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A Simplified Geriatric Assessment offers a validated objective tool for assessing fitness status and should be considered the new standard of the Elderly Prognosis Index (EPI) for predicting overall survival (OS) in older patients. with diffuse large B-cell lymphoma (DLBCL), results show. of the Elderly Project study (NCT02364050) published in the Journal of Clinical Oncology.
The tool integrates activities of daily living, instrumental activities of daily living, the cumulative assessment scale for geriatric illnesses and age (≥80 or <80) to refine and improve the tool. Original geriatric assessment adopted by the Fondazione Italiana Linfomi (FIL) which categorized patients into 3 categories of fitness: fit, unfit and fragile.
Using the simplified tool which also classified patients into the same fitness categories as the original tool, the 3-year median OS was 65% (95% CI, 62% -68%) in the overall patient population (n = 1163); however, the median OS varied considerably with physical fitness. The relative risk (HR) was 1.98 for unfit vs fit patients (95% CI, 1.55-2.54; P <.001), 3.27 for frail vs fit patients (95% CI, 2.52-4.22; P <.001) and 1.65 for frail vs unfit patients (95% CI, 1.26-2.14; P <.001). This resulted in 3-year OS rates of 87% (95% CI, 81% -91%), 69% (95% CI, 63% -73%) and 42% (95% CI, 36 % -49%) for fit, unfit and frail patients, respectively.
“The development and validation of the EPI [Elderly Prognostic Index] on an independent patient series provides clinicians with a unique tool to better take into account the complexity of each elderly patient with DLBCL ”, lead author of the study Francesco Merli, MD, general manager of the department of oncology and advanced technologies to Azienda Osperdaliera Santa Maria Nuova di Reggio Emilia in Italy, and his co-authors wrote.
DLBCL is the most common lymphoma subtype. In addition, about 70% of patients with DLBCL are over 65 years of age.
The integration of rituximab (Rituxan) into standard treatment regimens containing anthracyclines has significantly improved the survival of patients with DLBCL; however, older patients with DLBCL perform worse than younger patients. In addition, age-related comorbidities limit the available treatment options, which are associated with an increased risk of treatment-related toxicity. Notably, despite this disparity, elderly patients are significantly under-represented in clinical trials, so physician preference plays an important role in the choice of treatment.
The integration of geriatric assessment has provided a useful tool for assessing multiple geriatric conditions and then tailoring therapies in terms of patient goals, intensity, tolerance and prognosis.
“FIL uses the same [original geriatric assessment] in his studies of elderly patients with DLBCL for several years, ”the authors wrote.
The Elderly Project was a prospective, multicenter observational study to assess how simplified geriatric assessment affected OS in older patients with newly diagnosed DLBCL.
The 3-step study prospectively validated the original geriatric assessment, refined the new simplified geriatric assessment to account for confounding factors, and developed and validated a prognostic model that incorporated both patient and lymphoma-related factors.
The study evaluated 1163 patients from 36 FIL hematology / oncology centers in Italy.
Patients had to have histologically confirmed DLBCL, be 65 years of age or older, provide informed consent, and have original geriatric assessment results. Patients who had a diagnosis other than DLBCL including follicular grade 3b lymphoma or high grade lymphoma were not eligible for assessment.
Patients were classified as fit, unfit or frail according to the simplified geriatric assessment criteria and the results of an online calculator.
Overall, patients had a median age of 76 years (range 65 to 94 years; P <.001) and 32% were over 80 years old (P <.001). Half of the patients (50%) were men (P = 0.032), 67% had stage III or IV disease (P = .217), 29% had more than one extranodal site (P = 0.795) and 20% had an ECOG performance index greater than 1 (P <.001). Most patients' lactase dehydrogenase (55%) was above the upper limit of normal (P = .180), and 56% of patients had an IPI (International Prognostic Index) score between 3 and 5 (P = .004).
In particular, the simplified geriatric assessment protocol did not include any recommendations for patient management and the choice of treatment was left to the discretion of the provider and did not need to be informed by the results of the assessment. .
Of the total population, 54% (n = 652) were classified as fit at departure, 28% (n = 334) were unfit and 18% (n = 221) were frail. In addition, 63% of patients have already received full-dose chemotherapy, 24% have already received reduced-dose chemotherapy, and 13% have received palliative care. Full-dose chemotherapy was administered to 86%, 48%, and 16% of fit, unfit and frail patients, respectively.
“The prognostic score was obtained [by] give a weight to each variable according to its relative importance, derived from the z-Wald values found in the Cox PH [proportional-hazards] model. The weights were obtained [by] rounding up the ratio, and the score was the sum of [the] weight. We thus obtained a score ranging from 0 to 8 which showed a good correlation with OS ”, write the authors.
At a median follow-up of 30 months (range 1 to 59), 354 deaths were reported for causes including lymphoma progression (n = 243), treatment-related toxicity (n = 74), secondary malignancy (n = 10) and unknown (n = 27).
Fitness level, IPI score and hemoglobin level were found to be the most significant prognostic factors in establishing the EPI score. The EPI model was developed on the basis of a cohort of 1065 patients with a 3-year OS rate of 66% (95% CI, 62% -69%); the cohort excluded patients with incomplete data.
In addition to OS, the prognostic role of the EPI model has been validated for progression-free survival and disease-free survival, the authors wrote.
An external validation of 456 cases with a median follow-up of 30 months was carried out in Italy (n = 172), Australia (n = 204) and Brazil (n = 80). Complete data was available in 78% of cases. A total of 117 patients died during the study and the 3-year OS rate was 61% (95% CI, 55% -67%).
In the validation cohort, 22% were classified as low risk, 46% were intermediate risk, and 32% were high risk. The 3-year OS rates were 85% (95% CI, 71% -93%), 65% (95% CI, 55% -73%) and 44% (95% CI, 34% -54%) , respectively. The HR was 2.14 in the intermediate risk group compared to the low risk group (95% CI, 1.08-4.24; P = 0.029) and 2.18 in the high risk group vs the intermediate risk group (95% CI, 1.49-3.21; P <.001).
Notably, the simplified geriatric assessment takes less than 10 minutes to be completed by the oncologist / hematologist during a regular patient visit, the authors wrote.
“Now is the time to consider the health status of elderly patients with DLBCL in order to better identify their treatment goals. The EPI is the first prognostic index to integrate the assessment of physical condition into the prognosis in elderly patients with DLBCL, which helps to improve patient assessment, ”the authors concluded.
Reference
Merli F, Luminari S, Tucci A et al. Simplified Geriatric Assessment in Elderly Patients with Diffuse Large B-Cell Lymphoma: The Prospective Elderly Project of Fondazione Italiana Linfomi. J Clin Oncol. Published online February 12, 2021. doi: 10.1200 / JCO.20.02465
This article originally appeared on OncLive under the title “Simplified Geriatric Assessment Validated as a Predictor of OS in Elderly Patients with DLBCL”.
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