{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T18:54:50Z","timestamp":1789584890190,"version":"build-2803163510"},"reference-count":30,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"GERCOR"},{"DOI":"10.13039\/100004319","name":"Pfizer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004319","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100014382","name":"Ipsen","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100014382","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>Sunitinib, a multitarget tyrosine kinase inhibitor, showed encouraging antitumor activity and manageable toxicity in patients with advanced midgut neuroendocrine tumors (NETs) in earlier results from phase I and II trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and methods:<\/jats:title>\n                    <jats:p>In this phase II trial, patients with a nonresectable grade 1 or 2 midgut progressive NET and Eastern Cooperative Oncology Group performance status 0\u20131 were randomly assigned 1:1 to receive 37.5\u2009mg sunitinib or a placebo, combined with 120\u2009mg lanreotide autogel every 28\u2009days. The planned sample size was 104 patients. The primary outcome was investigator-assessed progression-free survival (PFS).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>The study was stopped early because of insufficient patient recruitment. Between January 2013 and December 2016, 44 patients were enrolled and received sunitinib ( n\u2009=\u200922) or placebo ( n\u2009=\u200922). The median age was 63.7\u2009years ( Q1\u2013 Q3 range, 56.6\u201368.1) and 26 patients (59.1%) were male. The main localization was ileum ( N\u2009=\u200937, 84.1%) and the majority were grade 2 ( n\u2009=\u200925, 56.8%). The median follow-up was 36.7\u2009months (95% confidence interval (CI) 34.6\u201348.2). The median PFS was 9.84\u2009months (95% CI 6.8\u201323.3) with sunitinib and 11.47\u2009months (95% CI 5.4\u201315.3) with placebo (hazard ratio (HR)\u2009=\u20090.80, 95% CI 0.41\u20131.56, p\u2009=\u20090.51). There was no difference in overall survival between treatment arms (HR\u2009=\u20090.81, (95% CI 0.32\u20132.01), p\u2009=\u20090.64). The objective response rate was 9.1% with sunitinib and 0.0% with placebo, and 19 patients (86.4%) had stable disease. Thirty-nine patients (88.6%) completed the baseline QLQ-C30 questionnaire. Baseline health-related quality of life level was similar between treatment arms, except for physical and emotional functioning which were higher ( p\u2009=\u20090.089) and lower ( p\u2009=\u20090.023) in the sunitinib arm, respectively. Trends toward longer time until a definitive deterioration in favor of the sunitinib arm were observed for 10 out of 15 dimensions (HRs\u2009&lt;\u20091), with a significant result for financial difficulties (HR\u2009=\u20090.31, (90% CI 0.10\u20130.94)). Twenty-seven patients (61.4%) had at least one adverse event grade \u2a7e3 (sunitinib: 72.7%, placebo: 50.0%), with only one patient grade 4 for hypertension and vomiting. Eleven deaths non-related to treatment occurred (sunitinib arm: n\u2009=\u20095, placebo arm: n\u2009=\u20096).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Our study does not provide enough evidence to conclude the role of sunitinib in advanced midgut NETs, primarily due to a lower-than-expected number of enrolled patients. While we cannot entirely rule out the efficacy of sunitinib, lanreotide alone may play a significant role.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>EudraCT: 2012-001098-94.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359241290140","type":"journal-article","created":{"date-parts":[[2024,11,19]],"date-time":"2024-11-19T05:11:40Z","timestamp":1731993100000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["SUNLAND: a randomized, double-blinded phase II GERCOR trial of sunitinib versus placebo and lanreotide in patients with advanced progressive midgut neuroendocrine tumors"],"prefix":"10.1177","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4630-4996","authenticated-orcid":false,"given":"Pascal","family":"Hammel","sequence":"first","affiliation":[{"name":"Digestive and Medical Oncology Department, H\u00f4pital Paul Brousse, University of Paris-Saclay, 12 Avenue Paul Vaillant-Couturier, 94800 Villejuif, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denis","family":"Smith","sequence":"additional","affiliation":[{"name":"CHU Haut-L\u00e9v\u00eaque, Pessac, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pauline","family":"Afchain","sequence":"additional","affiliation":[{"name":"H\u00f4pital Saint-Antoine (AP-HP), University of Paris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sophie","family":"Dominguez-Tinajero","sequence":"additional","affiliation":[{"name":"H\u00f4pital Saint-Vincent de Paul, Lille, 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