Patients With Early-Stage Breast Cancer Who Are Unrepresented in Clinical Trials Face Increased Mortality

2021 ◽  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Early Stage ◽  
Early Stage Breast Cancer

The relationship between treatment intensity and characteristics of patients with early-stage breast cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 125-125
Author(s):  
Jeffrey Franks ◽  
Nicole Caston ◽  
Courtney Williams ◽  
Andres Azuero ◽  
Monica S. Aswani ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
High Intensity ◽  
Early Stage ◽  
Standard Of Care ◽  
Early Stage Breast Cancer ◽  
Treatment Intensity ◽  
Low Intensity ◽  
Her2 Breast Cancer ◽  
To Receive

125 Background: Clinical trials are used to generate standard-of-care, yet often do not reflect patient populations treated in real-world settings. Elderly patients or patients of color who are often underrepresented in trials, which may impact what types of treatments are prescribed. This study examines how patient characteristics are associated with treatment intensity in early stage breast cancer. Methods: This retrospective cross-sectional study included women with a stage I-III breast cancer from American Society of Clinical Oncology’s CancerLinQ database treated by chemotherapy from 2005-2019. Seven standard-of-care regimens were characterized by intensity. For patients with ER+/- HER2- breast cancer, low-intensity regimens were Taxol and Cyclophosphamide or Adriamycin and Cyclophosphamide; while Taxol, Adriamycin, and Cyclophosphamide was considered high intensity. For patients with HER2+ breast cancer, the low intensity regimen was Taxol and Herceptin; while Adriamycin and Cyclophosphamide followed by Taxol and Herceptin; Taxol, Carboplatin, and Herceptin; or Taxol, Carboplatin, Herceptin, and Pertuzumab were considered high intensity. A model estimating the likelihood of intensity was calculated using log-binomial regression, in order to produce relative risks. The models were adjusted for patient demographics and cancer stage. Results: Of 24,383 patients, 51% had ER+HER2-, 20% ER-HER2-, and 29% HER2+ breast cancer. Most patients were White (60%), age 40-69 (80%), had stage II breast cancer (39%), and received higher intensity treatment (65%). Adjusted for the other covariates, patient who were Black were more likely to receive high-intensity treatment than patients who were White (61% vs 58%; RR 1.05, 95%CI 1.02-1.06. Additionally, older adults were more likely to receive low-intensity treatment, with 42% of patients over 70 receiving low intensity treatment, and 29% of patients between the ages 40 and 69 received low intensity treatment (RR 1.5, 95% CI 1.44 -1.54). Conclusions: Differences in treatment intensity were observed for patients with differing demographic characteristics. Further research is needed to determine lack of representation in clinical trials impacts on prescribing patterns, regimen intensity, and survival.

From clinical trials to clinical practice: outcome of NSABP-B27 neoadjuvant chemotherapy regimen for high-risk early-stage breast cancer

2017 ◽  
Vol 165 (3) ◽  
pp. 771-777 ◽  
Author(s):  
Hikmat Abdel-Razeq ◽  
Lina Marei ◽  
Salwa S. Saadeh ◽  
Hazem Abdulelah ◽  
Mahmoud Abu-Nasser ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Chemotherapy Regimen ◽  
Early Stage ◽  
Early Stage Breast Cancer

Clinical trial representativeness and treatment intensity in a real-world sample of women with early-stage breast cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6584-6584
Author(s):  
Nicole E. Caston ◽  
Courtney Williams ◽  
Jeffrey Franks ◽  
Monica S. Aswani ◽  
Andres Azuero ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Real World ◽  
High Intensity ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Treatment Intensity ◽  
Evidence Based ◽  
Race Ethnicity

6584 Background: Early stage breast cancer (EBC) treatment is used in women of all ages, races, and health states. However, as clinical trials often do not represent real-world populations, the extent to which evidence-based treatments are prescribed to populations not well represented in these trials is not known. This study evaluated treatment intensity for patients traditionally well represented, underrepresented, and unrepresented in clinical trials. Methods: This retrospective cohort study used the nationwide de-identified electronic health record derived Flatiron Health database for patients diagnosed with EBC between 2011-2020. We categorized treatments as either high- (AC-TH [doxorubicin, cyclophosphamide followed by paclitaxel or docetaxel, trastuzumab]; ACT [paclitaxel or docetaxel, doxorubicin, cyclophosphamide]; TCH [paclitaxel or docetaxel, carboplatin, trastuzumab]; TCHP [paclitaxel or docetaxel, carboplatin, trastuzumab, pertuzumab]) or low-intensity (AC [doxorubicin, cyclophosphamide]; TC [paclitaxel or docetaxel, cyclophosphamide]; TH [paclitaxel or docetaxel, trastuzumab]). Unrepresented patients often have one or more comorbidities and/or prior cancer; underrepresented patients are typically Black, Indigenous, people of color, or of age extremes ( < 45, 70+); well represented patients are White and between the ages of 45-69. Odds ratios (OR), predicted proportions, and 95% confidence intervals (CI) from a two-level (patients nested in practice) hierarchical logistic regression model evaluated associations between receipt of high-intensity chemotherapy and patient characteristics of clinical trial representation (age, race/ethnicity, presence of comorbidity). Results: Our study included 970 patients with EBC with 13%, 45%, and 41% characterized as unrepresented, underrepresented, and well represented in clinical trials, respectively. In the adjusted model, those aged ≥ 70 vs 45-69 had lower odds of receiving a high-intensity treatment (OR 0.40, 95% CI 0.26-0.60), while those aged < 45 vs 45-69 had higher odds of receiving high-intensity treatment (OR 1.82, 95% CI 1.10-3.01). The predicted proportion of patients receiving a high-intensity treatment was 87% (95% CI: 80%-92%) for patients aged < 45, 79% (95% CI: 74%-84%) for patients aged 45-69, and 60% (95% CI: 50%-70%) for patients aged ≥ 70. Neither race/ethnicity nor comorbidity status were associated with odds of receiving high-intensity chemotherapy. Conclusions: Over half of the EBC population is not well represented in clinical trials. Age was associated with differential treatment intensity, despite a lack of evidence that these differences are appropriate. Widening clinical trial eligibility criteria is one way to better understand survival outcomes, identify potential toxicities, and ultimately make evidence-based treatment decisions using a more diverse sample.

Understanding patient perspectives on window of opportunity clinical trials.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 181-181
Author(s):  
Divya Ahuja Parikh ◽  
Lisa Kody ◽  
Susie Brain ◽  
Diane Heditsian ◽  
Vivian Lee ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Clinical Trials ◽  
Side Effects ◽  
Qualitative Study ◽  
Early Stage ◽  
Patient Perspectives ◽  
Early Stage Breast Cancer ◽  
Window Of Opportunity ◽  
Newly Diagnosed

181 Background: In “window of opportunity” (WOO) clinical trials, people with newly diagnosed early-stage cancer are exposed to an experimental drug during the period of time between diagnosis and definitive anti-cancer treatment. These trials allow investigators to study drug efficacy in untreated disease, which can expedite drug development. However, for trial participants, the WOO approach requires them to decide about an altruistic clinical trial during an intense time immediately after cancer diagnosis. This qualitative study aimed to understand patient perspectives on WOO clinical trials. Methods: We recruited adults newly diagnosed with early-stage breast cancer who were awaiting definitive therapy at a single academic medical center. We developed an interview guide grounded in the theoretical framework, the Theory of Planned Behavior (TPB). TBP is a well-validated decision-making model with three domains that guide behavior: (1) attitudes (2) normative factors and (3) perceived difficulty of a behavior. We conducted one-on-one semi-structured interviews that were audio-recorded and transcribed. Transcripts were analyzed to ensure interrater reliability and content analysis was performed to assess themes that emerged. Results: We interviewed 15 women (age 32-72) with early-stage breast cancer, and the majority were White (n = 12, 80%) and at least college educated (n = 12, 80%). Key themes that emerged included favorable attitudes towards participating in a WOO trial that were altruistic, including the desire to contribute to science (n = 10, 67%) and to help future breast cancer patients (n = 5, 33%). Several individuals also identified a potential benefit to themselves (n = 10, 67%), including access to a targeted drug (n = 4, 27%) and adding meaning to their diagnosis (n = 3, 20%). However, most interviewees reported concerns about drug side effects (n = 12, 80%) and whether side effects would impact other planned treatments (n = 10, 67%). Interviewees also expressed family would be an important normative factor in decision-making (n = 8, 53%). A key theme that emerged as a difficulty was the potential delay in standard treatment (n = 14, 93%). Despite this concern, at the end of the interviews, most interviewees stated they would participate in a WOO trial if offered (n = 10, 67%). Conclusions: WOO trials are becoming increasingly common in oncology research. In this qualitative study, interviewees weighed altruism against the possibility delaying or impacting other treatments. Our results may inform trial design and communication approaches in future WOO efforts.

Sign in / Sign up

Export Citation Format

Share Document