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 - Funding Information:
K.H. has received honoraria from AstraZeneca, Eli Lilly Japan, Daiichi-Sankyo Pharmaceutical, Boehringer-Ingelheim, Nihon Kayaku, Taiho Pharmaceutical, and Chugai Pharmaceutical. KH also has received research funding from Eli Lilly Japan, MSD, and Chugai Pharmaceutical. J.S. has received honoraria from Pfizer, Eli Lilly, Taiho Pharmaceutical, Chugai Pharmaceutical, Boehringer-Ingelheim, AstraZeneca, and Kyowa Kirin. N.T. has received honoraria from Eli Lilly Japan, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer Japan Inc, and Boehringer-Ingelheim in Japan. K.K. has received honoraria from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical, and Sanofi-Aventis. The remaining authors have stated that they have no conflicts of interest.
Funding Information:
We thank the patients and their families for participating in this trial. We also thank Yasunari Nakata, Masafumi Fujii, Hiroshi Date (Kyoto University Hospital), Masahiro Osawa, Daisuke Morichika, Tomoki Tamura (Okayama University Hospital), Hiromasa Takeda (Tsuyama Central Hospital), Nobuhiro Honda (Kawasaki Hospital), and Toshi Murakami (Japanese Red Cross Society Himeji Hospital), for cooperating in this trial. This study has been conducted with support from the Center for Innovative Clinical Medicine, Okayama University Hospital.
Publisher Copyright:
© 2016, Springer-Verlag Berlin Heidelberg.
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
SN - 0344-5704
VL - 78
SP - 769
EP - 774
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 4
ER -