Background: Treatment toxicity and disease-related symptoms of metastatic colorectal cancer (mCRC) can adversely affect quality of life (QoL). Maintaining QoL is an important treatment goal alongside improving survival outcomes. Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST) measures the quality of patients' survival by assessing the proportion of survival time that is free of symptoms/toxicity. The phase III FRESCO-2 study met its primary endpoint, demonstrating improved overall survival with fruquintinib plus best supportive care (BSC) versus placebo plus BSC [hazard ratio 0.66, 95% confidence interval (CI) 0.55-0.80, P < 0.001]. This post hoc Q-TWiST analysis compared the benefit-risk of fruquintinib versus placebo in all patients randomized in FRESCO-2.
Methods: Patients with refractory mCRC in the USA, Europe, Japan, and Australia were randomized to receive fruquintinib (n = 461) or placebo (n = 230) plus BSC until disease progression or unacceptable toxicity. Patients' survival time was partitioned as follows: time from randomization with grade 3/4 treatment-emergent adverse events (TEAEs) before progression (TOX); time from randomization to progression without grade 3/4 TEAEs (TWiST); and time from progression to death/censoring (REL). Q-TWiST was calculated as the combined utility-weighted mean durations of each health state, assuming utility coefficients of 1 for TWiST and 0.5 for TOX and REL.
Results: Q-TWiST was improved when fruquintinib (versus placebo) was added to BSC, with a between-treatment difference of 2.0 months (95% CI 1.5-2.6 months, P < 0.05) and a relative improvement of 31.4%. This effect was primarily driven by the difference in the TWiST component [mean difference 2.1 months (95% CI 1.8-2.5 months), P < 0.05]. Q-TWiST improvements were consistent in all subgroups, including by age, sex, liver metastases, and primary tumor site. The subgroup and sensitivity analysis results confirmed the robustness of the primary analysis findings.
Conclusions: Fruquintinib provides a clinically meaningful quality-adjusted survival benefit versus placebo in refractory mCRC.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.esmoop.2025.104297 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Association of COMT genetic polymorphism with neuromodulation treatment response in women with fecal or urinary incontinence.
Am J Obstet Gynecol
March 2025
Social, Statistical, & Environmental Sciences, RTI International, Research Triangle Park, NC, United States.
Background: Prior studies have failed to demonstrate clinical or statistical difference in fecal incontinence (FI) symptom improvement with neuromodulation by percutaneous tibial nerve stimulation (PTNS) vs sham. The results of these studies may be indicative of a placebo or sham effect and led us to investigate possible genetic biomarkers of placebo response among women with FI.
Objective: To evaluate the relationship between response to PTNS or sham and genetic polymorphisms associated with placebo response in women with FI.
Value of tacrolimus 0.1% in the treatment of vitiligo in the era of targeted therapy.
Ann Dermatol Venereol
March 2025
Centre of Evidence of the French Society of Dermatology, Paris, France; Montpellier University, Montpellier, France. Electronic address:
Background: Vitiligo, a prevalent depigmenting condition, affects both adults and children, significantly impacting their quality of life. The standard treatment approach involves the application of topical corticosteroids in conjunction with narrow-band ultraviolet B (UVB) phototherapy. A novel topical treatment, ruxolitinib (a Janus kinase inhibitor), has recently received approval.
View Article and Find Full Text PDFA Controlled Trial for Preventing Priapism in Sickle Cell Anemia: Hydroxyurea plus Placebo vs Hydroxyurea plus Tadalafil.
Blood
March 2025
Vanderbilt UniversityVanderbilt-Meharry Center of Excellence in Sickle Cell Disease, Nashville, Tennessee, United States.
Recurrent ischemic priapism is a common complication of sickle cell anemia (SCA) and is associated with devastating physical and psychosocial consequences. All previous trials for priapism prevention have failed to demonstrate clear efficacy. We conducted a randomized, controlled, double-blind phase 2 feasibility trial comparing fixed moderate-dose hydroxyurea plus placebo (usual care arm) versus fixed moderate-dose hydroxyurea plus tadalafil (experimental arm) in 64 men (18- 40 years) with at least three episodes of SCA-related priapism in the past 12 months.
View Article and Find Full Text PDFBackground: Kidney transplantation (KT) has dramatically improved the quality of life of patients with end-stage kidney disease. However, the incidence of opportunistic infections has also increased because of immunosuppression. A common infection after KT is cytomegalovirus (CMV).
View Article and Find Full Text PDFVedolizumab for prevention of lower-GI acute GVHD in the Japanese subgroup analysis of the phase 3 GRAPHITE study.
Int J Hematol
March 2025
Department of Hematology, Hokkaido University Faculty of Medicine, Sapporo, Japan.
In the randomized, double-blind, phase 3 GRAPHITE study (NCT03657160), anti-αβ integrin antibody vedolizumab showed greater efficacy than placebo for prevention of lower-gastrointestinal (GI) acute graft-versus-host disease (aGVHD) after unrelated allogenic hematopoietic stem cell transplantation (allo-HSCT). This post hoc analysis assessed the efficacy and safety of vedolizumab versus placebo for lower-GI aGVHD prevention in Japanese and non-Japanese patients, when added to standard GVHD prophylaxis (calcineurin inhibitor + methotrexate/mycophenolate mofetil + / - anti-thymocyte globulin [ATG]). The analysis included 35 (18 vedolizumab-treated, 17 placebo-treated) Japanese and 298 (150 vedolizumab-treated, 148 placebo-treated) non-Japanese patients.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!