Response-guided neoadjuvant sacituzumab govitecan for localized triple-negative breast cancer: results from the NeoSTAR trial.

BACKGROUND: Sacituzumab govitecan (SG), a novel antibody-drug conjugate (ADC) targeting TROP2, is approved for pre-treated metastatic triple-negative breast cancer (mTNBC). We conducted an investigator-initiated clinical trial evaluating neoadjuvant (NA) SG (NCT04230109), and report primary results. PATIENTS AND METHODS: Participants with early-stage TNBC received NA SG for four cycles. The primary objective was to assess pathological complete response (pCR) rate in breast and lymph nodes (ypT0/isN0) to SG. Secondary objectives included overall response rate (ORR), safety, event-free survival (EFS), and predictive biomarkers. A response-guided approach was utilized, and subsequent systemic therapy decisions were at the discretion of the treating physician. RESULTS: From July 2020 to August 2021, 50 participants were enrolled (median age = 48.5 years; 13 clinical stage I disease, 26 stage II, 11 stage III). Forty-nine (98%) completed four cycles of SG. Overall, the pCR rate with SG alone was 30% [n = 15, 95% confidence interval (CI) 18% to 45%]. The ORR per RECIST V1.1 after SG alone was 64% (n = 32/50, 95% CI 77% to 98%). Higher Ki-67 and tumor-infiltrating lymphocytes (TILs) were predictive of pCR to SG (P = 0.007 for Ki-67 and 0.002 for TILs), while baseline TROP2 expression was not (P = 0.440). Common adverse events were nausea (82%), fatigue (76%), alopecia (76%), neutropenia (44%), and rash (48%). With a median follow-up time of 18.9 months (95% CI 16.3-21.9 months), the 2-year EFS for all participants was 95%. Among participants with a pCR with SG (n = 15), the 2-year EFS was 100%. CONCLUSIONS: In the first NA trial with an ADC in localized TNBC, SG demonstrated single-agent efficacy and feasibility of response-guided escalation/de-escalation. Further research on optimal duration of SG as well as NA combination strategies, including immunotherapy, are needed.

Cameron lesions in patients with hiatal hernias: prevalence, presentation, and treatment outcome.

Cameron lesions, as defined by erosions and ulcerations at the diaphragmatic hiatus, are found in the setting of gastrointestinal (GI) bleeding in patients with a hiatus hernia (HH). The study aim was to determine the epidemiology and clinical manifestations of Cameron lesions. We performed a retrospective cohort study evaluating consecutive patients undergoing upper endoscopy over a 2-year period. Endoscopy reports were systematically reviewed to determine the presence or absence of Cameron lesions and HH. Inpatient and outpatient records were reviewed to determine prevalence, risk factors, and outcome of medical treatment of Cameron lesions. Of 8260 upper endoscopic examinations, 1306 (20.2%) reported an HH. When categorized by size, 65.6% of HH were small (<3 cm), 23.0% moderate (3-4.9 cm), and 11.4% were large (≥5 cm). Of these, 43 patients (mean age 65.2 years, 49% female) had Cameron lesions, with a prevalence of 3.3% in the presence of HH. Prevalence was highest with large HH (12.8%). On univariate analysis, large HH, frequent non-steroidal anti-inflammatory drug (NSAID) use, GI bleeding (both occult and overt), and nadir hemoglobin level were significantly greater with Cameron lesions compared with HH without Cameron lesions (P ≤ 0.03). Large HH size and NSAID use were identified as independent risk factors for Cameron lesions on multivariate logistic regression analysis. Cameron lesions are more prevalent in the setting of large HH and NSAID use, can be associated with GI bleeding, and can respond to medical management.

The pectoralis major myocutaneous flap in head and neck reconstruction. Analysis of complications.

Sixty-seven patients underwent 73 pectoralis major myocutaneous flap procedures for the immediate reconstruction of defects after resection of head and neck cancers. Thirty-six patients experienced a total of 50 complications for an overall complication rate of 54 percent. There were 3 instances of total flap necrosis, 9 of partial flap necrosis, 12 orocutaneous fistulas, 9 suture line separations, 8 neck wound complications, 1 donor site complication, and 8 mandibular replacement complications. Most complications were minor and did not require a second procedure for correction; however, 36 percent did require a second operation. Eight of 10 patients in whom a metal appliance was placed to restore mandibular continuity required the removal of that appliance due to either flap necrosis, fistula formation, or exposure. Based on our experience, we conclude that attention to flap design, operative technique, and post-operative management were useful in reducing the incidence of complications. We also conclude that a metal appliance was an unsatisfactory means of restoring mandibular continuity when utilized beneath a pectoralis major myocutaneous flap. Although the overall incidence of complications was high, the actual incidence of flaps failing to accomplish their intended purpose and requiring secondary repair was acceptable. The pectoralis major myocutaneous flap was reliable in the reconstruction of defects in the head and neck region.

Malignant schwannoma of the vagus nerve: a case report and review of the literature.

A case of neuroectodermal tumor, a malignant schwannoma, of the cervical vagus nerve is presented. It had been previously misdiagnosed and was a recurrence. A review of the literature reveals this to be the sixth such case reported. The difficulties in establishing a diagnosis and the principals of adequate therapy are discussed; these include wide surgical resection and postoperative radiotherapy to the tumor bed. The correct recognition of their malignant potential is essential for long-term disease-free survival.