Systemic therapy in younger and elderly patients with advanced biliary cancer: Sub-analysis of ABC-02 and twelve other prospective trials

Mairéad Geraldine McNamara, John Bridgewater, Andre Lopes, Harpreet Wasan, David Malka, Lars Henrik Jensen, Takuji Okusaka, Jennifer J. Knox, Dorothea Wagner, David Cunningham, Jenny Shannon, David Goldstein, Markus Moehler, Tanios Bekaii-Saab, Juan W. Valle

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Abstract

Background: Outcomes in younger (<40years) and elderly (≥70years) patients with advanced biliary cancer (ABC) receiving palliative chemotherapy are unclear. This study assessed outcomes in those receiving monotherapy or combination therapy in thirteen prospective systemic-therapy trials. Methods: Multivariable analysis explored the impact of therapy on progression-free (PFS) and overall survival (OS) in two separate age cohort groups: <70years and ≥70years, and <40years and ≥40years. Results: Overall, 1163 patients were recruited (Jan 1997-Dec 2013). Median age of entire cohort: 63years (range 23-85); 36 (3%) were <40, 260 (22%); ≥70. Combination therapy was platinum-based in nine studies. Among patients <40 and ≥70years, 23 (64%) and 182 (70%) received combination therapy, respectively. Median follow-up was 42months (95%-CI 37-51). Median PFS for patients <40 and ≥40years was 3.5 and 5.9months (P=0.12), and OS was 10.8 and 9.7months, respectively (P=0.55). Median PFS for those <70 and ≥70years was 6.0 and 5.0months (P=0.53), and OS was 10.2 and 8.8months, respectively (P=0.08). For the entire cohort, PFS and OS were significantly better in those receiving combination therapy: Hazard Ratio [HR]-0.66, 95%-CI 0.58-0.76, P<0.0001 and HR-0.72, 95%-CI 0.63-0.82, P<0.0001, respectively; and in patients ≥70years: HR-0.54 (95%-CI 0.38-0.77, P=0.001) and HR-0.60 (95%-CI 0.43-0.85, P=0.004), respectively. There was no evidence of interaction between age and treatment for PFS (P=0.58, P=0.66) or OS (P=0.18, P=0.75). Conclusions: In ABC, younger patients are rare, and survival in elderly patients in receipt of systemic therapy for advanced disease, whether monotherapy or combination therapy, is similar to that of non-elderly patients, therefore age alone should not influence decisions regarding treatment.

Original languageEnglish (US)
Article number262
JournalBMC Cancer
Volume17
Issue number1
DOIs
StatePublished - Apr 12 2017

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Biliary Tract Neoplasms
Survival
Therapeutics
Platinum
Age Groups
Outcome Assessment (Health Care)

Keywords

  • Biliary cancer
  • Elderly
  • Prospective trials
  • Systemic therapy
  • Younger patients

ASJC Scopus subject areas

  • Oncology
  • Genetics
  • Cancer Research

Cite this

Systemic therapy in younger and elderly patients with advanced biliary cancer : Sub-analysis of ABC-02 and twelve other prospective trials. / McNamara, Mairéad Geraldine; Bridgewater, John; Lopes, Andre; Wasan, Harpreet; Malka, David; Jensen, Lars Henrik; Okusaka, Takuji; Knox, Jennifer J.; Wagner, Dorothea; Cunningham, David; Shannon, Jenny; Goldstein, David; Moehler, Markus; Bekaii-Saab, Tanios; Valle, Juan W.

In: BMC Cancer, Vol. 17, No. 1, 262, 12.04.2017.

Research output: Contribution to journalArticle

McNamara, MG, Bridgewater, J, Lopes, A, Wasan, H, Malka, D, Jensen, LH, Okusaka, T, Knox, JJ, Wagner, D, Cunningham, D, Shannon, J, Goldstein, D, Moehler, M, Bekaii-Saab, T & Valle, JW 2017, 'Systemic therapy in younger and elderly patients with advanced biliary cancer: Sub-analysis of ABC-02 and twelve other prospective trials', BMC Cancer, vol. 17, no. 1, 262. https://doi.org/10.1186/s12885-017-3266-9
McNamara, Mairéad Geraldine ; Bridgewater, John ; Lopes, Andre ; Wasan, Harpreet ; Malka, David ; Jensen, Lars Henrik ; Okusaka, Takuji ; Knox, Jennifer J. ; Wagner, Dorothea ; Cunningham, David ; Shannon, Jenny ; Goldstein, David ; Moehler, Markus ; Bekaii-Saab, Tanios ; Valle, Juan W. / Systemic therapy in younger and elderly patients with advanced biliary cancer : Sub-analysis of ABC-02 and twelve other prospective trials. In: BMC Cancer. 2017 ; Vol. 17, No. 1.
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abstract = "Background: Outcomes in younger (<40years) and elderly (≥70years) patients with advanced biliary cancer (ABC) receiving palliative chemotherapy are unclear. This study assessed outcomes in those receiving monotherapy or combination therapy in thirteen prospective systemic-therapy trials. Methods: Multivariable analysis explored the impact of therapy on progression-free (PFS) and overall survival (OS) in two separate age cohort groups: <70years and ≥70years, and <40years and ≥40years. Results: Overall, 1163 patients were recruited (Jan 1997-Dec 2013). Median age of entire cohort: 63years (range 23-85); 36 (3{\%}) were <40, 260 (22{\%}); ≥70. Combination therapy was platinum-based in nine studies. Among patients <40 and ≥70years, 23 (64{\%}) and 182 (70{\%}) received combination therapy, respectively. Median follow-up was 42months (95{\%}-CI 37-51). Median PFS for patients <40 and ≥40years was 3.5 and 5.9months (P=0.12), and OS was 10.8 and 9.7months, respectively (P=0.55). Median PFS for those <70 and ≥70years was 6.0 and 5.0months (P=0.53), and OS was 10.2 and 8.8months, respectively (P=0.08). For the entire cohort, PFS and OS were significantly better in those receiving combination therapy: Hazard Ratio [HR]-0.66, 95{\%}-CI 0.58-0.76, P<0.0001 and HR-0.72, 95{\%}-CI 0.63-0.82, P<0.0001, respectively; and in patients ≥70years: HR-0.54 (95{\%}-CI 0.38-0.77, P=0.001) and HR-0.60 (95{\%}-CI 0.43-0.85, P=0.004), respectively. There was no evidence of interaction between age and treatment for PFS (P=0.58, P=0.66) or OS (P=0.18, P=0.75). Conclusions: In ABC, younger patients are rare, and survival in elderly patients in receipt of systemic therapy for advanced disease, whether monotherapy or combination therapy, is similar to that of non-elderly patients, therefore age alone should not influence decisions regarding treatment.",
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T1 - Systemic therapy in younger and elderly patients with advanced biliary cancer

T2 - Sub-analysis of ABC-02 and twelve other prospective trials

AU - McNamara, Mairéad Geraldine

AU - Bridgewater, John

AU - Lopes, Andre

AU - Wasan, Harpreet

AU - Malka, David

AU - Jensen, Lars Henrik

AU - Okusaka, Takuji

AU - Knox, Jennifer J.

AU - Wagner, Dorothea

AU - Cunningham, David

AU - Shannon, Jenny

AU - Goldstein, David

AU - Moehler, Markus

AU - Bekaii-Saab, Tanios

AU - Valle, Juan W.

PY - 2017/4/12

Y1 - 2017/4/12

N2 - Background: Outcomes in younger (<40years) and elderly (≥70years) patients with advanced biliary cancer (ABC) receiving palliative chemotherapy are unclear. This study assessed outcomes in those receiving monotherapy or combination therapy in thirteen prospective systemic-therapy trials. Methods: Multivariable analysis explored the impact of therapy on progression-free (PFS) and overall survival (OS) in two separate age cohort groups: <70years and ≥70years, and <40years and ≥40years. Results: Overall, 1163 patients were recruited (Jan 1997-Dec 2013). Median age of entire cohort: 63years (range 23-85); 36 (3%) were <40, 260 (22%); ≥70. Combination therapy was platinum-based in nine studies. Among patients <40 and ≥70years, 23 (64%) and 182 (70%) received combination therapy, respectively. Median follow-up was 42months (95%-CI 37-51). Median PFS for patients <40 and ≥40years was 3.5 and 5.9months (P=0.12), and OS was 10.8 and 9.7months, respectively (P=0.55). Median PFS for those <70 and ≥70years was 6.0 and 5.0months (P=0.53), and OS was 10.2 and 8.8months, respectively (P=0.08). For the entire cohort, PFS and OS were significantly better in those receiving combination therapy: Hazard Ratio [HR]-0.66, 95%-CI 0.58-0.76, P<0.0001 and HR-0.72, 95%-CI 0.63-0.82, P<0.0001, respectively; and in patients ≥70years: HR-0.54 (95%-CI 0.38-0.77, P=0.001) and HR-0.60 (95%-CI 0.43-0.85, P=0.004), respectively. There was no evidence of interaction between age and treatment for PFS (P=0.58, P=0.66) or OS (P=0.18, P=0.75). Conclusions: In ABC, younger patients are rare, and survival in elderly patients in receipt of systemic therapy for advanced disease, whether monotherapy or combination therapy, is similar to that of non-elderly patients, therefore age alone should not influence decisions regarding treatment.

AB - Background: Outcomes in younger (<40years) and elderly (≥70years) patients with advanced biliary cancer (ABC) receiving palliative chemotherapy are unclear. This study assessed outcomes in those receiving monotherapy or combination therapy in thirteen prospective systemic-therapy trials. Methods: Multivariable analysis explored the impact of therapy on progression-free (PFS) and overall survival (OS) in two separate age cohort groups: <70years and ≥70years, and <40years and ≥40years. Results: Overall, 1163 patients were recruited (Jan 1997-Dec 2013). Median age of entire cohort: 63years (range 23-85); 36 (3%) were <40, 260 (22%); ≥70. Combination therapy was platinum-based in nine studies. Among patients <40 and ≥70years, 23 (64%) and 182 (70%) received combination therapy, respectively. Median follow-up was 42months (95%-CI 37-51). Median PFS for patients <40 and ≥40years was 3.5 and 5.9months (P=0.12), and OS was 10.8 and 9.7months, respectively (P=0.55). Median PFS for those <70 and ≥70years was 6.0 and 5.0months (P=0.53), and OS was 10.2 and 8.8months, respectively (P=0.08). For the entire cohort, PFS and OS were significantly better in those receiving combination therapy: Hazard Ratio [HR]-0.66, 95%-CI 0.58-0.76, P<0.0001 and HR-0.72, 95%-CI 0.63-0.82, P<0.0001, respectively; and in patients ≥70years: HR-0.54 (95%-CI 0.38-0.77, P=0.001) and HR-0.60 (95%-CI 0.43-0.85, P=0.004), respectively. There was no evidence of interaction between age and treatment for PFS (P=0.58, P=0.66) or OS (P=0.18, P=0.75). Conclusions: In ABC, younger patients are rare, and survival in elderly patients in receipt of systemic therapy for advanced disease, whether monotherapy or combination therapy, is similar to that of non-elderly patients, therefore age alone should not influence decisions regarding treatment.

KW - Biliary cancer

KW - Elderly

KW - Prospective trials

KW - Systemic therapy

KW - Younger patients

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