Prospective randomized reappraisal of 5-fluorouracil in metastatic colorectal carcinoma. A comparative trial with 6-thioguanine

C. A. Presant, Alex Denes, C. Liu, A. A. Bartolucci

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

In order to redefine the effectiveness of 5-fluorouracil (5-FU) as palliative therapy in patients with metastatic colorectal carcinoma, and to compare the effectiveness of 6-thioguanine (6-TG) with that of 5-FU, we studied 176 patients with metastatic colorectal carcinoma in a randomized prospective trial (SEG 79GI268). The pretreatment performance status of all patients was greater than 50% (ambulatory), and there was an equal distribution of patients with favorable pretreatment characteristics into each of the treatment regimens. Complete responses were only seen to 5-FU, but were obtained in only 3% of instances. The overall complete plus partial response rates were not different for 5-FU (8%) versus 6-TG (3%), or for patients who had shown prior progression on chemotherapy and who then received 6-TG in a nonrandomized fashion (7%). The time to tumor progression on each of the treatment programs was similar, 1.0 months. Survival was also similar in each regimen in the randomized study (6.3 months for 5-FU versus 7.9 months for 6-TG). However, survival was only 4.8 months for patients with previously drug-resistant tumors treated with 6-TG in the randomized arm. In 16 patients failing 6-TG who then received 5-FU, there were no objective responses. Similarly, in patients with failing 5-FU on this study who then received 6-TG, there were no responses in nine patients. Dose-limiting toxicity was observed in 40% to 51% of patients, and consisted of myelosuppression, vomiting, or diarrhea. It is concluded that 5-FU is a minimally effective agent in a very small number of patients with metastatic colorectal carcinoma. The drug 6-TG is equally ineffective in this setting. Alternative treatment programs to the systemic use of 5-FU should be considered in patients requiring palliative chemotherapy.

Original languageEnglish (US)
Pages (from-to)2610-2614
Number of pages5
JournalCancer
Volume53
Issue number12
StatePublished - 1984
Externally publishedYes

Fingerprint

Thioguanine
Fluorouracil
Colorectal Neoplasms
Drug Therapy
Survival
Palliative Care
Pharmaceutical Preparations
Vomiting
Diarrhea
Neoplasms

ASJC Scopus subject areas

  • Cancer Research

Cite this

Prospective randomized reappraisal of 5-fluorouracil in metastatic colorectal carcinoma. A comparative trial with 6-thioguanine. / Presant, C. A.; Denes, Alex; Liu, C.; Bartolucci, A. A.

In: Cancer, Vol. 53, No. 12, 1984, p. 2610-2614.

Research output: Contribution to journalArticle

Presant, CA, Denes, A, Liu, C & Bartolucci, AA 1984, 'Prospective randomized reappraisal of 5-fluorouracil in metastatic colorectal carcinoma. A comparative trial with 6-thioguanine', Cancer, vol. 53, no. 12, pp. 2610-2614.
Presant, C. A. ; Denes, Alex ; Liu, C. ; Bartolucci, A. A. / Prospective randomized reappraisal of 5-fluorouracil in metastatic colorectal carcinoma. A comparative trial with 6-thioguanine. In: Cancer. 1984 ; Vol. 53, No. 12. pp. 2610-2614.
@article{d800a397d70043f991ac170b0de54694,
title = "Prospective randomized reappraisal of 5-fluorouracil in metastatic colorectal carcinoma. A comparative trial with 6-thioguanine",
abstract = "In order to redefine the effectiveness of 5-fluorouracil (5-FU) as palliative therapy in patients with metastatic colorectal carcinoma, and to compare the effectiveness of 6-thioguanine (6-TG) with that of 5-FU, we studied 176 patients with metastatic colorectal carcinoma in a randomized prospective trial (SEG 79GI268). The pretreatment performance status of all patients was greater than 50{\%} (ambulatory), and there was an equal distribution of patients with favorable pretreatment characteristics into each of the treatment regimens. Complete responses were only seen to 5-FU, but were obtained in only 3{\%} of instances. The overall complete plus partial response rates were not different for 5-FU (8{\%}) versus 6-TG (3{\%}), or for patients who had shown prior progression on chemotherapy and who then received 6-TG in a nonrandomized fashion (7{\%}). The time to tumor progression on each of the treatment programs was similar, 1.0 months. Survival was also similar in each regimen in the randomized study (6.3 months for 5-FU versus 7.9 months for 6-TG). However, survival was only 4.8 months for patients with previously drug-resistant tumors treated with 6-TG in the randomized arm. In 16 patients failing 6-TG who then received 5-FU, there were no objective responses. Similarly, in patients with failing 5-FU on this study who then received 6-TG, there were no responses in nine patients. Dose-limiting toxicity was observed in 40{\%} to 51{\%} of patients, and consisted of myelosuppression, vomiting, or diarrhea. It is concluded that 5-FU is a minimally effective agent in a very small number of patients with metastatic colorectal carcinoma. The drug 6-TG is equally ineffective in this setting. Alternative treatment programs to the systemic use of 5-FU should be considered in patients requiring palliative chemotherapy.",
author = "Presant, {C. A.} and Alex Denes and C. Liu and Bartolucci, {A. A.}",
year = "1984",
language = "English (US)",
volume = "53",
pages = "2610--2614",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "12",

}

TY - JOUR

T1 - Prospective randomized reappraisal of 5-fluorouracil in metastatic colorectal carcinoma. A comparative trial with 6-thioguanine

AU - Presant, C. A.

AU - Denes, Alex

AU - Liu, C.

AU - Bartolucci, A. A.

PY - 1984

Y1 - 1984

N2 - In order to redefine the effectiveness of 5-fluorouracil (5-FU) as palliative therapy in patients with metastatic colorectal carcinoma, and to compare the effectiveness of 6-thioguanine (6-TG) with that of 5-FU, we studied 176 patients with metastatic colorectal carcinoma in a randomized prospective trial (SEG 79GI268). The pretreatment performance status of all patients was greater than 50% (ambulatory), and there was an equal distribution of patients with favorable pretreatment characteristics into each of the treatment regimens. Complete responses were only seen to 5-FU, but were obtained in only 3% of instances. The overall complete plus partial response rates were not different for 5-FU (8%) versus 6-TG (3%), or for patients who had shown prior progression on chemotherapy and who then received 6-TG in a nonrandomized fashion (7%). The time to tumor progression on each of the treatment programs was similar, 1.0 months. Survival was also similar in each regimen in the randomized study (6.3 months for 5-FU versus 7.9 months for 6-TG). However, survival was only 4.8 months for patients with previously drug-resistant tumors treated with 6-TG in the randomized arm. In 16 patients failing 6-TG who then received 5-FU, there were no objective responses. Similarly, in patients with failing 5-FU on this study who then received 6-TG, there were no responses in nine patients. Dose-limiting toxicity was observed in 40% to 51% of patients, and consisted of myelosuppression, vomiting, or diarrhea. It is concluded that 5-FU is a minimally effective agent in a very small number of patients with metastatic colorectal carcinoma. The drug 6-TG is equally ineffective in this setting. Alternative treatment programs to the systemic use of 5-FU should be considered in patients requiring palliative chemotherapy.

AB - In order to redefine the effectiveness of 5-fluorouracil (5-FU) as palliative therapy in patients with metastatic colorectal carcinoma, and to compare the effectiveness of 6-thioguanine (6-TG) with that of 5-FU, we studied 176 patients with metastatic colorectal carcinoma in a randomized prospective trial (SEG 79GI268). The pretreatment performance status of all patients was greater than 50% (ambulatory), and there was an equal distribution of patients with favorable pretreatment characteristics into each of the treatment regimens. Complete responses were only seen to 5-FU, but were obtained in only 3% of instances. The overall complete plus partial response rates were not different for 5-FU (8%) versus 6-TG (3%), or for patients who had shown prior progression on chemotherapy and who then received 6-TG in a nonrandomized fashion (7%). The time to tumor progression on each of the treatment programs was similar, 1.0 months. Survival was also similar in each regimen in the randomized study (6.3 months for 5-FU versus 7.9 months for 6-TG). However, survival was only 4.8 months for patients with previously drug-resistant tumors treated with 6-TG in the randomized arm. In 16 patients failing 6-TG who then received 5-FU, there were no objective responses. Similarly, in patients with failing 5-FU on this study who then received 6-TG, there were no responses in nine patients. Dose-limiting toxicity was observed in 40% to 51% of patients, and consisted of myelosuppression, vomiting, or diarrhea. It is concluded that 5-FU is a minimally effective agent in a very small number of patients with metastatic colorectal carcinoma. The drug 6-TG is equally ineffective in this setting. Alternative treatment programs to the systemic use of 5-FU should be considered in patients requiring palliative chemotherapy.

UR - http://www.scopus.com/inward/record.url?scp=0021255303&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0021255303&partnerID=8YFLogxK

M3 - Article

VL - 53

SP - 2610

EP - 2614

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 12

ER -