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 language | English |
|---|---|
| Article number | 262 |
| Journal | BMC Cancer |
| Volume | 17 |
| Issue number | 1 |
| DOIs | |
| State | Published - 12 Apr 2017 |
| Externally published | Yes |
Bibliographical note
Publisher Copyright:© 2017 The Author(s).
Funding
ABC-02 was an investigator-initiated study sponsored by University College London (UCL), funded by Cancer Research UK [CRUK] (funding reference number C1813/A4853) with gemcitabine provided by Lilly Oncology (unrestricted grant). Cancer Research UK was not involved in the design of the current study. They did fund the data collection for ABC-02 and analysis was performed by Andre Lopes, who is funded by CRUK. They did not have a role in the interpretation of the data or in writing the manuscript. BT22 was an Eli Lilly Japan-sponsored trial; Eli Lilly were not involved in the design of the current study. They did fund the data collection for BT22. They did not have a role in the analysis, interpretation of the data or in writing the manuscript. The ABC and TACTIC trials were Australasian Gastro Intestinal Trials Group trials funded in part by grants from Eli Lilly and Amgen, respectively, and the AGITG; additional data collection for OS and PFS was investigator-initiated and supported by the Ministry of Health, Labour, and Welfare, Health Labour Sciences Research Grant (with data transfer to CR UK & UCL Cancer Trials Centre (CTC) under a study-specific agreement). The funders were not involved in the design of the current study. They did fund the data collection for the ABC, TACTIC and AGITG studies. They did not have a role in the analysis, interpretation of the data or in writing the manuscript. JB is partly supported by the UCLH/UCL Biomedical Research Centre. The funders were not involved in the design of the current study. They did fund JB whose author contribution is described previously. They did not have a role in the analysis, interpretation of the data or in writing the manuscript. AL is supported by a CR UK grant C444/A15953 to the CR UK & UCL CTC. Cancer Research UK were not involved in the design of the current study. They did fund the data collection for ABC-02 and analysis was performed by Andre Lopes, who is funded by CRUK. They did not have a role in the interpretation of the data or in writing the manuscript.
| Funders | Funder number |
|---|---|
| CR UK & UCL CTC | |
| Eli Lilly and Amgen | |
| UCL Cancer Trials Centre | |
| Clinical Trial Center, China Medical University Hospital | |
| Ministry of Health | |
| Lilly Oncology | |
| Cancer Research UK | C1813/A4853 |
| University College London | |
| UCLH Biomedical Research Centre | C444/A15953 |
Keywords
- Biliary cancer
- Elderly
- Prospective trials
- Systemic therapy
- Younger patients
