SUNLAND: a randomized, double-blinded phase II GERCOR trial of sunitinib versus placebo and lanreotide in patients with advanced progressive midgut neuroendocrine tumors Article Swipe
Pascal Hammel
,
Denis Smith
,
Pauline Afchain
,
Sophie Dominguez-Tinajero
,
Jean‐François Seitz
,
Astrid Lièvre
,
Eric Van Cutsem
,
Eric Assenat
,
Frédéric Di Fiore
,
Marc Peeters
,
Iradj Sobhani
,
Eric Raymond
,
Émilie Charton
,
Déwi Vernerey
,
Louis de Mestier
,
Catherine Lombard‐Bohas
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1177/17588359241290140
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1177/17588359241290140
Background: 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. Patients and methods: In this phase II trial, patients with a nonresectable grade 1 or 2 midgut progressive NET and Eastern Cooperative Oncology Group performance status 0–1 were randomly assigned 1:1 to receive 37.5 mg sunitinib or a placebo, combined with 120 mg lanreotide autogel every 28 days. The planned sample size was 104 patients. The primary outcome was investigator-assessed progression-free survival (PFS). Results: The study was stopped early because of insufficient patient recruitment. Between January 2013 and December 2016, 44 patients were enrolled and received sunitinib ( n = 22) or placebo ( n = 22). The median age was 63.7 years ( Q1– Q3 range, 56.6–68.1) and 26 patients (59.1%) were male. The main localization was ileum ( N = 37, 84.1%) and the majority were grade 2 ( n = 25, 56.8%). The median follow-up was 36.7 months (95% confidence interval (CI) 34.6–48.2). The median PFS was 9.84 months (95% CI 6.8–23.3) with sunitinib and 11.47 months (95% CI 5.4–15.3) with placebo (hazard ratio (HR) = 0.80, 95% CI 0.41–1.56, p = 0.51). There was no difference in overall survival between treatment arms (HR = 0.81, (95% CI 0.32–2.01), p = 0.64). 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 = 0.089) and lower ( p = 0.023) 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 < 1), with a significant result for financial difficulties (HR = 0.31, (90% CI 0.10–0.94)). Twenty-seven patients (61.4%) had at least one adverse event grade ⩾3 (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 = 5, placebo arm: n = 6). Conclusion: 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. Trial registration: EudraCT: 2012-001098-94.
Related Topics
Concepts
Medicine
Sunitinib
Internal medicine
Hazard ratio
Gastroenterology
Placebo
Lanreotide
Neuroendocrine tumors
Tyrosine-kinase inhibitor
Tolerability
Progression-free survival
Confidence interval
Surgery
Chemotherapy
Adverse effect
Cancer
Pathology
Growth hormone
Hormone
Alternative medicine
Acromegaly
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1177/17588359241290140
- OA Status
- gold
- References
- 30
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4404504150
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4404504150Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1177/17588359241290140Digital Object Identifier
- Title
-
SUNLAND: a randomized, double-blinded phase II GERCOR trial of sunitinib versus placebo and lanreotide in patients with advanced progressive midgut neuroendocrine tumorsWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
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2024Year of publication
- Publication date
-
2024-01-01Full publication date if available
- Authors
-
Pascal Hammel, Denis Smith, Pauline Afchain, Sophie Dominguez-Tinajero, Jean‐François Seitz, Astrid Lièvre, Eric Van Cutsem, Eric Assenat, Frédéric Di Fiore, Marc Peeters, Iradj Sobhani, Eric Raymond, Émilie Charton, Déwi Vernerey, Louis de Mestier, Catherine Lombard‐BohasList of authors in order
- Landing page
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https://doi.org/10.1177/17588359241290140Publisher landing page
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YesWhether a free full text is available
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-
goldOpen access status per OpenAlex
- OA URL
-
https://doi.org/10.1177/17588359241290140Direct OA link when available
- Concepts
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Medicine, Sunitinib, Internal medicine, Hazard ratio, Gastroenterology, Placebo, Lanreotide, Neuroendocrine tumors, Tyrosine-kinase inhibitor, Tolerability, Progression-free survival, Confidence interval, Surgery, Chemotherapy, Adverse effect, Cancer, Pathology, Growth hormone, Hormone, Alternative medicine, AcromegalyTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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30Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| primary_location.raw_source_name | Therapeutic Advances in Medical Oncology |
| primary_location.landing_page_url | https://doi.org/10.1177/17588359241290140 |
| publication_date | 2024-01-01 |
| publication_year | 2024 |
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