Author/Editor		Rosen, Harald R; Jatzko, Gerhard; Repše, Stane; Potrč, Stojan; Neudorfer, Herbert; Sandbichler, Peter; Zacherl, Johannes; Rabl, Hans; Holzberger, Peter; Lisborg, Peter; Czeijka, Martin
Title		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
Type		članek
Source		J Clin Oncol
Vol. and No.		Letnik 16, št. 8
Publication year		1998
Volume		str. 2733-7
Language		eng
Abstract		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 carbo adsorbens intraperitoneally before closure of the abdominal wound (n - 46) or served as a sugical control group (n - 45). Postoperative complications and 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 patients onto 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 for prognosis following radical resection of locally advanced tumors was observed in this multicenter phase III trial.
Descriptors		STOMACH NEOPLASMS MITOMYCINS NEOPLASM STAGING ANTIBIOTICS, ANTINEOPLASTIC CARBON CHEMOTHERAPY, ADJUVANT PERITONEAL CAVITY POSTOPERATIVE COMPLICATIONS SURVIVAL RATE RANDOMIZED CONTROLLED TRIALS AUSTRIA SLOVENIA AGED MIDDLE AGE