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Long term outcomes and exploratory analyses of the randomised phase 3 BILCAP study

Long term outcomes and exploratory analyses of the randomised phase 3 BILCAP study
Long term outcomes and exploratory analyses of the randomised phase 3 BILCAP study
Purpose: the BILCAP study described a modest benefit for capecitabine as adjuvant therapy for curatively resected biliary tract cancer (BTC), and capecitabine has become the standard of care. We present the long-term data and novel exploratory subgroup analyses. Methods: this randomized, controlled, multicenter, phase III study recruited patients age 18 years or older with histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer after resection with curative intent and an Eastern Cooperative Oncology Group performance status of < 2. Patients were randomly assigned 1:1 to receive oral capecitabine (1,250 mg/m2 twice daily on days 1-14 of a 21-day cycle, for eight cycles) or observation. The primary outcome was overall survival (OS). This study is registered with EudraCT 2005-003318-13. Results: between March 15, 2006, and December 4, 2014, 447 patients were enrolled; 223 patients with BTC resected with curative intent were randomly assigned to the capecitabine group and 224 to the observation group. At the data cutoff of January 21, 2021, the median follow-up for all patients was 106 months (95% CI, 98 to 108). In the intention-to-treat analysis, the median OS was 49.6 months (95% CI, 35.1 to 59.1) in the capecitabine group compared with 36.1 months (95% CI, 29.7 to 44.2) in the observation group (adjusted hazard ratio 0.84; 95% CI, 0.67 to 1.06). In a protocol-specified sensitivity analysis, adjusting for minimization factors, nodal status, grade, and sex, the OS hazard ratio was 0.74 (95% CI, 0.59 to 0.94). We further describe the prognostic impact of R status, grade, nodal status, and sex. Conclusion: this long-term analysis supports the previous analysis, suggesting that capecitabine can improve OS in patients with resected BTC when used as adjuvant chemotherapy after surgery and should be considered as the standard of care.
0732-183X
2048-2057
Bridgewater, John
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Fletcher, Peter
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Palmer, Daniel H.
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Malik, Hassan Z.
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Prasad, Raj
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Mirza, Darius
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Anthony, Alan
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Corrie, Pippa G.
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Falk, Stephen
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Finch-Jones, Meg
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Wasan, Harpreet
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Ross, Paul J.
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Wall, Lucy
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Wadsley, Jonathan
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Evans, Thomas R Jeffry
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Stocken, Deborah D.
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Stubbs, Clive
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Praseedom, Raaj
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Ma, Yuk Ting
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Davidson, Brian
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Neoptolemos, John P.
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Iveson, Timothy
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Cunningham, David
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Garden, O James
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Valle, Juan W.
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Primrose, John
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Bridgewater, John
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Fletcher, Peter
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Palmer, Daniel H.
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Malik, Hassan Z.
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Prasad, Raj
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Mirza, Darius
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Anthony, Alan
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Corrie, Pippa G.
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Falk, Stephen
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Finch-Jones, Meg
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Wasan, Harpreet
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Ross, Paul J.
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Wall, Lucy
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Wadsley, Jonathan
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Evans, Thomas R Jeffry
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Stocken, Deborah D.
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Stubbs, Clive
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Praseedom, Raaj
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Ma, Yuk Ting
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Davidson, Brian
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Neoptolemos, John P.
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Iveson, Timothy
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Cunningham, David
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Garden, O James
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Valle, Juan W.
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Primrose, John
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Bridgewater, John, Fletcher, Peter, Palmer, Daniel H., Malik, Hassan Z., Prasad, Raj, Mirza, Darius, Anthony, Alan, Corrie, Pippa G., Falk, Stephen, Finch-Jones, Meg, Wasan, Harpreet, Ross, Paul J., Wall, Lucy, Wadsley, Jonathan, Evans, Thomas R Jeffry, Stocken, Deborah D., Stubbs, Clive, Praseedom, Raaj, Ma, Yuk Ting, Davidson, Brian, Neoptolemos, John P., Iveson, Timothy, Cunningham, David, Garden, O James, Valle, Juan W. and Primrose, John (2022) Long term outcomes and exploratory analyses of the randomised phase 3 BILCAP study. Journal of Clinical Oncology, 40 (18), 2048-2057. (doi:10.1200/JCO.21.02568).

Record type: Article

Abstract

Purpose: the BILCAP study described a modest benefit for capecitabine as adjuvant therapy for curatively resected biliary tract cancer (BTC), and capecitabine has become the standard of care. We present the long-term data and novel exploratory subgroup analyses. Methods: this randomized, controlled, multicenter, phase III study recruited patients age 18 years or older with histologically confirmed cholangiocarcinoma or muscle-invasive gallbladder cancer after resection with curative intent and an Eastern Cooperative Oncology Group performance status of < 2. Patients were randomly assigned 1:1 to receive oral capecitabine (1,250 mg/m2 twice daily on days 1-14 of a 21-day cycle, for eight cycles) or observation. The primary outcome was overall survival (OS). This study is registered with EudraCT 2005-003318-13. Results: between March 15, 2006, and December 4, 2014, 447 patients were enrolled; 223 patients with BTC resected with curative intent were randomly assigned to the capecitabine group and 224 to the observation group. At the data cutoff of January 21, 2021, the median follow-up for all patients was 106 months (95% CI, 98 to 108). In the intention-to-treat analysis, the median OS was 49.6 months (95% CI, 35.1 to 59.1) in the capecitabine group compared with 36.1 months (95% CI, 29.7 to 44.2) in the observation group (adjusted hazard ratio 0.84; 95% CI, 0.67 to 1.06). In a protocol-specified sensitivity analysis, adjusting for minimization factors, nodal status, grade, and sex, the OS hazard ratio was 0.74 (95% CI, 0.59 to 0.94). We further describe the prognostic impact of R status, grade, nodal status, and sex. Conclusion: this long-term analysis supports the previous analysis, suggesting that capecitabine can improve OS in patients with resected BTC when used as adjuvant chemotherapy after surgery and should be considered as the standard of care.

Text
BILCAP JCO 20211216 clean-J Clinical Oncology - Accepted Manuscript
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Accepted/In Press date: 9 February 2022
e-pub ahead of print date: 22 March 2022

Identifiers

Local EPrints ID: 455801
URI: http://eprints.soton.ac.uk/id/eprint/455801
ISSN: 0732-183X
PURE UUID: 7acf9961-7656-41fa-9b33-1243f727bd65
ORCID for Timothy Iveson: ORCID iD orcid.org/0000-0002-4681-2712
ORCID for John Primrose: ORCID iD orcid.org/0000-0002-2069-7605

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Date deposited: 05 Apr 2022 16:40
Last modified: 01 Jul 2022 17:01

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Contributors

Author: John Bridgewater
Author: Peter Fletcher
Author: Daniel H. Palmer
Author: Hassan Z. Malik
Author: Raj Prasad
Author: Darius Mirza
Author: Alan Anthony
Author: Pippa G. Corrie
Author: Stephen Falk
Author: Meg Finch-Jones
Author: Harpreet Wasan
Author: Paul J. Ross
Author: Lucy Wall
Author: Jonathan Wadsley
Author: Thomas R Jeffry Evans
Author: Deborah D. Stocken
Author: Clive Stubbs
Author: Raaj Praseedom
Author: Yuk Ting Ma
Author: Brian Davidson
Author: John P. Neoptolemos
Author: Timothy Iveson ORCID iD
Author: David Cunningham
Author: O James Garden
Author: Juan W. Valle
Author: John Primrose ORCID iD

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