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Background: Nivolumab (NIVO), a programmed death-1 immune checkpoint inhibitor, has demonstrated clinical efficacy across patients with different tumor types, including clear cell renal cell carcinoma (ccRCC), when administered via IV infusion. As an alternative to IV infusion, subcutaneous (SC) administration alleviates the need for IV ports, thereby lowering the risk of associated complications such as infections and phlebitis. SC formulation also reduces the time for dose preparation and administration, which may decrease overall treatment burden and reduce patient time in the clinic, benefiting patients and healthcare providers and improving overall healthcare resource utilization. SC-administered NIVO consists of NIVO co-formulated with the recombinant human hyaluronidase PH20 enzyme (NIVO + rHuPH20), which aims to increase the dispersion and absorption of NIVO within the SC space. SC NIVO + rHuPH20 was shown to be safe and well tolerated in a phase 1/2 study, warranting further investigation (Lonardi S et al. J Clin Oncol 2021;39(suppl 15):2575). Methods: CheckMate 67T is a multicenter, randomized, open-label, phase 3 study that will evaluate the noninferiority of SC NIVO + rHuPH20 versus IV NIVO in patients with advanced or metastatic ccRCC who have progressed after receiving ≤ 2 prior systemic treatment regimens. Key inclusion criteria are age ≥ 18 years, histologically confirmed advanced or metastatic ccRCC, measurable disease by RECIST v1.1 within 28 days prior to randomization, and a Karnofsky performance status ≥ 70. Key exclusion criteria are untreated symptomatic metastases to the central nervous system, other malignancy, autoimmune diseases, HIV-positive status with AIDS-defining infection within past year or current CD4 count < 350 cells/μL, other serious or uncontrolled disorders including severe, acute SARS-CoV-2 infection, and prior treatment with immune checkpoint inhibitors, other T-cell-targeting antibody drugs, or live attenuated vaccines within 30 days of first study treatment. At least 454 eligible patients will be randomized to receive SC NIVO + rHuPH20 or IV NIVO. The primary objectives are to demonstrate pharmacokinetic (PK) noninferiority of SC NIVO versus IV NIVO, as measured by time-averaged serum concentration over the first 28 days (Cavgd28) and trough serum concentration at steady state (Cminss) (co-primary endpoints). Secondary endpoints include objective response rate by blinded independent central review, additional PK parameters, safety, efficacy, and immunogenicity of SC NIVO and IV NIVO. This study is currently enrolling patients globally.
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Background: COVID-19 has been a challenge for health systems worldwide. Many hospitals were converted intoCOVID-19 centers, including our center. Diagnostic studies, ambulatory procedures, and elective surgeries werecanceled, and emergency care and inpatient services were closed for patients without COVID-19. Lack of access tohospital services represents a problem in the care of cancer, especially in low- and middle-income countries(LMICs). Our aim was to analyze the impact of hospital conversion to a COVID-19 center on the follow-up andmanagement of patients in our urologic oncology clinic. Methods: We analyzed data of all patients in our urologic oncology clinic with appointments scheduled from March16th to May 31st. A fellow reviewed all cases to evaluate if appointments were eligible for regular visit, telemedicine, or postponement and patients were contacted. Demographic, disease, and treatment characteristics were obtained.Population was analyzed according to type of visit (standard of care vs. clinical trial). We examined univariateassociations between groups. A p-value ≤0.05 indicated statistical significance. Results: A total of 336 patients were included;the median age was 65 (18-94) years, and 306 (91.1%) were men.The main neoplasms were prostate (49.4%), kidney (20.2%), germ cell tumors (21.4%), urothelial (8.6%), and penile(0.3%) cancer. 46.7% of patients were in active treatment, and 11.9% were enrolled in a clinical trial. Remotecommunication was established with 184/224 (82.1%) patients. We planned to reschedule the visits of 224/336(66.7%) patients. Medical appointments were rescheduled to a median of 91 days (IQR 65-105 days). All patientsenrolled in clinical trials visited the clinic as scheduled. Among patients eligible for telemedicine, 105 (46.9%) wereon surveillance, 68 (30.4%) on hormone therapy, 45 (20.1%) on no active treatment, and 6 (2.7%) on other therapy.The majority of the 111 patients who had an in-person appointment were receiving chemotherapy (24.3%), followedby immunotherapy (15.3%), targeted therapy (15.3%), and hormone therapy (13.5%). 13.5% had no activetreatment and 9.0% were on surveillance. Comparing non-protocol versus protocol patients, we found a significantdifference in loss of follow-up (12.2% vs 0% p = 0.012). During the study period, two (0.6%) confirmed cases andone (0.3%) death due to COVID-19 were recorded. Conclusions: In our initial experience, rescheduling of visits and remote follow-up was possible in most patientsduring hospital conversion to a COVID-19 center. Despite the constrained resources and communication barriers ofLMICs, the rate of patients lost to follow-up was not increased during the pandemic in our center. Telemedicine waspossible, particularly for those on surveillance and hormone therapy. Comparing standard clinical care versusclinical trial patients, we found a significant difference in terms of loss to follow-up.
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PURPOSE: The state of limited resource settings that Coronavirus (COVID-19) pandemic has created globally should be taken seriously into account especially in healthcare sector. In oncofertility, patients should receive their fertility preservation treatments urgently even in limited resource settings before initiation of anticancer therapy. Therefore, it is very crucial to learn more about oncofertility practice in limited resource settings such as in developing countries that suffer often from shortage of healthcare services provided to young patients with cancer. METHODS: As an extrapolation during the global crisis of COVID-19 pandemic, we surveyed oncofertility centers from 14 developing countries (Egypt, Tunisia, Brazil, Peru, Panama, Mexico, Colombia, Guatemala, Argentina, Chile, Nigeria, South Africa, Saudi Arabia, and India). Survey questionnaire included questions on the availability and degree of utilization of fertility preservation options in case of childhood cancer, breast cancer, and blood cancer. RESULTS: All surveyed centers responded to all questions. Responses and their calculated oncofertility scores showed different domestic standards for oncofertility practice in case of childhood cancer, breast cancer, and blood cancer in the developing countries under limited resource settings. CONCLUSIONS: Medical practice in limited resource settings has become a critical topic especially after the global crisis of COVID-19 pandemic. Understanding the resources necessary to provide oncofertility treatments is important until the current COVID-19 pandemic resolves. Lessons learned will be valuable to future potential worldwide disruptions due to infectious diseases or other global crises.