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Randomized Controlled Trial
. 2016 May 3;7(18):26888-97.
doi: 10.18632/oncotarget.8590.

Combined gemcitabine and S-1 chemotherapy for treating unresectable hilar cholangiocarcinoma: a randomized open-label clinical trial

Hao Li  1   2 , Zheng-Yun Zhang  2 , Zun-Qiang Zhou  2 , Jiao Guan  2 , Da-Nian Tong  2 , Guang-Wen Zhou  2
Affiliations
Randomized Controlled Trial

Combined gemcitabine and S-1 chemotherapy for treating unresectable hilar cholangiocarcinoma: a randomized open-label clinical trial

Hao Li et al. Oncotarget. .

Abstract

Although the combination of cisplatin and gemcitabine (GEM) is considered the standard first-line chemotherapy against unresectable hilar cholangiocarcinoma (HC), its efficacy is discouraging. The present randomized open-label clinical trial aimed to evaluate the efficacy and safety of the GEM plus S-1 (GEM-S-1) combination against unresectable HC. Twenty-five patients per group were randomly assigned to receive GEM, S-1 or GEM-S-1. Neutropenia (56%) and leukopenia (40%) were the most common chemotherapy-related toxicities in the GEM-S-1 group. Median overall survival (OS) in the GEM-S-1, GEM and S-1 groups was 11, 10 and 6 months, respectively. GEM plus S-1 significantly improved OS compared to S-1 monotherapy (OR=0.68; 95%CI, 0.50-0.90; P=0.008). Median progression-free survival (PFS) times in the GEM-S-1, GEM and S-1 groups were 4.90, 3.70 and 1.60 months, respectively. GEM plus S-1 significantly improved PFS compared to S-1 monotherapy (OR=0.50; 95%CI, 0.27-0.91; P=0.024). Response rates were 36%, 24% and 8% in the GEM-S-1, GEM and S-1 groups, respectively. A statistically significant difference was found in response rates between the gemcitabine-S-1 and S-1 groups (36% vs 8%, P=0.017). Patients with CA19-9<466 U/ml were more responsive to chemotherapeutic agents than those with CA19-9≥571 U/ml (88.9% vs 0%, P<0.001). We conclude that the combination of GEM plus S-1 provides a better OS, PFS and response rate than S-1 monotherapy, but it did not significantly differ from GEM monotherapy. (ChiCTR-TRC-14004733).

Keywords: CA19-9; S-1; chemotherapy; gemcitabine; hilar cholangiocarcinoma.

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Conflict of interest statement

The authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1. Patient selection flow chart
Seventy-five out of 79 patients completed the analysis, including 25 each in the GEM, S-1 and GEM-S-1 groups. GEM, gemcitabine; GEM-S-1, gemcitabine plus S-1.
Figure 2
Figure 2. Kaplan-Meier curves of OS according to treatment group
GEM, gemcitabine; GEM-S-1, gemcitabine plus S-1; 95%CI, 95% confidence interval.
Figure 3
Figure 3. Kaplan-Meier curves of PFS according to treatment group
GEM, gemcitabine; GEM-S-1, gemcitabine plus S-1; 95%CI, 95% confidence interval.
See this image and copyright information in PMC

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