Geriatric assessment-driven intervention (GAIN) on chemotherapy toxicity in older adults with cancer: A randomized controlled trial.

Abstract

12010 Background: Geriatric assessment (GA) can predict chemotherapy (chemo) toxicity in older adults (age ≥65) with cancer. However, evidence regarding the effect of GA-driven intervention (GAIN) on the incidence of chemo toxicity has been limited. Therefore, we conducted a randomized controlled trial evaluating the impact of GAIN vs. standard of care (SOC) on chemo toxicity in older adults with cancer. Methods: Patients (pts) age ≥65, diagnosed with a solid malignancy, and starting a new chemo regimen at City of Hope were eligible (NCT02517034). In a 2:1 ratio, 600 pts were randomly assigned to either GAIN (n = 398) or SOC (n = 202) arms. All pts completed a baseline GA prior to chemo. In the GAIN arm, a multidisciplinary team led by a geriatric oncologist, nurse practitioner, social worker, physical/occupation therapist, nutritionist, and pharmacist, reviewed GA results and implemented interventions based on predefined triggers built into the GA’s various domains. In the SOC arm, GA results were sent to treating oncologists to use at their discretion. Pts were followed until either end of chemo or 6 months after start of chemo, whichever occurred first. The primary endpoint was incidence of grade 3-5 chemo-related toxicity (NCI CTCAE v.4.0). Secondary endpoints included advance directive (AD) completion, emergency room (ER) visits, hospitalizations, and average length of stay (ALOS). Chi-square and Fisher’s exact tests were used to compare the categorical outcomes, and Kruskal-Wallis test was used to compare the ALOS between arms. Results: Pt characteristics were balanced between arms. Median age was 71 (range 65-91). Cancer types included: 33% gastrointestinal, 23% breast, 16% lung, 15% genitourinary, and 13% other. Most (71%) had stage IV disease. The incidence of grade 3-5 chemo-related toxicity was 50.5% (95% CI: 45.6-55.4%) in the GAIN arm and 60.4% (95% CI: 53.7-67.1%) in the SOC arm (p = 0.02). Compared to SOC, the GAIN arm had a reduction of 9.9% (95% CI: 1.6-18.2%) in chemo-related toxicity. At the end of study, AD completion increased 24.1% in the GAIN arm vs. 10.4% in the SOC arm (p < 0.001). No significant differences in ER visits (27.4% vs. 30.7%), hospitalizations (22.1% vs. 19.3%), or ALOS (median 4.8 vs. 5.0 days) were observed between the GAIN and SOC arms, respectively. Conclusions: Integration of multidisciplinary GA-driven interventions reduced grade 3-5 chemo-related toxicity and improved AD completion in older adults with cancer. GA-driven interventions should be included as a part of cancer care for all older adults. Clinical trial information: NCT02517034 .

Prediction of Unplanned Hospitalizations in Older Patients Treated with Chemotherapy

“…However, if therapy is used with curative intent, careful consideration should be taken as dose modification could reduce efficacy. Likewise, measures could be initiated to improve the nutritional and functional status of older patients, although the randomized study GAIN (Geriatric assessment-driven intervention) showed that such measures only reduce drug toxicity but not UH or the number of visits to the emergency department [ 22 ]. Supportive care and close monitoring should be established in high-risk patients.…”

ASCO 2020: The Geriatric Assessment Comes of Age

“…Although GA‐guided interventions are effective for improving survival and functional status in several scenarios [2], there is a lack of information regarding the effects of GA‐guided care on traditional “hard” oncological outcomes, such as overall survival (OS), treatment toxicity, or quality of life (QoL) [3]. Fortunately, four randomized clinical trials (RCT) presented at the 2020 ASCO Annual Meeting have provided new evidence showing that the implementation of GA‐guided interventions for older adults with cancer can in fact lead to improvements in QoL and decreased treatment toxicity, without compromising survival (Table 1) [ 4–6]. These RCTs represent a giant leap forward for geriatric oncology, because they provide a strong foundation that will allow for GA‐guided interventions to become the standard of care for all older adults with cancer.…”

“…The GAIN RCT studied the effect of a multidisciplinary team (MDT) GA‐guided intervention on the outcomes of patients with solid tumors treated at a single cancer center in southern California [5]. In GAIN, patients aged ≥65 years with solid tumors (any stage) starting a new line of chemotherapy were randomized 2:1 to the MDT GA intervention or to usual oncologist‐guided care.…”

Chemotherapy and Targeted Agents in the Treatment of Elderly Patients with Metastatic Colorectal Cancer

“…On the other hand, a recent study indicates that when the GA is not taken into account for prescribing chemotherapy, 34% of unfit patients are overtreated, which is associated with more grade 3-4 toxicity than those receiving treatment adapted to fragility (42% vs. 31%; p < 0.05) (9). In addition, recently, two randomized clinical trials evaluating the impact of GA vs. standard of care on chemo toxicity in older adults with cancer showed the integration of multidisciplinary GA-driven interventions reduced the incidence of grade 3-5 chemo-related toxicity by 10-20% [37,38].…”