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Observational Study
. 2021 Jul;194(1):69-77.
doi: 10.1111/bjh.17475. Epub 2021 Jun 14.

A retrospective observational study to evaluate the clinical outcomes and routine management of patients with chronic lymphocytic leukaemia treated with idelalisib and rituximab in the UK and Ireland (RETRO-idel)

Toby A Eyre  1 , Gavin Preston  2 , Huseini Kagdi  3 , Amin Islam  4 , Toby Nicholson  5 , Harry W Smith  6 , Adam P Cursley  7 , Heribert Ramroth  8 , Guan Xing  9 , Lin Gu  10 , Nishanthan Rajakumaraswamy  11 , Christopher Fegan  12
Affiliations
Observational Study

A retrospective observational study to evaluate the clinical outcomes and routine management of patients with chronic lymphocytic leukaemia treated with idelalisib and rituximab in the UK and Ireland (RETRO-idel)

Toby A Eyre et al. Br J Haematol. 2021 Jul.

Abstract

Idelalisib (IDL) is an oral first-in-class phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for chronic lymphocytic leukaemia (CLL) alongside rituximab (R) since 2014. However, little data exist on routine practice. The RETRO-idel was a protocol-led, retrospective study of 110 patients [n = 27 front-line (1L)] who received IDL-R. The primary end-point was clinical overall response rate (ORR). The median (range) follow-up of the whole cohort was 30·2 (0·1-51·9) months. The median (range) age was 72 (48-89) years. Tumour protein p53-disruption was common [100% 1L, 32·5% relapsed/refractory (R/R)]. The best ORR (intention-to-treat) was 88·2% (1L 96·3%, R/R 85·5%). Overall, the median event-free survival (mEFS) was 20·3 months and time-to-next treatment was 29·2 months. The mEFS for 1L patients was 18·7 months and R/R patients was 21·7 months. The 3-year overall survival was 56·1% (95% confidence interval 45·7-65·3). IDL was discontinued in 87·3% (n = 96). More patients discontinued due to adverse events in the front-line setting (1L 63·0% vs. R/R 44·6%) and due to progressive disease in R/R patients (20·5% vs. 3·7% in 1L). Lower respiratory tract infection/pneumonia were reported in 34·5% (Grade ≥3, 19·1%), diarrhoea in 30·9% (Grade ≥3, 6·4%), and colitis in 9·1% (Grade ≥3, 5·5%). Overall, these data describe clear efficacy for IDL-R in routine practice. No new safety signals were identified, although careful management of known toxicities is required.

Keywords: B-cell receptor inhibitor; PI3K; chronic lymphocytic leukaemia; idelalisib; retrospective.

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Conflict of interest statement

Toby A. Eyre: Gilead: Consultancy, Research Support, Honoraria; Loxo: Consultancy, Beigene: Consultancy, Research Support, AstraZeneca: Honoraria, Consultancy, Research Support Roche: Honoraria; Abbvie: Honoraria, Conference Sponsorship; Janssen: Honoraria, Conference Sponsorship; Takeda: Conference Sponsorship. Gavin Preston: None. Huseini Kagdi: None. Amin Islam: Gilead; Honoraria, Conference Sponsorship. Toby Nicholson: Pfizer; Conference Sponsorship; Takeda; Conference Sponsorship. Harry W. Smith: Gilead: Employee. Adam P. Cursley: Gilead: Employee. Heribert Ramroth: Gilead: Employee. Guan Xing: Gilead: Employee. Lin Gu: Gilead: Employee. Nishanthan Rajakumaraswamy: Gilead: Employee. Christopher Fegan: Gilead: Honoraria; Roche: Honoraria; Janssen: Honoraria; Abbvie: Consultancy, Conference Sponsorship.

Figures

Fig 1
Fig 1
Secondary survival outcomes. (A) Kaplan–Meier curve of event‐free survival (EFS), in months (full analysis set). (B) Kaplan–Meier curve of overall survival (OS), in months (full analysis set). [Colour figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

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References

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