Continuous prednisolone versus conventional prednisolone with VMCP–interferon‐α2b as first‐line chemotherapy in elderly patients with multiple myeloma

Abstract

SummaryWe report on a randomised trial that aimed to compare the efficacy of continued daily prednisolone treatment during the entire induction phase, with prednisolone given for 2 weeks of each cycle in combination with VMCP (vincristine, melphalan, cyclophosphamide, prednisolone)-interferon-a2b (IFN-a2b) treatment in 299 previously untreated elderly patients (median age: 67 years) with multiple myeloma. After completion of induction treatment patients were randomised to IFN-a2b with or without prednisolone, thrice weekly. Response rate was 62% in the continuous and 60% in the control arm (intent to treat analysis, P ¼ 0AE81). Progression-free survival [median: 20 months vs. 19 months; hazard ratio (HR): 0AE99, 95% confidence interval (CI): 0AE74-1AE33, P ¼ 0AE97] and overall survival (median: 34 months vs. 37 months; HR: 1AE16, 95% CI: 0AE85-1AE59, P ¼ 0AE35) were similar in both groups. Reduced performance status (Eastern Cooperative Oncology Group, grades 2-4) was the predominant risk factor for poor survival followed by age >65 years, high b2-microglobulin, and impaired renal function. There was more grades 3-4 dyspnoea and cardiac impairment and grades 1-2 hyperglycaemia, but less nausea, emesis and anaemia in patients on continuous prednisolone therapy. In conclusion, continuing prednisolone treatment during the entire duration of the induction phase with VMCP-IFN-a2b did not improve outcome.

Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma

“…[19][20][21] Among studies assessing the efficacy of the thalidomidebased regimens in untreated elderly patients with MM, the only one that is comparable to ours in terms of median age, exclusion criteria, and administered thalidomide dose is Palumbo et al, 13 who treated 129 patients with a combination of thalidomide, oral melphalan, and prednisone. With this regimen they observed combined CR and nCR in 28% of patients, near half the value that we obtained (48%).…”

Psychosocial QOL is an independent predictor of overall survival in newly diagnosed patients with multiple myeloma

“…The clinical trial showed similarity of the two treatment arms with respect to response rate, progression-free, and overall survival. Detailed results were published elsewhere (9). There was also no difference in outcome between patients taking or not taking part in the QOL sub-study.…”

“…Ninety‐two patients participated in the QOL sub‐study of a trial comparing continuous vs. intermittent prednisolone in combination with VMCP–IFNα2b during induction, and IFNα2b with or without prednisolone twice weekly during maintenance in elderly patients with recently diagnosed multiple myeloma (9). Only patients with recently diagnosed, previously untreated multiple myeloma, ECOG performance status ≤3 and adequate organ function were included.…”

“…The protocol was approved by the relevant ethics committees of the centers taking part in the study, and all patients gave informed, written consent. Further details of the treatment regimen and the patient cohort have been described previously (9).…”

Asking patients with hematological malignancies: ‘how do you feel?’ Does it really provide independent prognostic information for survival?

“…The authors found that psychosocial aspects of health‐related quality of life (HRQOL) provide independent prognostic information for survival, while the very few studies in patients with multiple myeloma found that physical and symptom focused HRQOL aspects provide independent prognostic information (4, 5). The results by Strasser‐Weippl and Ludwig are somehow limited, for example, they were not able to include cytogenetic data in the analysis, the research was conducted on a sub‐sample of 92 patients out of 299 enrolled in the original trial (6) and the issue of the possible harmful multicollinearity , which is relevant when using HRQOL scales of the EORTC QLQ‐C30, was not fully taken into account (7). Nevertheless, their results add to the scarce HRQOL literature in patients with hematological diseases and overall provide an important indication suggesting that what patients are telling us might indeed reveal important prognostic information, also in patients with hematological malignancies.…”