Evidence map›Paper›PMID 16443950›Full record

ArticleNeuro-oncology2006

Phase 1 study of erlotinib HCl alone and combined with temozolomide in patients with stable or recurrent malignant glioma.

Michael D Prados, Kathleen R Lamborn, Susan Chang, Eric Burton, Nicholas Butowski, Mary Malec, Ami Kapadia, Jane Rabbitt, Margaretta S Page, Ann Fedoroff and 2 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuro-oncology, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00770263 (Phase I Study of Erlotinib and Temsirolimus in Resistant Solid Malignancies), which is not on this map. Cited by 88 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed, 2 pooled it
15.6field-weighted citation impact, top 1% 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.

NCT00770263 phase1completednot on this mapstarted 2009, after this paper: background citation

Phase I Study of Erlotinib and Temsirolimus in Resistant Solid Malignancies

TypeinterventionalSponsorWashington University School of MedicineRan2009 to 2014Enrolled46ConditionsSolid TumorsArmsErlotinib, Temsirolimus
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 2 syntheses or guidelines pooled it, 217 citations in OpenAlex.

  1. Management of epilepsy in brain tumors.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2019
    Guideline
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  15. Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
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28 more citing papers are in PubMed but not listed here.

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 1 institution in 1 country.

Michael D PradosDepartment of Neurosurgery, University of California, San Francisco, CA 94143-0372, USA. pradosm@neurosurg.ucsf.edu
Kathleen R Lamborn
Susan Chang
Eric Burton
Nicholas Butowski
Mary Malec
Ami Kapadia
Jane Rabbitt
Margaretta S Page
Ann Fedoroff
Dong Xie
Sean K Kelley
University of California, San Francisco · US

Funding

Tissue CoreP50CA097257 · NCI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Joseph F Costello · 2002 to 2026
$57.4M
ZD1839 FOR MALIGNANT ASTROCYTOMA OR GLIOBLASTOMA AND MENINGIOMAM01RR000079 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$26.0M
PROGRAMS FOR TREATMENT OF MALIGNANT BRAIN TUMORSP01NS042927 · NINDS · UNIVERSITY OF CALIFORNIA SAN FRANCISCO · PI BERGER, MITCHEL S. · 2001 to 2004
$6.7M
NCI NIH HHS P50 CA097257NCI NIH HHS P50-CA097257NCRR NIH HHS M01 RR000079NCRR NIH HHS M01-RR00079NINDS NIH HHS P01 NS042927NINDS NIH HHS P01-NS42927
6 · The paper itself

Abstract

The purpose of this study was to define the maximum tolerated dose of erlotinib and characterize its pharmaco-kinetics and safety profile, alone and with temozolomide, with and without enzyme-inducing antiepileptic drugs (EIAEDs), in patients with malignant gliomas. Patients with stable or progressive malignant primary glioma received erlotinib alone or combined with temozolomide in this dose-escalation study. In each treatment group, patients were stratified by coadministration of EIAEDs. Erlotinib was started at 100 mg orally once daily as a 28-day treatment cycle, with dose escalation by 50 mg/day up to 500 mg/day. Temozolomide was administered at 150 mg/m2 for five consecutive days every 28 days, with dose escalation up to 200 mg/m2 at the second cycle. Eightythree patients were evaluated. Rash, fatigue, and diarrhea were the most common adverse events and were generally mild to moderate. The recommended phase 2 dose of erlotinib is 200 mg/day for patients with glioblastoma multiforme who are not receiving an EIAED, 450 mg/day for those receiving temozolomide plus erlotinib with an EIAED, and at least 500 mg/day for those receiving erlotinib alone with an EIAED. Of the 57 patients evaluable for response, eight had a partial response (PR). Six of the 57 patients had a progression-free survival of longer than six months, including four patients with a PR. Coadministration of EIAEDs reduced exposure to erlotinib as compared with administration of erlotinib alone (33%-71% reduction). There was a modest pharmacokinetic interaction between erlotinib and temozolomide. The favorable tolerability profile and evidence of antitumor activity indicate that further investigation of erlotinib is warranted.

Indexed as

AdultAgedAnticonvulsantsAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsDacarbazineDose-Response Relationship, DrugDrug InteractionsErlotinib HydrochlorideFemaleGliomaHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm Recurrence, LocalAnticonvulsantsDacarbazineErlotinib HydrochlorideQuinazolinesTemozolomide

Identifiers

PMID16443950
PMCPMC1871925
OpenAlexW2115078677

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.