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FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer.

Publication ,  Journal Article
Kelsen, D; Atiq, OT; Saltz, L; Niedzwiecki, D; Ginn, D; Chapman, D; Heelan, R; Lightdale, C; Vinciguerra, V; Brennan, M
Published in: J Clin Oncol
April 1992

PURPOSE: The chemotherapy regimens of high-dose methotrexate, high-dose fluorouracil (FU), Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), and leucovorin (FAMTX) and etoposide, Adriamycin, and cisplatin (EAP) have both been reported in nonrandom assignment trials to have high overall response rates and substantial complete response rates in patients with gastric cancer, as well as major toxicities of myelosuppression. Here we report a prospective, stratified, random-assignment comparison of the two combinations in previously untreated patients with advanced gastric cancer. PATIENTS AND METHODS: Sixty patients were entered onto the trial, 30 receiving EAP and 30 FAMTX. All patients had measurable or assessable tumor masses. Patient entry was stopped at the point when significant toxicity differences were seen at interim analysis. RESULTS: Response rates were similar between the two arms (FAMTX, 33% [95% confidence interval (CI), 16% to 50%]; EAP, 20% [95% Cl, 6% to 34%]). Three FAMTX and no EAP patients had complete remissions. The median survival for the two arms were similar (EAP, 6.1 months; FAMTX, 7.3 months). At 1 year, 7% of EAP and 17% of FAMTX patients were alive. EAP caused significantly more myelosuppression (leukopenia, P = .002; anemia, P = .03; thrombocytopenia, P = .0001) than did FAMTX. EAP also resulted in significantly longer hospitalizations per study month (8 v 5 days). Four EAP patients died of lethal toxicity, whereas no FAMTX patients died of treatment-related causes (P = .04). CONCLUSIONS: FAMTX is at least as active as EAP and is significantly less toxic. Although both regimens remain investigational, the toxicities of FAMTX are more manageable. Further studies involving FAMTX in both the adjuvant and advanced disease setting are underway.

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Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

April 1992

Volume

10

Issue

4

Start / End Page

541 / 548

Location

United States

Related Subject Headings

  • Survival Analysis
  • Stomach Neoplasms
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Methotrexate
  • Male
  • Leucovorin
  • Humans
  • Fluorouracil
 

Citation

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Kelsen, D., Atiq, O. T., Saltz, L., Niedzwiecki, D., Ginn, D., Chapman, D., … Brennan, M. (1992). FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol, 10(4), 541–548. https://doi.org/10.1200/JCO.1992.10.4.541
Kelsen, D., O. T. Atiq, L. Saltz, D. Niedzwiecki, D. Ginn, D. Chapman, R. Heelan, C. Lightdale, V. Vinciguerra, and M. Brennan. “FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer.J Clin Oncol 10, no. 4 (April 1992): 541–48. https://doi.org/10.1200/JCO.1992.10.4.541.
Kelsen D, Atiq OT, Saltz L, Niedzwiecki D, Ginn D, Chapman D, et al. FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol. 1992 Apr;10(4):541–8.
Kelsen, D., et al. “FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer.J Clin Oncol, vol. 10, no. 4, Apr. 1992, pp. 541–48. Pubmed, doi:10.1200/JCO.1992.10.4.541.
Kelsen D, Atiq OT, Saltz L, Niedzwiecki D, Ginn D, Chapman D, Heelan R, Lightdale C, Vinciguerra V, Brennan M. FAMTX versus etoposide, doxorubicin, and cisplatin: a random assignment trial in gastric cancer. J Clin Oncol. 1992 Apr;10(4):541–548.

Published In

J Clin Oncol

DOI

ISSN

0732-183X

Publication Date

April 1992

Volume

10

Issue

4

Start / End Page

541 / 548

Location

United States

Related Subject Headings

  • Survival Analysis
  • Stomach Neoplasms
  • Prospective Studies
  • Oncology & Carcinogenesis
  • Middle Aged
  • Methotrexate
  • Male
  • Leucovorin
  • Humans
  • Fluorouracil