دورية أكاديمية
Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study
| العنوان: | Adjuvant mitotane versus surveillance in low-grade, localised adrenocortical carcinoma (ADIUVO): an international, multicentre, open-label, randomised, phase 3 trial and observational study |
|---|---|
| المؤلفون: | Terzolo, Massimo, Fassnacht, Martin, Perotti, Paola, Libé, Rossella, Kastelan, Darko, Lacroix, André, Arlt, Wiebke, Haak, Harm Reinout, Loli, Paola, Decoudier, Bénédicte, Lasolle, Helene, Quinkler, Marcus, Haissaguerre, Magalie, Chabre, Olivier, Caron, Philippe, Stigliano, Antonio, Giordano, Roberta, Zatelli, Maria Chiara, Bancos, Irina, Fragoso, Maria Candida Barisson Villares, Canu, Letizia, Luconi, Michaela, Puglisi, Soraya, Basile, Vittoria, Reimondo, Giuseppe, Kroiss, Matthias, Megerle, Felix, Hahner, Stefanie, Kimpel, Otilia, Dusek, Tina, Nölting, Svenja, Bourdeau, Isabelle, Chortis, Vasileios, Ettaieb, Madeleine Hester, Cosentini, Deborah, Grisanti, Salvatore, Baudin, Eric, Berchialla, Paola, Bovis, Francesca, Sormani, Maria Pia, Bruzzi, Paolo, Beuschlein, Felix, Bertherat, Jerome, Berruti, Alfredo |
| المساهمون: | Terzolo, Massimo, Fassnacht, Martin, Perotti, Paola, Libé, Rossella, Kastelan, Darko, Lacroix, André, Arlt, Wiebke, Haak, Harm Reinout, Loli, Paola, Decoudier, Bénédicte, Lasolle, Helene, Quinkler, Marcu, Haissaguerre, Magalie, Chabre, Olivier, Caron, Philippe, Stigliano, Antonio, Giordano, Roberta, Zatelli, Maria Chiara, Bancos, Irina, Fragoso, Maria Candida Barisson Villare, Canu, Letizia, Luconi, Michaela, Puglisi, Soraya, Basile, Vittoria, Reimondo, Giuseppe, Kroiss, Matthia, Megerle, Felix, Hahner, Stefanie, Kimpel, Otilia, Dusek, Tina, Nölting, Svenja, Bourdeau, Isabelle, Chortis, Vasileio, Ettaieb, Madeleine Hester, Cosentini, Deborah, Grisanti, Salvatore, Baudin, Eric, Berchialla, Paola, Bovis, Francesca, Sormani, Maria Pia, Bruzzi, Paolo, Beuschlein, Felix, Bertherat, Jerome, Berruti, Alfredo |
| سنة النشر: | 2023 |
| المجموعة: | Università degli Studi di Ferrara: CINECA IRIS |
| مصطلحات موضوعية: | mitotane, adrenocortical carcinoma, Adjuvant treatment |
| الوصف: | Background: Adjuvant treatment with mitotane is commonly used after resection of adrenocortical carcinoma; however, treatment remains controversial, particularly if risk of recurrence is not high. We aimed to assess the efficacy and safety of adjuvant mitotane compared with surveillance alone following complete tumour resection in patients with adrenocortical carcinoma considered to be at low to intermediate risk of recurrence. Methods: ADIUVO was a multicentre, open-label, parallel, randomised, phase 3 trial done in 23 centres across seven countries. Patients aged 18 years or older with adrenocortical carcinoma and low to intermediate risk of recurrence (R0, stage I-III, and Ki67 ≤10%) were randomly assigned to adjuvant oral mitotane two or three times daily (the dose was adjusted by the local investigator with the target of reaching and maintaining plasma mitotane concentrations of 14-20 mg/L) for 2 years or surveillance alone. All consecutive patients at 14 study centres fulfilling the eligibility criteria of the ADIUVO trial who refused randomisation and agreed on data collection via the European Network for the Study of Adrenal Tumors adrenocortical carcinoma registry were included prospectively in the ADIUVO Observational study. The primary endpoint was recurrence-free survival, defined as the time from randomisation to the first radiological evidence of recurrence or death from any cause (whichever occurred first), assessed in all randomly assigned patients by intention to treat. Overall survival, defined as time from the date of randomisation to the date of death from any cause, was a secondary endpoint analysed by intention to treat in all randomly assigned patients. Safety was assessed in all patients who adhered to the assigned regimen, which was defined by taking at least one tablet of mitotane in the mitotane group and no mitotane at all in the surveillance group. The ADIUVO trial is registered with ClinicalTrials.gov, NCT00777244, and is now complete. Findings: Between Oct 23, 2008, and Dec 27, ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | STAMPA |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/37619579; info:eu-repo/semantics/altIdentifier/wos/WOS:001088790000001; volume:11; issue:10; firstpage:720; lastpage:730; numberofpages:11; journal:THE LANCET DIABETES & ENDOCRINOLOGY; https://hdl.handle.net/11392/2530293Test; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85172022000 |
| DOI: | 10.1016/S2213-8587(23)00193-6 |
| الإتاحة: | https://doi.org/10.1016/S2213-8587Test(23)00193-6 https://hdl.handle.net/11392/2530293Test |
| رقم الانضمام: | edsbas.36A1B86A |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/S2213-8587(23)00193-6 |
|---|