Patients with haematological malignancies receiving neutropenia inducing chemotherapy sometimes have delayed discharge because of debility relating to complications of treatment. We assessed if these problems could be reduced by human growth hormone (GH) and also if haemopoetic recovery was quicker because stem cells have receptors for GH. In a randomized, double blind, placebo-controlled, trial patients were assigned to receive either GH, 250 mcg BD (n =75) or placebo (n =75). The treatment continued for 6 weeks. Patient entry was from July 2002; total of 150 courses have been randomized on 119 patients. 4 patients died in the first 3 weeks and 102 were assessable for long tem survival. There was no significant demographic difference between the two groups, Acute leukaemia GH 44, PL 48, Myeloma GH 30, PL 23, Allografts, GH 6, PL 7, autografts GH 39, PL 35. The median follow-up is 239 days (range 71-734days). Survival was not significantly different in two arms (GH: 43/54 vs. Pl: 39/52, p=0.47). There was no difference in the whole group, or any sub-groups for the time to ANC recovery. Platelet recovery to 25 (GH 16d, PL 18d, p=0.043) was faster for the whole series of 150 patients in those receiving GH but there was no difference in platelet recovery to 50. Influence on hospital discharge was not seen. There was no benefit overall for GH although excluding patients relapsing within one week, there was a trend towards lower relapse risk with GH (GH: 6/52 vs. Pl: 13/52, p=0.0523). Chemotherapy+ BMT patients, there was a trend towards lower relapse in the GH arm (GH 2/18 vs. PL 6/19, p=0.0514). IGF-1 levels were significantly higher in GH arm at 6 weeks (median 411 vs. 284, p<0.001). This pilot trial provides information that may help rationalize the design of future studies to determine if there is role for GH in the treatment of cancer.
22 - 24 Mar 2004
British Endocrine Societies