Correlation of plasma trough levels of imatinib with molecular response in patients with chronic myeloid leukemia.
The present study looked at the correlation between mean trough Imatinib plasma levels and molecular response in 131 CML patients on imatinib. Patients receiving Glivec versus generic Imatinib were also compared. A ROC curve was constructed to estimate a threshold level that correlates with a favourable response. Patients were grouped into Responders (bcr/abl ration by RQ-PCR less than 1) and Non Responders (ration ≥ 1). The mean trough imatinib plasma level in the responders was significantly higher than in the non responders (p = 0.001). The area under ROC curve was 0.733, with best sensitivity (51.85%) and specificity (89.42%) at a plasma threshold of 0.988 g/ml [1.675 M]. Levels in the patients on Glivec versus generic drug (p > 0.05) were comparable. Trough Imatinib plasma levels may be a marker for suboptimal response and may identify patients in whom increase of drug dose or change in therapy may be indicated.
Division of Medical Oncology, Department of Medicine, SMS Medical College , Jaipur , India.
Hemant
H
Malhotra
Pratibha
P
Sharma
Shipra
S
Bhargava
Om Singh
OS
Rathore
Bharti
B
Malhotra
Madhu
M
Kumar
D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D001549:Benzamides / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D003967:Diarrhea / Q000139:chemically induced; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000235:genetics; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000235:genetics; D008297:Male; D008875:Middle Aged; D009120:Muscle Cramp / Q000139:chemically induced; D009325:Nausea / Q000139:chemically induced; D017063:Outcome Assessment, Health Care / Q000379:methods; D010879:Piperazines / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D012074:Remission Induction; D020133:Reverse Transcriptase Polymerase Chain Reaction; D055815:Young Adult
D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate; D016044:Fusion Proteins, bcr-abl
Chronic myeloid leukemia (CML); imatinib; major molecular response (MMR); real time polymerase chain reaction (RQ-PCR); receiver operating characteristic (ROC) curve