Naoyuki Nogami1, Nagio Takigawa2, Katsuyuki Hotta3, Yoshihiko Segawa4, Yuka Kato5, Toshiyuki Kozuki1, Isao Oze5, Daizo Kishino6, Keisuke Aoe6, Hiroshi Ueoka6, Shoichi Kuyama7, Shingo Harita8, Toshiaki Okada8, Shinobu Hosokawa9, Koji Inoue10, Kenichi Gemba11, Takuo Shibayama12, Masahiro Tabata13, Mitsuhiro Takemoto14, Susumu Kanazawa14, Mitsune Tanimoto15, Katsuyuki Kiura13. 1. Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan. 2. Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan; Department of General Internal Medicine 4, Kawasaki Hospital, Kawasaki Medical School, Okayama, Japan. 3. Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan; Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan. Electronic address: khotta@md.okayama-u.ac.jp. 4. Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan; Department of Medical Oncology, International Medical Center Comprehensive Cancer Center, Saitama Medical University, Hidaka, Japan. 5. Department of Thoracic oncology, NHO Shikoku Cancer Center, Matsuyama, Japan; Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan. 6. Department of Medical Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan. 7. Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan; Department of Respiratory Medicine, NHO Iwakuni Medical Center, Iwakuni, Japan. 8. Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan. 9. Department of Respiratory Medicine, Okayama Red Cross Hospital, Okayama, Japan. 10. Department of Respiratory Medicine, Ehime Prefectural Hospital, Matsuyama, Japan. 11. Department of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan. 12. Department of Respiratory Medicine, NHO Minami-Okayama Medical Center, Okayama, Japan; Department of Respiratory Medicine, NHO Okayama Medical Center, Okayama, Japan. 13. Department of Thoracic oncology, Okayama University Hospital, Okayama, Japan. 14. Department of Radiology, Okayama University Hospital, Okayama, Japan. 15. Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
Abstract
BACKGROUND: Although cisplatin-based chemotherapy combined with thoracic irradiation (TRT) is a standard treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC), this treatment outcome has remained unsatisfactory. We had previously conducted a phase I trial of cisplatin plus S-1, an oral 5-fluorouracil derivative, and TRT, which were safe and effective. METHODS: In this phase II trial, 48 patients with stage III NSCLC received cisplatin (40mg/m(2) on days 1, 8, 29 and 36) and S-1 (80mg/m(2) on days 1-14 and 29-42) and TRT (60Gy). The primary endpoint was the response rate. RESULTS: A partial response was observed in 37 patients (77%; 95% confidence interval: 63-88%). At a median follow up of 54 months, the median progression-free survival and median survival time were 9.3 and 31.3 months, respectively. No difference in efficacy was observed when the patients were stratified by histology. Toxicities were generally mild except for grade 3 or worse febrile neutropenia and pneumonitis of 8% and 4%, respectively. No patient developed severe esophagitis. At the time of this analysis, 35 (73%) of the 48 patients recurred; 15 (31%) showed distant metastasis, 17 (35%) had loco-regional disease, and 2 (4%) showed both loco-regional disease and distant metastasis. CONCLUSIONS: This chemoradiotherapy regimen yielded a relatively favorable efficacy with mild toxicities in patients with locally advanced NSCLC.
BACKGROUND: Although cisplatin-based chemotherapy combined with thoracic irradiation (TRT) is a standard treatment for unresectable, locally advanced non-small cell lung cancer (NSCLC), this treatment outcome has remained unsatisfactory. We had previously conducted a phase I trial of cisplatin plus S-1, an oral 5-fluorouracil derivative, and TRT, which were safe and effective. METHODS: In this phase II trial, 48 patients with stage III NSCLC received cisplatin (40mg/m(2) on days 1, 8, 29 and 36) and S-1 (80mg/m(2) on days 1-14 and 29-42) and TRT (60Gy). The primary endpoint was the response rate. RESULTS: A partial response was observed in 37 patients (77%; 95% confidence interval: 63-88%). At a median follow up of 54 months, the median progression-free survival and median survival time were 9.3 and 31.3 months, respectively. No difference in efficacy was observed when the patients were stratified by histology. Toxicities were generally mild except for grade 3 or worse febrile neutropenia and pneumonitis of 8% and 4%, respectively. No patient developed severe esophagitis. At the time of this analysis, 35 (73%) of the 48 patients recurred; 15 (31%) showed distant metastasis, 17 (35%) had loco-regional disease, and 2 (4%) showed both loco-regional disease and distant metastasis. CONCLUSIONS: This chemoradiotherapy regimen yielded a relatively favorable efficacy with mild toxicities in patients with locally advanced NSCLC.
Authors: Kenji Fujiwara; May Tun Saung; Hao Jing; Brian Herbst; MacKenzie Zarecki; Stephen Muth; Annie Wu; Elaine Bigelow; Linda Chen; Keyu Li; Neolle Jurcak; Alex B Blair; Ding Ding; Michael Wichroski; Jordan Blum; Nathan Cheadle; Jennifer Koenitzer; Lei Zheng Journal: J Immunother Cancer Date: 2020-07 Impact factor: 13.751