Evidence map›Paper›PMID 22371453›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2012

A phase II study of lapatinib in recurrent/metastatic squamous cell carcinoma of the head and neck.

Jonas A de Souza, Darren W Davis, Yujian Zhang, Arun Khattri, Tanguy Y Seiwert, Serdal Aktolga, Stuart J Wong, Mark F Kozloff, Sreenivasa Nattam, Mark W Lingen and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
9.8field-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.

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

46 citing papers in PubMed, 113 citations in OpenAlex.

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  13. Nephrotoxicity in cancer treatment: An overview.World journal of clinical oncology · 2020
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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

17 authors at 5 institutions in 1 country.

Jonas A de SouzaSection of Hematology/Oncology, Department of Medicine, The University of Chicago Medical Center, Chicago, Illinois, USA.
Darren W Davis
Yujian Zhang
Arun Khattri
Tanguy Y Seiwert
Serdal Aktolga
Stuart J Wong
Mark F Kozloff
Sreenivasa Nattam
Mark W Lingen
Rangesh Kunnavakkam
Kerstin M Stenson
Elizabeth A Blair
Jeffrey Bozeman
Janet E Dancey
Everett E Vokes
Ezra E W Cohen
Ingalls Memorial Hospital · USMedical College of Wisconsin · USFWRadiology · USUniversity of Chicago · USUniversity of Chicago Medical Center · US

Funding

VIRAL ONCOLOGY CORE FACILITYP30CA014599 · NCI · UNIVERSITY OF CHICAGO · PI MARK W. LINGEN · 1985 to 2026
$122.1M
NKLAM--A NOVEL GENE REQUIRED FOR NK FUNCTIONR01CA062201 · NCI · UNIVERSITY OF ARKANSAS MED SCIS LTL ROCK · PI KORNBLUTH, JACKI · 1994 to 1996
–
NCI NIH HHS N01 CM062201NCI NIH HHS N01-CM-17102NCI NIH HHS P30 CA014599NCI NIH HHS P30 CA14599
6 · The paper itself

Abstract

purposeThis study sought to determine the efficacy and safety profile of lapatinib in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN). EXPERIMENTAL

designThis phase II multiinstitutional study enrolled patients with recurrent/metastatic SCCHN into two cohorts: those without (arm A) and those with (arm B) before exposure to an epidermal growth factor receptor (EGFR) inhibitor. All subjects were treated with lapatinib 1,500 mg daily. Primary endpoints were response rate (arm A) and progression-free survival (PFS; arm B). The biologic effects of lapatinib on tumor growth and survival pathways were assessed in paired tumor biopsies obtained before and after therapy.

resultsForty-five patients were enrolled, 27 in arm A and 18 in arm B. Diarrhea was the most frequent toxicity occurring in 49% of patients. Seven patients experienced related grade 3 toxicity (3 fatigue, 2 hyponatremia, 1 vomiting, and 1 diarrhea). In an intent-to-treat analysis, no complete or partial responses were observed, and stable disease was the best response observed in 41% of arm A (median duration, 50 days, range, 34-159) and 17% of arm B subjects (median, 163 days, range, 135-195). Median PFS was 52 days in both arms. Median OS was 288 (95% CI, 62-374) and 155 (95% CI, 75-242) days for arms A and B, respectively. Correlative analyses revealed an absence of EGFR inhibition in tumor tissue.

conclusionLapatinib as a single agent in recurrent/metastatic SCCHN, although well tolerated, appears to be inactive in either EGFR inhibitor naive or refractory subjects.

Indexed as

Antineoplastic AgentsCarcinoma, Squamous CellDisease-Free SurvivalErbB ReceptorsFemaleHead and Neck NeoplasmsHumansLapatinibMaleNeoplasm Recurrence, LocalQuinazolinesSquamous Cell Carcinoma of Head and NeckAntineoplastic AgentsErbB ReceptorsLapatinibQuinazolines

Identifiers

PMID22371453
PMCPMC4467891
OpenAlexW2109609800

What OpenQuestion holds

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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.