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

A. Santo, S. Pilotto, D. Galetta, F. Grossi, G. Fasola, G. Romano, L. Bonanno, A. Bearz, M. Papi, E. Roca, A. Catino, A. Follador, E. Rijavec, C. Genova, P. Petrillo, A. Favaretto, L. Giannone, M. Milella, G. Tortora, D. GiannarelliE. Bria, Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer)

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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
Original languageItalian
Pages (from-to)121-126
Number of pages6
JournalLung Cancer
Publication statusPublished - 2019

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