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Analysis of radiation-induced gastric and duodenal bleeds using the Lyman-Kutcher-Burman model
Proceedings of the 45th Annual ASTRO Meeting
153
Dosimetric Parameters Predictive for Esophageal Injury 4,1
S. Ahn, D.A. Kahn,1 S. Zhou,1 X. Yu,1 D. Hollis,3 P.A. Antoine,1 T.D. Shafman,1 T.A. D’Amico,2 L.B. Marks1 1 Radiation Oncology, Duke University Medical Center, Durham, NC, 2Surgery, Duke University Medical Center, Durham, NC, 3Cancer Center Biostatistics, Duke University Medical Center, Durham, NC, 4Radiation Oncology, Chonnam National University Medical School, Gwangju, South Korea Purpose/Objective: To evaluate the 3D dosimetric parameters predicting for clinically significant esophageal injury after conformal radiotherapy of non-small cell lung cancer (NSCLC). Materials/Methods: The records of 254 patients treated with 3D conformal radiotherapy at Duke University for NSCLC between 1992 and 2001 were reviewed. Age range 26 – 87 years, median 64; men 143, women 111. Stage distribution; 36 stage I, 24 II, 102 IIIA, 86 IIIB, and 6 unknown. Radiation delivered dose to the isocenter was ranged from 30 Gy to 86.4 Gy with the median 66 Gy. The 3D dose distribution was reviewed and a variety of metrics describing the esophageal dose were extracted, including dose volume histogram (DVH), dose circumferential histogram (DCH) on the esophagus. All doses reflect tissue density heterogeneity. Chemotherapy was given in 143 patients (56%), concurrently in 32 and sequentially 111 patients. The RTOG toxicity criteria for grading of esophageal injury were used. Grade ⬎2 and ⬎3 acute and late esophageal toxicities were identified. Seventeen patients who died within three months after radiotherapy were excluded from the analysis of late esophageal injury. Logistic regression, contingency table analyses and Fisher’s exact tests were used to assess the relationship between various parameters (dosimetric, treatment, patient characteristics) and the incidence of esophageal toxicity. The median follow-up time of all patients was 43 months with the range of 0.5–120 months. Results: Acute esophageal toxicity occurred in 78% patients (199/254); 138 grade 1, 38 grade 2, 22 grade 3, and 1 grade 4. On univariate analysis, BID-RT, pre-RT dysphagia, nodal stage (dichotomous ⱕ1 vs ⱖ2), maximal esophageal point dose, the maximum percent of the circumference receiving ⬎50 –70 Gy, and the length of esophagus where ⱖ75% of the circumference received ⬎50 –70 Gy, and the percent esophageal volume receiving ⬎50 –70 Gy were predictive for the development of ⱖgrade 3 acute esophagitis. On multivariate analysis, the clinical factors of BID (vs. QD RT), and N-stage were dominant predictors. Of 238 patients evaluable for late esophageal toxicity, it occurred in 7% patients (17/238); 5 grade 1, 4 grade 2, 5 grade 3, and 3 grade 4. Late toxicity occurred in 2%, 3%, 16%, 23%, and 100% of patients with acute grade 0, 1, 2, 3 and 4 toxicity, respectively. The severity of acute esophagitis is significantly related to the occurrence of late esophageal injury (p⬍0.0001) with a greater than 3 fold increase in the probability of development with each increase in grade. Late toxicity appeared 3– 40 months after completion of radiotherapy with the median 5 months. On univariate analysis, the development of severe late symptoms, the percent esophageal volume receiving ⬎70 – 80 Gy, the length of esophagus where 75% of the circumference received ⬎55–70 Gy, the length of esophagus where the full circumference received ⬎50 Gy, and the maximum percent of the circumference receiving ⬎70 – 80 Gy were predictive. On multivariavte analysis, the severity of acute symptoms appeared to be a more powerful predictor than the dosimetric parameters. Conclusions: Dosimetric and clinical parameters are predictive for the development of acute and late esophageal injury. For both, the clinical parameters are more predictive than are the dosimetric parameters. The development of acute esophagitis is most related to the use of BID (vs QD) RT, and the nodal stage; but BID treatment typically resulted in higher doses. The latter is likely a surrogate for target proximity to the esophagus. For late injury, the severity of the acute injury was most predictive. Additional studies to better define predictors of RT-induced esophageal injury are needed. We gratefully acknowledge the University of North Carolina for the PLUNC treatment planning software.
154
Analysis of Radiation-Induced Gastric and Duodenal Bleeds Using the Lyman-Kutcher-Burman Model
C.C. Pan,1 L.A. Dawson,2 C.J. McGinn,1 T.S. Lawrence,1 R.K. Ten Haken1 1 Radiation Oncology, University of Michigan, Ann Arbor, MI, 2Radiation Oncology, University of Toronto, Princess Margaret Hospital, Toronto, ON, Canada Purpose/Objective: Although radiation induced upper GI bleeds (UGIB) have long been recognized, dose-response relationships are poorly documented. In this IRB-approved retrospective review, we sought to describe the dose-volume tolerance for radiation-induced gastric and duodenal bleeds using the Lyman-Kutcher-Burman (LKB) normal tissue complication probability (NTCP) model. Materials/Methods: Ninety-two patients treated sequentially with conformal radiation therapy for intrahepatic malignancies between January 1999 and April 2002 were analyzed. These patients were treated using 1.5Gy BID delivered with concurrent hepatic arterial chemotherapy or 1.8Gy to 3Gy QD without concurrent chemotherapy. Treatment generally required portions of the stomach and/or duodenum to be irradiated (maximum dose to the stomach ⫽ 93.0Gy and duodenum ⫽ 112Gy). The stomach and duodenum structures were defined by contouring the external and internal walls from the GE junction to the pyloric sphincter, and from the sphincter to the ascending duodenum, respectively. Physical dose values in the 3D dose distributions for each patient were converted to normalized effective doses at 2.0Gy per fraction using the linear quadratic model (␣/ ⫽ 2.5Gy) prior to DVH computation. Normal dose-volume histograms and gastric and/or duodenal bleed status for these patients were used as input data for determination of LKB model parameters. A complication was defined as an upper GI bleed after completion of radiotherapy. Median follow-up was 7.6 months (range: 0 to 32.1 months). Locations of bleeds were determined by endoscopy. Using data from all patients, a maximum likelihood analysis yielded best estimates for LKB model parameters for the entire upper GI tract (a composite structure of the stomach and duodenum). Refined LKB model parameters were obtained for patient subgroups with different sites of bleed — stomach or duodenum. Confidence intervals were determined by exploring the space around the maximum likely parameter set using profile-likelihood methods. A multivariate analysis of potential factors associated with upper GI bleeds was also completed. Results: Fifteen of 92 patients developed upper GI bleeds. The locations of the bleeds were as follows: 11 in the stomach, 3 in the duodenum, and 1 involving both the stomach and duodenum. Median time to UGIB was 3.5 months (range: 1.2 to 7.6 months). Average mean dose to the stomach was 14.06Gy (range: 0.10Gy to 67.55Gy), and 17.39Gy (range: 0.03Gy to 68.30Gy) to the duodenum. Mean duodenal dose was ⬍10Gy in 40.0% patients. The LKB model was fit to the complication data for the entire upper GI tract (a composite of the stomach and duodenum), the stomach alone, and the duodenum alone for
S217
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I. J. Radiation Oncology
● Biology ● Physics
Volume 57, Number 2, Supplement, 2003
the TD50(1), “m,” and “n” LKB model parameters, and 69% confidence intervals. For the entire upper GI tract, the parameters were 52.5Gy (42Gy, 64Gy), 0.35 (0.28, 0.47), and 0.21 (0.11, 0.50), respectively. After incorporation of the site of UGIB, the parameters for the stomach were 62Gy (53Gy, 71Gy), 0.30 (0.23, 0.39), and 0.07 (0.03, 0.16), respectively. For the duodenum, the parameters were 180Gy (⬃100Gy, ⬎200Gy), 0.49 (0.36, 0.61), and 0.12 (0.09, 0.30), respectively. Multivariate analysis demonstrated that in addition to NTCP, mean dose to stomach was significantly associated with GI bleed. Conclusions: This study confirms that the stomach and duodenum do not have a large volume effect, and that dose thresholds exist for GI bleed risk. The dose-NTCP curve is shallow for the duodenum, with a far higher tolerance to radiation than previously estimated. However, these results are based on a low number of duodenal events, and ongoing analysis of additional patients may lead to refinement of parameters. These findings should facilitate the design of future clinical trials of high dose radiation to upper abdominal sites.
155
Outcome Results of the 1996 –1999 Patterns of Care Survey of the National Practice for Patients Receiving Radiation Therapy for Carcinoma of the Esophagus
M. Suntharalingam,1 J. Moughan,2 L. Coia,4 T. Iarocci,2 M.J. Krasna,3 L. Kachnic,5 B. Minsky,6 C. Willet,7 J.B. Owen2 1 Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, 2Surgery, University of Maryland School of Medicine, Baltimore, MD, 3American College of Radiology, Philadelphia, PA, 4Community Medical Center, Toms River, NJ, 5Boston University, Boston, MA, 6Memorial Sloan-Kettering, New York, NY, 7Massachusetts General Hospital, Boston, MA Purpose/Objective: The national practice for patients receiving radiation therapy for carcinoma of the esophagus was evaluated by a Patterns of Care Study conducted for patients treated from 1996 –1999. This report describes the outcomes of these patients and compares these results to updated PCS data obtained during the 1992–1994 survey, in order to document whether previously reported changes in practice have resulted in improvements in survival for this patient population. Materials/Methods: A national survey was conducted at 59 institutions in a stratified random sample selected from a master list of radiation therapy facilities throughout the United States. A stratified two-step cluster sampling technique was used for data collection. 414 patients were sampled from the 59 institutions, which gives a weighted sample size of 11,340 patients nationwide. Eligibility criteria included either definitive or adjuvant RT delivered between 1996–1999, no evidence of distant metastases, squamous cell or adenocarcinoma histology, KPS ⬎ 60, tumors in the thoracic esophagus, and no prior malignancies within the previous 5 years. Patient, tumor, and treatment characteristics were evaluated SUDAAN statistical software was used to allow the incorporation of the design elements and weights that reflect the relative contribution of each institution and each patient in the analysis. Multivariate comparisons of survival times were made using the Cox proportional hazards model. Results: The median age of patients was 64 years, 77% were male, and 23% female. KPS was ⬎ 80% in 85% of pts. Adenocarcinoma was diagnosed in 51% of pts and squamous cell carcinoma in 49%. 16% were clinical stage I (AJCC 83 system), 39% CS II, and 33% CS III (12% unknown). Concurrent chemoradiation continued to be the most commonly employed treatment strategy (97%). The median follow up for the entire group was 7 months. 91 patients had died (55% of these from esophageal cancer) at time of analysis. Significant variables in the multivariate analysis of survival times included clinical stage and treatment approach. Patients with clinical stage III disease had a higher hazard risk of death as compared to other stages of disease (clinical stage III risk ratio [RR] 2.66 vs. clinical stage I, p ⫽ 0.004), whereas those treated with concurrent chemoradiation followed by surgery had a decreased risk of death compared to other treatment schemes (chemoradiation plus surgery RR 0.33 vs. chemo/RT only, p ⬍0.0001). Histology and size of treatment center were not significant. An updated analysis of the original survey performed between 1992–1994 confirmed these findings (median follow-up ⫽ 10 months). Multivariate analysis revealed that clinical stage I (p ⬍ 0.0001), treatment approach with trimodality therapy (p ⫽ 0.0013), and type of treatment center all predicted for improved overall survival times. When data from both surveys were combined these predictive variables continued to be significant. Patients presenting with clinical stage III disease had a RR of 2.26 as compared to other stage I patients (p⫽0.0004). Those patients receiving chemo/RT followed by surgery had an RR of 0.58 as compared to those receiving chemo/RT only (p⫽0.004). Conclusions: The outcome results of the 1996 –99 PCS survey confirm the findings of the 1992–94 study. Concurrent chemoradiation continued to be the most commonly utilized treatment approach during the time period studied. The observation that patients undergoing surgical resection following concurrent chemoradiation have a decreased hazard or chance of death (i.e., improved overall survival) compared to other treatment schemes highlights the need for a randomized trial comparing these strategies. Supported by NCI grant CA 65435.
156
Randomized Prospective Study Comparing High Dose Rate Intraluminal Brachytherapy (HDRILBT) Alone to HDRILBT and External Beam Radiotherapy (EBRT) in the Palliation of Advanced Esophageal Cancer
R. Sur,1,2 B. Donde,2 C. Falkson,1 S.N. Ahmed,2 V. Levin,3 S. Nag,4 G. Jones1 1 Radiation Oncology, McMaster University, Hamilton, ON, Canada, 2Radiation Oncology, University of the Witwatersrand, Johannesburg, Gauteng, South Africa, 3Human Health, International Atomic Energy Agency, Vienna, Austria, 4Radiation Oncology, Ohio State University, Columbus, OH Purpose/Objective: Previous studies have shown that HDRILBT is the best method of palliation for advanced esophageal cancer offering lasting palliation by improving dysphagia-free survival (DFS) in more than 60% of cases for prolonged periods of time. This, in turn, improves the overall survival (OS) in patients with advanced disease with a good quality of life. Encouraged by the results of HDRILBT alone in palliation of advanced cases, a study was designed to determine if the addition of EBRT would further improve the outcome in terms of DFS for advanced esophageal cancers. Materials/Methods: Patients with advanced inoperable esophageal cancer were entered into a randomized prospective study at the Johannesburg Hospital, University of the Witwatersrand, South Africa. All patients were initially investigated and found
153
Dosimetric Parameters Predictive for Esophageal Injury 4,1
S. Ahn, D.A. Kahn,1 S. Zhou,1 X. Yu,1 D. Hollis,3 P.A. Antoine,1 T.D. Shafman,1 T.A. D’Amico,2 L.B. Marks1 1 Radiation Oncology, Duke University Medical Center, Durham, NC, 2Surgery, Duke University Medical Center, Durham, NC, 3Cancer Center Biostatistics, Duke University Medical Center, Durham, NC, 4Radiation Oncology, Chonnam National University Medical School, Gwangju, South Korea Purpose/Objective: To evaluate the 3D dosimetric parameters predicting for clinically significant esophageal injury after conformal radiotherapy of non-small cell lung cancer (NSCLC). Materials/Methods: The records of 254 patients treated with 3D conformal radiotherapy at Duke University for NSCLC between 1992 and 2001 were reviewed. Age range 26 – 87 years, median 64; men 143, women 111. Stage distribution; 36 stage I, 24 II, 102 IIIA, 86 IIIB, and 6 unknown. Radiation delivered dose to the isocenter was ranged from 30 Gy to 86.4 Gy with the median 66 Gy. The 3D dose distribution was reviewed and a variety of metrics describing the esophageal dose were extracted, including dose volume histogram (DVH), dose circumferential histogram (DCH) on the esophagus. All doses reflect tissue density heterogeneity. Chemotherapy was given in 143 patients (56%), concurrently in 32 and sequentially 111 patients. The RTOG toxicity criteria for grading of esophageal injury were used. Grade ⬎2 and ⬎3 acute and late esophageal toxicities were identified. Seventeen patients who died within three months after radiotherapy were excluded from the analysis of late esophageal injury. Logistic regression, contingency table analyses and Fisher’s exact tests were used to assess the relationship between various parameters (dosimetric, treatment, patient characteristics) and the incidence of esophageal toxicity. The median follow-up time of all patients was 43 months with the range of 0.5–120 months. Results: Acute esophageal toxicity occurred in 78% patients (199/254); 138 grade 1, 38 grade 2, 22 grade 3, and 1 grade 4. On univariate analysis, BID-RT, pre-RT dysphagia, nodal stage (dichotomous ⱕ1 vs ⱖ2), maximal esophageal point dose, the maximum percent of the circumference receiving ⬎50 –70 Gy, and the length of esophagus where ⱖ75% of the circumference received ⬎50 –70 Gy, and the percent esophageal volume receiving ⬎50 –70 Gy were predictive for the development of ⱖgrade 3 acute esophagitis. On multivariate analysis, the clinical factors of BID (vs. QD RT), and N-stage were dominant predictors. Of 238 patients evaluable for late esophageal toxicity, it occurred in 7% patients (17/238); 5 grade 1, 4 grade 2, 5 grade 3, and 3 grade 4. Late toxicity occurred in 2%, 3%, 16%, 23%, and 100% of patients with acute grade 0, 1, 2, 3 and 4 toxicity, respectively. The severity of acute esophagitis is significantly related to the occurrence of late esophageal injury (p⬍0.0001) with a greater than 3 fold increase in the probability of development with each increase in grade. Late toxicity appeared 3– 40 months after completion of radiotherapy with the median 5 months. On univariate analysis, the development of severe late symptoms, the percent esophageal volume receiving ⬎70 – 80 Gy, the length of esophagus where 75% of the circumference received ⬎55–70 Gy, the length of esophagus where the full circumference received ⬎50 Gy, and the maximum percent of the circumference receiving ⬎70 – 80 Gy were predictive. On multivariavte analysis, the severity of acute symptoms appeared to be a more powerful predictor than the dosimetric parameters. Conclusions: Dosimetric and clinical parameters are predictive for the development of acute and late esophageal injury. For both, the clinical parameters are more predictive than are the dosimetric parameters. The development of acute esophagitis is most related to the use of BID (vs QD) RT, and the nodal stage; but BID treatment typically resulted in higher doses. The latter is likely a surrogate for target proximity to the esophagus. For late injury, the severity of the acute injury was most predictive. Additional studies to better define predictors of RT-induced esophageal injury are needed. We gratefully acknowledge the University of North Carolina for the PLUNC treatment planning software.
154
Analysis of Radiation-Induced Gastric and Duodenal Bleeds Using the Lyman-Kutcher-Burman Model
C.C. Pan,1 L.A. Dawson,2 C.J. McGinn,1 T.S. Lawrence,1 R.K. Ten Haken1 1 Radiation Oncology, University of Michigan, Ann Arbor, MI, 2Radiation Oncology, University of Toronto, Princess Margaret Hospital, Toronto, ON, Canada Purpose/Objective: Although radiation induced upper GI bleeds (UGIB) have long been recognized, dose-response relationships are poorly documented. In this IRB-approved retrospective review, we sought to describe the dose-volume tolerance for radiation-induced gastric and duodenal bleeds using the Lyman-Kutcher-Burman (LKB) normal tissue complication probability (NTCP) model. Materials/Methods: Ninety-two patients treated sequentially with conformal radiation therapy for intrahepatic malignancies between January 1999 and April 2002 were analyzed. These patients were treated using 1.5Gy BID delivered with concurrent hepatic arterial chemotherapy or 1.8Gy to 3Gy QD without concurrent chemotherapy. Treatment generally required portions of the stomach and/or duodenum to be irradiated (maximum dose to the stomach ⫽ 93.0Gy and duodenum ⫽ 112Gy). The stomach and duodenum structures were defined by contouring the external and internal walls from the GE junction to the pyloric sphincter, and from the sphincter to the ascending duodenum, respectively. Physical dose values in the 3D dose distributions for each patient were converted to normalized effective doses at 2.0Gy per fraction using the linear quadratic model (␣/ ⫽ 2.5Gy) prior to DVH computation. Normal dose-volume histograms and gastric and/or duodenal bleed status for these patients were used as input data for determination of LKB model parameters. A complication was defined as an upper GI bleed after completion of radiotherapy. Median follow-up was 7.6 months (range: 0 to 32.1 months). Locations of bleeds were determined by endoscopy. Using data from all patients, a maximum likelihood analysis yielded best estimates for LKB model parameters for the entire upper GI tract (a composite structure of the stomach and duodenum). Refined LKB model parameters were obtained for patient subgroups with different sites of bleed — stomach or duodenum. Confidence intervals were determined by exploring the space around the maximum likely parameter set using profile-likelihood methods. A multivariate analysis of potential factors associated with upper GI bleeds was also completed. Results: Fifteen of 92 patients developed upper GI bleeds. The locations of the bleeds were as follows: 11 in the stomach, 3 in the duodenum, and 1 involving both the stomach and duodenum. Median time to UGIB was 3.5 months (range: 1.2 to 7.6 months). Average mean dose to the stomach was 14.06Gy (range: 0.10Gy to 67.55Gy), and 17.39Gy (range: 0.03Gy to 68.30Gy) to the duodenum. Mean duodenal dose was ⬍10Gy in 40.0% patients. The LKB model was fit to the complication data for the entire upper GI tract (a composite of the stomach and duodenum), the stomach alone, and the duodenum alone for
S217
S218
I. J. Radiation Oncology
● Biology ● Physics
Volume 57, Number 2, Supplement, 2003
the TD50(1), “m,” and “n” LKB model parameters, and 69% confidence intervals. For the entire upper GI tract, the parameters were 52.5Gy (42Gy, 64Gy), 0.35 (0.28, 0.47), and 0.21 (0.11, 0.50), respectively. After incorporation of the site of UGIB, the parameters for the stomach were 62Gy (53Gy, 71Gy), 0.30 (0.23, 0.39), and 0.07 (0.03, 0.16), respectively. For the duodenum, the parameters were 180Gy (⬃100Gy, ⬎200Gy), 0.49 (0.36, 0.61), and 0.12 (0.09, 0.30), respectively. Multivariate analysis demonstrated that in addition to NTCP, mean dose to stomach was significantly associated with GI bleed. Conclusions: This study confirms that the stomach and duodenum do not have a large volume effect, and that dose thresholds exist for GI bleed risk. The dose-NTCP curve is shallow for the duodenum, with a far higher tolerance to radiation than previously estimated. However, these results are based on a low number of duodenal events, and ongoing analysis of additional patients may lead to refinement of parameters. These findings should facilitate the design of future clinical trials of high dose radiation to upper abdominal sites.
155
Outcome Results of the 1996 –1999 Patterns of Care Survey of the National Practice for Patients Receiving Radiation Therapy for Carcinoma of the Esophagus
M. Suntharalingam,1 J. Moughan,2 L. Coia,4 T. Iarocci,2 M.J. Krasna,3 L. Kachnic,5 B. Minsky,6 C. Willet,7 J.B. Owen2 1 Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, 2Surgery, University of Maryland School of Medicine, Baltimore, MD, 3American College of Radiology, Philadelphia, PA, 4Community Medical Center, Toms River, NJ, 5Boston University, Boston, MA, 6Memorial Sloan-Kettering, New York, NY, 7Massachusetts General Hospital, Boston, MA Purpose/Objective: The national practice for patients receiving radiation therapy for carcinoma of the esophagus was evaluated by a Patterns of Care Study conducted for patients treated from 1996 –1999. This report describes the outcomes of these patients and compares these results to updated PCS data obtained during the 1992–1994 survey, in order to document whether previously reported changes in practice have resulted in improvements in survival for this patient population. Materials/Methods: A national survey was conducted at 59 institutions in a stratified random sample selected from a master list of radiation therapy facilities throughout the United States. A stratified two-step cluster sampling technique was used for data collection. 414 patients were sampled from the 59 institutions, which gives a weighted sample size of 11,340 patients nationwide. Eligibility criteria included either definitive or adjuvant RT delivered between 1996–1999, no evidence of distant metastases, squamous cell or adenocarcinoma histology, KPS ⬎ 60, tumors in the thoracic esophagus, and no prior malignancies within the previous 5 years. Patient, tumor, and treatment characteristics were evaluated SUDAAN statistical software was used to allow the incorporation of the design elements and weights that reflect the relative contribution of each institution and each patient in the analysis. Multivariate comparisons of survival times were made using the Cox proportional hazards model. Results: The median age of patients was 64 years, 77% were male, and 23% female. KPS was ⬎ 80% in 85% of pts. Adenocarcinoma was diagnosed in 51% of pts and squamous cell carcinoma in 49%. 16% were clinical stage I (AJCC 83 system), 39% CS II, and 33% CS III (12% unknown). Concurrent chemoradiation continued to be the most commonly employed treatment strategy (97%). The median follow up for the entire group was 7 months. 91 patients had died (55% of these from esophageal cancer) at time of analysis. Significant variables in the multivariate analysis of survival times included clinical stage and treatment approach. Patients with clinical stage III disease had a higher hazard risk of death as compared to other stages of disease (clinical stage III risk ratio [RR] 2.66 vs. clinical stage I, p ⫽ 0.004), whereas those treated with concurrent chemoradiation followed by surgery had a decreased risk of death compared to other treatment schemes (chemoradiation plus surgery RR 0.33 vs. chemo/RT only, p ⬍0.0001). Histology and size of treatment center were not significant. An updated analysis of the original survey performed between 1992–1994 confirmed these findings (median follow-up ⫽ 10 months). Multivariate analysis revealed that clinical stage I (p ⬍ 0.0001), treatment approach with trimodality therapy (p ⫽ 0.0013), and type of treatment center all predicted for improved overall survival times. When data from both surveys were combined these predictive variables continued to be significant. Patients presenting with clinical stage III disease had a RR of 2.26 as compared to other stage I patients (p⫽0.0004). Those patients receiving chemo/RT followed by surgery had an RR of 0.58 as compared to those receiving chemo/RT only (p⫽0.004). Conclusions: The outcome results of the 1996 –99 PCS survey confirm the findings of the 1992–94 study. Concurrent chemoradiation continued to be the most commonly utilized treatment approach during the time period studied. The observation that patients undergoing surgical resection following concurrent chemoradiation have a decreased hazard or chance of death (i.e., improved overall survival) compared to other treatment schemes highlights the need for a randomized trial comparing these strategies. Supported by NCI grant CA 65435.
156
Randomized Prospective Study Comparing High Dose Rate Intraluminal Brachytherapy (HDRILBT) Alone to HDRILBT and External Beam Radiotherapy (EBRT) in the Palliation of Advanced Esophageal Cancer
R. Sur,1,2 B. Donde,2 C. Falkson,1 S.N. Ahmed,2 V. Levin,3 S. Nag,4 G. Jones1 1 Radiation Oncology, McMaster University, Hamilton, ON, Canada, 2Radiation Oncology, University of the Witwatersrand, Johannesburg, Gauteng, South Africa, 3Human Health, International Atomic Energy Agency, Vienna, Austria, 4Radiation Oncology, Ohio State University, Columbus, OH Purpose/Objective: Previous studies have shown that HDRILBT is the best method of palliation for advanced esophageal cancer offering lasting palliation by improving dysphagia-free survival (DFS) in more than 60% of cases for prolonged periods of time. This, in turn, improves the overall survival (OS) in patients with advanced disease with a good quality of life. Encouraged by the results of HDRILBT alone in palliation of advanced cases, a study was designed to determine if the addition of EBRT would further improve the outcome in terms of DFS for advanced esophageal cancers. Materials/Methods: Patients with advanced inoperable esophageal cancer were entered into a randomized prospective study at the Johannesburg Hospital, University of the Witwatersrand, South Africa. All patients were initially investigated and found