How representative are participants in geriatric oncology clinical trials? The case of the 5C RCT in geriatric oncology: A cross-sectional comparison to a geriatric oncology clinic

Habib, Mohammed H.; Alibhai, Shabbir M.H.; Puts, Martine

doi:10.1016/j.jgo.2024.101703

Cited by 1 publication

(1 citation statement)

References 31 publications

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“…recruitment in trials remains challenging, even in studies with broad inclusion criteria [ 3 , 37 ]. Irrespective of their eligibility status, patients with cancer who have comorbidities and those with an older age (frailty-related factors) are less frequently offered trial participation [ 38 – 40 ].…”

Section: Discussionmentioning

confidence: 99%

Tolerability and effectiveness of palbociclib in older women with metastatic breast cancer

Baltussen,

Mooijaart,

Vulink

et al. 2024

Breast Cancer Res Treat

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Purpose Palbociclib has become the standard of care for estrogen receptor-positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer, but real-world evidence in older women remains scarce. Therefore, we investigated tolerability of palbociclib in older women with metastatic breast cancer. Methods Consecutive women aged ≥ 70 with ER+/HER2- metastatic breast cancer, treated with palbociclib in any treatment line in six hospitals, were included. Primary endpoint was grade ≥ 3 palbociclib-related toxicity. Predictors of toxicity were identified using logistic regression models. Progression-free survival (PFS) and overall survival (OS) were estimated using Kaplan Meier. Results We included 144 women with a median age of 74 years. Grade 3–4 toxicity occurred in 54% of patients, of which neutropenia (37%) was most common. No neutropenic fever or grade 5 toxicity occurred. Dose reduction during treatment occurred in 50% of patients, 8% discontinued treatment due to toxicity and 3% were hospitalized due to toxicity. Polypharmacy (odds ratio (OR) 2.50; 95% confidence interval (CI) 1.12–5.58) and pretreatment low leukocytes (OR 4.81; 95% CI 1.27–18.21) were associated with grade 3–4 toxicity, while comorbidities were not. In first-line systemic therapy, median PFS was 12 months and median OS 32 months. In second-line, median PFS was 12 months and median OS 31 months. Conclusion Although grade 3–4 toxicity and dose reductions occurred frequently, most were expected and managed by dose reductions, showing that palbociclib is generally well tolerated and thus represents a valuable treatment option in the older population.

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