Study the Results of combination therapy with Thalidomide - Dexamethasone in Newly Diagnosed patients with Multiple Myeloma.

Kasi Viswanathan, T (2012) Study the Results of combination therapy with Thalidomide - Dexamethasone in Newly Diagnosed patients with Multiple Myeloma. Masters thesis, Christian Medical College, Vellore.


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BACKGROUND : The advent of novel agents (IMiDs-Thalidomide and Lenalidomide and Bortezomib) in the therapy of Multiple Myeloma (MM) has resulted in superior response rates and progression free survival (PFS). As there is only meagre data from India, we retrospectively analyzed the role of Thalidomide-Dexamethasone (TD) as initial therapy in newly diagnosed MM. AIMS AND OBJECTIVES : 1) To retrospectively analyze the response rate, progression free survival (PFS) and overall survival (OS) of newly diagnosed multiple myeloma cases treated with Thalidomide-Dexamethasone (TD) as induction therapy. 2) To analyze impact of Autologous Stem Cell Transplantation (ASCT) and Thalidomide maintenance in prolonging the PFS and OS. METHODOLOGY : All patients newly diagnosed to have MM and initiated on TD as initial therapy in the Department of Haematology, between March 2004 and September 2012 were analyzed. RESULTS : A total of 242 patients with a median age of 54 yrs (range 21 to 80yrs), with a male: female ratio of 2.5 was initiated on TD. At diagnosis anaemia (Hb <10 g/dl) was seen in 59.1%, bone involvement was seen in 57.4%, renal failure (Sr.Creat ≥ 2mg/dl) was seen in 21.1%, hypercalcemia (Corrected Sr.Calcium ≥ 10.5 mg/dl) was seen in 19.8% and plasmacytoma was seen in 23.6%. One patient with past history of MGUS and 5 patients with solitary plasmacytoma had progressed to MM. The proportion of patients according to the Durie Salmon staging (DSS) in the 242 patients was 12.8%, 35.5% and 51.7% for DSS I, II and III respectively. The proportion of patients according to the ISS categorisation of the 209 patients was 25.4%, 32.5% and 42.1% for ISS I, II and III respectively. Median number of cycles of TD was 7 (range-1 to 27) and the median dose of Thalidomide was 200mg OD (range-50mg to 400mg OD). The median dose of Dexamethasone was 40 mg OD (Range: 8 – 40 mg OD). Aspirin was given as DVT prophylaxis in 217 patients and one patient received Sintrom as he had deep vein thrombosis (DVT) at diagnosis. One patient was continued on Clopidogrel, which was initiated after a cerebrovascular event in the past. Seventeen patients were excluded for analysis and considered lost to follow up as they did not have response assessment after initiation of TD. The overall response to TD was 80.4%, with a complete response unconfirmed + complete response (CRu+CR) rate of 8.8%, very good partial response (VGPR) rate of 31.1%, partial response (PR) rate of 40.4% and no response (NR) rate of 19.6%. The median time to respond was 3 months (range: 1-13 months). ASCT was done in 29 patients, 13 patients upfront post TD induction and 16 patients after salvage therapy after relapse/progressive disease. Thalidomide maintenance was initiated post response to TD in for 49 patients. In one hundred and nineteen patients responding to TD did not have any further therapy. The progression free survival (PFS) at 36 months in the ASCT group, Thalidomide maintenance group and no treatment group was 83.3%, 55.1% and 14.7% respectively (p=0.0000). However the overall survival (OS) was not statistically significant among these groups. The 3yr The PFS and OS of the entire cohort of patient was 26.3% and 76.9% respectively. CONCLUSION : In this first large series from India, comprehensively analyzing outcome of patients with newly diagnosed MM treated with TD, the response to treatment was similar to those reported in the literature from other population. ASCT and Thalidomide maintenance therapy significantly improved the PFS.

Item Type: Thesis (Masters)
Uncontrolled Keywords: Multiple Myeloma ; Thalidomide ; Dexamethasone.
Subjects: MEDICAL > Clinical Haematology
Depositing User: Subramani R
Date Deposited: 16 Aug 2017 00:40
Last Modified: 16 Aug 2017 04:04

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