Combination Therapy with Capecitabine and Cisplatin as Second-Line Chemotherapy for Advanced Biliary Tract Cancer

Background/Aims: Palliative chemotherapy is the main treatment for advanced biliary tract cancer (BTC). However, there is a lack of established second-line chemotherapy to treat disease progression after first-line chemotherapy. We examined combination therapy with capecitabine and cisplatin for advanced BTC as a second-line regimen. Methods: We analyzed the medical records of 40 patients diagnosed with BTC who received palliative second-line chemotherapy with capecitabine and cisplatin. Results: The median overall survival from the start of second-line chemotherapy was 6.3 months. The median overall survival from diagnosis was 17.9 months. The median progression-free survival during second-line chemotherapy was 2.3 months. Nine (30%) patients experienced adverse events of grade ≥3. Eastern Cooperative Oncology Group performance score was an independent predictor of adverse events. Conclusions: Combination therapy with capecitabine and cisplatin may be an option for second-line chemotherapy in some of patients with advanced BTC.

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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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Analysis of 94 patients with advanced biliary tract cancer

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.15172 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 15172-15172

Author(s):

B. Andritzky ◽

S. Adler ◽

I. Burkholder ◽

I. Thöm ◽

G. Schuch ◽

...

Keyword(s):

Overall Survival ◽

Bile Duct ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Primary Tumor ◽

Median Overall Survival ◽

Response Rate ◽

Cytotoxic Agents ◽

Tract Cancer ◽

Line Chemotherapy

15172 Background: Cholangiocarcinoma or gallbladder cancer are often diagnosed at an advanced stage with limited treatment options. Methods: Between 1994 and 2004, 94 patients (pts) (47 male, 47 female) with advanced biliary tract cancer were treated at the Department of Oncology and Hematology, University Hospital Hamburg-Eppendorf. Clinical and histopathological characteristics, response to chemotherapy, and survival were investigated in a retrospective analysis. Median age was 59 years (range 30–80) and median Karnofsky performance status was 90%. Predominant histologic type was adenocarcinoma (94.7%). Primary tumor sites were extrahepatic bile duct (29.9%), gallbladder (28.7%), intrahepatic bile duct (10.6%), ampulla of Vater (2.1%), not specified (28.7%). Predominant localizations of metastases were liver (73 pts (77.7%)), lymph nodes (49 pts (52.1%)) and the peritoneum (14 pts (14.9%)). 33 pts (35.1%) underwent surgery of the primary tumor at time of diagnosis. Results: 72 of 94 pts (76.6%) received a first-line chemotherapy, all together 10 different chemotherapy regimens were used. The median number of cycles was 2.5 (range 1 - 12). A single agent chemotherapy with gemcitabine was the most often adminstered regimen (23 pts (31.9%)), followed by carboplatin and etoposide plus whole body hyperthermia (12 pts (16.7%)) and 5- fluorouracil and folic acid (10 pts (13.9%)). The overall response rate was 8.3% (95% CI 3.1 - 17.3) (34.7% SD, 47.2% PD, 9.7% not evaluable). Second-line chemotherapy was given in 27 patients, which induced no tumor response, but a stable disease rate of 22.2%. Median time to follow- up was 44.8 months. Survival was calculated for all 94 pts since time of diagnosis. Median overall survival was 12.2 months and median progression-free survival 9.2 months. The median overall survival time for the 72 pts who were treated with chemotherapy was 14.0 months, and for the 22 pts who did not receive chemotherapy 10.7 months (p=0.2). Conclusions: Our analysis showed a poor prognosis for patients with advanced biliary tract cancer. Response rate to chemotherapy was low. Therefore, well tolerated cytotoxic agents should be used and new treatment strategies (including molecular targeted therapy) should be further investigated. No significant financial relationships to disclose.

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

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.338 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 338-338

Author(s):

Thomas Walter ◽

Anne M. Horgan ◽

Elizabeth McKeever ◽

Trisha Min ◽

Mairead McNamara ◽

...

Keyword(s):

Disease Control ◽

Biliary Tract ◽

Biliary Tract Cancer ◽

Univariate Analysis ◽

Single Agent ◽

Objective Response ◽

Second Line ◽

Second Line Chemotherapy ◽

Tract Cancer ◽

Line Chemotherapy

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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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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