Patient-reported outcomes (PROs) with ibrutinib-rituximab in Waldenström macroglobulinemia (WM): Results from iNNOVATE.
Bibliographic record
Abstract
8018 Background: Anemia and fatigue can impair quality of life in patients (pts) with WM. Ibrutinib (ibr) as single agent or in combination with RTX is FDA-approved for WM. In pts with RTX-refractory WM, single-agent ibr induced meaningful improvements in PROs (Trotman, EHA 2017). In iNNOVATE, ibr-RTX (IR) produced higher rates of sustained hemoglobin improvement and meaningful improvements in PROs versus placebo-RTX (R; Dimopoulos NEJM 2018). Here, we report detailed PRO analyses from iNNOVATE. Methods: Pts with symptomatic WM requiring therapy were randomized to daily 420 mg oral ibr or placebo, both with RTX (375 mg/m2/week IV at weeks 1–4 and 17–20). PRO measures included FACIT-Fatigue (FACIT-F), FACT-An total score (TS) and anemia subscale score (AS), and EQ-5D-5L (EuroQol Research Foundation. EQ-5D is a trade mark of the EuroQol Research Foundation) visual analog scale (VAS), and utility score (US). Results: For 150 randomized pts (n=75/arm), most common reasons for initiating therapy were fatigue (61%), constitutional symptoms (32%), and anemia (32%). Baseline PRO scores were comparable in both arms. At a median follow-up of 26.5 mo, numerically more pts showed clinically meaningful improvement in FACIT-F, TS, and AS with IR than R (Table). Median time to PRO improvement was short (1-2 mo) in both arms. At week 25, the Pearson correlation coefficients were 0.28, 0.29, and 0.26 for changes in hemoglobin levels vs changes in FACIT-F, TS and AS, respectively, in the IR arm; no meaningful correlations were observed on R. The correlation coefficients were -0.32, -0.33, -0.35 and -0.26 for changes in IgM levels vs changes in FACIT-F, TS, AS, and EQ-VAS, respectively, for IR and 0.29 and 0.35 vs FACIT-F and TS for R. Conclusions: Clinical response and improvements in anemia with IR are consistent with more pts showing clinically meaningful improvement in PROs versus R. Changes in IgM correlate with improvements in PROs. Clinical trial information: NCT02165397. [Table: see text]
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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 | 0.005 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".