tbuckley/cabot-search huggingface dataset:
Estimating benefit from dose dense adjuvant chemotherapy for early breast cancer in the PANTHER randomized phase 3 trial.
Authors: Alexios Matikas, Michael Gnant, Hemming Johansson, Michael Untch, Nikolaos Tsiknakis, Richard Greil, Sibylle Loibl, Theodoros Foukakis, Jonas C. S. Bergh
Journal: Journal of Clinical Oncology (2024)

521 Background: Adjuvant dose dense chemotherapy for early breast cancer improves patient outcomes across all subgroups compared with standard interval treatment. However, the effect of dose dense treatment based on individual patient risk and over time, and the performance of the PREDICT model at this setting are not well-studied. Methods: This is an exploratory analysis from the phase 3 PANTHER trial (NCT00798070) that compared adjuvant sequential epirubicin/cyclophosphamide (EC) and docetaxel (D) administered in either tailored dose dense (tDD EC/D, every 2 weeks) or standard interval schedule (FEC/D, every 3 weeks) to patients with high-risk resected early breast cancer. Dose tailoring in the experimental arm was performed according to a predefined algorithm based on hematologic and non-hematologic toxicity. We evaluated the performance of PREDICT in terms of calibration and discrimination in the entire cohort and subgroups of interest, conducted a subpopulation treatment effect pattern plot (STEPP) analysis and observed the relative treatment effect over time. Results: The intention-to-treat population consists of n=2003 randomized patients. Median follow-up was 10.3 years (interquartile range, 9.1 – 10.5 years). PREDICT consistently underestimated 5-year (absolute difference 1.4%) and 10-year overall survival (absolute difference 6.6%) in the entire population and across all subgroups, but mostly so in the highest risk patients where the difference between observed and predicted 10-year survival reached 20.4% for patients with tumors larger than 5 cm. Discriminatory accuracy was lower for 10-year than for 5-year survival (AUC 0.728 and 0.786, respectively), although the difference in model performance between the two treatment groups was small. In STEPP analysis, absolute benefit from tDD EC/D in the primary endpoint of breast cancer relapse free survival was stable across risk-defined overlapping subpopulations and ranged from 3.8% in the lowest risk patients to 3.6% in the highest risk ones. There was no evidence of differential treatment effect through time (p interaction &gt;0.1 for all time-to-event endpoints). Conclusions: In this largely node-positive population, PREDICT consistently overestimated risk for death in all patient subgroups. We could not reliably identify any subgroup not benefiting from dose dense treatment, which should be the standard of care for primary resected high-risk breast cancer. Clinical trial information: NCT00798070 .
Impact of young age at diagnosis on survival outcomes in patients with early breast cancer according to tumor subtype: Pooled analysis of 5 randomized clinical trials from the Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM).
Authors: Marta Perachino, Eva Blondeaux, Michelino De Laurentiis, Grazia Arpino, Fabio Puglisi, Alessandra Fabi, Stefania Gori, Francesca Poggio, Luca Arecco, Diletta Favero, Matthew R. Sydes, Matteo Lambertini, Lucia Del Mastro
Journal: Journal of Clinical Oncology (2024)

523 Background: The incidence of breast cancer (BC) among young patients is increasing. Historically, young age itself has been recognised as a poor prognostic factor for BC. However, there is limited evidence regarding the impact of age at diagnosis and on survival outcomesaccording to tumor subtype. Methods: We collected individual patient (pt)-level data from newly diagnosed stage I to III BC pts participating in 5 randomized clinical trials conducted by Mammella InterGruppo (MIG) and Gruppo Italiano Mammella (GIM) study groups. Patients were categorized into the following age groups based on their age at BC diagnosis: ≤40, 41-50, 51-60, 61-70, &gt;70 years (yr). Multivariable Cox proportional hazards models were used to assess the relationship between age and breast cancer–free interval (BCFI) and breast cancer specific survival (BCSS). Results: 8,338 pts with stage I to III BC were included in the study: 778 (9%) aged ≤40 years, 1629 (20%) 41-50 years, 2,595 (31%) 51-60 years, 2,435 (29%) 61-70 years, and 901 (11%) &gt;70 years. Compared to older, young pts were more likely to have ductal tumors as histology, larger than 2 cm, with nodal involvement, G3 and triple negative or HER2 positive subtypes (p&lt;0.001). With a median follow-up of 9.0 years (IQR 5.5-14.4), 2,161 BCFI and 927 BCSS events were observed in the overall population. Pts ≤40 years at diagnosis had greater risk of reporting BC event (adjusted hazard ratio (adjHR) for BCFI 1.27, 95% CI 0.93-1.74) compared to pts aged 51-60 years (reference group), while pts 41-50 years had a lower risk (adjHR 0.74, 95%CI 0.55-0.99). Pts aged ≤40 years presented some evidence of a lower risk of BCSS events (adjHR 0.80, 95%CI 0.50-1.26) compared to pts aged 51-60 years, while pts aged 41-50 years had the lowest risk (adjHR 0.50, 95%CI 0.32-0.78). There was evidence of interaction between age and tumor subtype, nodal status both for BCFI and BCSS. A significant increase in risk of BC events was observed among pts ≤40 years with hormone-receptor positive/HER2 negative tumors (HR 1.70 for BCFI) and among ≤40 years with node negative tumors (HR for BCFI 2.43). Conclusions: The prognostic significance of young age at diagnosis may vary depending on tumor subtypes and nodal status, indicating poorer outcomes for young pts with hormone-receptor positive/HER2 negative and node negative tumors.
Patient-reported provider communication skills and adherence to recommended treatment in breast cancer.
Authors: Fumiko Chino, Junzo P. Chino, Bridgette Thom, Sam Meske, Patricia A. Ganz, Marisa C. Weiss
Journal: Journal of Clinical Oncology (2024)

537 Background: Effective communication is essential to build trust and improve patient understanding of cancer diagnosis and treatment. Little is known about patient comprehension of provider explanations and whether better communication influences adherence to recommended treatment especially in breast cancer (BC) which may require years of adjuvant treatment. Methods: Between 7/2023-8/2023, active patients and survivors were recruited from Breastcancer.org and consented to participate in an anonymous online survey in English or Spanish. Eligibility included: US resident, age ≥18, and diagnosed with BC within the past 10 years. Survey assessed patient-reported overall communication, side effect communication, and treatment adherence. Multivariate analysis (MVA) assessed relationship of patient-reported understanding and treatment adherence after controlling for gender, age, stage, race, ethnicity, and education. Results: Of 1266 screened, 997 met eligibility and participated. 98.2% identified as women, 81.2% White, 4.8% Black, and 4.2% Hispanic. Median age was 62 (interquartile range IQR 53-69) and median time since diagnosis 2.1 years (IQR 1-5.1). 6.5% had metastatic disease. 77.3% had a college degree. 93.4% participants reported their doctors “usually” or “always” explained things in a way they could understand. On MVA, there was a trend for minoritized groups (Black, Hispanic, Indigenous patients) to report their doctors were less likely to explain things well (OR 0.57, 95%CI 0.30-1.06, p=0.08) but there were no significant differences. Most felt their doctors “definitely” (45.8%) or “to some extent” (10.3%) explained possible short-term side effects. One-third (35.2%) stated their doctors explained “to some extent” and that they also did their own research to fully understand short-term side effects; 6.1% stated that their own research was the only thing that helped them understand as their doctors did not explain. Less than one-third (27.9%) felt their doctors “definitely” explained possible long-term side effects. 7.7% participants took less medication that their doctors prescribed due to treatment side effects, 15.1% stopped taking a medication or treatment altogether. Patients who reported that their doctors were “sometimes” or “never” understandable were more likely to reduce or stop their treatment (44.4% vs 21.3%, p&lt;0.001). This held true on MVA: patients reporting poor communication were less likely to adhere to recommended treatment (OR 0.36, 95%CI 0.21-0.62, p&lt;0.001). Conclusions: Surveyed patients with BC report good provider communication skills overall but note that side effect profiles are not always well-explained, especially for long-term side effects. More than 1 in 5 did not follow some aspect of BC treatment as recommended, and those who reported poor communication with their providers were 64% less likely to be adherent to recommended care.
Clinical application of novel mobile AI solution for real-time detection and differential diagnosis in breast ultrasound: The first prospective feasibility study.
Authors: Jeeyeon Lee, Fiona Cheng Tsui-Fen
Journal: Journal of Clinical Oncology (2024)

574 Background: Existing artificial intelligence (AI) solutions for breast ultrasound faced limitations due to their non-real-time detection and server dependency. However, novel mobile real-time AI solution now enable on-device detection and differential diagnosis, aiding in immediate decision-making. This study aims to evaluate the feasibility and effectiveness of such a mobile AI solution in clinical settings, by comparing it against expert breast imaging diagnoses. Methods: From August to December 2023, a feasibility study was conducted in tertiary medical center of Taiwan using mobile AI solution (CadAI-B for breast, BeamWorks Inc., Korea). CadAI-B is connected via HDMI or DVI to an ultrasound equipment using tablet PC. It supports healthcare providers to detect suspicious breast lesions by highlighting suspicious area during breast ultrasound scanning, and to make a differential diagnosis by providing BI-RADS categories and malignancy score (0-100%). The rate of real-time detection in malignancies and area under the receiver operating characteristic curve (AUC) was calculated. Distribution of BI-RADS categorized by CadAI-B were compared with those by breast imaging experts on independent review. Results: The analysis included 33 patients with an average age of 47 years (IQR, 44 – 62). There were 14 malignancies, 17 benign lesions, and 2 normal cases, and 30 patients (90.9%) underwent biopsy. For patients with malignancies, CadAI-B successfully identified all malignancies. Overall diagnostic performance, as AUCs calculated by the malignancy score and BI-RADS, was 0.835 and 0.850, respectively. The per-patient sensitivity of CadAI-B was 100.0%, while the specificity was 52.6%. The BI-RADS distribution between CadAI-B and expert was the same in malignant cases. In benign cases, CadAI-B categorized 9 cases (50.0%) as C4A or C4B, while experts classified 13 cases (72.2%), indicating a potential reduction in the need for biopsy. Conclusions: This study demonstrates that real-time processing capabilities of CadAI-B enable the identification of critical lesions during breast ultrasound, helping to reduce unnecessary biopsy. These findings may be helpful in diagnostic decisions and training of non-experts in clinical settings and offer the potential to improve workflow efficiency. [Table: see text]
An initial experience of robot-assisted breast conserving surgery: A multicenter study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG).
Authors: Hee Jun Choi, Se Hyun Paek, Jun-Hee Lee, Ku Sang Kim, Hyun Yul Kim, Hyung Seok Park, Jai Min Ryu
Journal: Journal of Clinical Oncology (2024)

543 Background: Robot-assisted breast conserving surgery (RABCS) have cosmetic benefit without any scar on the breast over conventional breast conserving surgery (CBCS). However, data on the feasibility and safety of the RABCS are limited. The aim of this study was to present the results of early experience of RABCS. Methods: A multi-center retrospective review was conducted to identify women who underwent RABCS as part of the Korea Robot-Endoscopy &amp; Minimal Access Breast Surgery Study Group (KoREa-BSG) between August 2019 and October 2023. Information of the clinicopathologic characteristics, perioperative complications, operation time, recurrence, and re-operation were collected. Results: A total of150 patients underwent the RABCS procedure conducted by 10 breast surgeons at seven institutions. Invasive breast cancer was noted in 121 cases and ductal carcinoma in-situ was detected in 29 cases. Further, 75.3% and 65.3% of the patients had an estrogen and progesterone receptor positive status, respectively. A total of 35.3% of the patients had a HER2-positive status. In terms of the surgical technique, the Da Vinci SP system was more frequently used (60%). Gas insufflation was applied in 97.33% of the cases, and s entinel lymph node biopsy (SLNB) only was the most common axillary surgery (89.3%). The median duration of postoperative days was 5.4 days (range, 1.0-15.0 days). The incision location was the mid-axillary line and the median incision length was 37.1 mm (range, 27.0-60.0 mm). The median total operation time was 133.8 minutes (range, 62.0-295.0 minutes). 11 cases (7.3%) showed frozen margin positive, however only one case (0.7%) required re-operation because of permanent margin positive. Six patients (4%) developed surgical complications. Postoperative bleeding was found in one case and skin burn was found in five cases (3.3%); two cases (1.3%) required skin excision and three cases (2.0%) showed spontaneous resolution. There were no cases of conversion to open surgery or mortality. Only one case (0.7%) had recurrence. Conclusions: This was the first multicenter report of RABCS in the world. RABCS could be a technically feasible and safe. Further subsequent comparative study with CBCS and prospective research are needed to evaluate the surgical and oncologic outcomes.
Prognostic value of Oncotype recurrence score (RS) and Mammaprint (MP) in premenopausal patients with hormone positive (HR+) breast cancer (BC) with low genomic risk, stratified by race: A study of the National Cancer Database (NCDB).
Authors: Abirami Sivapiragasam, Prashanth Ashok Kumar, Danning Huang, Dongliang Wang
Journal: Journal of Clinical Oncology (2024)

551 Background: It is hypothesized that in African American (AA) women, RS has a lower prognostic accuracy. We evaluated this with a large population based national database. Methods: The 2021 NCDB PUF was used to include premenopausal female BC patients aged 18-50 years. Inclusion criteria were N0, M0 patients with any T stage, RS ≤ 15 or MP low risk, estrogen or progesterone receptor+ and HER2-. Patients were stratified by their recorded race (Caucasians vs AA). Univariate analysis was used to study the distribution. Kaplan-Meier (KM) and multivariate (MV) propensity score (PS) weighted Cox model were used to compare survival between the cohorts. Results: 27523 patients had an RS≤15 [Caucasian-25227(91.66%) AA-2296(8.34%)] and 4818 had MP low [Caucasian-4393(91.18%) AA-425(8.82%)]. &gt;99% had regional lymph node surgery and &gt;90% of the patients did not get chemotherapy. &gt;70% of the patients were T1. Majority did get hormonal therapy (HT) [RS≤15 Caucasian-92.97% AA-91.81%, MP low- Caucasian-92.42% AA-89.65%]. On analyzing grade, AA had more poorly differentiated tumors [RS≤15 Caucasian-6.18% AA-9.46% p=&lt;0.001 MP low- Caucasian-9.1% AA-16.02% p=&lt;0.001]. KM survival estimates for RS≤15 at 5 years [Caucasian-99.3(99.2,99.5) %, AA-98.8(98.0,99.3) %] were similar and 10 years [Caucasian-97.5(97.0,97.9) %, AA-94.6(91.6,96.6)] showed a small difference. For MP low, the survival at 5 years [Caucasian- 99.0(98.6,99.3) %, AA-98.9(97.0,99.6) %] and 10 years [Caucasian- 97.0(95.9,97.8) %, AA-95.8(91.0,98.1) %] were almost equal. Adjusted Hazard Ratio estimate for Caucasian vs AA for RS≤15 did not reach significance overall [0.802 (95% CI 0.47-1.37)] nor when stratified by grade, histology, or T stage. Conclusions: Through our analysis, we show that there was no major difference in overall survival between Caucasians and AA among low genomic risk, premenopausal, hormone positive, N0 BC patients. There was a 2.9% difference between the racial groups at 10 years, but this was not seen in the adjusted analysis. The results show that genomic scores like RS and MP retain their prognostic utility even in the low-risk spectrum in both Caucasians and AAs. These results differ from other database studies, where the utility of these tools in the low-risk AA groups were questionable. Confounding associated with retrospective studies could be contributing to this and the predictive ability of genomic scores in varied racial groups needs to be analyzed in prospective models.
Effect of phospholipid curcumin Meriva on liver histology and kidney disease in nonalcoholic steatohepatitis: A randomized, double-blind, placebo-controlled trial
Authors: Giovanni Musso, Silvia Pinach, Filippo Mariano, Francesca Saba, Franco De Michieli, Luciana Framarin, Mara Berrutti, Elena Paschetta, Renato Parente, Yanina Lizet Castillo, Nicola Leone, Francesca Castellino, Maurizio Cassader, Roberto Gambino
Journal: Hepatology (2024)

NASH confers an increased liver-related and kidney morbidity. Phospholipid curcumin (Meriva) is a phospholipid formulation with ameliorated systemic curcumin absorption and delivery. We assessed the safety and efficacy of Meriva in NASH.
Clinical-pathological characteristics associated with multigene assay risk scores, and prognostic impact of multigene risk scores in patients with invasive lobular carcinoma.
Authors: Young-Won Lee, Jisun Kim, Sae Byul Lee, Il Yong Chung, Tae-Kyung Yoo, Hee Jeong Kim, Beom Seok Ko, Jong Won Lee, Byung Ho Son, Hee Jin Lee, Gyungyub Gong, Hyehyun Jeong, Jae Ho Jeong, Jin-Hee Ahn, Kyung Hae Jung, Sung-Bae Kim
Journal: Journal of Clinical Oncology (2024)

546 Background: Invasive Lobular Carcinoma (ILC), a unique breast cancer subtype, exhibits distinct clinical and pathological features. Multigene assays, notably the Oncotype DX (ODX) test, provide personalized prognostic insights in breast cancer. However, a research gap exists for clinical-pathological characteristics affecting multigene assay risk scores in ILC. This study aims to address this gap, investigating factors specific to ILC, distinct from those in invasive ductal carcinoma (IDC), contributing to refined risk stratification and personalized treatment decisions for ILC patients. Methods: Retrospective analysis was conducted on 238 ILC type breast cancer patients who underwent surgery at AMC between 2012 and 2022 and had undergone the ODX test. The ODX test assessed the Recurrence Score (RS) with defined categories: low (0-15), intermediate (16-25), and high (26 or above). Additionally, binary analysis categorized patients into low and high-risk groups using a cutoff of 25. The cutoffs were determined based on existing research findings. Results: Among patients undergoing ODX testing, the distribution of RS differed significantly between ILC and invasive ductal carcinoma (IDC) patients. Notably, the percentage of high-risk cases was higher in ILC (4.2%) compared to IDC (16.9%). Examination of patient characteristics revealed a prevalence of younger individuals, premenopausal status, and those undergoing breast-conserving surgery (BCS) among the low-risk binary group. In multivariate logistic regression analysis, PR negativity emerged as a significant factor influencing ODX high risk across the entire cohort (OR 23.224, 95% CI 3.732-144.527, p=0.001). Subgroup analysis by age identified specific risk factors, including PR negativity in younger patients (OR 11.896, 95% CI 1.247-113.523, p=0.031), larger tumor size (more than 2cm) (OR 4.180, 95% CI 1.229-14.214, p=0.022), and PR negativity in older patients (OR 25.030, 95% CI 3.505-178.756, p=0.001). Conclusions: In ILC, factors predicting ODX differ from IDC, emphasizing the need for tailored risk prediction models. PR negativity emerged as a consistent predictor of ODX high risk, warranting attention in risk stratification models. Recognizing this distinction is crucial for enhancing precision in prognostic assessments and optimizing patient management in ILC.
Clinical outcomes of patients with HER2-positive microinvasive breast cancer.
Authors: Yeokyeong Shin, Soo-Young Lee, Hyehyun Jeong, Hee Jin Lee, Gyungyub Gong, Hee Jeong Kim, Jong Won Lee, Byung-Ho Son, BeomSeok Ko, Jisun Kim, Jin-Hee Ahn, Kyung Hae Jung, Sung-Bae Kim, Sae Byul Lee, Jae Ho Jeong
Journal: Journal of Clinical Oncology (2024)

544 Background: Although previous studies have reported that adjuvant trastuzumab with paclitaxel resulted in excellent survival outcomes in small, node-negative HER2-positive breast cancer, the necessity of adjuvant chemotherapy in HER2-positive microinvasive breast cancer (MIBC) remains controversial. Methods: Between January 2000 and January 2020, women with curatively resected pT1mi N0 and/or N1mi in Asan Medical Center were retrospectively identified and their survival outcomes including invasive disease-free survival (IDFS, excluding second primary cancer), distant recurrence-free survival (DRFS), and overall survival (OS) and the effect of adjuvant chemotherapy were analyzed. Results: A total of 833 patients were included. The median age was 51 years, and 51% (n = 426) were premenopausal. Pathologic nodal stage was pN0 in 96% (n = 799) and pN1mi in 0.7% (n = 6), and estrogen receptor (ER) was positive in 30% (n = 247). Adjuvant chemotherapy was administered to 18% (n = 147) of patients, of which 95% were fluorouracil-based. Six patients (0.7%) received adjuvant trastuzumab. With the median follow-up of 118.7 months, the 8-year IDFS and DRFS rates were 90.6% (95% CI, 88.4-92.7), and 97.3% (95% CI, 96.1-98.4), respectively, and the 8-year OS were 98.6% (95% CI, 97.8-99.5). IDFS did not differ by adjuvant chemotherapy, as the 8-year IDFS rates for patients who did and did not receive adjuvant chemotherapy were 91.1% (95% CI, 86.6-95.8) and 90.3% (95% CI, 87.9-92.8), respectively ( p = 0.930). The lack of differences in IDFS by chemotherapy was consistent across subgroups including pre-/postmenopausal patients, grade 1-2/3 tumors, and ER-negative diseases. Conclusions: In HER2-positive MIBC, a clinically meaningful proportion of patients experience IDFS events with long-term follow-up. The role of modern adjuvant chemotherapy regimens, as well as the role of adjuvant trastuzumab, should be further explored in this early-stage patient population.