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Related Experiment Videos

[Correlation between response and survival].

A Ohtsu1, N Boku, Y Miyata

  • 1Division of GI Oncology/Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa, Japan.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|June 1, 2000
PubMed
Summary

Cancer chemotherapy endpoints focus on survival and quality of life, not just response rates. Phase III trials require survival data, not just phase II response rates, for robust evidence.

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Area of Science:

  • Oncology
  • Clinical Trials
  • Cancer Chemotherapy

Context:

  • True cancer chemotherapy endpoints are survival, symptom palliation, and quality of life.
  • Response rate is a surrogate endpoint, often used in early-phase trials.
  • Recent advancements include new response criteria and objective survival markers.

Purpose:

  • To evaluate the correlation between response rates and survival prolongation in gastrointestinal malignancies.
  • To emphasize the importance of survival data over response rates in phase III trial design.
  • To highlight the need for high-quality, large-scale randomized phase III trials for definitive evidence.

Summary:

  • Chemotherapy for esophageal cancer showed a correlation between complete response (CR) and survival prolongation with chemoradiotherapy.

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  • Gastric cancer patients receiving chemotherapy demonstrated a link between responders and prolonged survival.
  • Colorectal cancer chemotherapy data did not support a correlation between response and survival, despite literature suggestions.
  • Impact:

    • Findings underscore the need to consider survival data alongside response rates in phase II studies for phase III trial planning.
    • Establishes that robust "evidence" in cancer chemotherapy relies on large, high-quality randomized phase III trials.
    • Suggests that response rate alone is insufficient for definitive conclusions in cancer treatment efficacy.