Randomized blinded study comparing injection site pain from octreotide long-acting-release (LAR) versus lanreotide during the treatment of well differentiated neuroendocrine tumors (WDNETs).

Abstract

e16204 Background: The somatostatin analogs (SSAs) octreotide LAR and lanreotide are equally acceptable in the NCCN guidelines to treat WDNETs. Average Sales Price for 1 year of lanreotide at 120mg is $106,802 versus $53,471 for 1 year of octreotide LAR 20mg and $80,206 for 1 year of 30mg. Lanreotide is given by “deep subcutaneous injection” while octreotide LAR is given intramuscularly. We conducted a randomized, blinded trial evaluating patient (pt) experience, as measured by injection site pain, with octreotide LAR and lanreotide, during the treatment of advanced, nonfunctional, WDNETs. We also investigated drug preference and financial toxicity in this pt population. Methods: This randomized single-blinded pilot study enrolled 51 pts recommended to begin SSA therapy. Pts received injections q 4 weeks and received 6 injections on study; Arm 1: octreotide LAR for 3 injections then lanreotide for 3 injections; Arm 2: lanreotide for 3 injections then octreotide LAR for 3 injections. Pts were blinded as to which agent they received throughout the study. Self-reported injection site pain scores were obtained after each of the first 3 injections using a 0 to 10 scale (0: “I didn’t feel it”; 10: “worst pain ever”). Primary endpoint was comparison of mean pain scores over the first 3 injections of octreotide LAR (Arm 1) or lanreotide (Arm 2). Secondary endpoints, evaluated with descriptive statistics, included pt-reported preference of octreotide LAR versus lanreotide, and willingness to pay for the preferred therapy, both assessed after 6 months of therapy by questionnaire. Results: 51 pts were enrolled (Arm 1: N = 26, Arm 2: N = 25). All pts were evaluable for the study primary endpoint. All pts received lanreotide at a dose of 120mg monthly; among those pts (49) receiving octreotide LAR, 30 (61%) received 20mg, 18 (37%) received 30mg, 1 (2%) received 10mg. No significant difference was identified in mean pain scores over the first 3 SSA injections; Arm 1: mean 2.4, standard deviation 1.9 versus Arm 2: mean 1.9, standard deviation 1.5 (p = 0.5). 34/51 (67%) pts (15 pts in Arm 1; 19 pts in Arm 2) were evaluated for secondary endpoints and completed post-therapy questionnaires. 7 (47%) in Arm 1 and 8 (42%) in Arm 2 indicated no drug preference at the end of the 6 months. There was a trend towards preference for octreotide LAR versus lanreotide in both arms, with more pts indicating mild or strong preference for octreotide LAR. 7 (50%) and 10 (56%) of pts in Arms 1 and 2, respectively, were unwilling to pay more for their preferred SSA; the rest of the cohort was willing to experience increased financial toxicity to receive their preferred SSA. Conclusions: This randomized, blinded study evaluating pt comfort with SSAs found minimal pain with both agents and no significant differences in pain scores between octreotide LAR versus lanreotide. Clinical trial information: NCT03289741.