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Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127.

Publication ,  Journal Article
Dragovich, T; McCoy, S; Fenoglio-Preiser, CM; Wang, J; Benedetti, JK; Baker, AF; Hackett, CB; Urba, SG; Zaner, KS; Blanke, CD; Abbruzzese, JL
Published in: J Clin Oncol
October 20, 2006

PURPOSE: A phase II trial of the oral epidermal growth factor receptor (EGFR) inhibitor erlotinib in patients with gastroesophageal adenocarcinomas stratified according to primary tumor location into two groups: gastroesophageal junction (GEJ)/cardia and distal gastric adenocarcinomas. PATIENTS AND METHODS: Patients with a histologically proven diagnosis of adenocarcinoma of the GEJ or stomach (ST) that was unresectable or metastatic; presence of measurable disease; no prior chemotherapy for advanced or metastatic cancer; Zubrod performance status (PS) of 0 to 1; and adequate renal, hepatic, and hematologic function were treated with erlotinib 150 mg/d orally. Patient characteristics were median age, GEJ-63 years, ST-64 years; sex, GEJ-84% male and 16% female, ST-60 male and 40 female; Zubrod PS, GEJ-25 had a PS of 0 and 18 had a PS 1, ST-13 had a PS of 0 and 12 had a PS of 1. RESULTS: Percentage of common toxicities were skin rash, 86% and 72%; fatigue, 51% and 44%; and AST/ALT elevation, 28% and 28%, respectively for GEJ and ST. There has been one confirmed complete response, three confirmed partial responses (PRs) and one unconfirmed PR for an overall response probability of 9% confirmed (95% CI, 3% to 22%), all occurring in GEJ stratum. No responses were observed in ST stratum. The median survival was 6.7 months in GEJ and 3.5 months in ST stratum. Neither intratumoral EGFR, transforming growth factor-alpha or phosphorylated Akt kinase expression nor plasma proteomic analyses were predictive of clinical outcome. No somatic mutations of the EGFR exons 18, 19, or 21 were detected and there was no gross amplification of EGFR by fluorescence in situ hybridization. CONCLUSION: Erlotinib is active in patients with GEJ adenocarcinomas, but appears inactive in gastric cancers. The molecular correlates examined were not predictive of the patient therapeutic response.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 20, 2006

Volume

24

Issue

30

Start / End Page

4922 / 4927

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Stomach Neoplasms
  • Quinazolines
  • Protein Kinase Inhibitors
  • Predictive Value of Tests
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
 

Citation

APA
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ICMJE
MLA
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Dragovich, T., McCoy, S., Fenoglio-Preiser, C. M., Wang, J., Benedetti, J. K., Baker, A. F., … Abbruzzese, J. L. (2006). Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127. J Clin Oncol, 24(30), 4922–4927. https://doi.org/10.1200/JCO.2006.07.1316
Dragovich, Tomislav, Sheryl McCoy, Cecilia M. Fenoglio-Preiser, Jiang Wang, Jacqueline K. Benedetti, Amanda F. Baker, Christopher B. Hackett, et al. “Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127.J Clin Oncol 24, no. 30 (October 20, 2006): 4922–27. https://doi.org/10.1200/JCO.2006.07.1316.
Dragovich T, McCoy S, Fenoglio-Preiser CM, Wang J, Benedetti JK, Baker AF, et al. Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127. J Clin Oncol. 2006 Oct 20;24(30):4922–7.
Dragovich, Tomislav, et al. “Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127.J Clin Oncol, vol. 24, no. 30, Oct. 2006, pp. 4922–27. Pubmed, doi:10.1200/JCO.2006.07.1316.
Dragovich T, McCoy S, Fenoglio-Preiser CM, Wang J, Benedetti JK, Baker AF, Hackett CB, Urba SG, Zaner KS, Blanke CD, Abbruzzese JL. Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127. J Clin Oncol. 2006 Oct 20;24(30):4922–4927.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 20, 2006

Volume

24

Issue

30

Start / End Page

4922 / 4927

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Survival Analysis
  • Stomach Neoplasms
  • Quinazolines
  • Protein Kinase Inhibitors
  • Predictive Value of Tests
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans