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Comparison of Accelerated Versus Conventional Fractionated Chemoradiation Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
E350
International Journal of Radiation Oncology Biology Physics
Materials/Methods: We reviewed the charts of all patients with cT1-2 squamous cell carcinoma of the oral tongue treated with primary surgery from 1990 e 2010 at a single institution. Tumor and margin characteristics were abstracted from the original surgical pathology analysis. Patients received adjuvant radiation for accepted indications. For those with a worrisome intra-operative margin, subsequent re-excisions of either the area of concern or the entire operative bed were interpreted as the true final margin; an initially positive margin on the primary tumor specimen was not interpreted as an indication for adjuvant therapy. Overall survival (OS), disease free survival (DFS) and local control (LRC) were calculated using the Kaplan Meier method. Predictors of LC, OS, and DFS were analyzed via univariate and multivariate analysis (MVA). Results: 223 patients met the inclusion criteria. Median age was 62 years; 23% proved to be stage III/IV on pathologic staging. Sixty-seven (30%) of patients were administered adjuvant radiation and 25 (11%) of patients received adjuvant chemoradiation. Patients treated with adjuvant radiation were more likely to have perineural invasion (P < 0.0001) and pathologic stage III-IV disease (P < 0.0001). The initial specimen margin was involved with carcinoma or severe dysplasia in 73 cases (33%). Of the patients whose initially involved margin was superseded, 48 (66%) did not receive adjuvant radiation. With a median follow-up of 4.8 years, the 5 yr actuarial LRC and DFS for patients treated with surgery alone and surgery plus adjuvant (chemo)radiation was 74% and 79% (P Z 0.62) and 66% and 67% (P Z 0.83). Patients with a positive margin on the initial specimen superseded by additional specimens had similar 5-year local control (86% v 84%, P Z 0.18) and DFS (63% v 68%, P Z 0.98) when compared to those with a clear margin on the initial specimen. On MVA, no factor evaluated (stage, perineural invasion, initial involved margin, adjuvant radiation, adjuvant chemoradiation, smoking pack years, or age at diagnosis) was associated with local recurrence. Conclusion: An initially positive margin that is rendered negative at the same surgical procedure does not increase the chance of local recurrence and should not be considered an independent indication for adjuvant radiation. Author Disclosure: I. Dhawan: None. T. Li: None. C. Fundakowski: None. M. Lango: None. J.A. Ridge: None. J. Liu: None. T.J. Galloway: None.
Treatment interruptions noted in 5 patients in control arm versus 7 in study arm due to more grade III /IV mucositis. Ryles tube feeding was required in 11 patients in control arm vs 6 in study arm. Grade I /II Neutropenia was common in control arm [44.83% vs 17.85%] Acute mucosal toxicity of grade III was higher in study arm [35.71% vs 20.69%]. Grade II skin reactions were predominant in study arm [64.29% vs 34.48%]. Grade II dysphagia reported higher in control arm [65.52% vs 53.57%] whereas grade III was more in study arm [35.72% vs 20.69%]. Grade III laryngeal edema was slightly higher in the study arm but was statistically insignificant. Grade II xerostomia was higher in study arm [17.86% vs 13.79%]. Predominant Late toxicities in control versus study arm - xerostomia grade I [51.85% vs 48.15%], fibrosis grade-I [37.03% vs 29.63%], trismus grade-II [11.11% vs 3.70%] and laryngeal edema grade-II [18.52% vs 22.22%] were observed. Complete response [CR] rate at primary site was higher at 1 month [67.85% vs 71.42%], 3 months [67.86% vs 75%] and at 6 months [66.67% vs 77.78%] in the study arm. CR rate at the nodal site was higher at 1 month [78.57% vs 67.82%], 3 months [82.14% vs 65.36%] and at 6 months [77.08% vs 62.96%] in the control arm. Better CR rates were seen with well and moderately differentiated SCC in the study arm. Conclusion: Accelerated chemo radiation therapy showed an optimum balance between improved tumor control and avoidance of excess late morbidity with manageable acute toxicities. Therefore in limited resource settings and high volume centers, modified fractionation schedules should constitute a new baseline for further exploration of radiation therapy in head and neck cancers. Author Disclosure: R. Das: RESIDENT IN TRAINING; AIIMS. D. Kumaran: RESIDENT IN TRAINING; AIIMS. N. Das: None. A. Gupta: None. A. Rai: None.
2862 Comparison of Accelerated Versus Conventional Fractionated Chemoradiation Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma R. Das,1,2 D. Kumaran,2 N. Das,1 A. Gupta,1 and A.K. Rai1; 1VMMC and Safdarjung Hospital, New Delhi, India, 2All India Institute of Medical Sciences, New Delhi, India Purpose/Objective(s): To evaluate a) The efficacy of accelerated versus conventional fractionated radiation therapy with 3 weekly concomitant cisplatin in locally advanced squamous cell carcinoma [SCC] of head and neck patients excluding nasopharynx and maxillary sinus b) To determine and compare acute and late toxicities. Materials/Methods: A randomized study comparing: Arm A [control arm] - 5 fractions of radiation per week of 2Gy/day in telecobalt with compensators to a dose of 66Gy/33# over 61/2 weeks with concurrent cisplatin 100mg/m2 3 weekly on day 1, 22 and 43. ARM B [study arm]6 fractions of radiation per week of 2Gy/day in telecobalt with compensators to a dose of 66Gy/33# over 51/2 weeks with concurrent cisplatin 100mg/m2 3 weekly on day 1 and day 22. Toxicities were weekly assessed. Subsequently followed up with clinical examination monthly till 6 months & CT /MRI was done at first month and 6 month post treatment. Results: Standard statistical and Fischer’s test were applied. 60 patients were recruited in this study. In Control arm, 29 patients completed treatment versus 28 in study arm. Clinico-pathologic characteristics were comparable in both arms. Most patients were of oropharynx [17vs19]. Majority were T3 stage [44.82%vs50%] and N1 [55.17% vs 35.72%]
2863 Acute Side Effects of Proton Beam Therapy for Uveal Melanoma D.M. Trifiletti,1 R. Dagan,1 J. Bolling,2 R. Slopsema,1 M. MamaluiHunter,1 D. Yeung,1 K. Helow,1 and M.S. Rutenberg1; 1University of Florida Health Proton Therapy Institute, Jacksonville, FL, 2Mayo Clinic, Jacksonville, FL Purpose/Objective(s): There are limited data available describing the acute side effects associated with proton beam therapy (PBT) for the definitive management of patients with uveal melanoma. We report our initial experience with acute toxicities related to PBT for uveal melanoma. Materials/Methods: From 2012 to 2016, 55 patients were treated definitively for uveal melanoma with hypofractionated PBT. Tantalum fiducials were sutured onto the sclera prior to treatment planning for daily alignment. Treatment consisted of 60 CGE delivered in 15 CGE/fx on consecutive days using passive scattering PBT on a fixed beam eyeline. Prospectively recorded acute treatment related side effects within 180 days of treatment were analyzed. Results: Median follow-up was 1.1 years (range: 0.1- 3.0 years). The median age at treatment was 60 years old (range: 26 - 94). Twenty-nine right eyes and 26 left eyes were treated; T1 Z 9, T2 Z 17, T3 Z 17, and T4 Z 12. All patients but one (iris melanoma) had disease involving the posterior uveal structures. The median tumor size was 14.5 mm (range: 5.2 - 21.0) in maximum diameter and 6.0 mm (range: 1.2 - 13.0) in thickness. The median interval between tantalum clip placement and PBT was 13 days (range: 4 - 28). 82% had conjunctivitis and 9% had eyelid dysfunction following tantalum clip placement prior to PBT. At 6 weeks post-PBT conjunctivitis and radiation dermatitis were the most common toxicities, occurring in 49%, and 42% of patients, respectively. At 3 months, conjunctivitis, dermatitis, and epiphora occurred in 38%, 25% and 36% of patients, respectively. At 6 months, these side effects decreased in frequency (20%, 18% and 29%, respectively). There were 6 events of grade 3 toxicity consisting of eye pain (1), cataract (1), complete retinal detachment requiring surgery (1), and epiphora (3). There was one grade 4 toxicity (retinopathy) that occurred at 6 months postPBT. One patient was enucleated 3 months post-PBT due to tumor
International Journal of Radiation Oncology Biology Physics
Materials/Methods: We reviewed the charts of all patients with cT1-2 squamous cell carcinoma of the oral tongue treated with primary surgery from 1990 e 2010 at a single institution. Tumor and margin characteristics were abstracted from the original surgical pathology analysis. Patients received adjuvant radiation for accepted indications. For those with a worrisome intra-operative margin, subsequent re-excisions of either the area of concern or the entire operative bed were interpreted as the true final margin; an initially positive margin on the primary tumor specimen was not interpreted as an indication for adjuvant therapy. Overall survival (OS), disease free survival (DFS) and local control (LRC) were calculated using the Kaplan Meier method. Predictors of LC, OS, and DFS were analyzed via univariate and multivariate analysis (MVA). Results: 223 patients met the inclusion criteria. Median age was 62 years; 23% proved to be stage III/IV on pathologic staging. Sixty-seven (30%) of patients were administered adjuvant radiation and 25 (11%) of patients received adjuvant chemoradiation. Patients treated with adjuvant radiation were more likely to have perineural invasion (P < 0.0001) and pathologic stage III-IV disease (P < 0.0001). The initial specimen margin was involved with carcinoma or severe dysplasia in 73 cases (33%). Of the patients whose initially involved margin was superseded, 48 (66%) did not receive adjuvant radiation. With a median follow-up of 4.8 years, the 5 yr actuarial LRC and DFS for patients treated with surgery alone and surgery plus adjuvant (chemo)radiation was 74% and 79% (P Z 0.62) and 66% and 67% (P Z 0.83). Patients with a positive margin on the initial specimen superseded by additional specimens had similar 5-year local control (86% v 84%, P Z 0.18) and DFS (63% v 68%, P Z 0.98) when compared to those with a clear margin on the initial specimen. On MVA, no factor evaluated (stage, perineural invasion, initial involved margin, adjuvant radiation, adjuvant chemoradiation, smoking pack years, or age at diagnosis) was associated with local recurrence. Conclusion: An initially positive margin that is rendered negative at the same surgical procedure does not increase the chance of local recurrence and should not be considered an independent indication for adjuvant radiation. Author Disclosure: I. Dhawan: None. T. Li: None. C. Fundakowski: None. M. Lango: None. J.A. Ridge: None. J. Liu: None. T.J. Galloway: None.
Treatment interruptions noted in 5 patients in control arm versus 7 in study arm due to more grade III /IV mucositis. Ryles tube feeding was required in 11 patients in control arm vs 6 in study arm. Grade I /II Neutropenia was common in control arm [44.83% vs 17.85%] Acute mucosal toxicity of grade III was higher in study arm [35.71% vs 20.69%]. Grade II skin reactions were predominant in study arm [64.29% vs 34.48%]. Grade II dysphagia reported higher in control arm [65.52% vs 53.57%] whereas grade III was more in study arm [35.72% vs 20.69%]. Grade III laryngeal edema was slightly higher in the study arm but was statistically insignificant. Grade II xerostomia was higher in study arm [17.86% vs 13.79%]. Predominant Late toxicities in control versus study arm - xerostomia grade I [51.85% vs 48.15%], fibrosis grade-I [37.03% vs 29.63%], trismus grade-II [11.11% vs 3.70%] and laryngeal edema grade-II [18.52% vs 22.22%] were observed. Complete response [CR] rate at primary site was higher at 1 month [67.85% vs 71.42%], 3 months [67.86% vs 75%] and at 6 months [66.67% vs 77.78%] in the study arm. CR rate at the nodal site was higher at 1 month [78.57% vs 67.82%], 3 months [82.14% vs 65.36%] and at 6 months [77.08% vs 62.96%] in the control arm. Better CR rates were seen with well and moderately differentiated SCC in the study arm. Conclusion: Accelerated chemo radiation therapy showed an optimum balance between improved tumor control and avoidance of excess late morbidity with manageable acute toxicities. Therefore in limited resource settings and high volume centers, modified fractionation schedules should constitute a new baseline for further exploration of radiation therapy in head and neck cancers. Author Disclosure: R. Das: RESIDENT IN TRAINING; AIIMS. D. Kumaran: RESIDENT IN TRAINING; AIIMS. N. Das: None. A. Gupta: None. A. Rai: None.
2862 Comparison of Accelerated Versus Conventional Fractionated Chemoradiation Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma R. Das,1,2 D. Kumaran,2 N. Das,1 A. Gupta,1 and A.K. Rai1; 1VMMC and Safdarjung Hospital, New Delhi, India, 2All India Institute of Medical Sciences, New Delhi, India Purpose/Objective(s): To evaluate a) The efficacy of accelerated versus conventional fractionated radiation therapy with 3 weekly concomitant cisplatin in locally advanced squamous cell carcinoma [SCC] of head and neck patients excluding nasopharynx and maxillary sinus b) To determine and compare acute and late toxicities. Materials/Methods: A randomized study comparing: Arm A [control arm] - 5 fractions of radiation per week of 2Gy/day in telecobalt with compensators to a dose of 66Gy/33# over 61/2 weeks with concurrent cisplatin 100mg/m2 3 weekly on day 1, 22 and 43. ARM B [study arm]6 fractions of radiation per week of 2Gy/day in telecobalt with compensators to a dose of 66Gy/33# over 51/2 weeks with concurrent cisplatin 100mg/m2 3 weekly on day 1 and day 22. Toxicities were weekly assessed. Subsequently followed up with clinical examination monthly till 6 months & CT /MRI was done at first month and 6 month post treatment. Results: Standard statistical and Fischer’s test were applied. 60 patients were recruited in this study. In Control arm, 29 patients completed treatment versus 28 in study arm. Clinico-pathologic characteristics were comparable in both arms. Most patients were of oropharynx [17vs19]. Majority were T3 stage [44.82%vs50%] and N1 [55.17% vs 35.72%]
2863 Acute Side Effects of Proton Beam Therapy for Uveal Melanoma D.M. Trifiletti,1 R. Dagan,1 J. Bolling,2 R. Slopsema,1 M. MamaluiHunter,1 D. Yeung,1 K. Helow,1 and M.S. Rutenberg1; 1University of Florida Health Proton Therapy Institute, Jacksonville, FL, 2Mayo Clinic, Jacksonville, FL Purpose/Objective(s): There are limited data available describing the acute side effects associated with proton beam therapy (PBT) for the definitive management of patients with uveal melanoma. We report our initial experience with acute toxicities related to PBT for uveal melanoma. Materials/Methods: From 2012 to 2016, 55 patients were treated definitively for uveal melanoma with hypofractionated PBT. Tantalum fiducials were sutured onto the sclera prior to treatment planning for daily alignment. Treatment consisted of 60 CGE delivered in 15 CGE/fx on consecutive days using passive scattering PBT on a fixed beam eyeline. Prospectively recorded acute treatment related side effects within 180 days of treatment were analyzed. Results: Median follow-up was 1.1 years (range: 0.1- 3.0 years). The median age at treatment was 60 years old (range: 26 - 94). Twenty-nine right eyes and 26 left eyes were treated; T1 Z 9, T2 Z 17, T3 Z 17, and T4 Z 12. All patients but one (iris melanoma) had disease involving the posterior uveal structures. The median tumor size was 14.5 mm (range: 5.2 - 21.0) in maximum diameter and 6.0 mm (range: 1.2 - 13.0) in thickness. The median interval between tantalum clip placement and PBT was 13 days (range: 4 - 28). 82% had conjunctivitis and 9% had eyelid dysfunction following tantalum clip placement prior to PBT. At 6 weeks post-PBT conjunctivitis and radiation dermatitis were the most common toxicities, occurring in 49%, and 42% of patients, respectively. At 3 months, conjunctivitis, dermatitis, and epiphora occurred in 38%, 25% and 36% of patients, respectively. At 6 months, these side effects decreased in frequency (20%, 18% and 29%, respectively). There were 6 events of grade 3 toxicity consisting of eye pain (1), cataract (1), complete retinal detachment requiring surgery (1), and epiphora (3). There was one grade 4 toxicity (retinopathy) that occurred at 6 months postPBT. One patient was enucleated 3 months post-PBT due to tumor