Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 158 papers, 16 of them syntheses that pooled it.
What it found
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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
158 citing papers in PubMed, 16 syntheses or guidelines pooled it, 400 citations in OpenAlex.
- Expert consensus on the prevention and treatment of radiochemotherapy-induced oral mucositis.International journal of oral science · 2025Guideline
- Effectiveness of systemic treatments for advanced non-clear cell renal cell carcinoma: a systematic review and meta-analysis.Frontiers in oncology · 2024Pooled it
- Pooled it
- Systemic therapies for metastatic renal cell carcinoma in the second-line setting: A systematic review and network meta-analysis.Medicine · 2022Pooled it
- Kidney Cancer, Version 3.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022Guideline
- Targeted therapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2020Pooled it
- The Effectiveness of Sorafenib over Other Targeted Agents in the Second-Line Treatment of Metastatic Renal Cell Carcinoma: a Meta-Analysis.Pathology oncology research : POR · 2019Pooled it
- Pooled it
- Pooled it
- First-Line Treatments for Poor-Prognosis Metastatic Renal Cell Carcinoma: Experts' Prescribing Practices and Systematic Literature Review.Clinical drug investigation · 2016Pooled it
- Risk of treatment-related mortality with sorafenib in cancer patients: a meta-analysis of 20 randomly controlled trials : Risk of sorafenib-associated death.International journal of clinical pharmacy · 2015Pooled it
- Treatment-related fatigue with everolimus and temsirolimus in patients with cancer-a meta-analysis of clinical trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015Pooled it
- Pooled it
- Pooled it
- SEOM clinical guidelines for the treatment of renal cell carcinoma.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2014Guideline
- Pooled it
- A phase II study of alternating sunitinib and temsirolimus therapy in patients with metastatic renal cell carcinoma.Cancer medicine · 2023Trial
- Temsirolimus versus Pazopanib (TemPa) in Patients with Advanced Clear-cell Renal Cell Carcinoma and Poor-risk Features: A Randomized Phase II Trial.European urology oncology · 2020Trial
- Safety and efficacy of temsirolimus as second line treatment for patients with recurrent bladder cancer.BMC cancer · 2018Trial
- Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma.The New England journal of medicine · 2015Trial
98 more citing papers are in PubMed but not listed here.
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Authors and funding
11 authors at 1 institution in 1 country.
Funding
Abstract
purposeThis international phase III trial (Investigating Torisel As Second-Line Therapy [INTORSECT]) compared the efficacy of temsirolimus (mammalian target of rapamycin inhibitor) and sorafenib (vascular endothelial growth factor receptor [VEGFR] tyrosine kinase inhibitor) as second-line therapy in patients with metastatic renal cell carcinoma (mRCC) after disease progression on sunitinib. PATIENTS AND
methodsIn total, 512 patients were randomly assigned 1:1 to receive intravenous temsirolimus 25 mg once weekly (n = 259) or oral sorafenib 400 mg twice per day (n = 253), with stratification according to duration of prior sunitinib therapy (≤ or > 180 days), prognostic risk, histology (clear cell or non-clear cell), and nephrectomy status. The primary end point was progression-free survival (PFS) by independent review committee assessment. Safety, objective response rate (ORR), and overall survival (OS) were secondary end points.
resultsPrimary analysis revealed no significant difference between treatment arms for PFS (stratified hazard ratio [HR], 0.87; 95% CI, 0.71 to 1.07; two-sided P = .19) or ORR. Median PFS in the temsirolimus and sorafenib arms were 4.3 and 3.9 months, respectively. There was a significant OS difference in favor of sorafenib (stratified HR, 1.31; 95% CI, 1.05 to 1.63; two-sided P = .01). Median OS in the temsirolimus and sorafenib arms was 12.3 and 16.6 months, respectively. Safety profiles of both agents were consistent with previous studies.
conclusionIn patients with mRCC and progression on sunitinib, second-line temsirolimus did not demonstrate a PFS advantage compared with sorafenib. The longer OS observed with sorafenib suggests sequenced VEGFR inhibition may benefit patients with mRCC.
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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.