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An Ib/II PCYC-1102 study (NCT01105247) demonstrated the safety and effectiveness of Bruton tyrosine kinase (BTK) inhibitor ilutinib (1/day) in chronic lymphoblastic leukemia/small lymphocytic lymphoma (CLL/SLL).
researchers extended the follow-up time for the trial to eight years, the longest follow-up time to date for iruthini monodruds, or all BTK inhibitors, published recently in Clinical Cancer Research.
PCYC-1102 study and its extended study PCYC-1103 (NCT01109069) was included in patients receiving iluteni monotherapy as a first-line treatment or recurrent/incurable CLL/SLL.
overall remission rate was 89%, and the overall remission rate was similar for patients treated with iruthini as a first-line treatment or recurrent/incurable CLL/SLL (87% vs 89%; full remission rate: 35% vs 10%).
expected seven-year progression-free survival (PFS) rate for patients treated with iruthini as a first-line treatment was 83%, compared with 34% for patients with recurrent/incurable diseases.
CLL progression in 41 patients (11 with Richter transformation).
PFS was not reached in patients treated with iruthini as the first line of treatment.
In patients with recurrent/incurable CLL/SLL, the overall median PFS was 52 months, and the median PFS was 26 months, 51 months, under reached and 88 months in patients with chromosomal 17p loss, 11q loss, 12-3 body or 13q loss, and no chromosomal abnormalities, respectively.
7-year overall survival rates for patients with first-line treatment and recurrent/incurable backgrounds were 84% and 55%, respectively.
in 15% of patients with hypertension (28%), pneumonia (24%) and a decrease in neutral granulocytes (18%).
in addition to hypertension, level 3 AE generally decreases over time.
AE, which resulted in the termination of treatment in 2 or more patients, is only available in recurrent/incurable patients (sepsis, diarrhea, sub-epidural hematoma and Richter transformation) summary: after up to 8 years of follow-up, the first-line or recurrent/refractive CLL/SLL (including high-risk CLL/SLL) treatment with irutini monotherapy can provide long-lasting relief and long-term tolerance.
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