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

Giampaolo Tortora, Emilio Bria, Antonio Santo, Sara Pilotto, Domenico Galetta, Francesco Grossi, Gianpiero Fasola, Gianpiero Romano, Laura Bonanno, Alessandra Bearz, Maximilian Papi, Elisa Roca, Annamaria Catino, Alessandro Follador, Erika Rijavec, Carlo Genova, Patrizia Petrillo, Adolfo Favaretto, Luciana Giannone, Michele MilellaDiana Giannarelli

Risultato della ricerca: Contributo in rivistaArticolo in rivista

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.
Lingua originaleEnglish
pagine (da-a)121-126
Numero di pagine6
RivistaLung Cancer
Volume134
DOI
Stato di pubblicazionePubblicato - 2019

Keywords

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

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