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1.
HemaSphere ; 6:801-802, 2022.
Article in English | EMBASE | ID: covidwho-2032099

ABSTRACT

Background: The hypomethylating agents (HMAs) are an important therapeutic option for older patients (pts) with AML and have become the backbone for combination regimens (eg, with Venetoclax). However, there are very limited real-life prospective studies regarding clinical outcome of these pts, including infectious complications and infection related mortality (IRM) during treatment. Aims: To investigate the infectious complications and clinical outcome in AML patients treated with HMAs± Venetoclax (V) outside of clinical trials. Methods: The recruitment of this prospective multicentric study (CE-Id-study:2908) has been completed on December 31, 2020. We enrolled 230 AML pts with a median age of 75 years (range 25-94);157 pts (68%) had >2 relevant comorbidities. Of the 230 cases, 132 (57%) received a first-line therapy with a combination of HMAs+V while 98 (43%) were treated with HMAs monotherapy (azacitidine or decitabine). A total of 1550 cycles of HMAs have been administered (680/1550 with HMAs+V). Results: The best response achieved, with HMAs treatment, was: CR in 44% of cases (57,6% with HMAs+V and 25,5% with HMAs alone, P=0,0001), PR in 17% and SD in 14% of cases (ORR 61%;72% in HMAS+V and 46% in HMAs alone, P=0,0007). The microbiological or radiological proven infectious complications (almost one) occurred in 160/230 (70%) of pts, mainly pneumonia (in 42% of pts) and/or bacteremia/sepsis (one or more events in 29% of pts). Febrile neutropenia (one or more episodes) occurred in 38% of pts and 14 cases of Covid-19 (6%) were reported. After a median follow-up of 9 months (1-24) from the start of HMAs therapy, 144 (63%) pts died and 86 (37%) were alive. The 1 yr OS probability was 46% with a median OS of 10,3 months (11 months in HMAs+V and 9 months in HMAs alone;P=ns). The primary causes of death were: progression of AML (42%), Infection (26%-37/144), Infection+AML (24%), other causes (8%). The IRM was 26% and 19/144 (13%) pts died of infectious complication while in CR/PR (16 in HMAs+V group and only 3 in HMAs group;P=0,005). Data on antibiotic prophylaxis, hospitalization, drugdoses modulation, are available and analyzed in this study. Summary/Conclusion: The results of this real-life, multicentric, prospective study, confirm a higher CR rate in pts treated with HMAs+V compared to HMAs alone (P=0,0001). However, we found a high rate of infectious complications and IRM (26%) with a higher infection related deaths in patients in CR/PR who were treated with HMAs+V (P=0,005). Findings from this study highlight the critical relevance of infection prevention in reducing infectious mortality, which adversely impacts the OS of this frail AML population.

2.
Tumori ; 107(2 SUPPL):133, 2021.
Article in English | EMBASE | ID: covidwho-1571640

ABSTRACT

Background: During COVID pandemic, many cancer patients (pts) refused to come to hospital, suspending therapies, with ominous consequences. Based on positive (+) results of DOMONCOVID, our homecare project for COVID+ cancer pts, we created a new model of assistance, ONCOHOME, delivering cancer care at home to immune-compromised pts. We aim to provide data on feasibility, efficacy and costs of this innovative model. Material and Methods: ONCOHOME is a multicenter project involving 3 Cancer Center (CC) of the North of Italy: National Cancer Institute, San Raffaele in Milan and Cremona CC. We created an organizational homecare model based on a medical and nursing team with a car equipped for home visits and a secretariat managing patient calls, with a dedicated phone number. The team administers cancer care at home and provides pts with the same assistance usually delivered in hospital. Patientreported outcome (PRO) assessment is performed. Results: From August 3rd 2020 to May 5th 2021, 79 cancer pts were assisted at home by Cremona team, receiving oral (62 pts), subcutaneous (10pts) or intravenous therapy (7 pts). All types of cancer were included. 77% of pts had a metastatic disease, 88% had a PS ECOG 0-1. Median duration of assistance was 126 days [range 2-270 days]. Most of the pts received oral chemotherapy (41pts). TKIs (25 pts), hormonal therapy (12 pts), supportive care with denosumab and zolendronic acid (5 pts ) and immunotherapy (1 patient, pt) were successfully administered at home, too. 13 pts required hospitalization due to clinical complications. In this group, only 2 pts were admitted to hospital due to severe toxicity;in particular, 1 pt treated with trifluridin/ tipiracil developed febrile neutropenia and 1 pt treated with gefitinib reported Grade 3 diarrhea. Both pts were discharged and continued to be assisted at home. Conclusions: ONCOHOME showed that inpatient or outpatient cancer drug administration could be successfully replaced by home administration, for appropriate therapies and selected pts. This model is feasible at an affordable cost. The project is ongoing, planning to accrue other 100 pts for each center. ONCOHOME will be implemented with electronic devices for PRO evaluation, certified telemedicine service and non-invasive wearable smart tissue monitoring physiological parameters devices.

3.
Tumori ; 107(2 SUPPL):167-168, 2021.
Article in English | EMBASE | ID: covidwho-1571633

ABSTRACT

Background: Cancer patients (pts) have higher risk of serious COVID-19 symptoms, morbidity and mortality than general population. SARS-CoV-2 vaccine trials excluded patients with metastatic cancer or undergoing immunosuppressive therapies;therefore, the effectiveness of vaccines are unknown in this population. Hence, there is an urgent need to understand the correlation between cancer type, its treatment and vaccine efficacy. Material and Methods: This is a prospective study conducted by the Oncology Unit of Cremona Hospital, enrolling pts from Oncology, Hematology, Radiotherapy and Palliative Care divisions. The trial aims to evaluate effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], incidence of symptomatic COVID-19 infection, antibodies (Abs) response in a consecutive population of 300 cancer pts, undergoing antiblastic therapies, starting from March 2021. Primary endpoint: Number of symptomatic pts affected by COVID-19, diagnosed 7-60 days after the 2nddose of vaccines. Secondary endpoints: Abs variation at different timepoints;duration of abs;correlation between effectiveness of vaccines and antiblastic treatments. Statistical Analysis: The primary objective will be tested by non-inferiority one-single proportion test, compared with the value of 95% observed in the vaccine registration trials. The hypothesis of vaccine inferiority in the trial population is rejected if a rate of protection conferred by the vaccine is observed in 89% of the sample size. Results: 356 patients received mRNA anti-COVID-19 vaccines. None of them reported symptomatic COVID-19 infection after vaccination. Whereas almost all patients (95.6%) with solid tumors developed an antibody response, only 77% of patients with hematological malignancy demonstrated anti-COVID-19 antibody production after vaccination. The different antiblastic treatments didn't have a significant impact on the antibody response. In particular, patients treated with immunotherapies and with chemotherapy developed antibodies against COVID-19 in 98% and 92% of cases, respectively. Conclusions: Vaccination against COVID-19 demonstrated to be effective and to prevent symptomatic COVID- 19 infection in patients with solid and hematological tumors during antiblastic treatment. The depth of antibody response resulted different between patients with solid and hematological malignancies. Different antiblastic therapies didn't significantly impact on the development of the antibody response.

4.
Annals of Oncology ; 32:S1161, 2021.
Article in English | EMBASE | ID: covidwho-1432930

ABSTRACT

Background: Cancer patients (pts) have higher risk of serious COVID-19 symptoms, morbidity and mortality than general population. SARS-CoV-2 vaccine trials excluded patients with metastatic cancer or undergoing immunosuppressive therapies;therefore, the effectiveness of vaccines are unknown in this population. Hence, there is an urgent need to understand the correlation between cancer type, its treatment and vaccine efficacy. Trial design: Methods: This is a prospective study conducted by the Oncology Unit of Cremona (Cr) Hospital, enrolling pts from Oncology, Hematology, Radiotherapy (RT) and Palliative Care divisions. The trial aims to evaluate effectiveness of mRNA vaccines [BNT162b2 (Pfizer) and mRNA-1273 (Moderna)], incidence of symptomatic COVID-19 infection, antibodies (Abs) response and onset of adverse events (AEs) in a consecutive population of 300 cancer pts, undergoing antiblastic therapies, starting from March 2021. A vaccination point was set up by Cr Hospital, dedicated to cancer pts treated with chemotherapy (CT), TKIs, RT, hormones. Only pts in follow-up or treated with adjuvant hormone are excluded. CT was suspended at least 5 days before and 3 days after vaccination;targeted therapy, immunotherapy and RT are not interrupted. Primary endpoint: Number of symptomatic pts affected by COVID-19, diagnosed 7-60 days after the 2nddose of vaccines. The infection is defined according to the FDA criteria combined with a positive nasopharyngeal swab. Secondary endpoints: Abs variation at different timepoints compared to baseline;vaccine-related adverse events;duration of abs, up to 12 months after 2nd dose;correlation between effectiveness of vaccines and antiblastic treatments, tumor burden, PS ECOG. Statistical analysis: The primary objective will be tested by non-inferiority one-single proportion test, compared with the value of 95% observed in the vaccine registration trials. The hypothesis of vaccine inferiority in the trial population is rejected if a rate of protection conferred by the vaccine is observed in 89% of the sample size. Results Preliminary results will be available in July 2021. Clinical trial identification: NCT04878796. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

5.
Annals of Oncology ; 32:S1149, 2021.
Article in English | EMBASE | ID: covidwho-1432899

ABSTRACT

Background: During COVID pandemic, many cancer patients (pts) refused to come to hospital, suspending therapies, with ominous consequences. Based on positive (+) results of DOMONCOVID, our homecare project for COVID+ cancer pts, we created a new model of assistance, ONCOHOME, delivering cancer care at home to immune-compromised pts. We aim to provide data on feasibility, efficacy and costs of this innovative model. Methods: ONCOHOME is a multicenter project involving 3 Cancer Center (CC) of the North of Italy: National Cancer Institute, San Raffaele in Milan and Cremona CC. We created an organizational homecare model based on a medical and nursing team with a car equipped for home visits and a secretariat managing patient calls, with a dedicated phone number. The team administers cancer care at home and provides pts with the same assistance usually delivered in hospital. Patient-reported outcome (PRO) assessment is performed. Results: From August 3rd 2020 to May 5th 2021, 79 cancer pts were assisted at home by Cremona team, receiving oral (62 pts), subcutaneous (10pts) or intravenous therapy (7 pts). All types of cancer were included. 77% of pts had a metastatic disease, 88% had a PS ECOG 0-1. Median duration of assistance was 126 days [range 2-270 days]. Most of the pts received oral chemotherapy (41pts). TKIs (25 pts), hormonal therapy (12 pts), supportive care with denosumab and zolendronic acid (5 pts ) and immunotherapy (1 patient, pt) were successfully administered at home, too. 13 pts required hospitalization due to clinical complications. In this group, only 2 pts were admitted to hospital due to severe toxicity;in particular, 1 pt treated with trifluridin/tipiracil developed febrile neutropenia and 1 pt treated with gefitinib reported Grade 3 diarrhea. Both pts were discharged and continued to be assisted at home. Conclusions: ONCOHOME showed that inpatient or outpatient cancer drug administration could be successfully replaced by home administration, for appropriate therapies and selected pts. This model is feasible at an affordable cost. The project is ongoing, planning to accrue other 100 pts for each center. ONCOHOME will be implemented with electronic devices for PRO evaluation, certified telemedicine service and non-invasive wearable smart tissue monitoring physiological parameters devices. Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: All authors have declared no conflicts of interest.

6.
Tumori ; 106(2 SUPPL):69-70, 2020.
Article in English | EMBASE | ID: covidwho-1109856

ABSTRACT

Background: The province of Cremona had one of the highest incidence of COVID-19 (COV-19) infection in Italy. The pandemic determined a significant shrinkage of our healthcare resources with difficulty for many patients (pts) to be assisted in the hospital, especially for the risk of being infected. Therefore, we created a homecare project for cancer pts with the aim of reducing hospitalizations, accesses to the oncology ward and emergency room. Methods: The team was composed by oncologists and nurses from the Oncology Unit of Cremona Community Hospital, supported by a secretary with a dedicated telephone number. The assistance was provided from Monday to Saturday, 9 AM-5 PM. Cancer pts were eligible if presenting confirmed diagnosis or suggestive symptoms for COV-19. A telephonic triage was performed. Cancer pts and their cohabitants were tested with at least 2 nasopharyngeal swabs (NPS). Blood test, medical examinations and vital parameters were performed. We advised screened individuals to follow the quarantine procedures, providing them with an information leaflet. We administered oral/infusional treatments, including antiviral drugs. Results: From March 23rd to April 30th 2020, 71 cancer pts were assisted at home, with a total of 191 visits. Of the 71 pts tested with NPS, 26 resulted COV-19 positive (COV-19+). 19 of COV-19+ pts had mild symptoms;7 pts with stable vital parameters and initial pneumonia were successfully treated at home with hydroxychloroquine, antivirals and NSAIDs. 7 pts with severe symptoms were promptly hospitalized. 4 of them died, 2 due to the infection, 2 to progression disease. 52 cohabitants were screened with NPS, 28 lived with a COV-19+ cancer patient;in this subgroup, 16 resulted COV-19+. 15 of them were completely asymptomatic. Conclusions: This project demonstrated the feasibility of an innovative model based on homecare assistance for COV-19+ cancer pts with mild symptoms. This strategy, limiting the number of hospital accesses for COV-19+ pts, might be useful to contain the spread of the infection. Further studies are needed to test this strategy in COV-19 negative cancer pts. Moreover, our experience indicates a high probability of identifying asymptomatic positive individuals cohabiting with COVID+ pts. NPS screening for asymptomatic subjects is not routinely performed in Italy. There is a urgent need to extend the screening to this population.

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