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Journal of Clinical Oncology, Vol 17, Issue 2 (February), 1999: 600
© 1999 American Society for Clinical Oncology

Octreotide Acetate Long-Acting Formulation Versus Open-Label Subcutaneous Octreotide Acetate in Malignant Carcinoid Syndrome

Joseph Rubin, Jaffer Ajani, William Schirmer, Alan P. Venook, Ronald Bukowski, Rodney Pommier, Leonard Saltz, Paresh Dandona, Lowell Anthony

From the Mayo Clinic, Rochester, MN; M.D. Anderson Cancer Center, Houston, TX; the Ohio State University Hospital, Columbus, OH; University of California at San Francisco, San Francisco, CA; The Cleveland Clinic Foundation, Cleveland, OH; Oregon Health Sciences University, Portland, OR; Memorial Sloan-Kettering Hospital, New York, NY; the State University of New York, Buffalo, NY; and Louisiana State University Medical Center, New Orleans, LA.

Address reprint requests to Joseph Rubin, MD, Mayo Clinic, Division of Medical Oncology, 200 First St, SW, Rochester, MN 55905.

PURPOSE: Subcutaneous (SC) octreotide acetate effectively relieves the diarrhea and flushing associated with carcinoid syndrome but requires long-term multiple injections daily. A microencapsulated long-acting formulation (LAR) of octreotide acetate has been developed for once-monthly intramuscular dosing.

PATIENTS AND METHODS: A randomized trial compared double-blinded octreotide LAR at 10, 20, and 30 mg every 4 weeks with open-label SC octreotide every 8 hours for the treatment of carcinoid syndrome. Seventy-nine patients controlled with treatment of SC octreotide 0.3 to 0.9 mg/d whose symptoms returned during a washout period and who returned for at least the week 20 evaluation constituted the efficacy-assessable population.

RESULTS: Complete or partial treatment success was comparable in each of the four arms of the study (SC, 58.3%; 10 mg, 66.7%; 20 mg, 71.4%; 30 mg, 61.9%; P >= .72 for all pairwise comparisons). Control of stool frequency was similar in all treatment groups. Flushing episodes were best controlled in the 20-mg LAR and SC groups; the 10-mg LAR treatment was least effective in the control of flushing. Treatment was well tolerated by patients in all four groups.

CONCLUSION: Once octreotide steady-state concentrations are achieved, octreotide LAR controls the symptoms of carcinoid syndrome at least as well as SC octreotide. A starting dose of 20 mg of octreotide LAR is recommended. Supplemental SC octreotide is needed for approximately 2 weeks after initiation of octreotide LAR treatment. Occasional rescue SC injections may be required for possibly 2 to 3 months until steady-state octreotide levels from the LAR formulation are achieved.




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