Heterogeneity in Radiotherapeutic Parameter Assumptions in Cost-Effectiveness Analyses in Prostate Cancer: A Call for Uniformity.

OBJECTIVES: Cost-effectiveness analyses (CEAs) may provide useful data to inform management decisions depending on the robustness of a model's input parameters. We sought to determine the level of heterogeneity in health state utility values, transition probabilities, and cost estimates across published CEAs assessing primarily radiotherapeutic management strategies in prostate cancer. METHODS: We conducted a systematic review of prostate cancer CEAs indexed in MEDLINE between 2000 and 2018 comparing accepted treatment modalities across all cancer stages. Search terms included "cost effectiveness prostate," "prostate cancer cost model," "cost utility prostate," and "Markov AND prostate AND (cancer OR adenocarcinoma)." Included studies were agreed upon. A Markov model was designed using the parameter estimates from the systematic review to evaluate the effect of estimate heterogeneity on strategy cost acceptability. RESULTS: Of 199 abstracts identified, 47 publications were reviewed and 37 were included; 508 model estimates were compared. Estimates varied widely across variables, including gastrointestinal toxicity risk (0%-49.5%), utility of metastatic disease (0.25-0.855), intensity-modulated radiotherapy cost ($21 193-$61 996), and recurrence after external-beam radiotherapy (1.5%-59%). Multiple studies assumed that different radiotherapy modalities delivering the same dose yielded varying cancer control rates. When using base estimates for similar parameters from included studies, the designed model resulted in 3 separate acceptability determinations. CONCLUSIONS: Significant heterogeneity exists across parameter estimates used to perform CEAs evaluating treatment for prostate cancer. Heterogeneity across model inputs yields variable conclusions with respect to the favorability and cost-effectiveness of treatment options. Decision makers are cautioned to review estimates in CEAs to ensure they are up to date and relevant to setting and population.

Five- and seven-year outcomes for image-guided moderately accelerated hypofractionated proton therapy for prostate cancer.

BACKGROUND: To report 5- and 7-year outcomes after image-guided moderately accelerated hypofractionated proton therapy (AHPT) for prostate cancer. MATERIAL AND METHODS: We reviewed the first 582 prostate cancer patients enrolled on prospective outcomes tracking trial and treated with double-scattered moderately AHPT between 2008 and 2015. 269 patients had low-risk (LR) and 313 had intermediate-risk (IR) disease, including 149 with favorable intermediate-risk (FIR) and 164 with unfavorable intermediate-risk (UIR) disease. LR patients received a median 70.0GyRBE (2.5GyRBE/fraction) and IR patients received a median of 72.5 GyRBE. Seventeen patients (UIR, n = 12) received androgen deprivation therapy (ADT) for a median of 6 months. Toxicities were graded per the CTCAE, v4.0, and patient-reported quality-of-life data were reviewed. RESULTS: Median follow-up was 8.0 years (0.9-12.2). The 5- and 7-year rates of freedom from biochemical progression (FFBP) overall and in the LR and IR subsets, respectively, were 96.8/95.2%, 98.8/98.8%, and 95.0/91.9%. For the FIR and UIR subsets, they were 97.2/95.2% and 93.1/88.8%. Actuarial 5- and 7-year rates of late CTCAE, v4.0, grade 2 gastrointestinal (GI), grade 3 GI, and grade 3 genitourinary (GU) toxicities were 9.9%/11.2%, 1.4/1.4% and 1.3/2.1%, respectively. No grade ≥4 GI or GU toxicities occurred. The mean (standard deviation, SD) IPSS and EPIC Composite bowel function and bother scores were 7 (SD = 5), 97 (SD = 7), and 94 (SD = 6), respectively at baseline, 7 (SD = 5), 92 (SD = 13), and 92 (SD = 9) at the 5-year follow-up, and 7 (SD = 5), 93 (SD = 12), and 92 (SD = 10) at the 7-year follow-up. CONCLUSION: Image-guided AHPT 5- and 7-year outcomes show high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes in this cohort.

Long-term outcomes following proton therapy for prostate cancer in young men with a focus on sexual health.

BACKGROUND: We investigated long-term outcomes for men ≤60 years old treated with proton therapy (PT). METHODS: Of 254 men ≤60 years old were treated with proton therapy alone for prostate cancer. Risk stratification included 56% with low-, 42% with intermediate- and 2% with high-risk disease. Patients received 76-82 Gy at 2 Gy/fraction or 70-72.5 Gy at 2.5 Gy/fraction. Before treatment and every 6-12 months for 5 years, patients were evaluated by a physician, answered health-related quality of life surveys, including the EPIC, IIEF and IPSS, and had PSA evaluated. RESULTS: Median follow-up for the cohort was 7.1 years; 7-year biochemical-free survival was 97.8%. Eight men (one high-risk; five intermediate-risk and two low-risk) experienced biochemical progression, including one who died of disease 9 years after treatment. Potency (erections firm enough for sexual intercourse) was 90% at baseline and declined to 72% at the first-year follow-up, but declined to only 67% at 5 years. Only 2% of patients developed urinary incontinence requiring pads. The bowel habits mean score declined from a baseline of 96 to 88 at 1 year, which improved over the following years to 93 at 5 years. CONCLUSIONS: Young men with prostate cancer continue to have excellent results with respect to 7-year biochemical control and 5-year erectile function, without clinically significant urinary incontinence 5 years after proton therapy. Comparative effectiveness studies of proton therapy with surgery and IMRT are needed.

Definitive Radiotherapy for Squamous Cell Carcinoma of the Glottic Larynx.

BACKGROUND: Depending on the extent of disease, squamous cell carcinoma (SCC) of the glottis is managed with surgery, radiotherapy (RT), or a combination of these modalities. Patients with advanced disease may receive concomitant chemotherapy in conjunction with definitive or postoperative RT. METHODS: The treatment policies of the University of Florida and patient outcomes are reviewed. RESULTS: The likelihood of cure after RT for carcinoma in situ (Tis) to T2 glottic SCC varies from 70% to 94% depending on tumor stage. Consideration should be given to adding weekly cisplatin for patients with T2b SCC because of the high local recurrence rate after RT alone. The probability of cure is about 65% to 80% for select low-volume (≤ 3.5 cc) T3 to T4 glottic SCC after RT. These patients should be considered for concomitant weekly cisplatin. Higher-volume tumors, particularly those with airway compromise, should be treated with laryngectomy and postoperative RT. CONCLUSION: Definitive RT is an excellent treatment for select patients with laryngeal cancer.

Long-Term Outcomes Following Definitive or Adjuvant Proton Radiotherapy for Adenoid Cystic Carcinoma.

Purpose: Adenoid cystic carcinoma (ACC) is a rare malignancy accounting for 1% of all head and neck cancers. Treatment for ACC has its challenges and risks, yet few outcomes studies exist. We present long-term outcomes of patients with ACC of the head and neck treated with proton therapy (PT). Materials and Methods: Under an institutional review board-approved, single-institutional prospective outcomes registry, we reviewed the records of 56 patients with de novo, nonmetastatic ACC of the head and neck treated with PT with definitive (n = 9) or adjuvant PT (n = 47) from June 2007 to December 2021. The median dose to the primary site was 72.6 gray relative biological equivalent (range, 64-74.4) delivered as either once (n = 19) or twice (n = 37) daily treatments. Thirty patients received concurrent chemotherapy. Thirty-one patients received nodal radiation, 30 electively and 1 for nodal involvement. Results: With a median follow-up of 6.2 years (range, 0.9-14.7), the 5-year local-regional control (LRC), disease-free survival, cause-specific survival, and overall survival rates were 88%, 85%, 89%, and 89%, respectively. Intracranial extension (P = .003) and gross residual tumor (P = .0388) were factors associated with LRC rates. While the LRC rate for those with a gross total resection was 96%, those with subtotal resection or biopsy alone were 81% and 76%, respectively. The 5-year cumulative incidence of clinically significant grade ≥3 toxicity was 15%, and the crude incidence at the most recent follow-up was 23% (n = 13). Conclusion: This is the largest sample size with the longest median follow-up to date of patients with ACC treated with PT. PT can provide excellent disease control for ACC of the head and neck with acceptable toxicity. T4 disease, intracranial involvement, and gross residual disease at the time of PT following either biopsy or subtotal resection were significant prognostic features for worse outcomes.

Impact of mandated drug monitoring on opioid use during highly conformal radiotherapy for oropharynx cancer.

BACKGROUND: Prescription drug monitoring programs (PDMPs) have proliferated due to increasing opioid-related deaths. We evaluated acute opioid use changes for 64 patients treated with highly conformal radiotherapy (RT) following a state-mandated PDMP. METHODS: Patients receiving proton therapy (PT) (n=40), intensity-modulated RT (IMRT) (n=14), or both (n=10) were divided into preintervention (n=26) and postintervention cohorts (n=38); records were reviewed retrospectively under an institutional review board (IRB)-approved tracking protocol. Dosages prescribed during acute therapy (during RT-3 months post-RT) and patient-reported pain (Defense and Veterans Pain Rating Scale) were endpoints. Dosages were treated as responses in Chi-square tests (three-level ordinal response). RESULTS: Overall, 72% (n=46) received opioids; of which 22% (n=10) of all patients and 10% (n=2) of opioid-naive patients continued analgesic management 3 months post-RT. Median total doses were 975 and 1,025 morphine milligram equivalents (MME) in pre- and postintervention groups, with no significant differences in MME prescribed (P=0.8) or uncontrolled pain (P=0.3). Statistically significant factors were tonsil primaries (P<0.01) and alcohol use (P=0.02). Uncontrolled pain episodes during and post-RT did not vary per cohort (P=0.19). CONCLUSIONS: PDMP use was not associated with management changes in patient-reported acute pain during RT (IMRT or PT). Following highly conformal RT, few patients remained on narcotics 3 months post-RT.

Early-stage vocal cord cancer treated with hypofractionated radiotherapy to the larynx with or without concurrent chemotherapy.

BACKGROUND: We report outcomes among patients with T2 and select T3 glottic squamous cell carcinoma (SCC) treated with radiotherapy. METHODS: We reviewed T2 and T3 (only paraglottic space invasion) N0 M0 glottic SCC patients treated with curative-intent hypofractionated larynx radiotherapy, with or without concurrent systemic therapy. RESULTS: Of 71 patients, those who received concurrent chemotherapy (23/71; 32%) had worse prognostic factors, including impaired cord mobility (70% vs. 40%, p = 0.02) and larger median gross tumor volume (3.0 vs. 1.6 cm3 , p = 0.003). Over a median follow-up of 3.8 years, 2-year local control among patients with impaired cord mobility appeared higher for those who received chemotherapy (88% vs. 61%, p = 0.12), but the difference was not statistically significant. Acute and late toxicity rates were not higher among patients who received chemotherapy. CONCLUSIONS: The addition of concurrent platinum-based chemotherapy to hypofractionated larynx radiotherapy among patients with early-stage glottic SCC with impaired cord mobility appears safe and worthy of additional investigation.

Passively Scattered Proton Therapy for Nonmelanoma Skin Cancer with Clinical Perineural Invasion.

PURPOSE: To report our experience with the delivery of passively scattered proton therapy in the management of nonmelanoma skin cancers with clinical perineural invasion. MATERIALS AND METHODS: We reviewed the medical records of patients who received definitive or postoperative proton therapy for nonmelanoma skin cancer with clinical perineural invasion at our institution and updated patient follow-up when possible. All patients were treated with curative intent with or without the delivery of concurrent systemic therapy. We report disease control rates and the rates of late toxicity among this cohort. RESULTS: Twenty-six patients treated between 2008 and 2017 were included in the analysis. Following proton therapy, the 3-year overall, cause-specific, and disease-free survival rates were 59%, 73%, and 60%, respectively. The 3-year local control, local regional control, and distant metastasis-free survival rates were 80%, 65%, and 96%, respectively. On univariate analysis, surgical resection before radiation therapy significantly improved local regional control rates at 3 years (55% versus 86%; P = .04). Grade 3+ late toxicities occurred in 13 patients (50%) and the most common toxicities included grade 3+ keratitis of the ipsilateral eye, which occurred in 4 patients (15%) and grade 3+ brain necrosis in 4 patients (15%). CONCLUSION: Proton therapy is effective in the management of nonmelanoma skin cancer with clinical perineural invasion. Although disease control and complication rates compare favorably to those previously published for photon-based radiation therapy, the risk for late toxicity is significant and patients should be appropriately counseled.

Current Role of Radiotherapy in the Management of Oral Cavity Squamous Cell Carcinoma.

STUDY DESIGN: Literature review. OBJECTIVE: To review the current role of radiotherapy (RT) in the management of oral cavity squamous cell carcinoma (SCC). METHODS: Review of selected literature. RESULTS: T1-T2N0 SCCs may be treated with either RT alone or surgery with a high likelihood of cure. The pendulum swung toward surgery with postoperative RT (PORT) added depending on the pathological findings in the mid 1980s. Patients with positive margins, extranodal extension (ENE), and/or 4 or more positive nodes receive concomitant chemotherapy (POCRT). Patients with T3-T4 and/or positive regional nodes are treated with surgery and PORT alone or POCRT. The likelihood of cure is moderate to low depending on extent of disease. The likelihood of major complications ranges from 10% to 30% depending on the method of reconstruction and the aggressiveness of postoperative PORT/POCRT. Patients with very advanced disease are treated with palliative RT, chemotherapy, or supportive care. CONCLUSIONS: The role of RT in the management of oral cavity SCC is primarily in the postoperative setting with palliative RT being reserved for those with very advanced disease where the likelihood of cure is remote.

What men want: Results from a national survey on decision making for prostate cancer treatment and research participation.

Data comparing outcomes in prostate cancer and factors affecting treatment choice are sparse. To inform the design of a comparative effectiveness clinical trial, we engaged patients in developing a 28-question survey about decision making on treatment and research participation and dispersed it among men greater than or equal to 50 years of age. The 1046 respondents ranked long-term clinical outcomes as most important in making treatment decisions, specific functional outcomes as slightly less important, and duration, location, and cost of treatment as least important. Treatment choice was strongly impacted by side effect profile. Responses to whether the subject would agree to participation in a randomized trial between two types of radiation with minimal differences in outcomes were "yes" in 15%, "no" in 39%, and "undecided" in 46%. Responses to whether the subject would agree to participation in a randomized trial between two treatment durations with similar outcomes were yes in 36%, no in 24%, and undecided in 40%. Findings suggest many potential patients have strong treatment preferences and are averse to randomization, particularly when outcomes of importance may be affected. Patient engagement in study design and novel nonrandomized trial designs may offer a path to increase clinical trial success.

Postoperative or Salvage Proton Radiotherapy for Prostate Cancer After Radical Prostatectomy.

PURPOSE: Postprostatectomy radiation improves disease control, but limited data exist regarding outcomes, toxicities, and patient-reported quality of life with proton therapy. METHOD AND MATERIALS: The first 102 patients who were enrolled on an outcome tracking protocol between 2006 and 2017 and treated with double-scattered proton therapy after prostatectomy were retrospectively reviewed. Eleven (11%) received adjuvant radiation, while 91 (89%) received salvage radiation. Seventy-four received double-scattered proton therapy to the prostate bed only. Twenty-eight received a double-scattered proton therapy prostate-bed boost after prostate-bed and pelvic-node treatment. Eleven adjuvant patients received a median dose of 66.6 GyRBE (range, 66.0-70.2). Ninety-one salvage patients received a median dose of 70.2 GyRBE (range, 66.0-78.0). Forty-five patients received androgen deprivation therapy for a median 9 months (range, 1-30). Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0 criteria, and patient-reported quality-of-life data were reviewed. RESULTS: The median follow-up was 5.5 years (range, 0.8-11.4 years). Five-year biochemical relapse-free and distant metastases-free survival rates were 72% and 91% for adjuvant patients, 57% and 97% for salvage patients, and 57% and 97% overall. Acute and late grade 3 or higher genitourinary toxicity rates were 1% and 7%. No patients had grade 3 or higher gastrointestinal toxicity. Acute and late grade 2 gastrointestinal toxicities were 5% and 2%. The mean values and SDs of the International Prostate Symptom Score, International Index of Erectile Function, and Expanded Prostate Cancer Index Composite bowel function and bother were 7.5 (SD = 5.9), 10.2 (SD = 8.3), 92.8 (SD = 11.1), and 91.2 (SD = 6.4), respectively, at baseline, and 12.1 (SD = 9.1), 10.1 (SD = 6.7), 87.3 (SD = 18), and 86.7 (SD = 13.8) at the 5-year follow-up. CONCLUSION: High-dose postprostatectomy proton therapy provides effective long-term biochemical control and freedom from metastasis, with low acute and long-term gastrointestinal and genitourinary toxicity.

Consensus Statement on Proton Therapy for Prostate Cancer.

Proton therapy is a promising but controversial treatment in the management of prostate cancer. Despite its dosimetric advantages when compared with photon radiation therapy, its increased cost to patients and insurers has raised questions regarding its value. Multiple prospective and retrospective studies have been published documenting the efficacy and safety of proton therapy for patients with localized prostate cancer and for patients requiring adjuvant or salvage pelvic radiation after surgery. The Particle Therapy Co-Operative Group (PTCOG) Genitourinary Subcommittee intends to address current proton therapy indications, advantages, disadvantages, and cost effectiveness. We will also discuss the current landscape of clinical trials. This consensus report can be used to guide clinical practice and research directions.

Radiation Oncology for Head and Neck Cancer: Current Standards and Future Changes.

Treatment of head and neck cancer with curative intent consists of surgery and/or radiotherapy (RT) sometimes combined with adjuvant chemotherapy depending on the tumor site, extent, and histology. Herein, the authors review the role of RT in the management of head and neck mucosal squamous cell carcinoma (SCC). The authors focus on the outcomes of definitive RT and, depending on the primary site, postoperative RT. Unless otherwise specified, outcomes data cited are from the University of Florida.

Patient-Reported Sexual Survivorship Following High-Dose Image-Guided Proton Therapy for Prostate Cancer.

OBJECTIVE: To help guide individualized treatment, we sought to identify baseline predictive factors that impact long-term erectile function following high-dose image-guided radiotherapy (HD-IGRT). METHODS: Potent men with localized prostate cancer treated with radiotherapy alone were enrolled in an institutional review board-approved prospective cohort study. Men received HD-IGRT as primary treatment of prostate cancer. Patient-reported inventories were used to assess erectile function at baseline, 6 months, 2 years, and 5 years after treatment. Long-term potency rates were compared to validated models, and baseline factors were used to create a novel, internally validated nomogram for predicting long-term function. RESULTS: 1,159 men were treated with HD-IGRT. Among 676 men who were potent at baseline and did not receive hormone therapy, the potency rates at 6 months, 2 years, and 5 years were 81%, 68%, and 61%. Recursive partitioning categorized patients into 3 groups based on two factors: baseline response to EPIC Q57 (ability to have an erection) and pre-existing heart disease. At 5 years, the most favorable group reported "very good" on Q57 and had an 80% potency rate (n = 137; p = 0.83); the intermediate group reported "good" on Q57 and had no baseline cardiac disease with a 62% potency rate (n = 145; p = 0.86); and the remaining poor risk group had a 37% potency rate (n = 117; p = 0.19). CONCLUSIONS: Patient-reported pretreatment sexual function and comorbidities enables stratification and prediction of erectile function. EPIC subset questions with baseline comorbidities may potentially serve as a quick and practical clinical tool for predicting sexual survivorship.

Isolated leptomeningeal progression from sinonasal carcinomas: Implications for staging workup and treatment.

PURPOSE: To evaluate the rate and risk factors of isolated leptomeningeal progression in sinonasal carcinomas. METHODS: We retrospectively reviewed imaging and clinical records to determine progression patterns, and estimated rates using the Kaplan-Meier method. We evaluated risk factors using proportional hazard regression. RESULTS: We analyzed 120 patients who received adjuvant or primary radiotherapy for sinonasal carcinomas. Most patients had T4 disease (68%) and underwent surgery (84%) and chemotherapy (72%). Twenty-seven (23%) patients developed distant metastases (DM), including 20 (17%) with isolated DMs. Leptomeningeal progression was the most common site of isolated DMs (n = 9; 45%) with an average disease-free interval of 1.2 years (0.1-4.3 years). High-grade histology (P = 0.0003), intracranial invasion (P < 0.0001), and neuroendocrine histology (P = 0.06) were associated with increased risk. CONCLUSIONS: Isolated leptomeningeal progression is a common pattern of DM in advanced sinonasal carcinomas. We recommend adding cerebrospinal fluid cytology and contrast-enhanced spine MRI to routine staging evaluations for high-risk patients.

Rectal Culture and Sensitivity Analysis for Reducing Sepsis Risk After Fiducial Marker Placement.

PURPOSE: Placement of fiducial markers for prostate radiotherapy (RT) is associated with a 2% to 3% risk of bacterial urinary tract infection (UTI) that may progress to sepsis necessitating hospitalization. These bacterial UTIs are primarily due to flouroquinolone (FQ) resistant Escherichia coli (E. coli). The incidence of this complication has increased in recent years. The purpose of this study is to determine whether rectal culture and sensitivity (C&S) to identify FQ resistant E. coli obtained before placement of fiducial markers for prostate RT reduces the likelihood of this complication. METHODS: In total, 412 patients treated with RT at the University of Florida Proton Therapy Institute between 2015 and 2017 were included in the study. Rectal C&S were obtained at the time of initial consultation which preceded placement of fiducial markers for planning and realignment for prostate RT. Patients in whom resistant E. coli were identified had their prophylactic antibiotic regimen modified accordingly. Whether bacterial UTI requiring hospitalization following fiducial placement occurred was prospectively recorded in the medical record on the first day of RT. RESULTS: One of 412 patients (0.2%) developed bacterial sepsis requiring hospitalization after fiducial placement. CONCLUSION: Rectal C&S to identify FQ resistant E. coli before placement of fiducial markers for prostate RT likely reduces the risk of bacterial UTI necessitating hospitalization.

Definitive Radiotherapy for Skin and Adenoid Cystic Carcinoma with Perineural Invasion.

Adenoid cystic carcinomas (ACC) and, to a lesser extent, cutaneous squamous cell carcinomas and basal cell carcinomas may exhibit perineural invasion (PNI). A subset of patients have tumors with extensive PNI tracking to the skull base that are incompletely resectable and are treated with definitive radiotherapy (RT). RT may be administered with intensity-modulated RT or proton RT. Patients with ACC may also be considered for neutron RT, although the number of available neutron facilities is limited. A substantial proportion of patients with incompletely resectable ACCs and cutaneous carcinomas may be cured with definitive RT. Proton RT provides a more conformal dose distribution compared with other modalities and is likely associated with a lower risk of complications.

Treatment of Small Cell Carcinoma of the Bladder With Chemotherapy and Radiation after Transurethral Resection of a Bladder Tumor.

OBJECTIVES: Small cell carcinoma of the bladder is a rare, aggressive cancer with a high potential for metastases. We analyzed outcomes of patients with small cell carcinoma of the bladder treated curatively with chemotherapy and radiotherapy with bladder preservation. MATERIALS AND METHODS: We reviewed the medical records of 11 patients treated with radiotherapy at our institution between 1988 and 2010 for biopsy-proven small cell carcinoma of the bladder clinically localized to the true pelvis. Each patient received transurethral resection of the bladder tumor followed by induction chemotherapy and consolidative radiation or concurrent chemoradiation. After completing radiotherapy, cystoscopy was performed to evaluate local response. Overall survival, distant metastasis-free survival, local-regional control, and complete response rates are reported. RESULTS: The median follow-up was 1.1 years for all patients and 10 years for survivors. Nine patients had clinical T3-T4 disease and 3 had node-positive disease. All patients were treated with conventional radiotherapy (median dose, 59 Gy) and cisplatin-based chemotherapy. Eight patients had a cystoscopy after completing chemoradiation, all of whom had a biopsy-proven complete response. The remaining 3 patients developed a distant metastasis before cystoscopy could be performed. The 3-year overall survival rate was 24%; the distant metastasis-free survival rate was 27%; and the local-regional control rate was 78%. All patients who achieved local control maintained functioning bladders. No Common Terminology Criteria for Adverse Events toxicity scale, version 3.0 late grade 3 genitourinary or gastrointestinal toxicities occurred. CONCLUSIONS: Primary chemoradiation provides reasonable local-regional control rates with a functioning bladder, even for patients with locally advanced disease, and is an effective alternative to cystectomy when aiming for bladder conservation.

A Prospective Evaluation of Acute Toxicity from Proton Therapy for Targets of the Parotid Region.

PURPOSE: Mucosal toxicities are common acute effects from head-and-neck radiotherapy. The parotid region is ideal for proton therapy (PT) due to sparing radiosensitive tissues distal to the target. We prospectively evaluated acute mucosal toxicity in patients treated with PT for parotid cancers. PATIENTS AND METHODS: Twenty-three patients received primary (n=7) or adjuvant (n=16) PT for parotid cancers, including salivary gland carcinoma (n=17), skin carcinoma with perineural invasion (n=5), and Ewing sarcoma (n=1). PT consisted of 2-3 passively scattered fields. Median dose was 70 Gy (RBE) (range, 55.8-74.4) using various fractionation schedules. Seven patients received concurrent chemotherapy. Acute toxicities, nutritional status, and weight were prospectively evaluated weekly. RESULTS: Most patients experienced no or minimal toxicity throughout therapy. There were no grade 4 toxicities and only 1 transient grade 3 dysphagia. At the end of treatment, the worst mucositis was grade 2 in 35% with 43% experiencing no mucositis; the worst dysphagia was grade 2 in 26 % with 48% having no dysphagia; the worst dysgeusia was grade 2 in 23% with 50% experiencing no dysgeusia; and the worst xerostomia was grade 2 in 14% with 23% experiencing no xerostomia. The median weight loss was 3%. No patient required a feeding tube or intermittent intravenous hydration. CONCLUSIONS: PT for tumors of the parotid region results in very low rates of mucosal toxicity. Nutritional status and weight were preserved throughout therapy. These results should be validated with patient-reported outcomes, and their impact on functional recovery and treatment costs remain unexplored.