Trastuzumab and vinorelbine constitute effective and well-tolerated first-line treatment for HER2-positive metastatic breast cancer. Patients with normal LVEF can be observed with surveillance of LVEF at 16 weeks to identify those at risk for cardiotoxicity.

Neoadjuvant carboplatin and weekly paclitaxel +/- trastuzumab achieve high pCR rates in patients with HER2-positive and triple-negative disease without exposure to an anthracycline. Preliminary RFS results are encouraging but are likely influenced by adjuvant therapy received. Additional study of this regimen in high-risk patients is warranted.

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A 75-year-old woman was admitted to the hospital with complaints of lightheadedness and diaphoresis. For the past two weeks, these symptoms would occur and resolve spontaneously and last from 10 to 60 min per episode. These were unrelated to postural changes, urination or defecation. She has hypertension controlled with captopril, metoprolol, and furosemide. On admission, her blood pressure was 140/80 mmHg and heart rate was 62 beats/min. Physical exam was remarkable for a palpable left-sided neck mass. All medications were discontinued. However, she continued to have syncope with sinus bradycardia of 40 beats/min and hypotension with a palpable systolic blood pressure of 70 mmHg. These symptoms resolved after she was given 1 mg of intravenous atropine.Echocardiogram and electroencephalogram were normal. Computed tomography (CT) scan of the neck revealed a noncalcified 5 × 5 × 13 cm mass involving the left carotid artery and CT of the abdomen showed para-aortic lymphadenopathy. Histopathology of the neck mass revealed diffuse small, non-cleaved, non-Burkitt's, B cell non-Hodgkin's lymphoma. Chemotherapy with cyclophosphamide, adriamycin, vincristine, and prednisone was administered. After one cycle of chemotherapy, her neck mass decreased in size and her bradycardia and hypertension resolved. She completed six cycles of chemotherapy, and repeat CT of the neck, chest, and abdomen showed no evidence of disease.Three months later she presented with increasing shortness of breath and abdominal distention. She had recurrence of her disease in the neck and abdomen. The patient refused further treatment and expired six weeks later.Near-syncope is usually encountered in the setting of cardiac disease. A neurologic workup may be prompted by the inability to demonstrate cardiac disease. Near-syncope is rare in the setting of carotid disease and has been best described in carotid sinus hypersensitivity which is usually seen in hypertensive older males with arteriosclerotic disease [1]. It has also been associated with head and neck abscesses, metastatic cervical lymphadenopathy, and primary head and neck malignancies [2,3], but it has never been described in the setting of generalized non-Hodgkin's lymphoma. The neoplasm is thought to produce symptoms by direct compression of the carotid sinus, infiltration of the carotid sinus resulting in increased activity in Hering's nerve and in the parasympathetic arm of the reflex arc, and by inducing a permanent depolarization of the carotid sinus nerve endings thereby lowering their threshold for firing. Unopposed parasympathetic activity is responsible for a transient reduction in cerebral perfusion due to a cardio-inhibitory reflex bradycardia, a vasodepressor response with hypotension, or a combination of the two resulting in near-syncopal symptoms. Immediate therapy focuses on discontinuing medications that can enhance carotid sinus hypersensitivity. Symptomatic patients require atropine, cardiac pacing, or both. Permanent therapy focuses on treating the underlying cause. Chem...

e13506 Background: Multidisciplinary clinics (MDC) are one care model wherein patients can see physicians across specialties and other health professionals in a single appointment and shared space. While multidisciplinary care and MDCs have been studied, little is reported on patient experience. Our group previously reported that over 60% of people seen in a breast cancer (BC) MDC had severe distress at their initial visit, but that same-day MDC visit was associated with a significant reduction in the distress score. This study seeks to better understand the patients’ experience in a BC MDC. Methods: 429 unique patients (pts) identified diagnosed with BC and seen for MDC care from Nov 2020 - Nov 2021 were invited to participate in this RedCap survey via email. 116 (27%) respondents included in this analysis had their initial visit in MDC. Results: Pts demographics were representative of pt population (88% White, 4.3% Black, 3.4% Hispanic; 17.8% < 50yo, 55.9% 50-69yo, 26.3% ≥70yo). Most pts saw 3 physicians during their MDC visit (surgeon 89.4%, medical oncologist 92.0%, radiation oncologist 92%). However, only 23, 21, and 9.7% were seen by a social worker, navigator, or genetic counsellor, respectively. Prior to MDC, the majority (67%) reported being very or somewhat prepared; 15% reported being somewhat or very unprepared. Major positive feedback were that MDC was convenient (89.3%), an efficient use of time (65.2%), and a good way to get questions answered (65.2%); Major criticisms included that MDC was overwhelming (16.1%) and/or too long (4.5%). When asked to rate the top three aspects of MDC, pts chose seeing multiple providers during a single visit (80.4%), communication about the process before and throughout MDC (48.2%), and inclusivity of their support system (38.4%). The top three worst aspects identified included volume of information presented (42.9%), and pts emotional comfort (anxiety, stress) during MDC (30.2%). Among non-White pts, and pts > 70yo, wait time between diagnosis and MDC visit was a notable worst aspect (37.5%, 33.3% respectively).76.4% of pts would choose to be seen for initial consultation in the MDC again, while 14.2% stated that they would choose to have an initial consultation with just one specialist and receive second point of care in MDC. Pts rate overall MDC experience as excellent (83.0%) or satisfactory (12.5%) most of the time. Conclusions: Patients value seeing multiple providers simultaneously in an environment inclusive of their support systems, described as convenient and efficient. There is discordance between 42.9% of pts describing the volume of information presented as a negative aspect of the experience and only 16.1% of pts feeling overwhelmed during MDC. Similar numbers feel unprepared for and overwhelmed by MDC, and implementation of screening tools to identify these pts for alternative care models or to improve preparedness or reduce distress throughout MDC would optimize care for all.

5598 Background: Clear Cell Carcinoma (CCC) outside the kidney is a rare tumor that can arise from multiple organs, including the ovary, endometrium and cervix. Extra-renal CCC is chemoresistant and has a poor prognosis. Data suggest that CCC of the gynecologic tract resembles the genomic profile of Renal Cell Carcinoma (RCC), which is responsive to immune checkpoint inhibition (ICI) therapy. We are conducting a two-stage phase 2 trial evaluating immunotherapy for extra-renal CCC. The primary objective is to assess overall rate of response (ORR); Progression-Free (PFS), Overall Survival (OS), and correlative biomarker studies are secondary. Here we present the results of Stage 1. Methods: This is a randomized two-stage non-comparative phase II study evaluating nivolumab (240mg IV every two weeks) alone (N) and in combination with ipilimumab (1mg/kg every six weeks, [N+I]) in patients with relapsed extra-renal CCC after at least one prior chemotherapy (no prior ICI), and measurable disease. Treatment was continued until disease progression or unacceptable toxicity. Stage 1 of this trial called for up to 30 volunteers (15 per arm) after which the study was closed. Consideration to reopen to stage 2 called for two or more responses in either arm. Here we present the completion of Stage 1; the release of results was approved by Brown University Oncology Group (BrUOG) Data Safety and Monitoring Committee. Results: Between July 2018 and October 2021, 30 patients were enrolled and 29 were treated (Table). The majority (83%) had CCC of the ovary (n=24). The ORR with N and N+I was 14.2 and 26.7%, respectively. The 6 month PFS rate was 19.1 and 43.8%; median PFS was 2.7 (95%CI 1.3-5.1) and 5.1 months (95%CI 0.9-NR), respectively. Grade ≥3 treatment-related toxicities occurred in 4 (28.6%) on N and 5 (33.3%) on N+I. There were no treatment-related deaths and no new safety signals. One volunteer enrolled on N+I stopped treatment after two years and remains in CR to date. Conclusions: Although sufficient activity was seen in CCC in both arms, the single-agent activity of N is similar to published reports in platinum-resistant epithelial ovarian cancer and decision made not to pursue it further. However, the combination of ipilimumab and nivolumab warrants additional investigation, and the second stage of this study will enroll 14 more patients to receive N+I. Clinical trial information: NCT03355976. [Table: see text]

Purpose: In HER2-positive breast cancer (HER2+BC), neoadjuvant chemotherapy (NACT) with dual HER2-targeted therapy achieves high pathologic complete response (pCR) rates. Anthracycline-free NACT regimens avoid toxicities associated with anthracyclines, but every 3-week TCHP also has substantial side effects. We hypothesized that a weekly regimen might have equivalent efficacy with less toxicity; we also investigated whether poorly responding patients would benefit from switching to AC. Methods:Patients with clinical stage II-III HER2+BC received weekly paclitaxel 80 mg/m2 and carboplatin AUC2 with every 3-week trastuzumab and pertuzumab (wPCbTP), with the option of splitting the pertuzumab loading dose. After 12 weeks, responding patients continued wPCbTP for another 6 weeks, while non-responders switched to AC. Dose modifications and post-op therapy were at investigator discretion. Results:In 30 evaluable patients, the pCR rate was 77% (95% CI 58-90%); 12/14 (86%) in ER-negative and 11/16 (69%) in ER-positive. Only two patients transitioned to AC for non-response, of which one achieved pCR. There were no episodes of febrile neutropenia or grade >3 peripheral neuropathy, though several patients who continued wPCbTP stopped before week 18. Split-dose pertuzumab was associated with less grade >2 diarrhea (40%) than the standard loading dose (60%). Conclusions:pCR rates with our regimen were as high as reported with TCHP with fewer grade >3 toxicities, though diarrhea remains a concern. Too few patients had a suboptimal response to adequately test switching to AC. The wPCbTP regimen should be considered an alternative to TCHP as neoadjuvant therapy for HER2+BC.ClinicalTrials.gov identifier: NCT02789657