Outcome differences by sex in oncology clinical trials
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...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2024-03-01
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| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-024-46945-x |
| _version_ | 1797247142316736512 |
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| author | Ashwin V. Kammula Alejandro A. Schäffer Padma Sheila Rajagopal Razelle Kurzrock Eytan Ruppin |
| author_facet | Ashwin V. Kammula Alejandro A. Schäffer Padma Sheila Rajagopal Razelle Kurzrock Eytan Ruppin |
| author_sort | Ashwin V. Kammula |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T19:53:59Z |
| format | Article |
| id | doaj.art-8acb05eafc104689960ff4f9ac428631 |
| institution | Directory Open Access Journal |
| issn | 2041-1723 |
| language | English |
| last_indexed | 2024-04-24T19:53:59Z |
| publishDate | 2024-03-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj.art-8acb05eafc104689960ff4f9ac4286312024-03-24T12:26:48ZengNature PortfolioNature Communications2041-17232024-03-0115111310.1038/s41467-024-46945-xOutcome differences by sex in oncology clinical trialsAshwin V. Kammula0Alejandro A. Schäffer1Padma Sheila Rajagopal2Razelle Kurzrock3Eytan Ruppin4Cancer Data Science Laboratory, Center for Cancer Research, National Cancer InstituteCancer Data Science Laboratory, Center for Cancer Research, National Cancer InstituteCancer Data Science Laboratory, Center for Cancer Research, National Cancer InstituteWIN Consortium and Medical College of Wisconsin, Milwaukee, WI 53226 and University of NebraskaCancer Data Science Laboratory, Center for Cancer Research, National Cancer InstituteAbstract 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.https://doi.org/10.1038/s41467-024-46945-x |
| spellingShingle | Ashwin V. Kammula Alejandro A. Schäffer Padma Sheila Rajagopal Razelle Kurzrock Eytan Ruppin Outcome differences by sex in oncology clinical trials Nature Communications |
| title | Outcome differences by sex in oncology clinical trials |
| title_full | Outcome differences by sex in oncology clinical trials |
| title_fullStr | Outcome differences by sex in oncology clinical trials |
| title_full_unstemmed | Outcome differences by sex in oncology clinical trials |
| title_short | Outcome differences by sex in oncology clinical trials |
| title_sort | outcome differences by sex in oncology clinical trials |
| url | https://doi.org/10.1038/s41467-024-46945-x |
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