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Brandon, Florida, United States

Kotz T.,Mount Sinai Medical Center | Federman A.D.,Mount Sinai Medical Center | Kao J.,Florida Radiation Oncology Group | Milman L.,Mount Sinai Medical Center | And 3 more authors.
Archives of Otolaryngology - Head and Neck Surgery | Year: 2012

Objective: To assess the efficacy of prophylactic swallowing exercises on swallowing function in patients undergoing chemoradiation therapy (CRT) for head and neck cancer. Design: Randomized controlled trial. Setting: Tertiary care, academic medical center. Patients: Twenty-six patients with head and neck cancer receiving CRT. Intervention: Patients performed 5 targeted swallowing exercises throughout their CRT and participated in weekly swallowing therapy sessions to promote adherence and accurate technique. Controls had no prophylactic exercises and were referred for swallowing treatment after completion of CRT if indicated. Main Outcome Measures: Swallowing function was assessed with the Functional Oral Intake Scale (FOIS) and the Performance Status Scale for Head and Neck Cancer Patients (PSS-H&N) at baseline, immediately after CRT, and at 3, 6, 9, and 12 months after CRT. Results: There were no statistically significant differences in FOIS scores between intervention and control patients immediately after CRT (immediately after CRT: intervention group median score, 3 [range, 1-7], vs median control score, 4 [range, 1-6] (P=.88). However, intervention patients had significantly better scores at months 3 and 6 (median 3-month intervention score, 7 [range, 5-7], vs median control score, 5 [range, 3-7] [P=.03]; median 6-month intervention score, 7 [range, 6-7], vs median control score, 6 [range, 3-7] [P=.009]). There was no significant difference in scores at months 9 and 12 (P=.24 and P=.93, respectively). The same pattern between intervention and control patients was observed for scores on the PSS-H&N. Conclusions: Patients who performed prophylactic swallowing exercises had improved swallowing function at 3 and 6 months after CRT but not immediately after CRT or at 9 and 12 months after CRT. The small sample size may have limited our ability to detect significant differences beyond 6 months of observation as well as additional significant differences in our study. ©2012 American Medical Association. All rights reserved.

Burri R.J.,Mount Sinai School of Medicine | Ho A.Y.,Sloan Kettering Cancer Center | Forsythe K.,Mount Sinai School of Medicine | Cesaretti J.A.,Florida Radiation Oncology Group | And 2 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2010

Purpose: To evaluate retrospectively the biochemical outcomes of young men treated with low-dose-rate brachytherapy for prostate cancer. Methods and Materials: From 1990 to 2005, 1,665 men with clinically localized prostate cancer were treated with low-dose-rate brachytherapy ± hormone therapy (HT) ± external beam radiotherapy and underwent ≥2 years of follow-up. Patients were stratified on the basis of age: ≤60 (n = 378) and >60 years (n = 1,287). Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/mL. Univariate and multivariate analyses were used to determine the association of variables with freedom from biochemical failure (FFbF). Results: Median follow-up was 68 months (range, 24-180) for men ≤60 years and 66 months (range, 24-200) for men >60. For the entire group, the actuarial 5- and 8-year FFbF rates were 94% and 88%, respectively. Men ≤60 demonstrated similar 5- and 8-year FFbF (95% and 92%) compared with men >60 (93% and 87%; p = 0.071). A larger percent of young patients presented with low-risk disease; lower clinical stage, Gleason score (GS), and pretreatment PSA values; were treated after 1997; did not receive any HT; and had a high biologic effective dose (BED) of radiation (all ps <0.001). On multivariate analysis, PSA (p = 0.001), GS (p = 0.005), and BED (p < 0.001) were significantly associated with FFbF, but age was not (p = 0.665). Conclusion: Young men achieve excellent 5- and 8-year biochemical control rates that are comparable to those of older men after prostate brachytherapy. Young age should not be a deterrent when considering brachytherapy as a primary treatment option for clinically localized prostate cancer. Copyright © 2010 Elsevier Inc.

Tong C.C.L.,Mount Sinai Medical Center | Ko E.C.,Mount Sinai Medical Center | Sung M.W.,Mount Sinai Medical Center | Cesaretti J.A.,Florida Radiation Oncology Group | And 10 more authors.
PLoS ONE | Year: 2012

Background: Preclinical data suggest that sunitinib enhances the efficacy of radiotherapy. We tested the combination of sunitinib and hypofractionated image-guided radiotherapy (IGRT) in a cohort of patients with historically incurable distant metastases. Methods: Twenty five patients with oligometastases, defined as 1-5 sites of active disease on whole body imaging, were enrolled in a phase II trial from 2/08 to 9/10. The most common tumor types treated were head and neck, liver, lung, kidney and prostate cancers. Patients were treated with the recommended phase II dose of 37.5 mg daily sunitinib (days 1-28) and IGRT 50 Gy (days 8-12 and 15-19). Maintenance sunitinib was used in 33% of patients. Median follow up was 17.5 months (range, 0.7 to 37.4 months). Results: The 18-month local control, distant control, progression-free survival (PFS) and overall survival (OS) were 75%, 52%, 56% and 71%, respectively. At last follow-up, 11 (44%) patients were alive without evidence of disease, 7 (28%) were alive with distant metastases, 3 (12%) were dead from distant metastases, 3 (12%) were dead from comorbid illness, and 1 (4%) was dead from treatment-related toxicities. The incidence of acute grade ≥ 3 toxicities was 28%, most commonly myelosuppression, bleeding and abnormal liver function tests. Conclusions: Concurrent sunitinib and IGRT achieves major clinical responses in a subset of patients with oligometastases. Trial Registration: ClinicalTrials.gov NCT00463060. © 2012 Tong et al.

Kao J.,Mount Sinai School of Medicine | Kao J.,Florida Radiation Oncology Group | Genden E.M.,Mount Sinai School of Medicine | Chen C.-T.,Mount Sinai School of Medicine | And 7 more authors.
Cancer | Year: 2011

Backkground: Concurrent inhibition of epidermal growth factor receptor (EGFR) and cyclooxygenase-2 (COX-2) is an active and well tolerated regimen in recurrent head and neck cancer (HNC). In the current phase 1 trial, the authors sought to determine the maximum tolerated dose (MTD) and efficacy of concurrent erlotinib and celecoxib as a radiosensitizing regimen. Methods: Fourteen patients with previously irradiated HNC with no distant metastases who required reirradiation were eligible. Treatment consisted of daily erlotinib 150 mg and twice daily celecoxib (escalated from 200 mg to 600 mg using a 3 + 3 design with an expanded cohort at the MTD) starting on Day 1 and was continued during radiation. Daily radiation was started on Day 15, and maintenance erlotinib was recommended. Results: The recommended phase 2 dose of celecoxib was 400 mg. Three dose-limiting toxicities included late in-field orocutaneous fistula (Dose Level 2), osteonecrosis (Dose Level 3), and trismus (Dose Level 3). Acute grade ≥ 3 toxicities were uncommon and included mucositis (21%) and dermatitis (14%). At a median follow-up of 11 months, the 1-year locoregional control, progression-free survival, and overall survival rates were 60%, 37%, and 55%, respectively. Conclusions: Concurrent erlotinib, celecoxib, and reirradiation was a feasible and clinically active regimen in a population of patients with recurrent HNC who had a poor prognosis. © 2011 American Cancer Society.

Stoyanova R.,University of Miami | Stoyanova R.,Fox Chase Cancer Center | Pahlajani N.H.,Fox Chase Cancer Center | Egleston B.L.,Fox Chase Cancer Center | And 5 more authors.
Cancer | Year: 2013

BACKGROUND: Randomized trials have demonstrated that escalated-dose external-beam radiotherapy (EDRT) is better than standard-dose radiotherapy (SDRT) for patients with prostate cancer and that adding androgen-deprivation therapy (ADT) to SDRT is better than SDRT alone; however, no trials have compared EDRT versus SDRT plus ADT or EDRT versus EDRT plus ADT. The authors designed a model to estimate the results of various doses of radiotherapy (RT) combined with various durations of ADT. METHODS: From 1989 to 2007, 3215 men consecutively received definitive EDRT with or without ADT. In total, 2012 patients had complete records available for creating the nomogram. The duration of ADT varied for patients who received no RT (n = 1562), ≤6 months of RT (n = 145), from >6 months to <24 months of RT (n = 140), and ≥24 months of RT (n = 165) with a median follow-up of 65.7 months, 66.2 months, 60.1 months, and 63 months, respectively. The model included the following covariates: palpation T-category, biopsy Gleason score, the percentage of tumor cells with a Gleason pattern of 4 or 5, the percentage of tumor tissue, initial pretreatment prostate-specific antigen (PSA) level, ADT duration, and RT dose. Two nomograms, for outcomes with and without ADT, were created from a single competing-risks model. Biochemical failure was defined as a rise in serum PSA of 2 ng/mL over the post-treatment PSA nadir. RESULTS: According to the results from analyzing representative intermediate-risk to high-risk patient parameters, the gains from increasing the RT dose from 70 Gray (Gy) to 80 Gy were far less than the gains from adding ≥3 months of ADT. CONCLUSIONS: The nomograms provided unique patient-specific estimates of the effects of various doses and durations of RT and ADT. The results indicated that adding ADT to treatment for intermediate-risk and high-risk prostate cancer is far more beneficial than a modest RT dose escalation. Cancer 2013. © 2012 American Cancer Society.

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