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 |
| المساهمون: | 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 |
| بيانات النشر: | KARGER ALLSCHWILERSTRASSE 10, CH-4009 BASEL, SWITZERLAND |
| سنة النشر: | 2023 |
| المجموعة: | Sapienza Università di Roma: CINECA IRIS |
| مصطلحات موضوعية: | Carcinoid, Disease control rate, Lanreotide autogel, Progression-free survival, Temozolomide, Therapy, Thoracic neuroendocrine tumors |
| 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: disease control rate (DCR) at 9 months (primary; investigator-assessed), median progression-free survival (PFS), biomarkers and safety. Results: Patients: n=40; 60% male. Primary tumor site: lung (90%); thymus (10%). Carcinoid type: typical (20.0%), atypical (52.5%). DCR at 9 months was 35.0% (95% confidence interval [CI] 20.63-51.68) (non-acceptability 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 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 |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/36044870; info:eu-repo/semantics/altIdentifier/wos/WOS:000848465200001; volume:113; issue:3; firstpage:332; lastpage:342; numberofpages:11; journal:NEUROENDOCRINOLOGY; https://hdl.handle.net/11573/1675035Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85146822440 |
| DOI: | 10.1159/000526811 |
| الإتاحة: | https://doi.org/10.1159/000526811Test https://hdl.handle.net/11573/1675035Test |
| رقم الانضمام: | edsbas.CA6CAB53 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1159/000526811 |
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