Real-world efficacy and safety of nab-paclitaxel plus gemcitabine-cisplatin in patients with advanced biliary tract cancers: a multicenter retrospective analysis

Jaekyung Cheon, Choong-Kun Lee, Yun Beom Sang, Hye Jin Choi, Min Hwan Kim, Jun Ho Ji, Kwang Hyun Ko, Chang-Il Kwon, Dae Jung Kim, Sung Hoon Choi, Chan Kim, Beodeul Kang, Hong Jae Chon, Jaekyung Cheon, Choong-Kun Lee, Yun Beom Sang, Hye Jin Choi, Min Hwan Kim, Jun Ho Ji, Kwang Hyun Ko, Chang-Il Kwon, Dae Jung Kim, Sung Hoon Choi, Chan Kim, Beodeul Kang, Hong Jae Chon

Abstract

Background: A recent phase II trial reported prolonged survival in patients with advanced biliary tract cancer (BTC) following treatment with nab-paclitaxel plus gemcitabine-cisplatin (Gem/Cis/nab-P). We aimed to evaluate the clinical outcomes of Gem/Cis/nab-P in Asian patients with advanced BTC in a real-world setting.

Methods: We reviewed the data of patients who received Gem/Cis/nab-P for the management of advanced BTC between September 2019 and April 2021 at four institutes in Korea. Patients were classified into the Gem/Cis/nab-P and nab-P addition groups depending on the starting point of nab-P administration.

Results: A total of 178 patients treated with Gem/Cis/nab-P were included in the study. Of these, 43.8% had intrahepatic cholangiocarcinoma (CCA), 34.8% had extrahepatic CCA, and 21.3% had gall bladder cancer. A total of 117 (65.7%) patients received Gem/Cis/nab-P as the first-line treatment, while 61 (34.3%) were treated with gemcitabine-cisplatin-based chemotherapy followed by nab-P addition. The objective response rate (ORR) and disease control rate in all patients were 42.1% and 84.8%, respectively. The ORR in the Gem/Cis/nab-P group was 47.9%, while that in the nab-P addition group was 31.1%. The median progression-free survival and overall survival were 8.5 months [95% confidence interval (CI), 6.9-10.1] and 14.6 months (95% CI, 10.2-19.0), respectively. In patients who received Gem/Cis/nab-P as initial treatment, the median PFS was 9.4 months (95% CI, 7.9-10.9) and the median OS was not-reached (95% CI, not available). Anemia (n = 42, 23.6%), neutropenia (n = 40, 22.5%), and thrombocytopenia (n = 16, 9.0%) were the most common grade 3-4 toxicities. A total of 20 patients (11.2%) had conversions from unresectable to resectable disease and underwent surgery with curative intent.

Conclusion: Gem/Cis/nab-P showed favorable real-life efficacy and safety outcomes in Korean patients with advanced BTC, which was consistent with the phase II trial outcomes.

Keywords: biliary tract cancer; cisplatin; gemcitabine; nab-paclitaxel; real-world.

Conflict of interest statement

Conflict of interest statement: HJ.Chon has a consulting or advisory role at Roche, Bayer, Eisai, ONO, BMS, and MSD. J.Cheon received honoraria from Bayer, Eisai, Ipsen, MSD, BMS and Roche. All other authors have no potential conflicts of interest to declare.

© The Author(s), 2021.

Figures

Figure 1.
Figure 1.
CONSORT diagram and study scheme. Gem/Cis, gemcitabine-cisplatin; Gem/Cis/nab-P, nab-paclitaxel plus gemcitabine-cisplatin; nab-P, nab-paclitaxel; PD, progressive disease; PFS, progression-free survival; OS, overall survival.
Figure 2.
Figure 2.
Progression-free survival and overall survival with all patients (a) and patients who received nab-paclitaxel plus gemcitabine-cisplatin as initial treatment (b).

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