A geriatric assessment (GA) intervention to reduce treatment toxicity in older patients with advanced cancer: A University of Rochester Cancer Center NCI community oncology research program cluster randomized clinical trial (CRCT).

Authors

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Supriya Gupta Mohile

University of Rochester James Wilmot Cancer Institute, Rochester, NY

Supriya Gupta Mohile , Mostafa Refaat Mohamed , Eva Culakova , Huiwen Xu , Kah Poh Loh , Allison Magnuson , Marie Anne Flannery , Erika E. Ramsdale , Richard Francis Dunne , Nikesha Gilmore , Spencer Obrecht , Amita Patil , Sandy Plumb , Lisa M Lowenstein , Michelle Christine Janelsins , Karen Michelle Mustian , Judith O. Hopkins , Jeffrey L. Berenberg , Rakesh Gaur , William Dale

Organizations

University of Rochester James Wilmot Cancer Institute, Rochester, NY, University of Rochester Medical Center, Rochester, NY, The University of Texas MD Anderson Cancer Center, Houston, TX, Southeast Clinical Oncology Research Consortium, Winston Salem, NC, Hawaii MUNCORP, Honolulu, HI, St. Luke's Cancer Institute, Kansas City, MO, City of Hope National Medical Center, Duarte, CA

Research Funding

U.S. National Institutes of Health
U.S. National Institutes of Health

Background: GA evaluates aging-related domains (e.g., function) known to be associated with cancer treatment toxicity. In this CRCT, we evaluated if providing a GA summary with management recommendations to oncologists can reduce toxicity in older patients (pts) with advanced cancer receiving chemotherapy and/or other agents with a high reported prevalence of grade 3-5 toxicity. Methods: Pts aged > 70 with incurable solid tumors or lymphoma and > 1 impaired GA domain starting a new treatment regimen were enrolled. Community oncology practices were randomized to intervention (oncologists received GA summary/recommendations for impairments) or usual care (none given). The primary outcome was proportion of pts who experienced any grade 3-5 toxicity (CTCAE v.4) within 3 months. Practice staff prospectively captured toxicities; blinded oncology clinicians reviewed medical records to verify. Secondary outcomes included 6 month overall survival (OS) and treatment intensity (standard vs reduced). Outcomes were analyzed using generalized linear mixed/Cox models with Arm as a fixed effect, controlling for practice. Results: From 2013-19, 718 pts were enrolled from 41 practices. Age (mean 77 yrs), sex (43% women), number of impaired GA domains (median 4/8), and treatment type (chemotherapy 88%) were not different by Arm. More pts in intervention were Black (12% vs 3%, p<0.01), had GI cancer (38% vs 31%, p<0.01), and had prior chemotherapy (31% vs 23%, p=0.02). Pts in intervention experienced a lower proportion of grade 3-5 toxicity (175/349; 50%) than pts in usual care (262/369; 71%). The relative risk (RR: intervention vs usual care) of grade 3-5 toxicity was 0.74 (95% CI: 0.63-0.87; p=0.0002); the difference was mostly driven by non-heme toxicities (RR 0.73; 95% CI: 0.53-1.0, p<0.05). OS was not significantly different (71% vs 74%, p=0.3). More pts in intervention received reduced intensity treatment at cycle 1 (49% vs 35%, RR 0.81, p=0.01). Dose modifications due to toxicity were lower in intervention (42% vs 58%, p<0.0001), but results were not significant after controlling for practice (RR 0.85; 95% CI: 0.67-1.08, p=0.2). Conclusions: Providing GA information to oncologists reduces the proportion of older pts who experience grade 3-5 toxicity from high-risk palliative cancer treatment, without compromising OS. Reduced treatment intensity at cycle 1 may explain these results. Funding: R01CA177592, U01CA233167, UG1CA189961. Clinical trial information: NCT02054741.

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Clinical Science Symposium

Session Title

You're Only Old Once: Improving Outcomes for Older Adults With Cancer

Track

Symptom Science and Palliative Care

Sub Track

Geriatric Models of Care

Clinical Trial Registration Number

NCT02054741

Citation

J Clin Oncol 38: 2020 (suppl; abstr 12009)

DOI

10.1200/JCO.2020.38.15_suppl.12009

Abstract #

12009

Abstract Disclosures