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  1. AU="Soulis, Eileen"
  2. AU="Mark A. Schlautman"
  3. AU="Tang, Mitchell" AU="Tang, Mitchell"
  4. AU="Zu, Lingling"
  5. AU=Mac Donald Christine L.
  6. AU="Navascues, Carmen Alvarez"
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  1. Article ; Online: Central Venous Access Devices for the Delivery of Systemic Anticancer Therapy: An Economic Evaluation.

    Heggie, Robert / Jaiswal, Nishant / McCartney, Elaine / Moss, Jon / Menne, Tobias / Jones, Brian / Boyd, Kathleen / Soulis, Eileen / Hawkins, Neil / Wu, Olivia

    Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

    2023  Volume 27, Issue 1, Page(s) 7–14

    Abstract: Objectives: Patients undergoing long-term anticancer therapy typically require one of 3 venous access devices: Hickman-type device (HICK), peripherally inserted central catheter (PICC), or implantable chest wall port (PORT). Recent evidence has shown ... ...

    Abstract Objectives: Patients undergoing long-term anticancer therapy typically require one of 3 venous access devices: Hickman-type device (HICK), peripherally inserted central catheter (PICC), or implantable chest wall port (PORT). Recent evidence has shown PORT is safer and improves patient satisfaction. However, PORT did not show improvement in quality-adjusted life-years and was more expensive. Decisions regarding cost-effectiveness in the United Kingdom are typically informed by a cost-per-quality-adjusted life-year metric. However, this approach is limited in its ability to capture the full range of relevant outcomes, especially in the context of medical devices. This study assessed the potential cost-effectiveness of HICK, PICC, and PORT in routine clinical practice.
    Methods: This is a cost-consequence analysis to determine the trade-offs between the following outcomes: complication, infection, noninfection, chemotherapy interruption, unplanned device removals, health utilities, device insertion cost, follow-up cost, and total cost, using data from the Cancer and Venous Access clinical trial. We conducted value of implementation analysis of a PORT service.
    Results: PORT was superior in terms of overall complication rate compared with both HICK (incidence rate ratio 0.422; 95% CI 0.286-0.622) and PICC (incidence rate ratio 0.295; 95% CI 0.189-0.458) and less likely to lead to an unplanned device removal. There was no difference in chemotherapy interruption or health utilities. Total cost with device in situ was lower on PORT than HICK (-£98.86; 95% CI -189.20 to -8.53) and comparable with PICC -£48.57 (95% CI -164.99 to 67.86). Value of implementation analysis found that PORT was likely to be considered cost-effective within the National Health Service.
    Conclusion: Decision makers should consider including PORT within the suite of venous access devices available within in the National Health Service.
    MeSH term(s) Humans ; Catheterization, Central Venous/adverse effects ; Cost-Benefit Analysis ; State Medicine ; Neoplasms/drug therapy ; Neoplasms/etiology ; Catheterization, Peripheral/adverse effects
    Language English
    Publishing date 2023-10-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1471745-1
    ISSN 1524-4733 ; 1098-3015
    ISSN (online) 1524-4733
    ISSN 1098-3015
    DOI 10.1016/j.jval.2023.09.2996
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Venous access devices for the delivery of long-term chemotherapy: the CAVA three-arm RCT.

    Wu, Olivia / McCartney, Elaine / Heggie, Robert / Germeni, Evi / Paul, James / Soulis, Eileen / Dillon, Susan / Ryan, Caoimhe / Sim, Moira / Dixon-Hughes, Judith / Agarwal, Roshan / Bodenham, Andrew / Menne, Tobias / Jones, Brian / Moss, Jonathan

    Health technology assessment (Winchester, England)

    2021  Volume 25, Issue 47, Page(s) 1–126

    Abstract: Background: Venous access devices are used for patients receiving long-term chemotherapy. These include centrally inserted tunnelled catheters or Hickman-type devices (Hickman), peripherally inserted central catheters (PICCs) and centrally inserted ... ...

    Abstract Background: Venous access devices are used for patients receiving long-term chemotherapy. These include centrally inserted tunnelled catheters or Hickman-type devices (Hickman), peripherally inserted central catheters (PICCs) and centrally inserted totally implantable venous access devices (PORTs).
    Objectives: To evaluate the clinical effectiveness, safety, cost-effectiveness and acceptability of these devices for the central delivery of chemotherapy.
    Design: An open, multicentre, randomised controlled trial to inform three comparisons: (1) peripherally inserted central catheters versus Hickman, (2) PORTs versus Hickman and (3) PORTs versus peripherally inserted central catheters. Pre-trial and post-trial qualitative research and economic evaluation were also conducted.
    Setting: This took place in 18 UK oncology centres.
    Participants: Adult patients (aged ≥ 18 years) receiving chemotherapy (≥ 12 weeks) for either a solid or a haematological malignancy were randomised via minimisation.
    Interventions: Hickman, peripherally inserted central catheters and PORTs.
    Primary outcome: A composite of infection (laboratory confirmed, suspected catheter related and exit site infection), mechanical failure, venous thrombosis, pulmonary embolism, inability to aspirate blood and other complications in the intention-to-treat population.
    Results: Overall, 1061 participants were recruited to inform three comparisons. First, for the comparison of peripherally inserted central catheters (
    Conclusions: In the delivery of long-term chemotherapy, peripherally inserted central catheters should be considered a cost-effective option when compared with Hickman. There were significant clinical benefits when comparing PORTs with Hickman and with peripherally inserted central catheters. The health economic benefits were less clear from the perspective of incremental cost per quality-adjusted life-years gained. However, dependent on the willingness to pay, PORTs may be considered to be cost-effective from the perspective of complications averted.
    Future work: The deliverability of a PORTs service merits further study to understand the barriers to and methods of improving the service.
    Trial registration: This trial is registered as ISRCTN44504648.
    Funding: This project was funded by the National Institute for Health Research (NHIR) Health Technology Assessment programme and will be published in full in
    MeSH term(s) Adult ; Catheterization, Peripheral/adverse effects ; Central Venous Catheters/adverse effects ; Cost-Benefit Analysis ; Humans ; Quality-Adjusted Life Years ; Technology Assessment, Biomedical
    Language English
    Publishing date 2021-07-27
    Publishing country England
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 2006765-3
    ISSN 2046-4924 ; 1366-5278
    ISSN (online) 2046-4924
    ISSN 1366-5278
    DOI 10.3310/hta25470
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Central venous access devices for the delivery of systemic anticancer therapy (CAVA): a randomised controlled trial.

    Moss, Jonathan G / Wu, Olivia / Bodenham, Andrew R / Agarwal, Roshan / Menne, Tobias F / Jones, Brian L / Heggie, Robert / Hill, Steve / Dixon-Hughes, Judith / Soulis, Eileen / Germeni, Evi / Dillon, Susan / McCartney, Elaine

    Lancet (London, England)

    2021  Volume 398, Issue 10298, Page(s) 403–415

    Abstract: Background: Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication ... ...

    Abstract Background: Hickman-type tunnelled catheters (Hickman), peripherally inserted central catheters (PICCs), and totally implanted ports (PORTs) are used to deliver systemic anticancer treatment (SACT) via a central vein. We aimed to compare complication rates and costs of the three devices to establish acceptability, clinical effectiveness, and cost-effectiveness of the devices for patients receiving SACT.
    Methods: We did an open-label, multicentre, randomised controlled trial (Cancer and Venous Access [CAVA]) of three central venous access devices: PICCs versus Hickman (non-inferiority; 10% margin); PORTs versus Hickman (superiority; 15% margin); and PORTs versus PICCs (superiority; 15% margin). Adults (aged ≥18 years) receiving SACT (≥12 weeks) for solid or haematological malignancy from 18 oncology units in the UK were included. Four randomisation options were available: Hickman versus PICCs versus PORTs (2:2:1), PICCs versus Hickman (1:1), PORTs versus Hickman (1:1), and PORTs versus PICCs (1:1). Randomisation was done using a minimisation algorithm stratifying by centre, body-mass index, type of cancer, device history, and treatment mode. The primary outcome was complication rate (composite of infection, venous thrombosis, pulmonary embolus, inability to aspirate blood, mechanical failure, and other) assessed until device removal, withdrawal from study, or 1-year follow-up. This study is registered with ISRCTN, ISRCTN44504648.
    Findings: Between Nov 8, 2013, and Feb 28, 2018, of 2714 individuals screened for eligibility, 1061 were enrolled and randomly assigned, contributing to the relevant comparison or comparisons (PICC vs Hickman n=424, 212 [50%] on PICC and 212 [50%] on Hickman; PORT vs Hickman n=556, 253 [46%] on PORT and 303 [54%] on Hickman; and PORT vs PICC n=346, 147 [42%] on PORT and 199 [58%] on PICC). Similar complication rates were observed for PICCs (110 [52%] of 212) and Hickman (103 [49%] of 212). Although the observed difference was less than 10%, non-inferiority of PICCs was not confirmed (odds ratio [OR] 1·15 [95% CI 0·78-1·71]) potentially due to inadequate power. PORTs were superior to Hickman with a complication rate of 29% (73 of 253) versus 43% (131 of 303; OR 0·54 [95% CI 0·37-0·77]). PORTs were superior to PICCs with a complication rate of 32% (47 of 147) versus 47% (93 of 199; OR 0·52 [0·33-0·83]).
    Interpretation: For most patients receiving SACT, PORTs are more effective and safer than both Hickman and PICCs. Our findings suggest that most patients receiving SACT for solid tumours should receive a PORT within the UK National Health Service.
    Funding: UK National Institute for Health Research Health Technology Assessment Programme.
    MeSH term(s) Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/therapeutic use ; Catheter-Related Infections/etiology ; Catheterization, Peripheral/adverse effects ; Catheters, Indwelling/adverse effects ; Catheters, Indwelling/economics ; Central Venous Catheters/adverse effects ; Central Venous Catheters/economics ; Cost-Benefit Analysis ; Female ; Humans ; Male ; Middle Aged ; Neoplasms/drug therapy ; Vascular Access Devices/economics ; Young Adult
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2021-07-21
    Publishing country England
    Document type Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(21)00766-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: ATLANTIS: a randomised multi-arm phase II biomarker-directed umbrella screening trial of maintenance targeted therapy after chemotherapy in patients with advanced or metastatic urothelial cancer.

    Fulton, Ben / Jones, Robert / Powles, Thomas / Crabb, Simon / Paul, James / Birtle, Alison / Chowdhury, Simon / Hussain, Syed / Morris, Anna / Soulis, Eileen / Morrison, Paula

    Trials

    2020  Volume 21, Issue 1, Page(s) 344

    Abstract: Background: Metastatic urothelial cancer (UC) is the eighth most common cause of cancer death in the UK. Standard first-line treatment, for most patients, is cytotoxic chemotherapy. Although UC is initially sensitive to chemotherapy, relapse is almost ... ...

    Abstract Background: Metastatic urothelial cancer (UC) is the eighth most common cause of cancer death in the UK. Standard first-line treatment, for most patients, is cytotoxic chemotherapy. Although UC is initially sensitive to chemotherapy, relapse is almost inevitable and outcomes are poor; median overall survival is 8 months. Therefore, there is an urgent need for novel therapies to improve outcomes for this patient group.
    Methods: ATLANTIS is a randomised phase II umbrella-design screening trial of maintenance therapy in biomarker-defined subgroups of patients with advanced UC. The primary end point is progression-free survival, and the study involves over 30 UK cancer centres.
    Discussion: ATLANTIS is the first study in the UK to employ a precision-medicine approach to patients with UC for maintenance treatment. Agents with a positive efficacy signal will proceed to randomised phase III trials to confirm the activity of novel, biologically stratified therapies in UC.
    Registration: ATLANTIS trial EudraCT number 2015-003249-25. ISRCTN25859465.
    MeSH term(s) Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/pharmacology ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Biomarkers, Tumor/antagonists & inhibitors ; Biomarkers, Tumor/metabolism ; Carcinoma, Transitional Cell/drug therapy ; Carcinoma, Transitional Cell/epidemiology ; Carcinoma, Transitional Cell/metabolism ; Carcinoma, Transitional Cell/pathology ; Humans ; Mass Screening/methods ; Molecular Targeted Therapy/methods ; Multicenter Studies as Topic ; Neoplasm Metastasis/drug therapy ; Precision Medicine/methods ; Progression-Free Survival ; Randomized Controlled Trials as Topic ; United Kingdom/epidemiology ; Urologic Neoplasms/drug therapy ; Urologic Neoplasms/epidemiology ; Urologic Neoplasms/metabolism ; Urologic Neoplasms/pathology
    Chemical Substances Antineoplastic Agents ; Biomarkers, Tumor
    Language English
    Publishing date 2020-04-19
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-020-04283-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: A Randomized, Double-Blind, Biomarker-Selected, Phase II Clinical Trial of Maintenance Poly ADP-Ribose Polymerase Inhibition With Rucaparib Following Chemotherapy for Metastatic Urothelial Carcinoma.

    Crabb, Simon J / Hussain, Syed / Soulis, Eileen / Hinsley, Samantha / Dempsey, Laura / Trevethan, Avril / Song, YeePei / Barber, Jim / Frew, John / Gale, Joanna / Faust, Guy / Brock, Susannah / McGovern, Ursula / Parikh, Omi / Enting, Deborah / Sundar, Santhanam / Ratnayake, Gihan / Lees, Kathryn / Birtle, Alison J /
    Powles, Thomas / Jones, Robert J

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2022  Volume 41, Issue 1, Page(s) 54–64

    Abstract: Purpose: A DNA repair deficiency (DRD) phenotype exists within a subset of metastatic urothelial carcinomas (mUC) predicting benefit from platinum-based chemotherapy. We tested switch maintenance therapy with the poly ADP-ribose polymerase inhibitor ... ...

    Abstract Purpose: A DNA repair deficiency (DRD) phenotype exists within a subset of metastatic urothelial carcinomas (mUC) predicting benefit from platinum-based chemotherapy. We tested switch maintenance therapy with the poly ADP-ribose polymerase inhibitor rucaparib, following chemotherapy, for DRD biomarker-positive mUC.
    Methods: DRD biomarker-positive mUC patients, within 10 weeks of chemotherapy, and without cancer progression, were randomly assigned (1:1) to maintenance rucaparib 600 mg twice a day orally, or placebo, until disease progression. The primary end point was progression-free survival (PFS). Statistical analysis targeted a hazard ratio of 0.5 with a 20% one-sided α for this signal-seeking trial. PFS (RECIST 1.1) was compared between trial arms, by intention to treat, within a Cox model.
    Results: Out of 248 patients, 74 (29.8%) were DRD biomarker-positive and 40 were randomly assigned. A total of 12 (60%) and 20 (100%) PFS events occurred in the rucaparib and placebo arms, respectively (median follow-up was 94.6 weeks in those still alive). Median PFS was 35.3 weeks (80% CI, 11.7 to 35.6) with rucaparib and 15.1 weeks (80% CI, 11.9 to 22.6) with placebo (hazard ratio, 0.53; 80% CI, 0.30 to 0.92; one-sided
    Conclusion: Maintenance rucaparib, following platinum-based chemotherapy, extended PFS in DRD biomarker-selected patients with mUC and was tolerable. Further investigation of poly ADP-ribose polymerase inhibition in selected patients with mUC is warranted.
    MeSH term(s) Female ; Humans ; Ovarian Neoplasms/drug therapy ; Poly(ADP-ribose) Polymerases/therapeutic use ; Carcinoma, Transitional Cell/drug therapy ; Urinary Bladder Neoplasms/drug therapy ; Platinum/therapeutic use ; Biomarkers ; Adenosine Diphosphate Ribose/therapeutic use ; Double-Blind Method ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Maintenance Chemotherapy
    Chemical Substances rucaparib (8237F3U7EH) ; Poly(ADP-ribose) Polymerases (EC 2.4.2.30) ; Platinum (49DFR088MY) ; Biomarkers ; Adenosine Diphosphate Ribose (20762-30-5)
    Language English
    Publishing date 2022-08-12
    Publishing country United States
    Document type Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.22.00405
    Database MEDical Literature Analysis and Retrieval System OnLINE

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