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Poster session 17

102P - Potentially prognostic factors of overall survival in advanced biliary tract cancer in the randomised phase III TOPAZ-1 study

Date

21 Oct 2023

Session

Poster session 17

Topics

Tumour Site

Hepatobiliary Cancers

Presenters

Aiwu Ruth He

Citation

Annals of Oncology (2023) 34 (suppl_2): S215-S232. 10.1016/S0923-7534(23)01929-4

Authors

A.R. He1, M. Bouattour2, V.G. Gupta3, L. Evesque4, D.B. Zhen5, J.O. Park6, A. Sookprasert7, A. Salvatierra8, G.M. Vaccaro9, S.C. Oh10, S.A. Ostoich11, T. Satoh12, M. Żotkiewicz13, N. Rokutanda14, H. Kim15, D. Oh16

Author affiliations

  • 1 Division Of Hematology And Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, 20057 - Washington/US
  • 2 Medical Oncology, AP-HP Hôpital Beaujon, Paris/FR
  • 3 Department Of Medical Oncology, Artemis Hospitals, Gurugram/IN
  • 4 Medical Oncology Department, La Centre Antoine Lacassagne, Nice/FR
  • 5 Division Of Medical Oncology, Department Of Internal Medicine, University of Washington, Seattle, Fred Hutchinson Cancer Center, Seattle/US
  • 6 Division Of Hematology-oncology, Department Of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul/KR
  • 7 Medical Oncology Unit, Department Of Medicine, Faculty Of Medicine, Khon Kaen University, Khon Kaen/TH
  • 8 Fundacion Ars Medica, San Salvador de Jujuy, Jujuy/AR
  • 9 Clinical Oncology, Providence Cancer Institute, Portland/US
  • 10 Division Of Hematology And Oncology, Department Of Internal Medicine, College Of Medicine, Korea University, Seoul/KR
  • 11 Department Of Oncology, Hospital Provincial del Centenario, Rosario/AR
  • 12 Department Of Frontier Science For Cancer And Chemotherapy, Osaka University Graduate School of Medicine, Osaka/JP
  • 13 Late Oncology Statistics, Oncology Biometrics, AstraZeneca, Warsaw/PL
  • 14 Oncology R&d, Late-stage Development, AstraZeneca, Gaithersburg/US
  • 15 Statistics, AstraZeneca, Osaka/JP
  • 16 Division Of Medical Oncology, Department Of Internal Medicine, Seoul National University Hospital and Cancer Research Institute, Seoul National University College of Medicine, Seoul/KR

Resources

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Abstract 102P

Background

In TOPAZ-1 (NCT03875235), durvalumab (D) + gemcitabine and cisplatin (GC) improved overall survival (OS) vs placebo (PBO) + GC in participants with advanced biliary tract cancer (aBTC; primary analysis: hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.66–0.97, p=0.021 [significance threshold p=0.03]) and after a further 6.5 months of follow-up (HR 0.76, 95% CI 0.64–0.91). This exploratory analysis assessed baseline clinical factors for potential prognostic (associated with OS) or predictive (of OS benefit with D + GC) value in TOPAZ-1.

Methods

Potentially prognostic factors were evaluated using Cox proportional hazards models with treatment and each factor. An exploratory adjusted HR for D + GC vs PBO + GC was estimated with a model adjusting for prognostic factors identified by stepwise selection. Unstratified Cox proportional hazards models and interaction tests were performed to assess potential predictive factors. Data cut-off was 25 February 2022.

Results

Potentially prognostic clinical factors are shown (Table). The HR for D + GC vs PBO + GC, adjusted for disease status, primary tumour location, sex, PD-L1, neutrophil to lymphocyte ratio (NLR), cancer antigen 19-9 (CA19-9), carcinoembryonic antigen (CEA), liver metastasis, liver involvement (locally advanced or metastatic site in liver/gallbladder), body weight, LDH, albumin and total bilirubin, was 0.70 (95% CI 0.59–0.84). OS HRs for D + GC vs PBO + GC were <1 across assessed clinical (Table) and laboratory factors; no predictive factors for D + GC were found. Table: 102P

Predictive Prognostic
Factor Subgroup HR (95% CI), D + GC v PBO + GC Interaction p HR (95% CI), top v bottom subgroup p
Disease status IU .79 (.65–.95) .93 2.14 (1.69–2.76) <.01
R .76 (.49–1.20)
ECOG PS 0 .87 (.68–1.12) .14 1.29 (1.09–1.53) <.01
1 .70 (.55–.89)
Disease classification LA .54 (.32–.88) .13 1.35 (1.05–1.76) .02
M .80 (.67–.97)
NLR <3 .75 (.56–1.01) .83 2.14 (1.79–2.58) <.01
≥3 .76 (.61–.94)
CA19-9 <500 U/mL .72 (.57–.92) .53 2.08 (1.73–2.50) <.01
≥500 U/mL .82 (.62–1.08)
CEA <5 ng/mL .75 (.58–.97) .75 1.78 (1.49–2.14) <.01
≥5 ng/mL .81 (.63–1.05)
Liver metastasis Y .83 (.66–1.06) .32 1.37 (1.56–1.63) <.01
N .69 (.54–.88)
Liver involvement Y .76 (.63–.91) .76 1.67 (1.32–2.14) <.01
N .77 (.49–1.20)

IU, initially unresectable; LA, locally advanced; M, metastatic; R, recurrent

Conclusions

Benefit with D + GC was consistent across assessed factors and stable after adjusting for potentially prognostic factors, supporting D + GC as first-line treatment for aBTC.

Clinical trial identification

NCT03875235.

Editorial acknowledgement

Medical writing support, under the direction of the authors, was provided by Elaine Groat, PhD, of CMC Connect, a division of IPG Health Medical Communications, funded by AstraZeneca, in accordance with Good Publication Practice (GPP 2022) guidelines.

Legal entity responsible for the study

AstraZeneca.

Funding

AstraZeneca.

Disclosure

A.R. He: Financial Interests, Personal, Research Grant: AstraZeneca, Genentech, Merck; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Eisai, BMS. M. Bouattour: Financial Interests, Personal, Advisory Board: MSD, BMS, Sirtex Medical, Ipsen, AbbVie, AstraZeneca, Servier, Taiho; Financial Interests, Personal, Invited Speaker: Roche; Non-Financial Interests, Principal Investigator: MSD, BMS, Sirtex Medical, AstraZeneca. V.G. Gupta: Financial Interests, Personal, Stocks/Shares: Zydus Life, RPG Life. L. Evesque: Financial Interests, Personal, Advisory Board: Servier, Amgen, MSD, Merck. D.B. Zhen: Financial Interests, Personal, Advisory Board: QED Therapeutics, Ipsen; Financial Interests, Other, Local PI and Coordinating PI: Merck; Financial Interests, Invited Speaker: TME Pharma, AstraZeneca, Bristol Meyers Squibb, Legend Biotech, Genentech, Cornerstone Pharmaceuticals, Eli Lilly, Seagen, NeoTx Therapeutics, Daiichi Sankyo; Non-Financial Interests, Leadership Role, Binaytara Foundation: Gastrointestinal Oncology Education Chair; Non-Financial Interests, Other, Panel Member of NCCN Neuroendocrine and Adrenal Tumor Guidelines: National Comprehensive Cancer Network. J.O. Park: Financial Interests, Personal, Advisory Board: MedPacto, BMS (Celgene), Servier, MediRama, Adicet Bio, AstraZeneca, Merck Sereno; Financial Interests, Personal, Other, Travel support for a poster presentation at ASCO GI 2023: Minneamrita Therapeutics LLC; Financial Interests, Personal, Research Grant, Clinical research grant: MedPacto, Servier, BMS (Celgene); Financial Interests, Personal, Research Grant: Eutilex, ABL Bio. A. Sookprasert: Financial Interests, Personal, Invited Speaker: AstraZeneca, Bristol, Easai, Merck, Roche, Jansen, Pfizer, Novartis. A. Salvatierra: Non-Financial Interests, Personal and Institutional, Principal Investigator: Fundacion Ars Medica. G.M. Vaccaro: Financial Interests, Personal, Speaker’s Bureau: Incyte; Financial Interests, Personal, Advisory Board: AstraZeneca, GSK; Financial Interests, Personal, Advisory Role: Servier. S.A. Ostoich: Non-Financial Interests, Personal, Principal Investigator: Hospital Provincial del Centenario. T. Satoh: Financial Interests, Personal, Invited Speaker, invited speaker and advisory: Ono Pharmaceutical, Daiichi-Sankyo; Financial Interests, Personal, Invited Speaker, Invited speaer and adovisory: Bristol-Myers; Financial Interests, Personal, Invited Speaker, Invited speaker and advisory: Elli-Lilly, Yakult-HOnsha; Financial Interests, Personal, Invited Speaker: Chugai Pharmazeutical, Merck-Biopharm, Takeda, Taiho; Financial Interests, Personal, Advisory Board: Takara-Bio; Financial Interests, Institutional, Invited Speaker: Merck-Biopharm; Financial Interests, Institutional, Invited Speaker, Research Grant and Endosed Department: Ono Pharmaceutical, Chugai Pharmaceutical, Yakult Honsha; Financial Interests, Institutional, Invited Speaker, Research Grant: Bristol-Myers, Elli-Lilly, Daiichi Sankyo, Parexell, Giliad, Taiho, Hutch-Med. M. Żotkiewicz: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. N. Rokutanda: Financial Interests, Personal, Full or part-time Employment: AstraZeneca; Financial Interests, Personal, Stocks/Shares: AstraZeneca. H. Kim: Financial Interests, Personal, Full or part-time Employment: AstraZeneca. D. Oh: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Genentech/Roche, Merck Serono , Bayer, Taiho, ASLAN, Halozyme, Zymeworks, BMS/Celgene, BeiGene, Basilea, Turning Point, Yuhan, Arcus Biosciences, IQVIA, MSD; Financial Interests, Institutional, Research Grant: AstraZeneca, Novartis, Array, Eli Lilly, Servier, BeiGene, MSD, Handok. All other authors have declared no conflicts of interest.

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