Efficacy of high dose alpha Interferon therapy is well established in the management of chronic myeloid leukaemia (CML) especially in early chronic phase (CP). In this nonrandomised study with five year follow up, we administered moderate doses of Interferon alpha 2b (AI) with concurrent hydroxyurea in 37 patients of CML and compared haematological, molecular responses (bcr-abl) and survival with 92 controls managed with hydroxyurea alone. Of 53 registered patients of CML, four patients with blast crisis were excluded. Forty-nine patients in CP and accelerated phase (AP) had cytoreduction with hydroxyurea till TLC dropped to 10000/ml. Twelve patients who did not receive Interferon for various reasons along with 80 historical controls formed Group 1. Group 2 consisted of thirty seven patients who received AI (6 million units three times a week for two years) along with concurrent hydroxyurea. In group 1, there were 61 males and 31 females with median age of 34.8 years, while group 2 had 28 males and 9 females with median age of 31.4 years. In group 2. 23 patients had early CP. 10 late CP, 04 were in AP, while 5 patients in group 1 had AP. There was no significant difference in clinical & haematological parameters of both groups. Complete haematological responses (CR) were observed in 18 (48.04%). partial (PR) in 17 (45.94%), and no response (NR) in 2 patients (5.42%) in group 2 ; while 20 (21.7%) had CR , 62 (67.4%) had PR and 10 ( 10.9 %) had NR in group 1. Mean time taken to achieve CR was 6.2 months. Molecular responses were complete in 3 (11.1%). major in 4 (14.8%), minor in 8 (29.6%) amongst 27 assessed patients. Median survival for the control group was 43.2 months, with five-year survival of 33 % while it was 67.2 months with five-year survival of 71 % for the interferon group(p0.0002). Interestingly, two patients from group 2 who achieved CR had subsequent progression into extra-myeloid blast crisis (lymph nodes and chloroma).Common side effects experienced were fever, chills (94.5%), anorexia (64.8%), weight loss (45.9%); while uncommon ones were cough (2), bone pains (2), temporary pancytopenia (2), permanent bone marrow hypoplasia (2), acute psychosis ( 1 ) and pleurisy (1). Our results are similar to the published results using high doses of AI and in addition, we observed that benefit accrued to patients with late CP & AP, as in early CP.
|Issue number||11 PART II|
|Publication status||Published - 2000|
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