Clinical trial design in older adults with cancer—The need for new paradigms

Lichtman, Stuart M.

doi:10.1016/j.jgo.2012.03.002

Cited by 31 publications

(13 citation statements)

References 64 publications

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“…These findings are consistent with existing data, the improvement in OS by targeted therapies not being significant in many studies, even in younger populations . Nevertheless, a relevant evaluation of the effectiveness of cancer treatment in older adults should be based on other end points such as progression‐free survival, quality of life, and maintenance of independence . Data regarding these end points are currently lacking regarding the comparison of treatment with or without targeted therapy in real‐life settings.…”

Section: Discussionsupporting

confidence: 85%

“…For example, a patient aged 75 years treated with polymedication, without other comorbidities or physical dysfunction, has a G8 or modified G8 score, indicating that he or she could benefit from anticancer medications . Moreover, most older adult cancer patients use concomitant medications . Those that do not affect the patient's metabolism or constitute a formal contraindication to the use of anticancer medications should not lead to the systematic exclusion of older adults from these treatments .…”

Section: Discussionmentioning

confidence: 99%

“…18,19 Moreover, most older adult cancer patients use concomitant medications. 19,20 Those that do not affect the patient's metabolism or constitute a formal contraindication to the use of anticancer medications should not lead to the systematic exclusion of older adults from these treatments. 20,21 In this study, medical home visit, nurse at home, and medical transportation, which may be taken as potential markers of dependency (eg, unable to carry out any work activities), were not found to be associated with a lower likelihood of treatment.…”

Section: Discussionmentioning

confidence: 99%

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Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Gouverneur

Bezin

Jové

et al. 2019

J American Geriatrics Society

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OBJECTIVES Metastatic colorectal cancer (mCRC) is increasingly treated with targeted therapies, but little is known about real‐life mCRC treatment in older adults. The aims were to describe the real‐life first‐line treatment modalities in older adult mCRC patients, to identify factors associated with treatment modalities, and to evaluate survival with regard to treatment modalities. PATIENTS AND METHODS A cohort of mCRC patients aged 65 years and older at diagnosis was identified between 2009 and 2013 using French national healthcare insurance system claims data. Treatment modalities were: treatment with one or more anticancer medication vs best supportive care and, among treated patients, treatment with targeted therapy vs conventional chemotherapy alone. Multivariate logistic regression was used to identify factors associated with treatment by anticancer medication and by targeted therapy. Cox proportional hazards models were used to assess the independent effect of treatment modalities on overall survival while adjusting for baseline covariates identified with logistic regression. RESULTS A total of 503 patients were included with a median age of 78 years (54% were men). Of these, 299 (59%) were treated with anticancer medications. Among treated patients, 131 (44%) received targeted therapy. In multivariate analysis, age 75 years or older, renal failure, malnutrition, and five or more concomitant medications were associated with a lower likelihood of treatment with anticancer medications. Among treated patients, age 75 years or older, history of cancer, lymph node metastases, and a single metastatic site were associated with a lower likelihood of treatment with targeted therapy. Multivariate Cox proportional hazards models found that treatment with any anticancer medication tended to be associated with a lower risk of death; treatment with targeted therapy was not significantly associated. CONCLUSION A more appropriate prescription of anticancer medications in the older adult will require the definition of more explicit criteria to avoid undertreatment. The real benefit of targeted therapies vs conventional chemotherapy alone needs to be confirmed in this population. J Am Geriatr Soc 67:913–919, 2019.

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Section: Discussionsupporting

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Gouverneur

Bezin

Jové

et al. 2019

J American Geriatrics Society

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“…In this context, PROMs can also be useful in detecting a positive influence of treatment on cancer symptoms [13,29], particularly when comparing different types of TKIs or other types of novel combination therapies. Although there is general support for the incorporation of PROMs in clinical research, it should be noted that it is not always straightforward how this should be done, as the assessment and analysis of PROMs in a clinical trial can be complicated.…”

Section: Discussionmentioning

confidence: 99%

Patient-Centered Outcome Measures in Lung Cancer Trials

Schulkes

Nguyen

Bos

et al. 2016

Lung

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Patient-centered outcome measures are included in a minority of the currently recruiting clinical trials in pulmonary malignancies. If we do not investigate these outcome measures, it is not possible to increase our knowledge of the optimal treatment, as this should aim to optimize the patient's wellbeing as well as the course of disease. One option could be to incorporate combinations of patient- and disease-centered endpoints, for instance by using overall treatment utility or quality-adjusted outcome measures.

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“…This may be partly explained by the under-representation of older patients in clinical trials (Scher and Hurria, 2012). Special interest organisations are now actively promoting research in elderly patients with cancer (Lichtman, 2012; Wildiers et al , 2012), so appropriate patient-reported outcome measures are required to assess HRQOL.…”

mentioning

confidence: 99%

International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer

et al. 2013

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Background:Older people represent the majority of cancer patients but their specific needs are often ignored in the development of health-related quality of life (HRQOL) instruments. The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-ELD15 was developed to supplement the EORTC's core questionnaire, the QLQ-C30, for measuring HRQOL in patients aged >70 years in oncology studies.Methods:Patients (n=518) from 10 countries completed the QLQ-C30, QLQ-ELD15 and a debriefing interview. Eighty two clinically stable patients repeated the questionnaires 1 week later (test–retest analysis) and 107 others, with an expected change in clinical status, repeated the questionnaires 3 months later (response to change analysis, RCA).Results:Information from the debriefing interview, factor analysis and item response theory analysis resulted in the removal of one item (QLQ-ELD15→QLQ-ELD14) and revision of the proposed scale structure to five scales (mobility, worries about others, future worries, maintaining purpose and illness burden) and two single items (joint stiffness and family support). Convergent validity was good. In known-group comparisons, the QLQ-ELD14 differentiated between patients with different disease stage, treatment intention, number of comorbidities, performance status and geriatric screening scores. Test–retest and RCA analyses were equivocal.Conclusion:The QLQ-ELD14 is a validated HRQOL questionnaire for cancer patients aged ⩾70 years. Changes in elderly patients' self-reported HRQOL may be related to both cancer evolution and non-clinical events.

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Clinical trial design in older adults with cancer—The need for new paradigms

Cited by 31 publications

References 64 publications

Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Treatment Modalities and Survival in Older Adults with Metastatic Colorectal Cancer in Real Life

Patient-Centered Outcome Measures in Lung Cancer Trials

International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer

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