Abstract | BACKGROUND: The prognosis of patients with advanced gastric cancer (AGC) remains poor, and no single chemotherapy regimen is recognized as a global standard. A phase II trial was conducted to determine the efficacy and tolerability of capecitabine and oxaliplatin ( XELOX) given every 3 weeks in combination in patients with AGC. METHODS: Patients with previously untreated AGC received intravenous oxaliplatin 130 mg/m(2) over 2 h on day 1 plus oral capecitabine 1,000 mg/m(2) twice daily on days 1-14, every 3 weeks. Treatment was continued for 8 cycles or until disease progression or intolerable toxicity. RESULTS: Fifty patients were enrolled. In total, 210 cycles of XELOX were delivered. The OVERALL response rate was 42% (95% CI 28.6-56.7), with 2 complete and 19 partial responses. At 15.2 months of median follow-up, median time to progression and overall survival were 5.8 (95% CI 3.4-8.2) and 11.1 (95% CI 5.6-16.5) months, respectively. The most common hematological adverse event was neutropenia (56% of patients); grade 3-4 neutropenia was observed in 6 patients, with neutropenic fever in only 2 patients. The most common non-hematological toxicities were vomiting (34%), hand-foot syndrome (26%), diarrhea (24%) and neurosensory toxicity (22%). There were no treatment-related deaths. CONCLUSIONS:
XELOX is active for the first-line treatment of AGC with a manageable tolerability profile.
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Authors | Hui-yan Luo, Rui-hua Xu, Feng Wang, Miao-zhen Qiu, Yu-hong Li, Fang-hua Li, Zhi-wei Zhou, Xiao-qin Chen |
Journal | Chemotherapy
(Chemotherapy)
Vol. 56
Issue 2
Pg. 94-100
( 2010)
ISSN: 1421-9794 [Electronic] Switzerland |
PMID | 20357440
(Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | (c) 2010 S. Karger AG, Basel. |
Chemical References |
- Oxaloacetates
- Deoxycytidine
- Capecitabine
- Fluorouracil
|
Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Capecitabine
- Deoxycytidine
(adverse effects, analogs & derivatives, therapeutic use)
- Disease Progression
- Female
- Fluorouracil
(adverse effects, analogs & derivatives, therapeutic use)
- Follow-Up Studies
- Humans
- Male
- Middle Aged
- Neutropenia
(chemically induced)
- Oxaloacetates
- Stomach Neoplasms
(drug therapy, pathology)
- Survival
- Treatment Outcome
- Young Adult
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