Trial reportThe oncologist2011
Patient-reported outcomes in a phase iii study of everolimus versus placebo in patients with metastatic carcinoma of the kidney that has progressed on vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy.
Trial report in The oncologist, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.
- First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis.The Cochrane database of systematic reviews · 2023Pooled it
- Risk of infections in renal cell carcinoma (RCC) and non-RCC patients treated with mammalian target of rapamycin inhibitors.British journal of cancer · 2013Pooled it
- Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018Trial
- Active surveillance in metastatic renal-cell carcinoma: a prospective, phase 2 trial.The Lancet. Oncology · 2016Trial
- Quality of life in patients with metastatic renal cell carcinoma: assessment of long-term survivors.Clinical genitourinary cancer · 2013Trial
- Patient-reported outcomes for axitinib vs sorafenib in metastatic renal cell carcinoma: phase III (AXIS) trial.British journal of cancer · 2013Trial
- Using three-dimensional model-based tumour volume change to predict the symptom improvement in patients with renal cell cancer.3 Biotech · 2024Article
- Analyses of quality of life in cancer drug trials - a review of measurements and analytical choices in post-reimbursement studies.BMC cancer · 2024Review
- Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?Clinical drug investigation · 2023Review
- Patient-derived renal cell carcinoma organoids for personalized cancer therapy.Clinical and translational medicine · 2022Article
- The impact of targeted therapy on healthcare resource use in patients with metastatic renal cell carcinoma: The University of Sherbrooke experience.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2018Article
- Renal cell carcinoma.Nature reviews. Disease primers · 2017Review
- Review
- Everolimus in the management of metastatic renal cell carcinoma: an evidence-based review of its place in therapy.Core evidence · 2016Review
- The Role of Everolimus in Renal Cell Carcinoma.Journal of kidney cancer and VHL · 2015Review
- Assessment of health-related quality of life in Japanese patients with metastatic renal cell carcinoma during treatment with tyrosine kinase inhibitors.Medical oncology (Northwood, London, England) · 2014Article
- General population norms for the Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI).Cancer · 2013Article
- Quality of life and targeted treatment for metastatic renal cell carcinoma.The oncologist · 2011Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
Abstract
purposeA phase III, randomized, double-blind, placebo-controlled trial was conducted in patients with metastatic renal cell carcinoma. The focus of this paper is to evaluate the patient-reported outcomes.
methodsPatients were randomly assigned (2:1) to receive oral everolimus 10 mg once daily or placebo. The Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) and European Organization for the Research and Treatment of Cancer (EORTC) QLQ-C30 were administered before randomization and on day 1 of each cycle. The FKSI-DRS and the EORTC QLQ-C30 Physical Functioning and Global Quality of Life scores were the primary endpoints examined. Longitudinal models were used to compare treatment arms. Sensitivity analyses were conducted to explore the impact of missing data assumptions.
resultsLongitudinal trends for FKSI-DRS scores did not differ by treatment arm. Taking nonignorable missing data into account, there were significant differences between treatment arms in the trend over time for physical functioning and global quality of life, with the everolimus arm exhibiting greater decreases. All three of these measures of health-related quality of life were significantly related to progression-free survival.
conclusionsThere was no evidence of a difference between everolimus and placebo in longitudinal patterns of disease-related symptoms, and little difference between the arms in physical functioning or global quality of life trends. This supports the conclusion that delay in tumor progression demonstrated by everolimus is associated with minimal impact on symptoms, physical functioning, or quality of life, as reported by patients.
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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.