Evidence map›Paper›PMID 29371473›Full record

Trial reportThe oncologist2018

Single Arm, Phase II Study of Cisplatin, Docetaxel, and Erlotinib in Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas.

William N William, Anne S Tsao, Lei Feng, Lawrence E Ginsberg, J Jack Lee, Merrill S Kies, Bonnie S Glisson, Edward S Kim

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

Trial report in The oncologist, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.4field-weighted citation impact, top 22% 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

13 citing papers in PubMed, 19 citations in OpenAlex.

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  12. EGFRJournal of oncology · 2019
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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

8 authors at 2 institutions in 1 country.

William N WilliamThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA williamwilliamjr@gmail.com.
Anne S TsaoThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Lei FengThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Lawrence E GinsbergThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
J Jack LeeThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Merrill S KiesThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Bonnie S GlissonThe University of Texas MD Anderson Cancer Center, Houston, Texas, USA.
Edward S KimLevine Cancer Institute, Charlotte, North Carolina, USA.
The University of Texas MD Anderson Cancer Center · USLevine Cancer Institute · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

lessons learnedThe combination of cisplatin, docetaxel, and erlotinib as frontline treatment for recurrent and/or metastatic head and neck squamous cell carcinomas led to a response rate of 62%.This result exceeded the prespecified target response rate of 50% and represented an improvement compared with historical controls.This regimen warrants further investigation.

backgroundThe epidermal growth factor receptor (EGFR) plays a key role in the carcinogenesis of head and neck squamous cell carcinomas (HNSCC). We conducted this clinical study to test the hypothesis that the addition of erlotinib to first-line cisplatin and docetaxel for patients with recurrent and/or metastatic HNSCC would yield a response rate of at least 50%, representing an improvement from historical controls.

methodsPatients with recurrent and/or metastatic HNSCC, with at least one measurable lesion, no prior chemotherapy for recurrent and/or metastatic disease, prior combined modality therapy completed >6 months before enrollment, and performance status ≤2 were treated with cisplatin, docetaxel, and erlotinib for up to six cycles, followed by maintenance erlotinib until disease progression. The primary endpoint was response rate.

resultsFifty patients were enrolled (42 male, 12 never smokers, 19 with oropharynx cancer). The median number of cycles was five; 31 patients initiated maintenance erlotinib; 14 patients required erlotinib dose reductions. The objective response rate was 62%, and the median progression-free and overall survival were 6.1 and 11.0 months, respectively. Toxicity profiles were consistent with the known side effects of the study drugs.

conclusionThe study met its primary endpoint and improved response rates compared with historical controls. The findings support further evaluation of the regimen for recurrent and/or metastatic HNSCCs.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCisplatinDocetaxelErlotinib HydrochlorideFemaleHumansMaleMiddle AgedSquamous Cell Carcinoma of Head and NeckCisplatinDocetaxelErlotinib Hydrochloride

Identifiers

PMID29371473
PMCPMC5947451
OpenAlexW2784609734

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.