Bauhofer, Artur and Plaul, Ulrike and Torossian, Alexander and Koller, Michael and Stinner, Benno and Celik, Ilhan and Sitter, Helmut and Greger, Bernd and Middeke, Martin and Schein, Moshe and Wyatt, Jeremy and Nystrom, Per-Olof and Hartung, Thomas and Rothmund, Matthias and Lorenz, Wilfried (2007) Perioperative prophylaxis with granulocyte colony-stimulating factor (G-CSF) in high-risk colorectal cancer patients for an improved recovery: A randomized, controlled trial. SURGERY, 141 (4). pp. 501-510. ISSN 0039-6060,
Full text not available from this repository. (Request a copy)Abstract
Background. We aimed to improve the postoperative outcome of high-risk patients (American Society of Anesthesiologists class 3 and 4) recovering from colorectal cancer surgery by using recombinant human G-CSF (filgrastim) as perioperative prophylaxis. Methods. In a double-blinded, placebo-controlled trial, 80 patients undergoing left-sided colorectal resection were randomized to filgrastim or placebo. Filgrastim, (5 mu g/kg) or placebo was. administered in the afternoon on day -1, 0, and +1 relative to the operation. Primary endpoints were in a hierarchic order: quality of life (QoL) over true (determined at discharge, 2 and 6 months after operation with the European Organization for Research and Treatment of Cancer questionnaire) and the McPeek recovery score, which measures death and duration of stays in the intensive care unit and hospital. Predefined secondary endpoints were global QoL, subdomains of QoL, postoperative recovery, duration of stay, 6-month overall survival, complication rates, and cellular and immunologic parameters. Results. There were no significant differences in both primary endpoints between the treatment groups. A significant improvement (P < .05) was obtained by filgrastim prophylaxis in the QoL subdomain family life /- social functioning,; thus, more patients recovered to their preoperative state (14 vs 4 with placebo) as determined by structured interviews. Duration of hospital stay (14 vs 12 days) and noninfectious complications were decreased from 8% to 3%. Conclusions. High-risk patients undergoing major operation for colorectal cancer profited from filgrastim prophylaxis with regard to duration of hospital stay, noninfectious complications, social QoL, and subjective recovery from operation. These endpoints, however, were secondary, and the primary endpoints (overall QoL and the McPeek index) 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 for the prophylactic use of G-CSF in high-risk cancer patients can be given.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | QUALITY-OF-LIFE; CONTROLLED CLINICAL-TRIAL; POSTOPERATIVE INFECTIOUS COMPLICATIONS; INTERNATIONAL STUDY-GROUP; SUBOPTIMAL RECOVERY; FILGRASTIM TREATMENT; SEPTIC SHOCK; NEUTROPENIA; PREVENTION; MANAGEMENT; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Zentren des Universitätsklinikums Regensburg > Zentrum für Klinische Studien |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 21 Dec 2020 07:28 |
| Last Modified: | 21 Dec 2020 07:28 |
| URI: | https://pred.uni-regensburg.de/id/eprint/33016 |
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