Nivolumab plus platinum-doublet chemotherapy in treatment-naive patients with advanced grade 3 Neuroendocrine Neoplasms of gastroenteropancreatic or unknown origin: The multicenter phase 2 NICE-NEC trial (GETNE-T1913)

Maria Carmen Riesco-Martinez, Jaume Capdevila, Vicente Alonso, Paula Jimenez-Fonseca, Alex Teule, Enrique Grande, Isabel Sevilla, Marta Benavent, Teresa Alonso-Gordoa, Ana Custodio, Beatriz Anton-Pascual, Jorge Hernando, Eduardo Polo, Oscar Alfredo Castillo-Trujillo, Arantza Lamas-Paz, Ana Teijo, Yolanda Rodriguez-Gil, Beatriz Soldevilla and Rocio Garcia-Carbonero ()
Additional contact information
Maria Carmen Riesco-Martinez: Medical Oncology Department. Hospital Universitario 12 de Octubre
Jaume Capdevila: Vall Hebron Institute of Oncology (VHIO)
Vicente Alonso: Hospital Universitario Miguel Servet
Paula Jimenez-Fonseca: ISPA
Alex Teule: Institut Català d’Oncologia (ICO) - IDIBELL
Enrique Grande: MD Anderson Cancer Center Madrid
Isabel Sevilla: Investigación Clínica y Traslacional en Cáncer / Instituto de Investigaciones Biomédicas de Málaga (IBIMA) / Hospitales Universitarios Regional y Virgen de la Victoria de Málaga
Marta Benavent: Instituto de Biomedicina de Sevilla (IBIS)
Teresa Alonso-Gordoa: Hospital Universitario Ramón y Cajal
Ana Custodio: Hospital Universitario La Paz
Beatriz Anton-Pascual: Medical Oncology Department. Hospital Universitario 12 de Octubre
Jorge Hernando: Vall Hebron Institute of Oncology (VHIO)
Eduardo Polo: Hospital Universitario Miguel Servet
Oscar Alfredo Castillo-Trujillo: ISPA
Arantza Lamas-Paz: Center of Experimental Oncology. Gastrointestinal and Neuroendrocrine Tumors Research Group. Hospital 12 de Octubre Research Institute (imas12)
Ana Teijo: Hospital Universitario 12 de Octubre
Yolanda Rodriguez-Gil: Hospital Universitario 12 de Octubre
Beatriz Soldevilla: Center of Experimental Oncology. Gastrointestinal and Neuroendrocrine Tumors Research Group. Hospital 12 de Octubre Research Institute (imas12)
Rocio Garcia-Carbonero: Medical Oncology Department. Hospital Universitario 12 de Octubre

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract The prognosis of patients with advanced high-grade (G3) digestive neuroendocrine neoplasms (NENs) is rather poor. The addition of immune checkpoint inhibition to platinum-based chemotherapy may improve survival. NICE-NEC (NCT03980925) is a single-arm, phase II trial that recruited chemotherapy-naive, unresectable advanced or metastatic G3 NENs of gastroenteropancreatic (GEP) or unknown origin. Patients received nivolumab 360 mg intravenously (iv) on day 1, carboplatin AUC 5 iv on day 1, and etoposide 100 mg/m2/d iv on days 1–3, every 3 weeks for up to six cycles, followed by nivolumab 480 mg every 4 weeks for up to 24 months, disease progression, death or unacceptable toxicity. The primary endpoint was the 12-month overall survival (OS) rate (H0 50%, H1 72%, β 80%, α 5%). Secondary endpoints were objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), and safety. From 2019 to 2021, 37 patients were enrolled. The most common primary sites were the pancreas (37.8%), stomach (16.2%) and colon (10.8%). Twenty-five patients (67.6%) were poorly differentiated carcinomas (NECs) and/or had a Ki67 index >55%. The ORR was 56.8%. Median PFS was 5.7 months (95%CI: 5.1-9) and median OS 13.9 months (95%CI: 8.3-Not reached), with a 12-month OS rate of 54.1% (95%CI: 40.2-72.8) that did not meet the primary endpoint. However, 37.6% of patients were long-term survivors (>2 years). The safety profile was consistent with previous reports. There was one treatment-related death. Nivolumab plus platinum-based chemotherapy was associated with prolonged survival in over one-third of chemonaïve patients with G3 GEP-NENs, with a manageable safety profile.

Date: 2024
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DOI: 10.1038/s41467-024-50969-8

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