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Improved Local Control With Adjuvant Radiation Therapy in Localized Adrenocortical Carcinoma: A Case-Matched Retrospective Study
S84
International Journal of Radiation Oncology Biology Physics
grade 3 and digestive bleeding grade 3 with secondary anemia and hemodynamic angor in a patient with previous small bowel angiodysplasia. The most frequent toxicity was diarrhea. Pathological complete response was achieved in 8 of 9 patients evaluated. Salvage cystectomy has been performed in two patients due to recurrent superficial bladder tumor one and two years after combined therapy. One patient showed a distant node progression which respond to chemotherapy with cisplatin, One patient developed late radiation cystitis. After a median follow-up of 36 months, 7 patients remain disease-free with intact bladder. None significant relationship was found between dosimetric parameters and acute grade 3-4 toxicities. Conclusions: The combination of sorafenib and RT seems to be feasible and safe allowing long-term bladder preservation in selected patients. None of the dosimetric parameters showed significant contribution to grade 3-4 acute toxicity. Author Disclosure: F. Ferrer: None. G. Sancho: None. A. Rovirosa: None. J. Maroto: None. B. Mellado: None. F. Vigues: None. J. Palou: None. M. Ribal: None. A. Boladeras: None. X. Garcia del Muro: None.
collecting system or major vascular structures. Future studies may want to use, at a minimum, 16 Gy x 3. Author Disclosure: S.M. McBride: None. A.A. Wagner: None. I.D. Kaplan: None.
204 A Phase 1 Dose-Escalation Study of Robotic Radiosurgery in Inoperable Primary Renal Cell Carcinoma S.M. McBride,1 A.A. Wagner,2 and I.D. Kaplan2; 1Harvard Radiation Oncology Program, Boston, MA, 2Beth Israel Deaconess Medical Center, Boston, MA Purpose/Objective(s): Extreme hypofractionated radiation therapy has been shown to be effective in controlling metastatic disease in traditionally radioresistant tumors. We sought to evaluate the toxicity of hypofractionated radiation therapy in the treatment of medically inoperable, primary renal cell carcinoma. Materials/Methods: From November 2006 to December 2010, we enrolled 15 patients with medically inoperable Stage IA/B renal cell carcinoma (RCC) on a Phase I dose escalation study. Patients were eligible who had either biopsy-confirmed RCC or radiographic findings of sufficient concern to otherwise warrant partial or radical nephrectomy; primary lesions had to be 5cm and patients had to have KPS 70. Patients with tumors near the collecting system or large vessels were included. We examined five potential dose arms: 7 Gy x 3, 9 Gy x 3, 11 Gy x 3, 13 Gy x 3, and 16 Gy x 3. Dose-Limiting Toxicities (DLT) were defined as any non-hematologic grade 3-4 toxicity within 90 days of treatment. Treatment was delivered using the robotic radiosurgical device. Patients were followed every 6 months for a minimum of 2 years. Acute and late toxicities were examined using CTCAE v 3.0 and RTOG classifications, respectively. Serial creatinine, eGFR, and differential renal function (via renal scintigraphy scans) were obtained at each follow-up. Local tumor control was defined using RECIST criteria. Results: Median age was 75 years (range, 45-90); mean maximal tumor dimension was 3.4 cm; nine (60%) of patients had baseline chronic kidney disease (CKD). Median follow-up was 36.7 months (range, 24.2-72.2). There were no DLTs; we were able to escalate through all dose arms (3 patients per arm). Two patients had acute grade 1 nausea, and five had acute grade 1 fatigue. One patient had late grade 3 renal dysfunction. At 24 months, compared to baseline, there was a significant decline in both mean eGFR (from 55 mg/dL to 37 mg/dL, p Z 0.002) and differential renal function as assayed by renal scintigraphy (from 2.75 to 17.13, p Z 0.01). At 12 months, 11 patients had stable disease, 2 had partial response, 1 had complete response, and 1 had progressive disease. Ultimately, there were two local failures at 30.7 months and 31.2 months. Both were in low dose arms (7 Gy x 3 and 9 Gy x 3), and one patient was successfully salvaged with repeat treatment. Conclusions: With minimum follow-up of 2 years, extreme hypofractionation for primary renal cell carcinoma is safe, with minimal acute toxicities; decrements in renal function in a population with significant baseline chronic kidney disease were equivalent to historical series of partial nephrectomy. No toxicity was observed treating tumors near the
205 Improved Local Control With Adjuvant Radiation Therapy in Localized Adrenocortical Carcinoma: A Case-Matched Retrospective Study A. Sabolch, T. Else, W. Jackson, A. Williams, B.S. Miller, F. Worden, G.D. Hammer, and S. Jolly; University of Michigan, Ann Arbor, MI Purpose/Objective(s): Adrenocortical carcinoma (ACC) is a rare malignancy known for high rates of local and distant failures. For localized ACC, the benefit of postoperative radiation therapy (RT) has not been firmly established. In this study of non-metastatic ACC, we compare local control (LC) of patients treated with surgery followed by adjuvant RT to a matched cohort treated with surgery alone. Materials/Methods: A retrospective review was undertaken of a single institution’s experience with ACC. We aimed to identify patients with localized disease (Stage I through III) who underwent gross total surgical resection followed by adjuvant RT. Only patients treated with RT at our institution were included in our analysis to limit variations in RT techniques. These patients were then matched to controls who received surgery with curative intent but without adjuvant RT. Matching was performed on the basis of stage, surgical margin status, tumor grade, and adjuvant mitotane use. Characteristics were compared between groups using ANOVA and Chi-square methods. LC was defined as tumor recurrence within the adrenal fossa/radiation field. Kaplan-Meier estimates were generated for both LC and overall survival. Results: From 1991 to 2011, 360 ACC patients were evaluated. Of these, 20 were patients with localized disease who received postoperative adjuvant RT. These were matched to 20 controls per the criteria described above. The median age was 44 years for the surgery only group and 51 years for the RT group. In each group, 13 were Stage II and 7 were Stage III. Margin status was available for 14 RT patients, 12 with R0 resection and 2 with R1 resection. For the surgery alone group, margin status was available for 17 patients, 14 with R0 resection and 3 with R1 resection. There were no known instances of R2 resections in either group, and differences in resection status were non-significant (p Z 0.9). Half of the tumors were low grade and half were high grade in each group. Fifteen patients in each group received mitotane. Median RT dose was 55 Gy (range, 45-60). Following a median follow-up of 30 months, LC was 95% in the adjuvant RT group vs 45% in patients treated with surgery alone (p Z 0.001; HR: 0.08 [95% CI, 0.02-0.2]). Overall survival trended better in the RT group vs surgery alone (80% vs 55%, respectively, over the entire follow-up period) (p Z 0.16 HR: 0.4 [95% CI, 0.1-1.3]). Conclusions: Postoperative RT significantly improved LC compared to the use of surgery alone in this case-matched cohort analysis of localized ACC patients. While this retrospective series represents the largest study to date on adjuvant RT for ACC, its findings need to be confirmed in a prospective study. Author Disclosure: A. Sabolch: None. T. Else: None. W. Jackson: None. A. Williams: None. B.S. Miller: None. F. Worden: None. G.D. Hammer: None. S. Jolly: None.
206 Contemporary Management of Stage I and Stage II Seminoma P. Chung, S. Sridharan, M. Jewett, P. Bedard, E. Atenafu, M. Moore, J. Sweet, M. O’Malley, L. Anson-Cartwright, and P. Warde; Princess Margaret Hospital, Toronto, ON, Canada Purpose/Objective(s): Stage I and II seminoma management has evolved from historically almost universal use of radiation therapy (RT) to a modern approach of surveillance in stage I and selective use of RT or cisplatin-based chemotherapy (CT) for stage II disease. Recently, knowledge of late toxicities of RT has meant that increased use of chemotherapy
International Journal of Radiation Oncology Biology Physics
grade 3 and digestive bleeding grade 3 with secondary anemia and hemodynamic angor in a patient with previous small bowel angiodysplasia. The most frequent toxicity was diarrhea. Pathological complete response was achieved in 8 of 9 patients evaluated. Salvage cystectomy has been performed in two patients due to recurrent superficial bladder tumor one and two years after combined therapy. One patient showed a distant node progression which respond to chemotherapy with cisplatin, One patient developed late radiation cystitis. After a median follow-up of 36 months, 7 patients remain disease-free with intact bladder. None significant relationship was found between dosimetric parameters and acute grade 3-4 toxicities. Conclusions: The combination of sorafenib and RT seems to be feasible and safe allowing long-term bladder preservation in selected patients. None of the dosimetric parameters showed significant contribution to grade 3-4 acute toxicity. Author Disclosure: F. Ferrer: None. G. Sancho: None. A. Rovirosa: None. J. Maroto: None. B. Mellado: None. F. Vigues: None. J. Palou: None. M. Ribal: None. A. Boladeras: None. X. Garcia del Muro: None.
collecting system or major vascular structures. Future studies may want to use, at a minimum, 16 Gy x 3. Author Disclosure: S.M. McBride: None. A.A. Wagner: None. I.D. Kaplan: None.
204 A Phase 1 Dose-Escalation Study of Robotic Radiosurgery in Inoperable Primary Renal Cell Carcinoma S.M. McBride,1 A.A. Wagner,2 and I.D. Kaplan2; 1Harvard Radiation Oncology Program, Boston, MA, 2Beth Israel Deaconess Medical Center, Boston, MA Purpose/Objective(s): Extreme hypofractionated radiation therapy has been shown to be effective in controlling metastatic disease in traditionally radioresistant tumors. We sought to evaluate the toxicity of hypofractionated radiation therapy in the treatment of medically inoperable, primary renal cell carcinoma. Materials/Methods: From November 2006 to December 2010, we enrolled 15 patients with medically inoperable Stage IA/B renal cell carcinoma (RCC) on a Phase I dose escalation study. Patients were eligible who had either biopsy-confirmed RCC or radiographic findings of sufficient concern to otherwise warrant partial or radical nephrectomy; primary lesions had to be 5cm and patients had to have KPS 70. Patients with tumors near the collecting system or large vessels were included. We examined five potential dose arms: 7 Gy x 3, 9 Gy x 3, 11 Gy x 3, 13 Gy x 3, and 16 Gy x 3. Dose-Limiting Toxicities (DLT) were defined as any non-hematologic grade 3-4 toxicity within 90 days of treatment. Treatment was delivered using the robotic radiosurgical device. Patients were followed every 6 months for a minimum of 2 years. Acute and late toxicities were examined using CTCAE v 3.0 and RTOG classifications, respectively. Serial creatinine, eGFR, and differential renal function (via renal scintigraphy scans) were obtained at each follow-up. Local tumor control was defined using RECIST criteria. Results: Median age was 75 years (range, 45-90); mean maximal tumor dimension was 3.4 cm; nine (60%) of patients had baseline chronic kidney disease (CKD). Median follow-up was 36.7 months (range, 24.2-72.2). There were no DLTs; we were able to escalate through all dose arms (3 patients per arm). Two patients had acute grade 1 nausea, and five had acute grade 1 fatigue. One patient had late grade 3 renal dysfunction. At 24 months, compared to baseline, there was a significant decline in both mean eGFR (from 55 mg/dL to 37 mg/dL, p Z 0.002) and differential renal function as assayed by renal scintigraphy (from 2.75 to 17.13, p Z 0.01). At 12 months, 11 patients had stable disease, 2 had partial response, 1 had complete response, and 1 had progressive disease. Ultimately, there were two local failures at 30.7 months and 31.2 months. Both were in low dose arms (7 Gy x 3 and 9 Gy x 3), and one patient was successfully salvaged with repeat treatment. Conclusions: With minimum follow-up of 2 years, extreme hypofractionation for primary renal cell carcinoma is safe, with minimal acute toxicities; decrements in renal function in a population with significant baseline chronic kidney disease were equivalent to historical series of partial nephrectomy. No toxicity was observed treating tumors near the
205 Improved Local Control With Adjuvant Radiation Therapy in Localized Adrenocortical Carcinoma: A Case-Matched Retrospective Study A. Sabolch, T. Else, W. Jackson, A. Williams, B.S. Miller, F. Worden, G.D. Hammer, and S. Jolly; University of Michigan, Ann Arbor, MI Purpose/Objective(s): Adrenocortical carcinoma (ACC) is a rare malignancy known for high rates of local and distant failures. For localized ACC, the benefit of postoperative radiation therapy (RT) has not been firmly established. In this study of non-metastatic ACC, we compare local control (LC) of patients treated with surgery followed by adjuvant RT to a matched cohort treated with surgery alone. Materials/Methods: A retrospective review was undertaken of a single institution’s experience with ACC. We aimed to identify patients with localized disease (Stage I through III) who underwent gross total surgical resection followed by adjuvant RT. Only patients treated with RT at our institution were included in our analysis to limit variations in RT techniques. These patients were then matched to controls who received surgery with curative intent but without adjuvant RT. Matching was performed on the basis of stage, surgical margin status, tumor grade, and adjuvant mitotane use. Characteristics were compared between groups using ANOVA and Chi-square methods. LC was defined as tumor recurrence within the adrenal fossa/radiation field. Kaplan-Meier estimates were generated for both LC and overall survival. Results: From 1991 to 2011, 360 ACC patients were evaluated. Of these, 20 were patients with localized disease who received postoperative adjuvant RT. These were matched to 20 controls per the criteria described above. The median age was 44 years for the surgery only group and 51 years for the RT group. In each group, 13 were Stage II and 7 were Stage III. Margin status was available for 14 RT patients, 12 with R0 resection and 2 with R1 resection. For the surgery alone group, margin status was available for 17 patients, 14 with R0 resection and 3 with R1 resection. There were no known instances of R2 resections in either group, and differences in resection status were non-significant (p Z 0.9). Half of the tumors were low grade and half were high grade in each group. Fifteen patients in each group received mitotane. Median RT dose was 55 Gy (range, 45-60). Following a median follow-up of 30 months, LC was 95% in the adjuvant RT group vs 45% in patients treated with surgery alone (p Z 0.001; HR: 0.08 [95% CI, 0.02-0.2]). Overall survival trended better in the RT group vs surgery alone (80% vs 55%, respectively, over the entire follow-up period) (p Z 0.16 HR: 0.4 [95% CI, 0.1-1.3]). Conclusions: Postoperative RT significantly improved LC compared to the use of surgery alone in this case-matched cohort analysis of localized ACC patients. While this retrospective series represents the largest study to date on adjuvant RT for ACC, its findings need to be confirmed in a prospective study. Author Disclosure: A. Sabolch: None. T. Else: None. W. Jackson: None. A. Williams: None. B.S. Miller: None. F. Worden: None. G.D. Hammer: None. S. Jolly: None.
206 Contemporary Management of Stage I and Stage II Seminoma P. Chung, S. Sridharan, M. Jewett, P. Bedard, E. Atenafu, M. Moore, J. Sweet, M. O’Malley, L. Anson-Cartwright, and P. Warde; Princess Margaret Hospital, Toronto, ON, Canada Purpose/Objective(s): Stage I and II seminoma management has evolved from historically almost universal use of radiation therapy (RT) to a modern approach of surveillance in stage I and selective use of RT or cisplatin-based chemotherapy (CT) for stage II disease. Recently, knowledge of late toxicities of RT has meant that increased use of chemotherapy