Chemo adverse events more frequent in female colon cancer patients

Last Updated: 2018-06-14

By Anne Harding

NEW YORK (Reuters Health) - Female colorectal cancer (CRC) patients are at greater risk of toxic effects from standard chemotherapy than are their male peers, according to a new Research Letter published in JAMA Oncology.

A pooled analysis of more than 28,000 patients from the National Institutes of Health-sponsored ACCENT database, presented in June at the American Society of Clinical Oncology's annual meeting, had similar findings.

"We observed higher risks for women to develop chemotherapy-related toxicities, such as nausea and vomiting and diarrhea, but also objectively measurable hematologic side effects, for example neutropenia," Dr. Anna Wagner of Lausanne University Hospital in Switzerland, who helped conduct both studies, told Reuters Health via E-mail.

Dr. Wagner and colleagues in the EORTC-GI group analyzed data from the PETACC-3 trial, which enrolled 2,974 stage 2 and 3 CRC patients who received either adjuvant fluorouracil and leucovorin or FOLFIRI, a combination of both drugs with irinotecan.

In the overall patient population, rates of several treatment-emergent adverse events (AEs) were significantly higher for women than men, especially diarrhea, nausea, vomiting, stomatitis, lethargy, leukopenia, neutropenia and anemia.

Among patients treated with FOLFIRI, there were significant sex differences in rates of grade 3 or 4 alopecia, stomatitis, diarrhea and lethargy. Women on FOLIFRI also had a higher risk of grade 3 or 4 neutropenia.

Dose reductions were necessary for 25.9% of women and 16.8% of men (P<0.001), and the difference was larger in those being treated with FOLFIRI.

The study "demonstrates a statistically significant and clinically relevant greater risk of nonhematological and objectively measurable hematological AEs in women," Dr. Wagner and her team write.

"Drug targets, but also the optimal dose necessary to hit the target with an acceptable level of toxic effects, may be different between men and women," they add.

"Sex as a potential modulator of disease biology and treatment outcomes deserves more awareness in oncology," Dr. Wagner said.

"The balance between efficacy and toxicity of systemic treatments in oncology needs to be analyzed separately in men and women," she added. "For chemotherapy, which usually has a steep dose-response relationship, clinical trials which address the question of different dosing regimens for men and women may help to improve the patients' benefit. For other treatments, where less data on this question is available, pooled analyses of anti-tumor efficacy and toxic effects are important to understand such potential effects."

SOURCE: https://bit.ly/2JRsECw

JAMA Oncol 2018.