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

Small Cell Lung Carcinoma
Maintenance
Disease-Free Survival
Observation
Survival
lanreotide
Somatostatin Receptors
Random Allocation
Platinum
Radiotherapy
Therapeutics
Safety
Drug Therapy

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

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).

In: Lung Cancer, Vol. 134, 01.08.2019, p. 121-126.

Research output: Contribution to journalArticle

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, vol. 134, pp. 121-126. https://doi.org/10.1016/j.lungcan.2019.06.011
On behalf of the Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer). Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors: A multicenter, randomized, phase 3 trial. Lung Cancer. 2019 Aug 1;134:121-126. https://doi.org/10.1016/j.lungcan.2019.06.011
On behalf of the Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer). / Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors : A multicenter, randomized, phase 3 trial. In: Lung Cancer. 2019 ; Vol. 134. pp. 121-126.
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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.",
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author = "{On behalf of the Italian association FONICAP (Operative National Interdisciplinary Force against Lung Cancer)} and Antonio Santo and Sara Pilotto and Domenico Galetta and Francesco Grossi and Gianpiero Fasola and Gianpiero Romano and Laura Bonanno and Alessandra Bearz and Maximilian Papi and Elisa Roca and Annamaria Catino and Alessandro Follador and Erika Rijavec and Carlo Genova and Patrizia Petrillo and Adolfo Favaretto and Luciana Giannone and Michele Milella and Giampaolo Tortora and Diana Giannarelli and Emilio Bria",
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T1 - Maintenance with lanreotide in small-cell lung cancer expressing somatostatine receptors

T2 - A multicenter, randomized, phase 3 trial

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

AU - Santo, Antonio

AU - Pilotto, Sara

AU - Galetta, Domenico

AU - Grossi, Francesco

AU - Fasola, Gianpiero

AU - Romano, Gianpiero

AU - Bonanno, Laura

AU - Bearz, Alessandra

AU - Papi, Maximilian

AU - Roca, Elisa

AU - Catino, Annamaria

AU - Follador, Alessandro

AU - Rijavec, Erika

AU - Genova, Carlo

AU - Petrillo, Patrizia

AU - Favaretto, Adolfo

AU - Giannone, Luciana

AU - Milella, Michele

AU - Tortora, Giampaolo

AU - Giannarelli, Diana

AU - Bria, Emilio

PY - 2019/8/1

Y1 - 2019/8/1

N2 - 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.

AB - 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.

KW - Lanreotide

KW - Maintenance

KW - Small-cell lung cancer

KW - Somatostatine analogue

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