Dose and schedule modification are required for long-term continuation of sunitinib in Japanese patients with advanced pancreatic neuroendocrine tumors

Lingaku Lee, Tetsuhide Ito, Hisato Igarashi, Masami Miki, Nao Fujimori, Ken Kawabe, Robert T. Jensen, Yoshihiro Ogawa

研究成果: ジャーナルへの寄稿記事

3 引用 (Scopus)

抄録

Purpose: This study aimed to clarify the efficacy and safety of sunitinib in Japanese patients with pancreatic neuroendocrine tumors (PNET), especially by focusing on dose and schedule modification. Methods: Sixteen patients with advanced PNET treated with sunitinib were reviewed retrospectively. Efficacy was evaluated by progression-free survival (PFS) and objective tumor response. Toxicity profile was assessed regularly. Correlation between relative dose intensity (RDI) and treatment period was also evaluated. Results: The median PFS was 25.8 months, and the probability of PFS at 1-year was 92%. The objective response rate and clinical benefit rate were 44% and 69%, respectively. The common adverse drug reactions (ADRs) were hand-foot syndrome (88%), neutropenia (75%), leucopenia (75%), and diarrhea (63%). Due to the development of severe ADRs, 81% required dose reduction and 31% discontinued sunitinib treatment, respectively. Prolonged treatment period was significantly correlated with decreased RDI (Spearman r = − 0.57, P = 0.022). The median RDI among 9 patients whom continued sunitinib more than 1 year was 49%. Conclusions: Sunitinib showed significant clinical benefit in Japanese patients with advanced PNET in the real-world clinical setting. Successful management of ADRs with appropriate dose reduction and interruption can enable long-term continuation of sunitinib.

元の言語英語
ページ(範囲)163-169
ページ数7
ジャーナルCancer chemotherapy and pharmacology
81
発行部数1
DOI
出版物ステータス出版済み - 1 1 2018

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Neuroendocrine Tumors
Tumors
Appointments and Schedules
Drug-Related Side Effects and Adverse Reactions
Disease-Free Survival
Hand-Foot Syndrome
Pharmaceutical Preparations
Leukopenia
Neutropenia
Toxicity
sunitinib
Diarrhea
Therapeutics
Safety
Neoplasms

All Science Journal Classification (ASJC) codes

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

これを引用

Dose and schedule modification are required for long-term continuation of sunitinib in Japanese patients with advanced pancreatic neuroendocrine tumors. / Lee, Lingaku; Ito, Tetsuhide; Igarashi, Hisato; Miki, Masami; Fujimori, Nao; Kawabe, Ken; Jensen, Robert T.; Ogawa, Yoshihiro.

:: Cancer chemotherapy and pharmacology, 巻 81, 番号 1, 01.01.2018, p. 163-169.

研究成果: ジャーナルへの寄稿記事

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abstract = "Purpose: This study aimed to clarify the efficacy and safety of sunitinib in Japanese patients with pancreatic neuroendocrine tumors (PNET), especially by focusing on dose and schedule modification. Methods: Sixteen patients with advanced PNET treated with sunitinib were reviewed retrospectively. Efficacy was evaluated by progression-free survival (PFS) and objective tumor response. Toxicity profile was assessed regularly. Correlation between relative dose intensity (RDI) and treatment period was also evaluated. Results: The median PFS was 25.8 months, and the probability of PFS at 1-year was 92{\%}. The objective response rate and clinical benefit rate were 44{\%} and 69{\%}, respectively. The common adverse drug reactions (ADRs) were hand-foot syndrome (88{\%}), neutropenia (75{\%}), leucopenia (75{\%}), and diarrhea (63{\%}). Due to the development of severe ADRs, 81{\%} required dose reduction and 31{\%} discontinued sunitinib treatment, respectively. Prolonged treatment period was significantly correlated with decreased RDI (Spearman r = − 0.57, P = 0.022). The median RDI among 9 patients whom continued sunitinib more than 1 year was 49{\%}. Conclusions: Sunitinib showed significant clinical benefit in Japanese patients with advanced PNET in the real-world clinical setting. Successful management of ADRs with appropriate dose reduction and interruption can enable long-term continuation of sunitinib.",
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AU - Lee, Lingaku

AU - Ito, Tetsuhide

AU - Igarashi, Hisato

AU - Miki, Masami

AU - Fujimori, Nao

AU - Kawabe, Ken

AU - Jensen, Robert T.

AU - Ogawa, Yoshihiro

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N2 - Purpose: This study aimed to clarify the efficacy and safety of sunitinib in Japanese patients with pancreatic neuroendocrine tumors (PNET), especially by focusing on dose and schedule modification. Methods: Sixteen patients with advanced PNET treated with sunitinib were reviewed retrospectively. Efficacy was evaluated by progression-free survival (PFS) and objective tumor response. Toxicity profile was assessed regularly. Correlation between relative dose intensity (RDI) and treatment period was also evaluated. Results: The median PFS was 25.8 months, and the probability of PFS at 1-year was 92%. The objective response rate and clinical benefit rate were 44% and 69%, respectively. The common adverse drug reactions (ADRs) were hand-foot syndrome (88%), neutropenia (75%), leucopenia (75%), and diarrhea (63%). Due to the development of severe ADRs, 81% required dose reduction and 31% discontinued sunitinib treatment, respectively. Prolonged treatment period was significantly correlated with decreased RDI (Spearman r = − 0.57, P = 0.022). The median RDI among 9 patients whom continued sunitinib more than 1 year was 49%. Conclusions: Sunitinib showed significant clinical benefit in Japanese patients with advanced PNET in the real-world clinical setting. Successful management of ADRs with appropriate dose reduction and interruption can enable long-term continuation of sunitinib.

AB - Purpose: This study aimed to clarify the efficacy and safety of sunitinib in Japanese patients with pancreatic neuroendocrine tumors (PNET), especially by focusing on dose and schedule modification. Methods: Sixteen patients with advanced PNET treated with sunitinib were reviewed retrospectively. Efficacy was evaluated by progression-free survival (PFS) and objective tumor response. Toxicity profile was assessed regularly. Correlation between relative dose intensity (RDI) and treatment period was also evaluated. Results: The median PFS was 25.8 months, and the probability of PFS at 1-year was 92%. The objective response rate and clinical benefit rate were 44% and 69%, respectively. The common adverse drug reactions (ADRs) were hand-foot syndrome (88%), neutropenia (75%), leucopenia (75%), and diarrhea (63%). Due to the development of severe ADRs, 81% required dose reduction and 31% discontinued sunitinib treatment, respectively. Prolonged treatment period was significantly correlated with decreased RDI (Spearman r = − 0.57, P = 0.022). The median RDI among 9 patients whom continued sunitinib more than 1 year was 49%. Conclusions: Sunitinib showed significant clinical benefit in Japanese patients with advanced PNET in the real-world clinical setting. Successful management of ADRs with appropriate dose reduction and interruption can enable long-term continuation of sunitinib.

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