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Objectives/hypothesis: To evaluate the long-term disease control, survival, and complications after definitive radiotherapy (RT) alone or combined with adjuvant chemotherapy with or without planned neck dissection for base of tongue squamous cell carcinoma (SCC)., Study Design: We retrospectively reviewed the medical records of 467 patients treated at the University of Florida with definitive RT alone or combined with adjuvant chemotherapy between 1964 and 2011 for base of tongue SCC., Methods: Median follow-up was 5.6 years. Median total dose to the primary site was 74.4 Gy. Eighty-seven patients (19%) were treated with once-daily fractionation, and 380 (81%) received altered fractionation schedules. Intensity-modulated RT was used in 128 patients (27%). Chemotherapy was administered to 173 (37%) patients. Planned neck dissection after RT was performed in 226 patients (48%). Data regarding p16 pathway activation were available for 25 patients., Results: At 5 years, the local, local-regional, and regional control rates were 85.5%, 80.0%, and 90.0%, respectively. The 5-year overall, cause-specific, and distant metastasis-free survival rates were 59.1%, 71.5%, and 84.1%, respectively. Sixty-four patients (14%) developed one or more severe late complications. Fifty patients (11%) required late gastrostomy tube placement., Conclusions: This study supports the continued use of RT alone or combined with adjuvant chemotherapy for patients with base of tongue SCC, as this treatment yields high rates of cause-specific survival and disease control, with a relatively low rate of late complications., Level of Evidence: 4. Laryngoscope, 127:1589-1594, 2017., (© 2017 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives: To evaluate the efficacy of postoperative radiotherapy for oral cavity squamous cell carcinoma (OCSCC) by comparing outcomes of high-risk subgroups., Study Design: Retrospective review., Methods: Outcome study of 139 patients with OCSCC treated with gross total resection and postoperative radiotherapy ± chemotherapy and at least one high-risk pathologic finding: positive margin (52%), close (0.1-5 mm) margin (27%), or extracapsular nodal extension (ECE; 45%)., Results: Median follow-up was 2.3 years. Local-regional control (LRC), freedom from distant metastases, cause-specific survival, and overall survival (OS) rates at 5 years were 64%, 85%, 51%, and 36%, respectively. Five-year LRC for negative (>5 mm), close (0.1-5 mm), and positive (carcinoma in situ or tumor at ink) margins were 73%, 83%, and 63%, respectively (P = not significant). Five-year neck control was 100% for node-negative patients, 88% for node-positive patients with no ECE, and 86% for node-positive patients with ECE (P = not significant). The combination of close/positive margin and ECE resulted in worse 5-year LRC (37% vs. 70%, P < 0.001), progression-free survival (26% vs. 60%, P < 0.001), and OS (13 vs. 43%, P < 0.001) compared with a single high-risk indication., Conclusions: Local-regional control was the predominant mode of treatment failure. Outcome in our series was not statistically different based on margin status or nodal ECE. This finding is indirect evidence of the efficacy of adjuvant radiotherapy in this setting., (© 2014 The American Laryngological, Rhinological and Otological Society, Inc.)

Objectives/hypothesis: Is the severity of acute oral mucositis in patients who receive postoperative intensity-modulated radiotherapy (PO-IMRT) for oral tongue squamous cell carcinoma (SCC) reduced by sparing the oral mucosa outside of the planning target volume (PTV)?, Study Design: Prospective, randomized trial., Methods: Forty-eight patients with oral tongue SCC who received PO-IMRT at our institution were randomized to two groups: the oral-sparing (OR-SP) group and oral-unsparing (OR-USP) group. For the OR-SP group (n = 24), the oral mucosa outside of the PTV was spared. Furthermore, the mucosa including the bilateral cheeks, upper lip, and lower lip was defined as the united site and given <32 Gy. For the OR-USP group (n = 24), none of the oral mucosa was protected. The severity of clinical acute mucositis in each patient was assessed weekly during PO-IMRT until completely healed. Oral mucositis was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Dosimetry and therapeutic measures related to acute mucositis between the two groups were compared., Results: During PO-IMRT, no patient experienced grade 4+ acute mucositis in any oral site. Compared to the OR-USP group, there was less grade 2 and 3 mucositis in the united site of the OR-SP group (0% and 25% vs. 45.8% and 54.2%, respectively; P = .000). Also, the mean dose to the united site was significantly lower with OR-SP compared to OR-USP (41.8 ± 7.4 Gy vs. 58.8 ± 2.2 Gy; P = .000). The OR-SP group was associated with significant reductions in the use of analgesics (P = .043) and intravenous antibiotics (P = .039). No recurrences were detected in the vicinity of the spared oral mucosa (the united site) during a median follow-up time of 30 months., Conclusions: OR-SP PO-IMRT for patients with oral tongue SCC resulted in a significant decrease in the severity of acute mucositis and improved quality of life. The sparing of the oral mucosa outside of the PTV is safe and does not compromise oncologic outcomes., (Copyright © 2012 The American Laryngological, Rhinological, and Otological Society, Inc.)

Objectives/hypothesis: To define the role of elective neck dissection during salvage surgery for locally recurrent head and neck squamous cell carcinoma (SCCA) initially treated with elective nodal irradiation (ENI)., Study Design: Retrospective chart review., Methods: We reviewed the medical records of patients treated with ENI at our institution from 1965 to 2006 for T1-4 N0 M0 SCCA of the oropharynx, hypopharynx, or larynx who developed an isolated local recurrence and remained N0. Fifty-seven patients were salvaged, 40 with neck dissection and 17 with neck observation. We then compared toxicity and actuarial outcomes between the two groups. Results were compared to the pertinent literature in a pooled analysis., Results: Four of 46 (9%) heminecks were found to have occult metastases in dissected specimens. The 5-year local-regional control rate was 75% for all patients. Neck dissection resulted in poorer outcomes compared with observation. In the dissected group, the 5-year local control, regional control, cause-specific survival, and overall survival rates were 71%, 87%, 60%, and 45%, respectively, compared to 82%, 94%, 92%, and 56%, respectively, for the observed group. Toxicity was more likely with dissection. In the pooled analysis totaling 230 patients, the overall pathologic positive rate of neck-dissection specimens was 9.6%; the compiled data showed no improvement in outcomes when salvage included neck dissection., Conclusions: Routine elective neck dissection should not be included during salvage surgery for locally recurrent head and neck SCCA if initial radiotherapy includes ENI. The risk of occult neck disease is low, outcomes do not improve, and the likelihood of toxicity increases. Laryngoscope, 2010.

Objectives/hypothesis: To investigate changes in parotid and submandibular gland volumes of patients with head and neck cancer treated with postoperative intensity-modulated radiotherapy (IMRT) or conventional radiotherapy (CRT), and to relate the volume changes to different mean radiation therapy (RT) doses to the parotid and submandibular glands., Methods: Between May 2007 and May 2008, 82 head and neck cancer patients (oral cavity cancer, 71; oropharynx cancer, 11) were treated with surgery and postoperative RT (IMRT, 40; CRT, 42) at our institution. Every patient underwent four computed tomography (CT) scans: one before RT, one after 3 weeks or at the 15th fraction of RT, one upon completing RT, and one at 2 months after RT; 39 of 82 patients had an additional CT scan at 6 months after RT. A dose-volume histogram was used to evaluate the mean volumes of patients' parotid and submandibular glands and mean RT doses to the glands on every CT scan. Altogether, 241 salivary glands (parotid, 162; submandibular, 79) were analyzed. The volume changes of the glands were evaluated against three levels of mean gland doses: <30 Gy, 30 to 50 Gy, and >50 Gy., Results: The mean RT doses to spared parotid glands, spared submandibular glands, and irradiated submandibular glands in patients treated with IMRT were 22.21 Gy, 18.26 Gy, and 52.19 Gy, respectively. The mean doses to parotid and submandibular glands in patients treated with CRT were 50.22 Gy and 62.09 Gy, respectively. The average volume loss rates in parotid glands after 3 weeks of RT, at the end of RT, and 2 months after RT versus before RT were 20.01%, 26.93%, and 27.21%, respectively. The average volume loss rates in submandibular glands after 3 weeks of RT, at the end of RT, and 2 months after RT versus before RT was 11.49%, 16.76%, and 16.29%, respectively. Parotid and submandibular glands did not continue to shrink after completing RT. We observed more volume loss during RT in the parotid glands than in the submandibular glands. The average rates of volume loss during the first 3 weeks of RT (20.01% and 11.49%, respectively) were larger than in the last 3 weeks of RT (8.57% and 6.0%, respectively). No significant differences were observed in the mean volumes of both parotid and submandibular glands between the end of RT, 2 months post-RT, and 6 months post-RT (P > .05). Volume loss at higher doses (>30 Gy) to the glands was significantly larger than at low doses (<30 Gy; P < .001)., Conclusions: The parotid and submandibular glands shrunk during RT, but the parotid glands shrunk more than the submandibular glands. These gland volume reductions correlated significantly with the mean dose to the irradiated glands; the spared glands showed few changes.

Objectives/hypothesis: To discuss the role of radiotherapy (RT) in the treatment of cutaneous squamous and basal cell carcinomas of the head and neck., Methods: Review of the pertinent literature., Results: The likelihood of cure with a good cosmetic outcome is high for patients with early-stage cancers treated with definitive RT. The probability of local control is higher for previously untreated cancers and is inversely related to tumor size. The likelihood of cure for patients with perineural invasion (PNI) is related to the presence of symptoms and to the radiographic extent of disease. It decreases as the tumor extends centrally towards the central nervous system. Patients with incidental PNI have a local control rate of 80% to 90% compared with about 50% to 55% for those with clinical PNI. The optimal treatment for patients with clinically positive nodes is surgery and postoperative RT. The likelihood of cure for those with positive parotid nodes is approximately 70% to 80%., Conclusions: Definitive RT is useful for treating early-stage skin cancers where resection would result in a significant cosmetic and/or functional deficit. Postoperative RT is indicated in situations where the probability of residual disease after surgery is high and the chance of successful salvage is modest. Patients with parotid-area node metastases are optimally treated with surgery and postoperative RT.

Objectives/hypothesis: To analyze the outcomes of patients treated for minor salivary gland carcinoma with radiotherapy (RT), either alone or combined with surgery., Study Design: Retrospective review., Methods: Between September 1966 and December 2006, 140 patients were treated with curative intent at our institution for previously untreated minor salivary gland carcinomas (RT alone, 64 patients; combined RT and surgery, 76 patients). Median follow-up for all patients was 5.5 years., Results: The 10-year local control rate was 66%, and multivariate analysis revealed that treatment group (P = .0004) and T stage (P = .0001) significantly influenced this endpoint. Patients treated with RT alone had a lower local control rate than patients treated with RT and surgery. The 10-year local-regional control rate was 61%, and multivariate analysis revealed that treatment group (P = .0174), overall stage (P = .0004), and N stage (P = .0492) significantly influenced this endpoint. The 10-year distant metastasis-free survival rate was 67%, and multivariate analysis revealed that overall stage (P = .0016) significantly influenced this endpoint. The 10-year cause-specific survival rate was 56%, and multivariate analysis revealed that overall stage (P < .0001) significantly influenced this endpoint. The 10-year overall survival rate was 45%, and multivariate analysis revealed that overall stage (P = .0047), N stage (P = .0173), and nerve invasion (P = .0409) significantly influenced this endpoint., Conclusions: Most patients with minor salivary gland carcinoma were cured with RT alone or combined with surgery. Treatment group, T stage, and overall stage significantly influenced the probability of cure. Patients treated with combined surgery and RT had a better prognosis, perhaps due in part to selection bias.

Objectives/hypothesis: To determine the outcomes after radiotherapy (RT) alone or combined with surgery at the University of Florida for patients with carcinomas of the nasal cavity and paranasal sinuses., Methods: Between November 1964 and June 2005, 109 patients were treated with curative intent. Patients with maxillary sinus carcinomas were excluded. Fifty-six patients were treated with definitive RT, and 53 patients received surgery and preoperative (eight patients) or postoperative (45 patients) RT. Median follow-up was 4.3 years (range, 0.2-35.9 years). Median follow-up on living patients was 9.4 years (range, 2.0-35.9 years)., Results: The 5-year local control rates were: T1-T3, 82%; T4, 50%; and overall, 63%. Local control at 5 years was 43% after definitive RT versus 84% after surgery and adjuvant RT (P < .0001). Multivariate analysis of local control revealed that both overall stage and treatment group (definitive RT versus surgery and adjuvant RT) significantly impacted this endpoint. Cause-specific survival rates were: stages I to III, 81%; stage IV, 54%; and overall, 62%. Multivariate analysis revealed that T-stage, N-stage, and treatment group significantly influenced this endpoint. Thirty-one (20%) of 109 patients sustained severe complications; 17 of 56 patients (16%) after definitive RT and 14 of 53 patients (25%) after surgery and adjuvant RT., Conclusions: The probability of local control and cause-specific survival is better after surgery and RT compared with definitive RT. There is a modest increase in the risk of complications after surgery and RT. Thus, the preferred treatment is surgery combined with preoperative or postoperative RT.

From 1964 to 1990, 134 patients were treated at the University of Florida with continuous-course external beam irradiation, alone or followed by a planned neck dissection, for T1 (n = 17), T2 (n = 47), T3 (n = 49), or T4 (n = 21) carcinoma of the base of tongue. The 5-year rate of local control was 90% for stage T1, 92% for T2, 73% for T3, and 35% for T4. Probability of control above the clavicles at 5 years according to modified American Joint Committee on Cancer (AJCC) stage was 100% for stages I and II, 75% for stage III, 84% for stage IVa, and 52% for stage IVb. Probability of relapse-free survival at 5 years was 100% for stages I and II, 68% for stage III, 81% for stage IVa, and 37% for stage IVb. Severe complications occurred in 2% of patients. Compared with surgical resection of the primary tumor, external beam radiotherapy results in similar rates of local control and survival with a lower risk of severe complications.

Intraoperative tumor spill or inadequate resection may be associated with an increase in the recurrence rate of pleomorphic adenoma. An attempt was made to determine the recurrence rate when such factors were identified at the time of operation. From 1970 through 1989, 17 cases were identified in which there was a question of intraoperative tumor spill or inadequate resection of a salivary gland pleomorphic adenoma. Patients were either observed or given postoperative irradiation with a mean follow-up of 7.4 years. The overall initial local recurrence rate was 24%, and all recurrences were successfully salvaged. Inadequate resection, particularly enucleation, was predictive of local recurrence, but tumor spill was not. Postoperative irradiation after inadequate resection appeared to decrease the probability of recurrence. We conclude that recurrence of pleomorphic adenoma is not increased by tumor spill as compared with inadequate resection.

Forty patients with simultaneous multiple primaries of the head and neck were treated with curative intent between June 1964 and April 1983. The primary sites were treated with radiation therapy alone or in combination with surgery. Surgery was used to salvage local failures of radiation treatment. Neck disease was treated with radiation therapy alone or with neck dissection added after completion of radiation therapy to the primary lesions. Minimum follow-up was 2 years with a range of 2 to 20 years. For the 32 patients whose primary tumors were treated with radiation alone, the 2-year local control rates for the 53 individual tumors evaluated were as follows: T1, 18/21; T2, 16/23; and T3-T4, 1/9. In the T3-T4 group, there was only one successful surgical salvage. Local control rates for disease at all primary sites in each patient according to highest T-stage were as follows: T1, 4/5; T2, 9/15; and T3-T4, 1/9. Eight patients whose primary tumors were treated with radiation and surgery are discussed. The absolute disease-free survival rate at 2 years for 40 patients was 42%. Complications of treatment are described.

This is an analysis of 34 patients with carcinoma of the cervical esophagus treated with radiation therapy with curative intent at the University of Florida between September 1966 and May 1985. All patients have a minimum 2-year follow-up and 28 (82%) have at least 5 years of follow-up. Patients were staged according to the recommendations of the AJCC. Patients who died within 2 years of treatment with the primary site continuously disease-free were excluded from the local control analysis; all patients were included in the analysis of complications and survival. Irradiation resulted in control of the primary lesion in 1 of 2 patients who presented with T1 lesions, in 4 of the 12 patients with T2 lesions, and 3 of 17 patients who presented with T3 lesions. One patient with a T3 lesion that recurred locally was successfully salvaged by an operation. The 5-year absolute survival rates by stage were as follows: no patients with stage I lesions survived; of 11 stage II patients, one survived; and of 16 stage III patients, three survived. Interestingly, all four of the 5-year survivors were women.

Five patients were irradiated at the University of Florida for advanced and/or recurrent papillomas of the nasal cavity and paranasal sinuses from December 1969 through December 1981. Three patients were irradiated either before or after resection and two patients were treated with radiation therapy alone. Two patients had pure inverted papilloma, one patient had inverted papilloma associated with a focus of squamous cell carcinoma, and two patients had cylindrical cell papillomas. Four patients are alive and continuously disease free at 3, 3, 4, and 11 years following treatment. One patient died of intercurrent disease nine years following treatment without evidence of recurrent tumor.