Trial reportHaematologica2014
Comparison of placebo and best available therapy for the treatment of myelofibrosis in the phase 3 COMFORT studies.
Trial report in Haematologica, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Study of Ruxolitinib Tablets Compared to Best Available Therapy in Subjects With Primary Myelofibrosis, Post-Polycythemia Vera-Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor INCB018424 Tablets Administered Orally to Subjects With Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis
Who cites it
23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 39 citations in OpenAlex.
- Comparative efficacy and hematologic safety of different dosages of JAK inhibitors in the treatment of myelofibrosis: a network meta-analysis.Frontiers in oncology · 2024Pooled it
- Janus kinase-1 and Janus kinase-2 inhibitors for treating myelofibrosis.The Cochrane database of systematic reviews · 2015Pooled it
- A pooled analysis of overall survival in COMFORT-I and COMFORT-II, 2 randomized phase III trials of ruxolitinib for the treatment of myelofibrosis.Haematologica · 2015Trial
- Comparative effectiveness of an adult social physical play versus traditional group exercise program for adherence and fitness: Protocol for a randomized-controlled trial.Contemporary clinical trials communications · 2021Article
- Enhanced engraftment of human myelofibrosis stem and progenitor cells in MISTRG mice.Blood advances · 2020Article
- Tuberculosis Peritonitis During Treatment of Polycythemia Vera with Ruxolitinib.Infection and drug resistance · 2020Article
- Development of a symptom assessment in patients with myelofibrosis: qualitative study findings.Health and quality of life outcomes · 2019Article
- Working to Increase Stability through Exercise (WISE): Study protocol for a pragmatic randomized controlled trial of a coached exercise program to reduce serious fall-related injuries.Contemporary clinical trials · 2018Article
- Novel Therapies for Myelofibrosis.Current hematologic malignancy reports · 2017Review
- Review
- CBL family E3 ubiquitin ligases control JAK2 ubiquitination and stability in hematopoietic stem cells and myeloid malignancies.Genes & development · 2017Article
- Which patients with myelofibrosis should receive ruxolitinib therapy? ELN-SIE evidence-based recommendations.Leukemia · 2017Article
- Experience with ruxolitinib in the treatment of polycythaemia vera.Therapeutic advances in hematology · 2017Review
- Overcoming treatment challenges in myelofibrosis and polycythemia vera: the role of ruxolitinib.Cancer chemotherapy and pharmacology · 2016Review
- Effect of treatment with a JAK2-selective inhibitor, fedratinib, on bone marrow fibrosis in patients with myelofibrosis.Journal of translational medicine · 2015Article
- Review
- Methotrexate Is a JAK/STAT Pathway Inhibitor.PloS one · 2015Article
- Novel therapies for myelofibrosis.Leukemia & lymphoma · 2015Review
- Nucleo-cytoplasmic transport as a therapeutic target of cancer.Journal of hematology & oncology · 2014Review
- Novel myelofibrosis treatment strategies: potential partners for combination therapies.Leukemia · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
35 authors at 20 institutions in 12 countries.
Funding
Abstract
Prior to Janus kinase inhibitors, available therapies for myelofibrosis were generally supportive and did not improve survival. This analysis compares efficacy outcomes of patients with myelofibrosis in the control arms (placebo [n=154] and best available therapy [n=73]) from the two phase 3 COntrolled MyeloFibrosis study with ORal JAK inhibitor Treatment (COMFORT) studies. Spleen volume was assessed by magnetic resonance imaging/computed tomography at baseline and every 12 weeks through week 72; spleen length was assessed by palpation at each study visit. Health-related quality of life and symptoms were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items at baseline and in weeks 4, 8, 12, 16 and 24 in COMFORT-I and in weeks 8, 16, 24 and 48 in COMFORT-II. The demographic and baseline characteristics were similar between the control arms of the two studies. One patient who received placebo and no patients who received best available therapy had a ≥35% reduction in spleen volume from baseline at week 24. At 24 weeks, neither placebo nor best available therapy had produced clinically meaningful changes in global quality of life or symptom scales. Non-hematologic adverse events were mostly grade 1/2; the most frequently reported adverse events in each group were abdominal pain, fatigue, peripheral edema and diarrhea. These data suggest that non-Janus kinase inhibitor therapies provide little improvement in splenomegaly, symptoms or quality of life as compared with placebo. Both COMFORT-I (NCT00952289) and COMFORT-II (NCT00934544) studies have been appropriately registered with clinicaltrials.gov.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.