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Recombinant Human Keratinocyte Growth Factor (RHUKGF) Prevents Chemotherapy-Induced Mucositis In Patients With Advanced Colorectal Cancer: A Randomized Phase II Trial
Heather Jones, MD
University of Pennsylvania Cancer
Last Modified: May 14, 2001
Presenter: Stephen John Clarke
Affiliation: Royal Prince Alfred Hospital, Camperdown, Australia
Oral mucositis in cancer patients receiving chemotherapy can lead to dose reduction and/or treatment breaks, both of which could have a negative impact on treatment outcomes. The use of 5-fluorouracil (5-FU) and folinic acid for the treatment of advanced colon cancer is associated with a 70% oral mucositis rate overall and a 20 to 30 % severe mucositis rate. Recombinant HuKGF is an epithelial specific growth factor. A previously reported phase I clinical trial in patients with advanced colorectal cancer demonstrated that rHuKGF reduced the incidence of oral mucositis caused by chemotherapy as compared to placebo (43% and 67% respectively; p=0.06). To establish the efficacy of the agent this randomized phase II trial was carried out.
Materials and Methods:
- Sixty-four patients with advanced colorectal cancer were enrolled on to the trial, 42 males and 22 females
- Median age 65 (range 37-88)
- Median ECOG performance status of 1(range 0-2)].
- Patients were randomly assigned to receive 2 cycles of either rHuKGF 40 [Micro]g/kg/day or placebo by IV bolus on days 1-3, followed by bolus 5-FU 425 mg/m2/day plus leucovorin 20 mg/m2/day on days 4-8 of a 28 day cycle.
- Oral cryotherapy was not permitted in this trial.
- The incidence of Grade 2, 3, and 4 mucositis in two cycles combined was 78% in the placebo (n=36) and 32% in the rHuKGF group (n=28) [p=0.001].
- A significant reduction in the duration of mucositis was also observed (10.2 days for placebo and 3.4 days for rHuKGF; p=0.001).
- Recombinant HuKGF had no effect on median survival
- The most common treatment-related adverse events were mild to moderate skin-related events including rash, flushing, and edema
- Asymptomatic and reversible increases in amylase and lipase were observed after rHuKGF administration.
- These results confirm and extend previous clinical observations of the efficacy and safety profile of rHuKGF.
- Recombinant HuKGF is able to reduce the incidence, severity and duration of chemotherapy-induced mucositis.
This was a well-done study demonstrating the protective efficacy of this agent. Treating advanced malignancies often calls for aggressive therapy to get a positive out come. Often patients due to gastrointestinal mucositis are placed on a treatment break or have a reduction in the intensity of their treatment. Both actions can influence the treatment outcome. Having a protective agent, as rHuKGF helps reduce the likelihood of dose reduction and/or treatment delays. We look forward to the results of rHuKGF used in chemoradiation trials for head and neck cancer patients.
OncoLink ASCO 2001 coverage is provided by an unrestricted educational grant from Amgen