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Randomized Controlled Trial
. 2021 Nov 20;398(10314):1894-1904.
doi: 10.1016/S0140-6736(21)01789-X. Epub 2021 Nov 3.

Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study

Supriya G Mohile  1 , Mostafa R Mohamed  2 , Huiwen Xu  3 , Eva Culakova  3 , Kah Poh Loh  2 , Allison Magnuson  2 , Marie A Flannery  3 , Spencer Obrecht  2 , Nikesha Gilmore  3 , Erika Ramsdale  2 , Richard F Dunne  2 , Tanya Wildes  2 , Sandy Plumb  2 , Amita Patil  2 , Megan Wells  2 , Lisa Lowenstein  4 , Michelle Janelsins  3 , Karen Mustian  3 , Judith O Hopkins  5 , Jeffrey Berenberg  6 , Navin Anthony  5 , William Dale  7
Affiliations
Randomized Controlled Trial

Evaluation of geriatric assessment and management on the toxic effects of cancer treatment (GAP70+): a cluster-randomised study

Supriya G Mohile et al. Lancet. .

Abstract

Background: Older adults with advanced cancer are at a high risk for treatment toxic effects. Geriatric assessment evaluates ageing-related domains and guides management. We examined whether a geriatric assessment intervention can reduce serious toxic effects in older patients with advanced cancer who are receiving high risk treatment (eg, chemotherapy).

Methods: In this cluster-randomised trial, we enrolled patients aged 70 years and older with incurable solid tumours or lymphoma and at least one impaired geriatric assessment domain who were starting a new treatment regimen. 40 community oncology practice clusters across the USA were randomly assigned (1:1) to the intervention (oncologists received a tailored geriatric assessment summary and management recommendations) or usual care (no geriatric assessment summary or management recommendations were provided to oncologists) by means of a computer-generated randomisation table. The primary outcome was the proportion of patients who had any grade 3-5 toxic effect (based on National Cancer Institute Common Terminology Criteria for Adverse Events version 4) over 3 months. Practice staff prospectively captured toxic effects. Masked oncology clinicians reviewed medical records to verify. The study was registered with ClinicalTrials.gov, NCT02054741.

Findings: Between July 29, 2014, and March 13, 2019, we enrolled 718 patients. Patients had a mean age of 77·2 years (SD 5·4) and 311 (43%) of 718 participants were female. The mean number of geriatric assessment domain impairments was 4·5 (SD 1·6) and was not significantly different between the study groups. More patients in intervention group compared with the usual care group were Black versus other races (40 [11%] of 349 patients vs 12 [3%] of 369 patients; p<0·0001) and had previous chemotherapy (104 [30%] of 349 patients vs 81 [22%] of 369 patients; p=0·016). A lower proportion of patients in the intervention group had grade 3-5 toxic effects (177 [51%] of 349 patients) compared with the usual care group (263 [71%] of 369 patients; relative risk [RR] 0·74 (95% CI 0·64-0·86; p=0·0001). Patients in the intervention group had fewer falls over 3 months (35 [12%] of 298 patients vs 68 [21%] of 329 patients; adjusted RR 0·58, 95% CI 0·40-0·84; p=0·0035) and had more medications discontinued (mean adjusted difference 0·14, 95% CI 0·03-0·25; p=0·015).

Interpretation: A geriatric assessment intervention for older patients with advanced cancer reduced serious toxic effects from cancer treatment. Geriatric assessment with management should be integrated into the clinical care of older patients with advanced cancer and ageing-related conditions.

Funding: National Cancer Institute.

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Conflict of interest statement

Declaration of interests KPL reports consultant fees from Pfizer and Seattle Genetics and honoraria from Pfizer. RFD received honoraria for consulting from Exelixis. TW reports research funding from Janssen and consultant fees from Seattle Genetics and Carevive. All other authors declare no competing interests.

Figures

Figure 1.
Figure 1.. CONSORT flow diagram for the GAP-70+ Study 1
One cluster was combined with another cluster due te oncologist crossover 2: Sites are no longer associaed with their respective NCORP or with the University of Rochester Research Base 3: Clusters that mainatained IRB approval but never actually enrolled any participants 4: Patients who were screened but either failed screening eligibility or withdrew prior to completing the baseline visit. 5: A patient is considered active if they complete all or some PROs; this includes patients that have a missed visit due to illness, hospitalization, or scheduling. 6: Includes patients who withdrew or were active with missing data (AWMD) (e.g. entered hospice and no longer completed study procedures). Footnote: ^Practice clusters were built from community oncology practices that expressed interest in study participation. Practice clusters were comprised of community oncology practices that had overlap between any participating study team members. If an oncologist, coordinator, or research nurse or any other research study staff worked at multiple community practices those practices would be grouped into a cluster. Due to this crossover, multiple community oncology practices could be in one practice cluster. Practice clusters varied in size.
Figure 2.
Figure 2.
Prevalence of any Grade 3–5 CTCAE Toxicity over 3 Months by Study Arm Footnote: Abbreviations: GA: Geriatric Assessment; aRR: adjusted Risk Ratio
Figure 3.
Figure 3.
Treatment Intensity by Study Arm Footnote: Abbreviations: GA: Geriatric Assessment; aRR: adjusted Risk Ratio
Figure 4:
Figure 4:
Survival over 1 year by Study Arm
See this image and copyright information in PMC

Comment in

References

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