Older patients represent more than one-quarter of all new cancer cases, but they tend to be underrepresented in clinical trials. This phenomenon limits information about symptomatic toxicity and the impact on treatment tolerability.

A team of researchers set out to determine if providing oncologists with a geriatric assessment (GA) summary, including management recommendations, would reduce clinician-rated toxicity in older adults with advanced cancer. To do so, they conducted a secondary analysis of a national cluster randomized clinical trial. The findings were published in the Journal of Clinical Oncology.

As part of their analysis, they measured symptomatic toxicity using Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Symptomatic toxicity was measured by an increase in symptom severity in follow-up PRO-CTCAE reports.


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A total of 718 patients were enrolled in the study, and 706 provided information at baseline. Patients were 70 years and older, with at least 1 GA domain impairment; 43% were female, 88% were White. Patients had advanced solid tumors or lymphoma (59% had GI or lung cancer), and 27% had received prior chemotherapy. Patients were initiating a regimen with a high prevalence of toxicity.

The patients were asked to complete the PRO-CTCAE at 4 points: enrollment, 4 to 6 weeks, 3 months, and 6 months. They were asked to score the severity of 24 symptoms as at least moderate (grade 2 or higher) or severe/very severe (grade 3 or higher).

Of the 706 patients, 49.7% reported severe or very severe symptoms at the initiation of the regimen, and 86.1% reported at least 1 moderate symptom. Of the 623 patients who provided follow-up PRO-CTCAE data, fewer patients in the GA intervention arm reported grade 2 or higher symptomatic toxicity. Reports of grade 3 or higher toxicity were comparable but not significant.

“This analysis provides evidence that a GA intervention can decrease the prevalence of symptomatic toxicities as measured by patient-reported outcomes,” wrote the researchers.

The study did have limitations. The method may underestimate symptomatic toxicity in severe cases because it didn’t capture toxicity for patients who entered treatment with the highest symptom severity scores. The results have limited generalizability because the majority of the sample was White. Additionally, the PRO-CTCAE data was not collected weekly, so the selected time intervals are limited.

“Even with these limitations, this study adds to growing evidence that PRO-CTCAEs are feasible for patients to report symptoms during treatment,” the researchers concluded. “This analysis demonstrates their value for older patients with advanced cancer and aging-related conditions being cared for in community oncology clinics.”

Disclosures: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Culakova E, Mohile SG, Peppone L, et al. Effects of a geriatric assessment intervention on patient-reported symptomatic toxicity in older adults with advanced cancer. J Clin Oncol. Published online November 10, 2022. doi:10.1200/JCO.22.00738