Current negativity definition in esophageal cancer screening overlooks the risk heterogeneity between individuals with non-dysplastic Lugol's unstained lesions (ND-LULs) and normal-stained epithelium. We aimed to define the screening negativity by the incidence risk of severe dysplasia and above lesions (SDAs) after chromoendoscopy and ascertain their re-screening interval.

Treatment of high-risk soft-tissue sarcoma (STS) of extremity or trunk wall involves neoadjuvant chemotherapy (NACT) followed by surgery. Histopathological response could estimate patient outcomes.

In the DREAMM-8 trial, belantamab mafodotin, pomalidomide, and dexamethasone demonstrated a statistically significant reduction in the risk of progression or death compared with bortezomib, pomalidomide, and dexamethasone in lenalidomide-exposed patients with relapsed or refractory multiple myeloma. We present patient-reported outcomes from this trial.

The role of postmastectomy chest-wall irradiation in patients with breast cancer classified as pN1 (with involvement of one to three axillary nodes) or pN0 (pathologically node negative) with additional risk factors is uncertain.

A phase II trial (MO-Ped; NCT03442985) assessed palovarotene in pediatric patients with multiple hereditary exostosis (MHE). Patients aged ≤ 14 years with MHE were randomized 1:1:1 to placebo, palovarotene 2.5 mg, or palovarotene 5.0 mg daily. Due to concerns of premature physeal closure (PPC), a partial clinical hold was instituted, followed by trial termination. The primary efficacy endpoint was the annualized rate of new osteochondromas (OCs). Safety was assessed. Overall, 193 patients received ≥ 1 dose of palovarotene or placebo. Due to trial termination, no patients completed planned treatment. Prior to 06 December 2019 (patients notified of clinical hold and treatment stopped), 30 patients completed Month 12 efficacy imaging. No significant differences in the annualized rate of new OCs, or change from baseline in volume of OCs or OC cartilage, were observed between treatment groups. The adverse event profile was consistent with systemic retinoids. There was no evidence of an effect of palovarotene on linear growth and no cases of PPC. Overall, palovarotene showed no clear efficacy signal in MHE, resulting in a non-favorable benefit-risk profile. Interpretation of results was limited by the reduced treatment duration and smaller than expected cohort. The trial yielded important data on the natural history of MHE.Trial registration: NCT03442985 (first posted 22 February 2018).

Older adults with HER2-positive early breast cancer are underrepresented in clinical trials, and the benefit of chemotherapy in this population remains uncertain. We evaluated the HER2DX genomic assay within the randomized RESPECT trial (NCT01104935), which compared adjuvant trastuzumab with or without chemotherapy in patients aged 70-80 years. In this prespecified translational analysis (Trans-RESPECT), HER2DX scores were available for 154 patients. The HER2DX risk score classified 74.0% as low risk and 26.0% as high risk. Ten-year relapse-free and overall survival were higher in the low-risk group. HER2DX remained independently associated with overall survival in multivariable analysis. The HER2DX immune, luminal, and proliferation signatures that compose the risk score were also prognostic. While the HER2DX pCR score was not prognostic overall, exploratory subgroup analyses suggested a potential survival benefit from chemotherapy in the pCR-high group. HER2DX offers prognostic value and may guide chemotherapy use in older patients with HER2-positive early breast cancer. Clinical Trial Information NCT01104935.

Actinic keratoses (AKs) are precancerous lesions that may progress to squamous cell carcinoma (SCC). Photodynamic therapy (PDT) with methyl aminolevulinate (MAL) is an established treatment, often preceded by mechanical curettage to enhance photosensitizer penetration. However, curettage is associated with pain and discomfort, necessitating alternative pretreatment strategies, also applicable in daylight PDT.

Several studies have evaluated PD-1 inhibitors plus chemotherapy as neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma (ESCC), but comparative data with chemoradiotherapy (CRT) remain limited. This multicenter, randomized, open-label, phase 2 non-inferiority trial (REVO, NCT05007145) assessed the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy (ICT) versus CRT in patients with resectable, locally advanced ESCC. A total of 104 patients were randomized to ICT (camrelizumab, nab-paclitaxel, cisplatin) or CRT (nab-paclitaxel, cisplatin, radiotherapy). The primary endpoint was pathologic complete response (pCR). ICT achieved a pCR rate of 32.7% versus 34.6% with CRT (rate ratio 0.94, 90% CI 0.6-1.49), demonstrating non-inferiority and meeting the pre-specified primary endpoint. Major pathologic response was observed in 42.3% of ICT patients and 57.7% of CRT patients, with R0 resection achieved in 100% of both groups. 1-year disease-free survival was 89.1% versus 78.2%, and 1-year overall survival was 100% versus 92.3% for ICT and CRT, respectively. Grade ≥3 treatment-related adverse events occurred in 19.2% of ICT patients and 33.3% of CRT patients, and surgical complications were reported in 31.1% and 35.9%, respectively. These findings indicate that ICT is a safe and effective neoadjuvant strategy for resectable ESCC with a more favorable safety profile.

IntroductionPatients with cancer may overestimate their ability to adhere to oral anticancer treatments (OAT) which may significantly reduce adherence rates. However, only few studies have investigated the specific role of personality traits and cognitive distortions in the definition of the adherence trajectory in the cancer field.MethodsThis study is nested in the Pfizer project (65080791), and it is a secondary, observational analysis of prospectively collected data from a randomized controlled trial (RCT). To avoid potential bias from comparing measurements across different time points, we limited the evaluation of associations among variables to the baseline data. 94 metastatic breast cancer (MBC) patients (mean age 56.8) receiving OAT for MBC have been enrolled. Each participant filled a set of measures assessing personality (Big Five), adherence (AAI-28 and MMAS-8) (© 2006 Donald E Morisky), and optimistic bias (VAS), and Quality of Life (EORTC QLQ-C30 and EORTC QLQ-BR23).ResultsA discrepancy between self-oriented and other-oriented evaluation of the capacity to take the therapy in the doses, frequencies, and times prescribed was observed (P < 0.001). A negative association between adherence rate and the self-perception of treatment adherence was identified (P < 0.001). Further, conscientiousness correlated positively with the perception of risk to their own health (P = 0.034), and negative association between extraversion and self-perception of treatment adherence (P = 0.05) and between agreeableness and self-perception of treatment adherence have been observed (P = 0.029).ConclusionsOur findings suggest that optimistic bias and personality may contribute to shaping adherence in MBC patients. Personality traits influence adherence both directly, by increasing the perception of health risks, and indirectly, by influencing coping strategies and emotion regulation. MBC patients having an OB may underestimate the important side effects and physical comorbidities, as well as difficulties in the daily management and adjustment of therapy due to disease progression.

Gastric cancer (GC) patients often have nutritional risks or malnutrition, and neoadjuvant chemotherapy (NAC) tends to exacerbate malnutrition. Body composition parameters are associated with the prognosis of GC patients. Little is known about body composition changes during NAC and its role in clinical outcomes.

In several countries, whole-body imaging has been introduced in the routine follow-up of individuals with high-risk cutaneous malignant melanoma after surgery. However, there is scarce evidence that earlier detection of recurrent disease by regular scanning improves survival. In this interim analysis, we investigated whether imaging in the follow-up programme for high-risk cutaneous malignant melanoma improves survival and assessed whether the study should continue to include participants.

Abemaciclib, a potent CDK4 and CDK6 inhibitor, has shown antitumour activity in prostate cancer models and in patients with metastatic castration-resistant prostate cancer (mCRPC) who have been heavily treated. We aimed to evaluate the safety and efficacy of abemaciclib in combination with abiraterone in patients with mCRPC.

As antimicrobial resistance increases, safer alternative approaches to prostate biopsy are needed. PREVENT was a multi-institutional, randomized controlled trial comparing transperineal (TP) biopsy without antibiotic prophylaxis versus transrectal (TR) biopsy with targeted prophylaxis. The authors conducted a secondary cost-effectiveness analysis of PREVENT.

ImportanceIntraoperative narrow-band imaging (NBI) has been used to improve superficial (mucosal) resection margin clearance in oral squamous cell carcinoma (OSCC). However, no study has been conducted in a randomized controlled trial comparing OSCC resection using NBI and standard white light (WL).ObjectiveTo compare the rate of pathological margin clearance between NBI-guided and WL-guided resection in OSCC patients.DesignParallel-design, single-center, randomized controlled trial.SettingTertiary care center, Department of Otolaryngology.ParticipantsOne hundred and four OSCC patients undergoing surgical resection were included in the study.InterventionPatients were randomly assigned to have either NBI-guided (n = 52) or WL-guided (n = 52) resection.Main Outcome MeasuresFinal pathological margin status and clinical outcomes, including type of defect reconstruction and functional outcomes (persisting tracheostomy and tube feeding), were compared between the 2 groups.ResultsA significantly higher rate of clear superficial margin was achieved in patients in the NBI group than in the WL group (96.2% and 80.8%, respectively, P = .014). The locoregional or free flap reconstruction rates between the 2 groups were indistinguishable. Oral tongue and floor of the mouth primaries were detected more frequently in the NBI group, which may affect the postoperative deglutition function, leading to insignificantly higher rates of persistent tracheostomy and feeding tube (11.5% vs 5.8%, P = .488, and 19.2% vs 13.5%, P = .597, respectively).Conclusions and RelevanceThe study demonstrated that intraoperative NBI-guided resection in OSCC resulted in a more precise definition of superficial tumor margin than the standard WL-guided resection. In addition, the reconstruction method and functional outcomes were comparable between the 2 groups.

COMPEL (NCT04765059) was a global, randomized, double-blind study that evaluated osimertinib plus chemotherapy versus placebo plus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated advanced non-small-cell lung cancer (NSCLC) following non-central nervous system (CNS) progression on first-line osimertinib.

Endoscopic submucosal dissection (ESD), though effective in the treatment of gastric stromal tumor (GST), is limited by difficult procedures, a long learning curve and a high hospital cost. It is of great clinical value to explore new effective, simple, and safe surgical methods.

Surgical resection is the preferred curative approach for patients with early-stage hepatocellular carcinoma, but recurrence remains a major challenge. Consequently, neoadjuvant and adjuvant therapies have been proposed to reduce tumour burden and mitigate the risk of recurrence. The CARES-009 trial aimed to evaluate perioperative camrelizumab plus rivoceranib in patients with resectable hepatocellular carcinoma at intermediate or high risk of recurrence.

Squamous non-small-cell lung cancer (NSCLC) is associated with worse clinical outcomes than non-squamous NSCLC, but treatment options are scarce. We aimed to evaluate the efficacy and safety of ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy as a first-line therapy for patients with advanced squamous NSCLC.

With 5 years of follow-up in the phase 3 CROWN study, lorlatinib showed unprecedented improvement in progression-free survival coupled with prolonged intracranial efficacy in patients with ALK-positive metastatic non-small cell lung cancer (mNSCLC). Here, we report kinetics and mitigation practices of select adverse events (AEs) to inform therapy management strategies.

CD19-targeted chimeric antigen receptor-T cell (CART19) therapy is clinically effective in patients with relapsed or refractory B-cell lymphoma (BCL), but treatment failure and recurrence need to be overcome. Preclinical studies demonstrated that Bruton tyrosine kinase inhibitor (BTKi) improved the efficacy of CART19 therapy.