FDA Approval Summary: Datopotamab deruxtecan-dlnk for treatment of patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer.

On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (DATROWAY, Dato-DXd), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable or metastatic, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Approval was based on results from TROPION-Breast01 (TB01), a multicenter, randomized, open-label trial comparing Dato-DXd to investigator's choice of chemotherapy (ICC). The trial was designed with dual primary endpoints: progression-free survival (PFS) assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.

US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, -Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Locally Advanced or Metastatic Breast Cancer.

Purpose: The US Food and Drug Administration (FDA) approved inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, -mutated, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer (MBC), as detected by an FDA-approved test, FoundationOne Liquid CDx assay, after recurrence on or after completing adjuvant endocrine therapy.

Patients And Methods: Approval was based on INAVO120, a randomized, double-blind, placebo-controlled trial in 325 patients with endocrine-resistant, -mutated, hormone receptor-positive, HER2-negative, locally advanced or MBC. Patients were randomly assigned (1:1) to either inavolisib (n = 161) or placebo (n = 164) in combination with palbociclib and fulvestrant.

US Food and Drug Administration Approval Summary: Ribociclib With an Aromatase Inhibitor in the Adjuvant Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Stage II and III High-Risk Early Breast Cancer Treatment Setting.

Purpose: On September 17, 2024, the US Food and Drug Administration (FDA) approved ribociclib in combination with an aromatase inhibitor (AI) for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer (EBC) who are at high risk of recurrence.

Patients And Methods: The FDA approval was based on NATALEE, a randomized (1:1), open-label, multicenter, multinational trial in adults of any sex or menopausal status with hormone receptor-positive, HER2-negative stage II and III EBC who received ribociclib plus an AI (Ribo + AI, n = 2,549) versus an AI (n = 2,552); patients also received goserelin as clinically indicated. Ribociclib was given at 400 mg once daily (3 weeks on/1 week off) for up to 36 months.

Investigation of Two Outbreaks of Hepatitis A Virus Infections Linked to Fresh and Frozen Strawberries Imported from Mexico - 2022-2023.

Foodborne hepatitis A illnesses and outbreaks have been associated with the consumption of ready-to-eat foods contaminated with the feces of person(s) shedding hepatitis A virus (HAV). Outbreaks have been linked to fresh and frozen produce imported from countries where HAV is endemic, hygiene and sanitation are inadequate, or food safety standards are lacking or unenforced. In 2022 and 2023, federal, state, and international partners investigated two multijurisdictional outbreaks of infections involving the same HAV genotype IA strain linked to fresh and frozen organic strawberries sourced from a single grower in Baja California, Mexico.

A multi-provincial outbreak of Newport infections associated with red onions: A report of the largest outbreak in Canada in over 20 years.

An investigation into an outbreak of Newport infections in Canada was initiated in July 2020. Cases were identified across several provinces through whole-genome sequencing (WGS). Exposure data were gathered through case interviews.

False-Positive Circulating Tumor DNA Results Do Not Explain Lack of Efficacy for PARP Inhibitors in Patients With Castration-Resistant Prostate Cancer Harboring and Mutations.

False-positive ctDNA results do not explain lack of efficacy for PARPi in patients with ATMm and CHEK2m CRPC.

Comparison of Serial Amnioinfusion Strategies for Isolated Early-Onset Fetal Renal Anhydramnios.

Introduction: The optimal protocol for serial amnioinfusions to maintain amniotic fluid in pregnancies with early-onset fetal renal anhydramnios before 22 weeks is not known. We compared the performance of two different approaches.

Methods: A secondary analysis was conducted of serial amnioinfusions performed by a single center during the external pilot and feasibility phases of the Renal Anhydramnios Fetal Therapy (RAFT) trial.

Frailty as an Effect Modifier in Randomized Controlled Trials: A Systematic Review.

Background: The effect of clinical interventions may vary by patients' frailty status. Understanding treatment effect heterogeneity by frailty could lead to frailty-guided treatment strategies and reduce overtreatment and undertreatment. This systematic review aimed to examine the effect modification by frailty in randomized controlled trials (RCTs) that evaluate pharmacological, non-pharmacological, and multicomponent interventions.

Case report: prolonged durable clinical benefit and low toxicity from combination endocrine therapy in a patient with recurrent endometrial carcinoma.

Background: Endometrial carcinoma is the most common gynecologic cancer, with increasing incidence and mortality. Combination endocrine therapy comprised of tamoxifen and progestational agents has demonstrated promising results in treating recurrent disease. This case report describes the prolonged clinical benefit of treatment with tamoxifen and megestrol acetate in a woman with recurrent, metastatic endometrial endometrioid carcinoma positive for estrogen (ER) and progesterone receptors (PR).

Institutionalizing Community-engaged Translational Science in an Academic Institution: A Community Stakeholder-Driven Process.

Background: Although studies have described the power imbalance in academic-community partnerships, little has been published describing how community-based participatory research-informed practitioners can change academic institutions to promote more effective community-engaged research.

Objectives: This paper describes a university-funded community-based participatory project in which academic researchers and their community partners worked together to articulate, develop and advocate for institutionalizing best practices for equitable partnerships throughout the university.

Methods: Findings derive from a collaborative ethnographic process evaluation.

FDA Approval Summary: Tremelimumab in Combination with Durvalumab for the Treatment of Patients with Unresectable Hepatocellular Carcinoma.

On October 21, 2022, the FDA approved tremelimumab (Imjudo) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma. The approval was based on the results from the HIMALAYA study, in which patients with unresectable hepatocellular carcinoma who were naïve to previous systemic treatment were randomly assigned to receive one of three study arms: tremelimumab in combination with durvalumab (n = 393), durvalumab (n = 389), or sorafenib (n = 389). The primary objective of improvement in overall survival (OS) for tremelimumab in combination with durvalumab compared with sorafenib met statistical significance with a stratified HR of 0.

Duodenal Adenocarcinoma in a patient with Lynch Syndrome. A Case Report and Facts Related to Small Intestine Cancer.

Diagnosing small bowel cancer has been challenging due to its unusual presentation and inaccessibility on endoscopy. A 41-year-old male with a history of irritable bowel syndrome underwent esophagogastroduodenoscopy (EGD) for worsening fatigue and lightheadedness despite iron supplements therapy for low hemoglobin. Initial upper endoscopy showed esophagitis and non-bleeding duodenal bulb ulcer with exudate.

"At the End I Have a Say": Engaging the Chinese Community in Advance Care Planning.

Context: Despite the association of advance care planning (ACP) with improved patient and caregiver outcomes, Chinese American elders have low rates of ACP.

Objectives: Assess ACP facilitators/barriers in the San Francisco (SF) Chinese community and codesign, implement, and test community-based ACP-promoting pilot events.

Methods: A Chinese Community Committee (N = 19 community-based organization leaders, health system representatives, community members) conducted focus groups in Cantonese and English with Chinese older adults (age ≥55), caregivers, and community leaders.

Genetic and Functional Analyses of Cutibacterium Acnes Isolates Reveal the Association of a Linear Plasmid with Skin Inflammation.

Cutibacterium acnes is a commensal bacterium on the skin that is generally well-tolerated, but different strain types have been hypothesized to contribute to the disease acne vulgaris. To understand how some strain types might contribute to skin inflammation, we generated a repository of C. acnes isolates from skin swabs of healthy subjects and subjects with acne and assessed their strain-level identity and capacity to stimulate cytokine release.

FDA Approval Summary: Tucatinib with Trastuzumab for Advanced Unresectable or Metastatic, Chemotherapy Refractory, HER2-Positive RAS Wild-Type Colorectal Cancer.

On January 19, 2023, the FDA granted accelerated approval to tucatinib in combination with trastuzumab for the treatment of patients with unresectable or metastatic RAS wild-type, HER2-positive colorectal cancer who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Approval was based on the pooled analysis of patients receiving tucatinib in combination with trastuzumab in MOUNTAINEER (NCT03043313), an open-label, multicenter trial. The primary endpoint was overall response rate (ORR) by RECIST 1.

FDA Approval Summary: Futibatinib for Unresectable Advanced or Metastatic, Chemotherapy Refractory Intrahepatic Cholangiocarcinoma with FGFR2 Fusions or Other Rearrangements.

On September 30, 2022, the FDA granted accelerated approval to futibatinib for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) with FGFR2 fusions or other rearrangements. Approval was based on Study TAS-120-101, a multicenter open-label, single-arm trial. Patients received futibatinib 20-mg orally once daily.

Exceptional responses to PARP inhibitors in patients with metastatic breast cancer in oncologic crisis.

Purpose: Cancers deficient in homologous recombination DNA repair, such as those with BRCA1 or BRCA2 (BRCA1/2) mutations rely on a pathway mediated by the enzyme poly(adenosine diphosphate-ribose) polymerase (PARP). PARP inhibitors (PARPi's) have demonstrated efficacy in treating patients with germline (g)BRCA1/2, somatic (s)BRCA1/2, and gPALB2 mutations in clinical trials. However, patients with a poor performance status (PS) and those with severe organ impairment are often excluded from clinical trials and cancer-directed treatment.