PurposeTo compare the impact of a single fraction (8 Gy × 1 fraction) and multifraction (3 Gy × 10 fractions) radiotherapy regimens on pain relief, recalcification and the quality of life (QoL) in patients with bone destructions due to multiple myeloma (MM).Patients and methodsIn all, 101 patients were included in a randomised prospective clinical trial: 58 patients were included in the control arm (3 Gy × 10 fractions) and 43 patients into the experimental arm (8 Gy × 1 fraction). The response rate was defined according to the International Consensus on Palliative Radiotherapy criteria. Recalcification was evaluated with radiographs. QoL questionnaires were completed before and 4 weeks after treatment.ResultsPain relief was obtained in 81/101 patients (80.2%): complete response in 56 (69%) and partial in 25 patients (30.9%). No significant differences were observed in analgesic response between the groups. Significant factors for pain relief were female gender, age under 65, IgG MM type, presence of recalcification at the irradiated site. Recalcification was found in 32/101 patients (33.7%): complete in 17 (53.2%) and partial in 15 (46.2%). No significant differences were observed in recalcification between the groups. Significant factors for recalcification were Karnofsky index ≥ 60%, haemoglobin level ≤ 80 g/dl, MM stage II and analgesic response at the irradiated site. The QoL after radiotherapy was improved in the control group.ConclusionThe same analgesic and recalcification response was observed using two different radiotherapy regimens. Higher doses should be used to achieve a better QoL.
Background Melphalan flufenamide (melflufen), an alkylating peptide-drug conjugate, plus dexamethasone showed clinical activity and manageable safety in the phase 2 HORIZON study. We aimed to determine whether melflufen plus dexamethasone would provide a progression-free survival benefit compared with pomalidomide plus dexamethasone in patients with previously treated multiple myeloma. MethodsIn this randomised, open-label, head-to-head, phase 3 study (OCEAN), adult patients (aged ≥18 years) were recruited from 108 university hospitals, specialist hospitals, and community-based centres in 21 countries across Europe, North America, and Asia. Eligible patients had an ECOG performance status of 0-2; must have had relapsed or refractory multiple myeloma, refractory to lenalidomide (within 18 months of randomisation) and to the last line of therapy; and have received two to four previous lines of therapy (including lenalidomide and a proteasome inhibitor). Patients were randomly assigned (1:1), stratified by age, number of previous lines of therapy, and International Staging System score, to either 28-day cycles of melflufen and dexamethasone (melflufen group) or pomalidomide and dexamethasone (pomalidomide group). All patients received dexamethasone 40 mg orally on days 1, 8, 15, and 22 of each cycle. In the melflufen group, patients received melflufen 40 mg intravenously over 30 min on day 1 of each cycle and in the pomalidomide group, patients received pomalidomide 4 mg orally daily on days 1 to 21 of each cycle. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat (ITT) population. Safety was assessed in patients who received at least one dose of study medication. This study is registered with ClinicalTrials.gov, NCT03151811, and is ongoing. Findings Between June 12, 2017, and Sept 3, 2020, 246 patients were randomly assigned to the melflufen group (median age 68 years [IQR 60-72]; 107 [43%] were female) and 249 to the pomalidomide group (median age 68 years [IQR 61-72]; 109 [44%] were female). 474 patients received at least one dose of study drug (melflufen group n=228; pomalidomide group n=246; safety population). Data cutoff was Feb 3, 2021. Median progression-free survival was 6•8 months (95% CI 5•0-8•5; 165 [67%] of 246 patients had an event) in the melflufen group and 4•9 months (4•2-5•7; 190 [76%] of 249 patients had an event) in the pomalidomide group (hazard ratio [HR] 0•79, [95% CI 0•64-0•98]; p=0•032), at a median follow-up of 15•5 months (IQR 9•4-22•8) in the melflufen group and 16•3 months (10•1-23•2) in the pomalidomide group. Median overall survival was 19•8 months (95% CI 15•1-25•6) at a median follow-up of 19•8 months (IQR 12•0-25•0) in the melflufen group and 25•0 months (95% CI 18•1-31•9) in the pomalidomide group at a median follow-up of 18•6 months (IQR 11•8-23•7; HR 1•10 [95% CI 0•85-1•44]; p=0•47). The most common grade 3 or 4 treatment-emergent adverse events were thrombocytopenia (143 [63%] of 228 in the melflufen group vs...
Following our results, we concluded that HDR-BRT is a more effective and safer treatment approach for head and neck cancer recurrences than 3D-CRT.
Materials and methods Study populationFrom 2011 to 2013, 46 patients (27 women and 19 men; median age: 69 years, range: 51-88 years) with MM and painful bone destructions were involved in the study, which was conducted at the Department of Oncology and Hematology of the Hospital of the Lithuanian University of Health Sciences. Seven patients (16%) had stage II MM and 39 (84%) patients had stage III MM, as defined by the Durie and Salmon staging system (24). Thirty-two (70%) patients had IgG-type M protein, 8 (17%) patients had IgAtype, 4 (9%) patients had light chain-type, and 2 (4%) had nonsecretory MM. Inclusion criteria: patients diagnosed Background/aim: Radiotherapy is required to overcome pain and to promote recalcification in multiple myeloma (MM) patients. The aim of our prospective study was to evaluate the impact of one fraction of 8 Gy regimen in palliative treatment of MM. Materials and methods:Forty-six patients with MM and painful bone destructions were treated by 8 Gy single fraction regimen. The visual analog scale was used for evaluation of pain. Analgesic use was measured prior to and after radiotherapy (4, 12, and 24 weeks). Recalcification was evaluated with radiographs before and after radiotherapy at 1 and 3 months. Quality of life questionnaires were completed before and 4 weeks after treatment.Results: Decrease of pain was observed in 78.3% cases: according to the international consensus on palliative radiotherapy criteria, 43.5% were found to be completely and 34.8% partially responsive. Reduction of analgesic use was present in 68.4% and complete cessation in 31.6%. Recalcification was present in 55%: a complete response was observed in 35% and a partial response in 20%. The side effects after treatment were of the first grade and reversible. Conclusion:One fraction of 8 Gy regimen is effective in palliative treatment of MM patients with painful bone destructions.
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