Initial results of a phase II trial of high dose radiation therapy, 5- fluorouracil, and cisplatin for patients with anal cancer (E4292): An Eastern Cooperative Oncology Group study

James A. Martenson*, Stuart R. Lipsitz, Henry Wagner, Edward H. Kaplan, Larry A. Otteman, Lynn M. Schuchter, Edward G. Mansour, Mark S. Talamonti, Al B Benson III

*Corresponding author for this work

Research output: Contribution to journalArticle

109 Citations (Scopus)

Abstract

Purpose: A prospective clinical trial was performed to assess the response and toxicity associated with the use of high dose radiation therapy, 5-fluorouracil, and cisplatin in patients with anal cancer. Methods and Materials: Patients with anal cancer without distant metastasis were eligible for this study. Radiation therapy consisted of 59.4 Gy in 33 fractions; a 2 week break in treatment was taken after 36 Gy had been given. A treatment of 5-fluorouracil, 1,000 mg/m2 per day intravenously, was given for the first 4 days of radiation therapy, and cisplatin, 75 mg/m2 intravenously, was given on day 1 of radiation therapy. A second course of 5-fluorouracil and cisplatin was given after 36 Gy of radiation, when the radiation therapy was resumed. Results: Nineteen patients entered this study and received treatment. Thirteen (68%) had a complete response, 5 (26%) had a partial response, and 1 (5%) had stable disease. The patient with stable disease and one of the patients with a partial response had complete disappearance of tumor more than 8 weeks after completion of radiation therapy. Fifteen patients had toxicity of Grade 3 or higher: the worst toxicity was Grade 3 in eight patients, Grade 4 in six patients, and Grade 5 in one patient. The most common form of toxicity of Grade 3 or higher was hematologic. The one lethal toxicity was due to pseudomembranous colitis, which was a complication of antibiotic therapy for a urinary tract infection. Conclusion: Radiation therapy, cisplatin, and 5-fluorouracil resulted in an overall response rate of 95%. Significant toxicity occurred, an indication that this regimen is near the maximal tolerated dose. A Phase III clinical trial is planned in which radiation therapy, cisplatin, and 5-fluorouracil will be used as an experimental arm.

Original languageEnglish (US)
Pages (from-to)745-749
Number of pages5
JournalInternational Journal of Radiation Oncology Biology Physics
Volume35
Issue number4
DOIs
StatePublished - Jul 1 1996

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Anus Neoplasms
Fluorouracil
Cisplatin
radiation therapy
Radiotherapy
cancer
toxicity
dosage
grade
Pseudomembranous Enterocolitis
Radiation Dosage
Phase III Clinical Trials
Maximum Tolerated Dose
antibiotics
metastasis
infectious diseases
Therapeutics
Urinary Tract Infections
therapy
indication

Keywords

  • 5-Fluorouracil
  • Anal cancer
  • Cisplatin
  • Radiation therapy
  • Sphincter preservation

ASJC Scopus subject areas

  • Radiation
  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

Cite this

Martenson, James A. ; Lipsitz, Stuart R. ; Wagner, Henry ; Kaplan, Edward H. ; Otteman, Larry A. ; Schuchter, Lynn M. ; Mansour, Edward G. ; Talamonti, Mark S. ; Benson III, Al B. / Initial results of a phase II trial of high dose radiation therapy, 5- fluorouracil, and cisplatin for patients with anal cancer (E4292) : An Eastern Cooperative Oncology Group study. In: International Journal of Radiation Oncology Biology Physics. 1996 ; Vol. 35, No. 4. pp. 745-749.
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abstract = "Purpose: A prospective clinical trial was performed to assess the response and toxicity associated with the use of high dose radiation therapy, 5-fluorouracil, and cisplatin in patients with anal cancer. Methods and Materials: Patients with anal cancer without distant metastasis were eligible for this study. Radiation therapy consisted of 59.4 Gy in 33 fractions; a 2 week break in treatment was taken after 36 Gy had been given. A treatment of 5-fluorouracil, 1,000 mg/m2 per day intravenously, was given for the first 4 days of radiation therapy, and cisplatin, 75 mg/m2 intravenously, was given on day 1 of radiation therapy. A second course of 5-fluorouracil and cisplatin was given after 36 Gy of radiation, when the radiation therapy was resumed. Results: Nineteen patients entered this study and received treatment. Thirteen (68{\%}) had a complete response, 5 (26{\%}) had a partial response, and 1 (5{\%}) had stable disease. The patient with stable disease and one of the patients with a partial response had complete disappearance of tumor more than 8 weeks after completion of radiation therapy. Fifteen patients had toxicity of Grade 3 or higher: the worst toxicity was Grade 3 in eight patients, Grade 4 in six patients, and Grade 5 in one patient. The most common form of toxicity of Grade 3 or higher was hematologic. The one lethal toxicity was due to pseudomembranous colitis, which was a complication of antibiotic therapy for a urinary tract infection. Conclusion: Radiation therapy, cisplatin, and 5-fluorouracil resulted in an overall response rate of 95{\%}. Significant toxicity occurred, an indication that this regimen is near the maximal tolerated dose. A Phase III clinical trial is planned in which radiation therapy, cisplatin, and 5-fluorouracil will be used as an experimental arm.",
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Initial results of a phase II trial of high dose radiation therapy, 5- fluorouracil, and cisplatin for patients with anal cancer (E4292) : An Eastern Cooperative Oncology Group study. / Martenson, James A.; Lipsitz, Stuart R.; Wagner, Henry; Kaplan, Edward H.; Otteman, Larry A.; Schuchter, Lynn M.; Mansour, Edward G.; Talamonti, Mark S.; Benson III, Al B.

In: International Journal of Radiation Oncology Biology Physics, Vol. 35, No. 4, 01.07.1996, p. 745-749.

Research output: Contribution to journalArticle

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T1 - Initial results of a phase II trial of high dose radiation therapy, 5- fluorouracil, and cisplatin for patients with anal cancer (E4292)

T2 - An Eastern Cooperative Oncology Group study

AU - Martenson, James A.

AU - Lipsitz, Stuart R.

AU - Wagner, Henry

AU - Kaplan, Edward H.

AU - Otteman, Larry A.

AU - Schuchter, Lynn M.

AU - Mansour, Edward G.

AU - Talamonti, Mark S.

AU - Benson III, Al B

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