Cascinu 1995.

Methods	RCT: To assess the antitumour effect of octreotide vs. BSC in patients with advanced GI cancer refractory to chemotherapy Duration: Patients in both arms followed until death Jan 1990 to Dec 1992 (study recruitment period) Patients in both arms could receive supportive care. Journal: British Journal of Cancer 1995.
Participants	Participants: Advanced GI cancer patients refractory to chemotherapy Primary tumours were: stomach (n = 29) pancreas (n = 32) colon‐rectum (n = 46) Median Age (years and range): Octreotide: 68 (39 to 71) Controls (BSC): 66 (44 to 72) Gender: Male/Female ratio Octreotide: 35/20 Controls (BSC): 30/22. Performance Status: ECOG PS 0‐2.
Interventions	Total n = 107 T1: Octreotide (n = 55) (200 micrograms three times/day for five days a week (primary tumours were stomach (15), pancreas (16) and colon‐rectum (24) versus T2: Controls (BSC) (n = 52) (primary tumours were stomach (14), pancreas (16) and colon‐rectum (22)
Outcomes	Survival length (primary outcome variable). Outcome variable of secondary importance was response rate. Duration of survival : T1: Significant advantage in duration of survival, median survival time T1: 20 weeks versus T2: 11 weeks ( P < 0.0001) This advantage was also present considering the survival data for each tumour group Subgroup analysis: Stomach: survival curves comparing patients with stomach cancer treated with T1 (n = 15) or not (n = 14). There was a statistical difference between 2 curves: Mantel‐Cox (log‐rank), P = 0.003 Colon rectum Survival curves comparing patients with colorectal cancer treated with T1 (n = 24) or not (n = 22). There was a statistical difference between the two arms. Mantel‐Cox (log‐rank), P = 0.001. This trial had no specific quality of life data.
Notes	Authors conclusions: Octreotide therapy: seems to confer a survival benefit in advanced GI cancer patients refractory to chemotherapy. Although results are encouraging authors think that additional studies will be needed to confirm these results and to clarify other questions about dose and schedule of octreotide and the impact of octreotide treatment in terms of not only survival but also patients quality of life
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate