FOLFIRINOX or Gemcitabine Plus Nab-paclitaxel as First Line Treatment in Pancreatic Cancer: A Real-World Comparison.

Background/Aim: Advanced pancreatic cancer has a poor prognosis and a 5-year survival rate <5%; thus, treatment of patients with advanced unresectable or metastatic disease is challenging. Current guidelines recommend either gemcitabine plus nab-paclitaxel (GnP) or FOLFIRINOX (FOL) as first-line treatment. Data on both efficacy and toxicity of FOL versus GnP in metastatic cancer are limited. This study aimed to compare the two chemotherapy regimens in terms of efficacy and toxicity in a real-world setting. Patients and Methods: This retrospective propensity score matching study reviewed the medical records of 123 consecutive patients with advanced or metastatic pancreatic cancer who received either GnP or FOL between March 2013 and January 2019 in Guglielmo da Saliceto Hospital, Piacenza. Results: Fifty patients (40.65%) received FOL, administered in an attenuated dose, and seventy-three patients (59.35%) received GnP. After a propensity matching score, 100 patients were retrospectively evaluated. In the final matched cohort, there was no difference in neoadjuvant therapy, radiotherapy, and surgery performed before the first-line therapy between the two groups. Progression-free survival and overall survival were comparable between the two groups and no difference was found in the percentage of toxicity. Conclusion: There was no difference in outcomes between patients who received FOL and those who received GnP. Unexpectedly, no greater FOL-related toxicity was found, probably due to the dose reduction.

Humoral Response and Safety after a Fourth Dose of the SARS-CoV-2 BNT162b2 Vaccine in Cancer Patients Undergoing Active Treatment-Results of a Prospective Observational Study.

Only a few studies have been carried out on the efficacy and safety of a fourth dose of the COVID-19 vaccine in patients with cancer. In this prospective observational study, we aimed to assess the serological response and safety of the fourth booster shot of the BNT162b2 vaccine in 79 cancer patients, vaccinated between 1 March and 25 August 2022, under systemic anticancer therapy. The primary endpoint was to assess the increase in the anti-SARS-CoV-2 antibodies; secondary endpoints were the vaccine safety and side effects. Consequently, 40 patients (50.63%) revealed the maximum detection values in their IgG titers before the fourth dose of the vaccine, while 39 patients (49.37%) did not. Primary endpoint: Of 39 patients, 36 (92.31%) showed a significant increase in the anti-SARS-CoV-2 IgG titers, and 32 of them (82.05%) reached the maximum titration values. Secondary endpoints: The most common adverse events were mild in severity and included injection site pain, erythema and tiredness. The majority of the adverse reactions reported were grade 1 and no grade 3 and 4 reactions were detected. Our data provide evidence that a fourth dose of the BNT162b2 anti-SARS-CoV-2 vaccine is effective and safe in patients with solid tumors in active anticancer treatment.

Cancer Treatment Closer to the Patient Reduces Travel Burden, Time Toxicity, and Improves Patient Satisfaction, Results of 546 Consecutive Patients in a Northern Italian District.

Background and Objectives: The distance to cancer facilities may cause disparities by creating barriers to oncologic diagnosis and treatment, and travel burden may cause time and financial toxicity. Materials and Methods: To relieve travel burden, a program to deliver oncologic treatment closer to the patient was initiated in the district of Piacenza (Northern Italy) several years ago. The oncologic activities are performed by oncologists and by nurses who travel from the oncologic ward of the city hospital to territorial centres to provide cancer patient management. This model is called Territorial Oncology Care (TOC): patients are managed near their home, in three territorial hospitals and in a health centre, named "Casa della Salute" (CDS). A retrospective study was performed and the records of patients with cancer managed in the TOC program were analysed. The primary endpoints were the km and time saved, the secondary endpoints: reduction of caregiver need for transport and patient satisfaction. Results: 546 cancer patients managed in the TOC program from 2 January 2021 to 30 June 2022 were included in this study. Primary endpoints: median km to reach the city hospital: 26 (range 11-79 km) median time: 44 min (range 32-116); median km to reach the territorial clinicians in the TOC program: 7 (range 1-35 km), median time: 16 minutes (range 6-54), p < 0.001. Secondary endpoints: 64.8% of patients who needed a caregiver for the city hospital could travel alone in the TOC program and 99.63% of patients were satisfied. Conclusions: The results of this retrospective study highlight the possibility of treating cancer patients near their residence, reducing travel burden and saving time.

Targeting FGFR Pathways in Gastrointestinal Cancers: New Frontiers of Treatment.

In carcinogenesis of the gastrointestinal (GI) tract, the deregulation of fibroblast growth factor receptor (FGFR) signaling plays a critical role. The aberrant activity of this pathway is described in approximately 10% of gastric cancers and its frequency increases in intrahepatic cholangiocarcinomas (iCCAs), with an estimated frequency of 10-16%. Several selective FGFR inhibitors have been developed in the last few years with promising results. For example, targeting the FGFR pathway is now a fundamental part of clinical practice when treating iCCA and many clinical trials are ongoing to test the safety and efficacy of anti-FGFR agents in gastric, colon and pancreatic cancer, with variable results. However, the response rates of anti-FGFR drugs are modest and resistances emerge rapidly, limiting their efficacy and causing disease progression. In this review, we aim to explore the landscape of anti-FGFR inhibitors in relation to GI cancer, with particular focus on selective FGFR inhibitors and drug combinations that may lead to overcoming resistance mechanisms and drug-induced toxicities.

The Impact of NUTRItional Status at First Medical Oncology Visit on Clinical Outcomes: The NUTRIONCO Study.

Malnutrition affects up to 75% of cancer patients and results from a combination of anorexia and metabolic dysregulation. Metabolic and nutritional abnormalities in cancer patients can lead to cachexia, a multifactorial syndrome characterized by involuntary loss of skeletal muscle mass, systemic inflammation and increased protein catabolism. Cancer cachexia negatively affects patients' outcomes, response to anticancer treatments, quality of life, and survival. However, risk of malnutrition, and cachexia are still under-recognized in cancer patients. The Prevalence of Malnutrition in Oncology (PreMiO) study revealed that 51% of patients already had nutritional deficiencies at their first medical oncology visit. Here, we report the results of the subsequent retrospective, observational NUTRItional status at first medical oncology visit ON Clinical Outcomes (NUTRIONCO) study, aimed at assessing the impact of baseline nutritional and non-nutritional variables collected in the PreMiO study on the clinical outcomes of the same patients followed up from August 2019 to October 2021. We have highlighted a statistically significant association between baseline variables and patient death, rehospitalization, treatment toxicity, and disease progression at follow-up. We found a higher overall survival probability in the well-nourished general study population vs. malnourished patients (p < 0.001). Of major interest is the fact that patient stratification revealed that malnutrition decreased survival probability in non-metastatic patients but not in metastatic patients (p < 0.001). Multivariate analysis confirmed that baseline malnutrition (p = 0.004) and VAS score for appetite loss (p = 0.0104), in addition to albumin < 35 g/L (p < 0.0001) and neutrophil/lymphocyte ratio > 3 (p = 0.0007), were independently associated with the death of non-metastatic patients at follow-up. These findings highlight the importance of proactive, early management of malnutrition and cachexia in cancer patients, and in particular, in non-metastatic patients, from the perspective of a substantial improvement of their clinical outcomes.

Prognostic Impact of Ras Mutation on Surgical Strategy in Rectal Cancer Patients Undergoing Neoadjuvant Treatment.

BACKGROUND/AIM: Complete clinical response in rectal cancer after neoadjuvant chemo-radiotherapy is challenging. Indeed, indication to surgery vs. "watch and wait" is a debate due the poor predictive value of restaging exams in order to identify a pathological complete response (pCR). Improving the knowledge on mutational pathways such as MAPK/ERK could be helpful in assessing the real impact of disease on prognosis and in choosing the best therapeutic target. This study aimed to evaluate the significance of biomolecular parameters as prognostic factors in patients undergoing radical surgery after chemo-radiotherapy. PATIENTS AND METHODS: A retrospective analysis was performed including 39 patients who had undergone radical surgery after neoadjuvant chemo-radiotherapy for rectal adenocarcinoma stage II-III through additional evaluation of the following biomolecular markers on surgical specimens: exons 2, 3 and 4 of the KRAS and NRAS genes and exon 15 of BRAF by pyrosequencing. Kaplan-Meier survival curves were plotted to evaluate the association of pathologic response and RAS status with progression-free survival (PFS) and overall survival (OS). The log-rank test was used to assess statistical differences among the survival curves. RESULTS: Data analysis showed RAS mutation in 15 patients (38.46%). pCR was achieved in seven patients (18%), including only two RAS mutation cases. The distribution of evaluated variables was homogeneous in the two groups based on pathological response. The Kaplan-Meier curve showed poor outcomes in OS and PFS in patients with RAS mutation (p=0.0022 and p=0.000392, respectively), but no significant differences based on pathological response for both OS and PFS. CONCLUSION: RAS mutation seems to be related to poor prognosis and increased risk of recurrence in rectal cancer patients undergoing radical surgery after chemo-radiotherapy.

Non-Hodgkin Lymphoma Developed Shortly after mRNA COVID-19 Vaccination: Report of a Case and Review of the Literature.

We report on a 66-year-old man who presented with a right axillary lymphadenopathy approximately 10 days after receiving the third dose of the BNT162b2 vaccine. The lymphadenopathy gradually enlarged, and physical examination and ultrasound (US) revealed one right axillary 6.99 cm and one right supraclavicular 2.36 cm lymphadenopathy. Histologic examination of the right axillary nodule revealed anaplastic large-cell lymphoma that was ALK negative and CD30 positive. A total body computerized tomography (CT) scan, positron emission tomography (PET) and bone-marrow biopsy showed a stage-II non-Hodgkin lymphoma (NHL). The patient was treated with chemotherapy and a scheme of Brentuximab Vedotin, Cyclophosphamide, Doxorubicin and Prednisone (BV-CHP) for six cycles and is now well and in complete remission. The revision of the literature revealed eight additional cases of NHL developed shortly after COVID-vaccination. There were four cases of diffuse large-B-cell lymphoma (DLBCL) (one in a patient who was a heart transplant recipient and developed an Epstein-Bar-virus-positive DLBCL), one case of extranodal NK/T-cell lymphoma, one patient with subcutaneous panniculitis-like T-cell lymphoma, one case of marginal zone B-cell lymphoma and one primary cutaneous anaplastic large-cell lymphoma (PC-ALCL). In five cases, the lymphoma developed after BNT162b2 mRNA vaccination, including one case after ChAdOx1 nCOV-19, one case after the adenovirus type 26 (Ad26) vaccine and one after mRNA-1273/Spikevax (ModernaTX). We are aware that the link between COVID-19 vaccination and lymphoma most likely is a chance phenomenon, and that COVID-19 vaccines represent very efficient products for many people around the world. However, we believe that clinical events, even if only temporally associated with novel treatments or novel vaccines, should be reported for the benefit of the patients and the scientific community.

Role of visceral pleural invasion and tumor sizing at CT of resected NSCLC in clinical-radiological and pathological T agreement.

OBJECTIVE: To describe in non-small cell lung cancer (NSCLC) the impact of visceral pleural invasion (VPI) and of tumor sizing assessed at computed tomography (CT) on the agreement between clinical-radiological and pathological T staging and its prognostic value. METHODS: Patients affected by NSCLC treated by surgery in the period from January 2017 to September 2020 were retrospectively evaluated. Exclusion criteria were: (1) baseline CT not performed in our hospital; (2) failure of software segmentation at CT of the primary lesion. Clinical-radiological T (cT) was assessed at baseline CT, evaluating in particular T size by semi-automatic tool and VPI (cVPI) visually. Pathological T (pT) and VPI (pVPI) were recorded by pathological report and obtained after formalin-fixation and eventual elastic stain on surgical specimen. The agreement between cT and pT was evaluated by calculating the weighted kappa by Cohen (κw); the association between progression free survival (PFS) with both cT and pT was assessed by the Cox regression analysis. RESULTS: The study included 84 NSCLC in 82 patients (median age 71 years, IQR 63-76 years; females 22/82, 27%). The agreement between cT and pT was poor (κw 0.302, 95%CI 0.158-0.447). The main causes of disagreement were CT oversizing (21%) and false positive cVPI (29%). A significant association was found between PFS and pT2-T3 (HR 2.75, 95%CI 1.21-6.25, p=0.015) but not with cT2-T3 (not retained in the model). CONCLUSIONS: False positive cVPI and oversizing at CT are causes of disagreement between cT and pT in around one-third of resected NSCLC. PFS was significantly associated with pT but not with cT.

[Home care: home venous access device insertion during covid-19 pandemic in not autonomous patients. From an emergency activity to a daily work practice.] / Cure a casa: posizionamento di dispositivo venoso a domicilio per pazienti non autonomi durante la pandemia covid-19. Da attività in emergenza a pratica routinaria.

INTRODUCTION: Reliable venous access is essential in providing effective care for many patients. Various vascular access devices (VAD) are available, and are placed by a specialized team using ultrasound guidance in a dedicated room of the hospital; however, during the pandemic covid-19 many not autonomous or bedridden patients were unable to reach the hospital for VAD insertion, because the unavailability of ambulance for the transport. For this reason the specialized team organized a modality for positioning the VAD at bedside at home. METHODS: In 2012 a VAD-team was established by the health authority in the oncology-hematology Department at the hospital of Piacenza. This team was dedicated in positioning ultrasound-guided vascular access. During the covid-19 pandemic the VAD-team modified its organization to reach patients at home to position VAD, initially for oncologic people unable to go to the hospital; this procedure was subsequently extended to other bedridden patients with non-oncologic disease. The positioning of the VAD was performed under ultrasound guidance, according to the same modalities used in hospital. The primary endpoin was the suitability of the VAD to allow the planned treatment. The secondary endpoint was complications of the use of VADs. RESULTS: Between March 2020 to December 2020 and January 2021 to December 2021, VAD were positioned in 118 and 134 patients respectively. The VAD utilized were midlines for each patient. The mean age of the patients was 88 years, the majority were female (>60%). The majority of the patients had neurodegenerative disease (>60%) or advanced cancers (>25%). The VAD allowed the planned treatment in 94% of the patients. The complications were infrequent: VAD dislocation (<1%), thrombosis (<2%). No infection was registered. DISCUSSION AND CONCLUSION: During covid-19 pandemic, the VAD-team demonstrated the feasibility of VADs home positioning, for patients that need to be transported by ambulance to the hospital for a venous catheter insertion. This procedure allows saving of economic and human resources both for patients and caregivers, in addiction can leave the ambulance free for other use. Due to this study, this procedure has become routine practice in our health district for patients bedridden or not autonomous.

Bedside Peripheral Ultrasound-Guided Vascular Access in 253 Patients Hospitalized With COVID-19 Pneumonia: A Retrospective Italian Study.

Background Several studies have recommended the use of vascular access in the treatment of COVID-19 patients. However, little is known about the utility and safety of using a peripheral ultrasound-guided vascular access device (UGVAD) at the bedside of hospitalized COVID-19 patients. To examine this, a retrospective monocenter study was carried out at the oncology-hematology department of Azienda Sanitaria di Piacenza, Italy. Methods We retrospectively analyzed data from three general hospitals in a district in North Italy on the positioning of UGVADs used with hospitalized COVID-19 patients. The positioning of the VAD was performed by a dedicated team using ultrasound guidance. The primary endpoint was the duration of VAD until the patient's recovery or death. The secondary endpoints were complications of the use of VADs, which included vein thrombosis, infections, device malfunction, and viral contamination of the operators. Results Between February 21, 2020, and April 30, 2020, 253 consecutive hospitalized patients with COVID-19 pneumonia underwent UGVAD positioning. A midline was inserted in 88.53% of the patients, while peripheral central venous catheters and femoral central catheters were inserted in 9.88% and 1.59% of the patients, respectively. The mean lifespan of the VADs was 10.36±9.96 days (range: 1-73). Primary endpoint: The use of the VAD allowed the planned treatment in 92.88% of the patients; in the remaining 7.12%, the VAD was repositioned. Secondary endpoints: Complications of VAD were registered in 15.02% of the patients (dislocation, 9.49%; infection, 1.98%; thrombosis, 1.58%; occlusion, 1.19%; and malfunction, 0.79%). No contamination of the operators was registered. Discussion and conclusion With the limitation of being a retrospective study, our report suggests that ultrasound-guided positioning of VAD may allow the safe clinical management (drug infusion, hydration, parenteral nutrition, and phlebotomy) of hospitalized COVID-19 patients. The observance of recommended procedures protected all operators from infection.

COVID-19 Vaccination in Cancer Patients Older Than 70 Years Undergoing Active Treatment. Seroconversion Rate and Safety.

Patients with cancer have a high risk of intubation, intensive care unit admission, or death from the coronavirus disease (COVID-19); age and comorbidities are additional risk factors. Vaccination is effective against COVID-19; however, patients with cancer have been excluded from pivotal clinical trials for COVID-19 vaccines. Data on COVID-19 vaccination in cancer patients who are older are lacking. This observational study was conducted to evaluate the seropositivity rate and safety of a two-dose regimen of the BNT162b2 or mRNA1273 vaccine in older patients (age ≥ 70 years) with solid tumors or with hematological malignances who are undergoing active anticancer treatment or whose treatment has been terminated within 6 months of vaccination. The control group was composed of healthy volunteers that were age-matched with the patient group. The primary endpoint was the seropositivity rate, and the secondary endpoints were safety, the factors influencing seroconversion, the IgG titers of patients versus healthy volunteers, and post-vaccine COVID-19 infection between 20 March 2021 and 14 July 2021. At our Institution (Oncology and Hematology Department, Hospital of Piacenza, North Italy), 443 patients with cancer underwent a program for COVID-19 vaccination; 115 (25.95%) were older than 70 (range 71-86 years) and form the basis of this study. All 115 patients accepted the vaccination. There were 64 female patients (55.65%), 94 patients (81.74%) with solid tumors, and 21 patients (18.26%) with hematological malignances. The primary endpoint of seropositivity was observed in 75 patients (65.22%)-70.21% in patients with solid tumors and 42.86% in patients with hematological malignances-versus in 100% of patients in the control group. Of the secondary endpoints, no grade 3-4 side effects and no COVID-19 infections were reported. The factor influencing seroconversion was the type of cancer. The patients' median IgG titers were significantly lower than in the control groups. The COVID-19 vaccines BNT162b2 and mRNA1273 were effective and safe among older patients with cancer when administered in real-world conditions.

Impact of the COVID-19 pandemic on the oncologic activities (diagnosis, treatment, clinical trials enrollment) of a general hospital in a district with high prevalence of SARS-COV-2 in Italy.

PURPOSE: Little is known about the real impact of the COVID-19 outbreak on the qualitative and quantitative fall-out on the management of cancer patients. Our objective was to provide evidence of the effects of SARS-COV-2 on the management of cancer patients in the real world. METHODS: In a general hospital in a district in Italy with high prevalence of COVID-19 during the first wave, we retrospectively analyzed the data of oncologic activity, namely new cancer diagnosis, types of treatment (intravenous or by mouth), clinical research studies, and drug utilization, and compared the findings with those of 2019, before the pandemic. The data have been summarized in boxplot figures for median and interquartile range. RESULTS: In 2020, a significant reduction in new cancer diagnosis was demonstrated when compared with 2019, with 17.4% fewer cancer diagnoses, 84.5% fewer patients enrolled in clinical trials, a 10.6% reduction in intravenous antitumor treatment, and a 42.7% increase in oral anticancer treatment. CONCLUSION: Our data indicate a significant reduction in cancer diagnosis, antitumor venous treatment, and patients enrolled in clinical research studies in 2020 compared with 2019, although there was a significant increase in oral treatment. These data suggest that the COVID-19 pandemic had a deep impact on the real-world management of cancer patients in a district of Italy with a high prevalence of COVID-19.

[Territorial-based management of patients with cancer on active treatment following the Piacenza (north Italy) Model. Results of 4 consecutive years.] / Le cure oncologiche ed ematologiche sul territorio secondo il modello dell'ASL di Piacenza. Rendiconto di 4 anni consecutivi.

INTRODUCTION: The natural history of cancer has radically changed in the last decade. The burden of travel from patient's residence to health care providers is an important issue that can influence access to diagnosis and treatment of cancer; however this issue is quite neglect by the medical community and by the national health system. In addition, community care in the oncology field is actually debated. METHODS: In the district of Piacenza an innovative model to deliver onco-hematologic treatment near the residence of patients was initiated some years ago. The oncologic and hematologic treatments are delivered by specialized nurses under supervision of medical oncologists or hematologists at the 3 community hospital and at 1 house of health in the district of Piacenza. We conducted a retrospective study involving 1,339 cancer patients (CPs) managed and treated near their residence, CPs were on active medical treatment at the oncology and hematology department Azienda sanitaria (ASL) of Piacenza (North Italy). The electronic data base of the antiblastic drug unit (UFA) of the ASL Piacenza, provided: the number of patients treated each year, number of treatments and the accesses to the territorial medical structure each year. The kms saved to reach the nearest territorial structures instead of the oncologic unit of the city hospital, were registered and recorded. RESULTS: During a 4 years period, from January 2017 to December 2020, 1,339 CPs were treated near their residence, 278 in the year 2017, 347 in 2018, 354 in 2019 and 360 in 2020. The total accesses for treatment in 4 years were 10,003: 2,214 in the year 2017, 2,652 in 2018, 2,524 in 2019 and 2,613 in 2020. The mean distance saved for each patient was 937 kms in the year 2017, 891 in 2018, 879 in 2019, 920 in 2020, totally a mean of 3,627 kms in the 4 years. DISCUSSION AND CONCLUSION: We believe that the results of our retrospective study highlight the possibility of treating cancer patients in territorial structures near their residence, with advantages for patients themselves, their caregivers and for the entire community.

Herpes Zoster Following COVID-19 Vaccination in Long-Term Breast Cancer Survivors.

Mortality from coronavirus disease 2019 (COVID-19) is higher among patients with cancer. Vaccination represents a cornerstone in overcoming the disease, and vaccine safety needs to be closely assessed. This article discusses two cases of herpes zoster (HZ) following the administration of the BNT162b2 mRNA vaccine in patients who are long-term survivors of breast disease. HZ developed 24 days and two days after the second dose of the vaccine in women aged 81 and 61, respectively. These two patients were breast cancer operated respectively nine and 16 years before; interestingly HZ developed in the same site of previous surgical resection. The patients did not show lymphocytopenia or other signs of immunosuppression and were treated with acyclovir, resulting in the complete resolution of HZ. To our knowledge, these two patients are the first described cases of HZ reactivation following COVID-19 vaccination in cancer survivors.

COVID-19 vaccines in adult cancer patients with solid tumours undergoing active treatment: Seropositivity and safety. A prospective observational study in Italy.

INTRODUCTION: Patients with cancer 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 messenger RNA-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 the study. The control group was composed of healthy volunteers. Serum samples were evaluated for SARS-COV-2 antibodies before vaccinations and 2-6 weeks after the administration of the second vaccine dose. Primary end-point: seropositivity rate. Secondary end-points: safety, factors influencing seroconversion, IgG titers of patients versus healthy volunteers, COVID-19 infection. RESULTS: Between 20th March 2021 and 12th June 2021, 293 consecutive patients with cancer-solid tumours underwent a program of COVID-19 vaccinations; of these, 2 patients refused vaccination, 13 patients did not receive the second dose of the vaccine because of cancer progression, and 21 patients 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 end-point: seropositivity rate in patients was 75.88% versus 100% in the control group. Secondary end-points: 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 negative seroconversion. BNT162b2 or messenger RNA-1273 vaccines were immunogenic in cancer patients, showing good safety profile.

COVID-19 Outbreak in Italy: Report on the First 124 Consecutive Patients Treated at Home.

North Italy emerged as an epicenter of COVID-19 in the Western world. The majority of studies of patients with COVID-19 have focused on hospitalized patients, and data on early outpatient treatment are limited. This research retrospectively examines consecutive symptomatic adults who did not present to a hospital but who experience laboratory confirmed (nasopharyngeal swabs) or probable COVID-19 infection. From March 12 to April 12, 2020, 124 consecutive patients with laboratory-confirmed COVID-19 infection (84%) or with epidemiologically linked exposure to a person with confirmed infection (16%) were managed at home. The diagnosis of pneumonia was made with a portable ultrasound. COVID-19 treatment was based on low-dose hydroxychloroquine with or without darunavir/cobicistat or azithromycin and enoxaparine for bedridden patients. The patients were monitored by telemedicine. The primary endpoints were clinical improvement or hospitalization, and the secondary endpoints were mortality at day 30 and at day 60. Forty-seven (37.9%) patients had mild COVID-19 infection, 44 (35.5%) had moderate COVID-19 infection, and 33 (26.6%) had severe COVID-19 infection. Four patients (3.2%) were hospitalized and there were no deaths at day 30 and at day 60. Only mild side effects were reported. Early home treatment of COVID-19 patients resulted in a low hospitalization rate with no deaths, with the limitations of the small sample size and that it was conducted within a single geographic area. We believe that this model may be easily reproduced in both cities and rural areas around the world to treat COVID-19 infection.

COVID-19 Vaccines in Cancer Patients. Seropositivity and Safety. Systematic Review and Meta-Analysis.

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.

Characteristics and outcomes of five patients with COVID-19 and hematological malignancies.

Patients with hematological cancer are at major risk of developing infectious complication. The prevention and treatment of COVID-19 in these patients is challenging. This experience, with the limitation of a small number of patients, highlights that early treatment of COVID-19 can overcome the infection, also in hematological patients.