723P - Gemcitabine plus cisplatin versus capcitbine plus cisplatin for locally advanced or metastatic biliary tract cancer

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Hepatobiliary Cancers
Presenter Kwonoh Park
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors K. Park1, K. Kim2
  • 1Hematology-oncology, KEPCO Medical Center, Seoul, Korea, 132-703 - Seoul/KR
  • 2Department Of Oncology, Asan Medical Center, Seoul/KR

Abstract

Aim

Combination chemotherapy with gemcitabine and cisplatin is regarded as a standard chemotherapy for patients with advanced biliary tract cancer (BTC). Results of phase 2 trials of 5-FU or its derivatives combined with cisplatin in BTCs have shown modest benefits. It remains unclear whether capecitabine combined with cisplatin would show similar effects compared with standard therapy using gemcitabine with cisplatin.

Methods

A clinical database was used to identify all patients with locally advanced or metastatic BTC (cholangiocarcnoma, gallbladder cancer) who treated with first-linechemotherapy in the Asan Medical Center. All patients received either cisplatin (25mg/m2) followed by gemcitabine (1000mg/m2), each administered on days 1 and 8 every 3 weeks (GP-W group), or capecitabine (1000 mg/m2 twice daily) on days 1-14, and cisplatin (60 mg/m2) on day 1 every 3 weeks (XP group). Patients' medical characteristics, radiological responses, and survival status were analyzed.

Results

Of the 134 patients who met the inclusion criteria, 78 received XP and the other 56 were treated with GP-W. There were gallbladder cancer (25 [32%]) and cholangiocarcinoma (53 [68%]) in XP group, 15[27%] and 41[73%] in GP-W group (P = 0.57). The two groups were balanced including site of tumor except for a higher proportion of patients with relapsed setting in XP group (29 [37%] vs 6 [11%]). After a median follow-up duration of 26.2 months (95% CI 24.2-28.2), progression-free survival (PFS) was 5.7 month (95% C.I. 4.3 – 7.1) for XP and 4.1 month (95% C.I. 3.0 – 5.2) for GP-W. (hazard ratio [HR, GP-W vs XP] 0.81, 95% CI, 0.55-1.21, P = 0.31). The overall survival (OS) was 11.0 months (95% CI 7.1 - 14.9) for XP and 9.8 months (95% C.I. 7.5 - 12.2) for GP-W. (HR = 0.84, 95% CI 0.57–1.23, P = 0.36). The two groups showed same response rates (XP vs GP-W, 7 [9%] vs 5 [9%]) and were not stastically different in terms of disease control rate (75% vs 74%, P = 1.00).

Conclusions

The XP regimen seems to be as effective as GP-W in patients with advanced BTC. The XP regimen might be a viable option due to efficacy and conveniance, such as one visit schedule per one cycle.

Disclosure

All authors have declared no conflicts of interest.