Evidence map›Paper›PMID 24914044›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2014

A phase I/II study of lenalidomide in combination with sunitinib in patients with advanced or metastatic renal cell carcinoma.

B Rini, B Redman, J A Garcia, H A Burris, S Li, A Fandi, R Beck, U Jungnelius, J R Infante

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00975806 (A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

NCT00975806 phase1 / phase2terminatednot on this map

A Phase 1/2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Efficacy of Lenalidomide in Combination With Sunitinib in Subjects With Advanced or Metastatic Renal Cell Carcinoma

TypeinterventionalSponsorCelgeneRan2009 to 2011Enrolled16ConditionsRenal Cell CarcinomaArmsLenalidomide, Sunitinib
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

B RiniDepartment of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Glickman Urological Institute, Cleveland. Electronic address: rinib2@ccf.org.
B RedmanDivision of Hematology/Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor.
J A GarciaDepartment of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute, Glickman Urological Institute, Cleveland.
H A BurrisSarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville.
S LiCelgene Corporation.
A FandiCelgene Corporation.
R BeckCelgene Corporation.
U JungneliusCelgene Corporation.
J R InfanteSarah Cannon Research Institute/Tennessee Oncology, PLLC, Nashville.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase I/II study was conducted to determine the maximum tolerated dose (MTD), safety, and efficacy of lenalidomide plus sunitinib in metastatic renal cell carcinoma (RCC) patients. PATIENTS AND

methodsPatients with histologically confirmed, metastatic RCC were treated with 10 mg/day lenalidomide plus 37.5 mg/day sunitinib, orally in 21-day cycles. Doses were escalated to determine the MTD in phase I, with additional patients planned at this dose in phase II. Primary end points were MTD and response rate.

resultsSixteen patients received a median of 2, 3, and 5 cycles in cohort 1 [lenalidomide 10 mg (days 1-21) and sunitinib 37.5 mg (days 1-21)], cohort 2 [lenalidomide 10 mg (days 1-21) and sunitinib 37.5 mg (days 1-14)], and cohort 3 [lenalidomide 15 mg (days 1-21) and sunitinib 37.5 mg (days 1-14)], respectively. Median treatment durations were 41, 63, and 97 days for lenalidomide; and 41, 57, and 97.5 days for sunitinib. The MTD was found to be continuous dosing of lenalidomide 10 mg/day plus sunitinib 37.5 mg/day for 14 of 21 days. Dose-limiting toxicities included neutropenia, leukopenia, thrombocytopenia, asthenia, atrial fibrillation, and increased transaminases. The most frequent grade 3-4 treatment-emergent adverse events were hematologic, including neutropenia and leukopenia. One patient achieved partial response, and seven had stable disease of which three were confirmed at subsequent tumor assessments. B cells and several T-cell subsets were modulated versus baseline.

conclusionThe dose schedules of lenalidomide and sunitinib evaluated in this study were not well tolerated; cumulative toxicity precluded enrollment at the MTD.

Indexed as

AdultAgedAngiogenesis InhibitorsAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Renal CellDrug Administration ScheduleFemaleHumansIndolesKidney NeoplasmsLenalidomideMaleMaximum Tolerated DoseMiddle AgedPyrrolesAngiogenesis InhibitorsAntineoplastic AgentsIndolesLenalidomidePyrrolesSunitinibThalidomidelenalidomidemaximum tolerated dosemetastatic renal cell carcinomaphase I/IIsunitinib

Identifiers

PMID24914044
PMCPMC4311191

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Registered trials

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