Safety and efficacy of an indigenous recombinant interferon-alpha-2b in patients with chronic myelogenous leukaemia: results of a multicentre trial from India.

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dc.contributor.authorKumar, Laliten_US
dc.contributor.authorGangadharan, V Pen_US
dc.contributor.authorRao, D Raghunadhaen_US
dc.contributor.authorSaikia, Tapanen_US
dc.contributor.authorShah, Sandipen_US
dc.contributor.authorMalhotra, Hemanten_US
dc.contributor.authorBapsy, P Pen_US
dc.contributor.authorSingh, Kavitaen_US
dc.contributor.authorRao, Ramanen_US
dc.date.accessioned2005-03-29en_US
dc.date.accessioned2009-06-03T06:39:49Z
dc.date.available2005-03-29en_US
dc.date.available2009-06-03T06:39:49Z
dc.date.issued2005-03-29en_US
dc.description.abstractBACKGROUND: Compared to hydroxyurea, treatment with interferon-alpha (IFN-alpha) is known to prolong survival in patients with chronic phase of chronic myelogenous leukaemia (CML) and was considered as first-line therapy till recently. We conducted a multicentre trial using an indigenous recombinant IFN-alpha-2b to evaluate its efficacy and toxicity in chronic phase CML. METHODS: Between September 2000 and August 2001, patients with chronic phase CML were recruited within 8 weeks of diagnosis at 7 centres in India. The study was approved by the Ethics Committee of each participating Institute and Informed, written consent was obtained from all patients. All patients were given the study drug in a dose of 5 million units daily subcutaneously. Response and survival analyses were done with intent-to-treat analysis. RESULTS: One hundred and fourteen patients (75 men and 39 women) were included in the study. Their ages ranged from 18 to 62 years (median 37 years). Fifty-seven per cent of patients had a haematological response; complete response in 31.6% and partial response in 25.4%. The median time to achieve complete haematological response was 6 months (range 3-12 months). Cytogenetic response was seen in 39.4% of patients; complete in 1.8%, partial in 28% and minimal in 9.6%. The median time to achieve partial and complete cytogenetic response was 6 and 12 months, respectively. Nineteen patients had progression (blast crisis n=15, accelerated phase n=4) while on treatment. Two patients refused further treatment after the initial 4 weeks due to IFN-a toxicity, mainly bone pains and fever. The major toxic effects of treatment were fever (78%), fatigue (25.4%) and myalgia (52%). No patient died of toxicity. Currently, 95 patients are alive, 91 in the chronic phase and 4 in the accelerated phase. Four patients were lost to follow up and all 15 patients with blast crisis died of progressive disease at a median Interval of 6.5 months (range 1-15 months). The Kaplan-Meier probability of survival at 36 months was 76%. CONCLUSION: This study confirms the efficacy of the indigenous recombinant IFN-alpha-2b in chronic phase CML. The drug has a toxicity profile similar to that of other preparations.en_US
dc.description.affiliationDepartment of Medical Oncology, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110029, India. lalitaiims@yahoo.comen_US
dc.identifier.citationKumar L, Gangadharan VP, Rao DR, Saikia T, Shah S, Malhotra H, Bapsy PP, Singh K, Rao R. Safety and efficacy of an indigenous recombinant interferon-alpha-2b in patients with chronic myelogenous leukaemia: results of a multicentre trial from India. National Medical Journal of India. 2005 Mar-Apr; 18(2): 66-70en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/119196
dc.language.isoengen_US
dc.source.urihttps://www.nmji.inen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAntineoplastic Agents --administration & dosageen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshInterferon Alfa-2b --administration & dosageen_US
dc.subject.meshLeukemia, Myeloid, Acute --drug therapyen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshPichiaen_US
dc.titleSafety and efficacy of an indigenous recombinant interferon-alpha-2b in patients with chronic myelogenous leukaemia: results of a multicentre trial from India.en_US
dc.typeClinical Trialen_US
dc.typeClinical Trial, Phase IIen_US
dc.typeJournal Articleen_US
dc.typeMulticenter Studyen_US
dc.typeResearch Support, Non-U.S. Gov'ten_US
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