Publications by authors named "Oded Sagiv"

40 Publications

Kelly Punch Punctoplasty and Simple Punctal Dilatation Are Equally Effective for Punctal Stenosis: A Prospective Study.

Ophthalmic Plast Reconstr Surg 2021 Feb 11. Epub 2021 Feb 11.

Goldschleger Eye Institute Institute of Pathology, Sheba Medical Center, Tel Hashomer, Israel, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Purpose: To examine the clinical, imaging, and histopathologic differences between Kelly punch punctoplasty and punctal dilatation, both with mini Monoka stent insertion.

Methods: This is a prospective, comparative clinical study. Patients with bilateral punctal stenosis and for whom surgery was advised participated in the study. The right eye underwent Kelly punch punctoplasty and the left eye simple punctal dilatation, both with mini Monoka stents were participated. Data were collected and analyzed before and 3 months following the procedure and included the degree of epiphora (Munk score) and punctal size as measured by anterior segment optical coherence tomography (AC- OCT). All specimens removed by the Kelly punch punctoplasty were sent for histopathologic evaluation, including Masson's trichome muscle staining.

Results: The study included 46 eyes of 23 patients (4 males and 19 females) whose mean age at presentation was 60.43 ± 14.81 years (range 19-84 years). There was a significant decrease in the Munk score after both punctoplasties compared with baseline values (P < 0.01, matched pairs). There were no significant differences between groups in the delta Munk score. There was a significant increase in punctal size after both procedures compared with baseline values as measured by AS-OCT. Horner-Duverney's muscle was visible in only 3 of the 23 (13.04%) specimens from patients who underwent the Kelly punch punctoplasty.

Conclusions: The Kelly punch punctoplasty and the simple dilator punctoplasty, both with stents, are equally effective treatments for epiphora due to acquired punctal stenosis. Only a few specimens removed during the Kelly punch method show muscle fibers.
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http://dx.doi.org/10.1097/IOP.0000000000001940DOI Listing
February 2021

Quality of life of patients with thyroid eye disease: 3-year follow-up in a multidisciplinary clinic in Israel.

Graefes Arch Clin Exp Ophthalmol 2021 Feb 2. Epub 2021 Feb 2.

Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel.

Background: Changes in the quality of life (QOL) of patients with thyroid eye disease (TED) were examined during a 3-year follow-up in a multidisciplinary eye clinic, and factors that may improve QOL were identified.

Methods: A retrospective review of medical records of all patients who attended the TED clinic at Sheba Medical Center, Israel, from May 2016 to May 2019 was performed. The retrieved data included demographics, comprehensive ophthalmic examination findings, clinical activity scores (CAS), laboratory test results, and QOL assessments by the Graves' Orbitopathy QOL (GO-QOL) questionnaire.

Results: One hundred thirty-two TED clinic patients were examined. Thirty patients (22.72%) received medical treatment consisting of steroids according to the European Group on Graves' Orbitopathy (EUGOGO) protocol, high-dose steroids, or immunosuppressive drugs. Twenty-eight patients (21.21%) underwent surgical rehabilitation (decompression, strabismus, or eyelid surgery). There was a significant increase in total QOL score after steroid treatment according to the EUGOGO protocol, after decompression surgery, and after strabismus surgery compared to pre-treatment total QOL (p=0.04, p=0.021, and p=0.042, respectively, matched pairs). In addition, there were significant positive correlations between the changes in the total QOL score and the change in thyroid-stimulating immunoglobulin (TSI) as well as the change in CAS among the patients who underwent medical and surgical interventions.

Conclusions: QOL improved significantly after medical/surgical treatments. A change in the CAS and in the TSI may also correlate with change in QOL. Periodic evaluation of TED patients' QOL is recommended for enhanced and more comprehensive management.
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http://dx.doi.org/10.1007/s00417-021-05103-5DOI Listing
February 2021

Gender differences in clinical presentation and prognosis of thyroid eye disease.

Eur J Ophthalmol 2020 Nov 6:1120672120964112. Epub 2020 Nov 6.

Goldschleger Eye Institute, Sheba Medical Center, Tel-Hashomer, Israel.

Objective: To examine the clinical differences in manifestation, treatment, and prognosis of thyroid-eye-disease (TED) between men and women.

Methods: This is a longitudinal cohort study. Men and women, who diagnosed with TED and treated at a multidisciplinary TED clinic, were compared regarding differences in demographics, eye examination, disease activity, and quality of life evaluation.

Results: TED was diagnosed in 132 patients during the study period, and they included 38 men (28.78%) and 94 women (71.21%). There were six men and 20 women with active disease (Clinical-Activity-Score (CAS) ⩾ 3) during the entire follow-up period ( < 0.01). The mean time from TED diagnosis to CAS ⩾ 3 was 4.50 years for men and 2.35 years for women ( = 0.05). There were no significant differences in mean total Graves' Orbitopathy-Quality-of-Life questionnaire (GO-QOL) score. However, mean GO-QOL subtotal score of external appearance of women was significantly lower compare to men in the first and last visit ( = 0.04, 0.03, respectively).

Conclusion: Active disease was more common in women and the time-from-diagnosis of TED to CAS ⩾ 3 was shorter among women. Moreover, the appearance QOL score of women was poorer. These findings should be taken into consideration when planning the timing of treatment and when choosing the best treatment for TED patients.
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http://dx.doi.org/10.1177/1120672120964112DOI Listing
November 2020

Low-dose Bleomycin Injections for Orbital Lymphatic and Lymphatic-Venous Malformations: A Multicentric Case Series Study.

Ophthalmic Plast Reconstr Surg 2020 Nov 5. Epub 2020 Nov 5.

Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel.

Purpose: Orbital lymphatic malformations (LM) are associated with ocular morbidity and facial disfigurement. Surgery is challenging and may not be effective. We describe the outcome of bleomycin injections for venous LM and lymphatic-venous malformation (LVM) malformations of the orbit in 5 tertiary referral centers between January 2010 and December 2018.

Methods: Multicenter retrospective case series, 5 oculoplastic referral centers: Sheba and Rabin Medical Centers, Israel; Mulago Hospital, Uganda; Sri Sankaradeva Nethralaya, India; and Clinique Ophtalmologique de Tunis, Tunisia. All patients diagnosed with orbital LM/LVM were assigned to successive (range 1-6) intralesional 5 international units bleomycin injections. They all underwent complete ophthalmic and orbital evaluations, orbital imaging, and ancillary testing as needed. Clinical photographs were assessed pre- and posttreatment along with objective assessments of clinical improvement. Additional injections were provided in cases of incomplete response.

Results: A total of 21 patients (17 women, mean ± standard deviation age 18 ± 13 years, range 2-48 years) underwent bleomycin injections. The mean injection dose was 12 ± 10 international units in 1-3 injections. There was a dramatic improvement in lesion size, appearance, proptosis, and ocular motility in 20/21 patients (95%) after a mean follow-up of 18 months. Visual acuity slightly improved after treatment (20/50-20/30; P = 0.076). No side effects were noted after bleomycin injections.

Conclusions: Bleomycin injections for LM/LVM of the orbit are effective; local or systemic side effects were not seen in this series. To the best of our knowledge, this is the largest reported series of this treatment.
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http://dx.doi.org/10.1097/IOP.0000000000001870DOI Listing
November 2020

New insight into the physiologic function of Müller's muscle.

Exp Eye Res 2021 01 30;202:108336. Epub 2020 Oct 30.

The Goldschleger Eye Institute, Sheba Medical Center, Tel Hashomer, Israel, Affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address:

Purpose: Müller's muscle is a sympathetically innervated smooth muscle which serves as an accessory upper eyelid retractor. Its physiologic function and purpose have not yet been clearly defined. We hypothesize that sympathetic innervation to Müller's muscle serves to adjust the upper eyelid's position to variations in pupil size in response to changes in light intensity.

Methods: This is a single center cross-sectional study. Healthy volunteers were asked to fixate on a distant non-accommodative target, and a video scan of the anterior segment was performed for each subject's right eye using the Heidelberg Spectralis® optical coherence tomography scanner in infrared mode. The video was taken both in photopic and scotopic conditions, recording the resultant transition of the pupil and eyelids. The pupil diameter (PD), upper eyelid margin-to-reflex distance (MRD1), lower eyelid margin-to-reflex distance (MRD2), and vertical palpebral fissure height (PFH) were measured.

Results: Thirty-three healthy volunteers (19 women, 57.6%) with a median age of 40 years (range 30-58) were included. The mean PD under photopic conditions increased significantly under scotopic conditions, from 3483 ± 521 μm to 6135 ± 703 μm, respectively (P < 0.0001). An increase in MRD1 was observed following transition from light to dark, with a mean change of 348 ± 311 μm (P < 0.0001). There was no significant change in MRD2.

Conclusions: Upper eyelid retraction occurs after transition from photopic to scotopic conditions. This movement suggests the existence of an "eyelid-light reflex" involving Müller's muscle that adjusts the position of the eyelids as the pupil dilates under scotopic conditions.
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http://dx.doi.org/10.1016/j.exer.2020.108336DOI Listing
January 2021

Changes in Refraction and Visual Acuity after Upper Eyelid Blepharoplasty versus Posterior Approach Ptosis Procedures.

Ophthalmic Res 2020 5;63(6):588-592. Epub 2020 Mar 5.

Goldschleger Eye Institute, Sheba Medical Center, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Hashomer, Israel,

Purpose: To evaluate surgically induced refractive changes (SIRC) and visual acuity (VA) changes after blepharoplasty combined with posterior approach ptosis surgery (Müller's muscle-conjunctival resection [MMCR]) versus upper eyelid blepharoplasty alone.

Methods: In this prospective, comparative, clinical study on patients undergoing MMCR and blepharoplasty, comprehensive ophthalmic examinations were performed preoperatively and 3 months postoperatively. SIRC were calculated with the 10-step Holladay method.

Results: Fifty-six patients participated in the study, 31 in the blepharoplasty group and 25 in the ptosis group. logMAR VA improved significantly after surgery in both groups (p < 0.001). In both groups, most patients showed significant changes in SIRC sphere and spherical equivalent of >0.5 D (blepharoplasty group: 61.29 and 67.74%; ptosis group: 72.72 and 72.72%, respectively). Patients undergoing combined blepharoplasty ptosis surgery showed the greatest SIRC cylinder.

Conclusions: Upper eyelid blepharoplasty with or without MMCR is associated with significant SIRC 3 months postoperatively. This may affect decision-making for all patients, especially for those who intend to seek refractive correction in addition to the index upper eyelid surgery.
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http://dx.doi.org/10.1159/000506951DOI Listing
March 2020

PD-L1/PD1 Expression, Composition of Tumor-Associated Immune Infiltrate, and HPV Status in Conjunctival Squamous Cell Carcinoma.

Invest Ophthalmol Vis Sci 2019 05;60(6):2388-2398

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States.

Purpose: Conjunctival squamous cell carcinoma (SCC), a type of ocular surface neoplasia, is primarily treated by surgical resection and topical immuno- or chemotherapy. Metastatic disease may be treated with systemic chemo- or immunotherapy, albeit with variable response. The purpose of this study was to determine whether immune checkpoint blockade might be considered in the management of conjunctival SCC.

Methods: In this retrospective study, we evaluated tumor programmed death-ligand 1 (PD-L1) expression, high-risk human papillomavirus (HPV) status, and immunohistochemical expression of cluster of differentiation 3 (CD3), cluster of differentiation 8 (CD8), and programmed death 1 (PD1) in tumor-associated immune infiltrate in a series of 31 conjunctival SCCs.

Results: PD-L1 expression in ≥1% of tumor cells was noted in 14 conjunctival SCCs (47%) and was more prevalent in invasive than in situ SCC and among tumors with higher American Joint Committee on Cancer (AJCC) T category (≥T3 versus ≤T2). The density of CD3-positive T cells was higher in primary than recurrent tumors and higher in invasive than in situ tumors. Density of CD3-positive and CD8-positive T cells was higher in higher AJCC stage tumors. Density of CD8-positive T cells was higher in HPV-positive than HPV-negative tumors. PD-L1 expression correlated with a higher density of CD3-, CD8-, and PD1-positive cells in the tumor-associated immune infiltrate but not with HPV status.

Conclusions: Our findings demonstrate that PD-L1 is expressed in almost half of conjunctival SCCs. The density of tumor-associated immune cells correlated with invasive SCC, stage, and HPV status in conjunctival SCC. Our findings support further studies to establish the potential application of immune checkpoint blockade in the management of conjunctival SCC.
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http://dx.doi.org/10.1167/iovs.19-26894DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6890426PMC
May 2019

Validation Study of the AJCC Cancer Staging Manual, Eighth Edition, Staging System for Eyelid and Periocular Squamous Cell Carcinoma.

JAMA Ophthalmol 2019 05;137(5):537-542

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston.

Importance: To our knowledge, there are no validation studies to date of the prognostic value of the AJCC Cancer Staging Manual, eighth edition (AJCC 8), criteria for eyelid and periocular squamous cell carcinoma.

Objective: To determine the association of tumor (T) category in AJCC 8 with local recurrence, nodal metastasis, distant metastasis, and disease-specific survival (DSS) for eyelid and periocular squamous cell carcinoma.

Design, Setting, And Participants: In this retrospective, single-center cohort study, 109 consecutive patients with eyelid and periocular squamous cell carcinoma treated from January 1999 to April 2018 were included. Patients with secondary involvement of the periocular region were excluded.

Main Outcomes And Measures: Local recurrence, nodal metastasis, distance metastasis, and DSS.

Results: Of the 109 included patients, 81 (74.3%) were male, and the median (range) age was 66 (40-91) years. At presentation, 43 patients (39.4%) had recurrent tumor, 4 (3.7%) had nodal metastasis, and 1 (0.9%) had distant metastasis. The median (range) follow-up was 23 (1-161) months. During follow-up, 11 patients (10.1%) developed local recurrence, 7 (6.4%) developed nodal metastasis, 2 (1.8%) developed distant metastasis, and 9 (8.3%) died of disease. The 5-year DSS rate was 87.7% (95% CI, 79.5-96.9). Chronic immunosuppression (hazard ratio, 47.24; 95% CI, 7.33-304.30; P < .001) and presentation with recurrent squamous cell carcinoma (hazard ratio, 5.22; 95% CI, 1.12-24.31; P = .04) were associated with local recurrence during follow-up. Of the 11 patients with local recurrence during follow-up, 7 (64%) had perineural invasion. T category was associated with nodal metastasis; clinical stage of T2c or worse at presentation was associated with higher risk of nodal metastasis and death of disease but not with a higher risk of local recurrence. Distant metastasis was associated with nodal metastasis at presentation (hazard ratio, 32.50; 95% CI, 1.97-536.40; P = .02) and during follow-up. A total of 33 patients (30.3%) had different T categories depending on whether disease was staged according to the seventh or eighth edition of the AJCC Cancer Staging Manual. Compared with AJCC 7, AJCC 8 showed a better predictive value in terms of local recurrence (T3, 17% vs 14%; T4, 11% vs 16%) and DSS.

Conclusions And Relevance: These findings suggest that T category in AJCC 8 is associated with nodal metastasis and DSS. Immunosuppression and presentation with recurrent disease are associated with increased risk of future local recurrence. Patients with tumors of clinical stage T2c or worse at presentation are at increased risk of nodal metastasis and worse DSS and should undergo surveillance for nodal metastasis. Future studies, ideally prospective in design, could provide greater confidence in these findings.
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http://dx.doi.org/10.1001/jamaophthalmol.2019.0238DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6512305PMC
May 2019

Subcutaneous tranexamic acid in upper eyelid blepharoplasty: a prospective randomized pilot study.

Can J Ophthalmol 2018 12 27;53(6):600-604. Epub 2018 Mar 27.

Mohs Unit, Sheba Medical Center, Tel Hashomer, affiliated to the Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.

Objective: Postoperative ecchymoses or hematomas can prolong healing from surgery, and a search for locally administered agents that decrease bleeding is warranted. The objective of this study is to evaluate whether preoperative subcutaneous injection of tranexamic acid (TXA) reduces intra- and postoperative bleeding or ecchymoses in skin-only upper eyelid blepharoplasty surgery.

Design: This is a prospective randomized, double-blind, controlled study.

Participants: We included 34 consecutive patients who were referred to an upper eyelid blepharoplasty surgery in our institution.

Methods: The patients were equally randomized to a preoperative local injection of lidocaine mixed with either TXA or normal saline. All patients stopped antiaggregates 1 week before surgery. All surgeries were performed by a single surgeon who was unaware of group assignment. Total surgical time, cumulative time of cautery use, blood loss, the surgeon's assessment of bleeding extent, pain level reported by the patient, periocular ecchymoses during the first postoperative week, and time for patient's return to normal daily activity were recorded.

Results: There was a trend toward smaller ecchymoses in the TXA group compared with the placebo group on the seventh day (p = 0.072). There were no group differences in total surgery time, cumulative cautery time, net blood weight in surgical pads, patient-reported pain level, surgeon's assessment of hemostasis, or periocular ecchymosis size on the first postoperative day.

Conclusions: Subcutaneous TXA was associated with similar intra- and postoperative hemorrhage in upper eyelid blepharoplasty compared with placebo. The effect of TXA in patients who did not stop antiaggregate use before surgery warrants further study.
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http://dx.doi.org/10.1016/j.jcjo.2018.01.006DOI Listing
December 2018

Distinct Biological Types of Ocular Adnexal Sebaceous Carcinoma: HPV-Driven and Virus-Negative Tumors Arise through Nonoverlapping Molecular-Genetic Alterations.

Clin Cancer Res 2019 02 12;25(4):1280-1290. Epub 2018 Nov 12.

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.

Purpose: Ocular adnexal (OA) sebaceous carcinoma is an aggressive malignancy of the eyelid and ocular adnexa that frequently recurs and metastasizes, and effective therapies beyond surgical excision are lacking. There remains a critical need to define the molecular-genetic drivers of the disease to understand carcinomagenesis and progression and to devise novel treatment strategies.

Experimental Design: We present next-generation sequencing of a targeted panel of cancer-associated genes in 42 and whole transcriptome RNA sequencing from eight OA sebaceous carcinomas from 29 patients.

Results: We delineate two potentially distinct molecular-genetic subtypes of OA sebaceous carcinoma. The first is defined by somatic mutations impacting and/or [20/29 (70%) patients, including 10 patients whose primary tumors contained coexisting and mutations] with frequent concomitant mutations affecting genes. These tumors arise in older patients and show frequent local recurrence. The second subtype [9/29 (31%) patients] lacks mutations affecting , or family members, but in 44% (4/9) of these tumors, RNA sequencing and hybridization studies confirm transcriptionally active high-risk human papillomavirus. These tumors arise in younger patients and have not shown local recurrence.

Conclusions: Together, our findings establish a potential molecular-genetic framework by which to understand the development and progression of OA sebaceous carcinoma and provide key molecular-genetic insights to direct the design of novel therapeutic interventions.
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http://dx.doi.org/10.1158/1078-0432.CCR-18-1688DOI Listing
February 2019

Pathological Features and Clinical Course in Patients With Recurrent or Malignant Orbital Solitary Fibrous Tumor/Hemangiopericytoma.

Ophthalmic Plast Reconstr Surg 2019 Mar/Apr;35(2):148-154

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery.

Purpose: A risk assessment score for metastasis based on age, tumor size, and mitotic figures has been suggested for nonorbital solitary fibrous tumor (SFT)/hemangiopericytoma. The authors herein examine the clinicopathological features of recurrent and metastatic orbital SFT and evaluate the existing risk assessment score for orbital SFT.

Methods: The American Society of Ophthalmic Plastic and Reconstructive Surgery Oncology Database was queried for patients with recurrent or malignant orbital hemangiopericytoma/SFT. The medical records were reviewed for clinical and pathologic findings, treatments, and outcomes.

Results: Eight patients from 3 institutions were identified with recurrent orbital hemangiopericytoma/SFT. Median age at diagnosis was 59 years, and 4 patients were women. The mean size of tumor was 2.1 ± 1.1 cm. All patients were initially treated with surgery and experienced local recurrence after a median of 4 (range 0.5-10) years. Five patients were treated with orbital radiation. Two patients also developed distant metastases and eventually died of their disease. Median Ki-67 was 5% (range 1-65%) and 5 mitotic figures/10 high-power fields (range 2-30). The previously described risk stratification model for nonorbital SFT did not correlate with the propensity to develop metastases in this cohort; however, both patients with distant metastasis had > 4 mitotic figures /10 high-power fields.

Conclusions: In this cohort of recurrent orbital hemangiopericytoma/SFT, median time to recurrence was 4 years underscoring the importance of careful continued follow-up. The current risk stratification models have limited use for orbital lesions, mostly due to the fact that orbital SFTs are smaller than even the smallest size criteria in this risk assessment model.
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http://dx.doi.org/10.1097/IOP.0000000000001189DOI Listing
December 2019

Impact of Food and Drug Administration Approval of Vismodegib on Prevalence of Orbital Exenteration as a Necessary Surgical Treatment for Locally Advanced Periocular Basal Cell Carcinoma.

Ophthalmic Plast Reconstr Surg 2019 Jul/Aug;35(4):350-353

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery.

Purpose: To test the hypothesis that the US Food and Drug Administration approval of vismodegib in early 2012 has reduced the prevalence of orbital exenteration for locally advanced periocular basal cell carcinoma (BCC).

Methods: Following institutional review board approval, the authors reviewed clinical and pathological data of patients with locally advanced periocular BCC (T4 per the eyelid carcinoma classification in the 8th edition of the AJCC Cancer Staging Manual) treated by the senior author during 2006-2018. Patients were grouped into those who were treated before February 2012 ("before vismodegib approval") and those who presented later ("after vismodegib approval").

Results: Forty-two patients with locally advanced periocular BCC were treated during the study period, of whom 31 were men. The median age at presentation was 66 years (range, 43-90). Twenty-two patients had T4a and 20 had T4b tumors. Thirteen patients were treated before and 29 were treated after vismodegib approval. The 2 groups did not differ in age distribution (p = 0.164), sex distribution (p = 0.270), prevalence of recurrent tumor at presentation (p = 0.317), or duration of treatment with vismodegib (p = 0.605). Orbital exenteration was significantly more prevalent in patients treated before vismodegib approval than after (46% vs. 10%, p = 0.016), and vismodegib treatment was significantly more prevalent in patients treated after vismodegib approval than before (when vismodegib was given in clinical trials; 69% vs. 23%, p = 0.008). There was a trend toward more patients retaining their eyes at last follow-up in patients treated after vismodegib approval (83% vs. 54%, p = 0.066).

Conclusions: The prevalence of orbital exenteration as a necessary surgical procedure in patients with a locally advanced periocular BCC has fallen since the Food and Drug Administration approval of vismodegib. Although vismodegib is not specifically approved for organ-sparing, it has changed the authors' practice and enabled eye preservation in patients with locally advanced periocular BCC, who would otherwise require an orbital exenteration.
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http://dx.doi.org/10.1097/IOP.0000000000001251DOI Listing
December 2019

Immunotherapy With Programmed Cell Death 1 Inhibitors for 5 Patients With Conjunctival Melanoma.

JAMA Ophthalmol 2018 11;136(11):1236-1241

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston.

Importance: Conjunctival melanoma has the potential for regional lymphatic and distant metastasis. There is an urgent need for effective treatment for patients with metastatic or locally advanced conjunctival melanoma.

Objective: To describe the use of immune checkpoint inhibitors for the treatment of conjunctival melanoma in 5 adult patients.

Design, Setting, And Participants: A retrospective review was conducted of the medical records of 5 patients with conjunctival melanoma who were treated with immune checkpoint inhibitors from March 6, 2013, to July 7, 2017.

Main Outcomes And Measures: Response to treatment and disease-free survival.

Results: Of the 5 patients (4 women and 1 man) with metastatic conjunctival melanoma, 4 were treated with a programmed cell death 1 (PD-1) inhibitor, nivolumab, and had a complete response to treatment with no evidence of disease at 1, 7, 9, and 36 months after completing treatment. One patient with metastatic conjunctival melanoma was treated with another PD-1 inhibitor, pembrolizumab, and had stable metastases during the first 6 months of treatment. Later disease progression resulted in treatment cessation after 11 months and switching to another therapy. Two patients treated with nivolumab developed autoimmune colitis that necessitated stopping the immunotherapy; these patients subsequently were managed with systemic corticosteroids or infliximab.

Conclusions And Relevance: This case series report suggests that anti-PD-1 therapy can be used to treat metastatic conjunctival melanoma. Longer follow-up is needed to determine the long-term disease-free survival. Future studies might assess the potential for immune checkpoint inhibitors to obviate the need for orbital exenteration in selected patients with locally advanced disease.
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http://dx.doi.org/10.1001/jamaophthalmol.2018.3488DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6248169PMC
November 2018

Unilateral Triangular Cataract in an Adult.

JAMA Ophthalmol 2018 10 11;136(10):e182822. Epub 2018 Oct 11.

Goldschleger Eye Institute, Sheba Medical Center, Tel-Hashomer, Israel.

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http://dx.doi.org/10.1001/jamaophthalmol.2018.2822DOI Listing
October 2018

High expression of PD-1 and PD-L1 in ocular adnexal sebaceous carcinoma.

Oncoimmunology 2018;7(9):e1475874. Epub 2018 Jul 26.

Department of Pathology, Section of Dermatopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.

Ocular adnexal sebaceous carcinoma (OASC) is an aggressive malignancy that frequently recurs locally and metastasizes. Surgical extirpation may produce significant aesthetic morbidity, and effective systemic therapies for locally advanced or metastatic disease are largely ineffective. Immune checkpoint inhibitors have shown efficacy in the management of several solid tumors where tumor cell PD-L1 expression correlates with improved response. To determine whether OASC might be amenable to immune checkpoint blockade, we performed comprehensive immune profiling for CD3, CD8, PD-1, FOXP3, and PD-L1 in 24 patients with primary OASC. The composition, distribution and density of the tumor associated immune infiltrate were quantified by automated image analysis and correlated with measures of clinical outcome. Tumor cells in 12 OASCs (50%) expressed PD-L1. Higher densities of CD3+ (p = 0.01), CD8+ (p = 0.006), and PD-1+ (p = 0.024) tumor-associated T cells were associated with higher T category (≥T3a per the 7th edition of the American Joint Committee on Cancer staging manual). Higher tumor cell expression of PD-L1 correlated with higher density of PD-1+ tumor-associated T cells (p = 0.021). Since a CD3+ CD8+ PD-1 + T-cell infiltrate represents a "suppressed T-cell phenotype" apparently permissive toward OASC progression, our findings provide a mechanistic rationale for the effective application of immune checkpoint blockade in OASC to abrogate PD-1/PD-L1 interaction and effectively unleash the immune infiltrate to treat higher-stage tumors.
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http://dx.doi.org/10.1080/2162402X.2018.1475874DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6140585PMC
July 2018

Prognostic factors for local recurrence, metastasis and survival for sebaceous carcinoma of the eyelid: observations in 100 patients.

Br J Ophthalmol 2019 07 21;103(7):980-984. Epub 2018 Aug 21.

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Background/aims: To validate the predictive value of the American Joint Committee on Cancer (AJCC) 8th-edition classification for local recurrence, metastasis and survival in patients with eyelid sebaceous carcinoma.

Methods: We performed a retrospective review of 100 consecutive patients with eyelid sebaceous carcinoma. Eyelid carcinomas were staged according to the AJCC 7th-edition and 8th-edition criteria. Associations between T and N categories and disease-related outcomes including local recurrence, lymph node metastasis, distant metastasis and survival were evaluated.

Results: 60 women and 40 men had a median age of 67 years (range, 41-94 years). The proportions of patients who experienced local recurrence, lymph node metastasis, distant metastasis and death from disease were 6%, 21%, 7% and 6%, respectively. Two-year and 5-year disease-specific survival (DSS) rates were 93.8% and 92.0%, respectively. There were significant correlations between (1) T2c or worse category and lymph node metastasis (p=0.04) and distant metastasis (p=0.01), (2) T3b or worse category and local recurrence (p=0.01) and death from disease (p=0.01) and (3) N1 category at presentation and distant metastasis (p<0.01) and death from disease (p<0.01). The AJCC 8th-edition classification showed a better homogeneity of the T-category distribution (p<0.01) and a slightly higher discrimination ability for lymph node metastasis (C=0.734 vs C=0.728) than the 7th-edition.

Conclusions: T and N categories per AJCC 8th-edition classification are predictive of local recurrence, metastasis and DSS outcomes for eyelid sebaceous carcinoma. Surgeons should perform strict surveillance testing for nodal and systemic metastases in patients with T2c or worse T category and/or N1 disease at presentation.
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http://dx.doi.org/10.1136/bjophthalmol-2018-312635DOI Listing
July 2019

Prevalence of a Histologic Change of Ocular Adnexal Lymphoma in Patients With a History of Lymphoma.

Ophthalmic Plast Reconstr Surg 2019 May/Jun;35(3):243-246

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A.

Purpose: The authors examined the prevalence of a histologic change of ocular adnexal lymphoma (OAL) grade in patients with a history of lymphoma in nonocular sites.

Methods: In this retrospective study, the authors reviewed the clinical and pathological data of 209 patients with OAL treated by the senior author during 2000 to 2017.

Results: Of 209 patients with OAL, 65 (31%) had a history of lymphoma. In 54 of the 65 patients (83%), the original lymphoma and OAL were of the same histologic type. In 8 of the 65 patients (12.3%), the OAL was more indolent than the original lymphoma: 6 patients with a history of diffuse large B-cell lymphoma, one of mantle cell lymphoma, and one of grade 3 follicular lymphoma had biopsy-proven extranodal marginal-zone lymphoma in the orbital area. Two additional patients (3%) with a history of chronic lymphocytic leukemia developed OAL: diffuse large B-cell lymphoma in one patient and extranodal marginal-zone lymphoma in the other. One patient (1.5%) with a history of a low-grade follicular lymphoma relapsed as a different low-grade histology of extranodal marginal-zone lymphoma. Lower-grade OAL than the original lymphoma was more common than higher-grade OAL than the original lymphoma (p = 0.048).

Conclusions: In this cohort of 209 patients with OAL, the authors found that nearly one third had a history of lymphoma, 17% of whom had a different histologic type of lymphoma in the orbit, more commonly a more indolent type. This underscores the importance of biopsy of OAL even in patients with a known history of lymphoma to determine the histologic subtype of orbital lymphoma and to help guide appropriate treatment.
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http://dx.doi.org/10.1097/IOP.0000000000001215DOI Listing
January 2020

Ocular preservation with neoadjuvant vismodegib in patients with locally advanced periocular basal cell carcinoma.

Br J Ophthalmol 2019 06 18;103(6):775-780. Epub 2018 Jul 18.

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA

Background/aims: Locally advanced (T4 per American Joint Committee on Cancer (AJCC) 8th edition) periocular basal cell carcinoma (BCC) can lead to loss of the eye. We report the neoadjuvant use of vismodegib followed by surgery in patients with such lesions with eye preservation as primary goal.

Methods: This retrospective interventional study includes all patients with a T4 periocular BCC (per 8th edition AJCC for eyelid carcinoma) treated by the senior author between 2013 and 2017 with neoadjuvant vismodegib prior to definitive surgery.

Results: Eight patients had a T4 tumour. Six patients presented with recurrent disease. Indications for neoadjuvant treatment were an unresectable tumour in one patient, an attempt to avoid an orbital exenteration in six patients and an attempt to avoid disfiguring facial surgery in one patient. Patients were treated for a median of 14 months (range: 4-36 months). All patients underwent an eye-sparing surgery following neoadjuvant vismodegib and all final surgical margins were negative for tumour. Five patients had a complete response to vismodegib with no microscopic residual BCC found during surgery; three patients had a significant partial response with residual tumour found on pathology. At last follow-up, a mean of 18 (range: 6-43) months after surgery, all patients were off-vismodegib and alive without evidence of disease.

Conclusions: Neoadjuvant vismodegib for locally advanced (T4) periocular BCC enabled an eye-sparing surgery in all patients in our cohort. Prolonged treatment was well tolerated by most patients. Over half of patients achieved a complete response with no residual microscopic disease. Careful long-term follow-up is needed to confirm long-term disease-free survival.
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http://dx.doi.org/10.1136/bjophthalmol-2018-312277DOI Listing
June 2019

Periocular Ecchymoses in Neuroblastoma Metastatic to the Orbit.

Ophthalmology 2018 07;125(7):983

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.

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http://dx.doi.org/10.1016/j.ophtha.2018.03.033DOI Listing
July 2018

Extraocular Muscle Enlargement and Thyroid Eye Disease-like Orbital Inflammation Associated with Immune Checkpoint Inhibitor Therapy in Cancer Patients.

Ophthalmic Plast Reconstr Surg 2019 Jan/Feb;35(1):50-52

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery.

Purpose: To describe thyroid eye disease (TED)-like orbital inflammatory syndrome in 3 cancer patients treated with immune checkpoint inhibitors.

Methods: All consecutive patients treated by the senior author who were receiving immune checkpoint inhibitors and developed TED-like orbital inflammation were included.

Results: Three cancer patients treated with immune checkpoint inhibitors developed orbital inflammation. The first patient was treated with a combination of a cytotoxic T-lymphocyte antigen-4 inhibitor and a programmed cell death protein 1 inhibitor and developed TED-like orbital inflammation with normal thyroid function and antibody levels. The second patient had a previous diagnosis of Graves disease without TED, and developed TED soon after initiating treatment with a programmed cell death protein 1 inhibitor. The third patient developed acute hyperthyroidism with symptomatic TED following treatment with an investigational cytotoxic T-lymphocyte antigen-4 inhibitor agent. All 3 patients were managed with either systemic steroids or observation, with resolution of their symptoms and without the need to halt immune checkpoint inhibitor treatment for their cancer.

Discussion And Conclusions: TED-like orbital inflammation may occur as a side effect of immune checkpoint inhibitor therapy with anti-cytotoxic T-lymphocyte antigen-4 or anti-PD-1 inhibitors. To the best of their knowledge, this is the first reported case of TED as a result of programmed cell death protein 1 inhibitor monotherapy. All 3 patients were treated with systemic steroids and responded quickly while continuing treatment with immune checkpoint inhibitors for their cancer. With increasing use of this class of drugs, clinicians should be familiar with the clinical manifestations and treatments for this adverse reaction.
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http://dx.doi.org/10.1097/IOP.0000000000001161DOI Listing
December 2019

Change in Eyelid Carcinoma T Category With Use of the 8th Versus 7th Edition of the American Joint Committee on Cancer: Cancer Staging Manual.

Ophthalmic Plast Reconstr Surg 2019 Jan/Feb;35(1):38-41

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery.

Purpose: To evaluate the frequency and nature of changes in T category when eyelid carcinomas are staged using the criteria in the 8th edition instead of the 7th edition of the American Joint Committee on Cancer staging manual.

Methods: Following Institutional Review Board approval, a retrospective review was conducted for all consecutive patients with the diagnosis of eyelid carcinoma treated by the senior author from January 2012 through December 2016. After a review of the clinical and pathologic data, each patient's disease was staged using both the 7th-edition and 8th-edition American Joint Committee on Cancer criteria for eyelid carcinomas. Changes in T categories between the 2 staging systems were examined.

Results: The review initially identified 167 patients with the diagnosis of eyelid carcinoma. Four patients were excluded because of incomplete or unclear data. The remaining 163 patients included 78 men and 85 women aged 21 to 97 years (median, 68 years). Eighty-two patients had basal cell carcinoma; 35, squamous cell carcinoma; 32, sebaceous carcinoma; 6, mucinous eccrine carcinoma; 3, Merkel cell carcinoma; 3, adenocarcinomas; and 2, adnexal carcinoma. The most common T category according to the 7th-edition criteria was T2a; the most common T category according to the 8th-edition criteria was T1b. Of the 163 patients, 64 (39%) had a lower T category with the 8th-edition than with the 7th-edition criteria, 59 (36%) had a higher T category, and 40 (25%) had the same T category.

Conclusions: Application of the 8th-edition American Joint Committee on Cancer criteria for eyelid carcinoma changed the T category in 75% of patients. In general, the new 8th-edition American Joint Committee on Cancer tumor, node, metastasis (TNM) designations allow for a more objective and consistent designation of the T category.
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http://dx.doi.org/10.1097/IOP.0000000000001133DOI Listing
December 2019

Eye-Preserving Surgery Followed by Adjuvant Radiotherapy for Lacrimal Gland Carcinoma: Outcomes in 37 Patients.

Ophthalmic Plast Reconstr Surg 2018 Nov/Dec;34(6):570-574

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A.

Purpose: To describe the clinical outcomes of eye-preserving surgery followed by adjuvant radiotherapy in patients with lacrimal gland carcinoma.

Methods: Thirty-seven patients with lacrimal gland carcinoma who underwent eye-preserving surgery were studied.

Results: At last follow up, 32 patients were alive without disease, 3 patients were alive with disease with distant metastasis, 1 patient had died of disease, and 1 patient had died of other cause. The 5-year recurrence-free survival rate was worse in patients without than in patients with adjuvant radiotherapy (p = 0.001) and worse in patients with T3-T4 tumors than in patients with T1-T2 tumors (p = 0.027). At last follow up, 25 patients (68%) had visual acuity of 20/40 or better.

Conclusions: In patients with lacrimal gland carcinoma, eye-preserving surgery and adjuvant radiotherapy is associated with reasonable local control rates and visual and ocular function. Postoperative adjuvant radiotherapy seems to enhance local control rates.
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http://dx.doi.org/10.1097/IOP.0000000000001106DOI Listing
May 2019

Desmoplastic Melanoma of the Periorbital Region.

Ophthalmic Plast Reconstr Surg 2018 Mar/Apr;34(2):e48-e52

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, Department of Pathology, Department of Translational and Molecular Pathology, Department of Head and Neck Surgery, Department of Melanoma Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A, and St. John of Jerusalem Eye Hospital Group, East Jerusalem, Israel.

Desmoplastic melanoma (DM) is a rare subtype of melanoma and an even smaller proportion of periocular melanomas. Here, the authors report 2 cases of DM in the periocular region. Staged according to the American Joint Committee on Cancer (AJCC) eighth edition classification, patient 1 presented with a stage IIIC (pT4apN1cM0) DM in the left lateral canthus with upper and lower eyelid and patient 2 presented with a stage IIIB (T4aN1bM0) DM in the left brow and supraorbital region with a parotid lymph node metastasis. In both patients, the lesions were amelanotic, with inflammatory appearance, and had been noted for several years before the correct diagnosis was made. In both patients, wide excision led to large surgical defects, and perineural invasion prompted adjuvant radiation therapy postoperatively. Patient 2 was treated with an immune checkpoint inhibitor for his parotid metastasis. Ophthalmologists should be aware of DM, its neurotrophic nature, and potential to metastasize with locally advanced lesions.
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http://dx.doi.org/10.1097/IOP.0000000000001015DOI Listing
July 2018

Clinical Course of Preseptal and Orbital Cellulitis in 50 Immunocompromised Patients with Cancer.

Ophthalmology 2018 02 8;125(2):318-320. Epub 2017 Nov 8.

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas. Electronic address:

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http://dx.doi.org/10.1016/j.ophtha.2017.10.006DOI Listing
February 2018

Different Clinical Courses on Long-Term Follow-Up of Age-Related Macular Degeneration Patients Treated with Intravitreal Anti-Vascular Endothelial Growth Factor Injections.

Ophthalmologica 2017 20;238(4):217-225. Epub 2017 Sep 20.

The Goldschleger Eye Institute, Sheba Medical Center, Tel HaShomer, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.

Purpose: To assess the long-term outcome of neovascular age-related macular degeneration (AMD) treated with multiple intravitreal anti-vascular endothelial growth factor (VEGF) injections.

Methods: All patients treated with over 30 intravitreal anti-VEGF injections for neovascular AMD between 2007 and 2014 were retrospectively reviewed.

Results: A total of 67 eyes received 2,960 (mean 45 ± 9.1 per eye) anti-VEGF injections. Eyes with good final visual acuity (VA) had better initial VA (p = 0.020) and maintained it. Patients with moderate-to-poor final VA improved significantly after the first 3 monthly injections, and thereafter deteriorated consistently, mostly during the third (p = 0.019) and fourth (p = 0.006) years. Eyes with worse final VA had more intraretinal fluid (p = 0.05) and subretinal fibrosis (p = 0.04).

Conclusion: Two distinct clinical courses were identified: good final VA was associated with initial and long-term stability of good VA; eyes with worse final VA had worse initial VA, progressive deterioration following the initial improvement, and more scarring and intraretinal fluid. This probably underscores the long-term benefits of early detection and treatment.
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http://dx.doi.org/10.1159/000479437DOI Listing
November 2017

Rituximab Monotherapy Is Effective in Treating Orbital Necrobiotic Xanthogranuloma.

Ophthalmic Plast Reconstr Surg 2018 Jan/Feb;34(1):e24-e27

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, Department of Lymphoma and Myeloma, Department of Pathology, and Department of Translational and Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas, U.S.A.

The authors report a case of a patient with bilateral orbital necrobiotic xanthogranuloma and no associated systemic paraproteinemia. Orbital biopsy showed strong expression of CD20-positive cells. The patient was treated with systemic rituximab monotherapy, with excellent clinical response and marked regression of the orbital lesions on imaging. At the time of writing, the patient has been treated with bimonthly rituximab maintenance therapy for 22 months and has stable clinical and imaging findings with sustained response to treatment and no reported side effects. To the authors' knowledge, this is the first reported case of orbital necrobiotic xanthogranuloma successfully treated with rituximab monotherapy. They hope that this well-documented case will encourage clinicians to consider rituximab monotherapy as a possible treatment option, albeit one entailing an off-label use of this drug, for patients with necrobiotic xanthogranuloma of the orbit.
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http://dx.doi.org/10.1097/IOP.0000000000000988DOI Listing
February 2018

The impact of IgG-4-ROD on the diagnosis of orbital tumors: A retrospective analysis.

Orbit 2017 Dec 22;36(6):359-364. Epub 2017 Aug 22.

b Sheba Medical Center , Tel Hashomer , Israel.

This study was to determine the prevalence of immunoglobulin G4 (IgG4)-related orbital disease (IgG4-ROD) among patients who have previously undergone biopsy and were diagnosed to have idiopathic orbital inflammatory disease (IOID) or orbital lymphoproliferative disease (OLD), namely, lymphoma and benign reactive lymphoid hyperplasia (BRLH). This is a retrospective cross-sectional study. The charts and slides of all patients who underwent biopsies and were histopathologically diagnosed to have either IOID or OLD were reviewed. Demographics, clinical features, initial histopathological diagnoses, treatment received, and final outcome were noted. Using the diagnostic criteria for diagnosis for IgG4 disease, those cases that would classify as "possible IgG4-related disease (IgG4-RD)" were reviewed, reclassified, and reassigned a diagnosis of IgG4-ROD. We reviewed 105 patients' clinical charts. Of these 105 patients, upon reviewing the histopathology, 18 (17.15%) patients were found to fit the diagnostic criteria for possible IgG4-ROD. Of these 18 patients who were now reassigned the diagnosis of IgG4-ROD, the most common previous histopathological diagnosis was found to be IOID, for eight patients (44%), then BRLH, which was noted in five patients (27.8%), followed by lymphoma, which was noted in two patients (11.1%). Previously diagnosed cases of IOID and OLD were found to fulfill the criteria for IgG4-ROD. Given the advent of recent diagnostic and histopathological techniques, all cases of suspected IOID and OLD should be screened for IgG4-ROD and all previously diagnosed cases must be closely followed up, given the systemic implication of IgG4-RD. Histopathological reassessment of previously diagnosed cases may be considered.
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http://dx.doi.org/10.1080/01676830.2017.1337192DOI Listing
December 2017

Clinical Presentation and Anatomical Location of Orbital Plasmacytomas.

Ophthalmic Plast Reconstr Surg 2018 May/Jun;34(3):258-261

Orbital Oncology and Ophthalmic Plastic Surgery, Department of Plastic Surgery, The University of Texas M.D. Anderson Cancer Center, Houston, Texas.

Purpose: To evaluate the clinical and anatomical location of orbital plasmacytomas and assess local control following therapy.

Methods: The American Society of Ophthalmic Plastic and Reconstructive Surgery Oncology Database was queried to identify patients diagnosed with orbital plasmacytoma. These patients' records were reviewed for demographic characteristics, clinical and radiologic findings, treatments, and outcomes.

Results: Thirty patients from 4 institutions (24 from MD Anderson Cancer Center, 3 from SUNY Downstate Medical Center, 2 from University of California, Los Angeles, and 1 from Oregon Health and Science University) were identified. Eighteen patients (60%) were diagnosed with multiple myeloma (MM) before and 11 (37%) were diagnosed with MM immediately after orbital plasmacytoma. Based on imaging, 4 distinct anatomical patterns were identified: 1) bony plasmacytoma affecting the superotemporal orbit, epidural space, and temporal fossa (15 patients; 50%); 2) discrete orbital plasmacytoma (7 patients; 23%); 3) infiltrative plasmacytoma either originating from a sinus (4 patients; 13%); or 4) originating from the orbital floor and infiltrating facial soft tissue (4 patients; 13%). Of the 29 patients with available treatment data, 2 had radiation only, 3 had chemotherapy only, 6 had chemoradiation, and 18 had stem cell transplant following chemoradiation (n = 17) or only chemotherapy (n = 1). Following treatment, 10 patients achieved complete and 11 achieved partial responses.

Conclusion: Orbital plasmacytomas were found exclusively in patients with MM diagnosed before or immediately after orbital plasmacytoma. Plasmacytomas can have 4 distinct anatomical patterns of origin. Following treatment, all patients had good to excellent local control of their orbital lesions.
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http://dx.doi.org/10.1097/IOP.0000000000000939DOI Listing
July 2018