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Outcome differences by sex in oncology clinical trials

Author

Listed:
  • Ashwin V. Kammula

    (National Cancer Institute)

  • Alejandro A. Schäffer

    (National Cancer Institute)

  • Padma Sheila Rajagopal

    (National Cancer Institute
    National Cancer Institute)

  • Razelle Kurzrock

    (WI 53226 and University of Nebraska)

  • Eytan Ruppin

    (National Cancer Institute)

Abstract

Identifying sex differences in outcomes and toxicity between males and females in oncology clinical trials is important and has also been mandated by National Institutes of Health policies. Here we analyze the Trialtrove database, finding that, strikingly, only 472/89,221 oncology clinical trials (0.5%) had curated post-treatment sex comparisons. Among 288 trials with comparisons of survival, outcome, or response, 16% report males having statistically significant better survival outcome or response, while 42% reported significantly better survival outcome or response for females. The strongest differences are in trials of EGFR inhibitors in lung cancer and rituximab in non-Hodgkin’s lymphoma (both favoring females). Among 44 trials with side effect comparisons, more trials report significantly lesser side effects in males (N = 22) than in females (N = 13). Thus, while statistical comparisons between sexes in oncology trials are rarely reported, important differences in outcome and toxicity exist. These considerable outcome and toxicity differences highlight the need for reporting sex differences more thoroughly going forward.

Suggested Citation

  • Ashwin V. Kammula & Alejandro A. Schäffer & Padma Sheila Rajagopal & Razelle Kurzrock & Eytan Ruppin, 2024. "Outcome differences by sex in oncology clinical trials," Nature Communications, Nature, vol. 15(1), pages 1-13, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-46945-x
    DOI: 10.1038/s41467-024-46945-x
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    References listed on IDEAS

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    1. Youqiong Ye & Ying Jing & Liang Li & Gordon B. Mills & Lixia Diao & Hong Liu & Leng Han, 2020. "Sex-associated molecular differences for cancer immunotherapy," Nature Communications, Nature, vol. 11(1), pages 1-8, December.
    2. Janine A. Clayton & Francis S. Collins, 2014. "Policy: NIH to balance sex in cell and animal studies," Nature, Nature, vol. 509(7500), pages 282-283, May.
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    Cited by:

    1. Guo Zhao & Yuning Wang & Shuhang Wang & Ning Li, 2024. "Reporting outcome comparisons by sex in oncology clinical trials," Nature Communications, Nature, vol. 15(1), pages 1-3, December.

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