title: Everolimus plus octreotide long-acting repeatable in advanced neuroendocrine tumors in the routine tertiary cancer care setting: An Indian experience.
abstract: BACKGROUND
  Neuroendocrine tumors (NETs) are rare, heterogeneous, indolent tumors that are relatively insensitive to systemic chemotherapy. Therapeutic strategies for NETs broadly include somatostatin analogs, antiangiogenic therapy, and most recently, mammalian target of rapamycin inhibition. Combination therapy has shown promising antitumor activity and good tolerability in the randomized phase III trials.
  
  
  OBJECTIVE
  The aim was to evaluate the safety and efficacy of Everolimus plus Octreotide long-acting repeatable (LAR) in patients with advanced NETs in the routine tertiary cancer care setting in India in this postapproval, noninterventional trial.
  
  
  METHODS
  Patients presenting to selected centers between 2011 and 2013 with histologically confirmed low-, intermediate- or high-grade advanced NETs who may have had prior exposure to cytotoxic chemotherapy (≤2 lines) were treated with oral Everolimus (10 mg/day) plus intramuscular Octreotide LAR (30 mg once every 28 days) until disease progression or unacceptable toxicity was seen. Patients were evaluated every 3 months for a response to therapy as per Response Evaluation Criteria in Solid Tumors.
  
  
  RESULTS
  Everolimus plus Octreotide LAR was associated with a clinical benefit rate of 69% (best evaluable responses: Stable disease [SD] in 10 patients [63%], partial response in 1 patient [6%]). The average duration of therapy was 4.8 cycles, and 3 (17%) patients continued therapy for ≥12 cycles (all achieved SD). The therapy was found to be well-tolerated in all patients.
  
  
  CONCLUSIONS
  Everolimus plus Octreotide LAR appears to be safe and efficacious in patients with advanced NETs who may have had prior exposure to chemotherapy - a finding consistent with recently conducted major trials.
authors.forename: R
authors.initials: R
authors.lastname: Tippeswamy
authors.affiliation: HCG Hospital, Singasandra, Bengaluru, Karnataka, India.
authors.forename: S
authors.initials: S
authors.lastname: Patil
authors.forename: C T
authors.initials: CT
authors.lastname: Sateesh
authors.forename: H P
authors.initials: HP
authors.lastname: Shashidhara
authors.forename: S
authors.initials: S
authors.lastname: Prabhudesai
authors.forename: P
authors.initials: P
authors.lastname: Prashanth
authors.forename: K M
authors.initials: KM
authors.lastname: Haridas
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D000068338:Everolimus / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000473:pathology; D015282:Octreotide / Q000008:administration & dosage / Q000627:therapeutic use*; D062606:Tertiary Care Centers
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus; D015282:Octreotide