A PROSPECTIVE COMPARATIVE STUDY OF SAFETY OF LENALIDOMIDE PLUS DEXAMETHASONE COMBINATION THERAPY VERSUS VAD (VINCRISTINE, DOXORUBICIN AND DEXAMETHASONE) REGIMEN IN THE TREATMENT OF MULTIPLE MYELOMAAbstract
Background: Lenalidomide plus Dexamethasone (Len-Dex) and VAD (Vincristine, Doxorubicin and Dexamethasone) regimen are the two common drug therapies involved in the treatment of Multiple myeloma. These two groups of drugs act by different mechanisms and their safety profile also varies. Objectives: To compare the safety of Len-Dex versus VAD regimen based on World Health Organization toxicity criteria by grade as well as the performance status of the patients of both the regimen by using Karnofsky performance status scale definitions rating. Materials and Methods: Eighty patients (forty in each arm) of newly diagnosed cases of multiple myeloma, who were willing to give the informed consent, were included in the study. Their baseline investigations and follow up investigations were collected at regular intervals, based on these values, the adverse effect profile as well as the performance status were evaluated and the results were compared and analyzed. Results: In Len-Dex regimen, constipation, leucopenia, thrombocytopenia, slow wound healing, sedation, renal toxicity and hepatotoxicity were high. VAD regimen produce higher incidence of nausea, vomiting, diarrhoea, anaemia and peripheral neuropathy. The study indicates that patients moved to higher scores with 14 (35%) patients on VAD regimen and 17 (42.5%) patients on Len-Dex achieving 90% with respect to the performance status. There was statistically significant (p = 0.023) performance status of patients after treatment with Len-Dex regimen. Conclusion: The tolerability as well as the overall performance status of patients of Lenalidomide-Dexamethasone (Len-Dex) combination therapy is clearly higher than that of VAD regimen among the study population.
S. Remya, M. J. Sudha*, R. B. Nair and K. L. Jayakumar
Department of Pharmacology, Azeezia Institute of Medical Sciences, Kollam, Kerala, India.
23 February, 2017
28 April, 2017
27 October, 2017
01 November, 2017