Evidence map›Paper›PMID 25107914›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014

Phase II study of cetuximab in combination with cisplatin and radiation in unresectable, locally advanced head and neck squamous cell carcinoma: Eastern cooperative oncology group trial E3303.

Ann Marie Egloff, Ju-Whei Lee, Corey J Langer, Harry Quon, Alec Vaezi, Jennifer R Grandis, Raja R Seethala, Lin Wang, Dong M Shin, Athanassios Argiris and 6 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
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

15 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Review
  4. Review
  5. Review
  6. Review
  7. Article
  8. Safety and Efficacy of Pembrolizumab With Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma: A Phase IB Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Article
  9. Review
  10. Treatment de-intensification strategies for head and neck cancer.European journal of cancer (Oxford, England : 1990) · 2016
    Review
  11. Article
  12. AXL Is a Logical Molecular Target in Head and Neck Squamous Cell Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2015
    Article
  13. Review
  14. Squamous carcinoma of the ovary.Current oncology reports · 2014
    Review
  15. Article
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

16 authors.

Ann Marie EgloffUniversity of Pittsburgh, Pittsburgh, Pennsylvania. egloffam@upmc.edu.
Ju-Whei LeeDana-Farber Cancer Institute, Boston, Massachusetts.
Corey J LangerFox Chase Cancer Center, Philadelphia, Pennsylvania.
Harry QuonUniversity of Pennsylvania, Philadelphia, Pennsylvania.
Alec VaeziUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Jennifer R GrandisUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Raja R SeethalaUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Lin WangUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Dong M ShinEmory University, Atlanta, Georgia.
Athanassios ArgirisUniversity of Pittsburgh, Pittsburgh, Pennsylvania.
Donghua YangFox Chase Cancer Center, Philadelphia, Pennsylvania.
Ranee MehraFox Chase Cancer Center, Philadelphia, Pennsylvania.
John Andrew RidgeFox Chase Cancer Center, Philadelphia, Pennsylvania.
Urjeet A PatelNorthwestern University, Chicago, Illinois.
Barbara A BurtnessFox Chase Cancer Center, Philadelphia, Pennsylvania.
Arlene A ForastiereJohns Hopkins University School of Medicine and Sydney Kimmel Comprehensive Cancer Center, Baltimore, Maryland.

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer, MITCHELL D. SCHNALL · 2014 to 2026
$167.6M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO, CONSTANTINE A. GATSONIS · 2014 to 2026
$111.2M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
ONCOLOGYU10CA027525 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GOLDSTEIN, LORI J · 1985 to 2013
$6.2M
ONCOLOGYU10CA015488 · NCI · UNIVERSITY OF PENNSYLVANIA · PI LUGER, SELINA M · 1985 to 2013
$5.6M
PI3K Pathway Mutations in Head and Neck CancerR01DE023685 · NIDCR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI GRANDIS, JENNIFER RUBIN, JOHNSON, DANIEL E · 2014 to 2023
$5.1M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
ONCOLOGYU10CA039229 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KIRKWOOD, JOHN MUNN · 1985 to 2013
$3.3M
Genomic and Proteomic Biomarkers for Head and Neck Cancer Risk and PrognosisK07CA137140 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI EGLOFF, ANN MARIE · 2009 to 2013
$519k
NCI NIH HHS CA137140NCI NIH HHS CA15488NCI NIH HHS CA16116NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA27525NCI NIH HHS CA39229NCI NIH HHS CA66636NCI NIH HHS K07 CA137140NCI NIH HHS U10 CA015488NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA027525NCI NIH HHS U10 CA039229NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180820NCI NIH HHS U24 CA114737NIDCR NIH HHS R01 DE023685
6 · The paper itself

Abstract

purposeTreatment with cisplatin or cetuximab combined with radiotherapy each yield superior survival in locally advanced squamous cell head and neck cancer (LA-SCCHN) compared with radiotherapy alone. Eastern Cooperative Oncology Group Trial E3303 evaluated the triple combination. EXPERIMENTAL

designPatients with stage IV unresectable LA-SCCHN received a loading dose of cetuximab (400 mg/m(2)) followed by 250 mg/m(2)/week and cisplatin 75 mg/m(2) q 3 weeks ×3 cycles concurrent with standard fractionated radiotherapy. In the absence of disease progression or unacceptable toxicity, patients continued maintenance cetuximab for 6 to 12 months. Primary endpoint was 2-year progression-free survival (PFS). Patient tumor and blood correlates, including tumor human papillomavirus (HPV) status, were evaluated for association with survival.

resultsA total of 69 patients were enrolled; 60 proved eligible and received protocol treatment. Oropharyngeal primaries constituted the majority (66.7%), stage T4 48.3% and N2-3 91.7%. Median radiotherapy dose delivered was 70 Gy, 71.6% received all three cycles of cisplatin, and 74.6% received maintenance cetuximab. Median PFS was 19.4 months, 2-year PFS 47% [95% confidence interval (CI), 33%-61%]. Two-year overall survival (OS) was 66% (95% CI, 53%-77%); median OS was not reached. Response rate was 66.7%. Most common grade ≥3 toxicities included mucositis (55%), dysphagia (46%), and neutropenia (26%); one attributable grade 5 toxicity occurred. Only tumor HPV status was significantly associated with survival. HPV was evaluable in 29 tumors; 10 (all oropharyngeal) were HPV positive. HPV(+) patients had significantly longer OS and PFS (P = 0.004 and P = 0.036, respectively).

conclusionsConcurrent cetuximab, cisplatin, and radiotherapy were well tolerated and yielded promising 2-year PFS and OS in LA-SCCHN with improved survival for patients with HPV(+) tumors.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Squamous CellCetuximabCisplatinDisease ProgressionFemaleHead and Neck NeoplasmsHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingRadiotherapyAntibodies, Monoclonal, HumanizedCetuximabCisplatin

Identifiers

PMID25107914
PMCPMC4184913

What OpenQuestion holds

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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.