Evidence map›Paper›PMID 22878749›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2012

A phase I study of erlotinib and hydroxychloroquine in advanced non-small-cell lung cancer.

Sarah B Goldberg, Jeffrey G Supko, Joel W Neal, Alona Muzikansky, Subba Digumarthy, Panos Fidias, Jennifer S Temel, Rebecca S Heist, Alice T Shaw, Patricia O McCarthy and 4 more

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01026844 (A Phase I Study of Hydroxychloroquine With or Without Erlotinib in Advanced NSCLC), which is not on this map. Cited by 100 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 1 pooled it
9.0field-weighted citation impact, top 2% 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.

NCT01026844 phase1terminatednot on this map

A Phase I Study of Hydroxychloroquine With or Without Erlotinib in Advanced NSCLC

TypeinterventionalSponsorMassachusetts General HospitalRan2007 to 2012Enrolled27ConditionsNon-small Cell Lung CancerArmserlotinib, hydroxychloroquine
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 1 synthesis or guideline pooled it, 167 citations in OpenAlex.

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40 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

14 authors at 5 institutions in 1 country.

Sarah B GoldbergMassachusetts General Hospital Cancer Center, Boston, MA, USA.
Jeffrey G Supko
Joel W Neal
Alona Muzikansky
Subba Digumarthy
Panos Fidias
Jennifer S Temel
Rebecca S Heist
Alice T Shaw
Patricia O McCarthy
Thomas J Lynch
Sreenath Sharma
Jeffrey E Settleman
Lecia V Sequist
Harvard University · USCancer Prevention Institute of California · USMassachusetts General Hospital · USNovartis (United States) · USYale Cancer Center · US

Funding

Translational studies of Hsp90 inhibitors in NSCLCP50CA090578 · NCI · DANA-FARBER CANCER INST · PI JOHNSON, BRUCE D · 2008 to 2012
$11.4M
NCI NIH HHS P50 CA090578
6 · The paper itself

Abstract

introductionThis investigator-initiated study explores the safety, maximum tolerated dose, clinical response, and pharmacokinetics of hydroxychloroquine (HCQ) with and without erlotinib in patients with advanced non-small-cell lung cancer.

methodsPatients with prior clinical benefit from an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor were randomized to HCQ or HCQ plus erlotinib in a 3 + 3 dose-escalation schema.

resultsTwenty-seven patients were treated, eight with HCQ (arm A) and 19 with HCQ plus erlotinib (arm B). EGFR mutations were detected in 74% of the patients and 85% had received two or more prior therapies. Arm A had no dose-limiting toxicities, but the maximum tolerated dose was not reached as this arm closed early to increase overall study accrual. In arm B, one patient each experienced grade 3 rash, nail changes, skin changes, nausea, dehydration, and neutropenia; one had grade 4 anemia; and one developed fatal pneumonitis, all considered unrelated to HCQ. There were no dose-limiting toxicities, therefore the highest tested dose for HCQ with erlotinib 150 mg was 1000 mg daily. One patient had a partial response to erlotinib/HCQ, for an overall response rate of 5% (95% confidence interval, 1-25). This patient had an EGFR mutation and remained on therapy for 20 months. Administration of HCQ did not alter the pharmacokinetics of erlotinib.

conclusionsHCQ with or without erlotinib was safe and well tolerated. The recommended phase 2 dose of HCQ was 1000 mg when given in combination with erlotinib 150 mg.

Indexed as

AdenocarcinomaAdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungEnzyme InhibitorsErbB ReceptorsEverolimusFemaleFollow-Up StudiesHumansHydroxychloroquineImmunosuppressive AgentsLung NeoplasmsMaleMaximum Tolerated DoseEGFR protein, humanEnzyme InhibitorsErbB ReceptorsEverolimusHydroxychloroquineImmunosuppressive AgentsSirolimus

Identifiers

PMID22878749
PMCPMC3791327
OpenAlexW2084838499

What OpenQuestion holds

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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.