Evaluation of the efficacy and the safety of lanreotide autogel 120 mg on tumor growth stabilization in patients with progressive neuroendocrine tumors (NETs) who are not eligible to surgery or chemotherapy.
2011; Lippincott Williams & Wilkins; Volume: 29; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2011.29.15_suppl.e14660
ISSN1527-7755
AutoresMarta Martin‐Richard, Vicente Alonso, M. Mármol, Daniel Castellano, E. Fonseca, Àngela Velasco, Jose Luis Monteserin Garcia, Fernando Rivera, António Galán de Mera, María Quindós, I. Maetsu, Purificación Martínez de Prado, Javier Sastre, M D Diaz Llanos, Carles Pericay, Ángela María Segura Cardona, J.J. Arenas-Jiménez, Estela Pineda, Pascal Maisonobe, Bartomeu Massutí,
Tópico(s)Lung Cancer Research Studies
Resumoe14660 Background: Somatostatin analogs (SSTAs) are the treatment of choice for hormonal symptoms associated with NETs. Clinical studies have suggested stabilization or, in rare cases, partial response in the tumour mass. In a population of documented progressive NETs no data of antitumoral activity of SSTAs analogs given as sole treatment has been presented. We undertook a phase II trial (NCT0032646) to evaluate the efficacy of lanreotide Autogel 120mg on tumour growth stabilisation in patients with documented progressive NETs. Methods: Thirty patients from 17 Spanish hospitals with advanced and/or metastatic well-differentiated NETs progressive within the last 6 months were treated with lanreotide Autogel 120 mg every 28 days until progression. Treatment with SSTA during the previous 6 months was an exclusion criterion. No patients received chemotherapy (CT) or interferon (IFN) during the 4 weeks before study inclusion. Radiologic evaluation was performed every 3 cycles. Primary endpoint was progression-free survival (PFS) per central blind review. Clinical baseline characteristics were: Age median: 63y (40-78), M/F (50%/50%), Median time since diagnosis 5.5y (0.2-22.2), ECOG 0/1/2: 63%/30%/7% Foregut/Midgut/Unknown: 47%/40%/13%; Ki index: median 2.0 (1-20); Functioning/Non Funct. (63%/37%); Previous treatment: CT/ IFN/SSTAs (33%/23%/20%) Results: Median PFS (95% CI) was 12.9 months (7.9-16.5) both in ITT and PP populations. Best tumour responses were: 4%PR/89%SD/7% PD. Ki 67 index was the most likely prognostic factor for PFS (HR 1.17; p= 0.017). Discontinuation of treatment because of adverse events (AE) occurred in one patient. Only one severe related AE was detected (aerophagia). No impairment in EORTC QLQ-C30 for the whole group was detected during treatment. Conclusions: In this study, the sole treatment with lanreotide Autogel 120 mg in progressive NET patients provides a median PFS > 12 months with a very low toxicity. This apparent tumoral control effect should be confirmed in a phase III ongoing trial (Clarinet, NCT00842348). Acknowledgment: Study sponsored by IPSEN.
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