Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: A case-control study

Tack, Laura; Lefebvre, Tessa; Lycke, Michelle; Pottel, Lies; Cool, Lieselot; Ketelaars, Lore; Zutter, Jolien De; Martens, Evi; Pottel, Hans; Stellamans, Karin; Eygen, Koen Van; Werbrouck, Patrick; Vergauwe, Philippe; Wildiers, Hans; Schofield, Patricia; Boterberg, Tom; Debruyne, Philip R.

doi:10.1016/j.jgo.2019.09.003

Cited by 17 publications

(8 citation statements)

References 51 publications

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“…Moreover, some of these studies were focused on the age of the patients included in clinical trials compared to the median age of disease incidence [6][7][8]12]. Other studies were centered on patients treated for gastro intestinal cancer [9], included a small number of patients [10], or used a threshold of 65 years old [11].…”

Section: Discussionmentioning

confidence: 99%

“…They also present more acute organ dysfunctions, due to more comorbidities, illustrating the concept of frailty [5]. Moreover, older patients with metastatic disease are underrepresented in clinical trials [6][7][8][9][10][11] with no progress in the last years [12]. They may present different e cacy and/or toxicity pro les compared with younger adults that can affect outcomes [13,14].…”

Section: Introductionmentioning

confidence: 99%

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Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort

Bringuier

Carton

Lévy

et al. 2022

Breast Cancer Res Treat

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Purpose: Older cancer patients are underrepresented in clinical trials. We aimed to understand barriers to clinical trial recruitment in women aged 70 years old (yo) or over with metastatic breast cancer (MBC).Methods: We used the national Epidemio-Strategy and Medical Economics MBC Data Platform, a French multi-center real life database. We selected MBC women over 70yo, without central nervous system metastases, with at least one line of systemic treatment, between January 1 st , 2008 and December 31 st , 2016, and had no other cancer in the 5 years before MBC. The primary objective was to evaluate the proportion of patients enrolled in clinical trials according to their age. Secondary objective was to identify variables associated with enrollment.Results: 5552 women were aged ≥ 70 (median 74yo; IQR72-77). 14611 were less than 70. Of the older ones, 239 (4%) were enrolled in a clinical trial during rst line of treatment, compared with 1529 (10.5%) for younger ones. Multivariable analysis of variables predicting for enrollment during rst line of treatment in older patients were younger age (OR 0.50 [95%CI; for the 80-85yo class; OR 0.17 [95%CI; 0.06-0.39] for the 85yo and more class), good ECOG Performance Status (PS 0-1) (OR 0.15 [95%CI; 0.08-0.27] for the PS 2-4 class), HER2+ disease (OR 1.78 [95%CI;), type of treatment (chemotherapy/targeted therapy/immunotherapy OR 5.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort

Bringuier

Carton

Lévy

et al. 2022

Breast Cancer Res Treat

View full text Add to dashboard Cite

show abstract

“…Moreover, some of these studies were focused on the age of the patients included in clinical trials compared to the median age of disease incidence [6-8, 12]. Other studies were centered on patients treated for gastro intestinal cancer [9], included a small number of patients [10], or used a threshold of 65 years old [11].…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Enrollment of Older Metastatic Breast Cancer Patients in First Line Clinical Trials: 9-Year Experience of the Large-Scale Real-Life Multicenter French ESME Cohort

Bringuier¹,

Carton²,

Lévy³

et al. 2021

Preprint

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Purpose: Older cancer patients are underrepresented in clinical trials. We aimed to understand barriers to clinical trial recruitment in women aged 70 years old (yo) or over with metastatic breast cancer (MBC).Methods: We used the national Epidemio-Strategy and Medical Economics MBC Data Platform, a French multi-center real life database. We selected MBC women over 70yo, without central nervous system metastases, with at least one line of systemic treatment, between January 1st, 2008 and December 31st, 2016, and had no other cancer in the 5 years before MBC. The primary objective was to evaluate the proportion of patients enrolled in clinical trials according to their age. Secondary objective was to identify variables associated with enrollment.Results: 5552 women were aged ≥ 70 (median 74yo; IQR72-77). 14611 were less than 70. Of the older ones, 239 (4%) were enrolled in a clinical trial during first line of treatment, compared with 1529 (10.5%) for younger ones. Multivariable analysis of variables predicting for enrollment during first line of treatment in older patients were younger age (OR 0.50 [95%CI; 0.33-0.76] for the 80-85yo class; OR 0.17 [95%CI; 0.06-0.39] for the 85yo and more class), good ECOG Performance Status (PS 0-1) (OR 0.15 [95%CI; 0.08-0.27] for the PS 2-4 class), HER2+ disease (OR 1.78 [95%CI; 1.27-2.48]), type of treatment (chemotherapy/targeted therapy/immunotherapy OR 5.01 [95%CI; 3.13-8.18]), and period (OR 1.65 [95%CI; 1.22–2.26] for 2012-2016, compared to 2008-2011).Conclusions: In this large database, few older MBC patients were enrolled in a trial compared with younger ones.

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“…However, to deliver high-quality cancer care to vulnerable cancer patient populations, more research targeting this evidence gap will be required. In a previous study by our research group, we made suggestions for new trial designs to allow more vulnerable patients to receive upfront dose reductions or less intense regimens and stressed the concept of a dose-expansion cohort (DEC) dedicated to vulnerable older patients to be incorporated in phase 1b/2a protocols (5).…”

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confidence: 99%

Editorial: Clinical cancer research in vulnerable populations

Tack

Schofield²,

Boterberg³

et al. 2023

Front. Oncol.

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Editorial on the Research Topic Clinical cancer research in vulnerable populationsVulnerable populations in cancer care include a wide array of possible conditions (see Table 1). Their vulnerabilities, whether medical, sociocultural, age-or socioeconomicrelated, cause these cancer populations to be excluded from clinical trials. This introduces bias and a Matheus effect as clinical trial results are often not fully representative of the whole target population. This underrepresentation of the majority of cancer patients in clinical trials is a major drawback.The treatment of cancer patients with surgery, radiotherapy, and systemic anticancer drugs has reached an increasingly high level of effectiveness, sometimes shifting a cancer diagnosis towards the possibility of living a long life with a chronic cancer therapy treatment that takes place on a regular basis over a long period of time. Moreover, research is often so advanced that we may discuss "personalised cancer medicine" for different cancer types.Unfortunately, the progress that cancer research has made in cancer prevention, early detection, and treatment is not equitably accessible and applicable to vulnerable cancer patient populations. The main reason is that the patients included in clinical trials are not always representative of the whole target population. Indeed, the generalizability of trial results to all patients is usually hampered by the strict inclusion criteria of the clinical trials, leading potentially to overinflated reported benefits. In addition, the toxicity may be substantially higher in these vulnerable populations. Therefore, patients from the groups listed in Table 1 may not receive the best treatment option for their condition. Furthermore, the ethical implications of including vulnerable populations in clinical trials are often insurmountable for researchers attempting to gain approval for these studies.

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Underrepresentation of vulnerable older patients with cancer in phase II and III oncology registration trials: A case-control study

Cited by 17 publications

References 51 publications

Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort

Enrollment of older metastatic breast cancer patients in first-line clinical trials: 9-year experience of the large-scale real-life multicenter French ESME cohort

Enrollment of Older Metastatic Breast Cancer Patients in First Line Clinical Trials: 9-Year Experience of the Large-Scale Real-Life Multicenter French ESME Cohort

Editorial: Clinical cancer research in vulnerable populations

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