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Summary Gemcitabine and 5-fluorouracil are the only two compounds with reproducible activity against advanced pancreatic cancer (APC). We have evaluated a novel combination of gemcitabine and 5-fluorouracil on the clinical benefit response (CBR) end point. Eleven consecutive patients with symptomatic APC were entered in a two-stage phase II trial. Gemcitabine was administered by intravenous (i.v.) bolus injection at the dose of 1000 mg m -2 on days 1, 8, 15 and 5-fluorouracil 500 mg m -2 was given by continuous i.v. infusion on days 1-5. Treatment was repeated every 28 days. A CBR was achieved in 7/11 patients. The mean time to loss of CBR was 26.5 weeks (range 14-18, median 22). Toxicity was mild and no APC patient experienced WHO grade 3 toxicity. The gemcitabine/5-fluorouracil combination is well tolerated and produces a symptomatic relief in the majority of APC patients.

Background: To date, the clinical characteristics of coronavirus disease 19 (COVID-19)-infected urologic cancer patients are unknown. Methods: We have analyzed all patients with prostate cancer undergoing hormonal or chemotherapy treatment and receiving telephone and in person pre-triage between March 1 and 27, 2020, at the Tortora Hospital, Pagani, Italy. Results: Among 72 patients, 48 and 24 were hormone-sensitive (HS) and castration-resistant prostate cancer (CRPC), respectively; 0 HS and 2 (8.3%) CRPC (p < 0.05) were positive for COVID-19. Both patients were receiving LHRH agonist therapy, and 1 patient was receiving enzalutamide. Urgent intensive care unit admission was required due to clinical worsening. Blood tests showed severe lym-phopenia, anemia, and an increase in platelets. Retroviral therapy, antibiotics, heparin, and chloroquine were prescribed at the beginning. One patient also received tocilizumab as a salvage treatment. After 3 weeks of hospitalization, the patients were discharged from the hospital. Both patients suffered from an aggressive COVID-19 course due to concomitant comorbidities. Conclusions: Investigating whether hormonal therapy, especially in advanced disease, acts as a protective factor or a risk factor during COVID-19 could be useful.

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Background The COICA study is an ambispective, observational trial that was conceived to assess the clinical course of SARS-CoV-2 infection in cancer patients. A recently published, population-based, case-control study reported a reduced vaccine efficacy at 3-6 months in cancer patients compared to individuals without cancer. Objectives To describe COVID-19 outcomes in cancer patients and analyze differences in SARS-CoV-2 outcomes between vaccinated and unvaccinated patients Methods Descriptive statistics and frequency counts were used to summarize characteristics of the study population. Chi-square test and the log-rank test were used to compare outcomes between vaccinated and unvaccinated patients. Results A total of 141 cancer patients (80 males, 61 females) were recruited at two participating Institutions since March, 2020 until April, 2022 and observed since the time of positive SARS-CoV-2 test to time of negativization or death. Approximately 35% of patients had been vaccinated at the time of infection with 2 (16 patients) or 3 ( 33 patients) vaccine doses. Vaccinated patients consistently and significantly showed improved COVID-19 outcomes compared to unvaccinated patients, with CT diagnosed pneumonia, hospitalization required, O2 required and death in 0% vs. 48.6%, 2.0% vs. 15.2%, 0% vs. 14.1%, 0% vs. 7.6%, respectively, of assessable patients (p<0.05 for all comparisons). Vaccinated vs. unvaccinated patients showed a significantly shorter time to negativization, with a median (95% Confidence Interval) time of 12 (10-14) vs. 20 (17 – 23) days, respectively (p<0.001). Conclusions Vaccination consistently improved all COVID-19 outcomes. No deaths was recorded among vaccinated patients. Additional research is especially warranted to establish optimal timing and patient selection for administration of the fourth vaccination dose.