Phase II trial of 5-fluorouracil and folinic acid in the treatment of advanced breast cancer

Sheldon Fine, Charles Erlichman, Leonard Kaizer, David Warr, Tahany Gadalla

Research output: Contribution to journalArticlepeer-review

8 Scopus citations


Standard combination chemotherapy for metastatic breast cancer produces response rates between 30-60% with limited impact on survival. We undertook a phase II trial to determine the activity of 5 fluorouracil (5FU) and folinic acid (FA) in patients with measurable metastatic or recurrent breast cancer who had received no prior chemotherapy. Patients meeting the eligibility criteria received 5FU 370 mg/m2/day and FA 200 mg/m2/day for 5 days repeated every 28 days, toxicity allowing. Response defined by standard criteria was assessed every 8 weeks and toxicity according to WHO criteria was determined on every course. Thirty-three patients were entered on trial. Thirty-two patients were evaluable for response and 33 for toxicity. The dose limiting toxicity was stomatitis with 7/32, 19/32, and 5/32 patients experiencing grade 1, 2, and 3 toxicity. Grades 1 and 2 diarrhea occurred in 17/32 and 11/32 patients respectively. Myelosuppression was not significant. Two complete and 11 partial responses were observed. The overall response rate was 41% (95% CI, 24-58%). Responses were seen in soft tissue and visceral sites. Patients who had received adjuvant chemotherapy more than 6 months prior to receiving 5FU and FA responded also. Six of 29 patients receiving standard combination chemotherapy as second line treatment responded subsequently. We concluded: 1) 5FU and FA is an active combination in the treatment of breast cancer warranting further evaluation in combination with other drugs; 2) the dose-limiting toxicity of stomatitis is tolerable; 3) patients receiving 5FU and FA as first line therapy can respond to conventional combination chemotherapy as second line treatment.

Original languageEnglish (US)
Pages (from-to)205-209
Number of pages5
JournalBreast Cancer Research and Treatment
Issue number2
StatePublished - Jan 1 1994


  • 5FU
  • breast cancer
  • folinic acid
  • metastatic

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


Dive into the research topics of 'Phase II trial of 5-fluorouracil and folinic acid in the treatment of advanced breast cancer'. Together they form a unique fingerprint.

Cite this