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ESMO 2026 | GENE-TOX: gynecological vs non-gynecological cancer toxicity in Phase I trials

Kaissa Ouali, MD, Institut Gustave Roussy, Villejuif, France, comments on the retrospective GENE-TOX study comparing toxicity patterns between patients with gynecological and non-gynecological cancers enrolled in Phase I clinical trials. Despite more extensive prior treatment, patients with gynecological malignancies did not experience significantly more severe toxicity, dose-limiting toxicities, or hospitalizations, with similar response and survival outcomes. However, gastrointestinal toxicity, particularly diarrhea, and treatment discontinuation were more frequent. This interview took place at the European Society for Medical Oncology (ESMO) 2026 Congress in Madrid, Spain.

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Transcript

In phase one we know that they are usually heavily pretreated and the main thing we wanted to look at is if GYN patients actually have specific adverse events (AEs) that we don’t see in other patients, for example, they might be at higher risk of occlusion because of the peritoneal disease or other digestive adverse events, and what we saw is that this is not the case, actually, the patients have quite the same type of adverse events as non-gynecological patients, they don’t have more serious adverse events than the non-gynecological patients, and actually, they seem to be doing quite well in phase one trials, which is quite good, I think, and sends a message that we can actually include patients with this type of tumors in phase one...

In phase one we know that they are usually heavily pretreated and the main thing we wanted to look at is if GYN patients actually have specific adverse events (AEs) that we don’t see in other patients, for example, they might be at higher risk of occlusion because of the peritoneal disease or other digestive adverse events, and what we saw is that this is not the case, actually, the patients have quite the same type of adverse events as non-gynecological patients, they don’t have more serious adverse events than the non-gynecological patients, and actually, they seem to be doing quite well in phase one trials, which is quite good, I think, and sends a message that we can actually include patients with this type of tumors in phase one.

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