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Endocrine Abstracts (2024) 99 P90 | DOI: 10.1530/endoabs.99.P90

1Hospital Universitario La Paz, Endocrinology and Nutrition, Madrid, Spain; 2VHIO Institut d’Oncologia, Medical Oncology, Barcelona, Spain; 3Hospital Universitario Vall d’Hebron, Medical Oncology, Barcelona, Spain; 4Hospital Universitario Virgen del Rocío, Endocrinology and Nutrition, Sevilla, Spain; 5Comprehensive Cancer Center CLARA CAMPAL, Medical Oncology, Madrid, Spain; 6Hospital Universitario Virgen de la Victoria, Endocrinology and Nutrition, Málaga, Spain; 7Hospital Universitario Basurto, Bilbao, Spain; 8Hospital Universitario Gregorio Marañón, Endocrinology and Nutrition, Madrid, Spain; 9Hospital Universitario de Canarias, Endocrinology and Nutrition, La Laguna, Spain; 10Hospital Jerez de la Frontera, Endocrinology and Nutrition, Jerez de la Frontera, Spain; 11Hospital Universitario Ramón y Cajal, Medical Oncology, Madrid, Spain; 12Hospital Universitario Miguel Servet, Medical Oncology, Zaragoza, Spain; 13Hospital Universitario de Cabueñes, Endocrinology and Nutrition, Gijón, Spain; 14Hospital Universitario Virgen de la Arrixaca, Surgery, Murcia, Spain; 15Hospital Clínic de Barcelona, Endocrinology and Nutrition, Barcelona, Spain; 16Hospital Universitario Marqués de Valdecilla, Medical Oncology, Santander, Spain; 17Hospital Universitario Príncipe de Asturias, Endocrinology and Nutrition, Alcalá de Henares, Spain; 18Hospital de la Santa Creu i Sant Pau, Medical Oncology, Barcelona, Spain; 19Hospital Universitario Fundación Jiménez Díaz, Endocrinology and Nutrition, Madrid, Spain; 20Hospital Universitario de Cruces, Endocrinology and Nutrition, Baracaldo, Spain; 21Hospital Universitario Central de Asturias, Medical Oncology, Oviedo, Spain; 22Hospital Universitario Morales Meseguer, Medical Oncology, Murcia, Spain


Introduction: The role of mitotane as an adjuvant therapy for adrenocortical carcinoma (ACC) remains a contentious topic due to the scarcity of robust randomized clinical trials, attributed to the low incidence of this neoplasm. Despite this, the prognosis following surgery for localized tumors is generally poor, leading to varied clinical practices.

Methods: This study utilized patient data from the ICARO registry of the GETHY group and SEEN, with disease-free survival (DFS) and overall survival (OS) as endpoints. A Cox multivariable model was employed, considering factors such as tumor size, Ki67 index, age, T stage, nodal involvement, venous invasion, radiotherapy, and adjuvant mitotane usage.

Results: The ICARO database included 357 patients treated between 1983 and 2023 across 34 centers. Among these, 223 patients had localized, non-metastatic tumors at diagnosis and underwent surgery after a median of 41 days from diagnosis. Open surgery was performed in 142 (64%) cases, with laparoscopic procedures in the remainder. R0 resection was achieved in 162 (73%) cases. Of the 223 patients with follow-up data, 138 (62%) were female, aged between 20 and 88 years, with a median age of 50 years. Functional symptoms were present in 85 (38%) patients, with Cushing’s syndrome in 51 of these. Radiotherapy was administered in 27 (12%) cases, and 111 (49.7%) patients received adjuvant mitotane therapy for a median of 23 months. Mitotane levels were monitored in 93/111 patients, starting at 2 g/day. At the time of analysis, the median DFS was 28 months (95% CI, 20.8–61.3), and the median OS was 86.1 months (95% CI, 54.6–152). After adjusting for confounding factors, there is insufficient evidence to reject the null hypothesis of no effect of mitotane on DFS (Hazard Ratio [HR] 0.67, 95% CI, 0.42–1.05), or on OS (HR 0.58, 95% CI, 0.32–1.02). However, factors such as tumor size (T), nodal involvement (N), age, Ki67 index, and venous invasion were associated with recurrence and death. The effect was clearly time-variant (Schoenfeld test =0.008), with a crossing of the Kaplan-Meier curves at 24 months.

Conclusion: In post-operative ACC cases, current evidence on adjuvant mitotane’s efficacy is not definitive. However, if effective, its impact seems time-limited, likely reaching its peak within two years under conventional usage patterns. This suggests a potential requirement for prolonged maintenance therapy, emphasizing the need for in-depth research into its long-term outcomes.

Volume 99

26th European Congress of Endocrinology

Stockholm, Sweden
11 May 2024 - 14 May 2024

European Society of Endocrinology 

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