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• W2022090617 abstract "Purpose/ObjectiveIt is generally accepted that if high dose radiation could be delivered safely, treatment results for locally advanced NSCLC would improve. By using 3D conformal radiation therapy and limiting lung volume, we have demonstrated that very high dose radiation can be delivered with limited acute toxicity (Hayman, JCO, 2001). The purpose of this update is to report long-term disease control and late toxicity.Materials/MethodsA phase I radiation dose escalation study was carried out in University of Michigan between August, 1992 and February, 2002. Five bins were created based on the volume of normal lung included, and dose levels within each bin were chosen based on the estimated risk of radiation pneumonitis. Starting doses ranged from 63 to 84 Gy (heterogeneity corrected) given in 2.1-Gy fractions. Target volumes included the primary tumor and any lymph nodes > 1 cm on computed tomography. Elective nodal irradiation for radiographically uninvolved nodal regions was not given intentionally. Since 1999, selected stage III patients received neoadjuvant cisplatin and vinorelbine. Information on late toxicity and long-term disease control was obtained through extensive medical record review, including notes from primary care physicians, pulmonologists, and oncologists.ResultsA total 121 inoperable/unresectable NSCLC patients were enrolled at the University of Michigan Hospital and its Affiliates. One hundred and fifteen patients who received a radiation dose between 63 and 102.9 Gy are included in this analysis: 41 stage I/II, 45 stage IIIA, 29 stage IIIB; 83 males and 32 females. Median age is 65 year-old. Twenty-eight percent (32/115) received neoadjuvant chemotherapy. Median follow up is 18.8 months for the entire group and 46 months for patients who were alive at last follow-up.Overall survival: The median overall survival is 21 months (95% CI: 18 to 23). Overall survival rates at 2, 3, and 5 years are 42%, 27%, and 16% respectively. Cox multi-variance analysis demonstrated that radiation dose is the only significant independent factor for overall survival (p = 0.004).Long-term disease control: Median local/regional progression free survival is 12 months (95% CI: 9 to 15). Median distant metastasis free survival is 16 months (95% CI: 9 to 22). Local/regional progression-free survival rates at 2, 3, and 5 years are 35%, 27%, and 27% respectively. Excluding 10 patients with unknown disease status and 9 patients without failure, 41% (40/96) patients had a first failure site within or around the PTV, 44% patients (42/96) had first failure at a distant site, and 15% failed both at local and distant sites. Of the 73 patients who experienced local/regional failure, 62% failed within or around the PTV. There is no significant difference in local control amongst groups receiving <65.1, 69.6, 75.6, or 84 Gy. Patients in the higher dose groups (92.4 and 102.4 Gy) had significantly better 2, 3, and 5 year local/regional progression-free survival rates than those in lower dose groups (52%, 43% and 43% vs 35%, 28% and 20%; p = 0.003). The time to local/regional progression is also better in higher dose groups (p = 0.026).Late toxicity: Of 60 patients reviewed thus far, 43 (71%) had documented late lung toxicity: 24 grade 1 pneumonitis/fibrosis, 14 grade 2 pneumonitis/fibrosis, one grade 3 pneumonitis, 3 grade 3 hemoptysis, and 1 grade 5 hemoptysis with bronchial stenosis/deviation. One patient had grade 1 late esophageal toxicity and 2 had rib fractures. There is no spinal cord late toxicity.ConclusionsSevere late lung toxicity is limited and acceptable after high dose radiation. Although high dose radiation results better outcome, long term local control remains poor with the majority of patients still experiencing local/regional failure. Further study should focus on maximizing radiation dose, improving radiation technique and radiation sensitization to improve local disease control in NSCLC Purpose/ObjectiveIt is generally accepted that if high dose radiation could be delivered safely, treatment results for locally advanced NSCLC would improve. By using 3D conformal radiation therapy and limiting lung volume, we have demonstrated that very high dose radiation can be delivered with limited acute toxicity (Hayman, JCO, 2001). The purpose of this update is to report long-term disease control and late toxicity. It is generally accepted that if high dose radiation could be delivered safely, treatment results for locally advanced NSCLC would improve. By using 3D conformal radiation therapy and limiting lung volume, we have demonstrated that very high dose radiation can be delivered with limited acute toxicity (Hayman, JCO, 2001). The purpose of this update is to report long-term disease control and late toxicity. Materials/MethodsA phase I radiation dose escalation study was carried out in University of Michigan between August, 1992 and February, 2002. Five bins were created based on the volume of normal lung included, and dose levels within each bin were chosen based on the estimated risk of radiation pneumonitis. Starting doses ranged from 63 to 84 Gy (heterogeneity corrected) given in 2.1-Gy fractions. Target volumes included the primary tumor and any lymph nodes > 1 cm on computed tomography. Elective nodal irradiation for radiographically uninvolved nodal regions was not given intentionally. Since 1999, selected stage III patients received neoadjuvant cisplatin and vinorelbine. Information on late toxicity and long-term disease control was obtained through extensive medical record review, including notes from primary care physicians, pulmonologists, and oncologists. A phase I radiation dose escalation study was carried out in University of Michigan between August, 1992 and February, 2002. Five bins were created based on the volume of normal lung included, and dose levels within each bin were chosen based on the estimated risk of radiation pneumonitis. Starting doses ranged from 63 to 84 Gy (heterogeneity corrected) given in 2.1-Gy fractions. Target volumes included the primary tumor and any lymph nodes > 1 cm on computed tomography. Elective nodal irradiation for radiographically uninvolved nodal regions was not given intentionally. Since 1999, selected stage III patients received neoadjuvant cisplatin and vinorelbine. Information on late toxicity and long-term disease control was obtained through extensive medical record review, including notes from primary care physicians, pulmonologists, and oncologists. ResultsA total 121 inoperable/unresectable NSCLC patients were enrolled at the University of Michigan Hospital and its Affiliates. One hundred and fifteen patients who received a radiation dose between 63 and 102.9 Gy are included in this analysis: 41 stage I/II, 45 stage IIIA, 29 stage IIIB; 83 males and 32 females. Median age is 65 year-old. Twenty-eight percent (32/115) received neoadjuvant chemotherapy. Median follow up is 18.8 months for the entire group and 46 months for patients who were alive at last follow-up.Overall survival: The median overall survival is 21 months (95% CI: 18 to 23). Overall survival rates at 2, 3, and 5 years are 42%, 27%, and 16% respectively. Cox multi-variance analysis demonstrated that radiation dose is the only significant independent factor for overall survival (p = 0.004).Long-term disease control: Median local/regional progression free survival is 12 months (95% CI: 9 to 15). Median distant metastasis free survival is 16 months (95% CI: 9 to 22). Local/regional progression-free survival rates at 2, 3, and 5 years are 35%, 27%, and 27% respectively. Excluding 10 patients with unknown disease status and 9 patients without failure, 41% (40/96) patients had a first failure site within or around the PTV, 44% patients (42/96) had first failure at a distant site, and 15% failed both at local and distant sites. Of the 73 patients who experienced local/regional failure, 62% failed within or around the PTV. There is no significant difference in local control amongst groups receiving <65.1, 69.6, 75.6, or 84 Gy. Patients in the higher dose groups (92.4 and 102.4 Gy) had significantly better 2, 3, and 5 year local/regional progression-free survival rates than those in lower dose groups (52%, 43% and 43% vs 35%, 28% and 20%; p = 0.003). The time to local/regional progression is also better in higher dose groups (p = 0.026).Late toxicity: Of 60 patients reviewed thus far, 43 (71%) had documented late lung toxicity: 24 grade 1 pneumonitis/fibrosis, 14 grade 2 pneumonitis/fibrosis, one grade 3 pneumonitis, 3 grade 3 hemoptysis, and 1 grade 5 hemoptysis with bronchial stenosis/deviation. One patient had grade 1 late esophageal toxicity and 2 had rib fractures. There is no spinal cord late toxicity. A total 121 inoperable/unresectable NSCLC patients were enrolled at the University of Michigan Hospital and its Affiliates. One hundred and fifteen patients who received a radiation dose between 63 and 102.9 Gy are included in this analysis: 41 stage I/II, 45 stage IIIA, 29 stage IIIB; 83 males and 32 females. Median age is 65 year-old. Twenty-eight percent (32/115) received neoadjuvant chemotherapy. Median follow up is 18.8 months for the entire group and 46 months for patients who were alive at last follow-up. Overall survival: The median overall survival is 21 months (95% CI: 18 to 23). Overall survival rates at 2, 3, and 5 years are 42%, 27%, and 16% respectively. Cox multi-variance analysis demonstrated that radiation dose is the only significant independent factor for overall survival (p = 0.004). Long-term disease control: Median local/regional progression free survival is 12 months (95% CI: 9 to 15). Median distant metastasis free survival is 16 months (95% CI: 9 to 22). Local/regional progression-free survival rates at 2, 3, and 5 years are 35%, 27%, and 27% respectively. Excluding 10 patients with unknown disease status and 9 patients without failure, 41% (40/96) patients had a first failure site within or around the PTV, 44% patients (42/96) had first failure at a distant site, and 15% failed both at local and distant sites. Of the 73 patients who experienced local/regional failure, 62% failed within or around the PTV. There is no significant difference in local control amongst groups receiving <65.1, 69.6, 75.6, or 84 Gy. Patients in the higher dose groups (92.4 and 102.4 Gy) had significantly better 2, 3, and 5 year local/regional progression-free survival rates than those in lower dose groups (52%, 43% and 43% vs 35%, 28% and 20%; p = 0.003). The time to local/regional progression is also better in higher dose groups (p = 0.026). Late toxicity: Of 60 patients reviewed thus far, 43 (71%) had documented late lung toxicity: 24 grade 1 pneumonitis/fibrosis, 14 grade 2 pneumonitis/fibrosis, one grade 3 pneumonitis, 3 grade 3 hemoptysis, and 1 grade 5 hemoptysis with bronchial stenosis/deviation. One patient had grade 1 late esophageal toxicity and 2 had rib fractures. There is no spinal cord late toxicity. ConclusionsSevere late lung toxicity is limited and acceptable after high dose radiation. Although high dose radiation results better outcome, long term local control remains poor with the majority of patients still experiencing local/regional failure. Further study should focus on maximizing radiation dose, improving radiation technique and radiation sensitization to improve local disease control in NSCLC Severe late lung toxicity is limited and acceptable after high dose radiation. Although high dose radiation results better outcome, long term local control remains poor with the majority of patients still experiencing local/regional failure. Further study should focus on maximizing radiation dose, improving radiation technique and radiation sensitization to improve local disease control in NSCLC" @default.
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• W2022090617 title "Long term results of a phase I radiation dose escalation study in patients with inoperable/unresectable non-small cell lung cancer (NSCLC): Local disease control and late toxicity" @default.
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