Response at three months is a good predictive factor for newly diagnosed chronic myeloid leukemia patients treated by recombinant interferon-α

• Published in: Blood 1998-12, Vol.92 (11), p.4059-4065
• Main Authors: MAHON, F. X, FABERES, C, PIGNEUX, A, BERNARD, P, REIFFERS, J, PUEYO, S, CONY-MAKHOUL, P, SALMI, R, BOIRON, J. M, MARIT, G, BILHOU-NABERA, C, CARRERE, A, MONTASTRUC, M
• Format: Article
• Language: English
• Subjects: Administration, Cutaneous; Adolescent; Adult; Aged; Antineoplastic agents; Biological and medical sciences; Child; Female; Humans; Immunotherapy; Interferon Type I - administration & dosage; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - physiopathology; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Predictive Value of Tests; Prognosis; Recombinant Proteins; Survival Analysis; Time Factors
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.v92.11.4059

In a single institution, we have used recombinant interferon- (IFN-) to treat 116 newly diagnosed Philadelphia-positive (Ph+) chronic myeloid leukemia (CML) patients and analyzed the predictive factors for response and survival. The patients whose median age was 50.3 years (range, 9 to 70) were administered IFN- (5 million units/m2/d) subcutaneously. The IFN- dose was subsequently adjusted to maintain the white blood cell and platelet counts between 1.5 and 5 x 10(9)/L, 50 and 100 x 10(9)/L, respectively. At diagnosis, the Sokal score was used to classify the patients into three groups: low (n = 57), intermediate (n = 42), and high risk (n = 16). A complete hematological response (CHR) was achieved in 93 cases (80.2%). Of the 116 patients, 113 were available for cytogenetic evaluation. Fifty patients (43%) achieved a major cytogenetic response (MCR) (=65% marrow Ph- cells), 37 of them having a complete cytogenetic response (CCR). The estimated 5-year survival of the 116 patients was 68% +/- 11% (95% confidence interval [CI]) with a median follow-up of 42 months (range, 3 to 114) and 85% +/- 11% (95% CI) with a median follow-up of 30.9 (range, 3 to 111) when patients were censored at the time of transplantation. Event-free survival at 5 years (adding death and transplant as event) was 46% +/- 11% (95% CI). Using proportional hazards regression to study time-dependent variables, we confirmed that the most significant factor associated with survival was the cytogenetic response (MCR or CCR) (P