BACKGROUND:Recombinant human growth hormone (rhGH) promotes protein synthesis, accelerates wound healing, and maintains immune function in the catabolic state. It has also been claimed that rhGH may promote the activation of residual tumor cells, and therefore, increases the risk of tumor recurrence. This study aimed to investigate whether postoperative administration of rhGH increases the long-term risk of tumor recurrences in patients undergoing major gastrointestinal surgery for malignancy. METHODS:Patients (n =104) received three different doses of rhGH (0.075 IU/kg, 0.150 IU/kg, and 0.300 IU/kg) during 5 postoperative days in a placebo-controlled trial. Follow-up was performed for 56-70 months after radical tumor resection. Mean survival period and relapse-free survival were compared with the control group. RESULTS: Complete data were available for 75 patients. Thirty-five percent (n = 20) of all patients treated with rhGH showed tumor recurrences in comparison to 44% (n = 8) of patients given placebo. Mean survival period for rhGH-treated patients was 46 months (median 59 months); in controls, 42 months (median 58 months). The length of relapse-free survival tended to be longer in rhGH-treated patients (2-47 months; median, 21 months) compared with the patients who were given placebo (2-18 months; median, 13 months). CONCLUSIONS: The results demonstrate no evidence for an increased risk of tumor recurrence after rhGH treatment for a short period of time after removal of a gastrointestinal adenocarcinoma. Therefore, the positive metabolic effects of rhGH application can be used safely in the treatment of the postoperative catabolic state in the patient groups investigated.
RCT Entities:
BACKGROUND: Recombinant humangrowth hormone (rhGH) promotes protein synthesis, accelerates wound healing, and maintains immune function in the catabolic state. It has also been claimed that rhGH may promote the activation of residual tumor cells, and therefore, increases the risk of tumor recurrence. This study aimed to investigate whether postoperative administration of rhGH increases the long-term risk of tumor recurrences in patients undergoing major gastrointestinal surgery for malignancy. METHODS:Patients (n =104) received three different doses of rhGH (0.075 IU/kg, 0.150 IU/kg, and 0.300 IU/kg) during 5 postoperative days in a placebo-controlled trial. Follow-up was performed for 56-70 months after radical tumor resection. Mean survival period and relapse-free survival were compared with the control group. RESULTS: Complete data were available for 75 patients. Thirty-five percent (n = 20) of all patients treated with rhGH showed tumor recurrences in comparison to 44% (n = 8) of patients given placebo. Mean survival period for rhGH-treated patients was 46 months (median 59 months); in controls, 42 months (median 58 months). The length of relapse-free survival tended to be longer in rhGH-treated patients (2-47 months; median, 21 months) compared with the patients who were given placebo (2-18 months; median, 13 months). CONCLUSIONS: The results demonstrate no evidence for an increased risk of tumor recurrence after rhGH treatment for a short period of time after removal of a gastrointestinal adenocarcinoma. Therefore, the positive metabolic effects of rhGH application can be used safely in the treatment of the postoperative catabolic state in the patient groups investigated.