Abstract
Despite increasing treatment options, multiple myeloma (MM) remains incurable for most patients. Data on improvement of outcomes are derived from selected patient populations enrolled in clinical trials and might not be conferrable to all patients. Therefore, we assessed the trial eligibility, sequential treatment, and survival of non-transplant patients with MM treated in German routine care. The prospective clinical cohort study TLN (Tumour Registry Lymphatic Neoplasms) recruited 285 non-transplant patients with symptomatic MM at start of first-line treatment in 84 centres from 2009 to 2011. Demographic and clinical data were collected until August 2016. Trial-ineligibility was determined by presence of at least one of the common exclusion criteria: heart/renal failure, liver/renal diseases, polyneuropathy, HIV positivity. All other patients were considered potentially trial-eligible. Thirty percent of the patients in our study were classified as trial-ineligible. Median first-line progression-free survival (PFS) and overall survival (OS) of trial-ineligible patients were inferior to that of potentially trial-eligible patients: PFS 16.2 months (95% CI (confidence interval) 11.1–20.4) vs. 27.3 months (95% CI 23.3–33.0); OS 34.2 months (95% CI 21.6–48.1) vs. 58.6 months (95% CI 48.6–64.4). A high percentage of non-transplant patients with MM in German routine care would be ineligible for participation in clinical trials. Despite similar treatment algorithms, their first-line PFS and OS were shorter than those of potentially trial-eligible patients; the survival data of the latter were similar to results from clinical trials. Physicians should be aware of the fact that results from clinical trials may not mirror “real world” patient outcomes when discussing outcome expectations with patients. Trial registration: Clinicaltrials.gov identifier: NCT00889798.
Highlights
Leipzig, Germany 3 Joint Outpatient-Centre for Haematology and Oncology, Nordhorn, Germany 4 Joint Outpatient-Centre for Haematology and Oncology, Aschaffenburg, Germany 5 Medical Department, iOMEDICO, Freiburg, Germany 6 Clinical Epidemiology and Health Economics, iOMEDICO, Freiburg, Germany 7 Outpatient-Centre for Interdisciplinary Oncology and Haematology, Wirthstrasse 11c, 79110 Freiburg, GermanyMultiple myeloma (MM) is a malignant plasma cell disorder and accounts for approximately 10% of all haematologic malignancies [1]
Thirty-two percent (n = 91) of all patients were classified as trial-ineligible as explained by the criteria listed in the methods section
While the staging according to Durie Salmon was similar for both subgroups, more trial-ineligible patients were diagnosed in prognostic stage III according to the international staging system (ISS) criteria (32 vs 10%). 59% patients (65%) were classified as trial-ineligible due to one exclusion criterion, 23 patients (25%) met two exclusion criteria, eight patients (9%) met three, and one patient (1%) met four exclusion criteria
Summary
Germany 3 Joint Outpatient-Centre for Haematology and Oncology, Nordhorn, Germany 4 Joint Outpatient-Centre for Haematology and Oncology, Aschaffenburg, Germany 5 Medical Department, iOMEDICO, Freiburg, Germany 6 Clinical Epidemiology and Health Economics, iOMEDICO, Freiburg, Germany 7 Outpatient-Centre for Interdisciplinary Oncology and Haematology, Wirthstrasse 11c, 79110 Freiburg, GermanyMultiple myeloma (MM) is a malignant plasma cell disorder and accounts for approximately 10% of all haematologic malignancies [1]. Ann Hematol (2018) 97:2437–2445 continues to increase and treatment recommendations for elderly and transplant-ineligible patients are of growing interest. The proteasome inhibitor bortezomib and the immunomodulatory drug thalidomide have changed the treatment algorithm for elderly patients. The combination therapies bortezomib, melphalan, prednisone (VMP) and melphalan, prednisone, and thalidomide (MPT) were standard of care for non-transplant patients during the study period [4,5,6]. Combination therapies with novel proteasome inhibitors (like carfilzomib [9], ixazomib [10]), monoclonal antibodies (like elotuzumab, daratumumab [11]), or the histone de-acetylase inhibitor panobinostat [12] may well pave the way for new standards of care for non-transplant patient [13, 14]
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