Evidence map›Paper›PMID 33638305›Full record

ArticleCancer medicine2021

A phase I trial of the mTOR inhibitor temsirolimus in combination with capecitabine in patients with advanced malignancies.

Neel D Trivedi, Samantha Armstrong, Hongkun Wang, Marion Hartley, John Deeken, A Ruth He, Deepa Subramaniam, Heather Melville, Chris Albanese, John L Marshall and 2 more

Open access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

7 citing papers in PubMed, 16 citations in OpenAlex.

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  7. Autophagy Modulators in Cancer Therapy.International journal of molecular sciences · 2021
    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

12 authors at 4 institutions in 1 country.

Neel D TrivediLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Samantha ArmstrongLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Hongkun WangLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Marion HartleyThe Ruesch Center for the Cure of Gastrointestinal Cancers, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.ORCID 0000-0001-5516-297X
John DeekenInova Schar Cancer Institute, Inova Health System, Falls Church, VA, USA.
A Ruth HeLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Deepa SubramaniamLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Heather MelvilleLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
Chris AlbaneseLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.
John L MarshallLombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, DC, USA.ORCID 0000-0002-3449-2344
Jimmy HwangLevine Cancer Institute, Carolinas HealthCare System, Charlotte, NC, USA.
Michael J PishvaianDepartment of Oncology, Johns Hopkins University School of Medicine, SKCC, Washington, DC, USA.ORCID 0000-0002-1165-9041
Georgetown University · USCarolinas Healthcare System · USInova Health System · USJohns Hopkins University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTemsirolimus is an mTOR antagonist with proven anticancer efficacy. Preclinical data suggest greater anticancer effect when mTOR inhibitors are combined with cytotoxic chemotherapy. We performed a Phase I assessment of the combination of temsirolimus and capecitabine in patients with advanced solid tumors.

methodsPatients were enrolled in an alternating dose escalation of temsirolimus (at 15 or 25 mg IV weekly) and capecitabine (at 750, 1000, and 1250 mg/m

resultsForty-five patients were enrolled and 41 were evaluable for dose-limiting toxicities (DLTs). The most common adverse events (AEs) were mucositis, fatigue, and thrombocytopenia. The most common grade 3/4 AEs were hypophosphatemia and anemia. Five patients had DLTs, including hypophosphatemia, mucositis, and thrombocytopenia. The RP2Ds were temsirolimus 25 mg +capecitabine 1000 mg/m

conclusionsThe combination of temsirolimus and capecitabine is safe on both a Q2-week and a Q3-week schedule. The combination demonstrated promising evidence of disease control in this highly refractory population and could be considered for testing in disease-specific phase II trials.

Indexed as

AdultAgedAnemiaAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCapecitabineDrug Administration ScheduleFatigueFemaleFeverHumansHypophosphatemiaMaleMiddle AgedMucositisNeoplasmsAntineoplastic AgentsCapecitabineMTOR protein, humanOxaliplatinSirolimustemsirolimusTOR Serine-Threonine Kinases5-fluorouracilcapecitabinecolorectal cancermTORtemsirolimus

Identifiers

PMID33638305
PMCPMC7957175
OpenAlexW3130087493

What OpenQuestion holds

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LicenceCC BY
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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.