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Does primary tumor volume predict local control after definitive radiotherapy for squamous cell carcinoma of the head and neck
74
I. J. Radiation Oncology
123
● Biology ● Physics
Volume 54, Number 2, Supplement, 2002
A Phase III Double-Blind Randomized Placebo Controlled Study of Porfiromycin and Radiation Therapy in Patients with Head and Neck Cancer
E.F. Lartigau1, J. Giralt2, P. Glassman3, A. Lawton3, R. von Roemeling3 Department of Radiotherapy, Centre Oscar Lambret, Lille, France, 2Department of Radiotherapy, Hospital G. Vale d, Barcelona, Spain, 3Boehringer Ingelheim Ph., CT 1
Purpose/Objective: The present study was a multinational, double blind, Phase III trial designed to assess the efficacy and pharmakokinetics of profiromycin versus placebo in patients with advanced head and neck cancer who received radiation therapy (RT). Materials/Methods: An interim analysis on 338 patients revealed a lack of efficacy of porfiromycin over placebo and the trial was closed to further enrollment. As a result, only 413 of the projected 550 patients were enrolled into the trial. Four hundred and fifteen patients were randomized and 22 patients withdrew or were lost of follow up. One hundred and ninety-six patients received porfiromycin and 197 patients received placebo. Results: Overall, porfiromycin treatment demonstrated no additional efficacy over placebo (RT alone). Subset analysis relative to tumour site stratification showed similar lack of porfiromycin superiority over placebo. Myelosuppression was the only major (and expected) serious toxicity. Isolated lymphocytopenia grade IV occured equally in both porfiromycin treated patients and placebo patients. Hemoglobin levels less than 10 g/dL were found to occur in 46 (23.5%) porfiromycin patients and in 10 (5.1%) placebo patients during the treatment phase of the trial. These patients had a lower overall clinical response rate than placebo. Complete response was found in 89/197 (45.2%) porfiromycin patients and in 98/196 (50.0%) of placebo patients. A similar number of deaths occured in both arms of the trial. Conclusions: Concomitant intravenous porfiromycin administration did not provide additional benefit over RT alone in advanced head and neck patients. Myelosuppression and dysphagia were increased in porfiromycin patients and induced significantly decreased tumor local control.
124
Does Primary Tumor Volume Predict Local Control After Definitive Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
W.M. Mendenhall1, C.G. Morris1, R.J. Amdur1, R.W. Hinerman1, A.A. Mancuso2 Department of Radiation Oncology, University of Florida, Gainesville, FL, 2Department of Radiology, University of Florida, Gainesville, FL 1
Purpose/Objective: To analyze the influence of primary tumor volume on the likelihood of local control after definitive radiotherapy for head and neck cancer. Materials/Methods: Between April 1980 and January 2000, 404 patients were treated with definitive RT alone (358 patients) or combined with adjuvant chemotherapy (46 patients) at the University of Florida and were followed up for 0.25 to 20.25 years (median ⫽ 3.5 years.) All living patients were followed up for at least 2 years. All patients had the primary tumor volume calculated on pretreatment computed tomography. Endpoints were local control after RT and local control after radiotherapy without a severe late complication. Parameters evaluated in multivariate analyses of these endpoints included primary site, T stage, primary tumor volume, N stage, histologic differentiation, fractionation schedule, adjuvant chemotherapy, and sex. Results: The rates of local control and local control without a severe late complication after radiotherapy were significantly influenced by primary tumor volume for patients with cancer of the supraglottic larynx and true vocal cord. In contrast, the rates of local control and local control without severe complications for patients with tumors of the oropharynx and hypopharynx were less influenced by tumor volume. Multivariate analysis of the overall population revealed that the only parameter that was significantly related to the probability of local control after radiotherapy was T stage. Multivariate analyses stratified by primary site revealed that tumor volume significantly influenced local control for patients with cancers of the supraglottis (p ⫽ .0220) and glottis (p ⫽ .0042) but not for those with lesions of the tonsillar fossa/posterior tonsillar pillar (p ⫽ .0892), base of tongue (p ⫽ .9493), anterior tonsillar pillar/soft palate (p ⫽ .5909), and hypopharynx (p ⫽ .2282). Conclusions: The most important parameter that impacts local control after radiation therapy is T stage. Primary tumor volume also significantly influences the probability of local control depending on primary site.
125
Adjuvant External Beam Radiotherapy in High Risk Well-Differentiated Thyroid Cancer
P.V. Chen1, E. Ahn1, S. Avitia3, R. Osborne2, G. Juillard1 1 Department of Radiation Oncology, UCLA, Los Angeles, CA, 2Department of Head and Neck Surgery, UCLA, Los Angeles, CA, 3UCLA, Los Angeles, CA Purpose/Objective: The role of adjuvant external beam radiotherapy in well-differentiated thyroid cancer is not well recognized. Many clinicians rely on I131 alone to destroy thyroid remnants following thyroidectomy. However, I131 alone may not be sufficient to treat microscopic residual disease when no gross thyroid tissue remains to concentrate the isotope. This study examines the potential benefit of adjuvant external beam radiation in patients at high risk for microscopic residual disease following thyroidectomy. Materials/Methods: Between 1973 and 2001, 44 patients with well-differentiated papillary or follicular thyroid cancer were found to have extracapsular extension following thyroidectomy, and were treated either with adjuvant external beam radiation or I131 without external beam radiation. The 11 patients who were treated with adjuvant EBRT had an unfavorable prognosis based on age (mean age 62) compared to the 33 patients treated with I131 alone (mean age 45). The dose of EBRT ranged from
I. J. Radiation Oncology
123
● Biology ● Physics
Volume 54, Number 2, Supplement, 2002
A Phase III Double-Blind Randomized Placebo Controlled Study of Porfiromycin and Radiation Therapy in Patients with Head and Neck Cancer
E.F. Lartigau1, J. Giralt2, P. Glassman3, A. Lawton3, R. von Roemeling3 Department of Radiotherapy, Centre Oscar Lambret, Lille, France, 2Department of Radiotherapy, Hospital G. Vale d, Barcelona, Spain, 3Boehringer Ingelheim Ph., CT 1
Purpose/Objective: The present study was a multinational, double blind, Phase III trial designed to assess the efficacy and pharmakokinetics of profiromycin versus placebo in patients with advanced head and neck cancer who received radiation therapy (RT). Materials/Methods: An interim analysis on 338 patients revealed a lack of efficacy of porfiromycin over placebo and the trial was closed to further enrollment. As a result, only 413 of the projected 550 patients were enrolled into the trial. Four hundred and fifteen patients were randomized and 22 patients withdrew or were lost of follow up. One hundred and ninety-six patients received porfiromycin and 197 patients received placebo. Results: Overall, porfiromycin treatment demonstrated no additional efficacy over placebo (RT alone). Subset analysis relative to tumour site stratification showed similar lack of porfiromycin superiority over placebo. Myelosuppression was the only major (and expected) serious toxicity. Isolated lymphocytopenia grade IV occured equally in both porfiromycin treated patients and placebo patients. Hemoglobin levels less than 10 g/dL were found to occur in 46 (23.5%) porfiromycin patients and in 10 (5.1%) placebo patients during the treatment phase of the trial. These patients had a lower overall clinical response rate than placebo. Complete response was found in 89/197 (45.2%) porfiromycin patients and in 98/196 (50.0%) of placebo patients. A similar number of deaths occured in both arms of the trial. Conclusions: Concomitant intravenous porfiromycin administration did not provide additional benefit over RT alone in advanced head and neck patients. Myelosuppression and dysphagia were increased in porfiromycin patients and induced significantly decreased tumor local control.
124
Does Primary Tumor Volume Predict Local Control After Definitive Radiotherapy for Squamous Cell Carcinoma of the Head and Neck
W.M. Mendenhall1, C.G. Morris1, R.J. Amdur1, R.W. Hinerman1, A.A. Mancuso2 Department of Radiation Oncology, University of Florida, Gainesville, FL, 2Department of Radiology, University of Florida, Gainesville, FL 1
Purpose/Objective: To analyze the influence of primary tumor volume on the likelihood of local control after definitive radiotherapy for head and neck cancer. Materials/Methods: Between April 1980 and January 2000, 404 patients were treated with definitive RT alone (358 patients) or combined with adjuvant chemotherapy (46 patients) at the University of Florida and were followed up for 0.25 to 20.25 years (median ⫽ 3.5 years.) All living patients were followed up for at least 2 years. All patients had the primary tumor volume calculated on pretreatment computed tomography. Endpoints were local control after RT and local control after radiotherapy without a severe late complication. Parameters evaluated in multivariate analyses of these endpoints included primary site, T stage, primary tumor volume, N stage, histologic differentiation, fractionation schedule, adjuvant chemotherapy, and sex. Results: The rates of local control and local control without a severe late complication after radiotherapy were significantly influenced by primary tumor volume for patients with cancer of the supraglottic larynx and true vocal cord. In contrast, the rates of local control and local control without severe complications for patients with tumors of the oropharynx and hypopharynx were less influenced by tumor volume. Multivariate analysis of the overall population revealed that the only parameter that was significantly related to the probability of local control after radiotherapy was T stage. Multivariate analyses stratified by primary site revealed that tumor volume significantly influenced local control for patients with cancers of the supraglottis (p ⫽ .0220) and glottis (p ⫽ .0042) but not for those with lesions of the tonsillar fossa/posterior tonsillar pillar (p ⫽ .0892), base of tongue (p ⫽ .9493), anterior tonsillar pillar/soft palate (p ⫽ .5909), and hypopharynx (p ⫽ .2282). Conclusions: The most important parameter that impacts local control after radiation therapy is T stage. Primary tumor volume also significantly influences the probability of local control depending on primary site.
125
Adjuvant External Beam Radiotherapy in High Risk Well-Differentiated Thyroid Cancer
P.V. Chen1, E. Ahn1, S. Avitia3, R. Osborne2, G. Juillard1 1 Department of Radiation Oncology, UCLA, Los Angeles, CA, 2Department of Head and Neck Surgery, UCLA, Los Angeles, CA, 3UCLA, Los Angeles, CA Purpose/Objective: The role of adjuvant external beam radiotherapy in well-differentiated thyroid cancer is not well recognized. Many clinicians rely on I131 alone to destroy thyroid remnants following thyroidectomy. However, I131 alone may not be sufficient to treat microscopic residual disease when no gross thyroid tissue remains to concentrate the isotope. This study examines the potential benefit of adjuvant external beam radiation in patients at high risk for microscopic residual disease following thyroidectomy. Materials/Methods: Between 1973 and 2001, 44 patients with well-differentiated papillary or follicular thyroid cancer were found to have extracapsular extension following thyroidectomy, and were treated either with adjuvant external beam radiation or I131 without external beam radiation. The 11 patients who were treated with adjuvant EBRT had an unfavorable prognosis based on age (mean age 62) compared to the 33 patients treated with I131 alone (mean age 45). The dose of EBRT ranged from