Abstract 1732
Background
We investigated the safety and efficacy of bendamustine-rituximab (BR) in previously untreated symptomatic and advanced CLL patients, as there is no data available on BR from Indian subcontinent.
Methods
This retrospective study included 120 consecutive treatment naïve patients with CLL without del (17p), who were registered at Department of Medical Oncology, AIIMS between January 2010 and to July 2018. Bendamustine was given at a dose of 90 mg/m2on day 1 and 2, combined with rituximab 375 mg/m2 rituximab on day 1, every 28 days for up to 6 courses. Event free survival (EFS) was defined as date of treatment to date of relapse, disease progression or death due to any cause.
Results
The median age was 57 years (range: 30-75 years). As per clinical Rai stage 30(25%) patients were in stage II, 42(35%) were in stage III and 48(40%)were in stage IV. ZAP-70 was positive (>20%) in 50%, CD 38 was positive (>30%) in 33%, and CD49d was positive (>30%) in 49% of cases. Beta-2 microglobulin (B2M) was elevated (≥3.5 mg/L) in 80% of cases. Fifty five cases (50%, n = 110) were IGHV mutated. The mean number of cycles was 5 (1-6). Overall response rate (ORR) seen with BR was 90% and complete response was 45%. Median event free survival was 24 months with a median follow up period of 29 months. Haemoglobin (<10g/dL), elevated B2 M, unmutated IGHV had statistically significant adverse impact on EFS on univariate analysis but on multivariate analysis only IGHV mutation status was found to had significance on EFS. The median EFS was 27 months in IGVH mutaed vs 18 months in IGHV unmutated-CLL patients (p = 0.001). Grade III/IV neutropenia, thrombocytopenia, anaemia and infections were observed in 12%, 8%, 7.5% and 10% respectively. The most common non -haematological toxicity was skin rash which was observed grade I/II in 24 cases ( 20%) and grade III/IV in 12 cases (10%).
Conclusions
This is the first study of Asia to demonstrate safety and efficacy of BR in symptomatic CLL patients. BR is effective and safe regimen in the first-line treatment of CLL. Unmutaed- CLL patients have inferior EFS than mutated - CLL patients. Skin toxicity was the most common adverse effect seen in our population which was observed in around one third of cases.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5011 - LCSCAF1 maintains cancer stem-like traits by stabilizing c-Myc protein and promotes metastasis and recurrence in lung cancer
Presenter: Tao Guo
Session: Poster Display session 1
Resources:
Abstract
4955 - XAF1 Enhances Temozolomide Induced Autophagic Cell Death through AMPK signaling pathway
Presenter: Mingoo Lee
Session: Poster Display session 1
Resources:
Abstract
5616 - The effect of cortisol on methylation patterns in breast cancer cell lines
Presenter: Haya Intabli
Session: Poster Display session 1
Resources:
Abstract
4649 - Global and sex-specific epigenome-wide association studies for the identification of the main methylated loci related to smoking in a Mediterranean population
Presenter: Judith Begona Ramirez Sabio
Session: Poster Display session 1
Resources:
Abstract
4984 - Whole transcriptomics analyses of mimicking Circulating Tumor Cells (CTCs) by single-cell RNA sequencing (scRNAseq)
Presenter: Jessica Garcia
Session: Poster Display session 1
Resources:
Abstract
5926 - Comparison of enzymatic- and bisulfite conversion to map the plasma cell-free methylome in cancer
Presenter: Nicole Lambert
Session: Poster Display session 1
Resources:
Abstract
5454 - Detection of low mutations in hepatocellular carcinoma by using circulating tumor DNA
Presenter: Esl Kim
Session: Poster Display session 1
Resources:
Abstract
4428 - Variants in the JAK1 and JAK2 genes in the risk and prognosis of patients with cutaneous melanoma
Presenter: Bruna Carvalho
Session: Poster Display session 1
Resources:
Abstract
4409 - P-Rex1 expression in breast cancer patients.
Presenter: Angela Lara Montero
Session: Poster Display session 1
Resources:
Abstract
4185 - Modulation of Risk of Cutaneous Melanoma Patients by Variants in STAT3 Gene and Functional Analysis
Presenter: Gabriela Gomez
Session: Poster Display session 1
Resources:
Abstract