A phase II study of topotecan and cisplatin with sequential thoracic radiotherapy in elderly patients with small-cell lung cancer: Okayama Lung Cancer Study Group 0102

Toshio Kubo, Keiichi Fujiwara, Katsuyuki Hotta, Toshiaki Okada, Shoichi Kuyama, Shingo Harita, Takashi Ninomiya, Haruhito Kamei, Shinobu Hosokawa, Akihiro Bessho, Tadashi Maeda, Toshiyuki Kozuki, Nobukazu Fujimoto, Kiichiro Ninomiya, Mitsuhiro Takemoto, Susumu Kanazawa, Nagio Takigawa, Masahiro Tabata, Mitsune Tanimoto, Hiroshi UeokaKatsuyuki Kiura

Research output: Contribution to journalArticle

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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/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.

Original languageEnglish
Pages (from-to)1-6
Number of pages6
JournalCancer Chemotherapy and Pharmacology
DOIs
Publication statusAccepted/In press - Aug 20 2016

Fingerprint

Topotecan
Small Cell Lung Carcinoma
Radiotherapy
Cisplatin
Lung Neoplasms
Thorax
Cells
Toxicity
Chemotherapy
Febrile Neutropenia
Survival
Neutropenia
Thrombocytopenia
Disease-Free Survival
Confidence Intervals
Drug Therapy
Therapeutics

Keywords

  • Chemotherapy
  • Elderly patient
  • Lung cancer
  • Topotecan

ASJC Scopus subject areas

  • Medicine(all)
  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

Cite this

A phase II study of topotecan and cisplatin with sequential thoracic radiotherapy in elderly patients with small-cell lung cancer : Okayama Lung Cancer Study Group 0102. / Kubo, Toshio; Fujiwara, Keiichi; Hotta, Katsuyuki; Okada, Toshiaki; Kuyama, Shoichi; Harita, Shingo; Ninomiya, Takashi; Kamei, Haruhito; Hosokawa, Shinobu; Bessho, Akihiro; Maeda, Tadashi; Kozuki, Toshiyuki; Fujimoto, Nobukazu; Ninomiya, Kiichiro; Takemoto, Mitsuhiro; Kanazawa, Susumu; Takigawa, Nagio; Tabata, Masahiro; Tanimoto, Mitsune; Ueoka, Hiroshi; Kiura, Katsuyuki.

In: Cancer Chemotherapy and Pharmacology, 20.08.2016, p. 1-6.

Research output: Contribution to journalArticle

Kubo, Toshio ; Fujiwara, Keiichi ; Hotta, Katsuyuki ; Okada, Toshiaki ; Kuyama, Shoichi ; Harita, Shingo ; Ninomiya, Takashi ; Kamei, Haruhito ; Hosokawa, Shinobu ; Bessho, Akihiro ; Maeda, Tadashi ; Kozuki, Toshiyuki ; Fujimoto, Nobukazu ; Ninomiya, Kiichiro ; Takemoto, Mitsuhiro ; Kanazawa, Susumu ; Takigawa, Nagio ; Tabata, Masahiro ; Tanimoto, Mitsune ; Ueoka, Hiroshi ; Kiura, Katsuyuki. / A phase II study of topotecan and cisplatin with sequential thoracic radiotherapy in elderly patients with small-cell lung cancer : Okayama Lung Cancer Study Group 0102. In: Cancer Chemotherapy and Pharmacology. 2016 ; pp. 1-6.
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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/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.",
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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

PY - 2016/8/20

Y1 - 2016/8/20

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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