Evidence map›Paper›PMID 21447615›Full record

ArticleAnnals of oncology : official journal of the European Society for Medical Oncology2012

Temsirolimus in combination with carboplatin and paclitaxel in patients with advanced solid tumors: a NCIC-CTG, phase I, open-label dose-escalation study (IND 179).

C Kollmannsberger, H Hirte, L L Siu, J Mazurka, K Chi, L Elit, W Walsh, J Sederias, A Doyle, E A Eisenhauer and 1 more

Open access · bronzeAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Annals of oncology : official journal of the European Society for Medical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.5field-weighted citation impact, top 9% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 39 citations in OpenAlex.

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  9. New therapies for advanced, recurrent, and metastatic endometrial cancers.Gynecologic oncology research and practice · 2017
    Review
  10. A Review of mTOR Pathway Inhibitors in Gynecologic Cancer.Oxidative medicine and cellular longevity · 2017
    Review
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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

11 authors at 5 institutions in 2 countries.

C KollmannsbergerDivision of Medical Oncology, BC Cancer Agency, Vancouver Cancer Centre, Vancouver.
H HirteDivision of Medical Oncology, Juravinski Cancer Centre, Hamilton.
L L SiuPrincess Margaret Hospital, University Health Network, Drug Development Program, University of Toronto, Toronto.
J MazurkaDivision of Gynecologic Oncology, Juravinski Cancer Centre, Hamilton.
K ChiDivision of Medical Oncology, BC Cancer Agency, Vancouver Cancer Centre, Vancouver.
L ElitDivision of Gynecologic Oncology, Juravinski Cancer Centre, Hamilton.
W WalshNational Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Canada.
J SederiasNational Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Canada.
A DoyleCancer Therapy Evaluation Program, National Cancer Institute, Bethesda, USA.
E A EisenhauerNational Cancer Institute of Canada Clinical Trials Group, Queen's University, Kingston, Canada.
A M OzaPrincess Margaret Hospital, University Health Network, Drug Development Program, University of Toronto, Toronto. Electronic address: amit.oza@uhn.on.ca.
Juravinski Cancer Centre · CAQueen's University · CABC Cancer Agency · CANational Cancer Institute · USPrincess Margaret Cancer Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe purpose of the study was to assess the safety, tolerability, recommended phase II dose (RPTD), and preliminary antitumor activity of the combination of carboplatin-paclitaxel (Taxol)-temsirolimus. MATERIALS AND

methodsPatients with solid malignancies suitable for carboplatin-paclitaxel (CP) chemotherapy and two or less prior lines of chemotherapy received 15, 20, or 25 mg of temsirolimus per week with CP given every 21 days. Thirty-eight eligible patients were entered into six dose levels with the first two levels administering temsirolimus on days 8 and 15 and the subsequent four dose levels switching to days 1 and 8 temsirolimus administration.

resultsDays 8 and 15 administration of temsirolimus was not feasible due to myelosuppression on day 15. CP on day 1 with temsirolimus on days 1 and 8 was well tolerated. Dose-limiting toxicity (DLT) was grade 4 thrombocytopenia (n=2) and grade 3 fatigue (n=1). Relative dose intensities for carboplatin, paclitaxel, and temsirolimus at the RPTD were 92%, 82%, and 56%, respectively. Non-DLT treatment-related adverse events occurring in >20% of patients included fatigue, mucositis, alopecia, neuropathy, nausea, neutropenia, thrombocytopenia, and infection. Grade 3/4 non-hematological toxicity was rare. Partial responses (PRs) and disease stabilization were seen in 46% and 49% of patients, respectively. Nine of 11 (82%) endometrial cancer patients had objective PRs.

conclusionCarboplatin-paclitaxel-temsirolimus is well tolerated and the RPTD is carboplatin area under the curve 5 mg/ml/min, paclitaxel 175 mg/m2, both given on day 1 with temsirolimus 25 mg on days 1 and 8.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDose-Response Relationship, DrugFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsPaclitaxelSirolimusCarboplatinPaclitaxelSirolimustemsirolimus

Identifiers

PMID21447615
PMCPMC8890459
OpenAlexW2099712757

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.