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Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy-Related Macular Edema: 1-Year Outcomes.
Schefler, AC, Fuller, D, Anand, R, Fuller, T, Moore, C, Munoz, J, Kim, RS, ,
American journal of ophthalmology. 2020;:165-173
Abstract
PURPOSE To assess efficacy of intravitreal ranibizumab injections and targeted panretinal photocoagulation (TRP) for radiation retinopathy-related macular edema. DESIGN Phase IIb, prospective, randomized clinical trial. METHODS Setting: Multicenter. SUBJECTS Forty eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen equivalent). INTERVENTION Patients either received intravitreal 0.5 mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP. After week 52, all subjects entered a treat-and-extend protocol for ranibizumab. MainOutcomeMeasures: Mean Early Treatment Diabetic Maculopathy Study (ETDRS) BCVA change from baseline. RESULTS Mean patient age was 57 years (range, 22-80 years), ETDRS BCVA was 56.7 letters (20/74 Snellen equivalent), and central macular thickness (CMT) was 423 μm (range, 183-826 μm). Thirty-seven patients completed the month 12 visit (92.5%), at which time the change in mean BCVA was +4.0 letters, -1.9 letters, and +0.9 letters in the monthly, monthly plus laser, and PRN plus laser cohorts, respectively. There was a significant difference in mean BCVA at 1 year among all 3 cohorts (P < .001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. A total of 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters. CONCLUSIONS Ranibizumab may improve vision and anatomy in patients with radiation retinopathy-related macular edema and prevent vision loss through 48 weeks of therapy. Monthly injections were more effective than as-needed approach, and the addition of TRP yielded no therapeutic benefits.
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Validity and Reliability of Dermoscopic Criteria Used to Differentiate Nevi From Melanoma: A Web-Based International Dermoscopy Society Study.
Carrera, C, Marchetti, MA, Dusza, SW, Argenziano, G, Braun, RP, Halpern, AC, Jaimes, N, Kittler, HJ, Malvehy, J, Menzies, SW, et al
JAMA dermatology. 2016;(7):798-806
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Abstract
IMPORTANCE The comparative diagnostic performance of dermoscopic algorithms and their individual criteria are not well studied. OBJECTIVES To analyze the discriminatory power and reliability of dermoscopic criteria used in melanoma detection and compare the diagnostic accuracy of existing algorithms. DESIGN, SETTING, AND PARTICIPANTS This was a retrospective, observational study of 477 lesions (119 melanomas [24.9%] and 358 nevi [75.1%]), which were divided into 12 image sets that consisted of 39 or 40 images per set. A link on the International Dermoscopy Society website from January 1, 2011, through December 31, 2011, directed participants to the study website. Data analysis was performed from June 1, 2013, through May 31, 2015. Participants included physicians, residents, and medical students, and there were no specialty-type or experience-level restrictions. Participants were randomly assigned to evaluate 1 of the 12 image sets. MAIN OUTCOMES AND MEASURES Associations with melanoma and intraclass correlation coefficients (ICCs) were evaluated for the presence of dermoscopic criteria. Diagnostic accuracy measures were estimated for the following algorithms: the ABCD rule, the Menzies method, the 7-point checklist, the 3-point checklist, chaos and clues, and CASH (color, architecture, symmetry, and homogeneity). RESULTS A total of 240 participants registered, and 103 (42.9%) evaluated all images. The 110 participants (45.8%) who evaluated fewer than 20 lesions were excluded, resulting in data from 130 participants (54.2%), 121 (93.1%) of whom were regular dermoscopy users. Criteria associated with melanoma included marked architectural disorder (odds ratio [OR], 6.6; 95% CI, 5.6-7.8), pattern asymmetry (OR, 4.9; 95% CI, 4.1-5.8), nonorganized pattern (OR, 3.3; 95% CI, 2.9-3.7), border score of 6 (OR, 3.3; 95% CI, 2.5-4.3), and contour asymmetry (OR, 3.2; 95% CI, 2.7-3.7) (P < .001 for all). Most dermoscopic criteria had poor to fair interobserver agreement. Criteria that reached moderate levels of agreement included comma vessels (ICC, 0.44; 95% CI, 0.40-0.49), absence of vessels (ICC, 0.46; 95% CI, 0.42-0.51), dark brown color (ICC, 0.40; 95% CI, 0.35-0.44), and architectural disorder (ICC, 0.43; 95% CI, 0.39-0.48). The Menzies method had the highest sensitivity for melanoma diagnosis (95.1%) but the lowest specificity (24.8%) compared with any other method (P < .001). The ABCD rule had the highest specificity (59.4%). All methods had similar areas under the receiver operating characteristic curves. CONCLUSIONS AND RELEVANCE Important dermoscopic criteria for melanoma recognition were revalidated by participants with varied experience. Six algorithms tested had similar but modest levels of diagnostic accuracy, and the interobserver agreement of most individual criteria was poor.
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Long-term choroidal vascular changes after iodine brachytherapy versus transpupillary thermotherapy for choroidal melanoma.
Pilotto, E, Vujosevic, S, De Belvis, V, Parrozzani, R, Boccassini, B, Midena, E
European journal of ophthalmology. 2009;(4):646-53
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Abstract
PURPOSE To compare long-term choroidal vascular changes after iodine-125 brachytherapy (IBT) versus transpupillary thermotherapy (TTT) used as primary treatment of small choroidal melanoma. METHODS Ninety-five small choroidal melanomas were randomized: 49 eyes with TTT and 46 eyes with IBT alone. Fluorescein and indocyanine green angiography (ICGA) were performed at 3-month intervals during the first year, and every 6 months thereafter. RESULTS Mean follow-up was 56.2 months (range, 24-118 months; SD, 22.6). Tumor regressed in 45 (92%) TTT-treated vs 45 (98%) IBT-treated eyes (p=0.397). Four TTT-treated and one IBT-treated tumor recurred. Occlusion of choriocapillaris was present in all TTT and IBT cases. Closure of medium and large choroidal vessels was observed in 17 (35%) TTT-treated vs 44 (96%) IBT-treated eyes (p<0.001). Choroidal vascular remodeling was detected in 20 (41%) TTT-treated and 16 (35%) IBT-treated eyes (p=0.693). Retinochoroidal anastomosis was present in 4 of the 37 (11%) TTT-treated eyes with patency of medium and large choroidal vessels, but never observed in the IBT-treated eyes, and was associated with tumor recurrence. Among IBT-treated eyes, segments of choroidal vascular wall ICG staining and choroidal aneurysmal changes were detected in 30 (65%) and 7 (15%), respectively. These changes were never detected in TTT-treated cases (p<0.0001 and p=0.015, respectively). CONCLUSIONS The pattern of tumor choroidal vascular changes following IBT and TTT differs. TTT is less effective in closing all tumor vasculature. The role of long-term choroidal vascular remodeling observed after these two treatments needs longer follow-up.
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Controlled hypotension in adults undergoing choroidal melanoma resection: comparison between the efficacy of nitroprusside and magnesium sulphate.
Yosry, M, Othman, IS
European journal of anaesthesiology. 2008;(11):891-6
Abstract
BACKGROUND AND OBJECTIVE To determine whether magnesium sulphate could induce controlled hypotension, reduce choroidal blood flow, provide a 'dry' operative field and could be compared with sodium nitroprusside in the recently raised issue of the use of hypotensive anaesthesia in eye surgery, i.e. for choroidal tumour surgery as the choroid is the most fragile and vascular structure in the eye. METHODS Forty adult patients undergoing choroidal melanoma resection and anaesthetized with 2.5 mg kg(-1) propofol, followed by a constant infusion of 120 microg kg(-1) min(-1), and remifentanil 1 microg kg(-1), followed by a continuous infusion of 0.25 microg kg(-1) min(-1), were randomly assigned to two groups to receive either magnesium sulphate or sodium nitroprusside. RESULTS Controlled hypotension was achieved at the target systolic pressure of 80 mmHg within 107 +/- 16 and 69 +/- 4.4 s for magnesium sulphate and sodium nitroprusside, respectively. Choroidal blood flow decreased by 24 +/- 0.3% and 22 +/- 3.3% for magnesium sulphate and sodium nitroprusside, respectively. Controlled hypotension was sustained in both groups throughout surgery, and the surgical field rating decreased in a range of 80% in both groups. Sodium nitroprusside decreased pH and increased PaCO2. There were no postoperative complications in any of the groups. CONCLUSION Magnesium sulphate controlled hypotension, reduced intraoperative pressure and provided good surgical conditions for choroidal melanoma resection with no need for additional use of a potent hypotensive agent in adults.
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Current and future status of proton-beam radiation therapy in radiation oncology.
Cox, J
Clinical advances in hematology & oncology : H&O. 2007;(4):303-5
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Proton or stereotactic photon irradiation for posterior uveal melanoma? A planning intercomparison.
Höcht, S, Stark, R, Seiler, F, Heufelder, J, Bechrakis, NE, Cordini, D, Marnitz, S, Kluge, H, Foerster, MH, Hinkelbein, W
Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]. 2005;(12):783-8
Abstract
BACKGROUND AND PURPOSE Proton and stereotactic radiotherapy with photons (SRT) are both used to treat choroidal melanomas in proximity to optic disk and fovea centralis, a situation where plaque therapy is prone to complications. A comparative treatment- planning study was done to assess the capability of both modalities to preserve vision. PATIENTS AND METHODS In ten patients treated with 68-MeV protons, SRT with 6-MV photons was planned. Structures most important for visual acuity (fovea and optic disk, optic nerve) were contoured identically for both therapies. Safety margins of 1.5 mm for proton therapy were reduced to 1.0 mm for SRT. RESULTS Proton-beam therapy was superior in eight of ten situations, and this result did not differ significantly by changes in the weighting of the different parameters analyzed. CONCLUSION When dose deposition to those structures most important for the preservation of vision is taken into account, under the conditions examined proton therapy offers an advantage in the majority of the patients evaluated.
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Pegylated interferon-alpha2b treatment in melanoma patients: influence on amino acids, 5-hydroxyindolacetic acid and pteridine plasma concentrations.
Van Gool, AR, van Ojik, HH, Kruit, WH, Bannink, M, Mulder, PG, Eggermont, AM, Stoter, G, Fekkes, D
Anti-cancer drugs. 2004;(6):587-91
Abstract
Our objective was to study the influence of pegylated interferon-alpha2b (PEG-IFN-alpha) on the metabolism of amino acids and pteridines. We used an exploratory study into plasma concentrations of large neutral amino acids, 5-hydroxyindolacetic acid (5-HIAA), total biopterin (BIOP) and neopterin (NEOP) in 40 high-risk melanoma patients. Patients were randomized to treatment with PEG-IFN-alpha once a week in a dose of 6 microg/kg/week s.c. during 8 weeks, followed by a maintenance treatment of 3 microg/kg/week s.c. or to observation only. We found that treatment with PEG-IFN-alpha decreases tryptophan (TRP) concentrations in the first 3 months of treatment to a maximum of 25.3% compared to controls [95% confidence interval (CI): 14.9 to 34.4]. The TRP:LNAA ratio, an index for the availability of TRP to the central nervous system (CNS), decreases during 6 months with 18.8% (95% CI: 11.9 to 25.2). Concentrations of NEOP rose; however, concentrations of BIOP, the sum of tetrahydrobiopterin [BH4] and its oxidative products, did not decrease. The ratio of phenylalanine to tyrosine was increased with 11.7% (95% CI: 1.0 to 23.5) during 6 months. We conclude that, like conventional IFN-alpha, PEG-IFN-alpha lowers TRP concentrations and decreases the availability of TRP to the CNS. PEG-IFN-alpha has a similar influence on pteridine metabolism as standard IFN-alpha. If a lowered availability of TRP and a consequent decrease of serotonergic neurotransmission are indeed a mechanism underlying neuropsychiatric side-effects of IFN-alpha, patients on PEG-IFN-alpha are not at a lower risk of developing neuropsychiatric side-effects as patients on conventional IFN-alpha.
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Episcleral plaque 125I radiotherapy with episcleral LCF hyperthermia: a prospective randomized trial.
Girvigian, MR, Astrahan, MA, Lim, JI, Murphree, AL, Tsao-Wei, D, Petrovich, Z
Brachytherapy. 2003;(4):229-39
Abstract
PURPOSE The purpose of this study was to search for an optimal radiation dose in the treatment of patients with uveal melanoma using 125I episcleral plaque radiotherapy (EPRT) and episcleral hyperthermia (HT). METHODS AND MATERIALS From 1991-1998, 35 patients with uveal melanoma were enrolled in a phase II prospective randomized trial of 125I EPRT combined with episcleral HT. Two groups were closely matched for pre-treatment patient and tumor characteristics. Group 1: N = 16, and Group 2: N = 19. The median dose to the tumor apex for Group 1 was 80.0 Gy and 60.8 Gy for Group 2. Episcleral HT was given once for 45 min immediately prior to EPRT with a median temperature of 44 degrees C for both groups. The median follow-up was 5.5 years for Group 1 and 5.3 years for Group 2. RESULTS The median tumor height decreased 1.7 mm for patients of both groups. The 5- and 8-year probability of local recurrence was 33% for Group 1, and 25% for Group 2, p = 0.73. The 5-year probability of DFS was 54% for Group 1 and 67% for Group 2, p = 0.51. The 5- and 8-year overall survival was 68% and 34%, respectively, for Group 1, and 83% and 50%, respectively, for Group 2, p = 0.60. The rate of distant metastasis at 5- and 8-years for Group 1 was 29% and 62%, respectively, and 17% and 17%, respectively, for Group 2, p = 0.18. The incidence of enucleation was 4 (25%) in Group 1 vs. 4 (22%) in Group 2. The incidence of late complications was similar in either treatment group. The ambulatory visual acuity (> 5/200) at last follow-up was slightly better in Group 2 (80%) than Group 1 (64%). CONCLUSIONS Treatment outcomes were similar despite a 25% difference in radiation dose. In view of these findings and in an attempt to reduce the incidence of late treatment toxicity a still lower radiation dose in combination with HT needs to be studied. The reported outcomes need to be evaluated with caution due to the small number of patients in this study.
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The clinical relevance of molecular staging for melanoma.
Shivers, SC, Li, W, Lin, J, Stall, A, Stafford, M, Messina, J, Glass, LF, Reintgen, DS
Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer. 2001;:187-99
Abstract
The presence of metastatic disease in the regional nodal basin is the most important prognostic indicator for patients with malignant melanoma. The metastatic status of the sentinel lymph node (SLN), defined as the first node in the basin to drain a primary tumor, has been shown to represent that of the entire basin. Since routine histologic examination of lymph nodes often underestimates the presence of micrometastatic disease, a more sensitive assay for detecting tumor cells is needed. We have previously shown that a molecular assay based on the reverse transcriptase polymerase chain reaction (RT-PCR) was able to define a population of patients at higher risk for both recurrence and death, compared with routine H&E histology. Recently, we have compared "molecular staging" of patients by RT-PCR with conventional S-100 immunohistochemistry (IHC) staining of the SLNs. In these studies, SLN specimens were bivaled, and half of each specimen was examined by routine histology, including both H&E and S-100 IHC. The other half of each specimen was analyzed by a nested RT-PCR assay. H&E histology alone detected metastatic disease in 36 of 233 (16%) patients tested. Serial sectioning and IHC detected micrometastatic disease in another 16 patients, thus increasing the proportion of patients with nodal disease to 22%. RT-PCR detected micrometastatic disease in 114 of 181 patients who were negative by conventional methods, further increasing the proportion of patients with evidence of nodal disease to 70% overall. The clinical significance of these findings is still uncertain. The value of additional therapy (including elective lymph node dissection and interferon therapy) for patients who are positive only by the molecular method is currently being investigated by the national multi-center Sunbelt Melanoma Trial.