Dr Artur Bauhofer and colleagues from Germany aimed to improve the postoperative outcome of high-risk patients recovering from colorectal cancer surgery.
The research team used filgrastim, a recombinant human granulocyte colony-stimulating factor, as perioperative prophylaxis.
The team conducted a double-blinded, placebo-controlled trial.
The researchers randomised 80 patients to undergo left-sided colorectal resection or placebo.
Filgrastim or placebo was administered in the afternoon the day before, on the day and the day after the operation.
|Noninfectious complications decreased from 8% to 3%|
The team's primary endpoints were placed in a hierarchic order.
These included quality of life over time determined at discharge, 2 and 6 months after operation.
Quality of life was established by using the European Organization for Research and Treatment of Cancer questionnaire.
The researchers also used the McPeek recovery score, which measures death and duration of stays in the intensive care unit and hospital.
Predefined secondary endpoints were global quality of life, subdomains of quality of life, and postoperative recovery.
In addition, the team measured duration of stay, 6-month overall survival, complication rates, and cellular and immunologic parameters.
The researchers found no significant differences in both primary endpoints between the treatment groups.
A significant improvement was obtained by filgrastim prophylaxis in the quality of life subdomain family life, and social functioning.
The team observed that more patients recovered to their preoperative state as determined by structured interviews.
The researchers noted that duration of hospital stay, and noninfectious complications were decreased from 8% to 3%.
Dr Bauhofer's team concluded, “High-risk patients undergoing major operation for colorectal cancer profited from filgrastim prophylaxis with regard to duration of hospital stay. “
“Filgrastim prophylaxis also improved Noninfectious complications, social quality of life, and subjective recovery from operation.”
“These endpoints, however, were secondary, and the primary endpoints did not show comparable benefits.”
“A new confirmatory trial with the successful endpoints of this trial, as well as a cost analysis, will be needed to confirm the results before a general recommendation can be given.”