Pilot study of continuous-infusion 5-fluorouracil, oral leucovorin, and upper-abdominal radiation therapy in patients with locally advanced residual or recurrent upper gastrointestinal or extrapelvic colon cancer

James A. Martenson, Revathi Swaminathan, Patrick A. Burch, Roger G. Santala, Georgene Schroeder, Henry Clement Pitot, Keith Wright, John W. Kugler, Philip J. Stella, Graciela R. Garton

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose: The purpose of this study was to develop a satisfactorily tolerated regimen of radiation therapy, continuous infusion 5-fluorouracil, and leucovorin in patients with locally advanced upper-abdominal gastrointestinal cancer. Methods and Materials: Patients with locally advanced or locally recurrent gastric, pancreatic, or extrapelvic colon cancer were eligible for this study. Radiation therapy consisted of 45 Gy in 25 fractions to the tumor and regional lymph nodes, followed by 5.4-9 Gy in three to five fractions to the tumor. Treatment with leucovorin, 10 mg orally daily, and continuous infusion 5-fluorouracil was initiated on the first day of radiation therapy. 5-Fluorouracil was administered at an initial daily dose of 125 mg/m2, with dose escalation planned in 25-mg increments, depending on patient tolerance. Results: Twenty-one evaluable patients participated in this study. Six were treated at the initial daily 5- fluorouracil dose of 125 mg/m2. One patient experienced Grade 4 anorexia and nausea. No other Grade ≤ 3 toxicity was observed at this dose. Fifteen evaluable patients were entered at a planned 5-fluorouracil dose of 150 mg/m2 daily; 6 of them experienced Grade 3 toxicity, and none experienced Grade ≤ 4 toxicity. Grade 3 toxicities and the number of patients who developed each were: vomiting (three patients); nausea (two patients); diarrhea (two patients); and skin toxicity, hand-foot syndrome, catheter- related infection, and stomatitis in one patient each. Four of the six patients who experienced Grade 3 toxicity developed more than one type of Grade 3 toxicity. Conclusions: In patients with upper-abdominal gastrointestinal cancer, continuous infusion 5-fluorouracil (150 mg/m2 daily), leucovorin (10 mg orally daily), and radiation therapy (50-54 Gy) resulted in a 40% rate of severe toxicity but no life-threatening toxicity. This clinical trial excludes, with 90% confidence, a 20% risk of Grade 4 toxicity with this combination. The 40% rate of severe toxicity suggests that this combination of agents is near the maximal tolerated dose.

Original languageEnglish (US)
Pages (from-to)615-618
Number of pages4
JournalInternational Journal of Radiation Oncology Biology Physics
Volume37
Issue number3
DOIs
StatePublished - Feb 1 1997

Fingerprint

Leucovorin
Fluorouracil
Colonic Neoplasms
radiation therapy
toxicity
Radiotherapy
cancer
grade
dosage
nausea
Gastrointestinal Neoplasms
Nausea
tumors
vomiting
Hand-Foot Syndrome
Catheter-Related Infections
Stomatitis
Maximum Tolerated Dose
lymphatic system
Anorexia

Keywords

  • Continuous infusion 5- fiuorouracil
  • Leucovorin
  • Pancreatic cancer
  • Radiation therapy

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Radiation

Cite this

Pilot study of continuous-infusion 5-fluorouracil, oral leucovorin, and upper-abdominal radiation therapy in patients with locally advanced residual or recurrent upper gastrointestinal or extrapelvic colon cancer. / Martenson, James A.; Swaminathan, Revathi; Burch, Patrick A.; Santala, Roger G.; Schroeder, Georgene; Pitot, Henry Clement; Wright, Keith; Kugler, John W.; Stella, Philip J.; Garton, Graciela R.

In: International Journal of Radiation Oncology Biology Physics, Vol. 37, No. 3, 01.02.1997, p. 615-618.

Research output: Contribution to journalArticle

Martenson, James A. ; Swaminathan, Revathi ; Burch, Patrick A. ; Santala, Roger G. ; Schroeder, Georgene ; Pitot, Henry Clement ; Wright, Keith ; Kugler, John W. ; Stella, Philip J. ; Garton, Graciela R. / Pilot study of continuous-infusion 5-fluorouracil, oral leucovorin, and upper-abdominal radiation therapy in patients with locally advanced residual or recurrent upper gastrointestinal or extrapelvic colon cancer. In: International Journal of Radiation Oncology Biology Physics. 1997 ; Vol. 37, No. 3. pp. 615-618.
@article{c5bda09d468849e482e0900fee9a11e2,
title = "Pilot study of continuous-infusion 5-fluorouracil, oral leucovorin, and upper-abdominal radiation therapy in patients with locally advanced residual or recurrent upper gastrointestinal or extrapelvic colon cancer",
abstract = "Purpose: The purpose of this study was to develop a satisfactorily tolerated regimen of radiation therapy, continuous infusion 5-fluorouracil, and leucovorin in patients with locally advanced upper-abdominal gastrointestinal cancer. Methods and Materials: Patients with locally advanced or locally recurrent gastric, pancreatic, or extrapelvic colon cancer were eligible for this study. Radiation therapy consisted of 45 Gy in 25 fractions to the tumor and regional lymph nodes, followed by 5.4-9 Gy in three to five fractions to the tumor. Treatment with leucovorin, 10 mg orally daily, and continuous infusion 5-fluorouracil was initiated on the first day of radiation therapy. 5-Fluorouracil was administered at an initial daily dose of 125 mg/m2, with dose escalation planned in 25-mg increments, depending on patient tolerance. Results: Twenty-one evaluable patients participated in this study. Six were treated at the initial daily 5- fluorouracil dose of 125 mg/m2. One patient experienced Grade 4 anorexia and nausea. No other Grade ≤ 3 toxicity was observed at this dose. Fifteen evaluable patients were entered at a planned 5-fluorouracil dose of 150 mg/m2 daily; 6 of them experienced Grade 3 toxicity, and none experienced Grade ≤ 4 toxicity. Grade 3 toxicities and the number of patients who developed each were: vomiting (three patients); nausea (two patients); diarrhea (two patients); and skin toxicity, hand-foot syndrome, catheter- related infection, and stomatitis in one patient each. Four of the six patients who experienced Grade 3 toxicity developed more than one type of Grade 3 toxicity. Conclusions: In patients with upper-abdominal gastrointestinal cancer, continuous infusion 5-fluorouracil (150 mg/m2 daily), leucovorin (10 mg orally daily), and radiation therapy (50-54 Gy) resulted in a 40{\%} rate of severe toxicity but no life-threatening toxicity. This clinical trial excludes, with 90{\%} confidence, a 20{\%} risk of Grade 4 toxicity with this combination. The 40{\%} rate of severe toxicity suggests that this combination of agents is near the maximal tolerated dose.",
keywords = "Continuous infusion 5- fiuorouracil, Leucovorin, Pancreatic cancer, Radiation therapy",
author = "Martenson, {James A.} and Revathi Swaminathan and Burch, {Patrick A.} and Santala, {Roger G.} and Georgene Schroeder and Pitot, {Henry Clement} and Keith Wright and Kugler, {John W.} and Stella, {Philip J.} and Garton, {Graciela R.}",
year = "1997",
month = "2",
day = "1",
doi = "10.1016/S0360-3016(96)00544-5",
language = "English (US)",
volume = "37",
pages = "615--618",
journal = "International Journal of Radiation Oncology Biology Physics",
issn = "0360-3016",
publisher = "Elsevier Inc.",
number = "3",

}

TY - JOUR

T1 - Pilot study of continuous-infusion 5-fluorouracil, oral leucovorin, and upper-abdominal radiation therapy in patients with locally advanced residual or recurrent upper gastrointestinal or extrapelvic colon cancer

AU - Martenson, James A.

AU - Swaminathan, Revathi

AU - Burch, Patrick A.

AU - Santala, Roger G.

AU - Schroeder, Georgene

AU - Pitot, Henry Clement

AU - Wright, Keith

AU - Kugler, John W.

AU - Stella, Philip J.

AU - Garton, Graciela R.

PY - 1997/2/1

Y1 - 1997/2/1

N2 - Purpose: The purpose of this study was to develop a satisfactorily tolerated regimen of radiation therapy, continuous infusion 5-fluorouracil, and leucovorin in patients with locally advanced upper-abdominal gastrointestinal cancer. Methods and Materials: Patients with locally advanced or locally recurrent gastric, pancreatic, or extrapelvic colon cancer were eligible for this study. Radiation therapy consisted of 45 Gy in 25 fractions to the tumor and regional lymph nodes, followed by 5.4-9 Gy in three to five fractions to the tumor. Treatment with leucovorin, 10 mg orally daily, and continuous infusion 5-fluorouracil was initiated on the first day of radiation therapy. 5-Fluorouracil was administered at an initial daily dose of 125 mg/m2, with dose escalation planned in 25-mg increments, depending on patient tolerance. Results: Twenty-one evaluable patients participated in this study. Six were treated at the initial daily 5- fluorouracil dose of 125 mg/m2. One patient experienced Grade 4 anorexia and nausea. No other Grade ≤ 3 toxicity was observed at this dose. Fifteen evaluable patients were entered at a planned 5-fluorouracil dose of 150 mg/m2 daily; 6 of them experienced Grade 3 toxicity, and none experienced Grade ≤ 4 toxicity. Grade 3 toxicities and the number of patients who developed each were: vomiting (three patients); nausea (two patients); diarrhea (two patients); and skin toxicity, hand-foot syndrome, catheter- related infection, and stomatitis in one patient each. Four of the six patients who experienced Grade 3 toxicity developed more than one type of Grade 3 toxicity. Conclusions: In patients with upper-abdominal gastrointestinal cancer, continuous infusion 5-fluorouracil (150 mg/m2 daily), leucovorin (10 mg orally daily), and radiation therapy (50-54 Gy) resulted in a 40% rate of severe toxicity but no life-threatening toxicity. This clinical trial excludes, with 90% confidence, a 20% risk of Grade 4 toxicity with this combination. The 40% rate of severe toxicity suggests that this combination of agents is near the maximal tolerated dose.

AB - Purpose: The purpose of this study was to develop a satisfactorily tolerated regimen of radiation therapy, continuous infusion 5-fluorouracil, and leucovorin in patients with locally advanced upper-abdominal gastrointestinal cancer. Methods and Materials: Patients with locally advanced or locally recurrent gastric, pancreatic, or extrapelvic colon cancer were eligible for this study. Radiation therapy consisted of 45 Gy in 25 fractions to the tumor and regional lymph nodes, followed by 5.4-9 Gy in three to five fractions to the tumor. Treatment with leucovorin, 10 mg orally daily, and continuous infusion 5-fluorouracil was initiated on the first day of radiation therapy. 5-Fluorouracil was administered at an initial daily dose of 125 mg/m2, with dose escalation planned in 25-mg increments, depending on patient tolerance. Results: Twenty-one evaluable patients participated in this study. Six were treated at the initial daily 5- fluorouracil dose of 125 mg/m2. One patient experienced Grade 4 anorexia and nausea. No other Grade ≤ 3 toxicity was observed at this dose. Fifteen evaluable patients were entered at a planned 5-fluorouracil dose of 150 mg/m2 daily; 6 of them experienced Grade 3 toxicity, and none experienced Grade ≤ 4 toxicity. Grade 3 toxicities and the number of patients who developed each were: vomiting (three patients); nausea (two patients); diarrhea (two patients); and skin toxicity, hand-foot syndrome, catheter- related infection, and stomatitis in one patient each. Four of the six patients who experienced Grade 3 toxicity developed more than one type of Grade 3 toxicity. Conclusions: In patients with upper-abdominal gastrointestinal cancer, continuous infusion 5-fluorouracil (150 mg/m2 daily), leucovorin (10 mg orally daily), and radiation therapy (50-54 Gy) resulted in a 40% rate of severe toxicity but no life-threatening toxicity. This clinical trial excludes, with 90% confidence, a 20% risk of Grade 4 toxicity with this combination. The 40% rate of severe toxicity suggests that this combination of agents is near the maximal tolerated dose.

KW - Continuous infusion 5- fiuorouracil

KW - Leucovorin

KW - Pancreatic cancer

KW - Radiation therapy

UR - http://www.scopus.com/inward/record.url?scp=0030948421&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0030948421&partnerID=8YFLogxK

U2 - 10.1016/S0360-3016(96)00544-5

DO - 10.1016/S0360-3016(96)00544-5

M3 - Article

VL - 37

SP - 615

EP - 618

JO - International Journal of Radiation Oncology Biology Physics

JF - International Journal of Radiation Oncology Biology Physics

SN - 0360-3016

IS - 3

ER -