- Email: [email protected]
Patient-Reported Outcomes on the Impact of Single Versus Multiple Fraction Palliative Radiation Therapy for Uncomplicated Bone Metastases on Pain, Function, and Degree of Symptom Distress
S80
International Journal of Radiation Oncology Biology Physics
Results: A total of 1484 patients were identified (372 current, 1014 former, and 98 never smokers). The 5-year incidence of SPLC was 13%, 7%, and 0% for current, former, and never smokers (p Z 0.03 comparing current and never). In the follow-up period, only one never smoker developed a SPLC at 7 years. On MVA, when restricting the analysis to ever smokers with pack-years (PY) as a continuous variable, the risk of SPLC was significantly increased with tobacco exposure with a HR of 1.08 (95% CI Z 1.02-1.16, p Z 0.031), corresponding to an 8% increased risk per 10 PY. For the entire cohort, there were no differences in LC or DM based on smoking status. When grouped as never smokers (n Z 98), former smokers quit > 5 yrs prior to surgery (n Z 493), former smokers quit 5 yrs prior to surgery (n Z 521), and current smokers (n Z 372), OS was significantly worse for current smokers when compared to all other cohorts (p < 0.026 for all pairwise comparisons). Adjusting for baseline covariates, the HR for OS as compared to current smokers was 0.792 (95% CI Z 0.581-1.078, p Z 0.138) for never smokers, 0.826 (95% CI Z 0.693-0.984, p Z 0.032) for former smokers (> 5 years), and 0.783 (95% CI Z 0.66-0.929, p Z 0.005) for former smokers ( 5 years). There was a trend toward higher post-operative mortality in never smokers as compared to ever smokers (0% vs 3.3%, p Z 0.069). Conclusions: In this, the largest series of its kind, it was demonstrated that increasing tobacco exposure is associated with a higher risk of SPLC. Never smokers have a low incidence of SPLC. This has implications for post-treatment surveillance in this population as well as for patients undergoing stereotactic body radiation therapy. Finally, current smokers are at increased risk of mortality, while former and never smokers have comparable outcomes. Author Disclosure: J.M. Boyle: None. J.P. Chino: None. D. Tandberg: None. K.A. Higgins: None. C.R. Kelsey: None.
172
171 Interim Analysis Results of a Phase 2 Trial of Low-Dose Radiation Therapy for Palliation of Diffuse Large B-Cell Lymphoma C. Furlan,1 P. Bulian,1 M. Spina,1 M. Michieli,1 A. Ermacora,2 U. Tirelli,1 and M. Trovo1; 1CRO Aviano National Cancer Institute, Aviano, Italy, 2 Ospedale Santa Maria degli Angeli, Pordenone, Italy Purpose/Objective(s): The primary objective of this phase II study is to assess the response to low-dose irradiation (LDRT) in patients with diffuse large B cell lymphoma (DLCBL) with indication for palliative irradiation. Materials/Methods: We calculated by the two-stages Simon method a number of 11 patients required for the first step of the phase II study; if among these patients response number will be < 7 the study will be closed because of no-efficacy. Otherwise, accrual will be continued until 43 patients will be enrolled. Patients were administered LDRT consisting of 4 Gy in two fractions on symptomatic areas only. Clinical response was assessed 21 days after LDRT, and was defined as reduction > 50% of maximum diameter of the radiated lesions. Response evaluation was performed with CT-scan or clinical exam, depending upon depth of the mass. Toxicity was scored using the CTCAE v3.0. Quality of life was scored by the EORTC QLQ-C30 questionnaire that was administered to all patients before and 21 days after the radiation course. Results: Of 14 radiated patients, 11 patients resulted evaluable for response and 3 patients died of disease before the planned visit at 21-day. The radiated sites were the following: 4 cutaneous, 5 nodal (3 abdominal, 1 cervical, 1 mediastinum), and 5 extranodal (1 bone, 1 orbital, 2 CNS). The overall response rate was 63% (7/11 patients), with 4 complete responses and 3 partial responses. Only 1 case of toxicity was noted (grade 2 nausea). Median duration of response was 12 months (range, 1-17 months). Among responders, only one patient progressed within the radiated field at the time of last follow-up visit. Eight patients answered to the QLQ-C30 questionnaires, and an improved quality of life was documented in 6 cases. Conclusions: According to the trial design, LDRT is effective for palliation in patients with DLBCL and accrual will be continued. Author Disclosure: C. Furlan: None. P. Bulian: None. M. Spina: None. M. Michieli: None. A. Ermacora: None. U. Tirelli: None. M. Trovo: None.
Patient-Reported Outcomes on the Impact of Single Versus Multiple Fraction Palliative Radiation Therapy for Uncomplicated Bone Metastases on Pain, Function, and Degree of Symptom Distress J. Conway,1 I. Olivotto,1 S. Miller,2 R. Halperin,3 D. Hoegler,3 W. Beckham,4 J. Stephen,5 H. Daudt,4 J. French,1 and R. Olson2; 1 Vancouver Cancer Centre, Vancouver, BC, Canada, 2Centre for the North, Prince George, BC, Canada, 3Centre for the Southern Interior, Kelowna, BC, Canada, 4Vancouver Island Cancer Centre, Victoria, BC, Canada, 5 Fraser Valley Cancer Centre, Surrey, BC, Canada Purpose/Objective(s): To compare patient reported outcomes (PROs) following single fraction (SF) as compared with multiple fraction (MF) radiation therapy (RT) for uncomplicated bone metastases in a populationbased cohort. Materials/Methods: Six centers at our institution participated in the Prospective Outcomes and Support Initiative (POSI), to record PROs prior to and 3 weeks following RT for uncomplicated bone metastases. Patients treated between May and December 2013 who provided PROs before and after RT were identified. PROs were standardized and designed to assess patients’ perception of pain, function and symptom distress using a nondichotomous, ordinal, 5-point scale. Comparisons were made between patients who received SF versus MF RT. SFRT versus MFRT was at the discretion of the treating oncologist. A multivariate logistic regression analysis was performed. Results: Two hundred eighty-four patients completed both pre and postRT assessments. The mean age at diagnosis was 64 years, 50% were men, and 59% received SFRT. The three most common primary sites were genitourinary (29%), lung (24%), and breast (20%). The spine (47%) was the most common site treated. There were no significant differences in changes in mean PRO scores for pain (1.17 vs 1.02 point improvement; p Z 0.74), function (0.74 vs 0.82 point improvement; p Z 0.61) or degree of symptom distress (1.22 vs 1.21 point improvement; p Z 0.94) between patients who received SFRT versus MFRT. Likewise, the proportion of patients with at least a 1-point improvement in pain (68.2% vs 70.0%; p Z 0.78), function (73.2% vs 66.7%; p Z 0.41), and distress (78.5% vs 80.7%; p Z 0.74) were similar between SFRT and MFRT. After controlling for age at diagnosis, gender, fractionation, site of delivery, and disease site there was no significant difference in probability of having an improvement in at least one category between SFRT and MFRT (Odds Ratio Z 1.43; 95% CI Z 0.76-2.68; p Z 0.27). Conclusions: Improvements in patients’ pain, function and degree of distress were similar whether treated with SFRT or MFRT. These population-based data support the generalizability of the randomized controlled trials to real-world practice and confirm that SFRT should be the standard management policy for patients with uncomplicated bone metastases. Author Disclosure: J. Conway: None. I. Olivotto: None. S. Miller: None. R. Halperin: None. D. Hoegler: None. W. Beckham: None. J. Stephen: None. H. Daudt: None. J. French: None. R. Olson: None.
173 A Comparison of Palliative Inpatient Management Strategies for Cancer-Related Superior Vena Cava Obstruction W.A. Hall,1,2 C.E. Steuer,2,3 D.C. Nickleach,2,4 M. Behera,2,3 T.K. Owonikoko,2,3 K.A. Higgins,1,2 F.R. Khuri,2,3 W.J. Curran,1,2 and S.S. Ramalingam2,3; 1Department of Radiation Oncology, Emory University, Atlanta, GA, 2Winship Cancer Institute, Atlanta, GA, 3 Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, 4Emory University, Winship Biostatistics and Bioinformatics Shared Resource, Atlanta, GA Purpose/Objective(s): The optimal palliative inpatient management strategy of cancer-related superior vena cava obstruction remains controversial. Chemotherapy (chemo), radiation therapy (RT) and venous stenting are common treatment strategies. We performed an
International Journal of Radiation Oncology Biology Physics
Results: A total of 1484 patients were identified (372 current, 1014 former, and 98 never smokers). The 5-year incidence of SPLC was 13%, 7%, and 0% for current, former, and never smokers (p Z 0.03 comparing current and never). In the follow-up period, only one never smoker developed a SPLC at 7 years. On MVA, when restricting the analysis to ever smokers with pack-years (PY) as a continuous variable, the risk of SPLC was significantly increased with tobacco exposure with a HR of 1.08 (95% CI Z 1.02-1.16, p Z 0.031), corresponding to an 8% increased risk per 10 PY. For the entire cohort, there were no differences in LC or DM based on smoking status. When grouped as never smokers (n Z 98), former smokers quit > 5 yrs prior to surgery (n Z 493), former smokers quit 5 yrs prior to surgery (n Z 521), and current smokers (n Z 372), OS was significantly worse for current smokers when compared to all other cohorts (p < 0.026 for all pairwise comparisons). Adjusting for baseline covariates, the HR for OS as compared to current smokers was 0.792 (95% CI Z 0.581-1.078, p Z 0.138) for never smokers, 0.826 (95% CI Z 0.693-0.984, p Z 0.032) for former smokers (> 5 years), and 0.783 (95% CI Z 0.66-0.929, p Z 0.005) for former smokers ( 5 years). There was a trend toward higher post-operative mortality in never smokers as compared to ever smokers (0% vs 3.3%, p Z 0.069). Conclusions: In this, the largest series of its kind, it was demonstrated that increasing tobacco exposure is associated with a higher risk of SPLC. Never smokers have a low incidence of SPLC. This has implications for post-treatment surveillance in this population as well as for patients undergoing stereotactic body radiation therapy. Finally, current smokers are at increased risk of mortality, while former and never smokers have comparable outcomes. Author Disclosure: J.M. Boyle: None. J.P. Chino: None. D. Tandberg: None. K.A. Higgins: None. C.R. Kelsey: None.
172
171 Interim Analysis Results of a Phase 2 Trial of Low-Dose Radiation Therapy for Palliation of Diffuse Large B-Cell Lymphoma C. Furlan,1 P. Bulian,1 M. Spina,1 M. Michieli,1 A. Ermacora,2 U. Tirelli,1 and M. Trovo1; 1CRO Aviano National Cancer Institute, Aviano, Italy, 2 Ospedale Santa Maria degli Angeli, Pordenone, Italy Purpose/Objective(s): The primary objective of this phase II study is to assess the response to low-dose irradiation (LDRT) in patients with diffuse large B cell lymphoma (DLCBL) with indication for palliative irradiation. Materials/Methods: We calculated by the two-stages Simon method a number of 11 patients required for the first step of the phase II study; if among these patients response number will be < 7 the study will be closed because of no-efficacy. Otherwise, accrual will be continued until 43 patients will be enrolled. Patients were administered LDRT consisting of 4 Gy in two fractions on symptomatic areas only. Clinical response was assessed 21 days after LDRT, and was defined as reduction > 50% of maximum diameter of the radiated lesions. Response evaluation was performed with CT-scan or clinical exam, depending upon depth of the mass. Toxicity was scored using the CTCAE v3.0. Quality of life was scored by the EORTC QLQ-C30 questionnaire that was administered to all patients before and 21 days after the radiation course. Results: Of 14 radiated patients, 11 patients resulted evaluable for response and 3 patients died of disease before the planned visit at 21-day. The radiated sites were the following: 4 cutaneous, 5 nodal (3 abdominal, 1 cervical, 1 mediastinum), and 5 extranodal (1 bone, 1 orbital, 2 CNS). The overall response rate was 63% (7/11 patients), with 4 complete responses and 3 partial responses. Only 1 case of toxicity was noted (grade 2 nausea). Median duration of response was 12 months (range, 1-17 months). Among responders, only one patient progressed within the radiated field at the time of last follow-up visit. Eight patients answered to the QLQ-C30 questionnaires, and an improved quality of life was documented in 6 cases. Conclusions: According to the trial design, LDRT is effective for palliation in patients with DLBCL and accrual will be continued. Author Disclosure: C. Furlan: None. P. Bulian: None. M. Spina: None. M. Michieli: None. A. Ermacora: None. U. Tirelli: None. M. Trovo: None.
Patient-Reported Outcomes on the Impact of Single Versus Multiple Fraction Palliative Radiation Therapy for Uncomplicated Bone Metastases on Pain, Function, and Degree of Symptom Distress J. Conway,1 I. Olivotto,1 S. Miller,2 R. Halperin,3 D. Hoegler,3 W. Beckham,4 J. Stephen,5 H. Daudt,4 J. French,1 and R. Olson2; 1 Vancouver Cancer Centre, Vancouver, BC, Canada, 2Centre for the North, Prince George, BC, Canada, 3Centre for the Southern Interior, Kelowna, BC, Canada, 4Vancouver Island Cancer Centre, Victoria, BC, Canada, 5 Fraser Valley Cancer Centre, Surrey, BC, Canada Purpose/Objective(s): To compare patient reported outcomes (PROs) following single fraction (SF) as compared with multiple fraction (MF) radiation therapy (RT) for uncomplicated bone metastases in a populationbased cohort. Materials/Methods: Six centers at our institution participated in the Prospective Outcomes and Support Initiative (POSI), to record PROs prior to and 3 weeks following RT for uncomplicated bone metastases. Patients treated between May and December 2013 who provided PROs before and after RT were identified. PROs were standardized and designed to assess patients’ perception of pain, function and symptom distress using a nondichotomous, ordinal, 5-point scale. Comparisons were made between patients who received SF versus MF RT. SFRT versus MFRT was at the discretion of the treating oncologist. A multivariate logistic regression analysis was performed. Results: Two hundred eighty-four patients completed both pre and postRT assessments. The mean age at diagnosis was 64 years, 50% were men, and 59% received SFRT. The three most common primary sites were genitourinary (29%), lung (24%), and breast (20%). The spine (47%) was the most common site treated. There were no significant differences in changes in mean PRO scores for pain (1.17 vs 1.02 point improvement; p Z 0.74), function (0.74 vs 0.82 point improvement; p Z 0.61) or degree of symptom distress (1.22 vs 1.21 point improvement; p Z 0.94) between patients who received SFRT versus MFRT. Likewise, the proportion of patients with at least a 1-point improvement in pain (68.2% vs 70.0%; p Z 0.78), function (73.2% vs 66.7%; p Z 0.41), and distress (78.5% vs 80.7%; p Z 0.74) were similar between SFRT and MFRT. After controlling for age at diagnosis, gender, fractionation, site of delivery, and disease site there was no significant difference in probability of having an improvement in at least one category between SFRT and MFRT (Odds Ratio Z 1.43; 95% CI Z 0.76-2.68; p Z 0.27). Conclusions: Improvements in patients’ pain, function and degree of distress were similar whether treated with SFRT or MFRT. These population-based data support the generalizability of the randomized controlled trials to real-world practice and confirm that SFRT should be the standard management policy for patients with uncomplicated bone metastases. Author Disclosure: J. Conway: None. I. Olivotto: None. S. Miller: None. R. Halperin: None. D. Hoegler: None. W. Beckham: None. J. Stephen: None. H. Daudt: None. J. French: None. R. Olson: None.
173 A Comparison of Palliative Inpatient Management Strategies for Cancer-Related Superior Vena Cava Obstruction W.A. Hall,1,2 C.E. Steuer,2,3 D.C. Nickleach,2,4 M. Behera,2,3 T.K. Owonikoko,2,3 K.A. Higgins,1,2 F.R. Khuri,2,3 W.J. Curran,1,2 and S.S. Ramalingam2,3; 1Department of Radiation Oncology, Emory University, Atlanta, GA, 2Winship Cancer Institute, Atlanta, GA, 3 Department of Hematology and Medical Oncology, Emory University, Atlanta, GA, 4Emory University, Winship Biostatistics and Bioinformatics Shared Resource, Atlanta, GA Purpose/Objective(s): The optimal palliative inpatient management strategy of cancer-related superior vena cava obstruction remains controversial. Chemotherapy (chemo), radiation therapy (RT) and venous stenting are common treatment strategies. We performed an