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Assessing surrogacy using restricted mean survival time ratio for overall survival in non-small cell lung cancer immunotherapy studies.

Publication ,  Journal Article
Pang, H; Yang, G; Ho, JC; Leung, TH; Shi, Q; Hu, C; Stinchcombe, TE; Wang, X
Published in: Chin Clin Oncol
February 2022

BACKGROUND: Proportional hazards (PH) assumption is often violated in cancer immunotherapy studies. Restricted mean survival time (RMST) ratio is a valid metric to quantify the size of treatment effect when non-proportional hazard (NPH) is present. This study investigated the use of RMST ratio and hazard ratio (HR) in studying progression-free survival (PFS) as a surrogate endpoint for overall survival (OS) in non-small cell lung cancer immunotherapy trials. METHODS: Trial level data were collected from 14 phase III trials published between 2012 and 2018. A weighted least-square regression (WLSR) was performed to evaluate the trial-level surrogacy. Surrogacy was evaluated via the association between RMST ratios for PFS and OS and between HRs for PFS and OS. RESULTS: Using data extracted from published articles, low to moderate correlation (0.49) between PFS and OS was observed for HR while low correlation (0.35) was observed for RMST ratio. When trials violating PH in PFS were included, more consistent correlations for both HR (0.43) and RMST ratio (0.44) were observed. CONCLUSIONS: In summary, the strength of PFS surrogacy for OS depends on whether HR or RMST ratio are chosen. RMST ratio and additional sensitivity analysis should be considered in addition to HR.

Duke Scholars

Published In

Chin Clin Oncol

DOI

EISSN

2304-3873

Publication Date

February 2022

Volume

11

Issue

1

Start / End Page

7

Location

China

Related Subject Headings

  • Survival Rate
  • Survival Analysis
  • Lung Neoplasms
  • Immunotherapy
  • Humans
  • Disease-Free Survival
  • Clinical Trials, Phase III as Topic
  • Carcinoma, Non-Small-Cell Lung
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Pang, H., Yang, G., Ho, J. C., Leung, T. H., Shi, Q., Hu, C., … Wang, X. (2022). Assessing surrogacy using restricted mean survival time ratio for overall survival in non-small cell lung cancer immunotherapy studies. Chin Clin Oncol, 11(1), 7. https://doi.org/10.21037/cco-21-110
Pang, Herbert, Guangyu Yang, James C. Ho, Tiffany H. Leung, Qian Shi, Chen Hu, Thomas E. Stinchcombe, and Xiaofei Wang. “Assessing surrogacy using restricted mean survival time ratio for overall survival in non-small cell lung cancer immunotherapy studies.Chin Clin Oncol 11, no. 1 (February 2022): 7. https://doi.org/10.21037/cco-21-110.
Pang, Herbert, et al. “Assessing surrogacy using restricted mean survival time ratio for overall survival in non-small cell lung cancer immunotherapy studies.Chin Clin Oncol, vol. 11, no. 1, Feb. 2022, p. 7. Pubmed, doi:10.21037/cco-21-110.
Pang H, Yang G, Ho JC, Leung TH, Shi Q, Hu C, Stinchcombe TE, Wang X. Assessing surrogacy using restricted mean survival time ratio for overall survival in non-small cell lung cancer immunotherapy studies. Chin Clin Oncol. 2022 Feb;11(1):7.

Published In

Chin Clin Oncol

DOI

EISSN

2304-3873

Publication Date

February 2022

Volume

11

Issue

1

Start / End Page

7

Location

China

Related Subject Headings

  • Survival Rate
  • Survival Analysis
  • Lung Neoplasms
  • Immunotherapy
  • Humans
  • Disease-Free Survival
  • Clinical Trials, Phase III as Topic
  • Carcinoma, Non-Small-Cell Lung