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1.
J Dermatol ; 51(1): 40-47, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37927296

ABSTRACT

Optical coherence tomography (OCT), a non-invasive diagnostic modality, may replace biopsy for diagnosing basal cell carcinoma (BCC) if a high-confidence BCC diagnosis can be established. In other cases, biopsy remains necessary to establish a histopathological diagnosis and treatment regimen. It is, therefore, essential that OCT assessors have a high specificity for differentiating BCC from non-BCC lesions. To establish high-confidence BCC diagnoses, specific morphological BCC characteristics on OCT are used. This study aimed to review several cases of non-BCC lesions that were misclassified as BCC by experienced OCT assessors, thereby providing insight into the causes of these misclassifications and how they may be prevented. The study population consisted of patients who had a histopathologically-verified non-BCC lesion. Patients from Maastricht University Medical Center+ from February 2021 to April 2021 were included in the study. Two independent OCT assessors assessed OCT scans. One OCT assessor recorded the presence or absence of validated morphological BCC characteristics. A false-positive OCT test result was defined as certainty of BCC presence in a non-BCC lesion. The frequency of misclassifications and the presence or absence of morphological BCC features are discussed. A total of 124 patients with non-BCC lesions were included. Six patients were misclassified by both OCT assessors and are discussed in more detail. Histopathological diagnoses were squamous cell carcinoma (n = 2/21), actinic keratosis (n = 2/29), squamous cell carcinoma in situ/Bowen's disease (n = 1/16), or interphase dermatitis (n = 1/4). In all misclassified cases, multiple, apparent morphological BCC characteristics on OCT were present. Most non-BCC lesions are recognized as such by OCT assessors. However, there remains a small risk that a high-confidence BCC diagnosis is established in non-BCC lesions wherein features mimicking validated BCC characteristics are present. Misclassification may be prevented by careful delineation of epidermal layers and good differentiation between dermal ovoid structures typical of BCC versus squamous cell carcinoma.


Subject(s)
Carcinoma, Basal Cell , Carcinoma, Squamous Cell , Skin Neoplasms , Humans , Skin Neoplasms/diagnostic imaging , Skin Neoplasms/pathology , Tomography, Optical Coherence/methods , Sensitivity and Specificity , Carcinoma, Basal Cell/diagnostic imaging , Carcinoma, Basal Cell/pathology , Carcinoma, Squamous Cell/diagnostic imaging
2.
J Am Acad Dermatol ; 90(1): 58-65, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37666424

ABSTRACT

BACKGROUND: Randomized controlled trials comparing the effectiveness of 5-fluorouracil cream, methylaminolevulinate photodynamic therapy (MAL-PDT) and surgical excision in patients with Bowen's disease are lacking. METHODS: In this multicenter noninferiority trial, patients with a histologically proven Bowen's disease of 4-40 mm were randomly assigned to excision with 5 mm margin, 5% 5-fluorouracil cream twice daily for 4 weeks, or 2 sessions of MAL-PDT with 1 week interval. The primary outcome was the proportion of patients with sustained clearance at 12 months after treatment. A noninferiority margin of 22% was used. RESULTS: Between May 2019 and January 2021, 250 patients were randomized. The proportion of patients with sustained clearance was 97.4% (75/77) after excision, 85.7% (66/77) after 5-fluorouracil, and 82.1% (64/78) after MAL-PDT. Absolute differences were -11.7% (95% CI -18.9 to -4.5; P = .0049) for 5-fluorouracil versus excision and -15.4% (95% CI -23.1 to -7.6; P = .00078) for MAL-PDT versus excision. Both noninvasive treatments significantly more often led to good or excellent cosmetic outcome. CONCLUSIONS: Based on our predefined noninferiority margin of 22%, 5-fluorourcail is noninferior to excision and associated with better cosmetic outcome. For MAL-PDT noninferiority to excision cannot be concluded. Therefore, 5-fluorouracil should be preferred over excision and MAL-PDT in treatment of Bowen's disease.


Subject(s)
Bowen's Disease , Photochemotherapy , Skin Neoplasms , Humans , Photosensitizing Agents/therapeutic use , Bowen's Disease/drug therapy , Bowen's Disease/surgery , Aminolevulinic Acid/therapeutic use , Skin Neoplasms/drug therapy , Skin Neoplasms/surgery , Skin Neoplasms/pathology , Fluorouracil/therapeutic use , Treatment Outcome , Randomized Controlled Trials as Topic
3.
Patient Educ Couns ; 115: 107907, 2023 10.
Article in English | MEDLINE | ID: mdl-37487347

ABSTRACT

OBJECTIVE: This study evaluates whether using a patient decision aid (PDA) for patients with superficial basal-cell carcinoma (sBCC) results in a decreased decisional conflict level and increased knowledge. METHODS: In a prospective multicentre study, patient groups were included before and after implementation of a PDA. Decisional conflict levels were compared directly after making the treatment decision, measured once as the mean score on the decisional conflict scale (DCS). Higher scores correspond with higher conflict levels (0-100). Secondary outcomes were knowledge on treatment options, recognizing a BCC, and risk factors for developing a BCC measured on an adapted version of a validated knowledge questionnaire for melanoma patients, and patient satisfaction with the PDA. RESULTS: Data was available for 103 patients in the control-group and 109 in the PDA-group. The mean DCS score in the control-group was 22.78 (SD 14.76) compared to 22.34 (SD 14.54) in the PDA-group; the decrease was non-significant (p = 0.828). The average percentage correct answers on the knowledge questionnaire increased from 76.5% in the control-group to 80.5% in the PDA-group (p = 0.044). According to the majority of patients in the PDA-group (73.7%) the PDA had added value. CONCLUSION: Using the PDA had no significant effect on decisional conflict levels, but increased overall knowledge on relevant issues concerning sBCC. PRACTICE IMPLICATIONS: The PDA can be used as an informational tool by patients with sBCC.


Subject(s)
Carcinoma, Basal Cell , Skin Neoplasms , Humans , Decision Support Techniques , Prospective Studies , Carcinoma, Basal Cell/therapy , Patient Satisfaction , Skin Neoplasms/therapy , Decision Making
4.
Eur J Vasc Endovasc Surg ; 66(5): 678-685, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37517579

ABSTRACT

OBJECTIVE: Deep venous obstruction (DVO) is a great burden on the healthcare system and patients' quality of life (QoL). Case series show stenting is safe and effective, however most studies lack control groups and QoL changes have not been compared with conventional treatment. The aim was to assess the difference in QoL changes from baseline to 12 months between stent and conventionally treated patients with DVO. METHODS: Subjects > 18 years old with DVO due to post-thrombotic (PTS) or non-thrombotic iliac vein lesions (NIVLs) in a tertiary hospital were prospectively randomised to best medical therapy (BMT) or stent placement with BMT in a ratio 2:1, stratified for PTS or NIVL. The primary outcome was the between group difference in VEINES-QoL scores change from baseline to 12 months after treatment. Secondary outcomes included the difference in score changes for EuroQoL 5-Dimension 5 Level (EQ-5D-5L), Pain Disability Index (PDI), Venous Clinical Severity Score (VCSS), and the Villalta score. RESULTS: After three years, the inclusion rate dropped to almost zero, therefore the study had to be stopped. Sixty-three patients were randomised to either the stent (n = 42) or control group (n = 21). Overall, 50 patients had available data for primary outcome analysis. The adjusted mean difference between 12 month scores for VEINES-QoL and VEINES-Sym was 8.07 (95% CI 3.04 - 13.09) and 5.99 (95% CI 0.75 - 11.24) (p = .026), respectively, in favour of the stent group. The differences were significant, but a pre-defined meaningful 14 point improvement in QoL was not reached. The mean difference between 12 month scores for VCSS was -2.93 (95% CI -5.71 - 0.16, p = .040), -11.83 (95% CI -20.81 - 2.86, p = .011) for PDI, 0.015 (95% CI -0.12 - 0.15, p = .82) for the EQ-5D index, and -2.99 (95% CI -7.28 - 1.30, p = .17) for the Villalta score. CONCLUSION: Symptomatic patients with DVO who received dedicated venous stents had significantly higher VEINES-QoL/Sym scores at 12 months compared with the control group, but the between group difference was lower than the pre-specified clinically relevant QoL difference of at least 14 points. STUDY REGISTRATION NUMBER: NCT03026049.

7.
J Cancer ; 14(1): 174-182, 2023.
Article in English | MEDLINE | ID: mdl-36605487

ABSTRACT

Background: To provide a systematic review and meta-analysis that evaluates the diagnostic accuracy of contrast-enhanced mammography (CEM) compared to standard contrast-enhanced breast magnetic resonance imaging (breast MRI). Like breast MRI, CEM enables tumour visualization by contrast accumulation. CEM seems to be a viable substitute for breast MRI. Methods: This systematic search assessed the diagnostic accuracy of these techniques in women with suspicious breast lesions on prior imaging or physical examination, who have undergone both breast MRI and CEM. CEM had to be performed on a commercially available system. The MRI sequence parameters had to be described sufficiently to ensure that standard breast MRI sequence protocols were used. Pooled values of sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and diagnostic odds ratio (DOR), were estimated using bivariate mixed-effects logistic regression modeling. Hierarchical summary receiver operating characteristic curves for CEM and breast MRI were also constructed. Results: Six studies (607 patients with 775 lesions) met the predefined inclusion criteria. Pooled sensitivity was 96% for CEM and 97% for breast MRI. Pooled specificity was 77% for both modalities. DOR was 79.5 for CEM and 122.9 for breast MRI. Between-study heterogeneity expressed as the I2 -index was substantial with values over 80%. Conclusion: Pooled sensitivity was high for both CEM and breast MRI, with moderate specificity. The pooled DOR estimates, however, indicate higher overall diagnostic performance of breast MRI compared to CEM. Nonetheless, current scientific evidence is too limited to prematurely discard CEM as an alternative for breast MRI.

8.
EJNMMI Res ; 13(1): 5, 2023 Jan 23.
Article in English | MEDLINE | ID: mdl-36689007

ABSTRACT

BACKGROUND: To quantify the relationship between [18F]FDG uptake of the primary tumour measured by PET-imaging with immunohistochemical (IHC) expression of ER, PR, HER2, Ki-67, and clinical subtypes based on these markers in breast cancer patients. METHODS: PubMed and Embase were searched for studies that compared SUVmax between breast cancer patients negative and positive for IHC expression of ER, PR, HER2, Ki-67, and clinical subtypes based on these markers. Two reviewers independently screened the studies and extracted the data. Standardized mean differences (SMD) and 95% confidence intervals (CIs) were estimated by using DerSimonian-Laird random-effects models. P values less than or equal to 5% indicated statistically significant results. RESULTS: Fifty studies were included in the final analysis. SUVmax is significantly higher in ER-negative (31 studies, SMD 0.66, 0.56-0.77, P < 0.0001), PR-negative (30 studies, SMD 0.56; 0.40-0.71, P < 0.0001), HER2-positive (32 studies, SMD - 0.29, - 0.49 to - 0.10, P = 0.0043) or Ki-67-positive (19 studies, SMD - 0.77; - 0.93 to - 0.61, P < 0.0001) primary tumours compared to their counterparts. The majority of clinical subtypes were either luminal A (LA), luminal B (LB), HER2-positive or triple negative breast cancer (TNBC). LA is associated with significantly lower SUVmax compared to LB (11 studies, SMD - 0.49, - 0.68 to - 0.31, P = 0.0001), HER2-positive (15 studies, SMD - 0.91, - 1.21 to - 0.61, P < 0.0001) and TNBC (17 studies, SMD - 1.21, - 1.57 to - 0.85, P < 0.0001); and LB showed significantly lower uptake compared to TNBC (10 studies, SMD - 0.77, - 1.05 to - 0.49, P = 0.0002). Differences in SUVmax between LB and HER2-positive (9 studies, SMD - 0.32, - 0.88 to 0.24, P = 0.2244), and HER2-positive and TNBC (17 studies, SMD - 0.29, - 0.61 to 0.02, P = 0.0667) are not significant. CONCLUSION: Primary tumour SUVmax is significantly higher in ER-negative, PR-negative, HER2-positive and Ki-67-positive breast cancer patients. Luminal tumours have the lowest and TNBC tumours the highest SUVmax. HER2 overexpression has an intermediate effect.

10.
J Clin Pathol ; 2022 Dec 29.
Article in English | MEDLINE | ID: mdl-36581447

ABSTRACT

AIMS: The aim of this study is to evaluate whether agreement with autopsy-determined cause of death (COD) increases by use of postmortem CT (PMCT) or PMCT in combination with postmortem sampling (PMS), when compared with clinical assessment only. METHODS: This prospective observational study included deceased patients from the intensive care unit and internal medicine wards between October 2013 and August 2017. The primary outcome was percentage agreement on COD between the reference standard (autopsy) and the alternative postmortem examinations (clinical assessment vs PMCT or PMCT+PMS). In addition, the COD of patient groups with and without conventional autopsy were compared with respect to involved organ systems and pathologies. RESULTS: Of 730 eligible cases, 144 could be included for analysis: 63 underwent PCMT without autopsy and 81 underwent both PMCT and autopsy. Agreement with autopsy-determined COD was significantly higher for both PMCT with PMS (42/57, 74%), and PMCT alone (53/81, 65%) than for clinical assessment (40/81, 51%; p=0.007 and p=0.03, respectively). The difference in agreement between PMCT with PMS and PMCT alone was not significant (p=0.13). The group with autopsy had a significantly higher prevalence of circulatory system involvement and perfusion disorders, and a lower prevalence of pulmonary system involvement. CONCLUSION: PMCT and PMS confer additional diagnostic value in establishing the COD. Shortcomings in detecting vascular occlusions and perfusion disorders and susceptibility to pulmonary postmortem changes could in future be improved by additional techniques. Both PMCT and PMS are feasible in clinical practice and an alternative when autopsy cannot be performed.

11.
Lancet Oncol ; 23(8): 1087-1096, 2022 08.
Article in English | MEDLINE | ID: mdl-35835136

ABSTRACT

BACKGROUND: Punch biopsy is the gold standard for diagnosis and subtyping of basal cell carcinoma. The aim of this study was to assess whether use of optical coherence tomography (OCT), a non-invasive imaging tool, might avoid the need for biopsy. METHODS: In a multicentre, randomised, non-inferiority trial, patients (aged ≥18 years) with an indication for biopsy of a suspected basal cell carcinoma outside the H-zone (high-risk zone) of the face were randomly assigned (1:1) to receive either OCT or punch biopsy (regular care) via a web-based randomisation system. Patients were enrolled from three participating centres in the Netherlands: Maastricht University Medical Centre+, Catharina Hospital Eindhoven, and Zuyderland Medical Centre Heerlen. Stratification factors for randomisation were participating centre and the grade of clinical basal cell carcinoma suspicion (high vs low). The primary endpoint was the proportion of patients free from a recurrent or residual lesion (malignant or premalignant) 12 months after treatment. Modified intention-to-treat and per-protocol analyses were conducted, with a predefined non-inferiority margin of -10%. This trial is registered with ClinicalTrials.gov number, NCT03848078, and is complete. FINDINGS: Between Feb 25, 2019, and Sept 2, 2020, 598 patients were enrolled and randomly assigned to either the regular care group (n=299) or the OCT group (n=299). Data on the primary endpoint were available in 553 patients (n=268 in the regular care group, n=285 in the OCT group). After median follow-up of 12·7 months (IQR 11·2-14·1) in the OCT group and 12·6 months (10·8-14·3) in the regular care group, 253 (94%) of 268 patients in the OCT group and 266 (93%) of 285 patients in the regular care group were free from recurrent or residual lesions (malignant or pre-malignant) 12 months after treatment. According to our modified intention-to-treat analysis, the absolute difference (OCT vs regular care) was 1·07% (95% CI -2·93 to 5·06; one-sided p=0·30), with the lower limit of the 95% CI not exceeding the predefined non-inferiority margin of -10%. Per-protocol analyses led to proportions free from a residual or recurrent lesion (premalignant or malignant) of 95% (250 of 263) in the OCT group and 94% (262 of 278) in the regular care group, and an absolute difference of 0·81% (95% CI -2·98 to 4·60; one-sided p=0·34). INTERPRETATION: OCT-guided diagnosis and treatment of basal cell carcinoma is non-inferior to regular care punch biopsy. Implementation of OCT for diagnosis of basal cell carcinoma could reduce the number of consultations and invasive procedures. FUNDING: The Netherlands Organization for Health Research and Development and Maurits en Anna de Kock Stichting.


Subject(s)
Carcinoma, Basal Cell , Skin Neoplasms , Adolescent , Adult , Biopsy , Carcinoma, Basal Cell/diagnostic imaging , Carcinoma, Basal Cell/therapy , Humans , Netherlands , Tomography, Optical Coherence , Treatment Outcome
12.
Dermatology ; 238(6): 1044-1049, 2022.
Article in English | MEDLINE | ID: mdl-35598594

ABSTRACT

BACKGROUND: Photodynamic therapy (PDT) is a noninvasive treatment for patients with superficial basal-cell carcinoma (sBCC). The efficacy of PDT may vary with different photosensitizers and treatment schedules. OBJECTIVE: Our objective was to evaluate whether fractionated 5-aminolevulinic acid 20% (ALA)-PDT is superior to conventional two-stage methyl aminolevulinate (MAL)-PDT for sBCC. METHODS: We present the 5 years results of a single-blind, randomized, multicenter trial. 162 patients with a histologically confirmed primary sBCC were randomized to fractionated ALA-PDT or MAL-PDT. RESULTS: The 5-year tumor-free survival rate was 70.7% (95% CI 58.2-80.1%) for ALA-PDT and 76.5% (95% CI 64.4-85.0%) for MAL-PDT. In the first 3 years, there was no significant difference in risk of treatment failure (HR = 1.53, p = 0.283), but in the long-term, the risk of recurrence was significantly lower following MAL-PDT compared to ALA-PDT (HR = 0.125, p = 0.049). As judged by patients, the esthetic result was good-excellent in 96.8% (61/63) and 94.4% (56/59) of patients treated with ALA-PDT and MAL-PDT, respectively (p = 0.631). CONCLUSION: The long-term efficacy is significantly higher for conventional two-stage MAL-PDT than for fractionated ALA-PDT, whereas there was no significant difference in esthetic outcome between the treatments at 5 years after treatment. These results indicate that fractionated ALA-PDT offers no benefit over conventional two-stage MAL-PDT.


Subject(s)
Carcinoma, Basal Cell , Photochemotherapy , Skin Neoplasms , Humans , Aminolevulinic Acid/therapeutic use , Photochemotherapy/methods , Single-Blind Method , Skin Neoplasms/pathology , Treatment Outcome , Carcinoma, Basal Cell/drug therapy , Carcinoma, Basal Cell/pathology , Photosensitizing Agents/therapeutic use
13.
JAMA Dermatol ; 158(6): 634-640, 2022 06 01.
Article in English | MEDLINE | ID: mdl-35475852

ABSTRACT

Importance: Treatment of actinic keratosis (AK) aims to prevent cutaneous squamous cell carcinoma (cSCC). However, whether AK can progress into invasive cSCC is a matter of debate, and little is known about the effect of treatment on preventing cSCC. Objectives: To evaluate the risk of invasive cSCC and factors that may contribute to increased risk in patients with multiple AKs. Design, Setting, and Participants: In this secondary analysis of a multicenter randomized clinical trial, 624 patients with a minimum of 5 AKs within an area of 25 to 100 cm2 on the head were recruited from the Department of Dermatology of 4 hospitals in the Netherlands. Long-term follow-up was performed from July 1, 2019, to December 31, 2020. Interventions: Patients were randomized to treatment with 5% fluorouracil, 5% imiquimod cream, methylaminolevulinate photodynamic therapy, or 0.015% ingenol mebutate gel. Main Outcomes and Measures: The primary outcome was the proportion of patients with invasive cSCC in the target area during follow-up. Secondary outcomes were the associations between risk of invasive cSCC and a priori defined potential prognostic factors, including type of treatment, severity of AK (Olsen grade), history of nonmelanoma skin cancer, and additional treatment. Results: Of the 624 patients (558 [89.4%] male; median age, 73 years [range, 48-94 years]) in the study, 26 were diagnosed with a histologically proven invasive cSCC in the target area during follow-up. The total 4-year risk of developing cSCC in a previously treated area of AK was 3.7% (95% CI, 2.4%-5.7%), varying from 2.2% (95% CI, 0.7%-6.6%) in patients treated with fluorouracil to 5.8% (95% CI, 2.9%-11.3%) in patients treated with imiquimod. In patients with severe AK (Olsen grade III), the risk was 20.9% (95% CI, 10.8%-38.1%), and the risk was especially high (33.5%; 95% CI, 18.2%-56.3%) in patients with severe AK who needed additional treatment. Conclusions and Relevance: In this secondary analysis of a randomized clinical trial, risk of invasive cSCC was highest in patients with Olsen grade III AK and was substantially increased in patients who received additional treatment. These patients should be closely followed up after treatment. Trial Registration: ClinicalTrials.gov Identifier: NCT02281682.


Subject(s)
Carcinoma, Squamous Cell , Keratosis, Actinic , Skin Neoplasms , Aged , Carcinoma, Squamous Cell/epidemiology , Carcinoma, Squamous Cell/etiology , Female , Fluorouracil/adverse effects , Humans , Imiquimod/therapeutic use , Keratosis, Actinic/therapy , Male , Skin Neoplasms/epidemiology , Skin Neoplasms/etiology , Treatment Outcome
14.
Acta Derm Venereol ; 101(11): adv00607, 2021 Nov 30.
Article in English | MEDLINE | ID: mdl-34724068

ABSTRACT

Optical coherence tomography (OCT) is a non-invasive diagnostic method. Numerous morphological OCT features have been described for diagnosis of basal cell carcinoma (BCC). The aim of this study is to evaluate the diagnostic value of established OCT features and to explore whether the use of a small set of OCT features enables accurate discrimination between BCC and non-BCC lesions and between BCC subtypes. For each lesion, the presence or absence of specific OCT features was recorded. Histopathology was used as a gold standard. Diagnostic parameters were calculated for each OCT feature, and multivariate logistic regression analyses were performed to evaluate the loss in discriminative ability when using a small subset of OCT features instead of all features that are characteristic for BCC according to the literature. The results show that the use of a limited number of OCT features allows for good discrimination of superficial BCC from non-superficial BCC and non-BCC lesions. The prevalence of BCC was 75.3% (225/299) and the proposed diagnostic algorithm enabled detection of 97.8% of BCC lesions (220/225). Subtyping without the need for biopsy was possible in 132 of 299 patients (44%), with a predictive value for presence of superficial BCC of 84.3% vs 98.8% for presence of non-superficial BCC.


Subject(s)
Carcinoma, Basal Cell , Skin Neoplasms , Biopsy , Carcinoma, Basal Cell/diagnostic imaging , Humans , Palliative Care , Skin Neoplasms/diagnostic imaging , Tomography, Optical Coherence
15.
Acta Derm Venereol ; 101(6): adv00474, 2021 Jun 22.
Article in English | MEDLINE | ID: mdl-33903919

ABSTRACT

Optical coherence tomography is a non-invasive imaging technique that enables high-resolution in vivo imaging of skin. Although optical coherence tomography is promising for diagnosing basal cell carcinoma, its limited penetration depth may impede basal cell carcinoma subtyping. This study evaluated whether topical application of glycerol can increase penetration depth and improve the image quality and visibility of characteristic features of basal cell carcinoma. A total of 61 patients with a total of 72 basal cell carcinomas were included. Optical coherence tomography scans were obtained before and after application of an 85% glyce-rol solution. The mean penetration depth of each optical coherence tomography scan was acquired by automatically tracing both skin surface and the point of signal loss using a custom-made MATLAB program. Mean ± standard deviation penetration depth increased from 883 ± 108 to 904 ± 88 µm before and after glycerol application, respectively (p = 0.005). Topical application of glycerol leads to a significant 2.4% increase in penetration depth. However, no significant differences in image quality and visibility of basal cell carcinoma features were found.


Subject(s)
Carcinoma, Basal Cell , Skin Neoplasms , Carcinoma, Basal Cell/diagnostic imaging , Carcinoma, Basal Cell/drug therapy , Glycerol , Humans , Skin/diagnostic imaging , Skin Neoplasms/diagnostic imaging , Skin Neoplasms/drug therapy , Tomography, Optical Coherence
17.
BMJ Open ; 11(1): e041883, 2021 01 17.
Article in English | MEDLINE | ID: mdl-33455933

ABSTRACT

OBJECTIVE: High radiation exposure is a concern because of the association with cancer. The objective was to determine the probability of receiving a high radiation dose from CT (from one or more examinations within a 5-year period) and to assess the clinical context by evaluating clinical indications in the high-dose patient group. DESIGN: Observational cohort study. Effective radiation dose received from one or more CT examinations within a predefined 5-year calendar period was assessed for each patient. SETTING: Hospital setting. PARTICIPANTS: All patients undergoing a diagnostic CT examination between July 2013 and July 2018 at the Maastricht University Medical Center. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was the probability of receiving a high effective dose, defined as ≥100 mSv, from one or more CT examinations within 5 years as derived from a time-to-event analysis. Secondary outcomes were the clinical indication for the initial scan of patients receiving a high effective dose. RESULTS: 100 672 CT examinations were performed among 49 978 patients including 482 (1%) who received a high radiation dose. The estimated probability of a high effective dose from a single examination is low (0.002% (95% CI 0.00% to 0.01%)). The 4.5-year probability of receiving a high cumulative effective dose was 1.9% (95% CI 1.6% to 2.2%) for women and 1.5% (95% CI 1.3% to 1.7%) for men. The probability was highest in age categories between 51 and 74 years. A total of 2711 (5.5%) of patients underwent more than six CT examinations, and the probability of receiving a high effective dose was 16%. Among patients who received a high effective dose, most indications (80%) were oncology related. CONCLUSIONS: The probability of receiving a high radiation dose from CT examinations is small but not negligible. In the majority (80%) of high effective dose receiving patients, the indication for the initial CT scan was oncology related.


Subject(s)
Radiation Exposure , Tomography, X-Ray Computed , Aged , Cohort Studies , Female , Humans , Male , Middle Aged , Probability , Radiation Dosage , Radiation Exposure/adverse effects
18.
Br J Cancer ; 124(7): 1199-1206, 2021 03.
Article in English | MEDLINE | ID: mdl-33462360

ABSTRACT

BACKGROUND: Vismodegib has been used for the treatment of locally advanced basal cell carcinoma (laBCC) and metastatic BCC (mBCC) since 2011. Most efficacy and safety data are provided by clinical trials. This study evaluates the effectiveness of vismodegib for the treatment of laBCC, mBCC and basal cell nevus syndrome (BCNS) patients, and the tumour characteristics associated with a higher probability of achieving a complete response in the Netherlands. METHODS: A retrospective cohort study that included all patients ≥18 years with histologically proven basal cell carcinoma that received ≥1 dose of vismodegib between July 2011 and September 2019 in the Netherlands. RESULTS: In total, 48 laBCC, 11 mBCC and 19 BCNS patients were included. Median progression-free survival was 10.3 months (95% confidence interval (CI), 7.5-22.6) for laBCC, 11.7 (95% CI, 5.2-17.5) for mBCC and 19.1 (95% CI, 7.4-20.2) for BCNS. Larger laBCCs were associated with a lower probability of complete response (hazard ratio (HR) 0.77 per increase in cm, p = 0.02). Of all BCNS patients, 63% received ≥2 treatment sequences with vismodegib; all achieved partial responses. CONCLUSIONS: Half of the aBCC patients progress within 1 year after the start of vismodegib treatment. More research is needed to investigate other treatment strategies after vismodegib progression and to evaluate long-term effects of repetitive vismodegib treatment.


Subject(s)
Anilides/therapeutic use , Antineoplastic Agents/therapeutic use , Carcinoma, Basal Cell/drug therapy , Hamartoma Syndrome, Multiple/drug therapy , Pyridines/therapeutic use , Adult , Aged , Aged, 80 and over , Female , Follow-Up Studies , Humans , Middle Aged , Retrospective Studies , Time Factors
19.
Rofo ; 193(2): 151-159, 2021 Feb.
Article in English | MEDLINE | ID: mdl-33327033

ABSTRACT

BACKGROUND: Despite tremendous improvement in molecular properties over the last century, intravascular injection of iodinated contrast material may still have systemic and hemodynamic consequences. Patients with pre-existing renal insufficiency may be at risk for acute kidney injury, which may be associated with an increased risk of the need for dialysis and mortality in the long term. Many questions as to the physiological pathways, optimal definition, and incidence of contrast-induced acute kidney injury remain open. These uncertainties are reflected in the changing landscape of this field in terms of nomenclature, research, and clinical practice. METHODS: Clinical practice guidelines for the prevention of post-contrast acute kidney injury all recommend giving prophylaxis in the form of intravenous hydration to high-risk patients. Solid evidence for this strategy is lacking. This article gives an overview of the changing landscape of post-contrast acute kidney injury and prophylactic intravenous hydration, with the aim of supporting informed decision-making in clinical practice. RESULTS: Recent data have caused a shift in guideline recommendations: 90 % of patients formerly considered high-risk for contrast-induced acute kidney injury no longer qualify for prophylaxis. The remaining high-risk patients, with severe chronic kidney disease, represent a vulnerable population for whom intravenous hydration may provide some benefits but also carries risk. CONCLUSION: Intravenous hydration may benefit 'new' high-risk patients. However, it also confers risk. A dual approach to screening patients will help avoid this risk in clinical practice. KEY POINTS: · Intravenous hydration is the cornerstone for preventing contrast-induced acute kidney injury. · Solid evidence is lacking; recent data caused a shift in guideline recommendations. · Intravenous hydration may benefit 'new' high-risk patients with severe chronic kidney disease; however, it also confers risk. · A dual approach to screening patients will help avoid this risk in clinical practice. CITATION FORMAT: · Nijssen E, Rennenberg R, Nelemans P et al. Post-Contrast Acute Kidney Injury and Intravenous Prophylactic Hydration: An Update. Fortschr Röntgenstr 2021; 193: 151 - 159.


Subject(s)
Acute Kidney Injury/chemically induced , Clinical Decision-Making/ethics , Contrast Media/adverse effects , Fluid Therapy/methods , Acute Kidney Injury/epidemiology , Acute Kidney Injury/prevention & control , Contrast Media/administration & dosage , Fluid Therapy/adverse effects , Glomerular Filtration Rate/physiology , Humans , Incidence , Practice Guidelines as Topic/standards , Renal Dialysis/methods , Renal Insufficiency/complications , Renal Insufficiency/mortality , Renal Insufficiency/therapy , Risk Assessment
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