J Cancer 2019; 10(25):6185-6190. doi:10.7150/jca.37610

Research Paper

Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial

Seung Tae Kim1*, Sung Yong Oh2*, Jeeyun Lee1, Jung Hun Kang3, Hyun Woo Lee4, Myung Ah Lee5, Byeong Seok Sohn6, Ji Hyong Hong7, Young Suk Park1, Joon Oh Park1✉, Ho Yeong Lim1✉

1. Department of Medicine, Sungkyunkwan University School of Medicine, Samsung Medical Centre, Seoul, South Korea;
2. Department of Medicine, Dong-A University School of Medicine, Busan, South Korea;
3. Department of Medicine, Gyeongsang National University Hospital, Jinju, South Korea;
4. Department of Medicine, Ajou University School of Medicine, Suwon, South Korea;
5. Department of Medicine, Seoul St Mary's Hospital, Catholic University, Seoul, South Korea;
6. Department of Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, South Korea;
7. Department of Medicine, Incheon St Mary's Hospital, Catholic University, Incheon, South Korea.
*These authors contributed equally.

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Citation:
Kim ST, Oh SY, Lee J, Kang JH, Lee HW, Lee MA, Sohn BS, Hong JH, Park YS, Park JO, Lim HY. Capecitabine plus Oxaliplatin as a Second-Line Therapy for Advanced Biliary Tract Cancers: A Multicenter, Open-Label, Phase II Trial. J Cancer 2019; 10(25):6185-6190. doi:10.7150/jca.37610. Available from http://www.jcancer.org/v10p6185.htm

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Abstract

Background: Although biliary tract cancer (BTC) has a very aggressive nature, some patients maintain a relatively good performance status after failure with first-line treatment of gemcitabine plus cisplatin (GC). Thus, tolerable, feasible, and useful second-line treatments are needed for these patients. We investigated the efficacy of capecitabine plus oxaliplatin (XELOX) as a second-line therapy for patients with advanced BTC who failed first-line GC treatment.

Methods: In this prospective, phase II trial, we investigated XELOX (capecitabine 1,000 mg/m2 twice daily on days 1-14 and oxaliplatin 130 mg/m2 on day 1) as a second-line treatment, given every 3 weeks, totaling 8 cycles in patients with metastatic BTC who failed first-line GC treatment. The primary outcome was progression-free survival (PFS).

Results: From December 2015 to November 2016, 50 patients with metastatic intrahepatic or extrahepatic cholangiocarcinoma or gall bladder (GB) cancer were enrolled. The regimen was well tolerated. Toxicities mainly consisted of grade 1 or 2 events, and thrombocytopenia and neuropathy had the highest incidence. In intent-to-treat analysis, one complete response (CR) and six partial responses (PRs) were recorded with XELOX treatment. The overall response rate and the disease control rate from the intent-to-treat analysis were 14% and 52%, respectively. With a median follow-up of 15.6 months, PFS after XELOX was a median of 15.4 weeks (95% CI, 8.5-22.3). This PFS value supported the statistical hypothesis of this study. The median overall survival was 32.7 weeks (95% CI, 21.4-43.9).

Conclusion: This phase II trial showed that XELOX treatment was efficacious and had a tolerable toxicity profile in patients with advanced BTC who failed first-line treatment of gemcitabine and cisplatin.

Keywords: biliary tract cancer, capecitabine, oxaliplatin