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  • Adjuvant intraperitoneal chemotherapy with carbon-adsorbed mitomycin in patients with gastric cancer: results of a randomized multicenteer trial of the Austrian working group for surgical oncology
    Rosen, Harald R. ...
    Purpose: Previous studies have demonstrated a beneficial effect of intraperitoneally applied mitomycin bound to activated carbon particles (M-CH)in preventing intraabdominal recurrence following ... curative surgery for gastric cancer. The Austrian Working Group for Stomach Cancer, a subgroup of the Austrian Working Group for Surgical Oncology, initiated a multicentric phase III trial to evaluate the safety and effecicay of this treatment regimen. Patients and Methods: A total of 91 patients with a radically resected gastric cancer infiltrating the serosal surface were randomly assigned to receive either 50 mg mitomycin bound to a solution of 375 mg carboadsorbens intraperitoneally before closure of the abdominal wound (n - 46) or served as a sugical control group (n - 45). Postoperative complicationsand recurrence-free and overall survival were evaluated to analyze the risks and benefits of this treatment. Results: After a median observation period of 597 days (range, 72 to 1,096), a significantly higher postoperative complication rate was observed in the M-CH group (35%) compared with the control group (16%) (P < .02). In accordance with this finding, the postoperative (60 days) mortality rate was also significantly elevated in the M-CH group (11% v 2% in the control group). Since analysis of overall and recurrence-free survival failed to show any beneficial effect of M-CH therapy,the protocol committee decided to stop further recruitment of patientsonto this study. Conclusion: Adjuvant intraperitoneal therapy of gastric cancer by mitomycin bound to activated carbon particles is associated with an increased rate of postoperative complications. However, no benefit forprognosis following radical resection of locally advanced tumors was observed in this multicenter phase III trial.
    Source: Journal of clinical oncology. - ISSN 0732-183X (Letn. 16, št. 8, 1998, str. 2733-2737)
    Type of material - article, component part
    Publish date - 1998
    Language - english
    COBISS.SI-ID - 9344473

source: Journal of clinical oncology. - ISSN 0732-183X (Letn. 16, št. 8, 1998, str. 2733-2737)
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