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Bulletin Du Cancer Dec 2010Management of adverse events related to cancer therapies are seen as tertiary prevention. Concerning prostate cancer, dealing with secondary effects of treatments is... (Review)
Review
Management of adverse events related to cancer therapies are seen as tertiary prevention. Concerning prostate cancer, dealing with secondary effects of treatments is crucial. Indeed, if recent advances in cancer therapy have lead to an acceptable overall prognosis, these results face increasing cases of adverse events that can dramatically impact quality of life. Localized prostate cancer management (by radical prostatectomy, brachytherapy, external radiation therapy, hormonal treatment) leads to two main secondary effects: bladder and urinary sphincter dysfunction on one hand and sexual disorders on the other hand. Urinary disorders are stress urinary incontinence (mainly after radical prostatectomy), storage symptoms and overactive bladder, and outflow obstruction (mainly after radiation therapy). Stress urinary incontinence can be managed by pelvic floor muscle training and behavioural treatment. In case of failure, and after one year of evolution, surgical options are indicated (periurethral injections, artificial urinary sphincter, tapes and balloons). Storage symptoms respond to medical management (anticholinergics), and obstructive symptoms are treated by alpha-blockers, self-catheterization or surgery if necessary. Sexual disorders are erectile dysfunction, pelvic floor discomfort, orgasm disorder, and penile retraction and fibrosis. Available options gather medical treatment by phosphodiesterase-5 inhibitors, Vacuum, and penile prosthesis. Recent advances in this field point out the role of early penile rehabilitation and prevention of sexual disorders. Although often associated in the same patients, sexual and urinary disorders following prostate cancer management are often considered separately. Their combined treatment should be an objective for both clinical practice and research. New treatments for stress urinary incontinence management (latero-urethral balloons, new male slings) and for erectile dysfunction (penile rehabilitation, treatment penile retraction and optimal use of phosphodiesterase-5 inhibitors) will extend the therapeutic options in the next future, and improve the level of care for patients with prostate cancer.
Topics: Androgen Antagonists; Balloon Occlusion; Brachytherapy; Erectile Dysfunction; Humans; Male; Muscle Cells; Penile Prosthesis; Phosphodiesterase 5 Inhibitors; Prostatectomy; Prostatic Neoplasms; Radiotherapy; Suburethral Slings; Urethral Obstruction; Urinary Bladder, Overactive; Urinary Incontinence, Stress; Urinary Sphincter, Artificial
PubMed: 21220229
DOI: 10.1684/bdc.2010.1229 -
Journal of the American College of... Sep 1998Stent implantation represents a major step forward since the introduction of coronary angioplasty. As indications continue to expand, better understanding of the early... (Review)
Review
Stent implantation represents a major step forward since the introduction of coronary angioplasty. As indications continue to expand, better understanding of the early and late biocompatibility issues appears critical. Persisting challenges to the use of intracoronary stents include the prevention of early thrombus formation and late neointima development. Different metals and designs have been evaluated in animal models and subsequently in patients. Polymer coatings have been proposed to improve the biocompatibility of metallic stents or to serve as matrix for drug delivery and they are currently undergoing clinical studies. The promises of a biodegradable stent have not yet been fulfilled although encouraging results have recently been reported. Continuous low dose-rate brachytherapy combining the scaffolding effect of the stent with localized radiation therapy has witnessed the development and early clinical testing of radioactive stents. The combined efforts of basic scientists and clinicians will undoubtedly contribute to the improvement of stent biocompatibility in the future.
Topics: Angioplasty, Balloon, Coronary; Animals; Biocompatible Materials; Brachytherapy; Coronary Vessels; Equipment Design; Equipment Failure Analysis; Humans; Stents
PubMed: 9741494
DOI: 10.1016/s0735-1097(98)00289-7 -
BMJ (Clinical Research Ed.) Nov 2015What is the most safe and effective interventional treatment for coronary in-stent restenosis? (Meta-Analysis)
Meta-Analysis Review
STUDY QUESTION
What is the most safe and effective interventional treatment for coronary in-stent restenosis?
METHODS
In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses.
STUDY ANSWER AND LIMITATIONS
Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval -0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons.
WHAT THIS STUDY ADDS
Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy.
FUNDING, COMPETING INTERESTS, DATA SHARING
This study received no external funding. The authors declare no competing interests. No additional data available.
Topics: Bayes Theorem; Coronary Restenosis; Drug-Eluting Stents; Humans; Immunosuppressive Agents; Myocardial Revascularization; Percutaneous Coronary Intervention; Randomized Controlled Trials as Topic; Stents
PubMed: 26537292
DOI: 10.1136/bmj.h5392 -
Journal of Contemporary Brachytherapy Mar 2010Preliminary dosimetric findings in patients managed with the Contura Multi-Lumen Balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast...
PURPOSE
Preliminary dosimetric findings in patients managed with the Contura Multi-Lumen Balloon (MLB) breast brachytherapy catheter to deliver accelerated partial breast irradiation (APBI) on a multi-institutional phase IV registry trial were reviewed.
MATERIAL AND METHODS
CT-based 3D planning with dose optimization was performed for all patients. For the study, new ideal dosimetric goals were developed: 1) ≥ 95% of the prescribed dose (PD) covering ≥ 90% of the target volume (TV), 2) a maximum skin dose ≤ 125% of the PD, 3) maximum rib dose ≤ 145% of the PD, and 4) the V150 ≤ 50 cc and V200 ≤ 10 cc. The frequency of concurrently achieving these dosimetric goals using the Contura MLB was investigated.
RESULTS
194 cases were evaluable. Employing the MLB, all ideal dosimetric criteria were achieved in 76% of cases. Evaluating dosimetric criteria separately, 90% and 89% of cases met the new ideal skin and rib dose criteria, respectively. In 96%, ideal TV coverage goals were achieved and in 96%, dose homogeneity criteria (V150 and V200) were met. For skin spacing ≥ 5-7 mm, the median skin dose was 121% of the PD and when < 5 mm, the median skin dose was 124.4%. For rib distancees < 5 mm, the median rib dose was reduced to 136.4% of the PD. For skin spacing < 7 mm and distance to rib < 5 mm, the median skin and rib doses were concurrently limited to 121% and 142.8% of the PD, respectively.
CONCLUSIONS
The Contura MLB catheter provides potential improvements in dosimetric capabilities (i.e., reduced skin and rib doses and improved TV coverage) in many clinical scenarios.
PubMed: 28031736
DOI: 10.5114/jcb.2010.13716 -
Journal of Contemporary Brachytherapy Feb 2015To investigate the incidence of and potential risk factors for fat necrosis in high dose-rate (HDR) balloon-based breast brachytherapy (BBB).
PURPOSE
To investigate the incidence of and potential risk factors for fat necrosis in high dose-rate (HDR) balloon-based breast brachytherapy (BBB).
MATERIAL AND METHODS
Fifty-four patients were treated postoperatively with HDR-BBB between May 2007 and December 2010. Median age was 71 years (range: 50-88 years). Median tumor size was 1 cm (range: 0.1-2.7 cm). Forty-four had invasive histology; 43% were grade 1, 24% grade 2, and 15% grade 3. The median margin size was 0.7 cm (range: 0.1-1.5 cm).
RESULTS
With a median follow-up of 2.9 years (range: 0.5-5.2 years), local control was 98% with one in-breast failure, and overall survival was 89%. Fifty percent of patients experienced fat necrosis. Seven patients were symptomatic, with the remainder detected by mammography alone. Two patients required surgical resection with pathology confirming fat necrosis; 1 required i.v. steroids. At 1, 3, and 5 years following treatment, estimated cumulative incidences of fat necrosis were 7.5%, 52.7%, and 60.6%. Breast laterality, location, tumor size, histology, margin size, balloon volume, skin distance, skin dose, and number of dwell positions were not significantly associated with fat necrosis on univariate analysis.
CONCLUSIONS
In this retrospective review of HDR-BBB, we found a 50% incidence of both asymptomatic and symptomatic fat necrosis. Only three patients, however, required intervention. None of the risk factors considered were significantly associated with fat necrosis. Further studies evaluating factors associated with fat necrosis for patients undergoing HDR-BBB are necessary to appropriately assess the risks associated with treatment.
PubMed: 25829934
DOI: 10.5114/jcb.2015.49443 -
The British Journal of Surgery Aug 2013There are several additional techniques designed to enhance conventional percutaneous transluminal balloon angioplasty (PTA). This systematic review assessed current... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There are several additional techniques designed to enhance conventional percutaneous transluminal balloon angioplasty (PTA). This systematic review assessed current evidence on the clinical effectiveness of additional techniques for infrainguinal peripheral arterial occlusive disease (PAD).
METHODS
Relevant electronic databases, including MEDLINE, were searched in May 2011. The population comprised participants with symptomatic PAD undergoing endovascular treatment for disease distal to the inguinal ligament. Interventions were additional techniques compared with conventional PTA. Main outcome measures were restenosis and need for reintervention. Randomized clinical trials (RCTs) of clinical effectiveness were assessed for quality and data were extracted. Where appropriate, meta-analysis was undertaken to produce risk ratios (RRs).
RESULTS
Forty RCTs were selected. Meta-analysis showed a significant benefit in reducing restenosis rates at 6 months for self-expanding stents (RR 0.49) and drug-coated balloons (RR 0.40), and at 12 months for endovascular brachytherapy (RR 0.63). There was also evidence that use of a stent-graft significantly reduced restenosis compared with PTA, as did drug-eluting stents compared with bare-metal stents. Meta-analysis showed that use of drug-coated balloons was associated with significantly lower reintervention rates than PTA alone at 6 months (RR 0.24) and 24 months (RR 0.27) of follow-up. There was also evidence of significantly lower reintervention rates for self-expanding stents at 6 months. Other techniques did not show significant treatment effects for restenosis or reintervention.
CONCLUSION
The conclusions of this review should be tempered by small sample sizes, lack of clinical outcome measures and differing outcome definitions, making direct comparison across trials difficult. However, self-expanding stents, drug-eluting stents and drug-coated balloons appeared to be the most promising technologies worthy of future study.
Topics: Angioplasty, Balloon; Arterial Occlusive Diseases; Drug-Eluting Stents; Humans; Inguinal Canal; Peripheral Vascular Diseases; Randomized Controlled Trials as Topic; Reoperation; Secondary Prevention; Treatment Outcome
PubMed: 23842827
DOI: 10.1002/bjs.9196 -
Revista Espanola de Cardiologia Jul 2005Restenosis remains as the main limitation of percutaneous coronary intervention, even in the era of coronary stents. Recently, drug-eluting stents have been shown to... (Comparative Study)
Comparative Study Review
Restenosis remains as the main limitation of percutaneous coronary intervention, even in the era of coronary stents. Recently, drug-eluting stents have been shown to reduce significantly both the rate of in-stent restenosis and the need for subsequent revascularization procedures compared with bare-metal stents. At present, these beneficial effects have been demonstrated mainly with Cypher (Cordis Corporation) and Taxus (Boston Scientific) stents. They persist for at least 3 years after implantation. Although the results of some complex clinical angiographic studies are still awaited, all the indications suggest that use of this type of stent will become standard in percutaneous coronary interventions in the future. With regard to other techniques, intracoronary brachytherapy is effective only for the treatment of in-stent restenosis. The recent withdrawal from the market of brachytherapy catheters means that the technique has effectively disappeared from the interventional cardiologist's armamentarium, at least in our setting. Other devices, especially rotational atherectomy catheters and cutting balloons, will survive in the era of drug-eluting stents as they facilitate stent implantation in particularly complex lesions.
Topics: Angioplasty, Balloon, Coronary; Anti-Bacterial Agents; Atherectomy, Coronary; Brachytherapy; Coronary Restenosis; Delayed-Action Preparations; Forecasting; Humans; Immunosuppressive Agents; Paclitaxel; Polymers; Randomized Controlled Trials as Topic; Sirolimus; Stents; Time Factors
PubMed: 16022816
DOI: No ID Found -
Journal of Vascular Surgery Mar 2017Historically, edge stenosis and late thrombosis limited the effectiveness of adjunctive endovascular brachytherapy (EVBT) for in-stent restenosis (ISR) after...
OBJECTIVE
Historically, edge stenosis and late thrombosis limited the effectiveness of adjunctive endovascular brachytherapy (EVBT) for in-stent restenosis (ISR) after percutaneous transluminal angioplasty (PTA) and stenting. We evaluated an updated protocol of PTA and EVBT for ISR among patients with lower extremity occlusive disease.
METHODS
This is a retrospective, single-center review of patients treated with PTA and EVBT for ISR in the iliac and femoropopliteal segments between 2004 and 2012. A dose of 20 Gy was given at a depth of 0.5 mm beyond the radius of the largest PTA balloon using iridium 192, with at least 2-cm-long margins of radiation coverage proximal and distal to the injured area. Stents were assessed for patency by duplex ultrasound imaging at 1, 3, 6, 9, 12, and 18 months and then yearly. The primary end point was freedom from ≥50% restenosis in the treated segment at 6 months, 1 year, and 2 years. Patency data were estimated using the Kaplan-Meier method. Secondary end points were early and late thrombotic occlusion.
RESULTS
Among 42 consecutive cases in 35 patients of EVBT for ISR in common or external iliac (9 [20.8%]) and superficial femoral or popliteal (33 [76.7%]) arteries, or both, 21 patients (50%) had claudication, asymptomatic hemodynamically significant stenoses were identified on duplex ultrasound imaging in 16 (38.1%), and 4 (9.8%) had critical limb ischemia. Mean treated length was 23.5 ± 12.3 cm over a mean duration of 16.1 ± 9.6 minutes. There was one technical failure (2.3%). Median post-EVBT follow-up time was 682 days (range, 1-2262 days). There were two (4.9%) and five (11.9%) cases of early and late thrombotic occlusions, respectively. There was one death, believed to be secondary to acute coronary syndrome. Primary, assisted primary, and secondary patency in the entire cohort was 75.2%, 89.1%, and 89.1%, respectively, at 1 year and 63.7%, 80.6%, and 85.6%, respectively, at 2 years.
CONCLUSIONS
This contemporary protocol of PTA and adjunctive EVBT for lower extremity ISR, which is updated from those used in prior trials and includes a surveillance strategy that identifies at-risk stents for reintervention before occlusion, may be a promising treatment for lower extremity ISR at institutions where a close collaboration between vascular surgeons and radiation oncologists is feasible.
Topics: Aged; Angiography; Angioplasty, Balloon; Boston; Brachytherapy; Constriction, Pathologic; Critical Illness; Female; Femoral Artery; Humans; Intermittent Claudication; Ischemia; Kaplan-Meier Estimate; Lower Extremity; Male; Middle Aged; Peripheral Arterial Disease; Popliteal Artery; Radiation Dosage; Recurrence; Retreatment; Retrospective Studies; Risk Factors; Stents; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Vascular Patency
PubMed: 27986482
DOI: 10.1016/j.jvs.2016.10.002 -
Journal of Radiation Oncology Dec 2014(a) To prospectively determine if multidwell position dose delivery can decrease skin dose and resultant toxicity over single dwell balloon-catheter partial breast...
OBJECTIVES
(a) To prospectively determine if multidwell position dose delivery can decrease skin dose and resultant toxicity over single dwell balloon-catheter partial breast irradiation, and (b) to evaluate whether specific skin parameters could be safely used instead of skin-balloon distance alone for predicting toxicity and treatment eligibility.
METHODS
A single-arm phase II study using a Simon two-stage design was performed on 28 women with stage 0-II breast cancer. All patients were treated with multiple dwell position balloon-catheter brachytherapy. The primary endpoint was ≥ grade 2 skin toxicity. Initial entry required a balloon-skin distance ≥ 7 mm. Based on the toxicity in the first 16 patients, additional patients were treated irrespective of skin-balloon distance as long as the Dmax to 1 mm skin thickness was < 130%.
RESULTS
Compared to the phantom single dwell plans, multidwell planning yielded superior PTV coverage as per median V90, V95 and V100, but had slightly worse V150, V200 and DHI. Dmax to skin was decreased by multidwell planning at multiple skin thicknesses. The most common acute toxicity was grade 1 erythema (57%), and only two patients (7%) developed acute grade 2 toxicity (erythema). Late grade 1 fibrosis was seen in 32%. No patients experienced grade 3, 4, or 5 toxicity.
CONCLUSIONS
Multidwell position planning for balloon-catheter brachytherapy results in lower skin doses with equal to superior PTV coverage and an overall low rate of initial skin toxicity. Our data suggest that limiting the Dmax to < 130% to 1 mm thick skin is achievable and results in minimal toxicity.
PubMed: 25485042
DOI: 10.1007/s13566-014-0153-8 -
Journal of Contemporary Brachytherapy Mar 2013We perform a clinical retrospective study to determine whether a vaginal balloon-packing system provides a dosimetric reduction to organs at risk (OARs) versus...
PURPOSE
We perform a clinical retrospective study to determine whether a vaginal balloon-packing system provides a dosimetric reduction to organs at risk (OARs) versus traditional gauze packing for gynecological high-dose-rate brachytherapy (HDR-BT). We also test various balloon filling materials for optimizing imaging quality.
MATERIAL AND METHODS
Filling materials for balloon-packing were evaluated based on imaging quality with X-ray, computerized tomography, and magnetic resonance imaging modalities. We then retrospectively reviewed 45 HDR-BT plans of 18 patients performed with gauze packing and 39 plans of 16 patients performed with balloon-packing. Twelve patients received both gauze and balloon-packing. HDR-BT was delivered with an iridium-192 afterloader and a Fletcher-Suit-Declos-style T&O applicator. At each fraction, 3D imaging was obtained. The D2cc values of OARs were calculated, as well as ICRU-defined point doses.
RESULTS
In the 84 HDR fractions reviewed, vaginal balloon-packing provides statistically equivalent doses to rectum, bladder, and sigmoid compared to gauze packing. On average balloon-packing produced average reductions of 3.3% and 6.9% in the rectal and sigmoid D2cc doses and an increase of 3.2% to the bladder D2cc dose (normalized to prescription dose), although none of these values were statistically significant for the twelve patients who received both gauze and balloon-packing (32 and 40 total fractions, respectively).
CONCLUSIONS
In the 84 HDR fractions analyzed, vaginal balloon-packing is as effective as gauze packing for dose sparing to the rectum, bladder, and sigmoid. A 1: 1 solution of saline and contrast for filling material enables easy contouring for image-guided HDR with minimal artefacts.
PubMed: 23634151
DOI: 10.5114/jcb.2013.34449