LONG-TERM BOSUTINIB IN PATIENTS WITH CHRONIC PHASE CHRONIC MYELOID LEUKEMIA (CML) AFTER PRIOR IMATINIB FAILURE
Author(s): ,
Tim H. Brümmendorf
Affiliations:
Universitätsklinikum Aachen,Aachen,Germany;Department of Internal Medicine II, Hubertus Wald Tumor Center - University Cancer Center Hamburg,Hamburg,Germany
,
Jorge E. Cortes
Affiliations:
University of Texas MD Anderson Cancer Center,Houston, TX,United States
,
H. Jean Khoury
Affiliations:
Winship Cancer Institute of Emory University,Atlanta, GA,United States
,
Hagop M. Kantarjian
Affiliations:
University of Texas MD Anderson Cancer Center,Houston, TX,United States
,
Dong-Wook Kim
Affiliations:
Seoul St. Mary’s Hospital,Seoul,Korea, Republic Of
,
Philippe Schafhausen
Affiliations:
Department of Internal Medicine II, Hubertus Wald Tumor Center - University Cancer Center Hamburg,Hamburg,Germany
,
Mirjana Zeremski
Affiliations:
Pfizer Inc,La Jolla, CA,United States
,
Nathalie Bardy-Bouxin
Affiliations:
Pfizer Global Research and Development,Paris,France
,
Mark Shapiro
Affiliations:
Pfizer Inc,Cambridge, MA,United States
,
Eric Leip
Affiliations:
Pfizer Inc,Cambridge, MA,United States
,
Carlo Gambacorti-Passerini
Affiliations:
University of Milano-Bicocca,Monza,Italy
Jeff H. Lipton
Affiliations:
Princess Margaret Cancer Centre,Toronto, ON,Canada
EHA Library. BRUMMENDORF T. Jun 13, 2015; 100743; P602 Disclosure(s): Universitätsklinikum Aachen
Prof. Tim BRUMMENDORF
Prof. Tim BRUMMENDORF
Contributions
Abstract
Abstract: P602

Type: Poster Presentation

Presentation during EHA20: From 13.06.2015 17:15 to 13.06.2015 18:45

Location: Poster area (Hall C)

Background
Bosutinib (BOS) is a Src/Abl tyrosine kinase inhibitor for adults with Ph+ CML resistant/intolerant to prior therapy.

Aims
We assess long-term efficacy/tolerability of BOS after ≥5 y vs ≥2 y follow-up from last enrolled patient (pt).

Methods
Data were from an ongoing phase 1/2 study in chronic phase CML pts on 2nd-line BOS (500 mg/d start dose) after imatinib failure (n=284). Informed consent was obtained from all pts.

Results
41% of pts remained on BOS at 5 y (54% at 2 y; per protocol, 1 y=48 wk); 60% and 50% had newly attained or maintained baseline major cytogenetic response (MCyR) or complete cytogenetic response (CCyR) (most in ≤2 y). Kaplan-Meier probability of maintaining MCyR or CCyR in responders was similar at 2 y (76%, 79%) and 5 y (71%, 71%); 6 and 7 pts, respectively, lost MCyR and CCyR >2 y. Cumulative incidence of on-treatment transformation to accelerated phase (AP)/blast phase (BP) CML at 5 y was 4%; 55% discontinued without transformation 2 y transformed to AP in y3–5. Kaplan-Meier overall survival was 84% at 5 y (91% at 2 y; 40% censored  

37 pts discontinued BOS y3–5 (vs 131 ≤2 y), mostly for disease progression (n=11), AE (n=7, y3: coronary artery disease, scleroderma, renal failure; y4: ascites and serositis [same pt], blood creatinine increased, pulmonary hypertension; y5: thrombocytopenia), and unsatisfactory efficacy (n=7). Common newly occurring AEs (in >5 pts) in y3 were cough (n=7), blood creatinine increased (n=7), pyrexia (n=6), and blood creatine phosphokinase increased (n=6); y4: blood creatinine increased (n=6), pleural effusion (n=6); y5, none in >5 pts. Newly occurring AEs of interest (Table) were most common in y1–2; vascular AEs >y2 were primarily hypertension (y3, n=5; y4, n=3; y5, n=2). Four on-treatment deaths occurred y3–5, none BOS-related.

Newly Occurring AEs*

n (%)

Year 1

N=284

Year 2

N=189

Year 3

N=148

Year 4

N=130

Year 5

N=124

Diarrhea

239 (84)

3 (2)

0

1 (1)

0

Cardiac

23 (8)

7 (4)

8 (5)

7 (5)

4 (3)

Vascular

11 (4)

8 (4)

5 (3)

4 (3)

5 (4)

Renal

14 (5)

4 (2)

8 (5)

7 (5)

5 (4)

*Not experienced by same patient previously (denominator=patients on treatment each y; 1 y=52 wk)



Summary
BOS showed durable efficacy and manageable toxicity; a large proportion of chronic phase CML pts with prior imatinib failure remained successfully treated at 5 y.

Keyword(s): Chronic myeloid leukemia

Session topic: Chronic myeloid leukemia - Clinical 2

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