Abstract

Current recommendations for patients with CML (

Baccarani M, et al.
Blood
2006
;
108
:
1809
–20
) advocate regular treatment response monitoring, including evaluation of: cytogenetic response (CyR) at least every 6 months until complete CyR is achieved, then every 12 months; molecular response (MolR) every 3 months; mutational analysis in cases of failure/suboptimal response. Yet, few data exist on monitoring in current clinical practice. A survey of CML physicians in the US/Europe suggests practices in some CML management areas are not in line with recommendations (
Kantarjian H, et al.
Cancer
2007
;
109
:
1365
–75
). UNIC is a cross-sectional study, with retrospective chart review of currently treated CML or Ph+ALL patients in Austria, Belgium, France, Italy, Netherlands, Spain, Sweden and UK. Patients were recruited September 2006-March 2007. The study aimed to estimate the proportion of patients ever treated with imatinib and those who experienced imatinib resistance and/or intolerance (primary objectives). Here, we focus on data collected on patterns of disease monitoring (a secondary objective) in CML/Ph+ALL patients. A patient was defined as imatinib resistant if reported as such by the physician in the medical chart. Case Report Forms (CRFs) were completed for 1716 patients. CRFs were analyzable for 1551 CML and 48 Ph+ALL patients. Of the CML patients, 98% were in chronic phase; 2% were in advanced phases. Of the 1493 (96%) CML and 46 (96%) Ph+ALL patients who received imatinib, 241 (16%) CML and 6 (13%) Ph+ALL patients were reported as resistant. Patterns of cytogenetic, molecular and mutational testing are shown in the tables. In the last 12 months, 31% of CML patients had not had a cytogenetic analysis and 10% had not had a PCR analysis to assess MolR. Of imatinib-resistant patients, 57% CML and 50% Ph+ALL patients had not been assessed for mutations.

ExaminationCMLPh+ALL
Number of cytogenetic analyses per patient in the last 12 months, n (%) N=1427 N=42 
447 (31.3) 13 (31.0) 
559 (39.2) 15 (35.7) 
271 (19.0) 2 (4.8) 
≥3 150 (10.5) 12 (28.6) 
≥1 fluorescent in situ hybridization since diagnosis, n (%) N=1497 N=45 
No 852 (56.9) 18 (40.0) 
Yes 645 (43.1) 27 (60.0) 
≥1 PCR in the last 12 months, n (%) N=1504 N=48 
No 149 (9.9) 2 (4.2) 
Yes 1355 (90.1) 46 (95.8) 
Patients with 4 PCRs in the last 12 months, n (%) N=1422 N=40 
 200 (14.1) 4 (10.0) 
ExaminationCMLPh+ALL
Number of cytogenetic analyses per patient in the last 12 months, n (%) N=1427 N=42 
447 (31.3) 13 (31.0) 
559 (39.2) 15 (35.7) 
271 (19.0) 2 (4.8) 
≥3 150 (10.5) 12 (28.6) 
≥1 fluorescent in situ hybridization since diagnosis, n (%) N=1497 N=45 
No 852 (56.9) 18 (40.0) 
Yes 645 (43.1) 27 (60.0) 
≥1 PCR in the last 12 months, n (%) N=1504 N=48 
No 149 (9.9) 2 (4.2) 
Yes 1355 (90.1) 46 (95.8) 
Patients with 4 PCRs in the last 12 months, n (%) N=1422 N=40 
 200 (14.1) 4 (10.0) 
Number of mutational analyses since diagnosis in imatinib-resistant patients, n (%)Imatinib-resistant patients
CML (N=209)Ph+ALL (N=6)
120 (57.4) 3 (50.0) 
75 (35.8) 3 (50.0) 
12 (5.7) 
≥3 2 (1.0) 
Number of mutational analyses since diagnosis in imatinib-resistant patients, n (%)Imatinib-resistant patients
CML (N=209)Ph+ALL (N=6)
120 (57.4) 3 (50.0) 
75 (35.8) 3 (50.0) 
12 (5.7) 
≥3 2 (1.0) 

This large European observational study suggests different methods of disease monitoring are used less often in real life than according to recommendations. Further research into the consequences of suboptimal monitoring of patients’ disease status is warranted.

Author notes

Disclosure:Employment: Cosimo Paga, Carine Cohen, Isidro Villanueva, Veronique Halkin, Michele Intorcia, and Karin Cerri are all employees of Bristol-Myers Squibb. Consultancy: David Marin Costa has acted as a consultant for Novartis and Bristol-Myers Squibb. Ownership Interests: Cosimo Paga has ownership interests in a start-up company.; Cosimo Paga and Karin Cerri have ownership interests in a publicly traded company. Veronique Halkin has stock options in Bristol-Myers Squibb. Research Funding: Each Principal Investigator received funding from Bristol-Myers Squibb for the coordination of the UNIC study in their country. Juan Steegmann has received other research funding from Bristol-Myers Squibb. David Marin Costa and Gert Ossenkoppele have received research funding from Novartis. Honoraria Information: Juan Steegmann has received honoraria from Bristol-Myers Squibb, Novartis and Roche for chairing conferences, advisory board activities and giving lectures. Gert Ossenkoppele has received honoraria from Novartis and Bristol-Myers Squibb for advisory board activities and lectures.