TY - JOUR
T1 - Gemcitabine and S-1 versus gemcitabine and cisplatin treatment in patients with advanced biliary tract cancer
T2 - a multicenter retrospective study
AU - Takahara, Naminatsu
AU - Isayama, Hiroyuki
AU - Nakai, Yousuke
AU - Sasaki, Takashi
AU - Ishigaki, Kazunaga
AU - Saito, Kei
AU - Akiyama, Dai
AU - Uchino, Rie
AU - Mizuno, Suguru
AU - Yagioka, Hiroshi
AU - Kogure, Hirofumi
AU - Togawa, Osamu
AU - Matsubara, Saburo
AU - Ito, Yukiko
AU - Toda, Nobuo
AU - Tada, Minoru
AU - Koike, Kazuhiko
N1 - Publisher Copyright:
© 2017, Springer Science+Business Media New York.
PY - 2017/6/1
Y1 - 2017/6/1
N2 - Objective This study aimed to compare the safety and efficacy of the combination therapy of gemcitabine and S-1 (GS) versus gemcitabine and cisplatin (GC) in patients with advanced biliary tract cancer (BTC). Methods In this multicenter retrospective cohort study, a total of 212 patients with advanced BTC receiving GS (n = 125) or GC (n = 87) between July 2006 and August 2015 were analyzed. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), objective tumor response, and safety. Results Patient characteristics were well balanced between the two groups, except for tumor size (the baseline sum of the largest diameter of the tumor: 6.3 cm in the GS group vs. 8.6 cm in the GC group, p = 0.01). Although the response rate was higher in the GS group than in the GC group (28.8% vs. 10.3%, p = 0.01), the median PFS and OS were comparable between the two groups (PFS of 5.6 vs. 7.6 months, p = 0.74; OS of 12.4 vs. 9.2 months, p = 0.20, respectively). Stomatitis and skin rash were more frequently observed in the GS group, whereas anemia, thrombocytopenia, nausea, and renal toxicity were more commonly observed in the GC group. Conclusion This study demonstrates that GS and GC are similar with regard to their safety and efficacy in patients with advanced BTC. GS could serve as an alternative treatment for advanced BTC as a first-line chemotherapy.
AB - Objective This study aimed to compare the safety and efficacy of the combination therapy of gemcitabine and S-1 (GS) versus gemcitabine and cisplatin (GC) in patients with advanced biliary tract cancer (BTC). Methods In this multicenter retrospective cohort study, a total of 212 patients with advanced BTC receiving GS (n = 125) or GC (n = 87) between July 2006 and August 2015 were analyzed. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), objective tumor response, and safety. Results Patient characteristics were well balanced between the two groups, except for tumor size (the baseline sum of the largest diameter of the tumor: 6.3 cm in the GS group vs. 8.6 cm in the GC group, p = 0.01). Although the response rate was higher in the GS group than in the GC group (28.8% vs. 10.3%, p = 0.01), the median PFS and OS were comparable between the two groups (PFS of 5.6 vs. 7.6 months, p = 0.74; OS of 12.4 vs. 9.2 months, p = 0.20, respectively). Stomatitis and skin rash were more frequently observed in the GS group, whereas anemia, thrombocytopenia, nausea, and renal toxicity were more commonly observed in the GC group. Conclusion This study demonstrates that GS and GC are similar with regard to their safety and efficacy in patients with advanced BTC. GS could serve as an alternative treatment for advanced BTC as a first-line chemotherapy.
KW - Biliary tract cancer
KW - Chemotherapy
KW - Cisplatin
KW - Gemcitabine
KW - Retrospective study
KW - S-1
UR - http://www.scopus.com/inward/record.url?scp=85010748403&partnerID=8YFLogxK
U2 - 10.1007/s10637-017-0430-7
DO - 10.1007/s10637-017-0430-7
M3 - Article
C2 - 28124197
AN - SCOPUS:85010748403
SN - 0167-6997
VL - 35
SP - 269
EP - 276
JO - Investigational New Drugs
JF - Investigational New Drugs
IS - 3
ER -
