A multicenter phase II study of biweekly capecitabine in combination with oxaliplatin as first-line chemotherapy in patients with locally advanced or metastatic gastric cancer

Yee Chao, Jan Sing Hsieh, Hsien Tang Yeh, Yu Chieh Su, Cheng Chung Wu, Jen Shi Chen, Cheng Jeng Tai, Li Yuan Bai, Kun Huei Yeh, Wu Chou Su, Chung Pin Li

Research output: Contribution to journalArticle

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Abstract

Purpose: We evaluated the safety and efficacy of biweekly capecitabine in combination with oxaliplatin in previously untreated patients with locally advanced or metastatic gastric cancer. Methods: Patients received oral capecitabine 1,000 mg/m2 twice daily on days 1-10 plus oxaliplatin 85 mg/m2 as a 2-h intravenous infusion on day 1, every 2 weeks (XELOX). The primary endpoint was overall response rate. Secondary endpoints included progression-free survival, overall survival, and toxicity. Results: From March 2007 to October 2010, 46 patients were enrolled in this phase II study. The median age was 64 years (range 32-85). A total of 391 (median 7.5, range 1-29) cycles were delivered. Among the 41 patients evaluable for tumor response, 9 showed partial response and 25 had stable disease. The overall response rates of the evaluable and intent-to-treat (ITT) populations were 22 % (95 % CI 10-42 %) and 20 % (95 % CI 9-34 %), respectively. In the ITT analysis, the progression-free survival and overall survival were 5.6 months (95 % CI 4.1-6.3 months) and 8.0 months (95 % CI 6.3-10.1 months), respectively. The most common hematological toxicities were thrombocytopenia (35 %) and leucopenia (34 %), whereas the most common non-hematological toxicities were neuropathy (35 %), fatigue (33 %), diarrhea (27 %), vomiting (26 %), and hand-foot syndrome (25 %). Major grade 3-4 toxicities were anemia (11 %), diarrhea (9 %), and hand-foot syndrome (7 %). No patient died of treatment-related toxicities. Conclusions: Although the biweekly XELOX regimen failed its primary response rate endpoint, it showed modest efficacy and an acceptable safety profile in the treatment of advanced gastric cancer.

Original languageEnglish
Pages (from-to)799-806
Number of pages8
JournalCancer Chemotherapy and Pharmacology
Volume73
Issue number4
DOIs
Publication statusPublished - 2014

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oxaliplatin
Chemotherapy
Stomach Neoplasms
Toxicity
Drug Therapy
Hand-Foot Syndrome
Disease-Free Survival
Diarrhea
Safety
Survival
Leukopenia
Intravenous Infusions
Thrombocytopenia
Vomiting
Fatigue
Anemia
Tumors
Capecitabine
Fatigue of materials

Keywords

  • Biweekly XELOX
  • Capecitabine
  • Gastric cancer
  • Oxaliplatin
  • Phase II study

ASJC Scopus subject areas

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

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A multicenter phase II study of biweekly capecitabine in combination with oxaliplatin as first-line chemotherapy in patients with locally advanced or metastatic gastric cancer. / Chao, Yee; Hsieh, Jan Sing; Yeh, Hsien Tang; Su, Yu Chieh; Wu, Cheng Chung; Chen, Jen Shi; Tai, Cheng Jeng; Bai, Li Yuan; Yeh, Kun Huei; Su, Wu Chou; Li, Chung Pin.

In: Cancer Chemotherapy and Pharmacology, Vol. 73, No. 4, 2014, p. 799-806.

Research output: Contribution to journalArticle

Chao, Yee ; Hsieh, Jan Sing ; Yeh, Hsien Tang ; Su, Yu Chieh ; Wu, Cheng Chung ; Chen, Jen Shi ; Tai, Cheng Jeng ; Bai, Li Yuan ; Yeh, Kun Huei ; Su, Wu Chou ; Li, Chung Pin. / A multicenter phase II study of biweekly capecitabine in combination with oxaliplatin as first-line chemotherapy in patients with locally advanced or metastatic gastric cancer. In: Cancer Chemotherapy and Pharmacology. 2014 ; Vol. 73, No. 4. pp. 799-806.
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abstract = "Purpose: We evaluated the safety and efficacy of biweekly capecitabine in combination with oxaliplatin in previously untreated patients with locally advanced or metastatic gastric cancer. Methods: Patients received oral capecitabine 1,000 mg/m2 twice daily on days 1-10 plus oxaliplatin 85 mg/m2 as a 2-h intravenous infusion on day 1, every 2 weeks (XELOX). The primary endpoint was overall response rate. Secondary endpoints included progression-free survival, overall survival, and toxicity. Results: From March 2007 to October 2010, 46 patients were enrolled in this phase II study. The median age was 64 years (range 32-85). A total of 391 (median 7.5, range 1-29) cycles were delivered. Among the 41 patients evaluable for tumor response, 9 showed partial response and 25 had stable disease. The overall response rates of the evaluable and intent-to-treat (ITT) populations were 22 {\%} (95 {\%} CI 10-42 {\%}) and 20 {\%} (95 {\%} CI 9-34 {\%}), respectively. In the ITT analysis, the progression-free survival and overall survival were 5.6 months (95 {\%} CI 4.1-6.3 months) and 8.0 months (95 {\%} CI 6.3-10.1 months), respectively. The most common hematological toxicities were thrombocytopenia (35 {\%}) and leucopenia (34 {\%}), whereas the most common non-hematological toxicities were neuropathy (35 {\%}), fatigue (33 {\%}), diarrhea (27 {\%}), vomiting (26 {\%}), and hand-foot syndrome (25 {\%}). Major grade 3-4 toxicities were anemia (11 {\%}), diarrhea (9 {\%}), and hand-foot syndrome (7 {\%}). No patient died of treatment-related toxicities. Conclusions: Although the biweekly XELOX regimen failed its primary response rate endpoint, it showed modest efficacy and an acceptable safety profile in the treatment of advanced gastric cancer.",
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author = "Yee Chao and Hsieh, {Jan Sing} and Yeh, {Hsien Tang} and Su, {Yu Chieh} and Wu, {Cheng Chung} and Chen, {Jen Shi} and Tai, {Cheng Jeng} and Bai, {Li Yuan} and Yeh, {Kun Huei} and Su, {Wu Chou} and Li, {Chung Pin}",
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T1 - A multicenter phase II study of biweekly capecitabine in combination with oxaliplatin as first-line chemotherapy in patients with locally advanced or metastatic gastric cancer

AU - Chao, Yee

AU - Hsieh, Jan Sing

AU - Yeh, Hsien Tang

AU - Su, Yu Chieh

AU - Wu, Cheng Chung

AU - Chen, Jen Shi

AU - Tai, Cheng Jeng

AU - Bai, Li Yuan

AU - Yeh, Kun Huei

AU - Su, Wu Chou

AU - Li, Chung Pin

PY - 2014

Y1 - 2014

N2 - Purpose: We evaluated the safety and efficacy of biweekly capecitabine in combination with oxaliplatin in previously untreated patients with locally advanced or metastatic gastric cancer. Methods: Patients received oral capecitabine 1,000 mg/m2 twice daily on days 1-10 plus oxaliplatin 85 mg/m2 as a 2-h intravenous infusion on day 1, every 2 weeks (XELOX). The primary endpoint was overall response rate. Secondary endpoints included progression-free survival, overall survival, and toxicity. Results: From March 2007 to October 2010, 46 patients were enrolled in this phase II study. The median age was 64 years (range 32-85). A total of 391 (median 7.5, range 1-29) cycles were delivered. Among the 41 patients evaluable for tumor response, 9 showed partial response and 25 had stable disease. The overall response rates of the evaluable and intent-to-treat (ITT) populations were 22 % (95 % CI 10-42 %) and 20 % (95 % CI 9-34 %), respectively. In the ITT analysis, the progression-free survival and overall survival were 5.6 months (95 % CI 4.1-6.3 months) and 8.0 months (95 % CI 6.3-10.1 months), respectively. The most common hematological toxicities were thrombocytopenia (35 %) and leucopenia (34 %), whereas the most common non-hematological toxicities were neuropathy (35 %), fatigue (33 %), diarrhea (27 %), vomiting (26 %), and hand-foot syndrome (25 %). Major grade 3-4 toxicities were anemia (11 %), diarrhea (9 %), and hand-foot syndrome (7 %). No patient died of treatment-related toxicities. Conclusions: Although the biweekly XELOX regimen failed its primary response rate endpoint, it showed modest efficacy and an acceptable safety profile in the treatment of advanced gastric cancer.

AB - Purpose: We evaluated the safety and efficacy of biweekly capecitabine in combination with oxaliplatin in previously untreated patients with locally advanced or metastatic gastric cancer. Methods: Patients received oral capecitabine 1,000 mg/m2 twice daily on days 1-10 plus oxaliplatin 85 mg/m2 as a 2-h intravenous infusion on day 1, every 2 weeks (XELOX). The primary endpoint was overall response rate. Secondary endpoints included progression-free survival, overall survival, and toxicity. Results: From March 2007 to October 2010, 46 patients were enrolled in this phase II study. The median age was 64 years (range 32-85). A total of 391 (median 7.5, range 1-29) cycles were delivered. Among the 41 patients evaluable for tumor response, 9 showed partial response and 25 had stable disease. The overall response rates of the evaluable and intent-to-treat (ITT) populations were 22 % (95 % CI 10-42 %) and 20 % (95 % CI 9-34 %), respectively. In the ITT analysis, the progression-free survival and overall survival were 5.6 months (95 % CI 4.1-6.3 months) and 8.0 months (95 % CI 6.3-10.1 months), respectively. The most common hematological toxicities were thrombocytopenia (35 %) and leucopenia (34 %), whereas the most common non-hematological toxicities were neuropathy (35 %), fatigue (33 %), diarrhea (27 %), vomiting (26 %), and hand-foot syndrome (25 %). Major grade 3-4 toxicities were anemia (11 %), diarrhea (9 %), and hand-foot syndrome (7 %). No patient died of treatment-related toxicities. Conclusions: Although the biweekly XELOX regimen failed its primary response rate endpoint, it showed modest efficacy and an acceptable safety profile in the treatment of advanced gastric cancer.

KW - Biweekly XELOX

KW - Capecitabine

KW - Gastric cancer

KW - Oxaliplatin

KW - Phase II study

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