Giuseppe Procopio1, Michele Prisciandaro1, Roberto Iacovelli2, Enrico Cortesi3, Giuseppe Fornarini4, Gaetano Facchini5, Giacomo Cartenì6, Roberto Sabbatini7, Gabriella Del Bene8, Luca Galli9, Claudia Caserta10, Andrea Giovanni Multari11, Marco Bregni12, Francesco Massari13, Sebastiano Buti14, Ugo De Giorgi15, Fable Zustovich16, Michele Milella17, Fabio Calabrò8, Maria Laura Mancini3, Giampaolo Tortora2, Claudio Vernieri1, Daniele Santini18, Mariella Sorarù19, Riccardo Ricotta20, Cristina Masini21, Marcello Tucci22, Stefano Luzi Fedeli23, Cinzia Ortega24, Antonella Mecozzi25, Raffaele Ratta1, Cora N Sternberg8, Elena Verzoni26. 1. Department of Medical Oncology, Genitourinary Cancer Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy. 2. Medical Oncology Unit, Azienda Ospedaliera Universitaria Integrata (AOUI), University of Verona, Verona, Italy. 3. Department of Medical Oncology B, Policlinico Umberto I "Sapienza" University of Rome, Rome, Italy. 4. Medical Oncology Department, IRCCS Azienda Ospedaliera Universitaria San Martino-IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy. 5. Division of Medical Oncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale (IRCCS), Naples, Italy. 6. Oncology Unit, Antonio Cardarelli Hospital, Naples, Italy. 7. Department of Oncology and Hematology and Respiratory Disease, University Hospital, Modena, Italy. 8. Department of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy. 9. Department of Medical Oncology 2, Istituto Toscano Tumori, Pisa, Italy. 10. Oncology Department, Santa Maria Hospital, Terni, Italy. 11. Medical Oncology Unit, University of Siena, Siena, Italy. 12. Ospedale di Circolo di Busto Arsizio, Busto Arsizio, Italy. 13. Division of Oncology, S Orsola-Malpighi Hospital, Bologna, Italy. 14. Medical Oncology Unit, University Hospital of Parma, Italy. 15. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 16. San Martino Hospital, Medical Oncology, Belluno, Italy. 17. Medical Oncology Unit, Istituto Nazionale Tumori Regina Elena (IFO), Rome, Italy. 18. Medical Oncology Unit, Campus Bio-Medico University of Rome, Rome, Italy. 19. Medical Oncology Unit, Camposampiero, Italy. 20. Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. 21. Oncology Unit, Department of Oncology and Advanced Technologies, Arcispedale Santa Maria Nuova-IRCCS, Reggio Emilia, Italy. 22. Division of Medical Oncology, San Luigi Gonzaga Hospital, Department of Oncology, University of Turin, Orbassano, Turin, Italy. 23. Department of Medical Oncology, AOU Ospedali Riuniti, Università Politecnica delle Marche, Presidio San Salvatore, Pesaro, Italy. 24. Division of Oncology, Institute for Cancer Research and Treatment, ASL CN2 Alba-Bra, Alba, Italy. 25. Oncology Department, S. Giovanni Calibita' Fatebenefratelli Isola Tiberina Hospital, Rome, Italy. 26. Department of Medical Oncology, Genitourinary Cancer Unit, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy. Electronic address: elena.verzoni@istitutotumori.mi.it.
Abstract
BACKGROUND: The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment with at least one previous antiangiogenic inhibitor. The aim of this analysis was to evaluate the safety and activity of cabozantinib in an unselected population. METHODS: Data were collected across 24 Italian centers. Cabozantinib therapy was initiated at physician request between September and December 2016. Patients with mRCC with disease that progressed after one or more prior systemic treatment were evaluated. Cabozantinib 60 mg was administered orally once daily. Doses were reduced to 40 mg or 20 mg in patients experiencing grade 3 or intolerable grade 2 adverse events (AEs). RESULTS: Data from 96 patients were evaluated. Cabozantinib was administered as second-line therapy in 28 patients (29%) and as third-line therapy in 18 patients (19%), while the remaining 50 patients (52%) received cabozantinib in further treatment lines. Sixty-six patients began therapy with the full dose of 60 mg. Because of poor performance status, 29 patients began therapy with a reduced dose of 40 mg and 1 patient with 20 mg. At the time of our analysis, grade 3/4 AEs were observed in 35 patients (36%). Only 5 patients discontinued treatment as a result of AEs. Partial response was observed in 35 patients (36%), whereas 33 (34%) had stable disease and 28 (30%) progressive disease. Median progression-free survival was 8.0 months. CONCLUSION: Cabozantinib showed acceptable tolerability and activity in a large unselected population treated according to everyday clinical practice.
BACKGROUND: The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment with at least one previous antiangiogenic inhibitor. The aim of this analysis was to evaluate the safety and activity of cabozantinib in an unselected population. METHODS: Data were collected across 24 Italian centers. Cabozantinib therapy was initiated at physician request between September and December 2016. Patients with mRCC with disease that progressed after one or more prior systemic treatment were evaluated. Cabozantinib 60 mg was administered orally once daily. Doses were reduced to 40 mg or 20 mg in patients experiencing grade 3 or intolerable grade 2 adverse events (AEs). RESULTS: Data from 96 patients were evaluated. Cabozantinib was administered as second-line therapy in 28 patients (29%) and as third-line therapy in 18 patients (19%), while the remaining 50 patients (52%) received cabozantinib in further treatment lines. Sixty-six patients began therapy with the full dose of 60 mg. Because of poor performance status, 29 patients began therapy with a reduced dose of 40 mg and 1 patient with 20 mg. At the time of our analysis, grade 3/4 AEs were observed in 35 patients (36%). Only 5 patients discontinued treatment as a result of AEs. Partial response was observed in 35 patients (36%), whereas 33 (34%) had stable disease and 28 (30%) progressive disease. Median progression-free survival was 8.0 months. CONCLUSION:Cabozantinib showed acceptable tolerability and activity in a large unselected population treated according to everyday clinical practice.
Authors: Pablo Maroto; Camillo Porta; Jaume Capdevila; Andrea B Apolo; Santiago Viteri; Cristina Rodriguez-Antona; Lidia Martin; Daniel Castellano Journal: Ther Adv Med Oncol Date: 2022-07-13 Impact factor: 5.485
Authors: Chun Loo Gan; Shaan Dudani; J Connor Wells; Frede Donskov; Sumanta K Pal; Nazli Dizman; Nityam Rathi; Benoit Beuselinck; Flora Yan; Aly-Khan A Lalani; Aaron Hansen; Bernadett Szabados; Guillermo de Velasco; Ben Tran; Jae Lyun Lee; Ulka N Vaishampayan; Georg A Bjarnason; Mathushan Subasri; Toni K Choueiri; Daniel Y C Heng Journal: Cancer Med Date: 2021-01-18 Impact factor: 4.452
Authors: Stefanie D Krens; Nielka P van Erp; Stefanie L Groenland; Dirk Jan A R Moes; Sasja F Mulder; Ingrid M E Desar; Tom van der Hulle; Neeltje Steeghs; Carla M L van Herpen Journal: BMC Cancer Date: 2022-03-02 Impact factor: 4.430