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Poster display session

3015 - PFS/TTP as a potential surrogate for OS in HR+, HER2– MBC

Date

11 Sep 2017

Session

Poster display session

Topics

Breast Cancer

Presenters

Anna Forsythe

Citation

Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365

Authors

A. Forsythe1, D. Chandiwana2, J. Barth3, M. Thabane4, J. Baeck2, A. Shor1, G. Tremblay1

Author affiliations

  • 1 Purple Squirrel Economics, Purple Squirrel Economics, 10010 - New York/US
  • 2 Oncology, Novartis Pharmaceuticals Corporation, 07936-1080 - East Hanover/US
  • 3 Oncology, Novartis Pharma GmbH, Nuremberg/DE
  • 4 Oncology, Novartis Pharmaceuticals Canada Inc., Dorval/CA
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Resources

Abstract 3015

Background

Several, recent randomized controlled trials (RCTs) in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) metastatic breast cancer (MBC) have demonstrated a significant improvement in progression-free survival (PFS); however, few have reported an improvement in overall survival (OS). OS may be an imperfect endpoint due to the impact of factors such as baseline characteristics and subsequent therapies. Investigation of the use of PFS or time to progression (TTP) as a surrogate for OS in HR+, HER2– MBC has been limited. This study assesses the correlation of PFS/TTP and OS in HR+, HER2– MBC across all lines of therapy.

Methods

A systematic literature review of RCTs in HR+, HER2– MBC was conducted to identify studies that reported both median PFS/TTP and OS. The correlation between PFS/TTP and OS was evaluated using Pearson’s product-moment correlation and Spearman’s rank correlation. Subgroup analyses were performed to explore possible reasons for heterogeneity. Errors-in-variables weighted least squares regression (LSR) was used to model incremental OS months as a function of incremental PFS/TTP months. An exploratory analysis investigated the impact of 3 covariates (chemotherapy vs other, PFS vs TTP, and 1L vs > 1L) on the use of PFS/TTP in OS prediction. The lower 95% prediction band was used to determine the minimum incremental PFS/TTP months below which there would be no predicted OS benefit (the surrogate threshold effect [STE]).

Results

A total of 39 studies were identified. There was a statistically significant correlation between median PFS/TTP and OS (Pearson=0.741, p 

Conclusions

Results of this study indicate a significant association between PFS/TTP and OS, which may justify the use of PFS/TTP as surrogate for OS benefit during regulatory approval and subsequent reimbursement of new therapies in HR+, HER2– MBC.

Clinical trial identification

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation

Funding

Novartis Pharmaceuticals Corporation

Disclosure

A. Forsythe: Consultant for Novartis. D. Chandiwana, M. Thabane, J. Baeck: Novartis employee and Novartis stocks/shares. J. Barth: Novartis employee. All other authors have declared no conflicts of interest.

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