A randomised trial of octreotide vs best supportive care only in advanced gastrointestinal cancer patients refractory to chemotherapy.

Octreotide, a somatostatin analogue, has been shown to inhibit the growth of gastrointestinal cancers in vitro and in vivo. To assess the anti-tumour effect of octreotide, we performed a randomised trial comparing octreotide with best supportive care in advanced gastrointestinal cancer patients refractory to chemotherapy. A total of 107 patients with advanced gastrointestinal cancer refractory to chemotherapy were randomised to receive octreotide at the dose of 200 micrograms three times a day for 5 days a week, or the best supportive care only. The primary outcome variable was the survival duration. Response rate was an outcome variable of secondary importance. Fifty-five patients (15 stomach, 16 pancreas, 24 colon-rectum) received octreotide, while 52 (14 stomach, 16 pancreas, 22 colon-rectum) received the best supportive care. Patients treated with octreotide had a significant advantage in duration of survival with a median survival time of 20 weeks vs 11 in the control group (P < 0.0001). This advantage was present also considering the survival data for each tumour group. Twenty-five patients (45%) given octreotide showed stable disease vs only eight (15%) in the control group (P < 0.001). In conclusion, octreotide therapy seems to confer a survival benefit in advanced gastrointestinal cancer patients refractory to chemotherapy. Additional studies will be needed to confirm these results and to clarify other questions about dose and schedule of octreotide.

RCT Entities:   Population Interventions Outcomes