PURPOSE: In a preliminary non-randomized study, combination therapy with natural (i.e. non-recombinant) interferon-alpha plus @entity4444 obtained a high response rate in @entity1 with @entity1358 . We conducted a prospective randomized phase III trial to determine whether combination therapy with natural interferon-alpha plus @entity4444 is superior to natural interferon-alpha alone in @entity1 with @entity1358 with @entity358 . METHODS: @entity1 received 5 million units (MU) natural interferon-alpha per day, five times a week, or the 5 MU natural interferon-alpha regimen plus a daily oral @entity4444 . The primary and secondary end points were the response rate, and the @entity1054 ( @entity1054 ), respectively. RESULTS: Between April 1998 and March 2002, 71 @entity1 from 32 institutions were randomly assigned to the 2 treatment groups. One @entity1 in each group did not receive any natural interferon-alpha whatsoever. Two @entity1 in the natural interferon-alpha alone group stopped treatment: on day 9 and on day 10, respectively. In the intent-to-treat analysis, 1 complete response (CR), 4 partial responses (PRs), 16 no changes (NCs), and 12 @entity74 ( @entity74 ) were observed among the 36 @entity1 in the interferon-alpha alone group with a response rate of 13.9%. Of the 35 @entity1 in the natural interferon-alpha plus @entity4444 group, there were two CRs, 8 PRs, 13 NCs, and 11 @entity74 , yielding a response rate of 28.6% (P=0.13). @entity1054 ranged from 9 to 845 days (median 112 days) in the natural interferon-alpha-alone group, and from 31 to 1,568 days (median 125 days) in the natural interferon-alpha plus @entity4444 group (P=0.87). CONCLUSIONS: Combined treatment with natural interferon-alpha plus @entity4444 for @entity1358 did not result in a significant improvement in response rates or @entity1054 compared to natural interferon-alpha therapy alone.

Prospective randomized trial of natural interferon-alpha versus natural interferon-alpha plus @entity4444 in @entity1358 with XXXX .

@entity4444 :: ('MESH:D002927', 'Chemical') :: ['cimetidine'] @entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'patient'] @entity1358 :: ('MESH:D002292', 'Disease') :: ['advanced renal cell carcinoma'] @entity358 :: ('MESH:D008171', 'Disease') :: ['pulmonary metastasis'] @entity74 :: ('MESH:D030342', 'Disease') :: ['progressive diseases', 'PDs'] @entity1054 :: ('MESH:D000377', 'Disease') :: ['TTP', 'time to progression']
@entity358 :: (MESH:D008171,Disease) :: ['pulmonary metastasis']
