Background: We describe cancer patients with coronavirus disease-2019 (COVID-19) infection treated at the Piacenza’s general hospital (north Italy). Materials & methods: 25 cancer patients infected by COVID-19 admitted at the Piacenza’s general hospital from 21 February to 18 March 2020. Outcome from the infection were compared with infected noncancer patients. Results: 20 patients (80%) were treated with antiviral therapy and hydroxychloroquine and five (20%) received hydroxychloroquine alone. Nine (36%) patients died, while 16 (64%) overcome the infection. In the control group the mortality was 16.13% and the overcome from infection was 83.87%. Conclusion: Mortality for COVID-19 was greater in cancer patients when compared with noncancer patients, worse prognosis for older age, women and patients treated with hydroxychloroquine alone. However, the comparisons did not reach statistical significance in most cases. This could be due to the small sample size that is the main limitation of the study.

Background Tocilizumab blocks pro-inflammatory activity of interleukin-6 (IL-6), involved in pathogenesis of pneumonia the most frequent cause of death in COVID-19 patients. Methods A multicenter, single-arm, hypothesis-driven trial was planned, according to a phase 2 design, to study the effect of tocilizumab on lethality rates at 14 and 30 days (co-primary endpoints, a priori expected rates being 20 and 35%, respectively). A further prospective cohort of patients, consecutively enrolled after the first cohort was accomplished, was used as a secondary validation dataset. The two cohorts were evaluated jointly in an exploratory multivariable logistic regression model to assess prognostic variables on survival. Results In the primary intention-to-treat (ITT) phase 2 population, 180/301 (59.8%) subjects received tocilizumab, and 67 deaths were observed overall. Lethality rates were equal to 18.4% (97.5% CI: 13.6–24.0, P = 0.52) and 22.4% (97.5% CI: 17.2–28.3, P < 0.001) at 14 and 30 days, respectively. Lethality rates were lower in the validation dataset, that included 920 patients. No signal of specific drug toxicity was reported. In the exploratory multivariable logistic regression analysis, older age and lower PaO2/FiO2 ratio negatively affected survival, while the concurrent use of steroids was associated with greater survival. A statistically significant interaction was found between tocilizumab and respiratory support, suggesting that tocilizumab might be more effective in patients not requiring mechanical respiratory support at baseline. Conclusions Tocilizumab reduced lethality rate at 30 days compared with null hypothesis, without significant toxicity. Possibly, this effect could be limited to patients not requiring mechanical respiratory support at baseline. Registration EudraCT (2020-001110-38); clinicaltrials.gov (NCT04317092).

Introduction Cancer patients are presumed a frail group at high risk of contracting coronavirus disease (COVID-19), and vaccination represents a cornerstone in addressing the COVID-19 pandemic. However, data on COVID-19 vaccination in cancer patients are fragmentary and poor. Methods An observational study was conducted to evaluate the seropositivity rate and safety of a two-dose regimen of the BNT162b2 or mRNA-1273 vaccine in adult patients with solid cancer undergoing active anticancer treatment or whose treatment had been terminated within 6 months of the start of study. The control group was composed of healthy volunteers. Serum samples were evaluated for SARS-COV-2 antibodies prior vaccinations and 2-6 weeks after the administration of the second vaccine dose. Primary endpoint: seropositivity rate. Secondary endpoints: safety, factors influencing seroconversion, IgG titers of patients versus healthy volunteers, COVID-19 infection. Results Between 20 March 2021 and 12 June 2021, 293 consecutive cancer patients with solid tumors underwent a program of COVID-19 vaccinations: of these, 2 patients refused vaccination, 13 did not receive the second dose of the vaccine due to cancer progression and 21 had COVID-19 antibodies at baseline and were excluded. The 257 evaluable patients had a median age of 65 years (range 28-86), 66.15% with metastatic disease. Primary endpoint: seropositivity rate in patients was 75.88%, versus 100% in the control group. Secondary endpoints: no grade 3-4 side effects, no COVID-19 infections were reported. Patients median IgG titer was significantly lower than in the control group, male sex and active anticancer therapy influenced negatively seroconversion. BNT162b2 or mRNA-1273 vaccines were immunogenic in cancer patients, showing good safety profile.

Patients with cancer are among the most vulnerable groups of the COVID-19 pandemic, whereas vaccinations can represent a cornerstone in overcoming the pandemic itself. However, cancer patients were excluded from clinical trials for COVID-19 vaccinations, and thus the data on the immunogenicity and safety of COVID-19 vaccines in cancer patients are limited. In this systematic review, we assessed the seroconversion rate and the safety of COVID-19 vaccinations in cancer patients. We searched a bibliographic database up until 31 July 2021. Utilizing inclusion criteria, six studies were selected and analyzed for this meta-analysis. This included 621 cancer patients and 256 controls. Results show that patients with solid tumors show adequate antibody responses (>90%), though the antibody titers were significantly lower than those of healthy controls. Similarly, a significantly lower rate of seroconversion was registered in patients with hematologic malignances. The vaccines showed a good safety profile; no grade 3–4 adverse events were registered. This review demonstrates generally high immunogenicity from COVID-19 vaccines in patients with cancer, with better results for solid tumors than hematological malignances, and with a good safety profile.

Non-Small Cell Lung Cancer (NSCLC) patients with Epidermal Growth Factor Receptor (EGFR) mutation benefit from a first line of treatment with tyrosine kinase inhibitors (TKIs). After progression, the choice of treatment is between chemotherapy and immune checkpoint inhibitors, but the role of EGFR mutation in the response to immunotherapy is still unclear. A network meta-analysis was performed and 4 randomized trials comparing immune checkpoint inhibitors versus chemotherapy were identified. A Bayesian network meta-analysis was carried out to compare three checkpoint inhibitors (nivolumab, pembrolizumab and atezolizumab) versus chemotherapy (docetaxel), evaluating their Hazard Ratio (HR) and 95% Confidence Interval (CI) for Overall Survival (OS). Results suggest that patients with NSCLC and EGFR mutation, previously treated with TKIs, show better OS when treated with docetaxel in comparison to checkpoint inhibitors treatment.

Background: Cancer patients are considered a highly fragile group in the current coronavirus disease 2019 (COVID-19) pandemic. Material & methods: In this study, patients with COVID-19 and cancer, hospitalized in Piacenza, Italy, from 4 April to 4 May 2020 were included. Risk factors for death were analyzed. Results: Fifty-one COVID-19 cancer patients were included, of which the median age was 71.02 years (range: 51–86) and 70.59% were male. Cancer types included gastrointestinal (25.49%), genitourinary (25.49%) and lung (23.53%). Forty-five (88.24%) patients received hydroxychloroquine-based therapy. In addition, 25 of 51 patients died (49%): 12 of 51 (23.53%) owing to cancer and 13 of 51 (25.49%) owing to COVID-19. Conclusion: The risks for death were related to later onset of treatment for COVID-19, severe/critical COVID-19, age, elevated basal CRP and elevated lactate dehydrogenase.

Background Cancer patients are presumed a frail group at high risk to contract coronavirus disease (COVID-19). The aim of this study was to investigate the prevalence of SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection in asymptomatic cancer patients attending the outpatient clinic of a general hospital in a region with a high prevalence of SARS-CoV-2 infection (North Italy, first wave). Methods We retrospectively analyzed data of consecutive cancer patients attending the outpatient clinic of the oncology unit, General Hospital of Piacenza. All the patients having underlying cancer, without clinical suspicion of COVID-19, attending the outpatient clinic underwent nasopharyngeal swabs, from April 3, 2020 to June 3, 2020 and were included in this study. Results In a two-month period, 260 consecutive, asymptomatic (for COVID-19) cancer patients were tested for COVID-19. There were 160 women and 100 men; 218 patients were under active anticancer treatment, 32 in the diagnostic/staging phase waiting for treatment, and 10 treated with supportive care only. Ten of the 260 patients (3.85%) showed COVID-19 positivity. All but one (treated with hormone therapy) of the COVID-19 positive patients delayed anticancer treatment. The mean delay of anticancer treatment was 45.86±27.66 days (range 21-87 days), and the mean time for viral clearance was 25.7±22.68 days (range 7-79 days). All the 10 patients with COVID-19 and cancer overcame the infection, and treated patients could restart anticancer treatment. Conclusion Our data indicate a high prevalence of COVID-19 in cancer patients in an area with a high prevalence of SARS-CoV-2 infection. Routine COVID-19 testing of cancer patients when asymptomatic allowed an early detection, isolation, and treatment, avoiding viral spread among other frail patients and among medical/nurse staff.

Purpose: Metastatic pancreatic adenocarcinoma has a very poor prognosis. Although irinotecan, oxaliplatin and leucovorin-modulated fluorouracil (FOLFIRINOX) significantly increases survival in advanced pancreatic cancer, compared to employing only gemcitabine (GEM), toxicities have tempered enthusiasm for its use. Methods: This study retrospectively analyses the real-world clinical practice with full and attenuated doses of FOLFIRINOX in unselected patients with locally advanced unresectable or metastatic pancreatic cancer, treated at an Italian general hospital. Efficacy, tolerability, and toxicity were evaluated, and overall survival (OS) and progression-free survival (PFS) were estimated by Kaplan–Meier method. Results: Fifty consecutive patients with advanced (13) or metastatic (37) pancreatic adenocarcinomas were treated with FOLFIRINOX at the Medical Oncology Unit, Piacenza General Hospital, North Italy. The first enrolled consecutive 18 patients (36%) of this series started the treatment with a full dose of the regimen, while the subsequent 32 (64%) consecutive patients received dose attenuation (−20% bolus fluorouracil and −25% irinotecan). In the entire group, the response rate, median OS, and median PFS were 30%, 10.1 months, and 5.6 months, respectively, with no differences in objective response in the 32 patients that received an attenuated dose compared with the 18 patients receiving a full dose of chemotherapy. However, neutropenia, anemia, fatigue, and vomiting were statistically increased in the 18 patients receiving a full dose compared with the 32 patients receiving an attenuated dose of FOLFIRINOX ( p <0.05). Conclusion: This study demonstrates the efficacy and tolerability of modified FOLFIRINOX in advanced and metastatic pancreatic cancer.