Clinical Benefit of Maintenance Therapy for Advanced Biliary Tract Cancer Patients Showing No Progression after First-Line Gemcitabine Plus Cisplatin

Jaewon Hyung, Bumjun Kim, Changhoon Yoo, Kyo-Pyo Kim, Jae Ho Jeong, Heung-Moon Chang, Baek-Yeol Ryoo, Jaewon Hyung, Bumjun Kim, Changhoon Yoo, Kyo-Pyo Kim, Jae Ho Jeong, Heung-Moon Chang, Baek-Yeol Ryoo

Abstract

Purpose: Gemcitabine plus cisplatin (GemCis) is the standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC). In ABC-02 study, the BTC patients received up to 6-8 cycles of 3-weekly GemCis; however, those without progression often receive more than 6-8 cycles. The clinical benefit of maintenance treatment in patients without progression is uncertain.

Materials and methods: Advanced BTC patients treated with GemCis between April 2010 and February 2015 at Asan Medical Center, Seoul, Korea, were retrospectively analysed. The patients without progression after 6-8 cycles were stratified according to further treatment i.e., with or without further cycles of GemCis (maintenance vs. observation groups). The primary endpoint was overall survival (OS) and progression-free survival (PFS).

Results: Among the 740 BTC patients in the initial screen, 231 cases (31.2%) were eligible for analysis (111 in the observation group, 120 in the maintenance group). The median OS from the GemCis initiation was 20.5 months (95% confidence interval [CI], 15.4 to 25.6) and 22.4 months (95% CI, 17.0 to 27.8) in the observation and maintenance groups, respectively (p=0.162). The median PFS was 10.4 months (95% CI, 7.0 to 13.8) and 13.2 months (95% CI, 11.3 to 15.2), respectively (p=0.320).

Conclusions: GemCis maintenance is not associated with an improved survival outcome.

Keywords: Biliary tract neoplasms; Cholangiocarcinoma; Cisplatin; Gemcitabine.

Conflict of interest statement

Conflict of interest relevant to this article was not reported.

Figures

Fig. 1.
Fig. 1.
Study outline. BTC, biliary tract cancer; GemCis, gemcitabine plus cisplatin; PD, progressive disease.
Fig. 2.
Fig. 2.
Overall survival (OS) (A) and progression-free survival (PFS) (B) from the initiation of first-line gemcitabine plus cisplatin. CI, confidence interval.
Fig. 3.
Fig. 3.
Overall survival (OS) (A) and progression-free survival (PFS) (B) from the completion of scheduled gemcitabine plus cisplatin.
Fig. 4.
Fig. 4.
Overall survival (OS) (A) and progression-free survival (PFS) (B) with second-line therapy after disease progression on first-line gemcitabine plus cisplatin.

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