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Study includes review of lower dosages of Gleevec, so far

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#1 ChrisC


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Posted 17 April 2012 - 03:55 PM


Long-term outcome following imatinib therapy for chronic myelogenous leukemia, with assessment of dosage and blood levels: the JALSG CML202 study

Kazunori Ohnishi1,*, Chiaki Nakaseko2, Jin Takeuchi3, Shin Fujisawa4, Tadashi Nagai5, Hirohito Yamazaki6, Tetsuzo Tauchi7, Kiyotoshi Imai8, Naoki Mori9, Fumiharu Yagasaki10, Yasuhiro Maeda11, Noriko Usui12, Yasushi Miyazaki13, Koichi Miyamura14, Hitoshi Kiyoi15, Shigeki Ohtake16, Tomoki Naoe15, for the Japan Adult Leukemia Study Group

Article first published online: 16 APR 2012

DOI: 10.1111/j.1349-7006.2012.02253.x

A prospective multicenter Phase II study was performed to examine the efficacy and safety of imatinib therapy in newly diagnosed Japanese patients with chronic-phase CML. Patients were scheduled to receive imatinib 400 mg daily. Plasma imatinib concentrations were measured by liquid chromatography-tandem mass spectrometry. In 481 evaluable patients, estimated 7-year overall survival (OS) and event-free survival (EFS) at a median follow-up of 65 months were 93% and 87%, respectively. Because imatinib dosage was reduced in many patients due mainly to adverse events, subgroup analysis was performed according to the mean daily dose during the first 24 months of treatment: ?360 mg (400-mg group; n = 294), 270-359 mg (300-mg group; n = 90) and <270 mg (200-mg group; n = 67). There were no significant differences in OS and EFS between the 300- and 400-mg groups; however, cumulative rates of complete cytogenetic and major molecular responses differed significantly between the two groups. There were no significant differences in mean imatinib trough levels between these two groups for the patients in whom trough levels had been measured. Survival and efficacy in the 200-mg group were markedly inferior to the former two groups. These results suggest that, although a daily dose of 400 mg imatinib is associated with better outcomes, 300 mg imatinib may be adequate for a considerable number of Japanese patients who are intolerant to 400 mg imatinib. Blood level monitoring would be useful to determine the optimal dose of imatinib. (Cancer Sci, doi: 10.1111/j.1349-7006.2012.02253.x, 2012)

Be alert, but not overly concerned.


• Dx Oct. 22, 2008, WBC 459k, in ICU for 2 days + in hospital 1 week

• Leukapheresis for 1 week, to reduce WBC (wasn't given Hydroxyurea)

• Oct. 28, 2008: CML confirmed, start Gleevec 400mg

• Oct. 31, 2008: sent home when WBC reached 121k

• On/off, reduced dose Gleevec for 7 months

• April 2009: Started Sprycel 100mg

• Sept. 2009: PCRU 0.000

• Sept. 2011: after 2 years steady PCRU & taking Sprycel 100mg before bed, quit Sprycel (with permission)

• Currently: still steady PCRU, testing every 6 months 🤗

— Fatigue, hearing loss continue, alas, but I prefer to think it is all getting better!



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