Contributions
Abstract: PB1837
Type: Publication Only
Background
CML patients in developing world had to wait for the start of TKI treatment, from several months to years. The significant delay in proper treatment with imatinib has had drastic consequences on patient outcomes including survival, CCyR and MMR. Nilotinib was introduced in 2011 as front- and second-line therapy for newly diagnosed as well as patients who waited for TKI treatment for a long time.
Aims
In this study we compared the long-term real life clinical outcomes (OS, CCyR and MMR) of patients receiving front- line imatinib and front-line nilotinib therapy in Bosnia and Herzegovina in the period from 08/2005 to 08/2016, categorized based on delayed start of therapy.
Methods
All newly diagnosed CML patients in CML-CP (n=149) who started their TKI treatment in period from August 2005 to August 2016 were included in this multicentre retrospective cohort study. Patients were categorized as: Group 1 (n=118) consisted of patients who started with front-line imatinib (300 mg, 400 mg or 600 mg twice daily; Glivec or generic imatinib therapy) and Group 2 (n=31) contained patients receiving front-line nilotinib (300 mg twice daily). Patients on imatinib were further categorized by the duration of treatment delay into three subgroups (<5 months, 6-13 months and >13 months) and patients on nilotinib therapy were divided into two subgroups (patients who waited less and more than 6 months on the start of therapy). Nilotinib became available as front or second-line therapy in March 2011. Standard patients' variables were collected and disease progression was established as loss of CCyR and MMR. Survival probabilities were estimated with the Kaplan-Meier method and compared using the log-rank test.
Results
We analyzed 149 patients (median age was 54.5 years; 57% was males) in chronic phase of CML. The median follow-up from time of diagnosis and start of therapy was 45 months and 39 months, respectively (range 3-145 months). Median wait period for therapy in patients who waited less and more than 6 months was 0 months (range 0-6) vs 15 months in the waiting group (range 9-63). At 11 years, overall survival for patients on front-line imatinib (Group 1) and front-line nilotinib (Group 2) was 83% and 87%, respectively. According to ITT principle, achievement of CCyR and MMR at 24 months was higher in Group 2 compared to Group 1 (81% vs 66% and 74% vs 37%, respectively). Rate of death was similar in both studied groups (20/118 vs 4/31). When we analysed delayed treatment at 24 months, CCyR for patients who received therapy immediately, who waited 6-13 months and more than 13 months, was 74% vs 64% vs 40%, respectively. Regarding nilotinib treatment at 24 months, patients on 1st line immediate nilotinib vs 1st line delayed nilotinib achieved 83% vs 77% for CCyR and 78% vs 69% for MMR, respectively.
Conclusion
Our results after 11 years of follow up suggest that nilotinib demonstrated improved efficacy over imatinib therapy. Achievement of CCyR and MMR at 24 months was higher in patients on front-line nilotinib therapy. Patients who waited for therapy had optimal response regardless the wait period on nilotinib therapy.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Tyrosine kinase inhibitor, Molecular response, Cytogenetics, Chronic myeloid leukemia
Abstract: PB1837
Type: Publication Only
Background
CML patients in developing world had to wait for the start of TKI treatment, from several months to years. The significant delay in proper treatment with imatinib has had drastic consequences on patient outcomes including survival, CCyR and MMR. Nilotinib was introduced in 2011 as front- and second-line therapy for newly diagnosed as well as patients who waited for TKI treatment for a long time.
Aims
In this study we compared the long-term real life clinical outcomes (OS, CCyR and MMR) of patients receiving front- line imatinib and front-line nilotinib therapy in Bosnia and Herzegovina in the period from 08/2005 to 08/2016, categorized based on delayed start of therapy.
Methods
All newly diagnosed CML patients in CML-CP (n=149) who started their TKI treatment in period from August 2005 to August 2016 were included in this multicentre retrospective cohort study. Patients were categorized as: Group 1 (n=118) consisted of patients who started with front-line imatinib (300 mg, 400 mg or 600 mg twice daily; Glivec or generic imatinib therapy) and Group 2 (n=31) contained patients receiving front-line nilotinib (300 mg twice daily). Patients on imatinib were further categorized by the duration of treatment delay into three subgroups (<5 months, 6-13 months and >13 months) and patients on nilotinib therapy were divided into two subgroups (patients who waited less and more than 6 months on the start of therapy). Nilotinib became available as front or second-line therapy in March 2011. Standard patients' variables were collected and disease progression was established as loss of CCyR and MMR. Survival probabilities were estimated with the Kaplan-Meier method and compared using the log-rank test.
Results
We analyzed 149 patients (median age was 54.5 years; 57% was males) in chronic phase of CML. The median follow-up from time of diagnosis and start of therapy was 45 months and 39 months, respectively (range 3-145 months). Median wait period for therapy in patients who waited less and more than 6 months was 0 months (range 0-6) vs 15 months in the waiting group (range 9-63). At 11 years, overall survival for patients on front-line imatinib (Group 1) and front-line nilotinib (Group 2) was 83% and 87%, respectively. According to ITT principle, achievement of CCyR and MMR at 24 months was higher in Group 2 compared to Group 1 (81% vs 66% and 74% vs 37%, respectively). Rate of death was similar in both studied groups (20/118 vs 4/31). When we analysed delayed treatment at 24 months, CCyR for patients who received therapy immediately, who waited 6-13 months and more than 13 months, was 74% vs 64% vs 40%, respectively. Regarding nilotinib treatment at 24 months, patients on 1st line immediate nilotinib vs 1st line delayed nilotinib achieved 83% vs 77% for CCyR and 78% vs 69% for MMR, respectively.
Conclusion
Our results after 11 years of follow up suggest that nilotinib demonstrated improved efficacy over imatinib therapy. Achievement of CCyR and MMR at 24 months was higher in patients on front-line nilotinib therapy. Patients who waited for therapy had optimal response regardless the wait period on nilotinib therapy.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Tyrosine kinase inhibitor, Molecular response, Cytogenetics, Chronic myeloid leukemia