Kyorin University Hospital

The addition of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to endocrine therapy augments biological response in breast cancer. This phase III randomized, double-blind study evaluated the efficacy of adding palbociclib to neoadjuvant endocrine therapy (NET) for operable, hormone receptor-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients randomly received 16 weeks of endocrine therapy (letrozole for postmenopausal and tamoxifen plus ovarian function suppression for pre-/perimenopausal patients) plus palbociclib or placebo. The co-primary endpoints included preoperative endocrine prognostic index (PEPI) score and EndoPredict (EPclin) risk score according to the gatekeeping procedure. Of 141 randomized patients, 130 completed the treatment with surgical samples evaluable for endpoints in 126 patients. The proportion of patients with a low, moderate, and high PEPI score was 15.2, 50.0, and 34.8% in the palbociclib arm and 13.3, 55.0, and 31.7% in the placebo arm, respectively, with no statistical difference (one-sided P = 0.563). Statistical analysis was not performed on EPclin risk score. No new safety signals were reported. Permanent treatment discontinuation by adverse events was reported for seven (9.7%) and zero patients in the palbociclib and placebo arms, respectively. In conclusion, the addition of palbociclib to NET did not improve the efficacy. ClinicalTrials.gov NCT03969121.

The standardization of medical records through structured templates has gained importance in improving the quality and safety of patient care. The results showed that missing rates ranged from 40.0% (fever reduction) to 43.9% (pain), while redundant entries ranged from 11.7% (mild fever) to 20.0% (fever). Analysis of medication mentions revealed reliance on general classifications, such as "analgesics" (0.43%) and "antipyretics" (0.35%), over specific drugs like acetaminophen (0.44%) or bisacodyl (0.51%). Free-form documentation led to inefficiencies and ambiguities, whereas structured templates improved specificity, particularly for medications critical to patient safety. The findings highlight the need for user-friendly templates to reduce variability and enhance the completeness of nursing records. Structured templates can streamline documentation, reduce redundancy, and improve the quality of care by prompting detailed and accurate entries. Additionally, integrating advanced technologies like AI could further optimize adherence to templates, ensuring consistent and safe clinical practices. A deeper exploration of user experience and organizational factors is warranted in future studies to enhance implementation success. AI-based tools, such as intelligent assistants that prompt missing entries in real time, could further enhance template adherence and improve data completeness. This study analyzed 90,432 anonymized nursing records to evaluate adherence to predefined documentation templates across five key topics: mild fever, pain, fever, bowel control, and fever reduction. Text mining techniques identified missing items, redundant entries, and medication mentions.

574 Background: Postmastectomy radiotherapy (PMRT) is the standard treatment for improving the prognosis of patients with high-risk breast cancer. Expanded indications for breast reconstruction (BR) will likely increase the number of patients undergoing BR who require PMRT, but combining BR with PMRT raises concerns about complications and aesthetics. Evaluating the impact of PMRT on the health-related quality of life (HR-QOL) in Japanese patients is essential for shared decision-making (SDM). This study assessed differences in postoperative HR-QOL and complications between patients who underwent BR with or without PMRT. Methods: We conducted a multicenter cross-sectional study using a questionnaire survey of patients with primary breast cancer who underwent BR between January 2008 and December 2022 at participating institutions, which was approved by the respective institutional review boards. We used the Japanese version of the BREAST-Q questionnaire and questions on patient backgrounds. Results: We included 1078 patients with primary breast cancer. The questionnaire response rate was 77.0% (830/1078). The non-PMRT and PMRT groups comprised 616 and 214 patients, respectively. The PMRT group had higher rates of axillary lymph node dissection (11.7% vs. 52.4%; P<0.001), adjuvant hormonal therapy (67.2% vs. 90.6%; P<0.001), and perioperative chemotherapy (31.8% vs. 84.0%; P<0.001) than the non-PMRT group. Moreover, the overall complication rate (45.3% vs. 76.2%, P<0.001) and the rates of dermatitis (9.9 vs. 48.1%; P < 0.001), skin necrosis (2.9 vs. 9.8%; P<0.001), breast asymmetry (17.0% vs. 24.3%; P=0.002), capsular contracture (4.9 vs. 16.4%; P<0.001), and lymphedema of the upper limb (1.1% vs. 7.5%; P<0.001) were higher in the PMRT group. Multivariate analysis revealed PMRT as an independent risk factor for dermatitis, skin necrosis, and capsular contracture. In the BREAST-Q assessment, the PMRT group showed lower satisfaction with the breast (55 vs. 49; P<0.001), and with physical (85 vs. 76; P<0.001), psychosocial (55 vs. 49; P<0.001), and sexual well-being (36 vs. 34; P=0.021) than the non-PMRT group. Multiple regression analysis revealed PMRT as an independent factor associated with low BREAST-Q scores for breast satisfaction and physical and psychosocial well-being in patients with BR. Conclusions: This is the first large-scale, multi-institutional study to use patient-reported outcomes to assess the effects of PMRT on HR-QOL in Japanese patients with breast cancer who underwent BR. PMRT was associated with an increased risk of complications and decreased HR-QOL in patients with BR. Of note, these findings do not negate the role of PMRT in patients undergoing BR, but highlight the importance of SDM based on realistic HR-QOL expectations after breast reconstruction surgery with PMRT.

The Japanese Society for Sentinel Node Navigation Surgery conducted a multi-institutional prospective cohort study to compare sentinel node biopsy (SNB) with SNB followed by axillary lymph node dissection (ALND) in breast cancer patients with positive sentinel lymph node (SLN). Female patients with breast cancer with cT1-3N0-1M0 were eligible. In cases of one to three positive micro- or macrometastases in the SLN confirmed by histological or molecular diagnosis, SNB alone (SNB group) or additional ALND (ALND group) was performed under physician's discretion. The primary endpoint was the 5-year regional node (RN) recurrence rate in the SNB group. Propensity score matching (PSM) was performed to compare the prognosis between the two groups. Of the 871 eligible cases registered between 2013 and 2016, 308 underwent SNB alone. At the median follow-up of 6.3years, 5-year RN recurrence rate was 2.7%. After PSM, 209 cases were matched in each group. Breast-conserving surgery and mastectomy were performed in 225 (54%) and 193 cases (46%), respectively. One-positive SLN was recorded in 366 cases (88%), two in 48 (11%), and three in 4 (1%). Macro- and micrometastases in SLN were diagnosed in 271 (65%) and 147 cases (35%), respectively. Regional nodal irradiation (RNI) was performed in 42 (20%) and 13 (6%) cases of the SNB and ALND group. The 5-year RN recurrence rate was 2.1% and 2.0%, respectively. ALND is not necessary for early breast cancer patients with one-positive SLN despite type of breast surgery.