'Staging the Aging' Cancer Benefits Proven. Payment Coming?

Lack of Reimbursement Hurts Uptake

Nick Mulcahy

May 15, 2020

In 2013, William Dale, MD, PhD, wrote a prize-winning essay — about an elderly man with metastatic prostate cancer who is sliding toward death — with the seemingly hyperbolic title of "Geriatrics Saved His Life!"

Dale, a geriatrician who is chair of Supportive Care Medicine at City of Hope, Duarte, California, explains that the essay was provocative because geriatric medicine is perceived by oncologists as lacking powerful efficacy when compared with treatment interventions.  

But, as Dale's essay title suggests, carefully assessing an older cancer patient beyond the standard "eyeball test" can yield potent benefits.

Called "staging the aging" by insiders for more than a decade, geriatric assessment in oncology involves a set of screens for functioning, medical issues and other measures that may result in, for example, a dose reduction in chemotherapy or a polypharmacy adjustment.

How this can change clinical outcomes has now been demonstrated for the first time in three new randomized clinical trials to be presented at the 2020 American Society of Clinical Oncology (ASCO) virtual annual meeting later this month.

The new ground-breaking, level-one evidence shows that geriatric assessment significantly improves quality of life and reduces high-grade chemotherapy toxicity, treatment discontinuation, hospital utilization, and unplanned hospital admissions — vs usual care.

For the first time, randomized trials show that geriatric assessment and related interventions can change outcomes. Dr William Dale

"For the first time, randomized trials show that geriatric assessment and related interventions can change outcomes. We're excited. This validation will make a difference [in establishing its value]," said Dale, who is senior author of two of the three new trials.

The goal is to establish geriatric assessment as standard of care, he said, and eventually "get to the point where people say, 'if it's standard of care, then we will pay for it.' "

In the United States, there is no reimbursement for geriatric assessment, which takes about 20 to 30 minutes in the clinic, and that hurts uptake. Also, if a system benefits financially from, for example, hospitalization, then that does not incentivize something like geriatric assessment, Dale commented.

Despite no pay, there are plenty of potential patients.

Most patients with cancer are candidates, as between 60% to 70% of all adult cancer patients are 65 and older, said Richard Schilsky, MD, chief medical officer of ASCO in a pre-meeting press call.

ASCO published its first guideline for geriatric oncology, with a focus on patients undergoing chemotherapy, in 2018. But Schilsky acknowledged that not all clinicians use it or even know about it. "There is variability among oncologists in the awareness of the guideline," he said diplomatically.

"It's still not top of mind" even at City of Hope, said Dale, in part because oncology practice is increasingly "frenetic" having to accommodate a steady stream of new drugs and tests.

The agent of change in the US may eventually be value-based care, such as the Centers for Medicare & Medicaid's experimental Oncology Care Model, which financially rewards positive clinical outcomes that decrease costs, Dale observed.

Evidence from "Cadillac" Approach in Australia

One of the trials that provides new evidence of benefit from geriatric assessments comes from Australia. Oncologists and geriatricians cooperated to conduct the INTEGERATE clinical trial, randomly assigning 154 cancer patients age 70+ who were preparing to receive either chemotherapy, immunotherapy, or targeted therapy, to "comprehensive geriatric assessment" or routine care.

Patients in the intervention group received what Dale calls the "full Cadillac model" of geriatric assessment, a reference to the American luxury car manufacturer. Generally, the assessment or battery of screens are similar throughout practice globally, but the difference is in the subsequent intervention, he said.

In INTEGERATE, a multidisciplinary team intervened in a highly coordinated manner, explained lead investigator Wee-Kheng Soo, MBBS, a geriatrician and medical oncologist at Eastern Health in Melbourne, during the ASCO press briefing.

Importantly, geriatricians led the patient management in consultation with a host of other professionals, Soo said. That is a reversal of the norm, according to an ASCO press statement, which observed that patients with cancer are typically only referred to a geriatrician in the later stages of illness, as a result of impaired function with everyday tasks.

Soo said the study's assessment included screens for functional activity, medical issues, polypharmacy, nutrition, depression, and social isolation.

The intervention group had significantly better quality of life, the primary outcome, at 12, 18, and 24 weeks of follow-up, compared with the usual care group. The greatest difference was seen at week 18 (P = .001). The intervention group also had significant improvements in domains for physical and social functioning, mobility, burden of illness, and future worries.  

Unplanned hospital admissions (-1.2 admissions per person-years, P < .001) and early treatment discontinuation (32.9% vs 53.2%, P = .01) were also significantly better in the intervention group.

"All older people [with cancer]…should receive a comprehensive geriatric assessment to optimize their clinical care and health outcomes," summarized Soo during the press briefing.

More Evidence: Two Trials Look at Chemo Toxicity

More evidence showing benefits from geriatric assessment in older cancer patients with cancer comes from two other randomized trials — to be presented at the ASCO meeting — that demonstrate reductions in toxicity from chemotherapy.

In a multicenter randomized trial, American and Mexican investigators concluded that integration of multidisciplinary geriatric assessment-driven interventions (GAIN) reduced grade 3-5 chemo-related toxicity, which was the primary outcome measure, compared to usual care in older cancer patients.

A total of 600 patients, with a median age of 71 years, were randomly assigned 2:1 to either GAIN (n = 398) or standard of care (n = 202) groups. All patients completed a baseline geriatric assessment prior to chemotherapy. However, in the GAIN group, a multidisciplinary team led by a geriatric oncologist, nurse practitioner, social worker, physical/occupational therapist, nutritionist, and pharmacist, reviewed the assessments and implemented interventions based on predefined triggers built into the assessment's domains.

In the usual care group, assessment results were sent to treating oncologists to use at their discretion, said the investigators, led by Daneng Li, MD, of City of Hope.

Patients were followed until either the end of chemotherapy or 6 months after the start of chemo, whichever occurred first.

The incidence of grade 3-5 chemo-related toxicity was 50.5% in the GAIN group and 60.4% (95% confidence interval, 53.7 - 67.1%) in the usual care group (P = 0.02), an absolute reduction of nearly 10%.

In the other randomized trial, American investigators also evaluated the incidence of grade 3-5 toxicity, but among 718 patients with a mean age of 71 years who were undergoing high-risk palliative cancer treatment for incurable solid tumors or lymphoma.

Community oncology practices were randomly assigned to intervention (oncologists received a geriatric assessment summary/recommendations for impairments; patient number = 369) or usual care (none given; patient number = 349).

"Providing geriatric assessment information to oncologists reduces the proportion of older patients who experience grade 3-5 toxicity from high-risk palliative cancer treatment, without compromising overall survival," concluded the authors, led by Supriya Gupta Mohile, MD, University of Rochester James Wilmot Cancer Institute, New York.

Mohile and colleagues reported that the proportion of grade 3-5 treatment-related toxicity was 50% in the intervention group and 71% in the usual care group, an absolute difference of 21%. The relative risk of grade 3-5 toxicity was 0.74 (P = .0002) for the intervention vs usual care.

Reduced treatment intensity at cycle 1 of cancer treatment "may explain these results," said the authors.

City of Hope's Dale described this approach as "intervention lite" because of its relative absence of coordination among professionals.

He also said that in the US currently, this "lite" approach to geriatric assessment is more feasible because "the obstacles are greater than the rewards" with the multidisciplinary "Cadillac" model.

Nonetheless, ASCO President Howard A. Burris III, MD, observed that an aging global population is making geriatric assessment increasingly important.

"The number of people worldwide over the age of 65 is expected to continue to grow, making the need for more rigorous research to help optimize the quality of care we provide to older patients an urgent priority," Burris said in a statement.

The INTEGERATE study received funding from the National Health and Medical Research Council, Australia. The GAIN study was funded by the UniHealth Foundation and City of Hope's Center for Cancer and Aging.

Li and other authors report financial relationships with pharmaceutical companies. Mohile's study was funded by the US National Institutes of Health; she and other authors report funding from pharmaceutical and other companies. Schilsky reports research funding from multiple pharmaceutical companies. Dale and Soo have disclosed no relevant financial relationships. Burris is an employee of HCA Healthcare / Sarah Cannon and has stock/ownership in the company as well as financial ties to industry.

2020 annual meeting of the American Society of Clinical Oncology. Abstracts 12009, 12010, and 12011.

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