PURPOSE CheckMate 651 (ClinicalTrials.gov identifier: NCT02741570 ) evaluated first-line nivolumab plus ipilimumab versus EXTREME (cetuximab plus cisplatin/carboplatin plus fluorouracil ≤ six cycles, then cetuximab maintenance) in recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). METHODS Patients without prior systemic therapy for R/M SCCHN were randomly assigned 1:1 to nivolumab plus ipilimumab or EXTREME. Primary end points were overall survival (OS) in the all randomly assigned and programmed death-ligand 1 combined positive score (CPS) ≥ 20 populations. Secondary end points included OS in the programmed death-ligand 1 CPS ≥ 1 population, and progression-free survival, objective response rate, and duration of response in the all randomly assigned and CPS ≥ 20 populations. RESULTS Among 947 patients randomly assigned, 38.3% had CPS ≥ 20. There were no statistically significant differences in OS with nivolumab plus ipilimumab versus EXTREME in the all randomly assigned (median: 13.9 v 13.5 months; hazard ratio [HR], 0.95; 97.9% CI, 0.80 to 1.13; P = .4951) and CPS ≥ 20 (median: 17.6 v 14.6 months; HR, 0.78; 97.51% CI, 0.59 to 1.03; P = .0469) populations. In patients with CPS ≥ 1, the median OS was 15.7 versus 13.2 months (HR, 0.82; 95% CI, 0.69 to 0.97). Among patients with CPS ≥ 20, the median progression-free survival was 5.4 months (nivolumab plus ipilimumab) versus 7.0 months (EXTREME), objective response rate was 34.1% versus 36.0%, and median duration of response was 32.6 versus 7.0 months. Grade 3/4 treatment-related adverse events occurred in 28.2% of patients treated with nivolumab plus ipilimumab versus 70.7% treated with EXTREME. CONCLUSION CheckMate 651 did not meet its primary end points of OS in the all randomly assigned or CPS ≥ 20 populations. Nivolumab plus ipilimumab showed a favorable safety profile compared with EXTREME. There continues to be a need for new therapies in patients with R/M SCCHN.

BackgroundSymptoms of anxiety and depression are among the major mental health problems in cancer patients. These symptoms affect the quality of life and treatment adherence, and are associated with other symptoms and longer hospital stays. Valid and reliable screening instruments such as the Hospital Anxiety and Depression Scale (HADS), have made possible the detection of possible cases of depression and anxiety in medically ill patients. However, the psychometric properties of this instrument have not been documented in different types of cancer diagnoses in the Mexican population.

Background: Based on a potential synergistic effect of antiePD-L1 avelumab plus cetuximab and radiotherapy (RT), this combination was tested in a randomized phase III trial against 2 standards of care (SOC) in LA-SCCHN. Methods:The trial comprised 2 cohorts of patients (pts) fit for cisplatin (3 cycles of 100 mg/m 2 , Q3W) or unfit for cisplatin. The SOC was IMRT 70 Gy / 6.5 weeks with cisplatin in fit pts and with cetuximab in unfit pts (Bonner, 2006). In both cohorts, experimental arm (Exp) was 70 Gy / 6.5 weeks plus weekly cetuximab and avelumab 10 mg/kg at Day-7 and every 2 weeks during RT followed by avelumab for 12 months. The primary endpoint was progression-free survival (PFS). In Unfit pts, 115 events were needed / 277 pts to detect a HR of 0.62 (1-sided 0.05 type I error; power 80%). In Fit pts, 166 events were needed / 430 pts to detect a HR of 0.64 (2-sided 0.05 type I error; power 80%).Results: Between 2017 and 2020, 707 pts were randomized. For cisplatin unfit pts, out of 277 pts, the number of PFS events was reached. Median age 67 years, 88% smokers, 61% oropharyngeal tumors (35% p16+), 24% stage III, 76% stage IV. Grade >¼ 3 AEs were 80% in both arms (p¼0.91). Median follow-up was 21 months . PFS rate at 2 years (95%CI) was 44% (35%-53%) in Exp vs 31% (23%-40%) in Cetux-SOC (HR 0.85; p¼0.15). Loco-regional progression at 2 years (95%CI) was 34% (26%-43%) in Exp vs 44% (35%-53%) in Cetux-SOC (HR ¼ 0.83; p¼0.34). Distant metastasis rate was lower in Exp (HR ¼ 0.31, p¼0.007). The 2-year OS rate (95%CI) was 58% (48%-67%) in Exp vs 54% in SOC (44%-64%) (HR 1.08; p-¼0.69). For cisplatin fit pts, out of 430 pts, the number of PFS events was not reached. The interim analysis for futility based on 89 events in 317 first pts showed a 1-year PFS rate (95%CI) of 64% (54%-72%) in Exp vs 73% in SOC-cisplatin (65%-81%): HR 1.27 (95%CI 0.83-1.93), crossing the futility boundary. Conclusions:In cisplatin-Unfit pts, a favorable effect of adding avelumab to cetuximab was seen on PFS, local-regional control, distant metastases, but the primary endpoint on PFS was not met. In cisplatin-Fit pts, the futility boundary for efficacy was crossed, favoring SOC cisplatin.Clinical trial identification: NCT02999087.Legal entity responsible for the study: GORTEC.

ResumenLa sintomatología ansiosa es uno de los principales problemas psicológicos en pacientes oncológicos. La Escala de Ansiedad de Beck (BAI) ha demostrado ser un instrumento válido y confiable. Sin embargo, hasta ahora no se había documentado su comportamiento psicométrico en población oncológica en México.Objetivo: Determinar las propiedades psicométricas de la Escala de Ansiedad de Beck (BAI) en una muestra de pacientes con cáncer.Material y Método: participaron 250 pacientes del Instituto Nacional de Cancerología, de los cuales 138 eran mujeres (55,2%) y 112 eran hombres (44,8%); la edad promedio fue de 46,6 ± 14,3 años. Los participantes contestaron además del BAI, la Subescala de ansiedad de la Escala de Ansiedad y Depresión (HADS-A).Resultados: El análisis factorial varimax con 21 reactivos presentó una estructura con 4 factores: Subjetivo, Neurofisiológico, Autonómi-co y Síntomas vasomotores que explicaron el 46,38% de la varianza. La consistencia interna de la escala global mostró un índice satisfactorio (α=0,82). La validez por medio de correlación con el HADS-A mostraron resultados significativos (r de Pearson Conclusions: The BAI in Mexican population with cancer showed adequate psychometric characteristics. Detection of anxiety symp-

Prostate cancer is a significant burden and cause of mortality in Latin America. This article reviews the treatment options for patients with metastatic castration-resistant prostate cancer (mCRPC) and provides consensus recommendations to assist Latin American prostate cancer specialists with clinical decision making. A multidisciplinary expert panel from Latin America reviewed the available data and their individual experience to develop clinical consensus opinions for the use of life-prolonging agents in mCRPC, with consideration given to factors influencing patient selection and treatment monitoring. There is a lack of level 1 evidence for the best treatment sequence or combinations in mCRPC. In this context, consensus recommendations were provided for the use of taxane-based chemotherapies, androgen receptor axis-targeted agents and targeted alpha therapy, for patients in Latin America. Prostate-specific antigen (PSA) changes alone, during treatment, should be treated with caution; PSA may not be a suitable biomarker for radium-223. Bone scans and computed tomography are the standard imaging modalities in Latin America. Imaging should be prompted during treatment where symptomatic decline and/or significant worsening of laboratory evaluations are reported, or where a course of therapy has been completed and another antineoplastic agent is under consideration. Recommendations and guidance for treatment options in Latin America are provided in the context of country-level variable access to approved agents and technologies for treatment monitoring. Patients should be treated with the purpose of prolonging overall survival and preserving quality of life through increasing the opportunity to administer all available life-prolonging therapies when appropriate.Electronic supplementary materialThe online version of this article (10.1007/s12032-018-1105-8) contains supplementary material, which is available to authorized users.