Session: 632. Chronic Myeloid Leukemia: Therapy: Epidemiology, Prognosis, and Real Life Care
Hematology Disease Topics & Pathways:
Diseases, Biological, Adult, CML, Therapies, Study Population, Clinically relevant, Myeloid Malignancies
Results:A total of 445 patients were analyzed (Glivec=285; Generic=160). The median age was 54 years (18-87) in Glivec and 50 (18-89) in the Generic group (P=0.027). Sokal score stratification in Glivec and generic groups, was respectively: low risk 14.4%/25.7%; intermediate risk 42.3%/38.2% and high risk 43.3%/36.1% (P=0.02). B3a2 frequency was 51.5% vs. 37.7% in Glivec and Generic group, respectively, and b2a2 41.4% vs. 53.8% (P=0.017). There was no significant difference in gender, Hasford, EUTOS scores and ECOG. The median follow-up was 25 months (0-71) and 11 months (0-31) for Glivec and Generic groups, respectively (P<0.0001). The median time between diagnosis and imatinib starting was 18 days (0-119) in Glivec and 27 days (0-168) in the Generic group (P= 0.015). The rate of treatment failure at 3 months according to the ELN 2013 criteria was 6.6% and 14.7% in Glivec vs. Generic (P=0.04); whereas at 6 months there were no significant differences (12.3% vs. 18.9%; P=0.09). There was no significant difference in grade 3 and 4 hematological and non-hematological toxicity during the follow-up. There were 5 and 3 cases of progression in the Glivec and Generic group, respectively. In the Cox regression multivariate analysis, the independent factors for EFS were age at diagnosis (HR=1.03; CI95% 1.00-1.07; P=0.039) and toxicity grade 3-4 (HR 3.37; CI95% 1.08-10.4; P=0.036). The initial therapy was discontinued for the following reasons, in Glivec and generic group respectively: resistance (19.7% vs. 47.5%), intolerance (15.3% vs. 23.7%), non-adherence (4.4% vs. 3.4%), death (2.0% vs. 6.8%), clinical trial (0.5% vs. 10.2%), progression (2.0% vs. 5.0%), pregnancy (0 vs. 3.4%), switch from Glivec to generic (56.1%). OS, PFS and EFS at 24 months were higher in Glivec group in comparison to Generic (99% vs. 96%, P=0.016), (98% vs. 95%, P= 0.026) and (73% vs. 58%; P<0.0001 respectively.
Conclusion:The group treated with generic imatinib presented higher rate of failure at 3 months and lower OS, PFS and EFS at 24 months. Differences between the groups included a longer time to initiate treatment in the Generic group, a higher proportion of patients with b2a2 transcripts, which were related to an inferior rate of molecular responses and survival in other studies. There was no difference in the safety profile. The long-term impact in prognosis will be evaluated after a longer follow-up.
Disclosures: Pagnano: Shire: Other: Lecture; Abbvie: Consultancy; EMS: Other: Financial support for participation in congress; Novartis: Consultancy. Magalhaes: Novartis: Consultancy, Other: Lecture. Clementino: EMS: Other: Financial support for congress. Gaidano: AbbVie: Consultancy, Honoraria; Gilead: Consultancy, Honoraria; Morphosys: Honoraria; Amgen: Consultancy, Honoraria; Roche: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Centrone: EMS: Other: Financial support for congress, Speakers Bureau; Bristol Meiers-Squibb: Other: Financial support for congress, Speakers Bureau; Novartis: Other: Financial support for congress, Speakers Bureau; Astra Zeneca: Speakers Bureau; Janssen: Other: Financial support for congress, Speakers Bureau. Fogliatto: Novartis: Consultancy; Roche: Consultancy, Speakers Bureau; Janssen: Honoraria, Research Funding. Giai: Pfizer: Consultancy; Novartis: Consultancy. Bortolheiro: Abbvie: Consultancy, Speakers Bureau; Sanoffi: Speakers Bureau; Novartis: Consultancy, Speakers Bureau.
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