دورية أكاديمية
Efficacy and Safety of Lanreotide Autogel and Temozolomide Combination Therapy in Progressive Thoracic Neuroendocrine Tumors (Carcinoid): Results from the Phase 2 ATLANT Study
| العنوان: | Efficacy and Safety of Lanreotide Autogel and Temozolomide Combination Therapy in Progressive Thoracic Neuroendocrine Tumors (Carcinoid): Results from the Phase 2 ATLANT Study |
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| المؤلفون: | Ferolla, Piero, Berruti, Alfredo, Spada, Francesca, Brizzi, Maria Pia, Ibrahim, Toni, Marconcini, Riccardo, Giuffrida, Dario, Amoroso, Vito, La Salvia, Anna, Vaccaro, Vanja, Faggiano, Antongiulio, Colao, Annamaria, Volante, Marco, Ghizzoni, Simona, Mazzanti, Paola, Houchard, Aude, Fazio, Nicola |
| المصدر: | Neuroendocrinology ; volume 113, issue 3, page 332-342 ; ISSN 0028-3835 1423-0194 |
| بيانات النشر: | S. Karger AG |
| سنة النشر: | 2022 |
| الوصف: | Introduction: Lanreotide autogel (LAN) and temozolomide (TMZ) are guidelines-recommended monotherapies for thoracic neuroendocrine tumors (carcinoids; T-NETs), but prospective data for both combined and monotherapies are lacking. ATLANT (NCT02698410) evaluated efficacy and safety of LAN/TMZ in progressive T-NETs. Methods: ATLANT was a 12-month, Italian, phase 2, single-arm, open-label, multicenter pilot study. Eligible patients had unresectable, locally advanced/metastatic, well-/moderately differentiated T-NETs with radiological progression. Patients received subcutaneous LAN 120 mg every 28 days and oral TMZ 250 mg/day for 5 consecutive days every 28-day cycle. Main endpoints are disease control rate (DCR) at 9 months (primary; investigator-assessed), median progression-free survival (PFS), biomarkers, and safety. Results: The number of patients was 40; 60% were male. Primary tumor site was lung (90%) and thymus (10%). Carcinoid type was typical (20.0%) and atypical (52.5%). DCR at 9 months was 35.0% (95% confidence interval (CI) 20.63–51.68; nonacceptability threshold ≤10%, p < 0.0001; not significantly above clinically relevant threshold ≥30%, p = 0.2968). DCR between 7.5 and 10.5 months (sensitivity analysis) was 45.0% (95% CI: 29.26–61.51) and clinically relevant (p = 0.0320 at ≥30% threshold). Median PFS was 37.1 (95% CI: 24.1–52.9) weeks. No association was observed between biomarker variations (chromogranin A, neuron-specific enolase, somatostatin receptor type-2, Ki-67, 6-O-methylguanine-DNA-methyl-transferase) and DCR or PFS. Most patients (97.5%) had treatment-emergent adverse events (TEAEs); 72.5% had treatment-related TEAEs. TEAEs were mainly grade 1/2. No unanticipated TEAEs were reported. Conclusions: This study showed that the LAN/TMZ combination has promising efficacy in progressive T-NETs, and was well tolerated. Larger studies are warranted to support the clinical benefits of LAN/TMZ in patients with T-NETs. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1159/000526811 |
| الإتاحة: | https://doi.org/10.1159/000526811Test https://karger.com/nen/article-pdf/113/3/332/3962689/000526811.pdfTest |
| حقوق: | https://karger.com/pages/terms-and-conditionsTest ; https://karger.com/pages/terms-and-conditionsTest |
| رقم الانضمام: | edsbas.E66B40D |
| قاعدة البيانات: | BASE |
| DOI: | 10.1159/000526811 |
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