title: Interpreting biochemical control response rates with first-generation somatostatin analogues in acromegaly.
abstract: BACKGROUND
  The somatostatin analogues octreotide LAR and lanreotide Autogel have been evaluated for the treatment of acromegaly in numerous clinical trials, with considerable heterogeneity in reported biochemical response rates. This review examines and attempts to account for these differences in response rates reported in the literature.
  
  
  METHODS
  PubMed was searched for English-language studies of a minimum duration of 24 weeks that evaluated ≥10 patients with acromegaly treated with octreotide LAR or lanreotide Autogel from 1990 to March 2015 and reported GH and/or IGF-1 data as the primary objective of the study.
  
  
  RESULTS
  Of the 190 clinical trials found, 18 octreotide LAR and 15 lanreotide Autogel studies fulfilled the criteria for analysis. It is evident from the protocols of these studies that multiple factors are capable of impacting on reported response rates. Prospective studies reporting an intention-to-treat analysis that evaluated medically naïve patients and used the composite endpoint of both GH and IGF-1 control were associated with lower response rates. The use of non-composite biochemical control endpoints, heterogeneous patient populations, analyses that exclude treatment non-responders, assay variability and prior responsiveness to medical therapy are just a few of the factors identified that likely contribute to higher success rates.
  
  
  CONCLUSIONS
  The wide range of reported response rates with somatostatin analogues may be confusing and could lead to misinterpretation by both the patient and the physician in certain situations. Understanding the factors that potentially drive the variation in response rates should allow clinicians to better gauge treatment expectations in specific patients.
authors.affiliation: Dipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Via S Pansini 5, 80131, Naples, Italy. colao@unina.it.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Colao
authors.affiliation: Dipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Via S Pansini 5, 80131, Naples, Italy.
authors.forename: Renata S
authors.initials: RS
authors.lastname: Auriemma
authors.affiliation: Dipartimento di Medicina Clinica e Chirurgia, Università Federico II di Napoli, Via S Pansini 5, 80131, Naples, Italy.
authors.forename: Rosario
authors.initials: R
authors.lastname: Pivonello
authors.affiliation: Endocrine Unit, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
authors.forename: Leandro
authors.initials: L
authors.lastname: Kasuki
authors.affiliation: Endocrine Unit, Hospital Universitário Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.
authors.forename: Mônica R
authors.initials: MR
authors.lastname: Gadelha
mesh_terms: D000236:Adenoma / Q000188:drug therapy* / Q000378:metabolism; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D049912:Growth Hormone-Secreting Pituitary Adenoma / Q000188:drug therapy* / Q000378:metabolism; D019382:Human Growth Hormone / Q000378:metabolism*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000378:metabolism*; D015282:Octreotide / Q000627:therapeutic use*; D010456:Peptides, Cyclic / Q000627:therapeutic use*; D013004:Somatostatin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D010456:Peptides, Cyclic; C060347:lanreotide; D019382:Human Growth Hormone; D013004:Somatostatin; D007334:Insulin-Like Growth Factor I; D015282:Octreotide
keywords: Acromegaly; Lanreotide; Octreotide; Pasireotide; Response rate; Somatostatin analogue