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  • 1
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    Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy (ePIPAC) with oxaliplatin as a palliative monotherapy for isolated unresectable colorectal peritoneal metastases: protocol of a Dutch, multicentre, open-label, single-arm, phase II study (CRC-PIPAC)
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 7 ( 2019-07), p. e030408-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 7 ( 2019-07), p. e030408-
    Abstract: Repetitive electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) is offered as a palliative treatment option for patients with isolated unresectable colorectal peritoneal metastases (PM) in several centres worldwide. However, little is known about its feasibility, safety, tolerability, efficacy, costs and pharmacokinetics in this setting. This study aims to explore these parameters in patients with isolated unresectable colorectal PM who receive repetitive ePIPAC-OX as a palliative monotherapy. Methods and analysis This multicentre, open-label, single-arm, phase II study is performed in two Dutch tertiary referral hospitals for the surgical treatment of colorectal PM. Eligible patients are adults who have histologically or cytologically proven isolated unresectable PM of a colorectal or appendiceal carcinoma, a good performance status, adequate organ functions and no symptoms of gastrointestinal obstruction. Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled ePIPAC-OX (92 mg/m 2 body surface area (BSA)) with intravenous leucovorin (20 mg/m 2 BSA) and bolus 5-fluorouracil (400 mg/m 2 BSA) every 6 weeks. Four weeks after each procedure, patients undergo clinical, radiological and biochemical evaluation. ePIPAC-OX is repeated until disease progression, after which standard palliative treatment is (re)considered. The primary outcome is the number of patients with major toxicity (grade ≥3 according to the Common Terminology Criteria for Adverse Events v4.0) up to 4 weeks after the last ePIPAC-OX. Secondary outcomes are the environmental safety of ePIPAC-OX, procedure-related characteristics, minor toxicity, postoperative complications, hospital stay, readmissions, quality of life, costs, pharmacokinetics of oxaliplatin, progression-free survival, overall survival, and the radiological, histopathological, cytological, biochemical and macroscopic tumour response. Ethics and dissemination This study is approved by an ethics committee, the Dutch competent authority and the institutional review boards of both study centres. Results are intended for publication in peer-reviewed medical journals and for presentation to patients, healthcare professionals and other stakeholders. Trial registration number NCT03246321 , Pre-results; ISRCTN89947480 , Pre-results; NTR6603, Pre-results; EudraCT: 2017-000927-29, Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-030408
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2599832-8
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  • 2
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    Phenotypes and genetic architecture of focal primary torsion dystonia
    BMJ ; 2012
    In:  Journal of Neurology, Neurosurgery & Psychiatry Vol. 83, No. 10 ( 2012-10), p. 1006-1011
    Details
    In: Journal of Neurology, Neurosurgery & Psychiatry, BMJ, Vol. 83, No. 10 ( 2012-10), p. 1006-1011
    Type of Medium: Online Resource
    ISSN: 0022-3050 , 1468-330X
    URL: Article
    DOI: 10.1136/jnnp-2012-302729
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2012
    detail.hit.zdb_id: 1480429-3
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  • 3
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    Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin: protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial
    BMJ ; 2019
    In:  BMJ Open Vol. 9, No. 12 ( 2019-12), p. e034508-
    Details
    In: BMJ Open, BMJ, Vol. 9, No. 12 ( 2019-12), p. e034508-
    Abstract: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) has become standard of care for patients with peritoneal metastases of colorectal origin with a low/moderate abdominal disease load. In case of a peritoneal cancer index (PCI) score 〉 20, CRS-HIPEC is not considered to be beneficial. Patients with a PCI 〉 20 are currently offered palliative systemic chemotherapy. Previous studies have shown that systemic chemotherapy is less effective against peritoneal metastases than it is against haematogenous spread of colorectal cancer. It is suggested that patients with peritoneal metastases may benefit from the addition of intraperitoneal chemotherapy to systemic chemotherapy. Aim of this study is to establish the maximum tolerated dose of intraperitoneal irinotecan, added to standard of care systemic therapy for colorectal cancer. Secondary endpoints are to determine the safety and feasibility of this treatment and to establish the pharmacokinetic profile of intraperitoneally administered irinotecan. Methods and analysis This phase I, ‘3+3’ dose-escalation, study is performed in two Dutch tertiary referral centres. The study population consists of adult patients with extensive peritoneal metastases of colorectal origin who have a good performance status and no extra-abdominal metastases. According to standard work-up for CRS-HIPEC, patients will undergo a diagnostic laparoscopy to score the PCI. In case of a PCI 〉 20, a peritoneal access port will be placed in the abdomen of the patient. Through this port we will administer intraperitoneal irinotecan, in combination with standard systemic treatment consisting of 5-fluorouracil/leucovorin with oxaliplatin and the targeted agent bevacizumab. Therapy consists of a maximum of 12 cycles 2-weekly. Ethics and dissemination This study protocol is approved by a research medical ethics committee (Rotterdam, Netherlands) and the Dutch Competent Authority (CCMO, The Hague, Netherlands). The results of this trial will be submitted for publication in a peer-reviewed scientific journal. Trail registration number NL6988 and NL2018-000479-33; Pre-results.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2019-034508
    Language: English
    Publisher: BMJ
    Publication Date: 2019
    detail.hit.zdb_id: 2599832-8
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  • 4
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    First-line palliative systemic therapy alternated with electrostatic pressurised intraperitoneal aerosol chemotherapy (oxaliplatin) for isolated unresectable colorectal peritoneal metastases: protocol of a multicentre, single-arm, phase II study (CRC-PIPAC-II)
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 3 ( 2021-03), p. e044811-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 3 ( 2021-03), p. e044811-
    Abstract: Despite its increasing use, first-line palliative systemic therapy alternated with electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX), hereinafter referred to as first-line bidirectional therapy, has never been prospectively investigated in patients with colorectal peritoneal metastases (CPM). As a first step to address this evidence gap, the present study aims to assess the safety, feasibility, antitumour activity, patient-reported outcomes, costs and systemic pharmacokinetics of first-line bidirectional therapy in patients with isolated unresectable CPM. Methods and analysis In this single-arm, phase II study in two Dutch tertiary referral centres, 20 patients are enrolled. Key eligibility criteria are a good performance status, pathologically proven isolated unresectable CPM, no previous palliative systemic therapy for colorectal cancer, no (neo)adjuvant systemic therapy ≤6 months prior to enrolment and no previous pressurised intraperitoneal aerosol chemotherapy (PIPAC). Patients receive three cycles of bidirectional therapy. Each cycle consists of 6 weeks first-line palliative systemic therapy at the medical oncologists’ decision (CAPOX-bevacizumab, FOLFOX-bevacizumab, FOLFIRI-bevacizumab or FOLFOXIRI-bevacizumab) followed by ePIPAC-OX (92 mg/m 2 ) with an intraoperative bolus of intravenous leucovorin (20 mg/m2) and 5-fluorouracil (400 mg/m 2 ). Study treatment ends after the third ePIPAC-OX. The primary outcome is the number of patients with—and procedures leading to—grade ≥3 adverse events (Common Terminology Criteria for Adverse Events V.5.0) up to 4 weeks after the last procedure. Key secondary outcomes include the number of bidirectional cycles in each patient, treatment-related characteristics, grade ≤2 adverse events, tumour response (histopathological, cytological, radiological, biochemical, macroscopic and ascites), patient-reported outcomes, systemic pharmacokinetics of oxaliplatin, costs, progression-free survival and overall survival. Ethics and dissemination This study is approved by the Dutch competent authority, a medical ethics committee and the institutional review boards of both study centres. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals. Trial registration number NL8303.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-044811
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2599832-8
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  • 5
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    Colistin methanesulfonate infusion solutions are stable over time and suitable for home administration
    BMJ ; 2018
    In:  European Journal of Hospital Pharmacy Vol. 25, No. 6 ( 2018-11), p. 337-339
    Details
    In: European Journal of Hospital Pharmacy, BMJ, Vol. 25, No. 6 ( 2018-11), p. 337-339
    Type of Medium: Online Resource
    ISSN: 2047-9956 , 2047-9964
    URL: Article
    DOI: 10.1136/ejhpharm-2016-001128
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2650179-X
    SSG: 15,3
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  • 6
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    Incidence, treatment and survival of malignant pleural and peritoneal mesothelioma: a population-based study
    BMJ ; 2022
    In:  Thorax Vol. 77, No. 12 ( 2022-12), p. 1260-1267
    Details
    In: Thorax, BMJ, Vol. 77, No. 12 ( 2022-12), p. 1260-1267
    Abstract: Malignant mesothelioma (MM) is an aggressive cancer that primarily arises from the pleura (MPM) or peritoneum (MPeM), mostly due to asbestos exposure. This study reviewed the Dutch population-based incidence, treatment and survival since the national ban on asbestos in 1993. Materials and methods Patients with MPM or MPeM diagnosed from 1993 to 2018 were selected from the Dutch cancer registry. Annual percentage change (APC) was calculated for (age-specific and sex-specific) revised European standardised incidence rates (RESR). Treatment pattern and Kaplan-Meier overall survival analyses were performed. Results In total, 12 168 patients were included in the study. For male patients younger than 80 years, the MM incidence significantly decreased in the last decade (APC ranging between −9.4% and −1.8%, p 〈 0.01). Among both male and female patients aged over 80 years, the incidence significantly increased during the entire study period (APC 3.3% and 4.6%, respectively, p 〈 0.01). From 2003 onwards, the use of systemic chemotherapy increased especially for MPM (from 9.3% to 39.4%). Overall, 62.2% of patients received no antitumour treatment. The most common reasons for not undergoing antitumour treatment were patient preference (42%) and performance status (25.6%). The median overall survival improved from 7.3 (1993–2003) to 8.9 (2004–2011) and 9.3 months from 2012 to 2018 (p 〈 0.001). Conclusion The peak of MM incidence was reached around 2010 in the Netherlands, and currently the incidence is declining in most age groups. The use of systemic chemotherapy increased from 2003, which likely resulted in improved overall survival over time. The majority of patients do not receive treatment though and prognosis is still poor.
    Type of Medium: Online Resource
    ISSN: 0040-6376 , 1468-3296
    URL: Article
    DOI: 10.1136/thoraxjnl-2021-217709
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 1481491-2
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  • 7
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    Intraperitoneal paclitaxel for patients with primary malignant peritoneal mesothelioma: a phase I/II dose escalation and safety study—INTERACT MESO
    BMJ ; 2022
    In:  BMJ Open Vol. 12, No. 6 ( 2022-06), p. e062907-
    Details
    In: BMJ Open, BMJ, Vol. 12, No. 6 ( 2022-06), p. e062907-
    Abstract: Malignant peritoneal mesothelioma (MPM) is a rare, aggressive tumour arising primarily from the peritoneum. The only potentially curative treatment is cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC). However, the majority of patients are not eligible to undergo this treatment. The benefit of systemic treatment for these patients is limited at the cost of considerable morbidity. Hence, there is a need for appropriate palliative treatment options for patients with MPM. As MPM rarely disseminates outside the abdominal cavity, these patients might benefit from local treatment. A higher, more effective dose of chemotherapy can directly be delivered at the site of the disease. Systemic uptake will be limited, likely resulting in less toxicity. The aim of the INTERACT MESO trial is to determine the maximum tolerable dose of intraperitoneal paclitaxel monotherapy in patients with MPM. Secondary endpoints are to assess safety and toxicity, feasibility and the pharmacokinetic profile of this treatment. Methods and analysis The INTERACT MESO trial is a prospective, open-label, single-centre, phase I study with a classic three-plus-three dose escalation design. The study population consists of adult patients with primary MPM, without extra-abdominal disease, who are not eligible to undergo CRS-HIPEC. According to standard of care work-up for CRS-HIPEC, patients will undergo diagnostic laparoscopy to determine the feasibility of CRS-HIPEC. In case CRS-HIPEC is not considered feasible, a peritoneal port-a-cath (PAC) system will be placed. Through this PAC, 8–16 weekly cycles of intraperitoneal chemotherapy will be administered. Ethics and dissemination The Central Committee on Research Involving Human Subjects (CCMO, The Hague, The Netherlands) and the Medical Research Ethics Committee (METC, Rotterdam, The Netherlands) have granted permission to carry out this study protocol. The results of this trial will be submitted for publication in a peer-reviewed scientific journal. Trial registration number NL9718. EudraCT: 2021-003637-11.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2022-062907
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2599832-8
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  • 8
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    Understanding the NSAID related risk of vascular events
    BMJ ; 2006
    In:  BMJ Vol. 332, No. 7546 ( 2006-04-15), p. 895-898
    Details
    In: BMJ, BMJ, Vol. 332, No. 7546 ( 2006-04-15), p. 895-898
    Type of Medium: Online Resource
    ISSN: 0959-8138 , 1468-5833
    URL: Article
    DOI: 10.1136/bmj.332.7546.895
    Language: English
    Publisher: BMJ
    Publication Date: 2006
    detail.hit.zdb_id: 1479799-9
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  • 9
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    A living WHO guideline on drugs for covid-19
    BMJ ; 2020
    In:  BMJ
    Details
    In: BMJ, BMJ
    Abstract: This is the thirteenth version (twelfth update) of the living guideline, replacing earlier versions (available as data supplements). New recommendations will be published as updates to this guideline. Clinical question What is the role of drugs in the treatment of patients with covid-19? Context The evidence base for therapeutics for covid-19 is evolving with numerous randomised controlled trials (RCTs) recently completed and under way. Emerging SARS-CoV-2 variants (such as omicron) and subvariants are changing the role of therapeutics. This update does not include any changes to the strength or direction of recommendations, but rather concerns i) the use of nirmatrelvir/ritonavir, now considered to be an option also for pregnant and breastfeeding women with non-severe covid-19, and ii) evidence of reduction of in vitro neutralisation activity supporting the strong recommendations against the use of the neutralising monoclonal antibodies sotrovimab and casirivimab-imdevimab. Recommendations, unchanged from previous • Recommended for patients with severe or critical covid-19—strong recommendations for systemic corticosteroids, IL-6 receptor blockers (tocilizumab or sarilumab) in combination with corticosteroids, and baricitinib as an alternative to IL-6 receptor blockers, in combination with corticosteroids. Concerning the concomitant use of IL-6 receptor blockers (tocilizumab and sarilumab), and the JAK inhibitor baricitinib, these drugs may be combined, in addition to corticosteroids. • Recommended for patients with severe covid-19—a conditional recommendation for remdesivir. • Not recommended for patients with critical covid-19—a conditional recommendation against remdesivir. • Recommended for patients with non-severe covid-19 at highest risk of hospitalisation—a strong recommendation for nirmatrelvir/ritonavir; conditional recommendations for molnupiravir and remdesivir. • Not recommended for patients with non-severe covid-19—a conditional recommendation against systemic corticosteroids and colchicine; a strong recommendation against convalescent plasma; a recommendation against fluvoxamine, except in the context of a clinical trial. • Not recommended for patients with non-severe covid-19 at low risk of hospitalisation—a conditional recommendation against nirmatrelvir/ritonavir. • Not recommended for patients with severe or critical covid-19—a recommendation against convalescent plasma except in the context of a clinical trial; a conditional recommendation against the JAK inhibitors ruxolitinib and tofacitinib. • Not recommended, regardless of covid-19 disease severity—strong recommendations against hydroxychloroquine, lopinavir/ritonavir, sotrovimab, and casirivimab-imdevimab; and a recommendation against ivermectin except in the context of a clinical trial. About this guideline This living guideline from the World Health Organization (WHO) incorporates new evidence to dynamically update recommendations for covid-19 therapeutics. The Guideline Development Group (GDG) typically evaluates a therapy when the WHO judges sufficient evidence is available to make a recommendation. While the GDG takes an individual patient perspective in making recommendations, it also considers resource implications, acceptability, feasibility, equity, and human rights. This guideline was developed according to standards and methods for trustworthy guidelines, making use of an innovative process to achieve efficiency in dynamic updating of recommendations. The methods are aligned with the WHO Handbook for Guideline Development and according to a pre-approved protocol (planning proposal) by the Guideline Review Committee (GRC). A box at the end of the article outlines key methodological aspects of the guideline process. MAGIC Evidence Ecosystem Foundation provides methodological support, including the coordination of living systematic reviews with network meta-analyses to inform the recommendations. The full version of the guideline is available online in MAGICapp and in PDF, with a summary version here in The BMJ . These formats should facilitate adaptation, which is strongly encouraged by WHO to contextualise recommendations in a healthcare system to maximise impact. Future recommendations Recommendations on anticoagulation and updated recommendations on molnupiravir are planned for the next updates to this guideline.
    Type of Medium: Online Resource
    ISSN: 1756-1833
    URL: Article
    DOI: 10.1136/bmj.m3379
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 1479799-9
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  • 10
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    Treatment of bulky lymph nodes in locally advanced cervical cancer: boosting versus debulking
    BMJ ; 2022
    In:  International Journal of Gynecologic Cancer Vol. 32, No. 7 ( 2022-07), p. 861-868
    Details
    In: International Journal of Gynecologic Cancer, BMJ, Vol. 32, No. 7 ( 2022-07), p. 861-868
    Abstract: Treatment strategies for bulky lymph nodes in patients with locally advanced cervical cancer scheduled for definitive chemoradiation include nodal boosting with radiotherapy, surgical debulking, or both. The aim of this retrospective cohort study was to compare survival and toxicity in patients receiving these treatments and to compare them with a group that received neither form of treatment. Methods Women diagnosed between January 2009 and January 2017 with International Federation of Gynecology and Obstetrics (FIGO) 2009 stage IB2, IIA2–IVA cervical cancer with lymph nodes ≥1.5 cm without upper limit on pretreatment imaging and treated with definitive chemoradiation were selected from the Netherlands Cancer Registry. Patients were categorized by intention-to-treat strategy: boosting, debulking, or neither treatment, with subgroup analysis for patients receiving both treatments, that is, debulking with boosting. Overall and relapse-free survival outcomes were compared by Kaplan-Meier and Cox regression analyses and toxicity by logistic regression analysis. Results Of 190 patients, 101 (53%) received only nodal boosting, 31 (16%) debulking alone, 29 (15%) debulking combined with boosting, and 29 (15%) received neither treatment. The 5 year overall and relapse-free survival for the treatment groups were 58%, 45% and 45% (p=0.19), and 47%, 44% and 46% (p=0.87), respectively. Multivariable Cox regression analyses demonstrated no differences in overall and relapse-free survival. Combination of debulking with boosting was associated with decreased overall and relapse-free survival compared with debulking alone (HR 2.47, 95% CI 1.22 to 5.00; and HR 2.37, 95% CI 1.14 to 4.93). Nodal boosting was independently associated with a decreased toxicity risk compared with debulking strategy (OR 0.37, 95% CI 0.16 to 0.83). Conclusions This study showed no survival benefit from either nodal boosting or debulking strategy in patients with suspicious bulky nodes. Nodal boosting might, however, be associated with less toxicity. Dual treatment with debulking and boosting showed a worse survival outcome because this group probably represents patients with poor prognostic factors.
    Type of Medium: Online Resource
    ISSN: 1048-891X , 1525-1438
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.1136/ijgc-2022-003357
    DOI: 10.1136/ijgc-2022-003357.supp1
    DOI: 10.1136/ijgc-2022-003357.supp2
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2009072-9
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