Feasibility and potential benefits of second-line chemotherapy in patients with advanced biliary tract cancer.

338 Background: Chemotherapy is effective in metastatic or unresectable biliary tract cancer (BTC). The benefits of second-line chemotherapy (CT2) are unclear. Methods: We retrospectively studied all patients (pts) receiving at least one cycle of chemotherapy for advanced BTC at our institution between 1991 and 2011. We analyzed pt and chemotherapy characteristics (type of regimen; tumor response; time to progression (TTP); and overall survival (OS)). The objectives were: 1) to characterize pts eligible for CT2; 2) to evaluate the efficacy of CT2. Results: 367, 89 (24%), and 24 (6%) pts received CT1, CT2, and CT3, respectively. Primary tumor location was the gallbladder (30%), intraphepatic (16%), perihilar (20%), distal common bile duct (20%), and ampulla of Vater (14%). 88% had a baseline performance status of 0-1 prior to CT1. The regimen and efficacy data of CT1 and CT2 are presented in the Table . On univariate analysis females (p=0.002) and pts with TTP >6 months on CT1 (p=0.016) were the only variables associated with receiving CT2. The only factor associated with disease control (objective response+ stable disease) on CT2 was the regimen type (75% with a doublet versus 46% with monotherapy, p=0.03). Conclusions: Among patients with advanced BTC treated with chemotherapy, less than 25% received CT2; but responses were seen and were surprisingly high even in this selected population. Pts with a longer TTP on CT1 were more likely to be offered CT2. Better disease control with CT2 occurs with a doublet than single agent, however clearly more effective therapies must be found. Updated data will be presented. [Table: see text]

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Feasibility and benefits of second-line chemotherapy in advanced biliary tract cancer: A large retrospective study.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e14524 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e14524-e14524

Author(s):

Thomas Walter ◽

Anne Horgan ◽

Mairead Geraldine McNamara ◽

Elizabeth McKeever ◽

Trisha Min ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Performance Status ◽

Single Agent ◽

Objective Response ◽

Second Line ◽

Distal Common Bile Duct ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

e14524 Background: Chemotherapy is effective in advanced biliary tract cancer (ABTC). The benefits of second-line chemotherapy (CT2) are unclear. Methods: We retrospectively studied all patients starting at least one line of chemotherapy for ABTC at our institution between 1991 and 2011. We analyzed patient and chemotherapy characteristics in order to: 1) characterize patients eligible for CT2; 2) evaluate the efficacy of CT2. Results: Three hundred and ninety five, 100 (25%), and 25 (6%) patients received CT1, CT2, and CT3, respectively. Primary tumor location was the gallbladder (29%), intraphepatic (19%), perihilar (17%), distal common bile duct (19%), and ampulla of Vater (14%). Ninety-one percent had a baseline performance status (PS) of 0-1 prior to CT1. Females (p=0.005), age≤60 years (p=0.009), and patients with progression free survival (PFS) >6 months following CT1 (p=0.01) were more likely to be offered CT2. Objective response rates and stable disease with CT2 were 10% and 35%, respectively. Median PFS and median overall survival (OS) from the beginning of CT2 were 2.8 and 8.0 months, respectively. Prognostic factors impacting PFS with CT2 were the regimen type (doublet versus monotherapy, p=0.004) and PS<2 (p<0.0001). Conclusions: Among patients with ABTC, 25% received CT2, typically younger patients and those with longer PFS following CT1. Disease control occurred in 45% of patients, and more often with a doublet than single agent. However, clearly more effective therapies must be found.

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Capecitabine and cisplatin as a second-line chemotherapy for patients with advanced biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.4_suppl.543 ◽

2020 ◽

Vol 38 (4_suppl) ◽

pp. 543-543

Author(s):

Kabsoo Shin ◽

In Seok Lee ◽

Tae Ho Hong ◽

Joori Kim ◽

Myung Ah Lee

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Performance Status ◽

Objective Response ◽

Locally Advanced ◽

Second Line ◽

Primary Tumor Site ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

543 Background: Few data are available on second-line chemotherapy for patients with advanced biliary tract cancer. We retrospectively analyzed the efficacy and safety of capecitabine and cisplatin combination as second-line chemotherapy for advanced biliary tract cancer. Methods: Between Mar, 2014 and Dec, 2018, advanced BTC patients who received second-line capecitabine and cisplatin after the failure of the gemcitabine-platinum combination were analyzed. Progression‐free survival (PFS) and overall survival (OS) were estimated with the Kaplan‐Meier method. Cox models were used for multivariate analyses. Results: Of total 40 patients, male: female was 24(60%) to 16(40%), and the median age was 68 years old (range: 45-77) . As primary tumor site, 8(20%) was intrahepatic, 16(40%) was extrahepatic and 16(40%) was gallbladder. Initially metastatic disease was 22(55%), and recurrent disease after curative surgery was 17(42.5%) and locally advanced unresectable disease was 1(2.5%). 30(75%) patients had ECOG performance status of 0-1. The mean number of the chemotherapy cycles was 3.3 ± 2.0. Objective response rates and stable disease were 12.5% and 25%, respectively. Median PFS and median OS from the beginning of the capcitabine and cisplatin combination were 2.8 and 7.0 months, respectively. Grade 3-4 adverse event were neutropenia (n = 7, 17.5%), anemia(n = 3, 7.5%), hand-foot syndrome (n = 3, 7.5%), nausea and vomiting(n = 2, 5%), peripheral neuropathy (n = 2, 5%) and mucositis(n = 1, 2.5%). And there was no treatment related death. Conclusions: This study showed the possible survival benefit of capecitabine and cisplatin combination as second-line chemotherapy for advanced biliary tract cancer.

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FOLFOX as Second-Line Chemotherapy for Advanced Biliary Tract Cancer

SSRN Electronic Journal ◽

10.2139/ssrn.3709828 ◽

2020 ◽

Author(s):

Angela Lamarca ◽

Daniel Palmer ◽

Harpreet Wasan ◽

Paul J. Ross ◽

Yuk Ting Ma ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Second Line ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

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Second-line chemotherapy (CT2) in advanced biliary tract cancer (aBTC) patients (pts) progressed to first-line chemotherapy (CT1) with gemcitabine plus platinum: where are we now?

Annals of Oncology ◽

10.1093/annonc/mdv344.14 ◽

2015 ◽

Vol 26 ◽

pp. vi94

Author(s):

L. Fornaro ◽

S. Cereda ◽

F. Leone ◽

G. Aprile ◽

S. Lonardi ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Second Line ◽

First Line ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

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Second-line chemotherapy in patients with biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.15_suppl.e14590 ◽

2011 ◽

Vol 29 (15_suppl) ◽

pp. e14590-e14590 ◽

Cited By ~ 3

Author(s):

G. Brandi ◽

S. Di Girolamo ◽

F. de Rosa ◽

J. Corbelli ◽

V. Agostini ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Second Line ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

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P-0117 Second-Line Chemotherapy with S-1 after Cisplatin and Gemcitabine Failure in Patients with Advanced Biliary Tract Cancer

Annals of Oncology ◽

10.1016/s0923-7534(20)30036-3 ◽

2012 ◽

Vol 23 ◽

pp. iv65 ◽

Cited By ~ 1

Author(s):

Shinya Ueda ◽

Hisato Kawakami ◽

Wataru Okamoto ◽

Shinichi Nishina ◽

Toshihiro Kudo ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Second Line ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

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Benefit of second-line chemotherapy for advanced biliary tract cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e15621 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e15621-e15621 ◽

Cited By ~ 1

Author(s):

Florian Moik ◽

Jakob M. Riedl ◽

Thomas Winder ◽

Angelika Bezan ◽

Christopher Rossmann ◽

...

Keyword(s):

Biliary Tract ◽

Biliary Tract Cancer ◽

Randomized Study ◽

Study Groups ◽

Best Supportive Care ◽

Second Line ◽

Prognostic Variables ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

e15621 Background: Second-line chemotherapy (2LCTX) is increasingly applied in patients (pts) with advanced biliary tract cancer (aBTC), although no randomized trial has so far demonstrated the benefit of this intervention over best supportive care (BSC) alone. In the absence of randomized data, we thus conducted a comparative effectiveness analysis of survival outcomes in aBTC pts treated with BSC±2LCTX. Methods: In this single-center cohort study, we retrospectively included 80 pts with metastatic, recurrent, or inoperable aBTC who completed 1st-line CTX at our department between 2003 and 2016. Thirty-eight of these pts (48%) received 2LCTX+BSC (Fluoropyrimidine (FP) mono: n = 26 (68%), FP-based combination CTX: n = 9 (24%), Others: n = 3 (8%)). Primary endpoint was 18-month overall survival (OS). An inverse-probability-of-treatment-weighted analysis (IPTW) was implemented to rigorously account for imbalances in prognostic variables between the two study groups. Results: During a median follow-up of 14.8 months, we observed 49 deaths. Six-month, 12-month, and 18-month OS estimates were 77%, 53% and 23% in the BSC+2LCTX group, and 29%, 21%, and 14% in patients in the BSC group, for a univariable hazard ratio (HR) for OS of 0.36 (95%CI: 0.20-0.64, p = 0.001). However, pts receiving 2LCTX+BSC had a significantly higher prevalence of favorable prognostic variables, such as a higher Karnofsky Index (p = 0.0001), lower serum bilirubin (p = 0.03), higher hemoglobin (p = 0.002), and higher serum albumin (p = 0.0007). After careful adjustment for these imbalances using IPTW, 2LCTX+BSC was not associated with an OS benefit over BSC alone (Adjusted HR = 0.62, 95%CI: 0.30-1.29, p = 0.201). In IPTW analysis, 6-, 12-, and 18-month OS were 51%, 33% and 14% in the BSC+2LCTX group, and 35%, 29%, and 19% in patients in the BSC group. The beneficial association of 2LCTX with OS was highly time-dependent, with IPTW HRs of 0.07 (p = 0.002), 0.42 (p = 0.05), and 0.53 (p = 0.11) after 3, 6, and 12 months, respectively. Conclusions: Within the limitations of a non-randomized study, our data support the concept that 2LCTX is associated with a short-term OS benefit in pts with aBTC.

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