Summary:An interim report evaluating the feasibility of myeloablative therapy followed by peripheral blood stem cell (PBSC) autotransplant in patients aged Ͼ60 years is presented. In the last 2 years 19 patients Ͼ60 years old with several oncological conditions, mostly hematological, underwent PBSC autotransplant either as salvage therapy following relapse or resistance to conventional treatment, or as consolidating therapy as a part of a well defined protocol. There were 13 males and six females; the mean age was 66.9 years (range 61-76 years); nine patients had resistant or relapsed lymphoma, six myeloma, two acute leukemia, one Waldenstrom's disease and one lung cancer. Myeloablative schemes included BEAM exclusively for lymphomas, busulfan and melphalan (Bu-MPH) mainly for myeloma, busulfan and cyclophosphamide (Bu-CTX) for lymphomas and leukemia and VP-16 and CTX for lung cancer. Mobilization of CD34 ϩ cells was achieved in all patients with the combination of high-dose CTX and G-CSF with collections between 2.83 to 19.04 × 10 6 /kg (mean 7.1). All patients engrafted with a median time for recovery of PMN (Ͼ0.5 × 10 3 / l) of 10 days (range 8-12 days) and for PLT (Ͼ20 × 10 3 / l) of 12 days (range 10-17 days). Major responses were obtained in 15 of 16 patients evaluable for response and eight patients entered CR; overall eight patients are in CR, five are alive with disease, five are dead from disease progression and one is dead because of congestive heart failure 7 months following PBSC autotransplant. No early deaths following the procedure occurred; major side-effects were grade I-II mucositis (58%), fever with documented sepsis (10%), pneumonia (5%), cardiac, renal and liver toxicity (5%). Cardiac function was evaluated before and after myeloablative therapy by VEF in all patients; no significant modifications were necessary. In conclusion, our experience demonstrates that myeloablative therapies in older selected patients can be feasible; the feasibility of introducing PBSC

Background: A novel coronavirus (SARS-CoV-2)-induced pneumonia (COVID-19) emerged in December 2019 in China, spreading worldwide. The aim of the present investigation was to evaluate the immunological response and the clinical subset of peripheral lymphocyte subset alteration in COVID-19 infection. Methods: the study was conducted on four different clinical groups (n = 4; total n = 138). Each individual was assigned to different groups based on specific criteria evaluated at the admission such as fever, dyspnea, arterial blood gas analysis (ABG), oral-nasopharyngeal swab/RT-PCR, and thoracic CT-scan. Treatment was performed only after blood samples were collected from each patient (PP and PP) at day 1. The blood samples were analyzed and tested the same day (CBC and Flowcytometry). The positive–positive group (PP n = 45; F = 18/ M = 27; median age = 62.33), comprised individuals affected by COVID-19 who showed fever, dyspnea (ABG = pO2 < 60), confirmed positive by oral-nasopharyngeal swab/RT-PCR and with CT-scan showing ground-glass opacities. The negative–positive (NP; n = 37; F = 11/M = 26; median age = 75.94) or “COVID-like” group comprised individuals with fever and dyspnea (ABG = pO2 < 60), who tested negative to nasopharyngeal swab/RT-PCR, with CT-scans showing ground-glass opacities in the lungs. The negative–affected group (NA; n = 40; F = 14/M = 26; median age = 58.5) included individuals negative to COVID-19 (RT-PCR) but affected by different chronic respiratory diseases (the CT-scans didn’t show ground-glass opacities). Finally, the negative–negative group (NN; n = 16; F = 14/M = 2) included healthy patients (NN; n = 16; median age = 42.62). Data and findings were collected and compared. Results: Lymphocytes (%) cells showed a decline in COVID-19 patients. The subsets showed a significant association with the inflammatory status in COVID-19, especially with regard to increased neutrophils, T-killer, T-active, T-suppressor, and T-CD8+CD38+ in individuals belong to the either COVID-19 and Covid-like NP group. Conclusions: Peripheral lymphocyte subset alteration was associated with the clinical characteristics and progression of COVID-19. The level of sub-set cells T-lymphocytes (either high or low) and B-lymphocytes could be used as an independent predictor for COVID-19 severity and treatment efficacy.

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Association between fludarabine (Fluda) and cytosine arabinoside (ARA-C) have shown in a variety of single arm studies an effective antileukemic effect with acceptable toxicity in high risk myelodisplasias and acute myeloid leukemias in elderly patients. In order to increase the synergistic effect of fluda and ARA-C further association (i.e. anthracyclines) or different schedules of administration (i.e. continous infusion) have been performed but not compared. In order to asses if there is an advantage of an association or schedule compared to another we retrospectively analyzed results from two different fludarabine-based regimens administered as front-line therapy in patients with acute myeloid leukemias aged up to 60 years. A total of 42 patients were treated with fluda 25 mg/m2, ARA-C 1 gr/m2 and idarubicin 5 mg/m2 as single day administration for three days (FLAI) or fluda 20 mg/m2 and ARA-C 1,4 mg/m2 as continuous infusion for three days fluda and 4 days ARA-C (c.i.FLA). Total dosage of fluda was 75 mg/m2 in FLAI and 70 mg/m2 in c.i.FLA, while ARA-C total dose was 3 gr/m2 in FLAI and 6,15 gr/m2 in c.i.FLA. Dose administered of idarubicin in FLAI was 15 mg/m2. Patients who obtained complete remission (CR) defined as less of 5% of bone marrow blasts received a second course of the same chemotherapy as consolidation, reduced at 3 days in c.i.FLA. 19 patients were treated with FLAI regimen, 9 males and 10 females, mean age 69,3 years (range 61–75) and 23 received c.i.FLA regimen, 12 male and 11 female, mean age 69,4 years (range 61–84). 4 patients in each group showed unfavourable kariotype. Results were as follows: 8/19 (42%) patients obtained CR after induction with FLAI while 11/23 (48%) were in CR after first course c.i.FLA. Difference is not statistically significative. Median disease free survival (DFS) was 9,53 months for FLAI and 7,67 months for c.i.FLA (p=NS) and median overall survival (OS) in the group in CR was 10.8 in the FLAI group and 10 months in c.i.FLA group (p=NS). Induction deads were 1/19 in FLAI group (5%) and 3/23 in c.i.FLA group (13%). The global median OS, including resistant patients was 6,57 months for FLAI and 6 months for c.i.FLA (p=NS). Two patients in each group underwent autologous bone marrow transplantation in complete remission. Results of the comparison of this two different regimens suggest that there is no substantial difference between single daily administration added of idarubicin and continuous infusion of fluda and ARA-C. Both cycles seem to have the same antileukemic activity with overlapping toxicity. Median time to neutrophil recovery (> 1000/mmc) was 16 in c.i.FLA and 14,5 in FLAI while platelets recovery (> 20000/mmc) was 18 in c.i.FLA and 13 in FLAI. Both schedules can be, in our opinion, safely used as front-line therapy in elderly patients affected by acute myeloid leukemias. What is to underline in this setting of patients is the short duration of the CR. Probably some kind of maintenance or association without increasing toxicity is needed, and experience with monoclonal antibodies are an interesting way to follow.