E. Pujadelauraine et al., INTRAPERITONEAL RECOMBINANT INTERFERON-GAMMA IN OVARIAN-CANCER PATIENTS WITH RESIDUAL DISEASE AT 2ND-LOOK LAPAROTOMY, Journal of clinical oncology, 14(2), 1996, pp. 343-350
Purpose: The purpose of this study was to evaluate the efficacy and to
lerance of recombinant human interferon gamma (rIFN-gamma) as second-l
ine treatment in patients with persistent disease at second-look lapar
otomy. Patients and Methods: One hundred eight patients with residual
disease at second-look laparotomy were treated with rIFN-gamma (2O x 1
0(6) IU/m(2)) administered intraperitoneally (IP) twice a week for 3 t
o 4 months. In the absence of clinically assessable disease, response
to rIFN-gamma was assessed with a third-look laparotomy. Results: Of 9
8 assessable patients, 31 (32%) achieved a surgically documented respo
nse, including 23 patients (23%) with a complete response (CR). The ag
e and size of residual tumor were significant prognostic factors for t
he response to rIFN-gamma. A 41% CR rate was observed in 41 patients y
ounger than 60 years and with residual tumor less than 2 cm. The proba
bility of response was independent of previous response to first-line
chemotherapy. The median duration of response was 20 months and the 3-
year survival rate in responders was 62%. Response to rIFN-gamma was t
he most significant prognostic factor for survival of patients with re
sidual disease. Adverse events included fever, flu-like syndrome, neut
ropenia, and liver enzyme disturbances. No significant peritoneal fibr
osis was noted. Conclusion: These results support the potential intere
st of IP rIFN-gamma as adjuvant treatment in ovarian cancer. Controlle
d prospective trials are required to determine its place in the therap
eutic strategy of this malignancy. (C) 1996 by American Society of Cli
nical Oncology.