Phase II study of recombinant leukocyte A interferon (IFN-rA) plus XXXX in disseminated @entity320 .

@entity1 @entity4444 @entity137 @entity390 @entity66 @entity882 @entity5 @entity448 @entity1431 @entity925 @entity320
Thirty-five eligible @entity1 with disseminated @entity320 received intramuscular recombinant leukocyte interferon (IFN-rA), 50 X 10(6) U/m2 three times weekly (TIW) for an intended duration of 12 weeks concomitant with daily oral @entity4444 , 1,200 mg/d in four divided doses. For all study @entity1 , the median survival time was six months. Among 21 "good risk" @entity1 (performance score [PS] 0, 1 and no prior chemotherapy), we observed seven partial regressions (33%). Six @entity1 had stability of disease (29%), seven had immediate disease progression, and one discontinued treatment after two doses without @entity5 evaluation due to side effects. Times to disease progression of five @entity1 with regressions of soft-tissue disease were 2.1, 3.3, 3.5, 3.7, and 4.3 months. Two @entity1 had partial regressions of lung nodules for 2.0 and 3.8 months. We observed one regression among 14 "poor risk" @entity1 (PS 2, 3, or prior chemotherapy). A 46-year-old @entity1 with prior treatment had a partial regression of soft-tissue disease for 4.1 months. Four "poor risk" @entity1 @entity66 stability, and nine progressed immediately. @entity1431 (WBC count less than 4,100/microL) affected 21 (66%) of 32 @entity1 with WBC count data. The median count was 3,100/microL; range, 1,300 to 8,400/microL. We detected two cases of mild @entity882 (100,000 and 120,000/microL). Other noteworthy @entity137 included moderate-to-severe @entity390 (34%), @entity448 (63%), and fatigue (80%). All @entity1 experienced @entity925 . Twenty @entity1 had dosage decreases during the first cycle, and 14 of the 16 @entity1 remaining on study after the first cycle required dosage reductions. The overall response rate is similar to our prior studies with IFN-rA as a single agent using TIW doses of 50 X 10(6) U/m2 and 12 X 10(6) U/m2 among 31 and 30 @entity1 , respectively.
