The Effect of Vaccination against COVID-19 in Cancer Patients: Final Results of the COICA Trial.

Background: The COICA study is an ambispective, observational trial that was conceived to assess the clinical course of severe acute respiratory syndrome coronavirus 2 (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: The aim of the study was to describe coronavirus disease 19 (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. χ2 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 from March 2020 until April 2022 and observed from the time of positive SARS-CoV-2 test to the 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, O2 therapy, and death reported in 0% versus 48.6%, 2.0% versus 15.2%, 0% versus 14.1%, and 0% versus 7.6%, respectively, of assessable patients (p < 0.05). Vaccinated versus unvaccinated patients showed a significantly shorter time to negativization, with a median (95% confidence interval) time of 12 (10-14) versus 20 (17-23) days, respectively (p < 0.001). Conclusions: Vaccination consistently improved all COVID-19 outcomes. No death was recorded among vaccinated patients. Additional research is especially warranted to establish optimal timing and patient selection for administration of the fourth vaccination dose.

The Impact of Routine Molecular Screening for SARS-CoV-2 in Patients Receiving Anticancer Therapy: An Interim Analysis of the Observational COICA Study.

Introduction: Cancer aggravates COVID-19 prognosis. Nosocomial transmission of SARS-CoV-2 is particularly frequent in cancer patients, who need to attend hospitals regularly. Since March 2020, all cancer patients having access to the Oncology Unit at the "Andrea Tortora" Hospital (Pagani, Salerno - referred to as "the Hospital") as inpatients or outpatients receiving intravenous therapy have been screened for SARS-CoV-2 using RT-PCR nasal swab. The ongoing COICA (COVID-19 infection in cancer patients) study is an ambispective, multicenter, observational study designed to assess the prognosis of SARS-CoV-2 infection in cancer patients. The aim of the study presented here was to explore potential differences in COVID-19-related outcomes among screening-detected versus nonscreening-detected SARS-CoV-2-infected patients. Methods: The COICA study enrolled cancer patients who had received any anticancer systemic therapy within 3 months since the day they tested positive for SARS-CoV-2 on RT-PCR. The target accrual is 128 patients, and the study was approved by the competent Ethics Committee. Only the subgroup of patients enrolled at the Hospital was considered in this unplanned interim analysis. Logistic regression analysis was used to evaluate the association of screening-based versus nonscreening-based diagnosis. Results: Since March 15, 2020, until August 15, 2021, a total of 931 outpatients and 230 inpatients were repeatedly screened for SARS-CoV-2 using RT-PCR nasal swab at the Hospital. Among these, 71 asymptomatic patients were positive on routine screening and 5 patients were positive for SARS-CoV-2 outside the institutional screening. Seven patients died because of COVID-19. At univariate analysis, nonscreening- versus screening-detected SARS-CoV-2 infection was associated with significantly higher odds of O2 therapy (OR = 16.2; 95% CI = 2.2-117.1; p = 0.006), hospital admission (OR = 31.5; 95% CI = 3.1-317.8; p = 0.003), admission to ICU (OR = 23.0; 95% CI = 2.4-223.8; p = 0.007), and death (OR = 8.8; 95% CI = 1.2-65.5; p = 0.034). Conclusion: Routine screening with RT-PCR may represent a feasible and effective strategy in reducing viral circulation and possibly COVID-19 mortality in patients with active cancer having repeated access to hospital facilities.

COVID 19 therapies and anti-cancer drugs: A systematic review of recent literature.

BACKGROUND: It is reasonable to think that cancer patients undergoing chemotherapy, targeted therapy or immunotherapy could have a more aggressive course if positive for Coronavirus disease CoV-2 (COVID- 19). METHODS: We conducted a literature review on https://www.ncbi.nlm.nih.gov/pubmed/, https://scholar.google.com, www.arxiv.org, www.biorxiv.org, of all articles published using the keywords COVID-19 therapy or treatment and cancer until May 2, 2020. A total of 205 articles were identified and 53 were included in this review. RESULTS: We describe the ongoing COVID-19 therapies that should be known by oncologists and highlight the potential interactions with antineoplastic drugs, commonly used in clinical practice. The main drug interactions were found with tocilizumab, ruxolitinib and colchicine. CONCLUSIONS: The literature provides an inconclusive picture on potential preferred treatments for COVID-19 and their interactions with antineoplastic agents. Future clinical trials are needed to better understand the interactions between different drugs in the context of COVID-19 pandemic.

Irreversible electroporation of locally advanced solid pseudopapillary carcinoma of the pancreas: A case report.

INTRODUCTION: Solid pseudopapillary Carcinoma (SPC) is a rare pancreatic Tumor with variable, usually low, malignancy potential. Howewer, several SPC are associated with aggressive behavior, local vascular infiltration, organ invasion, distant metastasis, and can be unresectable. Irreversible Electroporation (IRE) is an emerging non-thermal ablation technique for the treatment of locally advanced pancreatic carcinoma. We report the results of four year disease-free follow-up in a case of locally advanced unresectable SPC treated with IRE. PRESENTATION OF CASE: A 24-year female patient with SPC of the pancreas underwent IRE during laparotomy under general anesthesia with intubation. Computed Tomography (CT) showed complete tumor thrombosis of splenic vein, encasement of celiac artery and mesenteric vein. Six insertions of 3-4 electrodes per insertion were performed. One month-CT-control showed shrinkage of the tumor. 6 months-post-treatment imaging showed complete regression of the mass, patent Splenic/mesenteric veins, absence of local recurrence or distant metastasis. Post treatment CTs at 12-18-24-30-36-42-48 months follow-up confirmed absence of local or distant recurrence. DISCUSSION: Surgery is the first choice curative treatment of SPC. Howewer aggressive surgery (duodeno-pancreasectomy) in unresectable cases, may have a high risk of recurrences, morbidities and death, and bring concerns about endocrine and exocrine insufficiency in a young patient. In these cases, IRE could be a safe and effective alternative treatment and could realize, in selected cases, the condition for a radical surgery, and a bridge to R-0 resection. CONCLUSIONS: IRE could represent an effective alternative therapy to surgery in local advanced, unresectable SPC.

Electrochemotherapy of cholangiocellular carcinoma at hepatic hilum: A feasibility study.

AIM: We evaluated feasibility, safety and efficacy of Electrochemotherapy (ECT) in a prospective series of patients with unresectable Perihilar-Cholangiocarcinoma (PHCCA). PATIENTS AND METHODS: Five patients with PHCCA underwent ECT. Three patients underwent percutaneous ECT of a single PHCCA nodule. One patient underwent resection of a nodule in the IV segment and intraoperative ECT of a large PHCCA in the VIII segment. Another patient underwent percutaneous ECT of a large PHCCA recurrence after left lobectomy and RF ablation of a synchronous metastasis in the VI segment. ECT was performed under US guidance. Efficacy was evaluated by contrast-enhanced multiple-detector-computed-tomography (MDCT) 4 weeks after treatment. Follow-up entailed MDCT every 6 months thereafter. RESULTS: No major complication occurred. Follow-up ranges from 10 to 30 months. Four weeks post-treatment CT showed complete response in 3 cases. These patients are still alive, and follow-up CT controls demonstrated no local or distant intrahepatic recurrences and no biliary duct dilation in 2 cases and local recurrence at 18 months follow-up control in 1 patient. In the remaining 2 cases, 4-weeks-post-treatment CT showed incomplete response (>90%). In these patients follow-up CT demonstrated local progression of the disease at 6 months. One of them had bilateral external biliary drainages and died because of tumor progression at 16-months-follow-up. The other patient, died at 10 months follow-up for cardiovascular failure not related to the hepatobiliary disease. CONCLUSIONS: ECT is feasible, safe and effective therapy to improve prognosis and quality of life of patients with unresectable PHCCA.

Percutaneous electrochemotherapy in the treatment of portal vein tumor thrombosis at hepatic hilum in patients with hepatocellular carcinoma in cirrhosis: A feasibility study.

AIM: To treated with electrochemotherapy (ECT) a prospective case series of patients with liver cirrhosis and Vp3-Vp4- portal vein tumor thrombus (PVTT) from hepatocellular carcinoma (HCC), in order to evaluate the feasibility, safety and efficacy of this new non thermal ablative technique in those patients. METHODS: Six patients (5 males and 1 female), aged 61-85 years (mean age, 70 years), four in Child-Pugh A and two in Child-Pugh B class, entered our study series. All patients were studied with three-phase computed tomography (CT), contrast enhanced ultrasound (CEUS) and ultrasound-guided percutaneous biopsy of the thrombus before ECT. All patients underwent ECT treatment (Cliniporator Vitae®, IGEA SpA, Carpi, Modena, Italy) of Vp3-Vp4 PVTT in a single session. At the end of the procedure a post-treatment biopsy of the thrombus was performed. Scheduled follow-up in all patients entailed: CEUS within 24 h after treatment; triphasic contrast-enhanced CT and CEUS at 3 mo after treatment and every six months thereafter. RESULTS: Post-treatment CEUS showed complete absence of enhancement of the treated thrombus in all cases. Post-treatment biopsy showed apoptosis and necrosis of tumor cells in all cases. The follow-up ranged from 9 to 20 mo (median, 14 mo). In 2 patients, the follow-up CT and CEUS demonstrated complete patency of the treated portal vein. Other 3 patients showed a persistent avascular non-tumoral shrinked thrombus at CEUS and CT during follow-up. No local recurrence was observed at follow-up CT and CEUS in 5/6 patients. One patient was lost to follow-up because of death from gastrointestinal hemorrage 5 wk after ECT. CONCLUSION: In patients with cirrhosis, ECT seems effective and safe for curative treatment of Vp3-Vp4 PVTT from HCC.

High b-Value Diffusion MRI to Differentiate Recurrent Tumors from Posttreatment Changes in Head and Neck Squamous Cell Carcinoma: A Single Center Prospective Study.

Recently DW-MR Imaging has shown promising results in distinguishing between recurrent tumors and posttreatment changes in Head and Neck Squamous Cell Carcinoma (HNSSC). Aim of this study was to evaluate the diagnostic performances of DWI at high b-value (b = 2000 s/mm(2)) compared to standard b-value (b = 1000 s/mm(2)) and ADCratio values (ADCratio = ADC2000/ADC1000 × 100) to differentiate recurrent tumors from posttreatment changes after treatment of HSNCC. 20 patients (16 M, 4 F) underwent MR Imaging between 2 and 16 months (mean 7) after treatment. Besides morphological sequences, we performed single-shot echo-planar DWI at b = 1000 s/mm(2) and b = 2000 s/mm(2), and corresponding ADC maps were generated (ADC1000 and ADC2000, resp.). By considering contrast-enhanced T1-weighted images as references, ROIs were drawn in order to evaluate mean ADC1000, ADC2000, and ADCratio. The mean ADC1000 and ADC2000 in recurrent tumors were significantly lower than those in posttreatment changes (P = 0.001 and P = 0.016, resp.). Moreover, the mean ADCratio between the two groups showed a statistically significant difference (P = 0.002). Sensitivity, specificity, and accuracy of ADCratio were 82.0%, 100%, and 90%, respectively, by considering an optimal cutoff value of 65.5%. ADCratio is a promising value to differentiate between recurrent tumors and posttreatment changes in HNSCC and may be more useful than ADC1000 and ADC2000.