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Clinical Trial
. 2015 Oct 14:15:693.
doi: 10.1186/s12885-015-1716-9.

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  1 , Sungmin Kim  2 , Moonjin Kim  3 , Jeeyun Lee  4 , Yeon Hee Park  5 , Young-Hyuck Im  6 , Se Hoon Park  7
Affiliations
Clinical Trial

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 et al. BMC Cancer. .

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/m(2) twice daily + D1 cisplatin 75 mg/m(2), every 3 weeks) or the CP arm (D1-14 capecitabine 1000 mg/m(2) twice daily + D1, 8 paclitaxel 80 mg/m(2), 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.

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Figures

Fig. 1
Fig. 1
Flow diagram of all registered patients
Fig. 2
Fig. 2
Progression-free survival for the capecitabine plus paclitaxel arm (CP, solid line) and capecitabine plus cisplatin arm (CC, dotted line)
Fig. 3
Fig. 3
Overall survival for the capecitabine plus paclitaxel arm (CP, solid line) and capecitabine plus cisplatin arm (CC, dotted line)
See this image and copyright information in PMC

References

    1. Kamangar F, Dores GM, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol. 2006;24:2137–50. doi: 10.1200/JCO.2005.05.2308. - DOI - PubMed
    1. Jung KW, Won YJ, Kong HJ, Oh CM, Seo HG, Lee JS. Cancer statistics in Korea: incidence, mortality, survival and prevalence in 2010. Cancer Res Treat. 2013;45:1–14. doi: 10.4143/crt.2013.45.1.1. - DOI - PMC - PubMed
    1. Enzinger PC, Ilson DH, Kelsen DP. Chemotherapy in esophageal cancer. Semin Oncol. 1999;26:12–20. - PubMed
    1. Cunningham D, Starling N, Rao S, Iveson T, Nicolson M, Coxon F, et al. Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med. 2008;358:36–46. doi: 10.1056/NEJMoa073149. - DOI - PubMed
    1. Bleiberg H, Conroy T, Paillot B, Lacave AJ, Blijham G, Jacob JH, et al. Randomised phase II study of cisplatin and 5-fluorouracil (5-FU) versus cisplatin alone in advanced squamous cell oesophageal cancer. Eur J Cancer. 1997;33:1216–20. doi: 10.1016/S0959-8049(97)00088-9. - DOI - PubMed

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