Phase II study of everolimus in patients with thymoma and thymic carcinoma previously treated with cisplatin-based chemotherapy
| Autor: | Fabio De Vincenzo, Sabino De Placido, Annarita Destro, Luca Di Tommaso, Paolo Andrea Zucali, Matteo Perrino, Adolfo Favaretto, Armando Santoro, Francesca Toffalorio, Matteo Simonelli, Fabio Conforti, Marcello Tiseo, Monica Bertossi, Erika Garbella, Angela Cioffi, Margaret Ottaviano, Antonio Chella, Giovannella Palmieri, Vincenzo Damiano, Laura Giordano, Michele Caruso, Giulia Pasello, Tommaso De Pas, M. Ali |
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| Přispěvatelé: | Zucali, P. A., De Pas, T., Palmieri, G., Favaretto, A., Chella, A., Tiseo, M., Caruso, M., Simonelli, M., Perrino, M., De Vincenzo, F., Toffalorio, F., Damiano, V., Pasello, G., Garbella, E., Ali, M., Conforti, F., Ottaviano, M., Cioffi, A., De Placido, S., Giordano, L., Bertossi, M., Destro, A., Di Tommaso, L., Santoro, A. |
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
0301 basic medicine
Male Cancer Research Time Factors medicine.medical_treatment Phases of clinical research Salvage therapy Gastroenterology 0302 clinical medicine Risk Factors Positron Emission Tomography Computed Tomography Antineoplastic Combined Chemotherapy Protocols 80 and over Thymic carcinoma Aged 80 and over Middle Aged Progression-Free Survival Everolimu Local Oncology Italy 030220 oncology & carcinogenesis Female medicine.drug Human Adult medicine.medical_specialty Thymoma Aged Carcinoma Cisplatin Everolimus Humans Neoplasm Recurrence Local Pneumonia Protein Kinase Inhibitors Risk Assessment Salvage Therapy Thymus Neoplasms Protein Kinase Inhibitor 03 medical and health sciences Internal medicine medicine Progression-free survival Thymus Neoplasm Chemotherapy Antineoplastic Combined Chemotherapy Protocol business.industry Risk Factor medicine.disease Surgery Clinical trial Neoplasm Recurrence 030104 developmental biology business |
| Popis: | Purpose No effective salvage treatments are available for patients with advanced/recurrent thymoma (T) or thymic carcinoma (TC) who have progressed after platinum-based chemotherapy. This study evaluated the activity of everolimus in patients with advanced/recurrent T or TC previously treated with cisplatin-containing chemotherapy. Patients and Methods This was a single-arm, single-stage, open-label, multicenter, phase II trial. Patients received oral everolimus 10 mg/d until disease progression, unacceptable toxicity, or patient refusal. A Fleming phase II trial was designed. The null hypothesis of a true disease control rate (DCR) of 40% was tested against a one-sided alternative of a true DCR of 60% (α = β = 0.10): If disease control were achieved in ≥ 21 of the first 41 evaluable patients, everolimus could be recommended for further evaluation. Progression-free survival, overall survival, and safety were also evaluated. Results From 2011 to 2013, 51 patients were enrolled (T, n = 32; TC, n = 19). Complete remission was observed in one patient with TC, partial response in five patients (T, n = 3; TC, n = 2), and stable disease in 38 patients (T, n = 27; TC, n= 11), with a DCR of 88% (T,: 93.8%; TC, 77.8%). With a median follow up of 25.7 months, median progression-free survival was 10.1 months (T,: 16.6 months; TC, 5.6 months), and median overall survival was 25.7 months (T, not reached; TC, 14.7 months). Fourteen patients had a serious drug-related adverse event; of these patients, nine permanently discontinued treatment. Three patients died of pneumonitis while in the study. Immunohistochemical positivity for p4E-BP1 or insulin-like growth factor-1 receptor was statistically significantly related to a shorter survival. Conclusion Everolimus may induce durable disease control in a high percentage of patients with T or TC, albeit with a potential high risk of fatal pneumonitis. |
| Databáze: | OpenAIRE |
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