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Introduction: The incidence of infections is poorly studied in patients with neuroendocrine tumors (NET) treated with everolimus outside of clinical trials. We aimed to evaluate the frequency of and risk factors for opportunistic infections (Opl) or any serious infection in eligible patients. Methods: This was a retrospective multicenter study of a Latin American cohort of consecutive patients with advanced NET treated with everolimus. Duration of everolimus, comorbidities, Charlson comorbidity score, type of prior treatment, institution, and concurrent immunosuppressive conditions were tested for possible associations with serious (grade 3–5) infections in univariate and multivariable logistic regression models. Results: One hundred eleven patients from 5 centers were included. The median duration of everolimus was 8.9 months. After a median follow-up of 32.9 months, 34 patients (30.6%; 95% CI 22.2–40.1) experienced infections of any grade, with 24 (21.6%; 95% CI 14.8–30.4) having a serious infection and 7 (6.3%; 95% CI 2.6–12.6) having at least 1 OpI (Candida sp., Toxoplasma gondi, Pneumocystis sp., Herpes sp., and Cryptococcus sp.). Four patients (3.6%) died from infections, but only 2 deaths (1.8%) were deemed to be related to everolimus. The multivariable analysis identified everolimus duration (every 6-month increase; OR = 1.28; 95% CI 1.02–1.60; p = 0.03) as an independent risk factor for serious infection. Conclusion: Infections are more frequent in NET patients using everolimus than previously reported in clinical trials. Patients on everolimus should be closely monitored for infections, especially those receiving it for several months. [ABSTRACT FROM AUTHOR]

The participation of patients in precision oncology trials needs to fulfill molecular‐based selection criteria. This strongly limits accrual, and as a consequence, screening successes have decreased, costs have increased, and fewer subjects are enrolled. To achieve narrowed targets, studies have been forced to be multicenter and multinational to reach a larger pool of candidates. However, this globalization faces many challenges, as, for example, in the case of precision oncology trials. These trials have a complex structure that is dependent upon a high‐tech infrastructure and knowledge in a dynamic environment. Given the movement of precision clinical cancer research to regions other than Europe and the U.S., it is important to evaluate the feasibility of performing such trials in lower‐middle‐ and low‐income countries. Here we critically discuss the advantages of conducting precision oncology clinical trials in Latin America and make suggestions on how to overcome the main challenges involved. Implications for Practice: Precision clinical trials in oncology are studies that require candidates to have tumors with specific molecular alterations, which are considered the target for the trial experimental therapy. Because many molecular alterations are rare, fewer patients are enrolled. This has led to trials being forced to be multicenter and multinational, including trials in Latin America. This article discusses the challenges and opportunities to conduct precision oncology trials in Latin America, aiming to help sponsors and investigators to solve complex issues that ultimately lead to more of such trials being run in the region, potentially benefiting more Latin American patients with cancer. Latin American countries have had one of the largest increases in clinical trial participation. This article analyzes the advantages and challenges to conducting precision oncology clinical trials in Latin America. [ABSTRACT FROM AUTHOR]

Background: HIV-positive patients are underrepresented in clinical trials of metastatic squamous cell carcinoma of the anal canal (mSCCA). We aimed to compare the clinical outcomes of mSCCA patients according to HIV infection., Methods: This was a retrospective multicenter cohort study of consecutive patients with mSCCA. All HIV-positive patients received antiretroviral therapy. The primary endpoint was overall survival (OS), and secondary endpoints were progression-free survival (PFS) and response rate (RR)., Results: From January 2005 to December 2019, 113 patients were included: 20 (17.6%) had HIV infection. HIV-positive patients were younger at diagnosis and more frequently male, and 20% (n = 8) received exclusively best supportive care in comparison with 8.6% of HIV-negative patients (P = .13). Both groups were similar in terms of Eastern Cooperative Oncology Group (ECOG) performance status, pattern of metastatic disease, and type of first-line chemotherapy. Five (25%) HIV-positive and 36 (38.7%) HIV-negative patients received second-line therapies (P = .24). RR and median PFS in first-line were similar between the groups: 35% and 30.1% (P = .78) and 4.9 and 5.3 months (P = .85) for patients with and without HIV infection, respectively. At a median follow-up of 26 months, median OS was 11.3 months (95% confidence interval [CI] 10.1 to 26.4) for HIV-infected patients versus 14.6 months (95% CI 11.1 to 18.1) for HIV-negative patients (P = .92). In the univariate analysis for OS, only ECOG performance status was significant., Conclusion: HIV-positive mSCCA patients under antiretroviral therapy have oncological outcomes similar to those of HIV-negative patients. These patients should be included in trials of mSCCA., Competing Interests: Declaration of Competing Interest None to declare, (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments., Methods: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group., Results: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine., Conclusion: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period., Competing Interests: Aline B. Lara GongoraHonoraria: MSD Oncology, Amgen Denis L. JardimHonoraria: Janssen-Cilag, Roche/Genentech, Astellas Pharma, MSD Oncology, BMS Brazil, Pfizer, Libbs, MerckConsulting or Advisory Role: Janssen-Cilag, Pfizer, MSDTravel, Accommodations, Expenses: MSD, BMS Brazil, Janssen-Cilag Angelica Nogueira-RodriguesHonoraria: Roche, MSD, AstraZenecaConsulting or Advisory Role: Roche, AstraZeneca, MSD, Eisai Carlos H. BarriosStock and Other Ownership Interests: Biomarker, MedSIR, TummiHonoraria: Novartis, Roche/Genentech, Pfizer, GlaxoSmithKline, Sanofi, Boehringer Ingelheim, Eisai, MSD, Lilly, Bayer, AstraZeneca, Zodiac PharmaConsulting or Advisory Role: Boehringer Ingelheim, Roche/Genentech, Novartis, GlaxoSmithKline, Eisai, Pfizer, AstraZeneca, Libbs, MSD Oncology, United Medical, LillyResearch Funding: Pfizer, Novartis, Amgen, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Roche/Genentech, Lilly, Sanofi, Taiho Pharmaceutical, Mylan, Merrimack, Merck, AbbVie, Astellas Pharma, Biomarin, Bristol Myers Squibb, Daiichi Sankyo, Abraxis BioScience, AB Science, Asana Biosciences, Medivation, Exelixis, ImClone Systems, LEO Pharma, Millennium, Janssen, Clinica Atlantis, INC Research, Halozyme, Covance, Celgene, inVentiv Health, Merck KGaA, Shanghai Henlius Biotech, Polyphor, PharmaMarTravel, Accommodations, Expenses: Roche/Genentech, Novartis, Pfizer, BMS Brazil, AstraZeneca, MSD Oncology, Lilly Fernando MalufHonoraria: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Sanofi/Aventis, Merck Serono, AstraZenecaConsulting or Advisory Role: Janssen Oncology, Astellas Pharma, Bayer Schering Pharma, Merck Sharp & Dohme, Roche/Genentech, BMS Brazil, Ipsen, Merck Serono, AstraZenecaResearch Funding: Janssen-Cilag, Merck Sharp & DohmeTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bayer Schering Pharma Rachel RiechelmannHonoraria: Novartis, Amgen, MSD Oncology, Servier, Roche/GenentechConsulting or Advisory Role: Bayer, Roche/Genentech, Ipsen, Astellas PharmaResearch Funding: Bayer, Roche/Foundation Medicine, Amgen Henry GomesConsulting or Advisory Role: AstraZenecaSpeakers' Bureau: Roche, Novartis, AstraZeneca, Bristol Myers Squibb, LillyResearch Funding: MSD Oncology William N. WilliamHonoraria: Roche/Genentech, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Merck, Lilly, PfizerConsulting or Advisory Role: AstraZeneca, Merck, Pfizer, Bristol Myers Squibb, Bayer, RocheSpeakers' Bureau: Boehringer IngelheimResearch Funding: OSI Pharmaceuticals, Boehringer Ingelheim, Merck, Lilly, Bristol Myers SquibbTravel, Accommodations, Expenses: AstraZeneca, Merck, Bristol Myers Squibb, Roche/Genentech Camilla A. F. YamadaSpeakers' Bureau: Janssen OncologyTravel, Accommodations, Expenses: Bayer, Janssen Gilberto de Castro JuniorHonoraria: AstraZeneca, Pfizer, Merck Sharp & Dohme, Bristol Myers Squibb, Novartis, RocheConsulting or Advisory Role: Boehringer Ingelheim, Pfizer, Bayer, Roche, Merck Sharp & Dohme, Bristol Myers Squibb, AstraZeneca, Yuhan, Merck SeronoSpeakers' Bureau: AstraZeneca, Bayer, Novartis, Roche, Merck Serono, Bristol Myers Squibb, Merck Sharp & Dohme, Boehringer Ingelheim, PfizerTravel, Accommodations, Expenses: Merck Sharp & Dohme, Novartis, Pfizer, Roche, AstraZeneca, Boehringer Ingelheim, Bayer, Bristol Myers Squibb Daniela D. RosaConsulting or Advisory Role: Roche, Novartis, AstraZeneca, Lilly, GlaxoSmithKline, Sanofi, Libbs, Pfizer, Amgen, Zodiac PharmaSpeakers' Bureau: Novartis, Lilly, PfizerTravel, Accommodations, Expenses: Roche Andreia C. de MeloHonoraria: MSD Oncology, Novartis, BMS BrazilSpeakers' Bureau: BMS Brazil, MSD OncologyResearch Funding: Roche, MSD Oncology, BMS Brazil, Novartis, Clovis Oncology, AstraZenecaTravel, Accommodations, Expenses: MSD Oncology Denisse BretelConsulting or Advisory Role: Merck Oscar ArrietaHonoraria: AstraZeneca, Merck Sharp & Dohme, RocheConsulting or Advisory Role: Boehringer Ingelheim, Bristol Myers Squibb, Lilly, PfizerResearch Funding: AstraZeneca, Roche, Merck Sharp & Dohme Andrés F. CardonaHonoraria: Bristol Myers Squibb, Roche, Boehringer Ingelheim, AbbVie, Merck Sharp & Dohme, CelldexConsulting or Advisory Role: Roche, Merck Sharp & Dohme, Novartis, AstraZeneca, Bristol Myers Squibb, Foundation Medicine, Boehringer Ingelheim, Foundation for Clinical and Applied Cancer Research (FICMAC)Speakers' Bureau: Merck Sharp & Dohme, Roche, Bristol Myers Squibb, Novartis, Foundation for Clinical and Applied Cancer Research (FICMAC), Foundation MedicineTravel, Accommodations, Expenses: Merck Sharp & Dohme, Bristol Myers Squibb, Roche, Boehringer Ingelheim, Foundation Medicine Diogo A. BastosHonoraria: MSD, Roche, Bristol Myers Squibb, Janssen-Cilag, Astellas Pharma, AstraZeneca, BayerConsulting or Advisory Role: Roche, Bayer, Janssen-Cilag, MSD OncologyResearch Funding: Janssen-Cilag, Pfizer, Astellas PharmaTravel, Accommodations, Expenses: Janssen-Cilag, BayerNo other potential conflicts of interest were reported.