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1.
J Urol ; : 101097JU0000000000002422, 2022 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-34986007

RESUMO

INTRODUCTION: Radical Cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available RCTs were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-months (mo) outcomes from the first RCT comparing ORC and RARC with totally intracorporeal (i) UD. METHODS: Patients were eligible for randomization if they had a diagnostic TURBt with cT2-4, cN0, cM0, or recurrent high-grade non-muscle invasive bladder cancer and no anesthesiologic contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: BMI, ASA score, baseline haemoglobin, planned UD, neoadjuvant chemotherapy and cT-stage. Primary endpoint was to demonstrate the superiority of RARC with i-UD in terms of a 50% transfusions rate's reduction. RESULTS: Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046). CONCLUSIONS: This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in RARC- and ORC-treated patients, respectively, confirming a significant benefit in favour to RARC with i-UD. However, perioperative complications, hospital stay, and 6-mo HRQoL were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer follow-up to observe potential differences between arms.

2.
Chemotherapy ; 2021 Dec 06.
Artigo em Inglês | MEDLINE | ID: mdl-34872098

RESUMO

BACKGROUND: Antibody response following SARS-CoV2 vaccination is somewhat defective in chronic lymphocytic leukemia (CLL). Moreover, the correlation between serologic response and status of cellular immunity has been poorly studied. OBJECTIVE: This study was undertaken to assess humoral immune and cellular responses to the BNT162b2 messenger RNA (mRNA) COVID-19 vaccination in CLL. METHODS: The presence of the spike antibodies was assessed at a median time of 14 days from the second vaccine dose of SARS-CoV2 in 70 CLL followed-up at a single institution. RESULTS: The antibody response rate (RR) in CLL patients was 58.5%, compared to 100% of 57 healthy controls of the same sex and age (P< 0.0001). Patients treatment-naïve and those in sustained clinical remission after therapy had the highest RR (87.0% and 87.7%, respectively). In contrast, patients on therapy with a pathway inhibitor as monotherapy and those treated with an association of anti-CD20 antibody were unlikely to respond to the SARS-CoV-2 vaccine (52% and 10%, respectively). In multivariate analysis, early Rai stage (OR, 0.19 [0.05-0.79]; P=0.02) and no previous therapy (OR, 0.06[0.02-0.27]; P<0.0001) were found to be independent predictors of vaccination response. An increase in absolute NK cells (i.e., CD16/CD56 positive cells) in patients with a serological response was found following the second dose of vaccine (P=0.02). CONCLUSIONS: These results confirm that serological response to the BNT162b2 vaccine in patients with CLL is impaired. A third boosting vaccine dosage should be considered for these patients.

3.
Oncology ; 2021 Dec 07.
Artigo em Inglês | MEDLINE | ID: mdl-34875670

RESUMO

BACKGROUND: To date, a consensus has not yet been reached about the therapy sequence after disease progression (PD) on CDK4/6 inhibitors in patients with HR+/HER2- metastatic breast cancer (MBC). OBJECTIVES: The present study assesses, in a real-world setting, the activity of different subsequent therapies in patients who experienced a PD on palbociclib (P) + endocrine therapy (ET), to evaluate the best therapy sequence. METHODS: This is a multicenter retrospective observational study. Records of consecutive HR+/HER2- MBC patients from January 2017 to May 2019 were reviewed. The primary endpoint was the evaluation of progression-free survival (PFS) according to subsequent treatment lines after progression on P+ET. Toxicity data were also collected. RESULTS: The outcomes were analyzed in 89 MBC patients that had progressed on previous P+ET: 17 patients were on hormone therapy (HT) and 31 patients on chemotherapy (CT) as second-line treatments; seven patients were on HT and 34 on CT as third-line therapies. PFS of patients treated with HT as second-line therapy is significantly improved when compared with patients treated with CT (p=0.01). Considering third-line settings, the difference in PFS was not statistically different between HT and CT. A better outcome in terms of toxicity is observed among HT patients for both second- and third-line therapies. CONCLUSIONS: patients who were progressive on P+ET could still benefit from a subsequent ET. In patients who experienced a good efficacy from prior ET, without visceral metastatic sites, HT seems the most suitable option, when compared to CT, also in terms of safety.

4.
Eur J Haematol ; 2021 Dec 02.
Artigo em Inglês | MEDLINE | ID: mdl-34856031

RESUMO

In immunocompetent persons, the mRNA vaccines BNT162b2 and mRNA-1273 have been shown to be safe and efficacious against SARS-CoV-2 infection (1). However, most patients with B-cell malignancies, such as those with chronic lymphocytic leukemia (CLL), fail to develop a robust antibody response following vaccination (2-3). This is considered to be largely due to the defects in innate and adaptive immunity in CLL which is observed even in the earlier phase of the disease (4). Furthermore, CLL treatment may exacerbate immune system dysfunction (3, 5, 6-17 ). In agreement with this notion and previous reports, CLL patients are considered to have a heterogeneous and in most instances sub-optimal response to SARS-CoV-2 mRNA vaccines (3,6-17).

5.
Recenti Prog Med ; 112(12): 792-801, 2021 Dec.
Artigo em Italiano | MEDLINE | ID: mdl-34924574

RESUMO

INTRODUCTION: In Italy, the monoclonal antibodies nivolumab and pembrolizumab are subjected to the AIFA monitoring registries for the indication "advanced melanoma (unresectable or metastatic) in adults". These two drugs have the same eligibility criteria, and they are indicated until failure due to progression or toxicity; both of these drugs have also undergone dosage changes from pro/kg to flat dose. In this observational study, also based on clinical eligibility parameters, we wanted to investigate the rwTTD, definitive and temporary suspensions, as well as dose modifications. METHODS: We enrolled patients who started a treatment with nivolumab or pembrolizumab and were admitted to the Regina Elena National Cancer Institute in the period between 01/01/2016 and 31/12/2018. Treatments were followed up to 31/01/2021. Data were collected from the AIFA monitoring registries and from local therapy monitoring databases. We used the Kaplan-Meier method to estimate rwTTD, and the differences between sample subgroups were evaluated using the Log-Rank Test. RESULTS: In the 123 patients enrolled, the rwTTD was 11.67 months (IC 95%: 7,93-17,27). On average, about one out of five patients stopped the therapy before 2 months. The treatments suspended for at least 45 consecutive days and then resumed were 49 (47.6%) with rwTTD= 26.4 months (95% CI 17.3-43.6), significantly higher (p=0.008) compared to treatments suspended for less than or equal to 45 days (rwTTD= 8.4 months (95% CI 4.3-17.1). Dosage changes of nivolumab from pro/kg to flat dose ended in percentage ranging from -23.8% to +56.9%, mean +7.2%. In the case of pembrolizumab, the transition to the flat dose led to variations between +22% and +81.8%, average +39.9%. DISCUSSION AND CONCLUSIONS: Patients who temporarily stopped the treatment had a median rwTTD that is three times higher than patients who stopped permanently and had at least 45 days of therapy. Other studies suggest that patients who had immunological response and side effects, then had better PFS and OS than those without side effects. It is confirmed that it is therefore important to manage toxicities and then resume treatment, whenever possible. In patients who switched to a flat dose, there was an evident increase in the dose administered, especially for pembrolizumab.

6.
Int J Nurs Stud ; 126: 104135, 2021 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-34923319

RESUMO

BACKGROUND: The number of patients using palliative care services, particularly residential hospices, is increasing. Policymakers are urging these services to reflect on the most effective organizational strategies for meeting patients' complex care needs. AIM: To analyze the predictive power of staffing, structure and process indicators towards optimal control of patients' clinically significant symptoms over time. DESIGN: Secondary analysis of data from a multicentre prospective longitudinal observational study (PRELUdiHO) collected between November 2017 and September 2018. SETTING/PARTICIPANTS: Adult patients (n = 992) enrolled in 13 Italian residential hospices. METHODS: Two generalized estimating equations logistic models were built, both with number of hospice beds and length of stay as independent variables as well as, in one case, patient-to-healthcare worker ratios, and, in the other, health professionals' qualification levels. Dependent variables were six not clinically significant (score<4) symptoms: pain, nausea, shortness of breath, feeling sad, feeling nervous, and 'how you feel overall', according to the Edmonton Symptom Assessment System revised (ESAS-r) scale. RESULTS: The generalized estimating equations indicators on staff revealed the following 'optimal' model: Patient-to-Physician ratio (5.5:1-6.5:1); Patient-to-Nurse ratio (1.5:1-2.7:1); Patient-to-Nurse-Assistant ratio (4.1:1-6.3:1); with the most balanced staff composition including 19% physicians, 23% nurse assistants, and 58% registered nurses; hospice beds (12-25); length of stay (median = 12 days). This model predicted an up to four times greater likelihood of controlling all six ESAS-r symptoms over time. The generalized estimating equations model on the educational level of physicians and registered nurses showed that it was significantly associated with optimal patients' symptom control during the entire hospice stay. CONCLUSIONS: This study showed the exact skill-mix composition and proportions of palliative care team able to ensure optimal control of patients' symptoms. The added value of physicians and nurses with a qualification in palliative care in terms of better patient outcomes reaffirmed the importance of education in guaranteeing quality care. Hospices with 12-25 beds, and recruitment methods guaranteeing at least 12-day stay ensured the most propitious organizational environment for optimal management of clinically significant symptoms. The transferability of these results mainly depends on whether the skills of health professionals in our `ideal' model are present in other contexts. Our results provide policymakers and hospice managers with specific, evidence-based information to support decision-making processes regarding hospice staffing and organization. Further prospective studies are needed to confirm the positive impact of this 'optimal' organizational framework on patient outcomes.

8.
Life (Basel) ; 11(11)2021 Nov 15.
Artigo em Inglês | MEDLINE | ID: mdl-34833111

RESUMO

An immune checkpoint blockade with mAbs to PD-1 and PD-L1 is an expanding therapeutic option for mNSCLC patients. This treatment strategy is based on the use of mAbs able to restore the anti-tumor activity of intratumoral T cells inhibited by PD-1 binding to PD-L1/2 on tumor and inflammatory cells. It has been speculated that a chronic status of systemic inflammation as well as the immunosenescence physiologically occurring in elderly patients may affect the efficacy of the treatment and the occurrence of irAEs. We performed a multi-institutional retrospective study aimed at evaluating the effects of these mAbs (nivolumab or atezolizumab) in 117 mNSCLC patients younger (90 cases) and older (27 cases) than 75 years in correlation with multiple inflammatory parameters (NLR, CRP, ESR, LDH and PCT). No differences were observed when the cohorts were compared in terms of the frequency of PFS, OS, inflammatory markers and immune-related adverse events (irAEs). Similarly, the occurrence of irAEs was strictly correlated with a prolonged OS survival in both groups. On the contrary, a negative correlation between the high baseline levels of inflammatory markers and OS could be demonstrated in the younger cohort only. Overall, PD-1/PD-L1-blocking mAbs were equally effective in young and elderly mNSCLC patients; however, the detrimental influence of a systemic inflammation at the baseline was only observed in young patients, suggesting different aging-related inflammation immunoregulative effects.

9.
Cancers (Basel) ; 13(21)2021 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-34771726

RESUMO

BACKGROUND: We aimed assess the detection rate (DR) of positron emission tomography/computed tomography with two novel tracers in patients referred for salvage radiotherapy (sRT) with a presumed local recurrence at multiparametric magnetic resonance (mpMR) after radical prostatectomy (RP). METHODS: The present prospective study was conducted at a single institution between August 2017 and June 2020. Eligibility criteria were undetectable PSA after RP; subsequent biochemical recurrence (two consecutive PSA rises to 0.2 ng/mL or greater); a presumed local failure at mpMR; no distant metastases at 18F-fluorocholine PET/CT (CH/PET); no previous history of androgen deprivation therapy. Patients were offered both 64CuCl2 PET/CT (CU/PET) and 64Cu-PSMA PET/CT (PSMA/PET) before sRT. After image co-registration, PET findings were compared to mpMR ones in terms of DR and independent predictors of DR investigated at logistic regression. RESULTS: A total of 62 patients with 72 nodules at mpMR were accrued. Compared to mpMR (DR = 100%, 95%CI: 94.9-100%), DRs were 47.2% (95%CI: 36.1-58.6%) and 54.4% (95%CI: 42.7-65.7%) for CU/PET and PSMA/PET, respectively (p < 0.001 for both). Both experimental PET/CT performed particularly poorly at PSA levels consistent with early sRT. CONCLUSIONS: The two novel radiotracers are inferior to mpMR in restaging the prostatic fossa for sRT planning purposes, particularly in the context of early salvage radiotherapy.

10.
BMJ Open ; 11(10): e049128, 2021 10 20.
Artigo em Inglês | MEDLINE | ID: mdl-34670762

RESUMO

OBJECTIVES: To measure and explain financial toxicity (FT) of cancer in Italy, where a public healthcare system exists and patients with cancer are not expected (or only marginally) to pay out-of-pocket for healthcare. SETTING: Ten clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes. PARTICIPANTS: From 8 October 2019 to 11 December 2019, 184 patients, aged 18 or more, who were receiving or had received within the previous 3 months active anticancer treatment were enrolled, 108 (59%) females and 76 (41%) males. INTERVENTION: A 30-item prefinal questionnaire, previously developed within the qualitative tasks of the project, was administered, either electronically (n=115) or by paper sheet (n=69). PRIMARY AND SECONDARY OUTCOME MEASURES: According to the protocol and the International Society for Pharmacoeconomics and Outcomes Research methodology, the final questionnaire was developed by mean of explanatory factor analysis and tested for reliability, internal consistency (Cronbach's α test and item-total correlation) and stability of measurements over time (test-retest reliability by intraclass correlation coefficient and weighted Cohen's kappa coefficient). RESULTS: After exploratory factor analysis, a score measuring FT (FT score) was identified, made by seven items dealing with outcomes of FT. The Cronbach's alpha coefficient for the FT score was 0.87 and the item-total correlation coefficients ranged from 0.53 to 0.74. Further, nine single items representing possible determinants of FT were also retained in the final instrument. Test-retest analysis revealed a good internal validity of the FT score and of the 16 items retained in the final questionnaire. CONCLUSIONS: The Patient-Reported Outcome for Fighting FInancial Toxicity (PROFFIT) instrument consists of 16 items and is the first reported instrument to assess FT of cancer developed in a country with a fully public healthcare system. TRIAL REGISTRATION NUMBER: NCT03473379.


Assuntos
Neoplasias , Medidas de Resultados Relatados pelo Paciente , Estudos Transversais , Atenção à Saúde , Feminino , Humanos , Masculino , Psicometria , Reprodutibilidade dos Testes , Inquéritos e Questionários
11.
Vaccines (Basel) ; 9(10)2021 Oct 03.
Artigo em Inglês | MEDLINE | ID: mdl-34696233

RESUMO

BACKGROUND: We present immunogenicity data 6 months after the first dose of BNT162b2 in correlation with age, gender, BMI, comorbidities and previous SARS-CoV-2 infection. METHODS: An immunogenicity evaluation was carried out among health care workers (HCW) vaccinated at the Istituti Fisioterapici Ospitalieri (IFO). All HCW were asked to be vaccine by the national vaccine campaign at the beginning of 2021. Serum samples were collected on day 1 just prior to the first dose of the vaccine and on day 21 just prior to the second vaccination dose. Thereafter sera samples were collected 28, 49, 84 and 168 days after the first dose of BNT162b2. Quantitative measurement of IgG antibodies against S1/S2 antigens of SARS-CoV-2 was performed with a commercial chemiluminescent immunoassay. RESULTS: Two hundred seventy-four HWCs were analyzed, 175 women (63.9%) and 99 men (36.1%). The maximum antibody geometric mean concentration (AbGMC) was reached at T2 (299.89 AU/mL; 95% CI: 263.53-339.52) with a significant increase compared to baseline (p < 0.0001). Thereafter, a progressive decrease was observed. At T5, a median decrease of 59.6% in COVID-19 negative, and of 67.8% in COVID-19 positive individuals were identified with respect to the highest antibody response. At T1, age and previous COVID-19 were associated with differences in antibody response, while at T2 and T3 differences in immune response were associated with age, gender and previous COVID-19. At T4 and T5, only COVID-19 positive participants demonstrated a greater antibody response, whereas no other variables seemed to influence antibody levels. CONCLUSIONS: Overall our study clearly shows antibody persistence at 6 months, albeit with a certain decline. Thus, the use of this vaccine in addressing the COVID-19 pandemic is supported by our results that in turn open debate about the need for further boosts.

12.
Clin Cancer Res ; 2021 Sep 28.
Artigo em Inglês | MEDLINE | ID: mdl-34583970

RESUMO

PURPOSE: We assessed the immunogenicity and safety of the BNT162b2 vaccine in a large cohort of patients with cancer (CP). EXPERIMENTAL DESIGN: From March 1, 2021 to March 20, 2021, this prospective cohort study included 816 CP afferent to our institution and eligible for the vaccination. A cohort of 274 health care workers (HCW) was used as age- and sex-matched control group. BNT162b2 was administered as a two-dose regimen given 21 days apart. Blood samples to analyze anti-Spike (S) IgG antibodies (Ab) were collected prevaccination [timepoint (TP) 0], and at 3 weeks (TP1) and 7 weeks (TP2) after the first dose. RESULTS: Patients characteristics: median age 62 (range, 21-97); breast/lung cancer/others (31/21/48%); active treatment/follow-up (90/10%). In the whole CP cohort, the serologic response rate (RR) and the titre of anti-S IgG significantly increased across the TPs; at TP2, the responders (IgG >15 AU/mL) were 94.2%. Active chemotherapy and chronic use of steroids were independent predictors of lower RR. Adverse events (AE) after the booster predicted higher likelihood of response (OR, 4.04; 95% confidence interval, 1.63-9.99; P = 0.003). Comparing the matched cohorts, the responders were significantly lower in CP than in HCW at TP1 (61.2% vs. 93.2%) and TP2 (93.3% vs. 100%), while the geometric mean concentration of IgG did not significantly differ at TP2 being significantly lower in CP (23.3) than in HCW (52.1) at TP1. BNT162b2 was well tolerated in CP; severe-grade AEs were 3.5% and 1.3% after the first and second doses, respectively. CONCLUSIONS: BNT162b2 assures serologic immunization without clinically significant toxicity in CP. The second dose is needed to reach a satisfactory humoral response.

15.
Front Immunol ; 12: 704110, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34447374

RESUMO

Patients diagnosed with malignancy, neurological and immunological disorders, i.e., fragile patients, have been excluded from COVID-19 vaccine trials. However, this population may present immune response abnormalities, and relative reduced vaccine responsiveness. Here we review the limited current evidence on the immune responses to vaccination of patients with different underlying diseases. To address open questions we present the VAX4FRAIL study aimed at assessing immune responses to vaccination in a large transdisease cohort of patients with cancer, neurological and rheumatological diseases.


Assuntos
Vacinas contra COVID-19/administração & dosagem , Adulto , Vacinas contra COVID-19/imunologia , Protocolos Clínicos , Humanos , Doenças do Sistema Imunitário/imunologia , Hospedeiro Imunocomprometido/imunologia , Neoplasias/imunologia , Doenças do Sistema Nervoso/imunologia , Seleção de Pacientes , Estudos Prospectivos
16.
Eye (Lond) ; 2021 Aug 03.
Artigo em Inglês | MEDLINE | ID: mdl-34345028

RESUMO

BACKGROUND: The prospective DIabetes and CATaract Study II (DICAT II) was performed to characterise the risks of cataract surgery to the retinae of patients with early diabetic macular oedema (E-DMO). METHODS: DICAT II was a prospective, comparative, multicentre, observational study involving six Italian clinics. Patients were aged ≥55 years, had type 1 or 2 diabetes with spectral-domain optical coherence tomography evidence of ESASO classification Early DMO. Group 1 eyes (78 eyes, 78 patients) underwent phacoemulsification-based cataract surgery. Group 2 eyes (65 eyes, 65 patients) had E-DMO and either clear media or had undergone uncomplicated cataract surgery ≥1 year previously. Central subfield thickness (CST) and best-corrected visual acuity (BCVA) were assessed in both groups. RESULTS: The negative impact of surgery on CST was evident after the first postoperative week; CST peaked during the first month, then rapidly decreased. CST worsening ≥10 µm was observed in 63/78 eyes (80.7%) and 29/65 eyes (44.6%) in Groups 1 and 2, respectively (p < 0.0001). CST worsening of ≥50 µm was observed in 51 eyes (65.4%) and 10 eyes (15.4%) in Groups 1 and 2, respectively (p < 0.0001). Mean CST worsening was lower in Group 2 than in Group 1 (38.6 ± 30.4 µm vs 85.5 ± 55.3 µm, p < 0.0001) with a lower BCVA loss (-2.6 ± 3.5 letters vs -8.2 ± 6.2 letters, p < 0.0001). Higher glycaemic levels and HBA1c levels were significantly associated with the risk of >50 µm CST worsening in eyes from both groups. CONCLUSION: Early DMO is associated with poorer outcomes after cataract surgery and requires close pre- and postoperative monitoring.

17.
EXCLI J ; 20: 1152-1169, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34345234

RESUMO

One of the key difficulties in glioma treatment is our limited ability to consistently assess cancer response or progression either by neuroimaging or specific blood biomarkers. An ideal biomarker could be measured through non-invasive methods such as blood-based biomarkers, aiding both early diagnosis and monitoring disease evolution. This is a single-center, case-control, 10-year retrospective, longitudinal study. We evaluated routine coagulation factors in 138 glioma patients (45 Females/93 Males; median [range] age, 56.4 [27-82] years; 64 non-recurrent/74 recurrent) and, for comparison, in 56 relapsing-remitting MS patients (41 Females/15 Males; 40.8 [25-62] years, 35 stable/21 active) and 23 controls (16 Females/7 Males; 41.7 [24-62] years) as well as Neutrophil-to-lymphocyte ratio (NLR) in subgroups of 127 glioma patients, 33 MS patients and 23 healthy controls. Secondly, we assessed whether these indicators could be predictive of overall (OS) and progression-free survival (PFS) in glioma patients. NLR, d-dimer, Antithrombin III and Factor VIII were significantly higher in glioma patients compared to both MS patients and controls (p<0.0001 for all). ROC curves confirmed that either NLR, Antithrombin III or Factor VIII were moderately accurate biomarkers (0.7

18.
Eur J Haematol ; 107(5): 566-572, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34297879

RESUMO

OBJECTIVES: Autologous stem cell transplantation is the gold standard for eligible newly diagnosed multiple myeloma patients. Patients are usually hospitalized for administration of mobilization chemotherapy. We aimed to assess safety and efficacy of mobilization therapy with low-dose (2 g/m2 ) and intermediate-dose (3-4 g/m2 ) cyclophosphamide administered as outpatient. METHODS: A total of 176 consecutive newly diagnosed transplant-eligible myeloma patients receiving outpatient mobilization were retrospectively evaluated. Induction therapy was mainly performed with new drugs (91%). RESULTS: Chemotherapy was very well tolerated with 16.6% of patients having all-grade adverse events (AEs) and only 1.2% having severe AEs. The most frequently reported AEs were nausea and vomiting grade 1-2 (6.8%). Only 5.7% of patients required hospitalization for AEs. Stem cell collection was successful in 93.1% of patients, with a median CD34+ harvest of 8.7 × 106 /kg. Target for 2 autologous stem cell transplantation (at least 6 CD34+  × 106 /kg) was reached by 76.3% of patients. Administration of plerixafor on demand was necessary in 12.1% of patients. CONCLUSIONS: Outpatient mobilization with low- and intermediate-dose cyclophosphamide appears an efficient and safe procedure, with minimal and manageable AEs and low rate of hospitalization.

19.
J Hematol Oncol ; 14(1): 119, 2021 07 29.
Artigo em Inglês | MEDLINE | ID: mdl-34325728

RESUMO

In a population of 42 Philadelphia negative myeloproliferative neoplasm patients, all on systemic active treatment, the likelihood of responding to anti-SARS-CoV-2 BNT162b2 vaccine at 2 weeks after the second dose was significantly lower in the ten patients with myelofibrosis compared to the 32 with essential thrombocythemia (n = 17) and polycythemia vera (n = 15) grouped together, both in terms of neutralizing anti-SARS-CoV-2 IgG titers and seroprotection rates (32.47 AU/mL vs 217.97 AU/mL, p = 0.003 and 60% vs 93.8%, p = 0.021, respectively). Ruxolitinib, which was the ongoing treatment in five patients with myelofibrosis and three with polycythemia vera, may be implicated in reducing vaccine immunogenicity (p = 0.076), though large prospective study is needed to address this issue.


Assuntos
Anticorpos Antivirais/sangue , Vacinas contra COVID-19/administração & dosagem , COVID-19/tratamento farmacológico , Policitemia Vera/imunologia , Mielofibrose Primária/imunologia , SARS-CoV-2/efeitos dos fármacos , Trombocitemia Essencial/imunologia , Idoso , Anticorpos Antivirais/imunologia , COVID-19/complicações , COVID-19/virologia , Feminino , Humanos , Masculino , Policitemia Vera/patologia , Policitemia Vera/virologia , Mielofibrose Primária/patologia , Mielofibrose Primária/virologia , Prognóstico , Trombocitemia Essencial/patologia , Trombocitemia Essencial/virologia
20.
Artigo em Inglês | MEDLINE | ID: mdl-34315390

RESUMO

BACKGROUND: In advanced non-small-cell lung cancer, without activating mutations and with PD-L1≥50%, Pembrolizumab monotherapy is the therapeutic standard in Europe. OBJECTIVE: to evaluate retrospectively the safety and the efficacy of this drug and to investigate potential prognostic factors in daily clinical practice. METHODS: From September 2017 to September 2019, 205 consecutive patients from 14 Italian Medical Oncology Units were enrolled in the study. Gender, Age (> or <70 years), ECOG-PS (0-1 or 2), histology (squamous or non-squamous), presence of brain, bone and liver metastases at baseline, PD-L1 score (>90% or <90%), smoking status (never or former or current) were applied to the stratified log-rank. Cox's proportional hazards model was used for multivariate analysis. RESULTS: At a median follow-up of 15.2 months, median progression-free and overall survival (mPFS and mOS) were 9.2 months (95% C.I., 4.8-13.5) and 15.9 months (95% C.I., not yet evaluable), respectively. Patients with Eastern Cooperative Oncology Group performance status (ECOG-PS) 2 had mPFS of 2.8 months (95% C.I., 2.1-3.4) and mOS of 3.9 months (95% C.I., 2.5-5.3). Patients with liver metastases at diagnosis had an mPFS of 3.2 months (95% C.I., 0.6-5.8) and an mOS of 6.0 months (95% C.I., 3.7-8.4). At multivariate analysis for OS gender, ECOG-PS 2, and presence of liver metastases were independent prognostic factors. CONCLUSION: Patients with ECOG-PS 2 derived little benefit from the use of first-line pembrolizumab. In patients with liver metastases the association of pembrolizumab with platinum-based chemotherapy could be a better option than pembrolizumab alone.

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