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Is response rate increment obtained by molecular targeted agents related to survival benefit in the phase III trials

K Tsujino1, J Shiraishi2, T Tsuji3

  • 1Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine, Suita, Osaka.

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|January 13, 2010
PubMed
Abstract

Insights

Response rate increment from molecular targeted agents (MTA) may predict survival benefits in advanced cancer trials. A 7% gain in response rate reliably indicated improved survival outcomes in phase III studies.

Area of Science:

  • Oncology
  • Clinical Trials
  • Pharmacology

Background:

  • Uncertainty exists regarding the relationship between response rate (RR) and survival benefit in advanced cancer patients treated with molecular targeted agents (MTA) combined with standard therapies.
  • Phase III trials are crucial for evaluating novel cancer treatments.

Purpose of the Study:

  • To investigate the association between response rate increment (DeltaRR) and survival benefit in phase III trials of advanced cancer treated with MTA plus standard therapy.
  • To determine if DeltaRR can serve as a predictive marker for survival outcomes.

Main Methods:

  • Systematic literature search of PubMed for randomized phase III trials involving four solid tumors.
  • Analysis of 26 trials (21,156 patients) evaluating MTA added to standard therapy.
  • Examination of the correlation between DeltaRR and survival benefit (overall survival and progression-free survival).

Main Results:

  • Trials demonstrating significant survival benefit showed a higher DeltaRR compared to those without significant benefit.
  • Receiver operating characteristic curve analysis indicated that a 7% DeltaRR threshold accurately predicted survival benefit with high sensitivity and specificity.
  • Linear regression analysis revealed significant relationships between DeltaRR and hazard ratios for overall and progression-free survival.

Conclusions:

  • Increment in response rate achieved by adding MTA to standard therapy can be a valuable predictor of survival benefit in phase III clinical trials for advanced cancer.
  • This finding supports the use of DeltaRR as an early indicator of treatment efficacy in oncology drug development.

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