Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2014
Erlotinib, erlotinib-sulindac versus placebo: a randomized, double-blind, placebo-controlled window trial in operable head and neck cancer.
Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
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 29 papers, 2 of them syntheses that pooled it.
0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
4.8field-weighted citation impact, top 5% of its field
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.
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.
Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 53 citations in OpenAlex.
- Meta-analysis of the effects of anti-epidermal growth factor receptor on recurrent/metastatic head and neck squamous cell carcinoma.Medicine · 2018Pooled it
- Interventions for the treatment of oral and oropharyngeal cancers: targeted therapy and immunotherapy.The Cochrane database of systematic reviews · 2015Pooled it
- Phase II Window Study of Olaparib Alone or with Cisplatin or Durvalumab in Operable Head and Neck Cancer.Cancer research communications · 2023Trial
- Biomarker and Tumor Responses of Oral Cavity Squamous Cell Carcinoma to Trametinib: A Phase II Neoadjuvant Window-of-Opportunity Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2017Trial
- Randomized, placebo-controlled window trial of EGFR, Src, or combined blockade in head and neck cancer.JCI insight · 2017Trial
- Sulindac exhibits anti-proliferative and anti-invasive effects in uterine serous carcinoma cells.Journal of cancer research and clinical oncology · 2024Article
- Mononuclear phagocyte system-related multi-omics features yield head and neck squamous cell carcinoma subtypes with distinct overall survival, drug, and immunotherapy responses.Journal of cancer research and clinical oncology · 2024Article
- Response to Neoadjuvant Targeted Therapy in Operable Head and Neck Cancer Confers Survival Benefit.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Article
- Balancing Risk and Efficiency in Drug Development for Rare and Challenging Tumors: A New Paradigm for Glioma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022Review
- NSAIDs OvercomeCancers · 2022Article
- Early [18]FDG PET/CT scan predicts tumor response in head and neck squamous cell cancer patients treated with erlotinib adjusted per smoking status.Frontiers in oncology · 2022Article
- Review
- Identification of extracellular vesicles-transported miRNAs in Erlotinib-resistant head and neck squamous cell carcinoma.Journal of cell communication and signaling · 2020Article
- Review
- Discordant Responses Between Primary Head and Neck Tumors and Nodal Metastases Treated With Neoadjuvant Nivolumab: Correlation of Radiographic and Pathologic Treatment Effect.Frontiers in oncology · 2020Article
- Clinical Development of Molecular Targeted Therapy in Head and Neck Squamous Cell Carcinoma.JNCI cancer spectrum · 2019Article
- Molecular and Clinical Activity of CDX-3379, an Anti-ErbB3 Monoclonal Antibody, in Head and Neck Squamous Cell Carcinoma Patients.Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Article
- Review
- Window of opportunity trials in head and neck cancer.Journal of cancer metastasis and treatment · 2019Article
- Window Studies in Squamous Cell Carcinoma of the Head and Neck: Values and Limits.Current treatment options in oncology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 7 institutions in 1 country.
Neil D GrossAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Julie E BaumanAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota baumanje@upmc.edu.
William E GoodingAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
William DenqAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Sufi M ThomasAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, MinnesotaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Lin WangAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Simion ChioseaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, MinnesotaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Brian L HoodAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, MinnesotaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Melanie S FlintAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Mai SunAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Thomas P ConradsAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, MinnesotaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Robert L FerrisAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Jonas T JohnsonAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Seungwon KimAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Athanassios ArgirisAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, MinnesotaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Lori WirthAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Marina N NikiforovaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Jill M SiegfriedAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, MinnesotaAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
Jennifer R GrandisAuthors' Affiliations: Division of Head and Neck Surgery, Department of Otolaryngology, Oregon Health and Science University, Portland, Oregon; Division of Hematology/Oncology, Department of Internal Medicine; Department of Pharmacology and Chemical Biology;Biostatistics Facility, University of Pittsburgh, University of Pittsburgh Cancer Institute; Departments of Otolaryngology and Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania; Department of Otolaryngology, University of Kansas Medical Center, Kansas City, Kansas; Women's Health Integrated Research Center, Gynecologic Cancer Center of Excellence, Annandale, Virginia; Division of Hematology/Oncology, Department of Medicine, University of Texas Health Science Center at San Antonio, San Antonio, Texas; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; and Department of Pharmacology, University of Minnesota, Minneapolis, Minnesota.
University of Kansas Medical Center · USUniversity of Minnesota · USUPMC Hillman Cancer Center · USMassachusetts General Hospital · USOregon Health & Science University · USThe University of Texas Health Science Center at San Antonio · USUniversity of Pittsburgh · US
Funding
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0MUniversity of Pittsburgh Clinical and Translational Science InstituteUL1TR000005 · NCATS · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI REIS, STEVEN E · 2012 to 2015
$50.8MWILD TYPE P53-BASED ADJUVANT IMMUNOTHERAPY FOR SCCHNP50CA097190 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI CHRISTOPHER J. BAKKENIST · 2004 to 2026
$49.6MPI3K Pathway Mutations in Head and Neck CancerR01DE023685 · NIDCR · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI GRANDIS, JENNIFER RUBIN, JOHNSON, DANIEL E · 2014 to 2023
$5.1MGRPR Signaling in SCCHN: Integration with EGFRR01CA098372 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI GRANDIS, JENNIFER RUBIN · 2004 to 2017
$3.8MNCATS NIH HHS UL1 TR000005NCI NIH HHS P30 CA047904NCI NIH HHS P30CA47904NCI NIH HHS P50 CA097190NCI NIH HHS P50CA097190NCI NIH HHS R01 CA098372NCI NIH HHS R01CA098372NIDCR NIH HHS R01 DE023685
Abstract
purposeThe EGF receptor (EGFR) and COX2 pathways are upregulated in head and neck squamous cell carcinoma (HNSCC). Preclinical models indicate synergistic antitumor activity from dual blockade. We conducted a randomized, double-blind, placebo-controlled window trial of erlotinib, an EGFR inhibitor; erlotinib plus sulindac, a nonselective COX inhibitor; versus placebo. EXPERIMENTAL
designPatients with untreated, operable stage II-IVb HNSCC were randomized 5:5:3 to erlotinib, erlotinib-sulindac, or placebo. Tumor specimens were collected before and after seven to 14 days of treatment. The primary endpoint was change in Ki67 proliferation index. We hypothesized an ordering effect in Ki67 reduction: erlotinib-sulindac > erlotinib > placebo. We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX2 signaling intermediates.
resultsFrom 2005-2009, 47 patients were randomized for the target 39 evaluable patients. Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation. Ki67 was significantly decreased by erlotinib or erlotinib-sulindac (omnibus comparison, two-sided Kruskal-Wallis, P = 0.04). Wilcoxon pairwise contrasts confirmed greater Ki67 effect in both erlotinib groups (erlotinib-sulindac vs. placebo, P = 0.043; erlotinib vs. placebo, P = 0.027). There was a significant trend in ordering of Ki67 reduction: erlotinib-sulindac > erlotinib > placebo (two-sided exact Jonckheere-Terpstra, P = 0.0185). Low baseline pSrc correlated with greater Ki67 reduction (R(2) = 0.312, P = 0.024).
conclusionsBrief treatment with erlotinib significantly decreased proliferation in HNSCC, with additive effect from sulindac. Efficacy studies of dual EGFR-COX inhibition are justified. pSrc is a potential resistance biomarker for anti-EGFR therapy, and warrants investigation as a molecular target.
Indexed as
AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarcinoma, Squamous CellCohort StudiesDouble-Blind MethodErbB ReceptorsErlotinib HydrochlorideFemaleFollow-Up StudiesHead and Neck NeoplasmsHumansImmunoenzyme TechniquesMaleBiomarkers, TumorEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideQuinazolinesSulindac
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