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Cited by 175Adrenal and Paraganglionic TumorsRenal cell carcinoma treatmentAdrenal Hormones and Disorders

The DOI matches its Crossref record; 39 of the 39 references it cites were found in a registry or an index.

Sunitinib in Refractory Adrenocortical Carcinoma: A Phase II, Single-Arm, Open-Label Trial

Kroiss, Matthias, Quinkler, Marcus, Johanssen, Sarah, van Erp, Nielka P., Lankheet, Nienke, Pöllinger, Alexander, Laubner, Katharina, Strasburger, Christian J., Hahner, Stefanie, Müller, Hans-Helge, Allolio, Bruno, Fassnacht, Martin·2012·The Journal of Clinical Endocrinology & Metabolism
DOI 10.1210/jc.2012-1419
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Abstract

CONTEXT: Treatment of refractory adrenocortical carcinoma (ACC) is not established. Animal experiments pointed toward adrenal toxicity of sunitinib. OBJECTIVE: The objective of the study was to determine the antitumor effects of sunitinib in refractory ACC. DESIGN: This was a phase II, open-label trial using a two-stage accrual design. SETTING: The study was conducted at two tertiary referral centers. PATIENTS: Thirty-eight patients with refractory ACC progressing after mitotane and one to three cytotoxic chemotherapies participated in the study. INTERVENTION: The intervention included sunitinib at a standard dose (50 mg/d, 4 wk on, 2 wk off). MAIN OUTCOME MEASURE: Response was defined as progression-free survival (PFS) of 12 wk or longer (first tumor evaluation). RESULTS: Thirty-five patients could be evaluated for response. Five patients experienced stable disease, 24 had progressive disease, and six patients died from ACC before the first evaluation (naïve estimate five of 35=14.3%, median unbiased response rate 15.4%, 95% confidence interval 5.0-33.4%). The median PFS was 2.8 months. In responders, PFS ranged between 5.6 and 11.2 months and overall survival between 14.0 and 35.5 months. Of 36 serious adverse events, only nine were possibly related to sunitinib. Concomitant mitotane appeared to negatively impact on outcome. Furthermore, a negative correlation between the serum concentrations of sunitinib plus its active metabolite N-desethylsunitinib (SU12662) and mitotane (r=-0.650; P=0.114) was observed in seven evaluable patients suggestive of a relevant drug interaction. CONCLUSION: Sunitinib has modest activity in advanced refractory ACC, which compares favorably with other targeted treatments in these patients. Sunitinib serum levels might have been profoundly reduced by mitotane induced cytochrome P450-3A4 activity attenuating its antitumor activity and adverse effects. Together these findings suggest that sunitinib deserves further investigation in mitotane-naïve ACC patients.

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Metadata

Authors
Kroiss, M., Quinkler, M., Johanssen, S., van Erp, N. P., Lankheet, N., Pöllinger, A., Laubner, K., Strasburger, C. J., Hahner, S., Müller, H.-H., Allolio, B., & Fassnacht, M.
Affiliations
  • University of Würzburg (DE)
  • Slotervaartziekenhuis (NL)
  • Charité – Universitätsmedizin Berlin (DE)
  • Ludwig-Maximilians-Universität München (DE)
Corresponding author
Fassnacht, Martin
ORCID
Venue
The Journal of Clinical Endocrinology & Metabolism
Publisher
The Endocrine Society
Published
2012-10
Volume
97
Issue
10
Pages
3495-3503
ISSN
  • 0021-972X (ISSN-L)
  • 1945-7197
DOI
10.1210/jc.2012-1419
OpenAlex
W2072709644
Cited by
175
References
39
Citations by year
2026: 5 · 2025: 13 · 2024: 10 · 2023: 6 · 2022: 14 · 2021: 15 · 2020: 13 · 2019: 15 · 2018: 16 · 2017: 7 · 2016: 13 · 2015: 16 · 2014: 15 · 2013: 15 · 2012: 1
FWCI
15.31
Type
journal article
Language
en
Open access
closed
Locations
  • The Journal of Clinical Endocrinology & Metabolism (publishedVersion)
  • PubMed (publishedVersion)
  • Radboud Repository (Radboud University) (submittedVersion)
Funders
Pfizer
Topics
  • Health Sciences › Medicine › Surgery › Adrenal and Paraganglionic Tumors
  • Health Sciences › Medicine › Oncology › Renal cell carcinoma treatment
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
Keywords
sunitinib, adrenocortical carcinoma, refractory cancer, mitotane, drug interactions, CYP3A4, progression-free survival, targeted therapy, adverse events
MeSH terms
Sunitinib, Adrenal Cortex Neoplasms, Adult, Aged, Antineoplastic Agents, Drug Interactions, Female, Humans, Indoles, Male, Middle Aged, Mitotane, Pyrroles, Treatment Outcome, Adrenocortical Carcinoma, Disease Progression, Antineoplastic Agents, Hormonal, Drug Resistance, Neoplasm, Young Adult

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