M. Federico et al., EFFECTS OF THYMOSTIMULIN WITH COMBINATION CHEMOTHERAPY IN PATIENTS WITH AGGRESSIVE NON-HODGKINS-LYMPHOMA, American journal of clinical oncology, 18(1), 1995, pp. 8-14
The purpose of this study was to test the efficacy and safety of thymo
stimulin (TS) administered in addition to conventional chemotherapy in
patients with intermediate- and high-grade non-Hodgkin's lymphoma (IG
, HG-NHL). A total of 150 patients with newly diagnosed IG- or HG-NHL
were entered in a multicenter trial to compare the effectiveness of tw
o different third-generation regimens (MACOP-B versus ProMACE-CytaBOM)
and were randomized to receive chemotherapy (CT) alone or CT + TS. In
both regimens doxorubicin was replaced by a 20% higher dose of epidox
orubicin. TS was administered i.m. at a dose of 1 mg/kg daily on days
22-28 of each drug course to patients treated with ProMACE-CytaBOM, an
d on days 22-29, 50-57, and 77-85 to patients treated with MACOP-B. Th
ere were 134 fully evaluable patients: 68 treated with CT alone and 66
treated with CT + TS. Patients treated with CT + TS had a higher comp
lete remission (CR) rate compared to patients given CT alone (59.1% vs
42.4%; P = .05). CR were significantly higher for patients treated wi
th CT + TS in the groups with IG-NHL (P = .01), in those aged less tha
n 60 years (P = .05), with good performance status (P = .05), and norm
al hemoglobin levels (P = .05). Four-year survival rates are 64.5% for
patients treated with CT + TS and 43.0% for those treated with CT alo
ne (P = .30). No difference between the two treatment arms have been o
bserved as regards drug-related toxicity and the number and severity o
f infectious episodes. The use of TS during the 7 days before chemothe
rapy has been associated with a significantly superior CR rate. The ad
vantage of CT + TS was mostly obtained in patients with IG-NHL, and th
ose with good performance status or normal hemoglobin levels. In these
patients TS may have potentiated the host reactions against the tumor
, leading to an increase in NK activity and the production of cytokine
s. This postulated increase in the effectiveness of chemotherapy after
TS might also explain the absence of the expected myeloprotective act
ion.