Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: A randomized phase II study

Su Jin Lee, Sungmin Kim, Moonjin Kim, Jeeyun Lee, Yeon Hee Park, Young Hyuck Im, Se Hoon Park

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Background: The aim of this study was to assess the efficacy and safety of a combination regimen of capecitabine plus cisplatin (CC) or capecitabine plus paclitaxel (CP) as a first-line treatment in patients with metastatic esophageal squamous cell carcinoma. Methods: Patients with recurrent or metastatic esophageal squamous cell carcinoma were enrolled in this open-label, phase II, randomized trial. Patients were assigned to either the CC arm (days [D]1-14 capecitabine 1000 mg/m2 twice daily + D1 cisplatin 75 mg/m2, every 3 weeks) or the CP arm (D1-14 capecitabine 1000 mg/m2 twice daily + D1, 8 paclitaxel 80 mg/m2, every 3 weeks). The primary endpoint of the study was response rate and secondary endpoints were progression-free survival (PFS), overall survival (OS), toxicity and quality of life. Results: A total of 94 patients were entered into this study between October 2008 and October 2012, 46 patients in the CC arm and 48 in the CP arm. Patients in both arms received a median of six cycles of treatment (range, 1-14) and the response rates were 57 and 58 % in the cisplatin and paclitaxel arm, respectively. With a median follow-up of 23 months, the median PFS was 5.1 months (95 % CI 4.0-6.2 months) in the cisplatin arm and 6.7 months (95 % CI 4.9-8.5 months) in the paclitaxel arm, whereas the median OS was 10.5 months (95 % CI 9.2-11.9 months) in the cisplatin arm and 13.2 months (95 % CI 9.4-17.0 months) in the paclitaxel arm. Patients in the cisplatin arm were more likely to experience neutropenia and thrombocytopenia, whereas patients in the paclitaxel arm had a higher frequency of neuropathy and alopecia. Quality of life was similar between treatment arms. Conclusions: Both CC and CP regimens were effective and well tolerated as a first-line treatment in patients with metastatic esophageal squamous cell carcinoma.

Original languageEnglish
Article number693
JournalBMC Cancer
Volume15
Issue number1
DOIs
StatePublished - 14 Oct 2015

Keywords

  • Capecitabine
  • Cisplatin
  • Esophageal squamous cell carcinoma
  • First-line palliative chemotherapy
  • Paclitaxel

Fingerprint

Dive into the research topics of 'Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: A randomized phase II study'. Together they form a unique fingerprint.

Cite this