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
860 - Dose differential modulation of the autophagic behavior of estrogen expressing breast carcinoma cells
Presenter: Mariam Fouad
Session: Poster Display session 1
Resources:
Abstract
2304 - Synthetic peptide of tumor–associated antigen L6 formulated with polymer-based adjuvant enhances anti-tumor effects in mice
Presenter: Shih-jen Liu
Session: Poster Display session 1
Resources:
Abstract
4419 - Improving detection level of somatic mosaicism in neurofibromatosis type 1
Presenter: Kristina Karandasheva
Session: Poster Display session 1
Resources:
Abstract
5283 - Preclinical pharmacokinetic/pharmacodynamic (PK/PD) relationship of ABN401, a highly selective Met inhibitor, in gastric and non-small-cell lung cancer models
Presenter: JooSeok Kim
Session: Poster Display session 1
Resources:
Abstract
5488 - Transcription factors of Snail family in the regulation of resistance of breast cancer cells to hypoxic conditions
Presenter: Alvina Khamidullina
Session: Poster Display session 1
Resources:
Abstract
5417 - Metastasis is impaired by endothelial-specific Dll4 loss-of-function through inhibition of epithelial-to-mesenchymal transition and reduction of cancer stem cells and circulating tumour cells
Presenter: Liliana Mendonça
Session: Poster Display session 1
Resources:
Abstract
5494 - Identification of novel and known FGFR gene fusions in Chinese non-small cell lung cancer
Presenter: Weixin Zhao
Session: Poster Display session 1
Resources:
Abstract
3412 - WNT pathway mutations (APC/CTNNB1) and immune checkpoint inhibitors (ICI) response in metastatic non-small cell lung cancer (NSCLC) patients.
Presenter: Francisco Javier Ros Montana
Session: Poster Display session 1
Resources:
Abstract
1815 - Leukocytosis as a negative prognostic factor in patients with lung cancer: Which subpopulation of leukocytes is responsible?
Presenter: Filip Kohutek
Session: Poster Display session 1
Resources:
Abstract
5022 - Identification of MET gene amplifications using next-generation sequencing in non-small cell lung cancer patients
Presenter: Sergi Clavé
Session: Poster Display session 1
Resources:
Abstract