tbuckley/cabot-search huggingface dataset:
Impact of adjuvant systemic cancer therapies on health-related quality of life: A systematic review of randomized controlled trials.
Authors: Maryam YousefiAsl, Michelle Parks, Gabriel Alemayehu, William McCamy, Salene M.W. Jones, Grete Ambrazeviciute, Teresa E. Jewell, Evan Thomas Hall
Journal: Journal of Clinical Oncology (2025)

e23200 Background: Adjuvant systemic treatments reduce the risk of cancer recurrence and can improve survival in various cancer types. However, adverse events (AE) caused by these therapies could potentially negatively impact patients' health-related quality of life (HRQoL). New symptoms can be reliably attributed to treatment rather than the underlying cancer in the adjuvant setting. Patient-reported outcomes (PRO) have become more widely implemented in randomized controlled trials (RCT). We sought to explore the impact of adjuvant systemic cancer therapies on HRQoL in adjuvant cancer therapy RCTs across all tumor types. Methods: We searched PubMed and Embase (1980-November 2023) for RCTs that reported HRQoL data and compared adjuvant systemic cancer therapies (experimental arm) to placebo or observation (control arm) after curative local cancer treatment. Our search and data collection focused on reviewing the impact of different adjuvant systemic cancer modalities on the HRQoL of various cancer patients. Results: Our study identified 33 trials meeting our criteria, 25 of which (75.8%) concluded that adjuvant therapy showed no clinically significant change in HRQoL compared to the placebo or observation. In contrast, the treatment arm in all evaluable studies had significantly higher rates of grade 3+ AEs, serious adverse events (SAEs), and treatment discontinuation (due to side effects) than the control arm. The most common cancer types were melanoma (30.3%), genitourinary (21.2%), breast (15.2%), and gastrointestinal (15.2%). Immunotherapy (36.4%), targeted therapy (27.2%), and chemotherapy (21.2%) were the predominant adjuvant systemic treatments (Table 1). Double-blinded studies rarely (11.1%) reported clinically significant changes in overall HRQoL in the experiment arm, while open-label studies more frequently (42.9%) reported CSC. Conclusions: Despite higher adverse event rates, most published RCTs reported no clinically significant impact of adjuvant systemic therapies on overall HRQoL compared to placebo or observation. This inconsistency may stem from low PRO specificity, insensitive measures, publication bias, response shift, and arbitrary minimal clinically important difference (MCID) thresholds. Minimal HRQoL impact does not indicate well-tolerated treatment. Further investigation is needed on PRO assessment efficiency and the relationship between AEs and HRQoL. Results stratified by therapy modality. Therapy Modality CSC n (%) NCSC n (%) Total (n) Targeted Therapy 1 (3.0) 8 (24.2) 9 Chemotherapy 2 (6.1) 5 (15.2) 7 Hormonal Therapy 0 (0.0) 4 (12.1) 4 Immune Checkpoint Inhibitor 0 (0.0) 6 (18.2) 6 Interferon 3 (9.1) 1 (3.0) 4 Chemotherapy and Immunotherapy 1 (3.0) 0 (0.0) 1 Other types of Immunotherapies 1 (3.0) 1 (3.0) 2 CSC: Clinically Significant Change; NCSC: No Clinically Significant Change.
Enhancing care of patients with HR+/HER2- early breast cancer at high risk of recurrence through an expansive curriculum: Real world outcomes (RWO) from a 6 month analysis.
Authors: Nabil Dorkhom, Urvi Patel, Victoria Phoenix, Jordan Schwartz, Katie Lucero
Journal: Journal of Clinical Oncology (2025)

e12509 Background: Although therapies for patients with HR+/HER2- early breast cancer have been available for several years, a number of clinical gaps remain present. These gaps minimize the optimization of care in this patient population. In an effort to overcome these gaps a large educational curriculum was developed to improve the learner’s ability to identify patients at high risk of recurrence, optimize treatment selection according to the biology of the disease, and improve adherence to therapy. Methods: The curriculum included 11 online CME activities that were distributed between October 2023 and May 2024. This study focuses on the 9 that launched between Oct and Dec 2023. A previous analysis illustrated the improvement of oncologists’ knowledge, competence, and confidence along the three core learning areas mentioned above. This RWO study was designed to assess the impact of the CME curriculum on the treatment selection of oncologists in managing patients with early breast cancer according to the biology of the disease. A retrospective matched case-control study was conducted to examine the primary outcome of interest—the number of patients with early breast cancer who also were managed according to guideline-based treatments. Medical and pharmacy claims were aggregated with patients and the coding oncologists between May 2023 to Sep 2024. Learners and non-learners were matched based upon specialty, geographic location. An analysis of covariance (ANCOVA) was conducted to assess the difference in number of patients treated according to the biology of their disease for CME learners versus control. Data were pulled for 6 months pre and 6 months-post first CME activity participation date (“index date”). Results: The sample analyzed includes 3,098 oncologist CME learners and 3,098 matched comparison non-participants in the CME activities who participated in activities between November 2023 and March 2024. All data are time aligned 6 months pre-/post-index date. ANCOVA results show a significant effect of CME on the proportion of patients who receive biology-based care (F(1,6190 ) = 33.79 ; P = .001), controlling for the proportion of patients who were already receiving biology-based care in the pre-period. There were 26% more patients (n=1,148) who received biology-based care in the 6 months post among the learner group compared to the control group, and 19% (n=139) more oncologists changed their practice in the CME group than the control group. Conclusions: The results of this RWO study confirms that participation in 1 or more activities within a CME curriculum is associated with improving the adoption of the latest clinical guideline recommendations by oncologists, aiming to improve the management and outcomes of HR+/HER2- EBC in patients.
The impact of adjuvant endocrine therapy on outcomes in estrogen receptor-low positive breast cancer patients.
Authors: Min Jung Lee, Jinyoung Byeon, Eunhye Kang, Hyelim Kang, Changhoon Lee, Ji-Jung Jung, Hong-Kyu Kim, Han-Byoel Lee, Hyeong-Gon Moon, Wonshik Han
Journal: Journal of Clinical Oncology (2025)

e12516 Background: Estrogen Receptor (ER)-low positive breast cancer, defined as ER expression of 1-10% by immunohistochemistry, is a rare subtype with molecular traits resembling ER-negative disease. While the 2020 American Society of Clinical Oncology (ASCO) guidelines recommend endocrine therapy for both ER-low and ER-high positive breast cancers, the benefit in the ER-low positive subgroup remains unclear. This study investigates the impact of adjuvant endocrine therapy on outcomes in Korean patients with ER-low positive, HER2-negative breast cancer. Methods: This retrospective cohort study patients with ER-low positive, HER2-negative breast cancer treated at Seoul National University Hospital between 2009 and 2023. Of 266 eligible patients, 247 received adjuvant endocrine therapy and 19 did not. Propensity score matching (PSM) was performed at a 1:1 ratio based on age, tumor stage, nodal stage, and chemotherapy administration. The primary endpoints were disease-free survival (DFS) and distant metastasis-free survival (DMFS). Multivariate analysis was conducted to identify variables affecting DFS. Results: The 5-year DFS was significantly higher in the endocrine therapy group compared to the non-endocrine therapy group (90.76% vs. 49.19%, p=0.00015), and this benefit persisted after PSM (p=0.026). Similarly, the 5-year DMFS was significantly improved in the endocrine therapy group both before (p=0.047) and after PSM (p=0.022). Multivariate analysis before PSM identified larger tumor size (HR 1.32, 95% CI 1.07-1.63, p=0.009), positive lymph node status (HR 2.71, 95% CI 1.07-6.87, p=0.036), and presence of lymphatic invasion (HR 3.62, 95% CI 1.67-7.85, p=0.001) as prognostic factors. After PSM, adjuvant endocrine therapy independently reduced the risk of recurrence (HR 0.0075, 95% CI 0.00008-0.71, p=0.035). Conclusions: This study demonstrates that endocrine therapy significantly improves survival outcomes in patients with ER-low positive, HER2-negative breast cancer. These findings support its clinical benefit in this distinct subtype and call for larger prospective studies to validate results and ultimately optimize treatment strategies.
Real-world clinical outcomes of capecitabine by BRCAm status in patients with early-stage triple-negative breast cancer.
Authors: Filipa Lynce, Meng Ru, Linlin Luo, Miguel Miranda, Xiaoqing Xu, Claudine Isaacs
Journal: Journal of Clinical Oncology (2025)

e12503 Background: The clinical benefit of adjuvant capecitabine (cape) in patients (pts) with early triple-negative breast cancer (eTNBC) and BRCA1 / BRCA2 mutation (BRCAm) is not well characterized. This retrospective, observational study explored the real-world effectiveness of cape in pts with eTNBC by BRCAm status. Methods: Data from pts ≥18 years old diagnosed with eTNBC from 2016–2024 were captured in the US Flatiron Health electronic health record-derived deidentified database. Included pts had initiated adjuvant cape ≤6 months after primary surgery and had known BRCA test results (BRCAm/non-BRCAm by germline or tumor testing). Pts who received neoadjuvant cape or any adjuvant therapy ≤30 days from metastatic diagnosis were excluded. Pts who received any adjuvant hormone therapy, PARP inhibitor, or immunotherapy were excluded to reduce bias when assessing the effectiveness of adjuvant cape. Demographics, clinical characteristics, and treatment patterns were described. Invasive disease-free survival (IDFS), distant disease-free survival (DDFS), and real-world overall survival (rwOS) rates were calculated from the first curative breast surgery to the earliest of death, last activity date, or database cutoff (May 1, 2024). Sensitivity analyses were performed in pts who met CREATE-X trial eligibility criteria (received neoadjuvant chemotherapy and adjuvant cape). Results: Of 882 pts who received adjuvant cape, 53 (6%) had BRCAm, and 829 (94%) had non-BRCAm. Median follow-up time was 31 (range: 1–92) months. Median age at eTNBC diagnosis was younger in pts with BRCAm vs non-BRCAm (47 vs 55 years). Among the 882 pts, cape initiation decreased from 2021 onwards. Most pts received cape after neoadjuvant treatment (BRCAm: n=49/53, 92%; non-BRCAm: n=755/829, 91%) and most received adjuvant cape monotherapy (BRCAm: n=52/53, 98%; non-BRCAm: n=790/829, 95%). Survival rates at 24 and 36 months were numerically lower in pts with BRCAm vs non-BRCAm; this was maintained in sensitivity analyses of pts who met CREATE-X trial eligibility criteria. Conclusions: This real-world analysis showed a trend for poorer survival in pts with eTNBC and BRCAm vs those with non-BRCAm. While this study is descriptive, data suggest an unmet need for pts with eTNBC and BRCAm who receive adjuvant cape; this could be addressed through wider BRCA testing and subsequent targeted therapy for pts with BRCAm. Survival rate, % (95% CI) All BRCAm (n=53) All non-BRCAm (n=829) BRCAm (CREATE-X eligible; n=47) Non-BRCAm (CREATE-X eligible; n=667) 24-month IDFS 69 (57–83) 77 (74–81) 68 (56–83) 79 (76–82) 36-month IDFS 59 (47–75) 72 (68–75) 60 (47–77) 74 (70–78) 24-month DDFS 71 (59–85) 79 (76–82) 70 (58–85) 80 (77–84) 36-month DDFS 59 (46–75) 73 (69–76) 60 (47–77) 75 (71–79) 24-month rwOS 77 (66–90) 86 (0.83–89) 77 (66–91) 87 (84–90) 36-month rwOS 67 (55–83) 80 (0.77–83) 70 (57–85) 82 (79–85) CI, Greenwood’s confidence interval.
Evaluating the role of dietary interventions in reducing chemotherapy toxicities in cancer patients: A systematic review.
Authors: Jessica Abene, Jie Deng
Journal: Journal of Clinical Oncology (2025)

e13869 Background: Despite advancements in cancer treatment, chemotherapy remains an indispensable treatment modality. Chemotherapy drugs inadvertently harm normal cells due to their toxic composition, leading to unpleasant toxicities. Chemotherapy toxicities are often described as being more detrimental to patients’ quality of life (QOL) than the malignancy itself. Unfortunately, patients receiving chemotherapy continue to struggle with toxicities despite pharmacological intervention, making it clear that medication alone is not adequate to manage toxicities. Dietary interventions represent a novel pathway for alleviating chemotherapy toxicities, thereby improving patients' QOL. This systematic review synthesizes current literature examining the relationship between various dietary patterns, chemotherapy toxicities, and QOL among patients currently receiving chemotherapy treatment. It aims to determine the most advantageous dietary pattern for patients with various malignancies. Methods: PubMed, CINAHL, and Embase were thoroughly searched to select quantitative studies that answered the research question and met the inclusion criteria as of July 2024. Results: Fourteen studies were analyzed: 10 randomized control trials (RCTs), 2 quasi-experimental, 1 case series, and 1 cohort study. Analyses were stratified by dietary pattern: fasting; Mediterranean diet; ketogenic diet; plant-based, high-protein diet; and anti-inflammatory diet. The results suggest these all have the ability to benefit patients’ experiences with chemotherapy. Fasting; a Mediterranean diet; a plant-based, high-protein diet; and an anti-inflammatory diet may reduce toxicities such as fatigue, diarrhea, insomnia, and nausea throughout chemotherapy. Additionally, fasting, a Mediterranean diet, and an anti-inflammatory diet may improve patients’ QOL throughout treatment. The ketogenic diet might offer initial advantages in improving diarrhea, physical activity, and QOL; however, these results may not be sustainable. Conclusions: Although no dietary intervention has enough supporting evidence to recommend it as the most advantageous in reducing chemotherapy toxicities and improving QOL in patients undergoing chemotherapy, no intervention can be ruled out. Cancer survivors may benefit from adopting specific dietary patterns to alleviate chemotherapy toxicities and improve QOL. These reductions may improve chemotherapy tolerance, minimize treatment interruptions, and enhance daily functioning. Further research is necessary to uncover the most beneficial dietary pattern.
Prognostic impact of ER staining patterns and heterogeneity of ER-positive HER2-negative breast cancer.
Authors: Yumiko Akita, Ravi Velaga, Madoka Iwase, Satoko Shimada, Toyone Kikumori, Dai Takeuchi, Yuko Takano, Takahiro Ichikawa, Norikazu Masuda
Journal: Journal of Clinical Oncology (2025)

e12535 Background: Estrogen receptor (ER) expression is critical in breast cancer treatment. While low ER (1%-9%) resembles triple-negative cancer with chemotherapy efficacy, the significance of “intermediate expression” (≥10%) and the therapeutic efficacy remain unclear. This study explores differences in staining patterns and molecular characteristics of ER-low to intermediate expression to guide treatment. Methods: A total of 104 breast cancer patients treated between January 2008 and July 2024 with an Allred Proportion Score (PS) of 2 to 4 were included. PS2 (n = 21) was classified as ER-low, while PS3 (n = 26) and PS4 (n = 57) as ER-intermediate (ER-int). ER-int was further divided by ER staining pattern: “Island” (heterogeneous) and “Scatter,” (uniform) subgroups. Prognosis, clinical factors, and gene expression profiles (n = 11) were analyzed. Results: The Island subgroup was associated with poorest prognosis ( p = 0.0116), particularly among patients treated with endocrine-only treatment patients ( p &lt; 0.0001). Elevated tumor-infiltrating lymphocyte (TIL) levels correlated with worse prognosis in endocrine-only treatment patients ( p &lt; 0.0043), with TIL levels highest in ER-low, followed by Island and Scatter subgroups. Island tumors were enriched in CD36, GZMB, and type I interferon genes; additionally, 23 “ISLAND” genes showed significant prognostic differences in the TCGA BRCA ER intermediate (10–69%) cohort. Conclusions: This study emphasizes the importance of recognizing heterogeneity within the ER-int subtype. Identifying distinct ER staining patterns and prognostic significance of TILs and transcriptome in ER-int tumors suggests the need for individualized treatment strategies for Island subtype.
SWOG S2302, PRAGMATICA-LUNG: A pragmatic trial designed to increase participant representation.
Authors: Karen L. Reckamp, Mary Weber Redman, Konstantin H. Dragnev, Maya Khalil, Brian S. Henick, James Moon, Pasarlai Ahmadzai, Michael Leo LeBlanc, Daniel R. Carrizosa, Roy S. Herbst, Charles D. Blanke, Jhanelle E. Gray
Journal: Journal of Clinical Oncology (2025)

11016 Background: Effective therapy following frontline immune checkpoint inhibitor (ICI)-based treatment for advanced non-small cell lung cancer (NSCLC) is needed as limited options are available. Lung-MAP S1800A was a Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care (SOC) for patients with NSCLC previously treated with immunotherapy that demonstrated benefit in overall survival (OS) with an improved toxicity profile over SOC. S2302 Pragmatica-Lung trial was pragmatically designed to evaluate the impact on OS while reducing barriers to participation and decreasing clinical trial staff burden. We assessed reduction in barriers to participation and clinical staff burden in S2302 in relationship to S1800A. Methods: S2302 (NCT05633602) is a registration-intent randomized phase III trial for patients with advanced NSCLC who previously received PD-(L)1 inhibitor therapy for at least 84 days and platinum-based therapy, stratified by immediate prior line of therapy including PD-(L)1 inhibition (yes/no) and PS (0/1 v. 2). The pragmatic design has limited eligibility criteria, which are focused on stage, prior therapy and safety to enroll patients as would occur in real world practice. Laboratory assessment and imaging with RECIST reads are not required due to the OS endpoint. Data collection was developed to minimize the burden with fewer time points for data submitted, number of forms and number of data elements. Concomitant medications are not collected. Given the known safety profile of both study drugs, only related and unexpected grade 3/4 and all grade 5 adverse events are collected. Results: Accrual to S2302 was robust with 838 patients enrolled from March 2023 to December 2024 (21 months), averaging &gt; 50 patients/month in the final 6 months. The trial enrolled 77% White and 13% Black patients. versus 87% and 8%, respectively on S1800A. Over 65% were ≥ 65 years of age. Reduced data collection on S2302 relative to S1800A results in an estimated decrease in the number of forms and data elements submitted within the first year on study by 45% and 66%, respectively. Conclusions: Incorporating pragmatic elements into S2302 resulted in robust accrual, increased participant representativeness and access for patients. The reduced burden on staff due to decreased data forms and elements is substantial. Pragmatic design elements should be considered as we develop trials to generalize to a broad and representative population. Clinical trial information: NCT05633602 .
Clinicopathological features and prognostic implications of HER2-low in early-stage male breast cancer: A retrospective analysis.
Authors: Qiang Sa, Hangcheng Xu, Yan Wang, Yiran Zhou, Yun Wu, Qing Li, Pin Zhang, Yang Luo, Ying Fan, Ruigang Cai, Qiao Li, Hongnan Mo, Bo Lan, Jiani Wang, Shanshan Chen, Fei Ma, Peng Yuan, Binghe Xu, Jiayu Wang
Journal: Journal of Clinical Oncology (2025)

e12518 Background: The clinicopathological and prognostic features of HER2-low female breast cancer (BC) have been widely studied. Current knowledge suggests that HER2-low could be identified as a special entity for treatment. However, limited research has focused on the HER2-low subtype in early-stage male breast cancer. Methods: This retrospective study screened male BC cases from all breast cancer patients at a single institution between January 2010 and September 2023. Early-stage cases with non-HER2-positive tumors were included and categorized into HER2-low and HER2-zero groups. Clinicopathological features were collected and compared between the two groups. The primary endpoints were disease-free survival (DFS) and overall survival (OS). Statistical analysis was conducted using descriptive statistics, the Kaplan-Meier method with the Log-rank test, and the Cox proportional hazards model to evaluate differences in DFS and OS between the groups. Results: A total of 99 early-stage non-HER2-positive male BC cases were identified, with 41 classified as HER2-low and 58 as HER2-zero, and these cases were included in the final analysis. Regarding the clinicopathological features, the HER2-low subgroup exhibited higher androgen receptor (AR) expression (P = 0.003). Regarding survival outcomes, no significant difference was observed in DFS (P = 0.1), but the HER2-low subgroup had a significantly longer OS compared to the HER2-zero subgroup (P = 0.01). Multivariate analysis identified age and TNM stage as independent prognostic factors for DFS, while age and HER2-low were independent prognostic factors for OS. Conclusions: HER2-low population in early-stage male BC had a different clinicopathological feature and prognostic role compared to HER2-zero counterparts. The HER2-low subgroup had a better OS compared to the HER2-zero subgroup, and HER2-low was determined as an independent prognostic factor for OS, but not for DFS.