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Purpose: Benzydamine is recommended for prophylaxis of oral mucositis (OM) in head and neck cancer (HNC) patients for radiation doses (<50 Gy). This study evaluates role of benzydamine for higher radiation doses (>50 Gy) with or without chemotherapy., Methods: One hundred twenty patients of HNC with planned radiation doses of ≥60 Gy were randomized to group A (control radiotherapy alone), group B (study radiotherapy alone), group C (control chemoradiotherapy), or to group D (study chemoradiotherapy). Groups A and C were advised saline mouth rinses, and in groups B and D, additional benzydamine rinses (0.15%) were advised. Mucositis grading was done with both WHO (WHO-M) and CTCAE (CTC-M) version 4.0 (common terminology criteria for adverse events) weekly., Results: Patient characteristics are presented in the table. Patients in group B had lesser grade 3 WHO-M and CTC-M as compared to group A, 62.1 vs. 36.4% (p = 0.038) and 51.7 vs. 27.3% (p = 0.043), respectively. The rates of Ryle's tube feeding (RTF), intravenous fluid supplementation (IVF), and hospitalization were also lesser in group B as compared to A, 34.5 vs. 21.2% (p = 0.18), 27.6 vs. 9.1% (p = 0.06), and 6.9 vs. 0% (p = 0.21), respectively. WHO-M and CTC-M in groups C and D were not statistically different, 64.3 vs. 43.3% (p = 0.091) and 53.6% vs. 43.3% (p = 0.30), respectively. The rates of RTF, IVF, and hospitalization were all lesser but p > 0.05., Conclusion: Benzydamine significantly reduces OM even at doses >50 Gy in HNC patients. Its role in patients receiving concurrent chemotherapy further needs to be evaluated.

Background: To study the long term results of two phase II concurrent chemoradiotherapy protocols and conduct pooled data analysis with special emphasis on nodal density., Materials and Methods: In the period from April 2001 to May 2003, phase II Mitomycin C (MMC) and late chemo-intensification (LCI) protocols were started in the same institute, enrolling 69 and 74 patients respectively. Long term results for these individual trials are reported along with pooled data analysis., Results: Median follow-up time for whole group, MMC protocol and LCI protocol was 43.8 months (SD619.8), 55 months (SD 618.5) and 47.5 months (SD 620.9) respectively. LRFS, DFS and OS at five years for whole group was 59.4, 43.5 and 47.1% respectively, for MMC protocol was 59.9, 45.5 and 49.5% respectively and for LCI, protocol was 53.6%, 41.5% and 44.4% respectively. Subgroup analysis revealed that MMC protocol was more effective than LCI protocol in terms of DFS and OS in patients with hypo dense nodes while opposite was true for Isodense nodes. Multivariate analysis revealed nodal density as an independent variable that had an impact on treatment outcome. Risk of death in patients with hypo dense nodes was 2.91 times that of Isodense nodes., Conclusions: Innovative and pragmatic approach is required to address locally advanced head neck cancer. Long term results for MMC and LCI protocols are encouraging. Integrating the basic concepts of these protocols may help develop new protocols, which will facilitate the search for the optimal solution.

Purpose: We have been using intensity-modulated radiotherapy (IMRT) for selective neck irradiation. This article presents an analysis of patterns of failure and their dosimetric correlation., Methods and Materials: Between October 2003 and January 2008, 83 patients with head-and-neck cancer were treated with IMRT. Nodal levels were contoured as per the Radiation Therapy Oncology Group (RTOG) consensus guidelines., Results: There were 32 relapses with 23 local relapses (21 local relapses alone and 2 local and regional relapses, simultaneously), 9 regional relapses (including 2 simultaneous local and regional relapses), and 5 distant relapses, of which 2 patients had local relapses. At 2 and 3 years, the locoregional relapse-free survival rates were was 68.3% and 60.8%, respectively, while the overall survival rates were 84.1% and 81.7%, respectively. Subgroup analyses revealed significant differences in locoregional relapse-free survival rates for total treatment times of <53 days vs. >53 days, a volume of CTV1PTV (i.e., the volume prescribed 70 Gy) <177 cc vs. >177 cc, a V100 for CTV1PTV of <91% vs. >91%, and a minimum dose to CTV1PTV of <54 Gy vs. >54 Gy. There were no failures in the elective nodal volume, substantiating both the nodal selection criteria and the RTOG consensus guidelines for delineation of neck node levels., Conclusions: IMRT for head-neck cancer is feasible, using elective nodal selection criteria along with RTOG consensus guidelines for the radiological boundaries of levels of neck nodes.

Objective: The aim of the present study was to define the prognostic impact of nodal density (ND) and total tumor volume along with many other tumor, treatment and patient related variables using the late chemo-intensification treatment regimen with conventionally fractionated radiotherapy (70 Gy/7 weeks)., Methods: A total of 74 patients with Stage III and IV biopsy proven squamous cell carcinoma of oropharynx, hypopharynx and larynx were treated with this regimen. ND and total tumor volume was measured on high resolution CT scans for all the patients. Chemotherapy consisted of continuous infusion of 5 FU at 350 mg/m(2)/day and cisplatin as 1 h infusion at 10 mg/m(2)/day on days 1-5 of week 6 and 7 of radiotherapy., Results: Grade III mucositis was present in 48 (64.9%) patients. Overall complete response rate was 77%. At 28 months, locoregional relapse-free survival (LRFS), overall survival (OS) and distant metastases-free survival (DMFS) was 70.8%, 66.9% and 81.9%, respectively. In the final multivariate Cox-regression model tumor stage, ND, primary site and nodal stage were independent variables predicting for LRFS. Similarly AJCC group staging, ND and total treatment volume were found to have significant impact, independently over LRFS., Conclusions: There is tremendous variation in terms of ND and total tumor volume within AJCC nodal staging and tumor staging, respectively. ND had significant impact over LRFS and OS. Future phase III trial may need stratification on the basis of these variables.

The aim of this study was to define the feasibility of a late chemo-intensification treatment regimen with conventionally fractionated radiotherapy (70 Gy/7 weeks). Seventy four patients with Stage III and IV biopsy proven squamous cell carcinoma of oropharynx, hypopharynx and larynx were treated with this regimen. Chemotherapy consisted of continuous infusion of 5-FU at 350 mg/m(2)/day and cisplatin as 1h infusion at 10 mg/m(2)/day on days 1-5 of week 6 and 7 of radiotherapy. Grade III mucositis was present in 48 (64.9%) patients. After surgical salvage 59 (79.7%) patients had overall complete response. Locoregional control rate at 3 year was 80.8%. Three year locoregional relapse free survival (LRFS), overall survival (OS) and disease free survival (DFS) was 63.1%, 66.7% and 44.4%, respectively. The late chemo-intensification regimen was feasible in terms of response rate, toxicity and survival functions.

Objective: The purpose of this study was to evaluate the efficacy of radiotherapy and concurrent mitomycin-C (MC) plus 5-fluorouracil (5FU) infusion in locally advanced squamous cell carcinoma of the head and neck (SCCHN)., Methods: Sixty-nine patients with SCCHN (6 Stage III and 63 Stage IV patients) were treated with external beam radiotherapy (70 Gy) and simultaneous intravenous chemotherapy with 5FU (600 mg/m(2)/day, Days 1-5) and MC (10 mg/m(2), Days 5 and 36)., Results: After a mean follow-up of 28.5 months, 59.4% of patients were alive without disease. Complete response was seen in 76.8% of patients. The 3 years overall survival, locoregional relapse-free survival and disease-free survival was 62.3, 63.1[corrected] and 49.5%, respectively. Treatment was well tolerated (Grade III mucositis in 43.5% and Grade II leukopenia in 5.8%)., Conclusions: This concurrent chemoradiotherapy regimen offers a curative option for our patients where primary and nodal disease is fairly large resulting in hypoxic radioresistant tumors.