Evaluation of physical function and quality of life before and after nonradical surgical therapy for stage IA1 and IA2-IB1 cervical cancer (GOG-0278).

Objective: To examine patient outcomes before and after cone biopsy (CB) or simple hysterectomy (SH) and pelvic lymph node dissection (PLND) for bladder, bowel, and sexual function, quality of life (QOL), cancer worry, reproductive concerns, and lymphedema.

Methods: We stratified women with stage IA1 (lymphovascular space invasion-positive) and IA2-IB1 (≤2 cm) cervical carcinoma by fertility preservation (CB) or none (SH) with PLND. All patients completed study questionnaires at baseline (preoperatively) and postoperatively at 4-6 weeks and 6-, 12-, 18-, and 24-months, consisting of: Functional Assessment Cancer Therapy - Cervical Cancer (FACT-Cx); Female Sexual Functioning Index (FSFI), and 2 Patient-Reported Outcomes Measurement Information System (PROMIS) items; Gynecologic Cancer Lymphedema Questionnaire (GCLQ); Impact of Events Scale (IES); and Reproductive Concerns Scale (RCS).

Evaluation of efficacy and fertility after nonradical surgical therapy (extra fascial hysterectomy or cone biopsy, with pelvic lymphadenectomy) for stage IA1, IA2, and IB1 cervical cancer (GOG-0278).

Objective: To estimate the efficacy and perioperative morbidity of nonradical surgery (simple hysterectomy [SH] or cone biopsy [CB] plus pelvic lymphadenectomy [PLND] and to report pregnancy outcomes after CB.

Methods: Prospective international study with 3-year follow-up of patients with stage IA1 (lymphovascular space invasion-positive) to IB1 (≤2 cm) cervical cancer stratified by fertility preservation (CB) or none (SH) (both with PLND). Criteria included ≤10 mm stromal invasion and negative margins on loop electrosurgical excision procedure or CB.

CITRINO: phase 1 dose escalation study of anti-LAG-3 antibody encelimab alone or in combination with anti-PD-1 dostarlimab in patients with advanced/metastatic solid tumours.

Background: Dual programmed cell death protein (ligand)-1 (PD-[L]1) and lymphocyte-activation gene-3 (LAG-3) blockade has demonstrated improved anti-tumour response in some advanced solid tumours. CITRINO, a two-part, Phase 1 dose-escalation study, evaluated encelimab (TSR-033; novel anti-LAG-3) monotherapy and in combination in patients with advanced/metastatic solid tumours.

Methods: Part 1 (P1) involved dose escalation (20-720 mg Q2W) of encelimab as monotherapy (P1A/B) and with dostarlimab (500 mg Q3W) in patients with previously treated advanced/metastatic solid tumours (P1C).

Tumor Treating Fields therapy in platinum-resistant ovarian cancer: Results of the ENGOT-ov50/GOG-3029/INNOVATE-3 pivotal phase 3 randomized study.

Purpose: Tumor Treating Fields (TTFields) are electric fields that disrupt processes critical for cancer cell viability and tumor progression. The pivotal, phase 3 ENGOT-ov50/GOG-3029/INNOVATE-3 study evaluated efficacy and safety of TTFields therapy with paclitaxel (PTX) vs PTX in patients with platinum-resistant ovarian cancer (PROC).

Patients And Methods: Adult patients with PROC with ≤ 5 total prior lines of therapy (LOT), including ≤ 2 prior LOT for platinum-resistant disease, and ECOG PS of 0-1 were randomized 1:1 to receive TTFields (200 kHz; ≥ 18 h/day) + PTX (80 mg/m weekly) or PTX.

Guiding Principles for Data Sharing and Harmonization: Results of a Systematic Review and Modified Delphi From the Society of Critical Care Medicine Data Science Campaign.

Objectives: This study aimed to establish a set of guiding principles for data sharing and harmonization in critical care, focusing on the use of real-world data (RWD) and real-world evidence (RWE) to improve patient outcomes and research efficacy. The principles were developed through a systematic literature review and a modified Delphi process, with the goal of enhancing data accessibility, standardization, and interoperability across critical care settings.

Data Sources: Data sources included a comprehensive search of peer-reviewed literature, specifically studies related to the use of RWD and RWE in healthcare, guidelines, best practices, and recommendations on data sharing and harmonization.

Comparison of Survival After Treatment of Presumed Intracranial Meningioma by Radiotherapy or Surgery in 285 Dogs.

Background: The comparative effectiveness of radiotherapy and surgery for treating intracranial meningioma is unknown.

Objectives: To compare survival after treatment of suspected intracranial meningioma by either surgery or radiotherapy.

Animals: Two hundred eighty-five companion dogs with suspected intracranial meningiomas presenting to 11 specialty clinics in three countries.

Characterization of plasma cell-free DNA variants as of tumor- or clonal hematopoiesis-origin in 16,812 advanced cancer patients.

Purpose: Plasma-based liquid biopsy tests can detect tumor-specific genetic alterations and offer many advantages that complement tissue-based Comprehensive Genomic Profiling (CGP). However, age-related clonal hematopoiesis (CH) mutations can confound liquid biopsy results and potentially lead to incorrect therapy choice.

Experimental Design: We assessed the landscape of 16,812 liquid profiles across 49 cancer types using the Caris Assure assay, a whole exome and whole transcriptome NGS workflow that independently sequences both plasma-derived cell-free total nucleic acids (cfTNA) as well as the white blood cell DNA and RNA from the buffy coat.

Results from an open-label phase 2a study of cerdulatinib, a dual spleen tyrosine kinase/janus kinase inhibitor, in relapsed/refractory peripheral T-cell lymphoma.

In this phase-2a study (NCT01994382), patients aged ≥18 years with relapsed/refractory peripheral T-cell lymphoma (PTCL; angioimmunoblastic T-cell lymphoma/T follicular helper [AITL/TFH],  = 29); PTCL-not otherwise specified [NOS],  = 11; and Other,  = 25) received 30 mg oral cerdulatinib, a reversible dual inhibitor of spleen tyrosine kinase and Janus kinase, twice daily in 28-day cycles until disease progression or unacceptable toxicity. Overall response rate (ORR) was 36.2% (12 complete responses [CR],9 partial responses [PR], and 14 stable disease); median time to response was 1.

Identifying consensus and areas for future research in chondrosarcoma : a report from the Birmingham Orthopaedic Oncology Meeting.

Aims: The Birmingham Orthopaedic Oncology Meeting (BOOM), held in January 2024, convened 309 delegates from 53 countries to discuss and refine 21 consensus statements on the optimal management of chondrosarcoma.

Methods: With representation from Europe (43%; n = 133), North America (17%; n = 53), South America (16%; n = 49), Asia (13%; n = 40), Australasia (5%; n = 16), the Middle East (4%; n = 12), and Africa (2%; n = 6), the combined experience of treating bone sarcomas among attendees totalled approximately 30,000 cases annually, equivalent to 66 years of experience in the UK alone. The meeting's process began with the formation of a local organizing committee, regional leads, and a scientific committee comprising representatives from 150 specialist units across 47 countries.

Preventing Infusion-Related Reactions With Intravenous Amivantamab-Results From SKIPPirr, a Phase 2 Study: A Brief Report.

Introduction: Amivantamab, an EGFR-MET bispecific antibody, is approved for multiple indications in EGFR-mutated advanced NSCLC as monotherapy or combined with other agents. Intravenous amivantamab is associated with a 67% infusion-related reaction (IRR) rate.

Methods: The phase 2 SKIPPirr study (NCT05663866) enrolled participants with EGFR-mutated (exon 19 deletion or exon 21 L858R) advanced NSCLC after progression on osimertinib and platinum-based chemotherapy who received intravenous amivantamab plus oral lazertinib (amivantamab-lazertinib), a third-generation tyrosine kinase inhibitor.

Racial and ethnic enrollment disparities in clinical trials leading to Food and Drug Administration approvals for gynecologic malignancies.

Background: Compared to White women, Black women and other minority groups have a higher age-adjusted incidence risk of cervical and endometrial cancer. However, the extent of racial and ethnic disparities in clinical trial enrollment among studies performed mainly in North America and Europe for gynecologic malignancy is unknown.

Objective: This study analyzed enrollment rates by race/ethnicity in trials that led to Food and Drug Administration approvals for gynecological cancers from 2010 to 2024.

Re-optimizing the Time Frame for Classifying Cerebral Venous Sinus Thrombosis: An Unmet Need.

Cerebral venous thrombosis (CVT) is a rare and complex form of stroke, representing a small percentage of all stroke cases. The disease's clinical presentation is highly variable, involving a wide range of medical specialists due to its diverse manifestations. Over the past decade, significant advancements in understanding CVT have been made, particularly in light of the COVID-19 pandemic and subsequent vaccination efforts.

International Expert-Based Consensus Definition, Classification Criteria, and Minimum Data Elements for Osteoradionecrosis of the Jaw: An Inter-Disciplinary Modified Delphi Study.

Purpose: Osteoradionecrosis of the jaw (ORNJ) is a severe iatrogenic disease characterized by bone death after radiation therapy (RT) to the head and neck. With over 9 published definitions and at least 16 classification systems, the true incidence and severity of ORNJ are obscured by lack of a standard for disease definition and severity assessment, leading to inaccurate estimation of incidence, reporting ambiguity, and likely under-diagnosis worldwide. This study aimed to achieve consensus on an explicit definition and phenotype of ORNJ and related precursor states through data standardization to facilitate effective diagnosis, monitoring, and multidisciplinary management of ORNJ.

Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials.

Background: Ribociclib + endocrine therapy (ET) showed significant progression-free survival (PFS) and overall survival (OS) benefits in the MONALEESA trials in patients with HR+ /HER2 - advanced breast cancer (ABC). We report efficacy, safety, and patient-reported outcomes (PROs) across age groups, including older patients, in these trials.

Methods: Data from the MONALEESA-2, -3, and -7 trials for pre- and postmenopausal patients receiving first-line treatment for ABC were pooled and analyzed by age (<65y, 65-74y, and ≥75y).

Tucatinib and trastuzumab in HER2-mutated metastatic breast cancer: a phase 2 basket trial.

Human epidermal growth factor receptor 2 (HER2, also known as ERBB2) signaling promotes cell growth and differentiation, and is overexpressed in several tumor types, including breast, gastric and colorectal cancer. HER2-targeted therapies have shown clinical activity against these tumor types, resulting in regulatory approvals. However, the efficacy of HER2 therapies in tumors with HER2 mutations has not been widely investigated.

Safety and Efficacy of Toripalimab in Patients with Cholangiocarcinoma: An Open-Label, Phase 1 Study.

Introduction: This was the first phase 1 study conducted in the United States. It consisted of dose-escalation (part A) and multiple indication-specific cohort expansion (part B), investigating the safety and preliminary efficacy of toripalimab (anti-programmed cell death-1 inhibitor) in patients with advanced malignancies.

Methods: Patients with advanced malignancies that progressed after treatment with at least one prior line of standard systemic therapy, including the patients with advanced/recurrent cholangiocarcinoma (CCA), received toripalimab 240 mg every 3 weeks in part B.

Updated Review for Guidelines for Cervical Cancer Screening in Immunosuppressed Women Without HIV Infection.

Objective: The purpose of this review was to examine new evidence since our 2019 guidelines for cervical cancer (CC) screening in non-HIV immunocompromised persons and to provide updated recommendations based on literature review and expert opinion. In addition, human papillomavirus (HPV) vaccine efficacy in these populations was reviewed.

Methods: A literature search was performed similar to our previous publication but was conducted through March 2023.

Safety in Subsequent Lines of Therapy in Patients With Relapsed/Refractory Follicular Lymphoma.

Follicular lymphoma (FL) is a disease often characterized by chronic and successive relapses after first-line chemoimmunotherapy. Although chemoimmunotherapy and combination therapy, such as lenalidomide with rituximab, are well established in the treatment sequence of FL, there is a need to streamline treatment options and determine placement of novel agents, such as chimeric antigen receptor T-cell therapy, an enhancer of zeste homolog 2 inhibitor, or a phosphoinositide 3 kinase inhibitor, into the treatment landscape. As such, the purpose of this review is to compare the safety profiles of approved agents in subsequent lines of therapy for relapsed or refractory FL and to assess how the management of adverse events may impact treatment choice.

AGA Clinical Practice Update on Noncolorectal Cancer Screening and Vaccinations in Patients With Inflammatory Bowel Disease: Expert Review.

Description: The aim of this American Gastroenterological Association (AGA) Clinical Practice Update (CPU) is to provide Best Practice Advice statements for gastroenterologists and other healthcare providers who provide care to patients with inflammatory bowel disease (IBD). The focus is on IBD-specific screenings (excluding colorectal cancer screening, which is discussed separately) and vaccinations. We provide guidance to ensure that patients are up to date with the disease-specific cancer screenings and vaccinations, as well as advice for mental health and general well-being.

Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial.

Aim: Cemiplimab has demonstrated significantly longer survival than physician's choice of chemotherapy in patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. We report the final survival analysis from the phase III randomized study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9).

Methods: Cemiplimab (n = 304) or chemotherapy (n = 304) were administered every 3 weeks.

State of Lung Cancer in Egypt: Moving Towards Improved Guidelines for Prevention, Screening, Treatment, and Clinical Care Programs.

Lung cancer remains a leading cause of cancer-related mortality globally and presents significant challenges in Egypt. In 2023, the first annual meeting of the Thoracic Oncology Multidisciplinary Faculty, organized by the Egyptian Cancer Research Network and the Egyptian Society of Respiratory Neoplasms, was held in Cairo, Egypt. The meeting aimed to address gaps in lung cancer management across Egypt and the broader Middle East and North Africa region.

Incorporating immune checkpoint inhibitors in epithelial ovarian cancer.

Objective: Therapeutic interventions for epithelial ovarian cancer (EOC) have increased greatly over the last decade but improvements outside of biomarker selected therapies have been limited. There remains a pressing need for more effective treatment options that can prolong survival and enhance the quality of life of patients with EOC. In contrast to the significant benefits of immunotherapy with immune checkpoint inhibitors (CPI) seen in many solid tumors, initial experience in EOC suggests limited efficacy of CPIs monotherapy.