Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors: A multicenter, randomized, phase 3 trial

On behalf of the Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer)

Research output: Contribution to journalArticle

Abstract

Objectives: Considering the frequent expression of somatostatine receptors, we designed the G04.2011 trial to investigate the efficacy of the somatostatine analogue lanreotide in maintenance for SCLC patients after response to standard treatment. Materials and Methods: A multicenter, randomized, phase 3 trial was conducted in SCLC expressing somatostatine receptors at baseline Octreoscan, responding after platinum-based chemotherapy with/without radiotherapy. Patients were randomized 1:1 to receive maintenance lanreotide 120 mg subcutaneously every 28 days, up to 1 year or progression versus observation. Randomization was stratified according to stage (limited/extended, LD/ED). The primary end-point was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety. Results: Seventy-one patients were randomly assigned (39 to lanreotide, 32 to observation) in 9 Italian institutions. Median PFS was 3.6 (95% CI 3.2–3.9) with lanreotide versus 2.3 months (95% CI 1.7–2.9) with observation (HR 1.51, 95% CI 0.90–2.50; P = 0.11). Stage was an independent predictor for PFS (HR 3.14, 95% CI 1.77–5.57; P < 0.0001). Median PFS was 7.0 (95% CI <1-13.5) with lanreotide versus 3.8 months (95% CI <1-8.6) with observation in LD (P = 0.21), and 3.0 (95% CI 2.2–3.8) versus 2.2 (95% 1.7–2.7) in ED (P = 0.19). Median OS was 9.5 (95% CI 4.8–14.3) with lanreotide versus 4.7 months (95% CI <1-16.6) with observation (P = 0.47). Treatment-related adverse events occurred in 28% of patients with lanreotide (grade 3 in two patients). Conclusion: Although survival outcomes were not significantly prolonged with lanreotide as a maintenance in SCLC expressing somatostatin receptors after response to standard treatment, lanreotide showed a slight PFS benefit in LD SCLC deserving further investigations.

Original languageEnglish
Pages (from-to)121-126
Number of pages6
JournalLung Cancer
Volume134
DOIs
Publication statusPublished - Aug 1 2019

    Fingerprint

Keywords

  • Lanreotide
  • Maintenance
  • Small-cell lung cancer
  • Somatostatine analogue

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

Cite this

On behalf of the Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer) (2019). Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors: A multicenter, randomized, phase 3 trial. Lung Cancer, 134, 121-126. https://doi.org/10.1016/j.lungcan.2019.06.011