TY - JOUR
T1 - A phase II study of topotecan and cisplatin with sequential thoracic radiotherapy in elderly patients with small-cell lung cancer
T2 - Okayama Lung Cancer Study Group 0102
AU - Kubo, Toshio
AU - Fujiwara, Keiichi
AU - Hotta, Katsuyuki
AU - Okada, Toshiaki
AU - Kuyama, Shoichi
AU - Harita, Shingo
AU - Ninomiya, Takashi
AU - Kamei, Haruhito
AU - Hosokawa, Shinobu
AU - Bessho, Akihiro
AU - Maeda, Tadashi
AU - Kozuki, Toshiyuki
AU - Fujimoto, Nobukazu
AU - Ninomiya, Kiichiro
AU - Takemoto, Mitsuhiro
AU - Kanazawa, Susumu
AU - Takigawa, Nagio
AU - Tabata, Masahiro
AU - Tanimoto, Mitsune
AU - Ueoka, Hiroshi
AU - Kiura, Katsuyuki
N1 - Publisher Copyright:
© 2016, Springer-Verlag Berlin Heidelberg.
Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 2016/10/1
Y1 - 2016/10/1
N2 - 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/m2, days 1–3) and cisplatin (20 mg/m2, 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.
AB - 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/m2, days 1–3) and cisplatin (20 mg/m2, 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.
KW - Chemotherapy
KW - Elderly patient
KW - Lung cancer
KW - Topotecan
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U2 - 10.1007/s00280-016-3135-2
DO - 10.1007/s00280-016-3135-2
M3 - Article
C2 - 27544764
AN - SCOPUS:84982295415
VL - 78
SP - 769
EP - 774
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 4
ER -