Trial reportMedical oncology (Northwood, London, England)2015
Improved health-related quality of life of patients with metastatic renal cell carcinoma treated with a 2 weeks on and 1 week off schedule of sunitinib.
Trial report in Medical oncology (Northwood, London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 4 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Tolerability of Alternative Dosing Schedules for Sunitinib: A Systematic Review and Meta-Analysis.Yonsei medical journal · 2020Pooled it
- A 2/1 Sunitinib Dosing Schedule Provides Superior Antitumor Effectiveness and Less Toxicity Than a 4/2 Schedule for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis.Frontiers in oncology · 2020Pooled it
- Pooled it
- Population Pharmacokinetic/Pharmacodynamic Modeling of Sunitinib by Dosing Schedule in Patients with Advanced Renal Cell Carcinoma or Gastrointestinal Stromal Tumor.Clinical pharmacokinetics · 2016Pooled it
- Safety and Efficacy of Bis-Glyceryl Ascorbate as Prophylaxis for Hand-Foot Skin Reaction: A Single-Arm, Open-Label Phase I/II Study (DGA Study).The oncologist · 2022Trial
- A Systematic Evaluation of the Dosing Regimens for Approved Targeted Therapies and Immune Checkpoint Inhibitors in Metastatic Renal Cell Carcinoma From a Project OPTIMUS Perspective.Journal of clinical pharmacology · 2025Review
- Thyroid profile during the alternative Sunitinib dosing 2/1 schedule in metastatic renal cell carcinoma.Endocrine · 2020Observational
- Tolerability and outcome of sunitinib by giving 4/2 schedule versus 2/1 schedule in metastatic renal cell carcinoma patients: a prospective randomized multi-centric Egyptian study.Contemporary oncology (Poznan, Poland) · 2020Article
- Review
- Safety and Efficacy of Bis-Glyceryl Ascorbate (Amitose DGA) to Prevent Hand-Foot Skin Reaction in Patients With Renal Cell Carcinoma Receiving Sunitinib Therapy: Protocol for a Phase I/II, Uncontrolled, Single-Arm, Open-Label Trial.JMIR research protocols · 2019Article
- Therapy Management Using Modified 2-Weeks-On/1-Week-Off Dosing Schedule in Patients With Metastatic Renal Cell Carcinoma Receiving Sunitinib: A Hypothetical, Illustrative Case Scenario.Journal of the advanced practitioner in oncology · 2019Article
- Significance of introduction of alternative dosing schedule for sunitinib during first-line treatment of patients with metastatic renal cell carcinoma.Medical oncology (Northwood, London, England) · 2018Article
- Evaluation of relative dose intensity during the early phase of first-line sunitinib treatment using a 2-week-on/1-week-off regimen for metastatic renal cell carcinoma.Medical oncology (Northwood, London, England) · 2018Article
- Improved Long-Term Clinical Outcomes And Safety Profile Of Sunitinib Dosing Schedule With 4/2 Switched To 2/1 In Patients With Metastatic Renal Cell Carcinoma.Journal of Cancer · 2018Article
- Comparison of efficacy, safety, and quality of life between sorafenib and sunitinib as first-line therapy for Chinese patients with metastatic renal cell carcinoma.Chinese journal of cancer · 2017Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The objective of this study was to investigate the significance of changes from the standard dosing schedule of sunitinib, which is 4 weeks of treatment and 2 weeks off (schedule 4/2), to an alternative schedule with 2 weeks of treatment and 1 week off (schedule 2/1), after encountering dose-limiting toxicity in 45 consecutive Japanese patients with metastatic renal cell carcinoma (mRCC). Despite a definitively improved relative dose intensity of sunitinib by changing from schedule 4/2 to 2/1, this difference was not significant. Adverse events (AEs) occurred in all patients on both schedules 4/2 and 2/1; however, the proportion of patients experiencing AEs ≥ grade 3 on schedule 2/1 was significantly lower than that on schedule 4/2. Quality of life (QOL) analysis using SF-36 revealed that all eight scores during schedule 2/1 were more favorable than those during schedule 4/2, and there were significant differences in 2 of the 8 scores between these two schedules. Furthermore, multivariate analyses, which were performed to evaluate the contribution of several AEs on schedule 2/1 to the improvement of each score in SF-36, revealed that fatigue had independent impacts on two scores, despite the lack of an independent association between any scores and the remaining AEs examined. These findings suggest that schedule 2/1 is the optimal dosing schedule of sunitinib against mRCC that balances efficacy and toxicity, since treatment on schedule 2/1 resulted in a markedly improved QOL compared with that on schedule 4/2 by relieving the profile of sunitinib-related AEs.
Indexed as
Identifiers
25698532What 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.