SEROLOGICAL RESPONSES AFTER SARS‐COV‐2 VACCINATION FIRST DOSE IN PATIENTS WITH LYMPHOID MALIGNANCY: FIRST INTERIM ANALYSIS OF THE UK PROSECO STUDY

Abstract Abstract 3428 Poster Board III-316 Introduction Despite the increasing use of fludarabine (F) plus cyclophosphamide (C), and recently rituximab (R)-FC combinations in CLL, chlorambucil (Chl) remains a first-line treatment option, particularly for elderly patients and those with co-morbidities with chronic lymphocytic leukemia (CLL). However, rates of complete response (CR) are relatively low (up to 7%) as are overall responses (approximately 65%) with Chl. In this study we assessed the feasibility of adding R to Chl in order to improve outcomes. Methods Previously untreated patients with CLL who required therapy according to IWCLL criteria received R (day 1; 375 mg/m2 i.v. cycle 1, 500 mg/m2 cycles 2–6) plus Chl (days 1-7; 10mg/m2/day p.o.) repeated every 28 days for 6 cycles. A further 6 cycles of Chl alone was permitted in patients with continuing clinical response at 6 cycles. The primary endpoint was the adverse event (AE) profile. Secondary endpoints included response rates, progression-free and overall survival and assessment of minimal residual disease. Efficacy results from this study were compared with historical data from patients in the UK LRF CLL4 study who received Chl at the same dose but as monotherapy between 1999 and 2004. Each of the 50 patients in the Chl-R trial were matched to 3 patients from the CLL4 trial by Binet Stage (B or C), VH Mutation (mutated or unmutated), 11q FISH (deleted or not) and age. Results This is a planned interim analysis (IA) based on the first 50 patients out of the total 100 patients from 12 centres. Of these 47 patients were evaluable (2 missing bone marrow at time of IA; 1 protocol violation received only 1 cycle). The median age of patients was 70.5 years (range 48–86), 62% were male and 52% had Binet stage C CLL. The most common AEs were gastrointestinal disorders. There were 25 serious AEs (SAEs) reported in 17 patients. The most common SAEs were infections (10 SAEs, in 6 patients). Additionally there were 3 SAEs (in 3 patients) of febrile neutropenia – grade 3 or 4 neutropenia was reported in 40% of patients. Overall response rate on an intent-to-treat analysis was 84%. When compared with the well matched subset of Chl patients from the UK LRF CLL4 study, the overall response rate was 17.3% higher (95% CI 4.7% - 30.0%), indicating that the Chl-R patients have improved responses. Conclusions Based on this planned interim analysis, the addition of R to Chl is a feasible combination with no unexpected AEs. The combination of R and Chl was effective for untreated patients with CLL. It is important to note that the median age of patients in this study was considerably greater than the median age of patients in the UK LRF CLL4 and other large trials in CLL, and more representative of the typical age of patients presenting with CLL in the clinic. The combination of R and Chl was well-tolerated and effective for untreated patients with CLL who cannot tolerate a more intensive regimen, and suggest investigation in a Phase III study is warranted. Disclosures Hillmen: Alexion Pharmaceuticals: Consultancy; F.Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Bayer Schering: Consultancy. Hayward:F.Hoffmann-La Roche Ltd: Former Employee.

Download Full-text

1236. Staphylococcus aureus Surgical Site Infection: Epidemiology in Europe (SALT)

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.1099 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S445-S446

Author(s):

Sibylle Mellinghoff ◽

Caroline Bruns ◽

Markus Albertrsmeier ◽

Matteo Bassetti ◽

Juan P Horcajada ◽

...

Keyword(s):

Cohort Study ◽

Surgical Procedures ◽

Preliminary Data ◽

Surgical Procedure ◽

Interim Analysis ◽

Epidemiological Data ◽

Case Control ◽

Electronic Database ◽

The Uk ◽

Nested Case Control

Abstract Background We conduct a retrospective, multinational cohort study with a nested case–control (NCT03353532). Data from all patients undergoing any surgical procedure in 2016 are collected within the cohort, comprising more than 150,000 procedures. S. aureus SSI cases are documented in an electronic database and matched 1:1 to controls within each center. Criteria for matching include epidemiological data and type of procedure. Participating sites are 14 major surgical centers in France, Germany, Italy, Spain, and the UK. We here present preliminary data from the interim analysis. Methods We conduct a retrospective, multinational cohort study with a nested case–control (NCT03353532). Data from all patients undergoing any surgical procedure in 2016 are collected within the cohort, comprising more than 150,000 procedures. S. aureus SSI cases are documented in an electronic database and matched 1:1 to controls within each center. Criteria for matching include epidemiological data and type of procedure. Participating sites are 14 major surgical centers in France, Germany, Italy, Spain, and the UK. We here present preliminary data from the interim analysis. Results We determine overall and procedure-specific incidence of S. aureus SSI. To date, 619 cases have been documented with a mean age of 59.0 years, 50,7% male and 49.3% female. Chronic cardiovascular disease (23%), diabetes (22%), and solid tumors (18%) are the most frequent comorbidities. Overall length of hospitalization is 19 days. A total of 20% SSI cases were treated at the intensive care unit, 49% were readmitted to the hospital, and 47% patients needed revision surgery. Conclusion The study includes all surgical procedures at participating centers allowing us to determine the incidence for all common surgical procedures aiming to better understand the risk of certain procedures. Furthermore, the study will analyze the risk composition of the surgical patient population to enable the calculation of the number of patients at risk in the overall surgical population in Europe. Predictive factors for S. aureus SSIwill be analyzed and thus allow future investigation into targeted prophylactic strategies such as S. aureus vaccines. Disclosures All authors: No reported disclosures.

Download Full-text

OC-0441: An interim analysis of outcome data from the UK Proton Overseas Programme

Radiotherapy and Oncology ◽

10.1016/s0167-8140(21)00463-1 ◽

2020 ◽

Vol 152 ◽

pp. S243

Author(s):

S. Gaito ◽

N. Burnet ◽

M. Aznar ◽

P. Foden ◽

C. Howell ◽

...

Keyword(s):

Interim Analysis ◽

Outcome Data ◽

The Uk

Download Full-text

Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK

The Lancet ◽

10.1016/s0140-6736(20)32661-1 ◽

2021 ◽

Vol 397 (10269) ◽

pp. 99-111 ◽

Cited By ~ 18

Author(s):

Merryn Voysey ◽

Sue Ann Costa Clemens ◽

Shabir A Madhi ◽

Lily Y Weckx ◽

Pedro M Folegatti ◽

...

Keyword(s):

South Africa ◽

Interim Analysis ◽

Randomised Controlled Trials ◽

Controlled Trials ◽

Safety And Efficacy ◽

Randomised Controlled ◽

The Uk

Download Full-text

Rates of Breast Reconstruction in Women Over 70 Years of Age in the UK: An Interim Analysis of the Age Gap Study

International Journal of Surgery ◽

10.1016/j.ijsu.2017.08.096 ◽

2017 ◽

Vol 47 ◽

pp. S16

Author(s):

M. Coulson ◽

L. Wyld

Keyword(s):

Breast Reconstruction ◽

Interim Analysis ◽

Age Gap ◽

The Uk

Download Full-text

Effect of oxandrolone and timing of pubertal induction on final height in Turner syndrome: final analysis of the UK randomised placebo-controlled trial

Archives of Disease in Childhood ◽

10.1136/archdischild-2019-317695 ◽

2019 ◽

Vol 106 (1) ◽

pp. 74-76

Author(s):

Emma Jane Gault ◽

Tim J Cole ◽

Sarah Casey ◽

Peter C Hindmarsh ◽

Peter Betts ◽

...

Keyword(s):

Growth Hormone ◽

Turner Syndrome ◽

Interim Analysis ◽

Maximum Dose ◽

Controlled Trial ◽

Final Height ◽

Final Analysis ◽

The Uk ◽

Rotation Model

The UK Turner syndrome (TS) study examined the effect on final height of oxandrolone 0.05 mg/kg/day (maximum dose 2.5 mg) versus placebo from 9 years of age; and delaying ethinylestradiol induction of puberty by 2 years from 12 (E12) to 14 (E14) years in growth hormone-treated girls with TS. The study ran from 1999 to 2013. By 2011, eighty-two of 92 participants had reached final height and an interim analysis using the Super-Imposition by Translation And Rotation model showed significant increases in final height with both oxandrolone and E14. The analysis has been repeated now that all 92 patients have reached final height. Oxandrolone still significantly increased final height by 4.1 cm (95% CI 1.6 to 6.6, n=92) compared with 4.6 cm previously. However, the E14 effect was no longer significant at 2.7 cm (95% CI −0.8 to 6.1, n=56) compared with 3.8 cm previously.

Download Full-text