort groups based on the patients' choice either to receive postoperative adjuvant chemotherapy (Cohort B) or not (Cohort A). All the patients were observed for 2 years after enrollment. The primary endpoint was the postoperative change of Karnofsky Performance Status (KPS) at 2 years. The secondary endpoints were postoperative recurrence-free survival (RFS) and overall survival (OS) at 2 years, and the completion rate of the adjuvant chemotherapy. RESULTS: Two hundred and seventy-two patients were enrolled (Cohort A, n = 225; Cohort B, n = 47). At any time point after surgery, no marked difference of KPS was observed between Cohort B and Cohort A. The RFS at 2 years was 70.8% (95% confidence interval [CI], 64.3-76.4) in Cohort A and 76.0% (95% CI 60.8-85.9) in Cohort B. The OS at 2 years was 85.9% (95% CI 80.4-89.9) in Cohort A and 89.1% (95% CI 75.8-95.3) in Cohort B. The completion rate of planned chemotherapy was 49.9% (95% CI 34.1-63.9%). CONCLUSIONS: The elderly patients were not likely to choose to receive postoperative adjuvant chemotherapy; however, no significant adverse effect on postoperative KPS was identified. TRIAL REGISTRATION: Clinical Trial Registration ID: UMIN000020736.
BACKGROUND: To examine the effects of postoperative adjuvant chemotherapy for elderly (≥ 75 years of age) patients with completely resected non-small cell lung cancer (NSCLC), we conducted a multi-institutional and prospective observational study. METHODS: Patients were recruited between January 2014 and December 2017, and assigned to two cohort groups based on the patients' choice either to receive postoperative adjuvant chemotherapy (Cohort B) or not (Cohort A). All the patients were observed for 2 years after enrollment. The primary endpoint was the postoperative change of Karnofsky Performance Status (KPS) at 2 years. The secondary endpoints were postoperative recurrence-free survival (RFS) and overall survival (OS) at 2 years, and the completion rate of the adjuvant chemotherapy. RESULTS: Two hundred and seventy-two patients were enrolled (Cohort A, n = 225; Cohort B, n = 47). At any time point after surgery, no marked difference of KPS was observed between Cohort B and Cohort A. The RFS at 2 years was 70.8% (95% confidence interval [CI], 64.3-76.4) in Cohort A and 76.0% (95% CI 60.8-85.9) in Cohort B. The OS at 2 years was 85.9% (95% CI 80.4-89.9) in Cohort A and 89.1% (95% CI 75.8-95.3) in Cohort B. The completion rate of planned chemotherapy was 49.9% (95% CI 34.1-63.9%). CONCLUSIONS: The elderly patients were not likely to choose to receive postoperative adjuvant chemotherapy; however, no significant adverse effect on postoperative KPS was identified. TRIAL REGISTRATION: Clinical Trial Registration ID: UMIN000020736.