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Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803).

Publication ,  Journal Article
Saltz, LB; Niedzwiecki, D; Hollis, D; Goldberg, RM; Hantel, A; Thomas, JP; Fields, AL; Carver, G; Mayer, RJ
Published in: J Clin Oncol
July 15, 2004

3500 Background: Irinotecan prolongs survival in second line 5FU-refractory metastatic colorectal cancer (MCRC). First line irinotecan, weekly bolus 5FU, and leucovorin (IFL) was superior to daily x 5 bolus 5FU and leucovorin alone (FL) in a phase III trial in MCRC in terms of response rate, progression free survival and overall survival (OS). We conducted a phase III randomized study to evaluate whether IFL was also superior to weekly bolus FL after curative resection for stage III colon cancer. METHODS: Eligible patients had TxN1-2M0 disease, Zubrod 0-2, and no prior chemotherapy. Patients (pts) received either IFL (irinotecan 125mg/m2 over 90 minutes followed by leucovorin 20 mg/m2 IV bolus and then 5FU 500mg/m2 IV bolus, given 4 weeks on, 2 weeks off, x 5 cycles (30 weeks total)) or the Roswell Park schedule of FL (leucovorin 500mg/m2 IV over 2 hours plus 5FU 500 mg/m2 at 1 hour after start of leucovorin, given 6 weeks on, two weeks off, x 4 cycles (32 weeks total)). Pts were stratified for N1 vs. N2 disease, high vs. low grade histology, and preoperative CEA of < 5 ng/ml, ≥ 5ng/ml, or unknown. RESULTS: 1264 pts were randomized between April, 1999 and April, 2001. Median follow up is 2.6 years, and 67% of total expected deaths and 85% of total expected failures have occurred. Median OS and failure-free survival (FFS) have not yet been reached. IFL shows no improvement over FL in terms of either OS (p=0.88) or FFS (p=0.84) Futility boundaries for both of these endpoints have been exceeded. Toxicities are shown in the table. 18 deaths occurred on the IFL arm during treatment vs. 6 deaths on the FL arm (p=0.008). CONCLUSIONS: In stage III colon cancer, IFL, as compared to FL, is associated with a greater degree of neutropenia, neutropenic fever, and death on treatment, with no associated clinical benefit. Weekly bolus IFL should not be used in the management of stage III colon cancer. [Figure: see text] [Table: see text].

Duke Scholars

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

July 15, 2004

Volume

22

Issue

14_suppl

Start / End Page

3500

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

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MLA
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Saltz, L. B., Niedzwiecki, D., Hollis, D., Goldberg, R. M., Hantel, A., Thomas, J. P., … Mayer, R. J. (2004). Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). J Clin Oncol, 22(14_suppl), 3500.
Saltz, L. B., D. Niedzwiecki, D. Hollis, R. M. Goldberg, A. Hantel, J. P. Thomas, A. L. Fields, G. Carver, and R. J. Mayer. “Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803).J Clin Oncol 22, no. 14_suppl (July 15, 2004): 3500.
Saltz LB, Niedzwiecki D, Hollis D, Goldberg RM, Hantel A, Thomas JP, et al. Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). J Clin Oncol. 2004 Jul 15;22(14_suppl):3500.
Saltz LB, Niedzwiecki D, Hollis D, Goldberg RM, Hantel A, Thomas JP, Fields AL, Carver G, Mayer RJ. Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). J Clin Oncol. 2004 Jul 15;22(14_suppl):3500.

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

July 15, 2004

Volume

22

Issue

14_suppl

Start / End Page

3500

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences