Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL.

Howard, D R and Munir, T and McParland, L and Rawstron, A C and Milligan, D and Schuh, A and Hockaday, A and Allsup, D J and Marshall, S and Duncombe, A S and O'Dwyer, J L and Smith, A F and Longo, R and Varghese, A and Hillmen, P (2017) Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL. Leukemia, 31 (11). pp. 2416-2425. ISSN 1476-5551. This article is available to all HEFT staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their HEFT Athens login IDs

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Official URL: https://www.nature.com/articles/leu201796

Abstract

ARCTIC was a multicenter, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated chronic lymphocytic leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cyclophosphamide and rituximab (FCR). The trial hypothesized that including mitoxantrone with low-dose rituximab (FCM-miniR) would be non-inferior to FCR. A total of 200 patients were recruited to assess the primary end point of complete remission (CR) rates according to IWCLL criteria. Secondary end points were progression-free survival (PFS), overall survival (OS), overall response rate, minimal residual disease (MRD) negativity, safety and cost-effectiveness. The trial closed following a pre-planned interim analysis. At final analysis, CR rates were 76 FCR vs 55% FCM-miniR (adjusted odds ratio: 0.37; 95% confidence interval: 0.19-0.73). MRD-negativity rates were 54 FCR vs 44% FCM-miniR. More participants experienced serious adverse reactions with FCM-miniR (49%) compared to FCR (41%). There are no significant differences between the treatment groups for PFS and OS. FCM-miniR is not expected to be cost-effective over a lifetime horizon. In summary, FCM-miniR is less well tolerated than FCR with an inferior response and MRD-negativity rate and increased toxicity, and will not be taken forward into a confirmatory trial. The trial demonstrated that oral FCR yields high response rates compared to historical series with intravenous chemotherapy.

Item Type: Article
Additional Information: This article is available to all HEFT staff and students via ASK Discovery tool http://tinyurl.com/z795c8c by using their HEFT Athens login IDs
Subjects: WH Haemic and lymphatic systems. Haematology
Divisions: Planned IP Care > Oncology and Clinical Haematology
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Depositing User: Mrs Semanti Chakraborty
Date Deposited: 17 Apr 2018 15:46
Last Modified: 17 Apr 2018 15:46
URI: http://www.repository.heartofengland.nhs.uk/id/eprint/1569

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