A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy

Yeul Hong Kim, Kei Muro, Hirofumi Yasui, Jen Shi Chen, Min Hee Ryu, Se Hoon Park, Kent Man Chu, Su Pin Choo, Teresa Sanchez, Christine DelaCruz, Pralay Mukhopadhyay, Ioannis Lainas, Chung Pin Li

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose The highest rates of gastric cancer occur in Eastern Asia. Fluoropyrimidine-based therapy is used initially in unresectable and metastatic disease, but no single standard of care exists following disease progression. Ixabepilone, an epothilone B analog, is a non-taxane microtubule- stabilizing agent with clinical activity across multiple tumor types approved by the United States Food and Drug Administration for treatment of metastatic breast cancer. Methods Asian patients with unresectable or metastatic gastric adenocarcinoma who had failed fluoropyrimidinebased chemotherapy received ixabepilone 40 mg/m2 by 3-h intravenous infusion every 3 weeks. The primary endpoint was objective response rate (ORR). Results Fifty-two patients were treated (65.4 % men; median age: 56.5 years). The ORR was 15.4 % (95 % confidence interval [CI] 6.9-28.1); 8 patients achieved partial responses for a median duration of 3.1 months (95 % CI 2.6-4.1 months) and 26 patients (50.0 %) had stable disease. Median progression-free survival was 2.8 months (95 % CI 2.1-3.5 months). The most common grade 3 non-hematological toxicities were fatigue (9.6 %), decreased appetite (7.7 %), sensory neuropathy (5.8 %), and diarrhea (5.8 %). Grade 3/4 neutropenia occurred in 46.2 % of patients. Conclusions Ixabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types.

Original languageEnglish
Pages (from-to)583-590
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume70
Issue number4
DOIs
Publication statusPublished - 2012 Oct 1

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Chemotherapy
Stomach Neoplasms
Drug Therapy
Toxicity
Tumors
Excipients
Confidence Intervals
Fatigue of materials
Far East
Appetite
United States Food and Drug Administration
Standard of Care
Neutropenia
Intravenous Infusions
Microtubules
Disease-Free Survival
Fatigue
Disease Progression
ixabepilone
Diarrhea

Keywords

  • Asian patients
  • Gastric cancer
  • Ixabepilone
  • Second-line therapy

ASJC Scopus subject areas

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

Cite this

A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy. / Kim, Yeul Hong; Muro, Kei; Yasui, Hirofumi; Chen, Jen Shi; Ryu, Min Hee; Park, Se Hoon; Chu, Kent Man; Choo, Su Pin; Sanchez, Teresa; DelaCruz, Christine; Mukhopadhyay, Pralay; Lainas, Ioannis; Li, Chung Pin.

In: Cancer Chemotherapy and Pharmacology, Vol. 70, No. 4, 01.10.2012, p. 583-590.

Research output: Contribution to journalArticle

Kim, YH, Muro, K, Yasui, H, Chen, JS, Ryu, MH, Park, SH, Chu, KM, Choo, SP, Sanchez, T, DelaCruz, C, Mukhopadhyay, P, Lainas, I & Li, CP 2012, 'A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy', Cancer Chemotherapy and Pharmacology, vol. 70, no. 4, pp. 583-590. https://doi.org/10.1007/s00280-012-1943-6
Kim, Yeul Hong ; Muro, Kei ; Yasui, Hirofumi ; Chen, Jen Shi ; Ryu, Min Hee ; Park, Se Hoon ; Chu, Kent Man ; Choo, Su Pin ; Sanchez, Teresa ; DelaCruz, Christine ; Mukhopadhyay, Pralay ; Lainas, Ioannis ; Li, Chung Pin. / A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy. In: Cancer Chemotherapy and Pharmacology. 2012 ; Vol. 70, No. 4. pp. 583-590.
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abstract = "Purpose The highest rates of gastric cancer occur in Eastern Asia. Fluoropyrimidine-based therapy is used initially in unresectable and metastatic disease, but no single standard of care exists following disease progression. Ixabepilone, an epothilone B analog, is a non-taxane microtubule- stabilizing agent with clinical activity across multiple tumor types approved by the United States Food and Drug Administration for treatment of metastatic breast cancer. Methods Asian patients with unresectable or metastatic gastric adenocarcinoma who had failed fluoropyrimidinebased chemotherapy received ixabepilone 40 mg/m2 by 3-h intravenous infusion every 3 weeks. The primary endpoint was objective response rate (ORR). Results Fifty-two patients were treated (65.4 {\%} men; median age: 56.5 years). The ORR was 15.4 {\%} (95 {\%} confidence interval [CI] 6.9-28.1); 8 patients achieved partial responses for a median duration of 3.1 months (95 {\%} CI 2.6-4.1 months) and 26 patients (50.0 {\%}) had stable disease. Median progression-free survival was 2.8 months (95 {\%} CI 2.1-3.5 months). The most common grade 3 non-hematological toxicities were fatigue (9.6 {\%}), decreased appetite (7.7 {\%}), sensory neuropathy (5.8 {\%}), and diarrhea (5.8 {\%}). Grade 3/4 neutropenia occurred in 46.2 {\%} of patients. Conclusions Ixabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types.",
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T1 - A phase II trial of ixabepilone in Asian patients with advanced gastric cancer previously treated with fluoropyrimidine-based chemotherapy

AU - Kim, Yeul Hong

AU - Muro, Kei

AU - Yasui, Hirofumi

AU - Chen, Jen Shi

AU - Ryu, Min Hee

AU - Park, Se Hoon

AU - Chu, Kent Man

AU - Choo, Su Pin

AU - Sanchez, Teresa

AU - DelaCruz, Christine

AU - Mukhopadhyay, Pralay

AU - Lainas, Ioannis

AU - Li, Chung Pin

PY - 2012/10/1

Y1 - 2012/10/1

N2 - Purpose The highest rates of gastric cancer occur in Eastern Asia. Fluoropyrimidine-based therapy is used initially in unresectable and metastatic disease, but no single standard of care exists following disease progression. Ixabepilone, an epothilone B analog, is a non-taxane microtubule- stabilizing agent with clinical activity across multiple tumor types approved by the United States Food and Drug Administration for treatment of metastatic breast cancer. Methods Asian patients with unresectable or metastatic gastric adenocarcinoma who had failed fluoropyrimidinebased chemotherapy received ixabepilone 40 mg/m2 by 3-h intravenous infusion every 3 weeks. The primary endpoint was objective response rate (ORR). Results Fifty-two patients were treated (65.4 % men; median age: 56.5 years). The ORR was 15.4 % (95 % confidence interval [CI] 6.9-28.1); 8 patients achieved partial responses for a median duration of 3.1 months (95 % CI 2.6-4.1 months) and 26 patients (50.0 %) had stable disease. Median progression-free survival was 2.8 months (95 % CI 2.1-3.5 months). The most common grade 3 non-hematological toxicities were fatigue (9.6 %), decreased appetite (7.7 %), sensory neuropathy (5.8 %), and diarrhea (5.8 %). Grade 3/4 neutropenia occurred in 46.2 % of patients. Conclusions Ixabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types.

AB - Purpose The highest rates of gastric cancer occur in Eastern Asia. Fluoropyrimidine-based therapy is used initially in unresectable and metastatic disease, but no single standard of care exists following disease progression. Ixabepilone, an epothilone B analog, is a non-taxane microtubule- stabilizing agent with clinical activity across multiple tumor types approved by the United States Food and Drug Administration for treatment of metastatic breast cancer. Methods Asian patients with unresectable or metastatic gastric adenocarcinoma who had failed fluoropyrimidinebased chemotherapy received ixabepilone 40 mg/m2 by 3-h intravenous infusion every 3 weeks. The primary endpoint was objective response rate (ORR). Results Fifty-two patients were treated (65.4 % men; median age: 56.5 years). The ORR was 15.4 % (95 % confidence interval [CI] 6.9-28.1); 8 patients achieved partial responses for a median duration of 3.1 months (95 % CI 2.6-4.1 months) and 26 patients (50.0 %) had stable disease. Median progression-free survival was 2.8 months (95 % CI 2.1-3.5 months). The most common grade 3 non-hematological toxicities were fatigue (9.6 %), decreased appetite (7.7 %), sensory neuropathy (5.8 %), and diarrhea (5.8 %). Grade 3/4 neutropenia occurred in 46.2 % of patients. Conclusions Ixabepilone is active in Asian patients with advanced gastric cancer and shows a toxicity profile similar to those previously reported in other tumor types.

KW - Asian patients

KW - Gastric cancer

KW - Ixabepilone

KW - Second-line therapy

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