@article{Timothy P. Hughes_Andreas Hochhaus_Hagop M. Kantarjian_Francisco Cervantes_François Guilhot_Dietger Niederwieser_Philipp D. le Coutre_Gianantonio Rosti_Gert Ossenkoppele_Clarisse Lobo_Hirohiko Shibayama_Xiaolin Fan_Hans D. Menssen_Charisse Kemp_Richard A. Larson_Giuseppe Saglio_2014, place={Pavia, Italy}, title={Safety and efficacy of switching to nilotinib 400 mg twice daily for patients with chronic myeloid leukemia in chronic phase with suboptimal response or failure on front-line imatinib or nilotinib 300 mg twice daily}, volume={99}, url={https://haematologica.org/article/view/7085}, DOI={10.3324/haematol.2013.091272}, abstractNote={In a randomized, phase III trial of nilotinib <em>versus</em> imatinib in patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase, more patients had suboptimal response or treatment failure on front-line imatinib than on nilotinib. Patients with suboptimal response/treatment failure on imatinib 400 mg once or twice daily or nilotinib 300 mg twice daily could enter an extension study to receive nilotinib 400 mg twice daily. After a 19-month median follow up, the safety profile of nilotinib 400 mg twice daily in patients switching from imatinib (n=35) was consistent with previous reports, and few new adverse events occurred in patients escalating from nilotinib 300 mg twice daily (n=19). Of patients previously treated with imatinib or nilotinib 300 mg twice daily, respectively, 15 of 26 (58%) and 2 of 6 (33%) without complete cytogenetic response at extension study entry, and 11 of 34 (32%) and 7 of 18 (39%) without major molecular response at extension study entry, achieved these responses at any time on nilotinib 400 mg twice daily. Estimated 18-month rates of freedom from progression and overall survival after entering the extension study were lower for patients switched from imatinib (85% and 87%, respectively) <em>versus</em> nilotinib 300 mg twice daily (95% and 94%, respectively). Nilotinib dose escalation was generally well tolerated and improved responses in about one-third of patients with suboptimal response/treatment failure. Switch to nilotinib improved responses in some patients with suboptimal response/treatment failure on imatinib, but many did not achieve complete cytogenetic response (<em><a href="http://clinicaltrials.gov">clinicaltrials.gov</a> identifiers:00718263, 00471497 - extension</em&gt;).}, number={7}, journal={Haematologica}, author={Timothy P. Hughes and Andreas Hochhaus and Hagop M. Kantarjian and Francisco Cervantes and François Guilhot and Dietger Niederwieser and Philipp D. le Coutre and Gianantonio Rosti and Gert Ossenkoppele and Clarisse Lobo and Hirohiko Shibayama and Xiaolin Fan and Hans D. Menssen and Charisse Kemp and Richard A. Larson and Giuseppe Saglio}, year={2014}, month={Jul.}, pages={1204-1211} }