ABSTRACT
[Formula presented] Introduction. The recent spread of the COVID-19 infection has represented an important challenge in the management of acute lymphoblastic leukemia (ALL) patients. Aims and methods. To investigate the incidence, features, source of contagion and outcome of patients with ALL who developed a COVID-19 infection, a survey was conducted among 34 hematology centers throughout Italy within the Campus ALL network. The period covered by the survey spanned from February 2020 to April 2021 and included 756 adult ALL patients actively followed during this time period. Results. Sixty-three of the 756 ALL patients (8.3%) developed a COVID-19 infection, with an equal distribution among the various regions. The majority of cases (90.5%) was recorded during the second wave of the pandemic, between September 2020 and April 2021. The source of the infection was nosocomial in 26 cases (41.3%), familial in 23 (36.5%), unknown in 13 (20.6%) and work-related in 1 (1.6%). The infected patients were prevalently male (n=43, 68.2%) with a similar distribution among age groups: 21 patients aged 18-35 years, 17 35-50, 15 50-65 and 10 older than 65. Seventeen patients (27%) had a diagnosis of T-ALL, 28 (44.4%) of Ph- B-ALL and 18 (28.6%) of Ph+ ALL. Thirty-six (57.1%) of the infected patients had no concomitant comorbidities, whereas 27 (42.9%) had one or more comorbidities. The infection was documented at the onset of the disease in 4 patients (6.3%), during induction in 10 (15.9%), consolidation in 13 (20.6%), chemotherapy maintenance in 11 (17.5%), after allogenic transplant in 15 (23.8%), during maintenance with tyrosine kinase inhibitors (TKI) treatment or off-treatment in 8 (12.7%) and at relapse in 2 (3.2%). Of the infected patients, 9 were asymptomatic, 10 had only isolated fever, 36 had respiratory symptoms and 8 presented other symptoms, including - but not limited to - ageusia and anosmia. As a consequence, management of the infection was variable: 29 (46%) patients did not require hospitalization, 28 (44.4%) were hospitalized in a COVID ward and 13 of them required respiratory assistance;finally, 6 (9.5%) patients were transferred to an ICU. Importantly, in 54 patients (85.7%) there were no sequelae, in 1 patient a pulmonary fibrosis was documented and in 1 patient the delay in treatment led to a relapse of the disease, while 7 (11.1%) succumbed to the infection. Finally, in 6 cases (9.5%) the infection was still ongoing at the time of the survey, and at the last update (July 2021) it had resolved in all. Since a key aspect in the management of ALL is the adherence to the timing of treatment, we also investigated if COVID-19+ patients stopped treatment during the infection. Out of the 42 evaluable patients (patients who had undergone an allogeneic transplant or were off-treatment were excluded from this analysis), ALL treatment was suspended in 28 (66.6%). Importantly, while in Ph+ ALL only very few patients stopped treatment (3/12), in Ph- B-ALL the majority did interrupt it (18/22, p<0.001);likewise, also in T-ALL most patients suspended treatment (7/8). Conclusions. The incidence of SARS-CoV-2 infection in adult ALL patients in Italy over a 15 month period has been similar to that observed in the general population and has been recorded mostly during the second wave of the pandemic. The contagion was mainly nosocomial, suggesting that outward care should be pursued as much as possible in ALL. The infection was manageable, with 46% of patients not requiring any medical intervention and an overall death rate of 11%. Strikingly, in line with previous reports 1, it appears that Ph+ ALL patients were more manageable, with less treatment interruptions. These findings underline the advantage of the TKI-based induction/consolidation strategy without systemic chemotherapy in Ph+ ALL used in the GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) protocols and further point to a possible protective role of TKIs in COVID-19-infected patients. 1. Foà R et al, Br J Haematol. 2020;190(1):e3-e5 Disclosures: Chiarett : Incyte: Consultancy;novartis: Consultancy;pfizer: Consultancy;amgen: Consultancy. Bonifacio: Bristol Myers Squibb: Honoraria;Pfizer: Honoraria;Novartis: Honoraria;Amgen: Honoraria. Marco: Jazz: Consultancy;Insight,: Consultancy;Janssen: Consultancy. Curti: Novartis: Membership on an entity's Board of Directors or advisory committees;Abbvie: Membership on an entity's Board of Directors or advisory committees;Pfizer: Membership on an entity's Board of Directors or advisory committees;Jazz Pharma: Membership on an entity's Board of Directors or advisory committees. Delia: Gilead: Consultancy;Amgen: Consultancy;abbvie: Consultancy;Jazz pharmaceuticals: Consultancy. Forghieri: Jannsen: Membership on an entity's Board of Directors or advisory committees;Novartis: Speakers Bureau;Jazz: Honoraria. Lussana: Amgen: Honoraria;Astellas Pharma: Honoraria;Pfizer: Honoraria;Incyte: Honoraria.
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.
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.
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.
ABSTRACT
Background: Venetoclax (VEN) and Hypomethylating agents (HMA) have demonstrated remarkable activity in elderly front-line and R/R AML patients. NPM1-mutated (NPM1+) AML seems to benefit most from such therapy. In this patient subset exploring new applications of VEN-HMAs could be an interesting and promising strategy. Methods: We report 3 patients with NPM+ AML treated with VENHMAs in early molecular relapse (EMR) after first line chemotherapy. EMR was evaluated as 1 log increase of NPM1 qRT-PCR transcript, minimal residual disease (MRD) negativity was defined as ratio NPM1+/ABL × 100 transcript < 0.01. Results: From December 2019 to April 2020 we treated three fit AML NPM1+ patients in EMR with Azacitidine (AZA) 75 mg/m2 from days 1-5 in association with VEN at standard dosage of 400 mg. Patientâs characteristics and previous therapy lines are summarized in Table 1. All patients had received an intensive induction chemotherapy-program and, considering the favorable disease risk, had not received a front-line allogeneic stem cell transplant (ASCT). Patient 1 experienced EMR after 1 year from the end of chemotherapy program. Patient 2 and patient 3 developed a log increase of NPM1 transcript during consolidation chemotherapy. In all cases an ASCT could not be performed quickly as first choice due to logistic and concomitant SARS-CoV-2 management complications. In patient 2 and 3 a further chemotherapy approach was contraindicated for recent severe infections occurred during the previous hospitalization. All patients were treated in out-patient setting and VEN full 400 mg dose was reached after a quick 6-days ramp-up. Blood count and chemistry were performed weekly during 1st cycle. Patient 1 received 3 cycles of VEN-AZA and achieved CR MRD- A fter the 1st cycle, confirmed after 3rd cycle. No AEs were reported and patient 1 is now proceeding to ASCT in optimal disease conditions. Patient 2 received 2 cycles of VEN-AZA, 1 cycle of AZA single-agent and achieved CR MRD- A fter 3rd. Patient 2 suspended VEN after 2nd cycle for G3 neutropenia and G2 thrombocytopenia;WBC recovered after 2 weeks of suspension. Patient 2 is now proceeding to consolidation with natural killer (NK) adoptive immunotherapy. Patient 3 received 3 cycles of VEN-AZA and achieved CR MRD- A t 3rd cycle evaluation. AEs reported for patient 3 were G4 neutropenia during cycle 2 for which VEN was suspended from C2 day 21 to day 28. Patient 3 is also now proceeding to ASCT in optimal disease conditions. Conclusions: VEN-HMAs represent a promising approach for the treatment of the unexplored EMR setting in NPM1+ AML patients as bridge to intensified consolidation strategies. This approach allowed to avoid disease expansion, recover from infective complications and even more to achieve MRD-.