Health-related quality of life in non-transplant eligible newly diagnosed multiple myeloma patients treated with melphalan/prednisolone plus either thalidomide or lenalidomide; results of the HOVON87/NMSG18 study
Bibliographic record
Abstract
Aims: The aim is to evaluate the health-related quality of life (HRQoL) results of HOVON87/NMSG18 study (Zweegman et al., Blood 2016;127(9):1109-1116). Non-transplant eligible, newly diagnosed multiple myeloma patients were randomized between melphalan/prednisolone plus either thalidomide or lenalidomide for nine induction cycles, followed by thalidomide or lenalidomide maintenance (MPT-T or MRP-R). The study showed comparable efficacy of treatment. Methods: The validated instruments, EORTC QLQ-C30 and EORTC QLQ-MY20, were used for HRQoL measurement and were optional in the study. The patients answered the questionnaires at baseline, after 3 and 9 induction cycles and after 6 and 12 months of maintenance. Changes in HRQoL score over time during treatment and between groups were evaluated according to previously published levels of minimal important difference. Results: 613 of the total of 637 randomized patients chose to participate in the HRQoL reporting, and the baseline questionnaire was available from 553 patients (90.2%). Patient drop-out during follow-up was due to progressive disease, toxicity, death and other, and reduced the number of patients completing the therapy to 42 (15%) patients in the MPT-T and 93 (33%) in the MPR-R group. Both groups reported clinically meaningful improvement in global quality of life (QoL), physical functioning, pain, disease symptoms and insomnia. In the evaluation of difference between groups, the patients receiving MPR-R reported increasing diarrhea, better controlled pain at induction phase and increased global QoL and physical functioning during maintenance phase compared to MPT-T. The patients receiving MPT-T reported increasing constipation, better controlled pain during maintenance phase, better controlled fatigue during induction treatment and decreased insomnia compared to MPR-R. Conclusions: HRQoL during treatment is important to myeloma patients, especially when treatment efficacy of the treatment regimens is comparable. MPR-R and MPT-T both demonstrated improvements in global QoL, physical functioning and pain. Fatigue and insomnia were better controlled in the MPT-T group, which can be attributed to the thalidomide side effect of sleepiness. For interpretation of the HRQoL results patient drop-out rate must be taken in account, and we will recommend a HRQoL study design with high focus on data completeness and registration of reasons for missing data. (Figure Presented).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".