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

Tomislav Dragovich, Sheryl McCoy, Cecilia M. Fenoglio-Preiser, Jiang Wang, Jacqueline K. Benedetti, Amanda F. Baker, Christopher B. Hackett, Susan G. Urba, Ken S. Zaner, Charles Blanke, James L. Abbruzzese

Research output: Contribution to journalArticle

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)4922-4927
Number of pages6
JournalJournal of Clinical Oncology
Volume24
Issue number30
DOIs
StatePublished - Oct 20 2006
Externally publishedYes

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Esophagogastric Junction
Stomach
Adenocarcinoma
Epidermal Growth Factor Receptor
Erlotinib Hydrochloride
Transforming Growth Factor alpha
Cardia
Exanthema
Fluorescence In Situ Hybridization
Proteomics
Stomach Neoplasms
Fatigue
Exons
Neoplasms
Phosphotransferases
Kidney
Drug Therapy
Mutation
Survival

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. Journal of Clinical Oncology, 24(30), 4922-4927. https://doi.org/10.1200/JCO.2006.07.1316

Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas : SWOG 0127. / Dragovich, Tomislav; McCoy, Sheryl; Fenoglio-Preiser, Cecilia M.; Wang, Jiang; Benedetti, Jacqueline K.; Baker, Amanda F.; Hackett, Christopher B.; Urba, Susan G.; Zaner, Ken S.; Blanke, Charles; Abbruzzese, James L.

In: Journal of Clinical Oncology, Vol. 24, No. 30, 20.10.2006, p. 4922-4927.

Research output: Contribution to journalArticle

Dragovich, T, McCoy, S, Fenoglio-Preiser, CM, Wang, J, Benedetti, JK, Baker, AF, Hackett, CB, Urba, SG, Zaner, KS, Blanke, C & Abbruzzese, JL 2006, 'Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127', Journal of Clinical Oncology, vol. 24, no. 30, pp. 4922-4927. 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. Journal of Clinical Oncology. 2006 Oct 20;24(30):4922-4927. https://doi.org/10.1200/JCO.2006.07.1316
Dragovich, Tomislav ; McCoy, Sheryl ; Fenoglio-Preiser, Cecilia M. ; Wang, Jiang ; Benedetti, Jacqueline K. ; Baker, Amanda F. ; Hackett, Christopher B. ; Urba, Susan G. ; Zaner, Ken S. ; Blanke, Charles ; Abbruzzese, James L. / Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas : SWOG 0127. In: Journal of Clinical Oncology. 2006 ; Vol. 24, No. 30. pp. 4922-4927.
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abstract = "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.",
author = "Tomislav Dragovich and Sheryl McCoy and Fenoglio-Preiser, {Cecilia M.} and Jiang Wang and Benedetti, {Jacqueline K.} and Baker, {Amanda F.} and Hackett, {Christopher B.} and Urba, {Susan G.} and Zaner, {Ken S.} and Charles Blanke and Abbruzzese, {James L.}",
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T1 - Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas

T2 - SWOG 0127

AU - Dragovich, Tomislav

AU - McCoy, Sheryl

AU - Fenoglio-Preiser, Cecilia M.

AU - Wang, Jiang

AU - Benedetti, Jacqueline K.

AU - Baker, Amanda F.

AU - Hackett, Christopher B.

AU - Urba, Susan G.

AU - Zaner, Ken S.

AU - Blanke, Charles

AU - Abbruzzese, James L.

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Y1 - 2006/10/20

N2 - 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.

AB - 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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