[Capecitabine combined with cisplatin as first-line therapy in Chinese patients with advanced gastric carcinoma-a phase II clinical study].

Abstract

OBJECTIVE:

To evaluate the effectiveness and safety of the combination chemotherapy of capecitabine (X) with fractionated administration of cisplatin (C) in Chinese patients with advanced gastric cancer (AGC).

METHODS:

141 patients with AGC were enrolled between July 2002 and August 2004. All patients had measurable tumor according to the criteria of RECIST, Karnofsky performance status > or = 60, adequate bone marrow, renal and hepatic functions. Prior radiotherapy or adjuvant chemotherapy was not permitted. Patients received oral administration of capecitabine at a dose of 1000 mg/m(2) twice a day on D1-D14, and intravenous infusion of fractionated cisplatin at a dose of 20 mg/m(2)/day on D1-D5. The regimen was repeated every 3 weeks, totally for 6 cycles.

RESULTS:

Of the 141 evaluable patients, there were 104 men and 37 women, with a median age of 54 years (range, 23 - 80 years). Metastases before chemotherapy were detected in lymph nodes (46.8%), liver (40.4%), lung (5.7%) and other area (10.6%). The median treatment duration was 6 cycles (range, 3 - 6 cycles). The objective response rate (RR) was 36.2% (51/141). The median follow-up period was 17.5 months. The median time to progress (TTP) was 9.0 months, and the median overall survival (OS) was 12.0 months. The most common treatment-related adverse events (grade 3/4) were: hand-foot syndrome (HFS) (2.1%), leucopenia (0.7%), abnormal alanine transaminase elevation (2.8%). There was no treatment-related death.

CONCLUSION:

Capecitabine combined with fractionated cisplatin is highly effective and well tolerated as a first-line treatment for advanced gastric cancer, with comparable results to 5-Fu plus cisplatin combination therapy.

• Authors: Bing Hu, Ji-Ren Yu, Zhao-Zhang Wen, Yong-Qian Shu, Bao-Cheng Wang, Hao-Ran Yin, Li Chen, Yu-Xian Bai, Jun Liang, Li Chen, Ying Cheng, Lin Shen, Yun Zhou, Hong-Gang Zhang, Jie Li, De-Sen Wan, Shuang Chen, Ting-Zhen Jia, Mao-Lin Jin
• Journal: Zhonghua zhong liu za zhi [Chinese journal of oncology] (Zhonghua Zhong Liu Za Zhi) Vol. 30 Issue 12 Pg. 940-3 (Dec 2008) ISSN: 0253-3766 [Print] China
• PMID: 19173999 (Publication Type: Clinical Trial, Phase II, English Abstract, Journal Article, Multicenter Study)

Chemical References

• Deoxycytidine
• Capecitabine
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Capecitabine
• Cisplatin (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Follow-Up Studies
• Foot Dermatoses (chemically induced)
• Hand Dermatoses (chemically induced)
• Humans
• Leukopenia (chemically induced)
• Liver Neoplasms (drug therapy, secondary)
• Lung Neoplasms (drug therapy, secondary)
• Lymphatic Metastasis
• Male
• Middle Aged
• Neoplasm Staging
• Remission Induction
• Stomach Neoplasms (drug therapy, pathology)
• Survival Rate
• Vomiting (chemically induced)
• Young Adult