- Email: [email protected]
Endorectal Balloon in Post-operative Radiation Therapy for Prostate Cancer
Proceedings of the 52nd Annual ASTRO Meeting 4. In one patient new planning CTs were made during the treatment course due to a substantial systematic difference between the rectal filling at the planning CT and the CBCTs. 5. The treatment was tolerated well by all patients. At the end of the treatment no grade 3 urinary or gastro-intestinal toxicity was observed. 6. After a median follow-up of 6 months no local relapses occurred. Conclusions: Using the adapted treatment approach, we were able to deliver a highly conformal dose distribution to all bladder patients. Online IGART is feasible for patients with localized bladder cancer and enables us to steer the right dose to the right tissues. Author Disclosure: G. Meijer, None; J. Migchielsen, None; D. Schuring, None; P. van der Toorn, None; J. Weterings, None; M. De Wildt, None; M. Bal, Employee Philips Medical Systems, A. Employment.
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Endorectal Balloon in Post-operative Radiation Therapy for Prostate Cancer
L. K. Morikawa, R. Kudchadker, J. Kanke, M. Oyervides, S. Frank, A. K. Lee, K. Hoffman, S. Choi, Q. Nguyen, D. Kuban MDACC, Texas, TX Purpose/Objective(s): Anatomical changes after radical prostatectomy may significantly increase the volume of rectum treated to intermediate and high doses in post-operative radiation therapy (RT). There are no data available on endorectal balloon (EB) use in the post-operative setting. The aim of this study was to investigate the advantage of using EB in prostate cancer patients who undergo post-operative RT and investigate the effects of EB on dose volume histograms (DVH) for the rectum. Materials/Methods: We retrospectively analyzed 5 patients treated post-operatively for prostate cancer at M.D. Anderson Cancer Center. EB was utilized during CT-based simulation in all patients. Two scans for each patient were generated and identified as scan A (without EB) and scan B (with EB). The same physician contoured scan A and B in all patients. A total of 10 IMRT plans were generated, optimized and approved using scan A and B. DVH analyses of PTV, CTV, V30, V40, V60 and V70 were generated and compared between scan A and B for each patient. Absolute and mean relative dose reduction between each plan was calculated. Results: EB improved the DVH for the rectum in all patients studied. The PTV and CTV coverage was equivalent in scan A and B. There was a substantial decrease in rectal volumes treated to high doses (60-70Gy) in patients using EB. The relative mean dose reduction to the rectum was: 46.2% for the V70 (range 34-54%); 38.4% for V60 (range 28-47%); 27.6% for V40 (range 13-51%) and 27% for V30 (range 16-51%) in scan B compared with scan A. EB also optimized anatomy in 2 cases: one case of local recurrence located on the anterior rectal wall and another patient with residual seminal vesicles asymmetrically oriented. Conclusions: EB demonstrated advantage in decreasing the rectum volume treated to doses between 30 and 70Gy in all patients studied. EB may be a useful tool in decreasing the risk of rectal complications in patients irradiated post-operatively and should be considered in post-operative RT. Confirmation of these results in additional patients may help to guide optimal post-operative RT planning and delivery. Author Disclosure: L.K. Morikawa, None; R. Kudchadker, None; J. Kanke, None; M. Oyervides, None; S. Frank, None; A.K. Lee, None; K. Hoffman, None; S. Choi, None; Q. Nguyen, None; D. Kuban, None.
2430
RTOG 0417: A Phase II Study of Bevacizumab in Combination with Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients with Locally Advanced Cervical Carcinoma
T. Schefter1, K. Winter2, J. S. Kwon3, K. Stuhr1, M. Rotman4, B. P. Yaremko5, W. Small6, D. Gaffney7 1 University of Colorado Comprehensive Cancer Center, Aurora, CO, 2RTOG Statistical Center, Philadelphia, PA, 3University of British Columbia and BC Cancer Agency, Vancouver, Vancouver, BC, Canada, 4SUNY Health Science Center/Brooklyn, Brooklyn, NY, 5University of Western Ontario, London Regional Cancer Program, London, ON, Canada, 6The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, 7University of Utah Health Science Center, Salt Lake City, UT
Purpose/Objective(s): Concurrent cisplatin-based chemoradiotherapy is the standard treatment for locally advanced cervical cancer. RTOG 0417 was a phase II studying exploring the safety and efficacy of the addition of bevacizumab to chemoradiotherapy. Materials/Methods: Eligible patients with bulky IB-IIIB disease were treated with once-weekly cisplatin (40 mg/m2) chemotherapy and standard pelvic radiotherapy and brachytherapy. Bevacizumab was administered at 10 mg/kg IV Q2 weeks for 3 cycles during chemoradiation. Treatment-related serious and other adverse event (SAE/AE) rates within the first 90 days from treatment start were determined. Treatment-related SAEs were defined as any grade $ 4 vaginal bleeding or thrombotic event or grade $ 3 arterial event, GI bleeding or bowel/bladder perforation or any grade 5 treatment-related death. Treatment-related AEs included all SAEs and grade 3 or 4 GI toxicity persistent for . 2 weeks despite medical intervention, grade 4 neutropenia or leucopenia persisting for . 7 days, febrile neutropenia, grade 3 or 4 other hematologic toxicity and grade 3 or 4 GI, renal, cardiac, pulmonary, hepatic or neurologic AEs. All adverse events were scored using the CTCAE v 3.0 criteria (MedDRA version 6.0). Results: 60 patients from 25 institutions were enrolled between 2006 and 2009 and 49 patients were evaluable (10 ineligible and 1 received no protocol treatment). The median follow-up was 12.4 months (min-max: 4.6-31.4 months). The median age was 45 (min-max: 22-80). Most patients were FIGO IIB (63%) and had Zubrod performance status of 0 (67%). 80% were squamous. There were no treatment-related SAEs. There were 15 (31%) protocol specified treatment-related AEs, most common were hematologic (12/15 = 80%) and 18 (37%) occurring at any time. 37 of 49 (76%) had cisplatin and bevacizumab administered per protocol and 32 of 35 (91%) with completed radiation treatment reviews had both external beam and brachytherapy administered per protocol or with acceptable variation. Conclusions: Bevacizumab in addition to standard pelvic chemoradiotherapy for locally advanced cervical cancer is feasible and safe with respect to the protocol-specified SAEs and AEs. This project was supported by RTOG grant U10 CA21661, and CCOP grant U10 CA37422 from the National Cancer Institute (NCI). This publication’s contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute Author Disclosure: T. Schefter, None; K. Winter, None; J.S. Kwon, None; K. Stuhr, None; M. Rotman, None; B.P. Yaremko, None; W. Small, funding from Genetech for a research project with bevacizumab in pancreatic cancer, C. Other Research Support; D. Gaffney, None.
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2429
Endorectal Balloon in Post-operative Radiation Therapy for Prostate Cancer
L. K. Morikawa, R. Kudchadker, J. Kanke, M. Oyervides, S. Frank, A. K. Lee, K. Hoffman, S. Choi, Q. Nguyen, D. Kuban MDACC, Texas, TX Purpose/Objective(s): Anatomical changes after radical prostatectomy may significantly increase the volume of rectum treated to intermediate and high doses in post-operative radiation therapy (RT). There are no data available on endorectal balloon (EB) use in the post-operative setting. The aim of this study was to investigate the advantage of using EB in prostate cancer patients who undergo post-operative RT and investigate the effects of EB on dose volume histograms (DVH) for the rectum. Materials/Methods: We retrospectively analyzed 5 patients treated post-operatively for prostate cancer at M.D. Anderson Cancer Center. EB was utilized during CT-based simulation in all patients. Two scans for each patient were generated and identified as scan A (without EB) and scan B (with EB). The same physician contoured scan A and B in all patients. A total of 10 IMRT plans were generated, optimized and approved using scan A and B. DVH analyses of PTV, CTV, V30, V40, V60 and V70 were generated and compared between scan A and B for each patient. Absolute and mean relative dose reduction between each plan was calculated. Results: EB improved the DVH for the rectum in all patients studied. The PTV and CTV coverage was equivalent in scan A and B. There was a substantial decrease in rectal volumes treated to high doses (60-70Gy) in patients using EB. The relative mean dose reduction to the rectum was: 46.2% for the V70 (range 34-54%); 38.4% for V60 (range 28-47%); 27.6% for V40 (range 13-51%) and 27% for V30 (range 16-51%) in scan B compared with scan A. EB also optimized anatomy in 2 cases: one case of local recurrence located on the anterior rectal wall and another patient with residual seminal vesicles asymmetrically oriented. Conclusions: EB demonstrated advantage in decreasing the rectum volume treated to doses between 30 and 70Gy in all patients studied. EB may be a useful tool in decreasing the risk of rectal complications in patients irradiated post-operatively and should be considered in post-operative RT. Confirmation of these results in additional patients may help to guide optimal post-operative RT planning and delivery. Author Disclosure: L.K. Morikawa, None; R. Kudchadker, None; J. Kanke, None; M. Oyervides, None; S. Frank, None; A.K. Lee, None; K. Hoffman, None; S. Choi, None; Q. Nguyen, None; D. Kuban, None.
2430
RTOG 0417: A Phase II Study of Bevacizumab in Combination with Definitive Radiotherapy and Cisplatin Chemotherapy in Untreated Patients with Locally Advanced Cervical Carcinoma
T. Schefter1, K. Winter2, J. S. Kwon3, K. Stuhr1, M. Rotman4, B. P. Yaremko5, W. Small6, D. Gaffney7 1 University of Colorado Comprehensive Cancer Center, Aurora, CO, 2RTOG Statistical Center, Philadelphia, PA, 3University of British Columbia and BC Cancer Agency, Vancouver, Vancouver, BC, Canada, 4SUNY Health Science Center/Brooklyn, Brooklyn, NY, 5University of Western Ontario, London Regional Cancer Program, London, ON, Canada, 6The Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, IL, 7University of Utah Health Science Center, Salt Lake City, UT
Purpose/Objective(s): Concurrent cisplatin-based chemoradiotherapy is the standard treatment for locally advanced cervical cancer. RTOG 0417 was a phase II studying exploring the safety and efficacy of the addition of bevacizumab to chemoradiotherapy. Materials/Methods: Eligible patients with bulky IB-IIIB disease were treated with once-weekly cisplatin (40 mg/m2) chemotherapy and standard pelvic radiotherapy and brachytherapy. Bevacizumab was administered at 10 mg/kg IV Q2 weeks for 3 cycles during chemoradiation. Treatment-related serious and other adverse event (SAE/AE) rates within the first 90 days from treatment start were determined. Treatment-related SAEs were defined as any grade $ 4 vaginal bleeding or thrombotic event or grade $ 3 arterial event, GI bleeding or bowel/bladder perforation or any grade 5 treatment-related death. Treatment-related AEs included all SAEs and grade 3 or 4 GI toxicity persistent for . 2 weeks despite medical intervention, grade 4 neutropenia or leucopenia persisting for . 7 days, febrile neutropenia, grade 3 or 4 other hematologic toxicity and grade 3 or 4 GI, renal, cardiac, pulmonary, hepatic or neurologic AEs. All adverse events were scored using the CTCAE v 3.0 criteria (MedDRA version 6.0). Results: 60 patients from 25 institutions were enrolled between 2006 and 2009 and 49 patients were evaluable (10 ineligible and 1 received no protocol treatment). The median follow-up was 12.4 months (min-max: 4.6-31.4 months). The median age was 45 (min-max: 22-80). Most patients were FIGO IIB (63%) and had Zubrod performance status of 0 (67%). 80% were squamous. There were no treatment-related SAEs. There were 15 (31%) protocol specified treatment-related AEs, most common were hematologic (12/15 = 80%) and 18 (37%) occurring at any time. 37 of 49 (76%) had cisplatin and bevacizumab administered per protocol and 32 of 35 (91%) with completed radiation treatment reviews had both external beam and brachytherapy administered per protocol or with acceptable variation. Conclusions: Bevacizumab in addition to standard pelvic chemoradiotherapy for locally advanced cervical cancer is feasible and safe with respect to the protocol-specified SAEs and AEs. This project was supported by RTOG grant U10 CA21661, and CCOP grant U10 CA37422 from the National Cancer Institute (NCI). This publication’s contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute Author Disclosure: T. Schefter, None; K. Winter, None; J.S. Kwon, None; K. Stuhr, None; M. Rotman, None; B.P. Yaremko, None; W. Small, funding from Genetech for a research project with bevacizumab in pancreatic cancer, C. Other Research Support; D. Gaffney, None.
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