Cancer Res Treat.  2019 Jul;51(3):901-909. 10.4143/crt.2018.326.

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

• Hyung J
• Kim B
• Yoo C
• Kim KP
• Jeong JH
• Chang HM
• Ryoo BY

• KMID: 2454282
• DOI: http://doi.org/10.4143/crt.2018.326

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).
CONCLUSION
sGemCis maintenance is not associated with an improved survival outcome.

Keyword

Biliary tract neoplasms; Gemcitabine; Cisplatin; Cholangiocarcinoma

MeSH Terms

Biliary Tract Neoplasms*
Biliary Tract*
Cholangiocarcinoma
Chungcheongnam-do
Cisplatin*
Disease-Free Survival
Drug Therapy
Humans
Korea
Retrospective Studies
Seoul
Cisplatin

Figure

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  Fig. 1. Study outline. BTC, biliary tract cancer; GemCis, gemcitabine plus cisplatin; PD, progressive disease.

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  Fig. 2. Overall survival (OS) (A) and progression-free survival (PFS) (B) from the initiation of first-line gemcitabine plus cisplatin. CI, confidence interval.

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  Fig. 3. Overall survival (OS) (A) and progression-free survival (PFS) (B) from the completion of scheduled gemcitabine plus cisplatin.

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  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.

Reference

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