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HSR22-177: Real-World Utilization of Lenvatinib+Pembrolizumab Combination Therapy for the Treatment of Advanced Endometrial Cancer in the United States: ENdometrial cancer DOsing in the real-World (ENDOW) Study

Keiko Wada, Vimalanand Prabhu, Yi Wang, and Jingchuan Zhang

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CLO20-066: Comparative Efficacy, Safety and Acceptability of Single-Agent Poly (ADP-ribose) Polymerase (PARP) Inhibitors in BRCA Mutated HER2-Negative Metastatic or Advanced Breast Cancer: A Network Meta-Analysis

Ju Wang, Ye Zhang, Long Yuan, Lin Ren, Yi Zhang, and Xiaowei Qi

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CLO22-078: Dual-Tracer PET/CT-Targeted, mpMRI-Targeted, Systematic Biopsy, and Combined Biopsy for the Diagnosis of Prostate Cancer

Dong-Xu Qiu, Jian Li, Jin-Wei Zhang, Min-Feng Chen, Xiao-Mei Gao, Yong-Xiang Tang, Ye Zhang, Xiao-Ping Yi, Hong-ling Yin, Yu Gan, Gui-Lin Wang, Xiong-Bing Zu, Shuo Hu, and Yi Cai

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Neoadjuvant Immunotherapy Leads to Major Response and Low Recurrence in Localized Mismatch Repair–Deficient Colorectal Cancer

Bin-Yi Xiao, Xuan Zhang, Tai-Yuan Cao, Dan-Dan Li, Wu Jiang, Ling-Heng Kong, Jing-Hua Tang, Kai Han, Chen-Zhi Zhang, Wei-Jian Mei, Jian Xiao, Zhi-Zhong Pan, Yun-Feng Li, Xiao-Shi Zhang, and Pei-Rong Ding

Background: Our study aimed to evaluate the efficacy and feasibility of neoadjuvant anti–PD-1 treatment for localized mismatch repair–deficient (dMMR) colorectal cancer (CRC). Patients and Methods: The study cohort included patients with localized dMMR CRC who received PD-1 inhibitors as neoadjuvant therapy from 3 medical centers in Southern China. Main eligibility criteria included age between 18 and 75 years, ECOG performance status of 0 or 1, and receipt of ≥2 doses of PD-1 inhibitors. Results: A total of 73 patients were included. Most of the tumors were locally advanced, including 19 (26.0%) T4a and 29 (39.7%) T4b. Most patients (79.5%) received PD-1 inhibitor monotherapy. Objective response per radiologic assessment was achieved in 62 (84.9%) patients, including 17 (23.3%) with complete response (CR) and 45 (61.6%) with partial response, with a median time to response of 9.6 weeks. Patients with T4a/4b disease had a similar response rate as those with T2–3 disease (84.0% vs 85.4%; P=.999). As of writing, a total of 50 patients have undergone surgery. Pathologic CR was achieved in most (57.1%) patients and remained high (59.5%) even among the 38 patients with T4a/4b disease. The 17 patients with CR did not undergo surgery and adopted a watch-and-wait strategy. After a median follow-up of 17.2 months (range, 3.4–45.1 months), the overall median recurrence-free and overall survivals were not reached. Among patients undergoing surgery or achieving CR, the 2-year tumor-specific disease-free and overall survival rates were both 100%. During neoadjuvant treatment, grade 3–4 adverse events occurred in 8 patients; 4 required acute intervention. Severe postoperative complications were recorded in 4 patients, 3 of whom required a second surgery. Conclusions: Neoadjuvant therapy with PD-1 blockade is highly effective for localized dMMR CRC, with an acceptable safety profile and low recurrence rate. This treatment holds promise for becoming the new standard of care for localized dMMR CRCs.

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Impact of the Breast Cancer Index for Extended Endocrine Decision-Making: First Results of the Prospective BCI Registry Study

Tara B. Sanft, Jenna Wong, Brandon O’Neal, Natalia Siuliukina, Rachel C. Jankowitz, Mark D. Pegram, Jenny R. Fox, Yi Zhang, Kai Treuner, and Joyce A. O’Shaughnessy

Background: The Breast Cancer Index (BCI) test assay provides an individualized risk of late distant recurrence (5–10 years) and predicts the likelihood of benefitting from extended endocrine therapy (EET) in hormone receptor–positive early-stage breast cancer. This analysis aimed to assess the impact of BCI on EET decision-making in current clinical practice. Methods: The BCI Registry study evaluates long-term outcomes, decision impact, and medication adherence in patients receiving BCI testing as part of routine clinical care. Physicians and patients completed pre-BCI and post-BCI test questionnaires to assess a range of questions, including physician decision-making and confidence regarding EET; patient preferences and concerns about the cost, side effects, drug safety, and benefit of EET; and patient satisfaction regarding treatment recommendations. Pre-BCI and post-BCI test responses were compared using McNemar’s test and Wilcoxon signed rank test. Results: Pre-BCI and post-BCI questionnaires were completed for 843 physicians and 823 patients. The mean age at enrollment was 65 years, and 88.4% of patients were postmenopausal. Of the tumors, 74.7% were T1, 53.4% were grade 2, 76.0% were N0, and 13.8% were HER2-positive. Following BCI testing, physicians changed EET recommendations in 40.1% of patients (P<.0001), and 45.1% of patients changed their preferences for EET (P<.0001). In addition, 38.8% of physicians felt more confident in their recommendation (P<.0001), and 41.4% of patients felt more comfortable with their EET decision (P<.0001). Compared with baseline, significantly more patients were less concerned about the cost (20.9%; P<.0001), drug safety (25.4%; P=.0014), and benefit of EET (29.3%; P=.0002). Conclusions: This analysis in a large patient cohort of the BCI Registry confirms and extends previous findings on the significant decision-making impact of BCI on EET. Incorporating BCI into clinical practice resulted in changes in physician recommendations, increased physician confidence, improved patient satisfaction, and reduced patient concerns regarding the cost, drug safety, and benefit of EET.

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Long-Term Outcomes of dMMR/MSI-H Rectal Cancer Treated With Anti–PD-1–Based Immunotherapy as Curative-Intent Treatment

Jie-Hai Yu, Le-En Liao, Bin-Yi Xiao, Xuan Zhang, Ai-Wen Wu, Yong Cheng, Jing-Hua Tang, Wu Jiang, Ling-Heng Kong, Kai Han, Wei-Jian Mei, Zhi-Gang Hong, Wan-Jun Yang, Dan-Dan Li, Zhi-Zhong Pan, Yun-Feng Li, Xiao-Shi Zhang, and Pei-Rong Ding

Background: Neoadjuvant anti–PD-1 therapy has shown encouraging efficacy in patients with deficient DNA mismatch repair (dMMR)/microsatellite instability-high (MSI-H) locally advanced rectal cancer (LARC), which suggests its potential as a curative-intent therapy and a promising treatment option for organ preservation. We aimed to investigate the long-term outcomes of patients with dMMR/MSI-H LARC who experienced clinical complete response (cCR) after anti–PD-1 therapy. Methods: We retrospectively analyzed patients with dMMR/MSI-H LARC who achieved cCR and received nonoperative management following neoadjuvant anti–PD-1–based treatment from 4 Chinese medical centers. Patients were followed up for at least 1 year after they achieved cCR, their clinical data were collected, and survival outcomes were analyzed using the Kaplan-Meier method. Results: A total of 24 patients who achieved cCR and received nonoperative management from March 2018 to May 2022 were included, with a median age of 51.0 years (range, 19.0–77.0 years). The median treatment course to reach cCR was 6.0 (range, 1.0–12.0). Fifteen patients (62.5%) continued their treatments after experiencing cCR, and the median treatment course was 17.0 (range, 3.0–36.0). No local regrowth or distant metastasis was observed in a median follow-up time of 29.1 months (range, 12.6–48.5 months) after cCR. The 3-year disease-free and overall survivals were both 100%. Conclusions: Patients with dMMR/MSI-H locally advanced or low-lying rectal cancer who achieved cCR following anti–PD-1–based therapy had promising long-term outcomes. A prospective clinical trial with a larger sample size is required to further validate these findings.