Current palliative chemotherapy trials in the elderly neglect patient-centred outcome measures

Bekkum, Marlies L. van; Munster, Barbara C. Van; Thunnissen, P. L. M.; Smorenburg, Carolien H.; Hamaker, Marije E.

doi:10.1016/j.jgo.2014.09.181

Cited by 17 publications

(9 citation statements)

References 23 publications

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“…In order to improve cancer care for older patients with a high risk of enhanced treatment-induced morbidity, international consensus guidelines and position papers on the use of a geriatric assessment (GA) have been created [3,4,5]. However, older patients are under-represented in clinical trials, resulting in difficulties with incorporating evidence-based clinical decision making for this heterogeneous group of patients [6]. As data are based on younger patients, survival estimates might have to be adjusted [7], making it more difficult to discuss the advantages and disadvantages of treatment in elderly patients.…”

Section: Introductionmentioning

confidence: 99%

A Questionnaire Study to Assess the Value of the Vulnerable Elders Survey, G8, and Predictors of Toxicity as Screening Tools for Frailty and Toxicity in Geriatric Cancer Patients

et al. 2016

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Background: The aim of this study was to identify an appropriate screening instrument for the identification of frail elderly patients in a tertiary cancer center. In order to improve cancer care for older patients, the use of a geriatric assessment (GA) has been proposed to identify frail patients or those who are at a higher risk for chemotherapy-related toxicities. In busy clinical routine, an appropriate screening instrument could be used to spare time- and resource-consuming application of GA. Patients and Methods: We administered the Vulnerable Elders Survey (VES-13), G8 questionnaire, and Predictors of Toxicity (POT) as well as a GA at the first visit of 84 consecutive patients at a single Comprehensive Cancer Center. Analysis for patients' characteristics as well as sensitivity, specificity, and positive and negative predictive value (npv) was conducted. Results: The median age of the patients was 73 years (range 63-93 years), 61.9% were male, most (63%) suffered from gastrointestinal tumors, 39.3% had a multiple cancer diagnosis, and 53.6% had metastasis. 30 (35.7%) individuals were classified as ‘frail' by the GA. Sensitivity of G8 was 38.3%, and the npv was 63.8%. Sensitivity for VES-13 was 57.1%, and npv was 76.3%. Sensitivity of POT was 72.7%, and the npv was 80.6%. Conclusion: For the first time, the VES-13, G8, and POT are compared in a sample of older German patients. The POT seems to be a sufficient screening tool to identify frail patients in a tertiary referral cancer center and helps to save time and resources compared with a complete GA.

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Section: Introductionmentioning

confidence: 99%

A Questionnaire Study to Assess the Value of the Vulnerable Elders Survey, G8, and Predictors of Toxicity as Screening Tools for Frailty and Toxicity in Geriatric Cancer Patients

et al. 2016

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“…Both studies reported a PFS improvement in the bevacizumab arm [ 7 , 8 ] without significant OS improvement. Some concerns also raised for the use of usual oncologic end points as OS and PFS in elderly patients [ 9 ]. It has been reported that if elderly patients have a good acceptance of CT they are less willing to have a toxicity than their younger counterparts [ 10 ].…”

Section: Introductionmentioning

confidence: 99%

Bevacizumab+chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial—PRODIGE 20 study results

Aparicio

Bouché

Taı̈eb³

et al. 2018

Annals of Oncology

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BackgroundMetastatic colorectal cancer frequently occurs in elderly patients. Bevacizumab in combination with front line chemotherapy (CT) is a standard treatment but some concern raised about tolerance of bevacizumab for these patients. The purpose of PRODIGE 20 was to evaluate tolerance and efficacy of bevacizumab according to specific end points in this population.Patients and methodsPatients aged 75 years and over were randomly assigned to bevacizumab + CT (BEV) versus CT. LV5FU2, FOLFOX and FOLFIRI regimen were prescribed according to investigator’s choice. The composite co-primary end point, assessed 4 months after randomization, was based on efficacy (tumor control and absence of decrease of the Spitzer QoL index) and safety (absence of severe cardiovascular toxicities and unexpected hospitalization). For each arm, the treatment will be consider as inefficient if 20% or less of the patients met the efficacy criteria and not safe if 40% or less met the safety criteria.ResultsAbout 102 patients were randomized (51 BEV and 51 CT), median age was 80 years (range 75–91). Primary end point was met for efficacy in 50% and 58% and for safety in 61% and 71% of patients in BEV and CT, respectively. Median progression-free survival was 9.7 months in BEV and 7.8 months in CT. Median overall survival was 21.7 months in BEV and 19.8 months in CT. The 36-month overall survival rate was 27% in BEV and 10.1% in CT. Severe toxicities grade 3/4 were mainly non-hematologic toxicities (80.4% in BEV, 63.3% in CT).ConclusionBevacizumab combined with CT was safe and efficient. Both arms met the primary safety and efficacy criteria.

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“…In their consensus, they established that the domains that should appear in any CGA model are functional status, comorbidity, cognitive status, emotional state, social situation, nutritional status, and the presence of fatigue and geriatric syndromes [ 16 ]. Despite these recommendations, a recent publication-addressing seniors undergoing chemotherapy reflected that certain components of CGA are only ascertained in a small percentage of older patients [ 26 ].…”

Section: Recommendations Regarding Evaluation and Scalesmentioning

confidence: 99%

General recommendations paper on the management of older patients with cancer: the SEOM geriatric oncology task force’s position statement

et al. 2018

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Population aging is associated with greater numbers of older people with cancer. Thanks to treatment advances, not only are more seniors diagnosed with cancer, but there are also more and more older cancer survivors. This upward trend will continue. Given the heterogeneity of aging, managing older patients with cancer poses a significant challenge for Medical Oncology. In Spain, a Geriatric Oncology Task Force has been set up within the framework of the Spanish Society for Medical Oncology (SEOM). With the aim of generating evidence and raising awareness, as well as helping medical oncologists in their training with respect to seniors with cancer, we have put together a series of basic management recommendations for this population. Many of the patients who are assessed in routine clinical practice in Oncology are older. CGA is the basic tool by means of which to evaluate older people with cancer and to understand their needs. Training and the correct use of recommendations regarding treatment for comorbidities and geriatric syndromes, support care, and drug–drug interactions and toxicities, including those of antineoplastic agents, as detailed in this article, will ensure that this population is properly managed.

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Current palliative chemotherapy trials in the elderly neglect patient-centred outcome measures

Cited by 17 publications

References 23 publications

A Questionnaire Study to Assess the Value of the Vulnerable Elders Survey, G8, and Predictors of Toxicity as Screening Tools for Frailty and Toxicity in Geriatric Cancer Patients

A Questionnaire Study to Assess the Value of the Vulnerable Elders Survey, G8, and Predictors of Toxicity as Screening Tools for Frailty and Toxicity in Geriatric Cancer Patients

Bevacizumab+chemotherapy versus chemotherapy alone in elderly patients with untreated metastatic colorectal cancer: a randomized phase II trial—PRODIGE 20 study results

General recommendations paper on the management of older patients with cancer: the SEOM geriatric oncology task force’s position statement

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