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S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach.

Publication ,  Journal Article
Blanke, CD; Chansky, K; Christman, KL; Hundahl, SA; Issell, BF; Van Veldhuizen, PJ; Budd, GT; Abbruzzese, JL; Macdonald, JS
Published in: Am J Clin Oncol
April 2010

OBJECTIVE: The primary objective of this trial was to evaluate the response rate for trimetrexate in conjunction with 5-FU and leucovorin (LV) (= TFL) in the treatment of advanced gastric cancer in a phase II, cooperative group setting. METHODS: Patients with locally advanced, unresectable, or metastatic adenocarcinoma of the stomach received trimetrexate 110 mg/m IV over 60 minutes day 1, followed by 5-FU 500 mg/m IV bolus and LV 200 mg/m IV over 60 minutes day 2, followed by oral LV 15 mg every 6 hours x 7 doses, all weekly for 6 weeks followed by 2 weeks of rest, continued until progression. RESULTS: Characteristics for 37 eligible patients: median age 63 (range: 23-83); male/female: 69% of 31%; performance status 0/1/2 15/20/1. The confirmed response rate was 19%, and median overall survival was 6 months. Two patients died as a result of therapy, 1 because of infection without significant neutropenia, and 1 due to perforation of a responding gastric lesion. Seventy-two percent experienced grades 3 and 4 toxicity, most commonly diarrhea, fatigue, and lymphopenia. CONCLUSIONS: This regimen achieves response rates comparable to other 5-FU-based regimens, when used in treatment of incurable gastric cancer. Toxicity appears manageable.

Duke Scholars

Published In

Am J Clin Oncol

DOI

EISSN

1537-453X

Publication Date

April 2010

Volume

33

Issue

2

Start / End Page

117 / 120

Location

United States

Related Subject Headings

  • Young Adult
  • Trimetrexate
  • Treatment Outcome
  • Survival Rate
  • Stomach Neoplasms
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Leucovorin
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Blanke, C. D., Chansky, K., Christman, K. L., Hundahl, S. A., Issell, B. F., Van Veldhuizen, P. J., … Macdonald, J. S. (2010). S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach. Am J Clin Oncol, 33(2), 117–120. https://doi.org/10.1097/COC.0b013e318199fb84
Blanke, Charles D., Kari Chansky, Kathy L. Christman, Scott A. Hundahl, Brian F. Issell, Peter J. Van Veldhuizen, G Thomas Budd, James L. Abbruzzese, and John S. Macdonald. “S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach.Am J Clin Oncol 33, no. 2 (April 2010): 117–20. https://doi.org/10.1097/COC.0b013e318199fb84.
Blanke CD, Chansky K, Christman KL, Hundahl SA, Issell BF, Van Veldhuizen PJ, et al. S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach. Am J Clin Oncol. 2010 Apr;33(2):117–20.
Blanke, Charles D., et al. “S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach.Am J Clin Oncol, vol. 33, no. 2, Apr. 2010, pp. 117–20. Pubmed, doi:10.1097/COC.0b013e318199fb84.
Blanke CD, Chansky K, Christman KL, Hundahl SA, Issell BF, Van Veldhuizen PJ, Budd GT, Abbruzzese JL, Macdonald JS. S9511: a Southwest Oncology Group phase II study of trimetrexate, 5-fluorouracil, and leucovorin in unresectable or metastatic adenocarcinoma of the stomach. Am J Clin Oncol. 2010 Apr;33(2):117–120.

Published In

Am J Clin Oncol

DOI

EISSN

1537-453X

Publication Date

April 2010

Volume

33

Issue

2

Start / End Page

117 / 120

Location

United States

Related Subject Headings

  • Young Adult
  • Trimetrexate
  • Treatment Outcome
  • Survival Rate
  • Stomach Neoplasms
  • Oncology & Carcinogenesis
  • Neoplasm Staging
  • Middle Aged
  • Male
  • Leucovorin