Real-World Study of the Effectiveness and Safety of Intracameral Bimatoprost Implant in a Clinical Setting in the United States.

Purpose: A sustained-release, biodegradable, intracameral 10-µg bimatoprost implant (Durysta) is approved for single administration per eye to lower intraocular pressure (IOP) in open-angle glaucoma (OAG) and ocular hypertension (OHT). The purpose of this study was to evaluate the IOP-lowering effectiveness and safety of a single implant administration per eye in patients with OAG or OHT in a real-world clinical setting.

Methods: This was a retrospective, single-site study involving 105 consecutive adult patients with OAG or OHT treated with the bimatoprost implant in 1 or both eyes in routine clinical practice.

Single Administration of Intracameral Bimatoprost Implant 10 µg in Patients with Open-Angle Glaucoma or Ocular Hypertension.

Introduction: This study evaluated the intraocular pressure (IOP)-lowering efficacy and safety of a single intracameral administration of bimatoprost implant 10 µg in adults with open-angle glaucoma or ocular hypertension.

Methods: Two identically designed, randomized, 20-month, parallel-group, phase 3 clinical trials (one study eye/patient) compared three administrations of 10- or 15-µg bimatoprost implant (day 1, weeks 16 and 32) with twice-daily topical timolol maleate 0.5%.

Two-year interim safety results of the 0.2 µg/day fluocinolone acetonide intravitreal implant for the treatment of diabetic macular oedema: the observational PALADIN study.

Background: The 0.2 µg/day fluocinolone acetonide (FAc) implant delivers continuous, low-dose, intravitreal corticosteroid for the treatment of diabetic macular oedema (DMO). This ongoing, 3-year, observational clinical trial provides long-term, 'real-world' safety results for the FAc implant in DMO.

Evaluation of intraoperative magnetic resonance imaging/ultrasound fusion optimization for low-dose-rate prostate brachytherapy.

Purpose: Intraoperative planning with transrectal ultrasound (US) is used for accurate seed placement and optimal dosimetry in prostate brachytherapy. However, prostate magnetic resonance imaging (MRI) has shown superiority in delineation of prostate anatomy. Accordingly, MRI/US fusion may be useful for accurate intraoperative planning.

The Dynamic and Transient Immune Microenvironment in Locally Advanced Esophageal Adenocarcinoma Post Chemoradiation.

Objective: The aim of this study was to assess the impact of chemoradiation on the immune microenvironment to influence and optimally design future neoadjuvant clinical trials.

Summary Background Data: Programmed death (PD)-1 inhibitors in metastatic gastroesophageal cancer have demonstrated response rates of approximately 25% in programmed death ligand-1 (PD-L1+) tumors. Unfortunately, the majority of patients do not respond.

The use of radiotherapy in the management of follicular cystitis refractory to conservative and surgical management.

Follicular cysitis is a proliferative benign lesion which can act locally malignant. Conservative management is best; however, when this fails, surgical resection is necessary up to and including cystectomy in extreme refractory cases. We present a clinical review and our results using radiation in this disease in a woman facing cystectomy.

A comprehensive analysis of cardiac dose in balloon-based high-dose-rate brachytherapy for left-sided breast cancer.

Purpose: To investigate radiation dose to the heart in 60 patients with left-sided breast cancer who were treated with balloon-based high-dose-rate brachytherapy using MammoSite or Contura applicators.

Methods And Materials: We studied 60 consecutive women with breast cancer who were treated with 34 Gy in 10 twice-daily fractions using MammoSite (n = 37) or Contura (n = 23) applicators. The whole heart and the left and right ventricles were retrospectively delineated, and dose-volume histograms were analyzed.

Audiometric outcomes for acoustic neuroma patients after single versus multiple fraction stereotactic irradiation.

Objective: To compare tumor control and changes in audiometric parameters of acoustic neuroma patients treated with either linac-based stereotactic radiosurgery (SRS) or stereotactic radiotherapy (SRT) at Allegheny General Hospital.

Study Design: Twenty-three patients with acoustic neuroma were treated between February 2003 and April 2009 with either SRS (n = 13) or SRT (n = 10). The median age for all patients was 69 years and the median size of lesions was 1.

Evaluation of the interfractional biological effective dose (BED) variation in MammoSite high dose rate brachytherapy.

The objective of this work is to evaluate the interfractional biological effective dose (BED) variation in MammoSite high dose rate (HDR) brachytherapy. Dose distributions of 19 patients who received 34 Gy in 10 fractions were evaluated. A method was employed to account for nonuniform dose distribution in the BED calculation.

Comparison of conservative management techniques in the re-treatment of ipsilateral breast tumor recurrence.

Purpose: To compare brachytherapy and three-dimensional (3-D) conformal external beam radiotherapy for breast cancer presenting in the previously irradiated breast.

Methods And Materials: Thirty-six patients with TIS-T2 breast carcinomas received brachytherapy or 3-D conformal radiotherapy (3-D CRT) after lumpectomy in a previously irradiated breast as an alternative to salvage mastectomy. Brachytherapy consisted of low-dose-rate (LDR) interstitial technique in 21 patients, whereas 11 patients were treated using high-dose-rate (HDR) balloon technique.

Influence of concurrent anastrozole on acute and late side effects of whole breast radiotherapy.

Objectives: To retrospectively compare radiation toxicity in patients treated with concurrent anastrozole and whole breast irradiation versus women treated sequentially with whole breast irradiation followed by hormonal suppression.

Methods: The records of 249 consecutive estrogen or progesterone receptor positive breast cancer patients treated with breast-conserving surgery and postoperative whole breast irradiation were reviewed. Of total, 57 patients (the concurrent anastrozole group) received concurrent anastrozole prior to and during radiotherapy.

Mature follow-up for high-risk stage I non-small-cell lung carcinoma treated with sublobar resection and intraoperative iodine-125 brachytherapy.

Purpose: To update the Allegheny General Hospital experience of high-risk Stage I non-small-cell lung cancer patients treated with sublobar resection and intraoperative (125)I Vicryl mesh brachytherapy.

Methods And Materials: Between January 5, 1996 and February 19, 2008, 145 patients with Stage I non-small-cell lung cancer who were not lobectomy candidates because of cardiopulmonary compromise underwent sublobar resection and placement of (125)I seeds along the resection line. The (125)I seeds embedded in Vicryl suture were attached with surgical clips to a sheet of Vicryl mesh, inserted over the target area, and prescribed to a 0.

Mammary fat necrosis following radiotherapy in the conservative management of localized breast cancer: does it matter?

Purpose: Fat necrosis is a well-described and relatively common complication arising from post-lumpectomy irradiation of the breast, most commonly breast brachytherapy. We wish to assess the clinical significance of fat necrosis resulting from post-lumpectomy breast irradiation.

Methods: We reviewed the literature to determine the overall incidence and significance of fat necrosis to determine whether or not fat necrosis poses a significant clinical problem.

Bioequivalence of single and multiple doses of venlafaxine extended-release tablets and capsules in the fasted and fed states: four open-label, randomized crossover trials in healthy volunteers.

Background: Venlafaxine extended-release (ER) tablets use osmotic pressure to deliver venlafaxine hydrochloride at a controlled rate over approximately 24 hours.

Objective: These studies were conducted to evaluate the bioequivalence of venlafaxine ER tablets and capsules based on the US Food and Drug Administration (FDA) definition.

Methods: Four pharmacokinetic studies of the capsule (reference) and tablet (test) formulations were conducted in healthy adult volunteers.

Reduction in radiation-induced morbidity by use of an intercurrent boost in the management of early-stage breast cancer.

Purpose: Electron or photon boost immediately following whole-breast irradiation performed after conservation surgery for early-stage breast cancer is the accepted standard of care. This regimen frequently results in Grade III dermatitis, causing discomfort or treatment interruption. Herein, we compare patients treated with whole-breast irradiation followed by boost compared with a cohort with a planned intercurrent radiation boost.

The allegheny general modification of the Harvard Breast Cosmesis Scale for the retreated breast.

The use of brachytherapy--and to a lesser extent, external-beam radiotherapy--in the management of locally recurrent breast cancer following ipsilateral breast tumor recurrence (IBTR) followed by repeat breast-conservation surgery and irradiation is currently an area of intense study. The current cosmetic scoring system is inadequate to score the outcome resulting from retreatment because it does not account for the cosmetic effect of the initial treatment. We propose a modification of the scale for patients who undergo retreatment--the Allegheny General Modification of the Harvard/NSABP/RTOG scoring scale.

Assessment of "best practice" treatment patterns for a "radiation oncology community outreach group" engaged in cancer disparities outcomes.

Objective: Minority patients with cancer have higher recurrence rates than the general population and are more likely to be treated at community centers where the standard of care has been reported to be inferior to that at academic centers. These issues are being explored by Radiation Oncology Community Outreach Group (ROCOG), a consortium of 5 Community Radiation Oncology centers participating in a National Cancer Institute-funded Disparities Grant. As a quality assurance/quality improvement initiative, this study was undertaken to ensure that treatment was at a "best practice" level.

Tolerance of the aorta using intraoperative iodine-125 interstitial brachytherapy in cancer of the lung.

Purpose: A retrospective review to assess the efficacy and morbidity of surgical resection and (125)I interstitial lung brachytherapy placed in approximation to the aorta.

Methods And Materials: The records and postoperative films of 278 patients who had undergone intrathoracic (125)I brachytherapy at our institution were reviewed. All patients had undergone a gross total resection of a non-small-cell lung cancer using segmental resection, wedge resection, or sublobar resection.

Breast conservation surgery and interstitial brachytherapy in the management of locally recurrent carcinoma of the breast: the Allegheny General Hospital experience.

Purpose: To evaluate lumpectomy followed by interstitial brachytherapy as an acceptable salvage therapy for women who have developed localized recurrence of breast cancer after conservation surgery and postoperative external radiotherapy.

Methods And Materials: Between 1/1998 and 10/2006, 21 patients with T0 or T1 in-breast recurrence of carcinoma were offered interstitial low-dose rate brachytherapy after tumor re-excision as an alternative to salvage mastectomy. All patients had failed lumpectomy followed by standard postoperative external beam radiotherapy (range, 5000-6040cGy) as treatment for the initial breast carcinoma.

Dosimetric comparison of partial and whole breast external beam irradiation in the treatment of early stage breast cancer.

A dosimetric comparison was performed on external-beam three-dimensional conformal partial breast irradiation (PBI) and whole breast irradiation (WBI) plans for patients enrolled in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-39/Radiation Therapy Oncology Group (RTOG) 0413 protocol at our institution. Twenty-four consecutive patients were treated with either PBI (12 patients) or WBI (12 patients). In the PBI arm, the lumpectomy cavity was treated to a total dose of 38.

Hypothermia-enhanced human tumor cell radiosensitivity.

Ablation of neoplastic disease by freezing has found increasing utility as a potential therapeutic modality. To assess the effect of cooling temperatures on cellular radiation response, an established human cervical carcinoma cell line (HTB35) was subjected to holding temperatures of 0, 5, or 15 degrees C for up to 24 h before irradiation. Survival was measured by in vitro clonogenic assay of colonies containing at least 50 cells.

Radiation survival of two human cervical carcinoma cell lines after multifraction irradiation.

Purpose: Multifraction irradiation may contribute to radiation therapy treatment failure if selection of radiation resistant subpopulations occurs. We sought to determine whether surviving cells following daily fraction irradiation of two human cervical squamous cell carcinoma lines would express different radiation survival characteristics compared to the unirradiated parent.

Methods And Materials: A late-passage line (HTB35) and an early-passage line (RECA) received daily 2 Gy x-irradiation.