Giulio Metro1, Antonio Passaro2, Giuseppe Lo Russo3, Laura Bonanno4, Raffaele Giusti5, Vanesa Gregorc6, Enrica Capelletto7, Olga Martelli8, Fabiana L Cecere9, Diana Giannarelli9, Andrea Luciani10, Alessandra Bearz11, Alessandro Tuzi12, Vieri Scotti13, Giuseppe Tonini14, Domenico Galetta15, Annamaria Carta16, Hector Soto Parra17, Alberto Rebonato18, Alessandro Morabito19, Rita Chiari1. 1. Medical Oncology, Santa Maria della Misericordia Hospital, AOU di Perugia, Perugia, Italy. 2. Division of Thoracic Oncology, European Institute of Oncology, Milano, Italy. 3. Division of Thoracic Oncology, Fondazione IRCCS, Istituto Nazionale Tumori, Milano, Italy. 4. Medical Oncology 2, Istituto Oncologico Veneto IRCCS, Padova (PD), Italy. 5. Medical Oncology, Sant'Andrea Hospital, Roma, Italy. 6. Department of Medical Oncology, IRCCS, San Raffaele Hospital, Milano, Italy. 7. Department of Oncology, University of Torino, AOU San Luigi Orbassano, Torino, Italy. 8. Medical Oncology, AO San Giovanni Addolorata, Roma, Italy. 9. Medical Oncology 1, Regina Elena National Cancer Institute, Roma, Italy. 10. Medical Oncology, San Paolo Hospital, Milano, Italy. 11. CRO-IRCCS, Aviano (PN), Italy. 12. Medical Oncology, ASST-Settelaghi, Varese, Italy. 13. Department of Oncology, Division of Radiotherapy, AOU Careggi, Firenze, Italy. 14. Oncologia Medica, Policlinico Universitario Campus Bio-Medico, Roma, Italy. 15. Division of Thoracic Oncology, IRCCS Oncologico Giovanni Paolo II, Bari, Italy. 16. Medical Oncology, Businco Hospital, Cagliari, Italy. 17. Medical Oncology, AOU Policlinico Vittorio Emanuele, Catania, Italy. 18. Department of Diagnostic Imaging, Santa Maria della Misericordia Hospital, University of Perugia, Perugia, Italy. 19. Division of Thoracic Oncology, Istituto Nazionale Tumori, Fondazione G. Pascale, IRCCS, Napoli, Italy.
Abstract
AIM: Ceritinib was evaluated within a compassionate use program of Italian patients. PATIENTS & METHODS: 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib. RESULTS: Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07). CONCLUSION: The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome.
AIM: Ceritinib was evaluated within a compassionate use program of Italian patients. PATIENTS & METHODS: 70 patients with anaplastic lymphoma kinase-positive crizotinib-refractory advanced non-small-cell lung cancer received ceritinib. RESULTS: Overall response was 40.6%, median progression-free survival was 8.2 months and median survival was 15.5 months. Dose reduction due to treatment-related adverse events occurred in 50.8% of patients starting at 750 mg/day. No significantly different progression-free survival was observed between patients who underwent any time dose reduction (n = 38) versus those who remained on the recommended dose of 750 mg/day (n = 32; p = 0.07). CONCLUSION: The efficacy of ceritinib compassionate use program resembled that of clinical trials. Dose reductions and adjustments did not appear to negatively affect clinical outcome.
Entities:
Keywords:
ALK; ceritinib; non-small-cell lung cancer