31 research outputs found
Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma
This is an accepted manuscript of an article published by Taylor & Francis in Leukemia & Lymphoma on 09/04/2020, available online: https://www.tandfonline.com/doi/full/10.1080/10428194.2020.1747066
The accepted version of the publication may differ from the final published version.In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.This work was supported by Celgene Corporation.Published versio
Ibrutinib as initial therapy for patients with chronic lymphocytic leukemia
Background: chronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma. Methods: we randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee. Results: the median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P<0.001). Ibrutinib significantly prolonged overall survival; the estimated survival rate at 24 months was 98% with ibrutinib versus 85% with chlorambucil, with a relative risk of death that was 84% lower in the ibrutinib group than in the chlorambucil group (hazard ratio, 0.16; P=0.001). The overall response rate was higher with ibrutinib than with chlorambucil (86% vs. 35%, P<0.001). The rates of sustained increases from baseline values in the hemoglobin and platelet levels were higher with ibrutinib. Adverse events of any grade that occurred in at least 20% of the patients receiving ibrutinib included diarrhea, fatigue, cough, and nausea; adverse events occurring in at least 20% of those receiving chlorambucil included nausea, fatigue, neutropenia, anemia, and vomiting. In the ibrutinib group, four patients had a grade 3 hemorrhage and one had a grade 4 hemorrhage. A total of 87% of the patients in the ibrutinib group are continuing to take ibrutinib. Conclusions: ibrutinib was superior to chlorambucil in previously untreated patients with CLL or small lymphocytic lymphoma, as assessed by progression-free survival, overall survival, response rate, and improvement in hematologic variables. (Funded by Pharmacyclics and others; RESONATE-2 ClinicalTrials.gov number, NCT01722487.)
The Impact of Chemotherapy on Hepatitis B Antibody Titer in Patients with Hematological Malignancies
Objective: To investigate the influence of chemotherapy (CT) on HBsAb
titer in patients receiving CT due to hematological malignancy.
Materials and Methods: The data of 75 patients who received CT with the
diagnosis of various hematological malignancies and who had serum HBsAb
levels measured prior to and after the cessation of CT were evaluated
retrospectively.
Results: The median age of the patients was 52 years (range: 16-78) with
49 (65\%) males and 26 (35\%) females. Median HBsAb titer decreased
significantly after CT compared to the pre-CT median HBsAb titer {[}68
(range: 0-1000) vs. 100 (range: 6.2-1000)] (p=0.001). In subgroup
analysis, median HBsAb titer decreased significantly after CT in acute
leukemia patients {[}110 (range: 6.2-1000) vs. 67.8 (range: 0-1000)]
(p=0.003) and in patients receiving intensive CT {[}97.2 (range:
6.2-1000) vs. 71 (range: 0-1000)] (p=0.036). The decrease in median
HBsAb titer was significant in male patients (p<0.001). HBsAb became
negative after CT in 9 patients who were HBcAb-negative and had lower
pre-CT HBsAb levels.
Conclusion: HBsAb decreased after CT, especially in acute leukemia and
male patients, and in patients receiving intensive CT
Miller-Fisher syndrome associated with chronic lymphocytic leukemia
Chronic lymphocytic leukemia (CLL) is a frequent hematological
malignancy, with meningeal or peripheral nerve infiltrations being the
most commonly encountered neurological complications. In this report,
we describe a CLL patient with Miller-Fisher syndrome (MFS) who
responded to immune modulation with plasmapheresis. A 47-year-old man
diagnosed as B-cell CLL admitted with neutropenic fever. He complained
of diplopia and numbness of both arms. Neurological examination
revealed a bilateral external ophthalmoplegia, dysphagia, dysarthria,
mild shoulder girdle muscle weakness and gait ataxia, accompanied by
absent tendon reflexes. Nerve conduction studies were indicative of a
predominantly axonal sensori-motor peripheral neuropathy. This
association of CLL with MFS had not been previously reported in the
literature
A Randomized Study Comparing the Efficacy of Three Hepatitis B Vaccine Induction Regimens in Adult Patients with Hematological Malignancies
Objective: Non-responsiveness to hepatitis B virus (HBV) vaccines is not
rare in hemato-oncological patients due to disease-associated or
treatment-induced immune suppression. Although different strategies have
been employed to improve the response rates, to date there is not an
approved schedule for HBV immunization in patients with hematological
malignancies. We designed a prospective randomized study to evaluate the
efficacy of 3 different induction regimens for HBV vaccination.
Materials and Methods: In the standard-dose (SD) group, total vaccine
dose delivered was 40 mu g and patients were vaccinated with 20 mu g at
weeks 0 and 4. In the high-dose dose-intensive (HDDI) group, total
vaccine dose delivered was 80 mu g and patients were vaccinated with 40
mu g at weeks 0 and 4. In the high-dose time-intensive (HDTI) group,
total vaccine dose delivered was 80 mu g and patients were vaccinated
with 20 mu g at weeks 0, 2, 4, and 6.
Results: In a cohort of 114 patients, 38.6\% responded to HBV
vaccination. The response rate in the SD arm, HDDI arm, and HDTI arm was
26.2\%, 29.7\%, and 44.4\%, respectively (p>0.05). Age was the only
variable identified as having a negative impact on response.
Conclusion: Short of achieving statistical significance, a higher
response rate was observed in the HDTI arm. Therefore, this study
supports a high-dose, time-intensive HBV vaccine induction regimen in
patients with hematological malignancies who are not on chemotherapy
Health-related quality-of-life results from the phase 3 OPTIMISMM study: pomalidomide, bortezomib, and low-dose dexamethasone versus bortezomib and low-dose dexamethasone in relapsed or refractory multiple myeloma
Lucio, Paulo/0000-0003-0175-7534; LAROCCA, Alessandra/0000-0002-2070-3702; Cascavilla, Nicola/0000-0002-8901-2379; moreau, philippe/0000-0003-1780-8746WOS:000558375200001PubMed: 32268815In the randomized phase-3 OPTIMISMM study, the addition of pomalidomide to bortezomib and low-dose dexamethasone (PVd) resulted in significant improvement in progression-free survival (PFS) in lenalidomide-pretreated patients with relapsed or refractory multiple myeloma (RRMM), including lenalidomide refractory patients. Here, we report health-related quality of life (HRQoL) results from this trial. Patients received PVd or Vd in 21-day cycles until disease progression or discontinuation. HRQoL was assessed using the EORTC QLQ-C30, QLQ-MY20, and EQ-5D-3L instruments on day 1 of each treatment cycle. Mean score changes for global QoL, physical functioning, fatigue, side effects of treatment domains, and EQ-5D-3L index were generally stable over time across treatment arms. The proportion of patients who experienced clinically meaningful worsening in global QoL and other domains of interest was similar. These HRQoL results with PVd along with previously demonstrated improvement in PFS vs Vd continue to support its use in patients with RRMM.Celgene Corporation, a Bristol Myers Squibb CompanyThis work was supported by Celgene Corporation, a Bristol Myers Squibb Company
Value of F-18-fluorodeoxyglucose uptake in positron emission tomography/computed tomography in predicting survival in multiple myeloma
WOS: 000290574100008PubMed: 21287167We assessed the role of the maximum standardized uptake value (SUVmax) of bone marrow and the extramedullary lesion with the highest SUVmax in positron emission tomography/computed tomography (PET/CT) of newly diagnosed multiple myeloma (MM) patients in predicting overall survival (OS). A total of 61 newly diagnosed patients (55 MM and 6 plasmacytoma) were enrolled in the study [37 men and 24 women with a median age of 57 years (range 28-80 years)]. The SUVmax of bone marrow and the extramedullary lesion in PET/CT was correlated with the levels of beta(2)-microglobulin, C-reactive protein (CRP), albumin, creatinine, per cent of bone marrow plasma cells, serum free light chain (FLC) ratio, International Staging System (ISS) score and Durie-Salmon stage. The extramedullary lesion with the highest SUVmax showed significant correlation with bone marrow fluorodeoxyglucose (FDG) uptake (p = 0.027) and near significant correlation with ISS (p = 0.048). Bone marrow SUVmax correlated significantly with the per cent of bone marrow plasma cell count (p = 0.024), CRP (p = 0.012) and ISS (p = 0.013). In stage III MM the mean values of SUVmax in extramedullary lesions were significantly higher than stages I and II (6.23 +/- 6.32 vs 2.85 +/- 3.44, p = 0.023). The serum FLC ratio did not show any correlation with SUVmax of lesions and bone marrow (p > 0.05). Forty-four MM patients with FDG-positive lesions in PET/CT showed inferior 5-year estimated survival (61.73%) when compared to 11 patients without FDG-positive lesions, all of whom were alive (p = 0.01). In multivariate analysis an extramedullary lesion with the highest SUVmax was the only independent predictor of OS (p = 0.03). PET/CT allows identification of high-risk myeloma patients, and extramedullary lesions with the highest SUVmax independently predict inferior OS
Multicenter Early Access Program Results from Turkey: Efficacy and Safety of Daratumumab Among Heavily Pretreated Relapse/Refractory Multiple Myeloma Patients
Pomalidomide, Bortezomib, and Dexamethasone in Lenalidomide-Pretreated Multiple Myeloma : A Subanalysis of OPTIMISMM by Frailty and Bortezomib Dose Adjustment
The study was supported by Celgene, a Bristol-Myers Squibb company. All the authors contributed to and approved the manuscript. Professional medical writing support for this manuscript was provided by Joels Wilson-Nieuwenhuis, PhD, of Caudex, a division of IPG Health Medical Communications, funded by Bristol Myers Squibb.Introduction: A proportion of patients with multiple myeloma (MM) are older and/or have comorbidities, requiring dose adjustments. Data from OPTIMISMM (NCT01734928) supported the use of pomalidomide, bortezomib, and dexamethasone (PVd) for treating relapsed/refractory MM. This subanalysis of OPTIMISMM assessed outcome by frailty and/or bortezomib dose adjustment. Methods: Patient frailty (nonfrail vs. frail) was classified using age, Charlson Comorbidity Index, and Eastern Cooperative Oncology Group performance status. Data from patients requiring a bortezomib dose reduction, interruption, and/or withdrawal during PVd treatment were assessed. Results: Among 559 patients, 93 of 281 (33.1%) and 93 of 278 (33.5%) patients who received PVd and bortezomib and dexamethasone (Vd), respectively, were frail. Overall response rate (ORR) and median progression-free survival (PFS) were higher in nonfrail vs. frail with PVd treatment (ORR, 82.8% vs. 79.6%; PFS, 14.7 vs. 9.7 months); significantly higher than with Vd regardless of frailty. Grade ≥ 3 treatment-emergent adverse events (TEAEs) were higher with PVd vs. Vd, regardless of frailty. Discontinuations of PVd were lower in nonfrail vs. frail patients (19.2% vs. 30.1%); the median duration of treatment was similar (DoT; 8.8 vs. 8.9 months, respectively). Patients who received PVd with a bortezomib dose adjustment (n = 240) had a longer median DoT (9.3 vs. 4.5 months) and PFS (12.1 vs. 8.4 months) vs. those without. Conclusion: Frail patients treated with PVd demonstrated a higher ORR and a longer PFS and DoT vs. Vd, despite a higher frequency of grade ≥ 3 TEAEs leading to pomalidomide, bortezomib, and/or dexamethasone discontinuation. Therefore, PVd treatment may improve patient outcomes, regardless of frailty