Geriatric Assessment Intervention Helps Reduce Symptom Burden for Older Patients With Advanced Cancer

Eva Culakova, PhD, MS

Providing oncologists with a baseline geriatric assessment (GA) summary with guidelines to manage toxicities may help reduce symptom burden in older patients with advanced cancer, according to an analysis of a national cluster randomized clinical trial (NCT02054741), published in the Journal of Clinical Oncology.

Among 623 patients with available follow-up data using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), fewer patients in the GA intervention arm (n = 296) reported grade 2 or worse symptomatic toxicity compared with those in the nonintervention arm (n = 327; 88.9% vs 94.8%; P = .035). Similarly, the rate of patients who experienced grade 2 or worse core symptom toxicities as defined by the National Cancer Institute (NCI), was lower in the intervention group (83.4% vs91.7%; 95% CI, 0.860-0.962; P = .001). A lower percentage of patients in the intervention arm reported grade 2 or worse symptomatic toxicities in every measured category except decreased appetite.

Overall, the results for grade 3 toxicity were comparable but were ultimately statistically insignificant (P > .05).

“This study is one of a very few to report patient-reported symptomatic toxicities as an outcome in a randomized controlled trial,” wrote Eva Culakova, PhD, MS, of the department of Supportive Care in Cancer, at University of Rochester Medical Center, and coinvestigators, in the study. “Previously, PRO-CTCAEs were evaluated in trials examining the efficacy of therapeutic agents in advanced prostate cancer and non–small cell lung cancer. The results reinforce the feasibility of collecting PRO-CTCAE longitudinally from older adults with advanced cancer and aging-related conditions.”

More than a quarter of new cancer diagnosis are for patients who are 75 years and older. Unfortunately, this patient population is typically underrepresented in clinical trials. At the same time, older patients with advanced cancer often experience a high volume of treatment-related symptomatic toxicities.

This analysis leveraged data from the GAP70+ trial, which was a nationwide study conducted by the University of Rochester NCI Community Oncology Research Program. Community oncology practices were randomly assigned to GA intervention or usual care.

The age range of participants was from 70 to 96 years and the median age was 77 years. Forty-three percent of participants were women, 88% were White, 59% had either a lung or gastrointestinal cancer, and 27% had received prior chemotherapy.

Between 2014 and 2019, investigators enrolled patients who were at least 70 years and who had what the investigators deemed as incurable solid tumors or lymphoma, had at least 1 geriatric domain impairment besides polypharmacy, and who were about to start treatments known for high rates of toxicities (grade 3-5).

Prior to initiating treatment, patients completed the PRO-CTCAEs, which evaluated the severity of 24 symptoms, 11 of which are classified as core symptoms. The NCI has identified fatigue, insomnia, pain, anorexia, dyspnea, cognitive problems, anxiety, nausea, depression, sensory neuropathy, constipation, and diarrhea as 13 cores symptoms. Anxiety and depression were not included in the PRO-CTCAE because these symptoms are covered in the GA assessment.

Participants completed the follow-up assessments at 4 to 6 weeks, 3 months, and 6 months into treatment.

In both arms, patients underwent a GA before initiating treatment. However, in the intervention arm, oncologists received a GA summary and management guideline for each enrolled patient. Oncologists in the nonintervention arm did not receive such recommendations but were notified of positive screenings for depression and cognitive impairment.

Notably, more patients in the GA intervention started treatment with a reduced dose whereas more patients in the nonintervention arm required dose reductions during treatment.

A total of 706 patients provided PRO-CTCAE data at baseline, 340 of whom were allocated to the GA intervention group and 366 of whom were allocated to usual care, 86.1% of whom reported at least 1 moderate symptom, and 49.7% of whom reported severe or very severe symptoms at regimen initiation.

Patients who had gastrointestinal cancers (P = .043), a lower performance status (Karnofsky performance score ≤ 80, P = .002), or a GA domain impairment in nutrition (P = .002), psychologic status (P = .002), or cognitive status (P = .048) were also less likely to continue providing PRO-CTCAE throughout their treatment.

“This analysis provides evidence that a GA intervention can decrease the prevalence of symptomatic toxicities as measured by patient-reported outcomes,” study authors concluded. “Future trials should examine whether GA-based models of care that integrate symptom monitoring and management can further improve outcomes of older patients with advanced cancer and aging-related conditions.”

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