Toshio Kubo1, Keiichi Fujiwara2, Katsuyuki Hotta3,4, Toshiaki Okada5,6, Shoichi Kuyama7,6, Shingo Harita6, Takashi Ninomiya8,9, Haruhito Kamei9,10, Shinobu Hosokawa11, Akihiro Bessho11, Tadashi Maeda10, Toshiyuki Kozuki12, Nobukazu Fujimoto13, Kiichiro Ninomiya8, Mitsuhiro Takemoto14,15, Susumu Kanazawa15, Nagio Takigawa16, Masahiro Tabata1, Mitsune Tanimoto17, Hiroshi Ueoka6,10, Katsuyuki Kiura8. 1. Center for Clinical Oncology, Okayama University Hospital, Okayama, Japan. 2. Department of Respiratory Medicine, Okayama Medical Center, Okayama, Japan. 3. Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan. khotta@okayama-u.ac.jp. 4. Center for Innovative Clinical Medicine, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. khotta@okayama-u.ac.jp. 5. Department of Respiratory Medicine, Fukuyama Medical Center, Fukuyama, Japan. 6. Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Japan. 7. Department of Respiratory Medicine, Iwakuni Medical Center, Iwakuni, Japan. 8. Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan. 9. Department of Clinical Oncology, Sumitomo Besshi Hospital, Niihama, Japan. 10. Department of Medical Oncology, Yamaguchi-Ube Medical Center, Ube, Japan. 11. Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Japan. 12. Department of Thoracic Oncology and Medicine, Shikoku Cancer Center, Matsuyama, Japan. 13. Department of Respiratory Medicine, Okayama Rosai Hospital, Okayama, Japan. 14. Department of Radiotherapy, Japanese Red Cross Society Himeji Hospital, Himeji, Japan. 15. Department of Radiology, Okayama University Hospital, Okayama, Japan. 16. Department of General Internal Medicine 4, Kawasaki Medical School, Okayama, Japan. 17. Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
Abstract
PURPOSE: The treatment outcome in elderly patients with limited-disease small-cell lung cancer (LD-SCLC) remains poor. We carried out a phase II trial of split topotecan and cisplatin (TP) therapy and sequential thoracic radiotherapy for elderly LD-SCLC patients as a follow-up to our previous phase I trial. METHODS: In total, 30 patients aged 76 years or older, with untreated LD-SCLC were enrolled. Four courses of topotecan (1.0 mg/m(2), days 1-3) and cisplatin (20 mg/m(2), days 1-3) were administered, followed by thoracic radiotherapy (1.8 Gy/day, total of 45 Gy). The primary end point was the overall response rate (ORR). RESULTS: The trial was terminated early with 22 patients because of slow accrual. Their median age was 79 years. The median number of courses of chemotherapy administered was three, and the actual completion rate of the entire treatment course was 41 %. The ORR was 68 % with a 95 % confidence interval of 47-89 % (15/22 cases). The median progression-free survival and overall survival were 9.1 and 22.2 months, respectively. The main toxicity was myelosuppression, with grades 3-4 neutropenia (96 %), thrombocytopenia (50 %), and febrile neutropenia (32 %). CONCLUSIONS: This regimen produced a favorable survival outcome, despite moderate-to-severe toxicity profiles. Further efforts are necessary to define an optimal regimen for elderly patients with limited SCLC.
PURPOSE: The treatment outcome in elderly patients with limited-disease small-cell lung cancer (LD-SCLC) remains poor. We carried out a phase II trial of split topotecan and cisplatin (TP) therapy and sequential thoracic radiotherapy for elderly LD-SCLCpatients as a follow-up to our previous phase I trial. METHODS: In total, 30 patients aged 76 years or older, with untreated LD-SCLC were enrolled. Four courses of topotecan (1.0 mg/m(2), days 1-3) and cisplatin (20 mg/m(2), days 1-3) were administered, followed by thoracic radiotherapy (1.8 Gy/day, total of 45 Gy). The primary end point was the overall response rate (ORR). RESULTS: The trial was terminated early with 22 patients because of slow accrual. Their median age was 79 years. The median number of courses of chemotherapy administered was three, and the actual completion rate of the entire treatment course was 41 %. The ORR was 68 % with a 95 % confidence interval of 47-89 % (15/22 cases). The median progression-free survival and overall survival were 9.1 and 22.2 months, respectively. The main toxicity was myelosuppression, with grades 3-4 neutropenia (96 %), thrombocytopenia (50 %), and febrile neutropenia (32 %). CONCLUSIONS: This regimen produced a favorable survival outcome, despite moderate-to-severe toxicity profiles. Further efforts are necessary to define an optimal regimen for elderly patients with limited SCLC.
Authors: Mohammad Hassan Hodroj; Achraf Jardaly; Sarah Abi Raad; Annalise Zouein; Sandra Rizk Journal: Cancer Manag Res Date: 2018-05-10 Impact factor: 3.989