Source: DGNews  |  Posted 4 years ago

By Jill Stein

BARCELONA, SPAIN -- September 26, 2007 -- A regimen of oral tegafur-uracil (UFT) plus leucovorin with alternating oxaliplatin and irinotecan (SCOUT regimen) appears to be highly effective and well tolerated in patients with metastatic colorectal cancer, researchers reported here at the 14th European Cancer Conference (ECCO).

"Our findings document the usefulness of this regimen for front-line management of patients with metastatic colorectal cancer," said Hamid Y. Sheikh, MD, Consultant Oncologist, Christie Hospital, Manchester, United Kingdom.

"It is particularly important that patients with advanced disease like those in our study population are able to receive second-line therapy. Typically, only about 50% of patients with metastatic colorectal cancer are well enough to receive second-line therapy," Dr. Sheikh added in a presentation on September 24th.

In addition to UFT's potential utility as first-line therapy for metastatic colorectal cancer, the agent offers a convenient alternative to IV 5-fluorouracil, he added. "Since the medication is oral, patients are able to take it at home, thereby saving themselves time and saving hospitals time and money," he said.

Dr. Sheikh and colleagues tested the SCOUT regimen in 45 patients who had histologically confirmed, advanced adenocarcinoma of the colon or rectum with inoperable, measurable, metastatic disease.

Treatment consisted of three phases:

· irinotecan 180 mg/m² as a 90-minute infusion on day 1 of the 28-day cycle
· UFT capsules 200 to 300 mg/m²/day taken orally with leucovorin 90 mg/day in 3 divided doses on days 1 to 21
· oxaliplatin 85 to 100 mg/m² as a 2-hour infusion on day 15

The maximum tolerated dose was established at UFT 250 mg/mm²/day, leucovorin 90 mg/day, irinotecan 180 mg/m², and oxaliplatin 100 mg/m². In the second phase of the study, patients received the maximum tolerated dose.

Results showed an objective response rate of 66%. At a median follow-up of 14.9 months, median time to progression was 8.7 months and the overall survival was 16.8 months.

The SCOUT regiment was well tolerated, with a low incidence of alopaecia and neurotoxicity. Five patients receiving the maximal tolerated dose had grade 3/4 adverse events.

There were no cases of hand-foot syndrome.

One patient who had received two cycles of treatment and had a partial response had a sudden cardiac death. Another patient who was known to have a history of atrial fibrillation died from myocardial infarction after four treatment cycles.

Colorectal cancer is the third most common malignancy worldwide. Approximately 370,000 new cases of the disease are diagnosed in Europe each year.

Funding for the study was provided by Merck Serono.

[Presentation title: Study of CPT-11, Oxaliplatin, UFT Triple Therapy (SCOUT) in Metastatic Colorectal Cancer: An Effective and Well Tolerated Regimen. Abstract 3069]