Sunitinib in refractory adrenocortical carcinoma: a phase II, single-arm, open-label trial
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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A study using sunitinib raised concerns that several subjects did not reach therapeutic levels of this drug.
“A study using sunitinib, which is metabolized by CYP3A4, raised concerns that several of the study subjects did not reach therapeutic levels of this drug (302, 304).”
From Adrenocortical carcinoma (2014) · cites this paper as [304]
The reasons for the negative effect of mitotane on sunitinib response are induction of CYP3A4 by mitotane and metabolism of sunitinib by the same enzyme.
“The reasons for these findings are induction of CYP3A4 by mitotane and metabolism of sunitinib by the same enzyme (301, 304).”
From Adrenocortical carcinoma (2014) · cites this paper as [304]
Concomitant mitotane treatment negatively affected patient response to sunitinib, and sunitinib and mitotane levels were anticorrelated.
“Interestingly, concomitant mitotane treatment negatively affected patient response, and sunitinib and mitotane levels were anticorrelated.”
From Adrenocortical carcinoma (2014) · cites this paper as [304]
In a study of sunitinib in advanced ACC, stable disease occurred in 5 of 35 patients.
“A study using the multikinase inhibitor sunitinib led to stable disease in 5 of 35 patients (304).”
From Adrenocortical carcinoma (2014) · cites this paper as [304]
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- 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
- 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 › Pulmonary and Respiratory Medicine › 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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