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ePoster Display

872P - Association between event-free (EFS) and overall survival (OS) in newly diagnosed patients (pts) with locally advanced (LA) head and neck squamous cell carcinoma (HNSCC) ineligible for surgery

Date

16 Sep 2021

Session

ePoster Display

Topics

Head and Neck Cancers

Presenters

Christopher Black

Citation

Annals of Oncology (2021) 32 (suppl_5): S786-S817. 10.1016/annonc/annonc704

Authors

C.M. Black1, S. Keeping2, D. Chirovsky1, K. Ramakrishnan1, A. Mojebi2, N. Upadhyay1, D. Ayers2

Author affiliations

  • 1 Center Of Observational Research & Real World Evidence, Merck & Co., Inc., 07033 - Kenilworth/US
  • 2 Evidence Synthesis, PRECISIONheor, V6H 3Y4 - VANCOUVER/CA
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Abstract 872P

Background

Improvement in OS is the gold standard for assessing treatment efficacy. To avoid delays in novel treatment approval, early treatment decisions may be based on validated surrogate endpoints which predict OS. A prior meta-analysis of clinical trials in LA HNSCC pts by Michiels 2009 showed a strong correlation of EFS with OS, supporting EFS as a surrogate endpoint in LA HNSCC. This study aimed to assess whether the correlation between EFS and OS is maintained with updated literature in pts with LA HNSCC ineligible for surgery and receiving chemoradiation therapy (CRT).

Methods

A systematic literature review (SLR) conducted on May 20, 2020 identified randomized controlled trials assessing CRT regimens in the surgery ineligible LA HNSCC population. The primary endpoints of interest were OS and EFS, defined as time from randomization to progression, surgery, or death. Trials with progression-free survival, disease- and failure-free survival endpoints were included if definitions were sufficiently similar to EFS. Trials reporting hazard ratios (HRs) or Kaplan-Meier curves for OS and EFS were included in the analysis. Correlation was assessed with regression models across all CRT trials, as well as in subgroups defined by type of CRT (concurrent CRT, sequential CRT and cisplatin + RT). The strength of the relationship between EFS log HR and OS log HR was measured with Pearson’s correlation coefficient (R).

Results

The SLR identified 27 trials with OS and EFS results. A strong correlation between EFS and OS was observed in the overall CRT analysis (R=0.85, 95% confidence interval [CI]: 0.70-0.93). Similar results were found by type of CRT, and in studies with alternative EFS definitions (see table). Table: 872P

Analyses a R (95% CI) Slope Intercept
All CRT trials (n=27) 0.85 (0.70, 0.93) 0.825 0.033
Concurrent CRT vs concurrent CRT trials (n=12) 0.88 (0.62, 0.97) 0.707 0.12
Sequential CRT vs any CRT b trials (n=15) 0.83 (0.37, 0.96) 1.155 0.107
Cisplatin + RT vs any CRT b trials (n=15) 0.79 (0.47, 0.93) 0.694 0.031
Cisplatin + RT vs concurrent CRT trials (n=9) 0.82 (0.33, 0.96) 0.653 0.028
All trials where EFS was defined as time from randomization to disease progression or death (n=19) 0.87 (0.69, 0.95) 0.737 0.006

a Conducted for all trials and subgroups of trials based on the use of any concurrent CRT, adjuvant/neoadjuvant (‘sequential’) CRT, or concurrent cisplatin + RT in their armsb Concurrent or sequential CRT

Conclusions

Associations between OS and EFS were strong (R=0.79-0.88), suggesting EFS is a valid surrogate for OS in surgery ineligible LA HNSCC pts receiving CRT.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Merck & Co., Inc.

Funding

Merck & Co., Inc.

Disclosure

C.M. Black: Financial Interests, Personal and Institutional, Full or part-time Employment: Merck & Co Inc; Financial Interests, Institutional, Stocks/Shares: Merck & Co Inc. S. Keeping: Financial Interests, Institutional, Funding, Employee of PRECISIONheor, which received funding from Merck & Co, Inc. to conduct the study.: PRECISIONheor. D. Chirovsky: Financial Interests, Institutional, Full or part-time Employment: Merck and Co., Inc.; Financial Interests, Institutional, Stocks/Shares: Merck and Co, Inc. K. Ramakrishnan: Financial Interests, Institutional, Full or part-time Employment: Merck & Co., Inc.; Financial Interests, Institutional, Ownership Interest: Merck & Co., Inc. A. Mojebi: Financial Interests, Institutional, Funding, Employee of PRECISIONheor, which received funding from Merck & Co, Inc. to conduct the study.: PRECISIONheor. N. Upadhyay: Financial Interests, Institutional, Full or part-time Employment: Merck & Co., Inc. D. Ayers: Financial Interests, Institutional, Funding, Employee of PRECISIONheor, which received funding from Merck & Co, Inc. to conduct the study.: PRECISIONheor.

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