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Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901.

Publication ,  Journal Article
Cancer and Leukemia Group B 89901; Ryan, DP; Niedzwiecki, D; Hollis, D; Mediema, BE; Wadler, S; Tepper, JE; Goldberg, RM; Mayer, RJ
Published in: J Clin Oncol
June 1, 2006

PURPOSE: The addition of oxaliplatin to fluorouracil in patients with advanced colorectal cancer improves survival. This phase I/II study evaluated the addition of weekly oxaliplatin to preoperative continuous infusion fluorouracil (FU) and external-beam radiation therapy (RT) in patients with locally advanced rectal adenocarcinoma. PATIENTS AND METHODS: Patients with clinical T3/T4 rectal adenocarcinoma and no evidence of metastases were treated with weekly oxaliplatin, continuous infusion FU 200 mg/m2 intravenously, and RT. A total of 6 weekly doses of oxaliplatin were planned. RT dose was 1.8 Gy/fraction to a total dose of 50.4 Gy. In the phase I portion, oxaliplatin was escalated from 30 to 60 mg/m2. RESULTS: Forty-four patients were entered onto the study, 18 on the phase I portion and 26 on the phase II portion. The maximum-tolerated dose (MTD) for oxaliplatin was determined to be 60 mg/m2. At the MTD, 12 patients experienced grade 3 or 4 diarrhea, two patients experienced grade 3 neutropenia, and one patient experienced grade 3 thrombocytopenia. Fifty-six percent of patients entered at the MTD completed all 6 weeks of oxaliplatin. Eight (25%) of 32 patients enrolled at the phase II dose experienced a pathologic complete response. CONCLUSION: In this multicenter study, the addition of oxaliplatin to intravenous continuous infusion FU and RT for patients with locally advanced rectal cancer was associated with a high pathologic complete response rate but more toxicity than when FU is used alone. A regimen of weekly oxaliplatin, continuous infusion FU, and radiation therapy is now being evaluated by the National Surgical Adjuvant Breast and Bowel Project.

Duke Scholars

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

June 1, 2006

Volume

24

Issue

16

Start / End Page

2557 / 2562

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thrombocytopenia
  • Rectal Neoplasms
  • Radiotherapy, Adjuvant
  • Oxaliplatin
  • Organoplatinum Compounds
  • Oncology & Carcinogenesis
  • Neutropenia
  • Neoadjuvant Therapy
  • Middle Aged
 

Citation

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Cancer and Leukemia Group B 89901, Ryan, D. P., Niedzwiecki, D., Hollis, D., Mediema, B. E., Wadler, S., … Mayer, R. J. (2006). Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901. J Clin Oncol, 24(16), 2557–2562. https://doi.org/10.1200/JCO.2006.05.6754
Cancer and Leukemia Group B 89901, David P. Ryan, Donna Niedzwiecki, Donna Hollis, Brent E. Mediema, Scott Wadler, Joel E. Tepper, Richard M. Goldberg, and Robert J. Mayer. “Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901.J Clin Oncol 24, no. 16 (June 1, 2006): 2557–62. https://doi.org/10.1200/JCO.2006.05.6754.
Cancer and Leukemia Group B 89901, Ryan DP, Niedzwiecki D, Hollis D, Mediema BE, Wadler S, et al. Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901. J Clin Oncol. 2006 Jun 1;24(16):2557–62.
Cancer and Leukemia Group B 89901, et al. “Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901.J Clin Oncol, vol. 24, no. 16, June 2006, pp. 2557–62. Pubmed, doi:10.1200/JCO.2006.05.6754.
Cancer and Leukemia Group B 89901, Ryan DP, Niedzwiecki D, Hollis D, Mediema BE, Wadler S, Tepper JE, Goldberg RM, Mayer RJ. Phase I/II study of preoperative oxaliplatin, fluorouracil, and external-beam radiation therapy in patients with locally advanced rectal cancer: Cancer and Leukemia Group B 89901. J Clin Oncol. 2006 Jun 1;24(16):2557–2562.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

June 1, 2006

Volume

24

Issue

16

Start / End Page

2557 / 2562

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thrombocytopenia
  • Rectal Neoplasms
  • Radiotherapy, Adjuvant
  • Oxaliplatin
  • Organoplatinum Compounds
  • Oncology & Carcinogenesis
  • Neutropenia
  • Neoadjuvant Therapy
  • Middle Aged