Abstract 465P
Background
Although older women comprise a large and rapidly growing proportion of patients diagnosed with breast cancer, the trial-level evidence base for treating this population is limited. This study assessed the completeness of reporting of older subgroups enrolled to registration trials in breast cancer between 2012-2021.
Methods
Trials which supported novel FDA approvals of systemic therapies in breast cancer between 01/2012 and 12/2021 were included. Individual trial-level PUBMED searches according trial/drug name, and trial registration number, were conducted on 31/08/22. Following title/abstract review, relevant publications and supplementary material were retrieved. Clinicaltrials.gov registry data was also retrieved. Non-efficacy (n = 1), site-agnostic (n = 1) biosimilar (n = 4), and trials conducted exclusively among premenopausal women (n = 1), were excluded. Immature endpoints (n = 5), for which no interim data were available in the full cohort, and studies which did not collect HRQOL data (n = 3), were excluded from relevant analyses. The availability and completeness of data for baseline characteristics, protocol-defined (co-)primary and secondary efficacy endpoints, toxicity, and HRQOL among older subgroups, was assessed systematically by two reviewers according to methods adapted from Chan & Altman (JAMA, 2004).
Results
27 trials were included. 785 unique publications were identified, of which 569 were excluded. 216 publications (median: 6 per trial, IQR: 4), and registry data, were assessed in full. 20.3% of enrolled patients were aged ≥65. 70.0% of patients were ECOG 0; 29.8% ECOG 1, and 0.2% ECOG 2. The completeness of data across efficacy endpoints, baseline characteristics, toxicity and HRQOL domains are reported in the table. Table: 465P
Completeness of reporting of geriatric subgroups enrolled to registration trials in breast cancer 2012-2022
n | Complete | Partial | Qualitative | Unreported | ||
Efficacy endpoints | ||||||
All efficacy endpoints | 133 | 37 (27.8%) | 3 (2.3%) | 8 (6.0%) | 95 (71.4%) | |
Primary endpoints | 33 | 24 (72.7%) | 3 (9.1%) | 1 (3.0%) | 5 (15.2%) | |
Secondary endpoints | 110 | 13 (11.8%) | 0 (0.0%) | 7 (6.4%) | 90 (81.8%) | |
Overall survival | 22 | 11 (50.0%) | 1 (4.5%) | 2 (9.1%) | 8 (36.4%) | |
Baseline Characteristics | 27 | 6 (22.2%) | 2 (7.4%) | 0 (0.0%) | 19 (70.4%) | |
Toxicity | 27 | 12 (44.4%) | 0 (0.0%) | 0 (0.0%) | 15 (55.6%) | |
HRQOL | 24 | 1 (4.2%) | 0 (0.0%) | 2 (8.3%) | 21 (87.5%) | |
Rows 1-4: n Endpoints (%) Rows 5-7: n Trials (%).
Conclusions
This study identified significant gaps in the reporting of older subgroups enrolled to registration breast cancer trials. Improved reporting practices are required to support evidence-based decision making in this population.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1301P - A prognostic clinical and circulating biomarker model to identify futile chemo-radiotherapy (CRT) in stage III NSCLC
Presenter: Rianne Vaes
Session: Poster session 04
1302P - Treatment outcomes and safety of durvalumab following definitive chemoradiotherapy among patients with stage III NSCLC in Thai populations: A real-world, multi-center observational study
Presenter: Piyada Sitthideatphaiboon
Session: Poster session 04
1303P - Immune-modulating effects on tumor draining lymph nodes following neoadjuvant chemoradiotherapy combined with immunotherapy in patients with T3-4N0-1 NSCLC
Presenter: Ezgi Ulas
Session: Poster session 04
1304P - A structured multidisciplinary approach for diagnosing immune-related pneumonitis in patients undergoing adjuvant durvalumab for stage III non-small cell lung cancer
Presenter: Illaa Smesseim
Session: Poster session 04
1305P - Importance of the resected lung tumor specimen in patients with locally advanced and metastatic non-small cell lung cancer undergoing prior targeted therapy
Presenter: Jeong Uk Lim
Session: Poster session 04
1307P - The Biocartis Idylla GeneFusion Assay (RUO) for lung cancer testing: The experience of testing over 5000 tumours in routine practice
Presenter: Lee Robertson
Session: Poster session 04
1308P - Diameter threshold for lung nodules at low-dose CT screening: Chinese population screening experience
Presenter: YE WENJUN
Session: Poster session 04
1309P - Immune exhaustion in tumor-free lymph nodes of non-small cell lung cancer (NSCLC) patients is associated with performance status and survival
Presenter: Laura Sellmer
Session: Poster session 04
1310P - Loratadine: A potential game-changer in lung cancer treatment with improved survival outcomes
Presenter: Xiwen Liu
Session: Poster session 04
1311P - Understanding the basis for intrinsic resistance to KRASG12C inhibitors
Presenter: Alba Santos Ramos
Session: Poster session 04