A phase II trial of Ifosfamide combination with recommended supportive therapy for recurrent SCLC in second-line and heavily treated setting

Ichidai Tanaka, Kenji Kawada, Masahiro Morise, Tetsunari Hase, Hiroaki Hayashi, Akihiko Sokai, Asuki Fukatsu, Masashi Kondo, Fumio Nomura, Yoshinori Hasegawa

Research output: Contribution to journalArticle

Abstract

Purpose: The response rate of ifosfamide (IFM) monotherapy for small-cell lung cancer (SCLC) is reported as 42.4% in Japanese package insert. However, these efficacy data are based on clinical studies conducted in 1970s. This phase II study evaluated the efficacy and safety of IFM combination with recommended current supportive therapy for recurrent SCLC in second-line and heavily treated setting. Methods: Recurrent SCLC patients pretreated with one to three prior regimens received IFM monotherapy (1.5 g/m 2 for 3 days every 3 weeks). Treatment was continued until disease progression or unacceptable toxicity. The primary end point was objective response rate. Results: Twelve patients were enrolled in the study from June 2009 to January 2013. The study was early terminated at interim analysis due to futility stop. Patient characteristics were as follows: median age was 65 years, 11 were males (91.7%) and eight (66.7%) and four (33.3%) were Performance Status 0 and 1, respectively. Four patients (33.3%) enrolled in second-line setting were all refractory relapse SCLC and 8 (66.7%) were heavily treated patients. No patient showed objective response. Stable disease was observed in 3 patients. Median progression-free survival and overall survival were 0.9 months (95% CI, 0.3–1.5) and 4.8 months (95% CI, 1.6–9.9), respectively. Although one grade 4 amylase increase possibly related to IFM was observed, toxicity profile was totally favorable. Conclusions: IFM monotherapy should not be used for refractory relapse or heavily treated SCLC, and no further investigation is required in these populations.

Original languageEnglish
Pages (from-to)339-345
Number of pages7
JournalCancer Chemotherapy and Pharmacology
Volume81
Issue number2
DOIs
Publication statusPublished - 01-02-2018

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Ifosfamide
Small Cell Lung Carcinoma
Refractory materials
Toxicity
Cells
Therapeutics
Amylases
Medical Futility
Product Labeling
Recurrence
Disease-Free Survival
Disease Progression
Safety
Survival
Population

All Science Journal Classification (ASJC) codes

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

Cite this

Tanaka, Ichidai ; Kawada, Kenji ; Morise, Masahiro ; Hase, Tetsunari ; Hayashi, Hiroaki ; Sokai, Akihiko ; Fukatsu, Asuki ; Kondo, Masashi ; Nomura, Fumio ; Hasegawa, Yoshinori. / A phase II trial of Ifosfamide combination with recommended supportive therapy for recurrent SCLC in second-line and heavily treated setting. In: Cancer Chemotherapy and Pharmacology. 2018 ; Vol. 81, No. 2. pp. 339-345.
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abstract = "Purpose: The response rate of ifosfamide (IFM) monotherapy for small-cell lung cancer (SCLC) is reported as 42.4{\%} in Japanese package insert. However, these efficacy data are based on clinical studies conducted in 1970s. This phase II study evaluated the efficacy and safety of IFM combination with recommended current supportive therapy for recurrent SCLC in second-line and heavily treated setting. Methods: Recurrent SCLC patients pretreated with one to three prior regimens received IFM monotherapy (1.5 g/m 2 for 3 days every 3 weeks). Treatment was continued until disease progression or unacceptable toxicity. The primary end point was objective response rate. Results: Twelve patients were enrolled in the study from June 2009 to January 2013. The study was early terminated at interim analysis due to futility stop. Patient characteristics were as follows: median age was 65 years, 11 were males (91.7{\%}) and eight (66.7{\%}) and four (33.3{\%}) were Performance Status 0 and 1, respectively. Four patients (33.3{\%}) enrolled in second-line setting were all refractory relapse SCLC and 8 (66.7{\%}) were heavily treated patients. No patient showed objective response. Stable disease was observed in 3 patients. Median progression-free survival and overall survival were 0.9 months (95{\%} CI, 0.3–1.5) and 4.8 months (95{\%} CI, 1.6–9.9), respectively. Although one grade 4 amylase increase possibly related to IFM was observed, toxicity profile was totally favorable. Conclusions: IFM monotherapy should not be used for refractory relapse or heavily treated SCLC, and no further investigation is required in these populations.",
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A phase II trial of Ifosfamide combination with recommended supportive therapy for recurrent SCLC in second-line and heavily treated setting. / Tanaka, Ichidai; Kawada, Kenji; Morise, Masahiro; Hase, Tetsunari; Hayashi, Hiroaki; Sokai, Akihiko; Fukatsu, Asuki; Kondo, Masashi; Nomura, Fumio; Hasegawa, Yoshinori.

In: Cancer Chemotherapy and Pharmacology, Vol. 81, No. 2, 01.02.2018, p. 339-345.

Research output: Contribution to journalArticle

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AU - Tanaka, Ichidai

AU - Kawada, Kenji

AU - Morise, Masahiro

AU - Hase, Tetsunari

AU - Hayashi, Hiroaki

AU - Sokai, Akihiko

AU - Fukatsu, Asuki

AU - Kondo, Masashi

AU - Nomura, Fumio

AU - Hasegawa, Yoshinori

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N2 - Purpose: The response rate of ifosfamide (IFM) monotherapy for small-cell lung cancer (SCLC) is reported as 42.4% in Japanese package insert. However, these efficacy data are based on clinical studies conducted in 1970s. This phase II study evaluated the efficacy and safety of IFM combination with recommended current supportive therapy for recurrent SCLC in second-line and heavily treated setting. Methods: Recurrent SCLC patients pretreated with one to three prior regimens received IFM monotherapy (1.5 g/m 2 for 3 days every 3 weeks). Treatment was continued until disease progression or unacceptable toxicity. The primary end point was objective response rate. Results: Twelve patients were enrolled in the study from June 2009 to January 2013. The study was early terminated at interim analysis due to futility stop. Patient characteristics were as follows: median age was 65 years, 11 were males (91.7%) and eight (66.7%) and four (33.3%) were Performance Status 0 and 1, respectively. Four patients (33.3%) enrolled in second-line setting were all refractory relapse SCLC and 8 (66.7%) were heavily treated patients. No patient showed objective response. Stable disease was observed in 3 patients. Median progression-free survival and overall survival were 0.9 months (95% CI, 0.3–1.5) and 4.8 months (95% CI, 1.6–9.9), respectively. Although one grade 4 amylase increase possibly related to IFM was observed, toxicity profile was totally favorable. Conclusions: IFM monotherapy should not be used for refractory relapse or heavily treated SCLC, and no further investigation is required in these populations.

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