Phase II study of capecitabine plus cisplatin as first-line chemotherapy in advanced gastric cancer

被引:104
作者
Kim, TW
Kang, YK
Ahn, JH
Chang, HM
Yook, JH
Oh, ST
Kim, BS
Lee, JS
机构
[1] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Med,Sect Hematol Oncol, Seoul 138736, South Korea
[2] Univ Ulsan, Coll Med, Asan Med Ctr, Dept Gen Surg, Seoul 138736, South Korea
关键词
capecitabine; chemotherapy; cisplatin; stomach cancer;
D O I
10.1093/annonc/mdf323
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: A phase II study was conducted to assess the efficacy and tolerability of combination therapy with capecitabine and cisplatin in patients with advanced gastric cancer. Patients and methods: Patients with previously untreated metastatic or unresectable measurable gastric adenocarcinoma received oral capecitabine 1250 mg/m(2) twice daily, days 1-14, and i.v. cisplatin 60 mg/m(2) on day 1. This cycle was repeated every 3 weeks. Results: Forty-two patients were enrolled in this study. Of these, 38 patients were assessable for efficacy and 40 were assessable for toxicity. One patient achieved a complete response and 22 patients had partial responses, giving an overall response rate of 54.8% in the intention-to-treat population (95% confidence interval 39.8% to 69.8%). The median time to progression was 6.3 months and the median overall survival was 10.1 months. The principal adverse events were neutropenia and hand-foot syndrome. Grade 3/4 adverse events were neutropenia (32.5% of patients), thrombocytopenia (10%), stomatitis (2.5%) and diarrhea (5%). Grade 2 and 3 hand-foot syndrome occurred in 20% and 7.5% of patients, respectively. There were no treatment-related deaths. Conclusions: The combination of capecitabine and cisplatin is active and well tolerated in patients with advanced gastric cancer.
引用
收藏
页码:1893 / 1898
页数:6
相关论文
共 20 条
  • [1] Ahn Myung-Ju, 1998, Journal of Korean Medical Science, V13, P612
  • [2] DETERMINATION OF NUMBER OF PATIENTS REQUIRED IN A PRELIMINARY AND A FOLLOW-UP TRIAL OF A NEW CHEMOTHERAPEUTIC AGENT
    GEHAN, EA
    [J]. JOURNAL OF CHRONIC DISEASES, 1961, 13 (04): : 346 - &
  • [3] Comparison of oral capecitabine versus intravenous fluorouracil plus leucovorin as first-line treatment in 605 patients with metastatic colorectal cancer: Results of a randomized phase III study
    Hoff, PM
    Ansari, R
    Batist, G
    Cox, J
    Kocha, W
    Kuperminc, M
    Maroun, J
    Walde, D
    Weaver, C
    Harrison, E
    Burger, HU
    Osterwalder, B
    Wang, AO
    Wong, R
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2001, 19 (08) : 2282 - 2292
  • [4] Ishikawa T, 1998, CANCER RES, V58, P685
  • [5] Capecitabine: preclinical pharmacology studies
    Ishitsuka, H
    [J]. INVESTIGATIONAL NEW DRUGS, 2000, 18 (04) : 343 - 354
  • [6] KIM NK, 1993, CANCER, V71, P3813, DOI 10.1002/1097-0142(19930615)71:12<3813::AID-CNCR2820711205>3.0.CO
  • [7] 2-5
  • [8] KOIZUMI W, 1993, CANCER, V72, P658, DOI 10.1002/1097-0142(19930801)72:3<658::AID-CNCR2820720306>3.0.CO
  • [9] 2-K
  • [10] KOIZUMI W, 2001, P AN M AM SOC CLIN, V20, pB142