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OC-0160: Toxicity and cosmetic results of partial vs whole breast irradiation: 10-year results of a randomized trial
ESTRO 33, 2014 Results: By November 2013, 339 pts have been enrolled. Clinical/endpoint data were available for 264 patients (pts): 140 treated at 2Gy/frand 124 at 2.5-2.7Gy/fr. Observed rates of moderate/severe acute urinary symp were: frequency 19%, intermittency 13%, urgency 17%, Weak Stream 23%, straining 8%, nicturia 21%. Smoke proved to bean important risk factor for frequency (OR=2.6), intermittency (OR=2.3) and urgency (OR=2.4). AD was a predictor of intermittency (OR=4.5); alcohol for straining (OR=2.1) and hypertension for weak stream (OR=1.5). All results were confirmed when excluding pts with severe symp before RT. Full models are as follows: FREQUENCY (AUC=0.66): smoke (OR=2.6), lymph node RT (OR=1.6), bladder surface receiving>11.5Gy/week (S11.5w, continuous variable OR=1.02); INTERMITTENCY (AUC=0.72): smoke (OR=2.3), lymph node RT (OR=1.4), S11.5w (OR=1.02), AD(OR=4.5); URGENCY (AUC=0.70):smoke (OR=2.4), T stage (2-3 vs 1, OR=2.6), S6w (OR=1.01); WEAK STREAM (AUC=0.70): basal weak stream (OR=1.5), hypertension (OR=1.5), S6w (OR=1.01); STRAINING (AUC=0.78): alcohol (OR=2.1), Tstage (OR=4.4), S12.5w (OR=1.04). NOCTURIA was predicted by (AUC=0.80) basal nocturia (OR=2.4), T stage (OR=2.1), S11.5w(OR=1.02) and it is the specific topic of another abstract submitted to this conference. Figures show the probability of acute frequency and weak stream as a function of smoke/alcohol and DSHw.
S61 months after IMRT. Complete hydrogel absorption was verified in MRI scans six months after treatment (single exception with remaining traces of an initial 15ml volume). Acute grade 1 and 2 GI toxicity rates were 40% and 13%, respectively (no grade 3 toxicity), but only 4% experienced late grade 1 GI toxicity (n=2, one of these patients with baseline grade 1 problems). No late grade 2 or greater GI toxicity was found in the study. Acute grade 1, 2 and 3 GU toxicity rates were 42%, 35% and 2%, respectively. Late grade 1 and 2 GU toxicity was noticed in 17% and 2% of patients. With a VRS score of 0, no relevant findings were seen during proctoscopy in 71% of patients. Higher scores of 1, 2 and 3 were given to 13%, 13% and 2% of patients, respectively. The reason forscores >0 was single or confluent teleangiectasia seen in some areas of anterior rectal wall with a single exception of grade 2 congested mucosa (confluent reddening with oedema). There was no evidence of ulceration, stricture or necrosis at the 12 months proctoscopic examination. Conclusions: The hydrogel spacer gel is a safe and effective method to increase the distance between the prostate and rectum. Late GI toxicity is hardly detectable and the rectal wall without radiotherapy related changes for the majority of patients on endoscopy.
PROFFERED PAPERS: BRACHYTHERAPY 2: BREAST AND MISCELLANEOUS OC-0160 Toxicity and cosmetic results of partial vs whole breast irradiation: 10-year results of a randomized trial C. Polgár1, T. Major1, Z. Sulyok2, Z. Takácsi-Nagy1, J. Fodor1 1 National Institute of Oncology, Centre of Radiotherapy, Budapest, Hungary 2 National Institute of Oncology, Centre of Surgery, Budapest, Hungary Purpose/Objective: The 10-year survival results of our randomized study comparing breast-conserving treatment with partial breast irradiation (PBI) or whole breast irradiation (WBI) have been published recently. In this analysis long-term toxicity and cosmetic results are reported.
Conclusions: Ad interim analyses show that specific severe acute urinary symp are related to different clinical risk factors. Smoke, AD, alcohol and hypertension play a role in predicting radio-induced acute GU toxicity together with some dosimetric constraints (mainly high weekly bladder doses, 11.5-12.5Gy/week). OC-0159 Hydrogel spacer use for prostate cancer radiotherapy - 12 month toxicity and proctoscopy results M. Pinkawa1, M.J. Eble1, M. Uhl2, K. Herfarth2, B. Van Triest3, R. Kalisvaart3, D.C. Weber4, R. Miralbell4, D.Y. Song5, T.L. DeWeese5 1 RWTH Aachen University Hospital, Department of Radiation Oncology, Aachen, Germany 2 University of Heidelberg, Department of Radiation Oncology, Heidelberg, Germany 3 NKI-AVL Nederlands Kanker Instituut-Antoni van Leeuwenhoek, Department of Radiation Oncology, Amsterdam, The Netherlands 4 Geneva University Hospital, Department of Radiation Oncology, Geneva, Switzerland 5 Johns Hopkins University School of Medicine, Department of Radiation Oncology and Molecular Radiation Sciences, Baltimore, USA Purpose/Objective: Dose escalated radiotherapy for prostate cancer is associated with improved biochemical control but a higher risk of rectal toxicity. A prospective European multicentre phase II study was performed to evaluate dosimetric and clinical effects of a hydrogel spacer. Materials and Methods: Fifty two patients with localized prostate cancer received a transperineal TRUS guided hydrogel (SpaceOAR, Augmenix Inc.) injection between theprostate and rectum. The initial hydrogel volume of 15ml was reduced to 10ml during the study. All patients were treated with 2Gy fractions using an IMRT technique up to a total dose of 78Gy. Gastrointestinal (GI) and genitourinary (GU) toxicity were recorded during treatment and at 3, 6 and 12 months following irradiation by using the RTOG/EORTC criteria. Proctoscopy was performed 12 months after treatment and the results were scored using the Vienna Rectoscopy Score (VRS). Results: A prostate to rectal wall distance (mean±standard deviation) of 10±6mm at midgland level resulted after hydrogel injection, remaining stable at the end of treatment (11±6mm) and decreasing to 3±4mm three
Materials and Methods: Between 1998 and 2004, 258 selected, low-risk breast cancer patients were randomized after breast-conserving surgery to receive 50 Gy WBI (n=130) or PBI (n=128). The latter consisted of either 7 x 5.2 Gy high-dose-rate multicatheter brachytherapy (PBI-HDR; n=88) or 50 Gy electron beam irradiation (PBI-ELE; n=40). Late radiation side effects were scored by the RTOG/EORTC late radiation morbidity scoring scheme. Follow-up mammograms were reviewed searching for visible signs of fat necrosis. Cosmetic results were evaluated using the Harvard criteria. At the time of analysis median follow-up time was 10.2 years (range 1.5-13.5 years). Results: The rate of subcutaneous and parenchymal fibrosis (any grade) was 49.4%, 22.5%, and 42.7% after PBI-HDR, PBI-ELE, and WBI, respectively (pHDR vs WBI =NS, pHDR vs ELE =0.0034, pELE vs WBI =0.0166). The respective rate of grade 3 fibrosis was only 2.4%, 0%, and 0.9%; p=NS). Skin side effect (any grade) occurred in 12.9%, 40.0%, and 20.5% after PBI-HDR, PBI-ELE, and WBI, respectively (pHDR vs WBI =NS, pHDR vs ELE =0.0009, pELE vs WBI =NS). The respective rate of grade 3 telangiectasia was 0%, 7.5%, and 2.6% (pHDR vs WBI =NS, pHDR vs ELE =0.0311, pELE vs WBI =NS). Fat necrosis was detected on follow-up mammograms in 58.1%, 30.0%, and 52.1%, respectively (pHDR vs WBI =NS, pHDR vs ELE =0.0019, pELE vs WBI =0.0119). Only one patient (1.2%) in the PBI-HDR group developed fat necrosis requiring surgical intervention. The overall rate of grade 3 late toxicities was 2.4%, 7.5%, and 3.4% after PBI-HDR, PBI-ELE, and WBI, respectively (p=NS). The rate of excellent-good cosmetic result was 81.2% in the PBIHDR, 75.0% in the PBI-ELE, and 62.1% in the control group (pHDR vs WBI =0.0003, pHDR vs ELE =NS, pELE vs WBI =0.0972). Conclusions: Both WBI and PBI (either with HDR or ELE) are well tolerated and severe late side effects are minimal. Slightly more skin side effects occur after external beam PBI and WBI. On the contrary, parenchymal side effects occur more frequently after PBI-HDR. Significantly better cosmetic outcome can be achieved with carefully designed PBI-HDR multicatheter implants compared with the outcome after PBI-ELE or WBI. OC-0161 Is it possible to deliver efficacious and high quality APBI treatment outside a clinical trial? E. Gruszczynska1, M. Dabkowski2, A. Kulik2, M. Kawczynska1, M. Bijok1, A. Kasprowicz2, A. Zolciak-Siwinska2
S61 months after IMRT. Complete hydrogel absorption was verified in MRI scans six months after treatment (single exception with remaining traces of an initial 15ml volume). Acute grade 1 and 2 GI toxicity rates were 40% and 13%, respectively (no grade 3 toxicity), but only 4% experienced late grade 1 GI toxicity (n=2, one of these patients with baseline grade 1 problems). No late grade 2 or greater GI toxicity was found in the study. Acute grade 1, 2 and 3 GU toxicity rates were 42%, 35% and 2%, respectively. Late grade 1 and 2 GU toxicity was noticed in 17% and 2% of patients. With a VRS score of 0, no relevant findings were seen during proctoscopy in 71% of patients. Higher scores of 1, 2 and 3 were given to 13%, 13% and 2% of patients, respectively. The reason forscores >0 was single or confluent teleangiectasia seen in some areas of anterior rectal wall with a single exception of grade 2 congested mucosa (confluent reddening with oedema). There was no evidence of ulceration, stricture or necrosis at the 12 months proctoscopic examination. Conclusions: The hydrogel spacer gel is a safe and effective method to increase the distance between the prostate and rectum. Late GI toxicity is hardly detectable and the rectal wall without radiotherapy related changes for the majority of patients on endoscopy.
PROFFERED PAPERS: BRACHYTHERAPY 2: BREAST AND MISCELLANEOUS OC-0160 Toxicity and cosmetic results of partial vs whole breast irradiation: 10-year results of a randomized trial C. Polgár1, T. Major1, Z. Sulyok2, Z. Takácsi-Nagy1, J. Fodor1 1 National Institute of Oncology, Centre of Radiotherapy, Budapest, Hungary 2 National Institute of Oncology, Centre of Surgery, Budapest, Hungary Purpose/Objective: The 10-year survival results of our randomized study comparing breast-conserving treatment with partial breast irradiation (PBI) or whole breast irradiation (WBI) have been published recently. In this analysis long-term toxicity and cosmetic results are reported.
Conclusions: Ad interim analyses show that specific severe acute urinary symp are related to different clinical risk factors. Smoke, AD, alcohol and hypertension play a role in predicting radio-induced acute GU toxicity together with some dosimetric constraints (mainly high weekly bladder doses, 11.5-12.5Gy/week). OC-0159 Hydrogel spacer use for prostate cancer radiotherapy - 12 month toxicity and proctoscopy results M. Pinkawa1, M.J. Eble1, M. Uhl2, K. Herfarth2, B. Van Triest3, R. Kalisvaart3, D.C. Weber4, R. Miralbell4, D.Y. Song5, T.L. DeWeese5 1 RWTH Aachen University Hospital, Department of Radiation Oncology, Aachen, Germany 2 University of Heidelberg, Department of Radiation Oncology, Heidelberg, Germany 3 NKI-AVL Nederlands Kanker Instituut-Antoni van Leeuwenhoek, Department of Radiation Oncology, Amsterdam, The Netherlands 4 Geneva University Hospital, Department of Radiation Oncology, Geneva, Switzerland 5 Johns Hopkins University School of Medicine, Department of Radiation Oncology and Molecular Radiation Sciences, Baltimore, USA Purpose/Objective: Dose escalated radiotherapy for prostate cancer is associated with improved biochemical control but a higher risk of rectal toxicity. A prospective European multicentre phase II study was performed to evaluate dosimetric and clinical effects of a hydrogel spacer. Materials and Methods: Fifty two patients with localized prostate cancer received a transperineal TRUS guided hydrogel (SpaceOAR, Augmenix Inc.) injection between theprostate and rectum. The initial hydrogel volume of 15ml was reduced to 10ml during the study. All patients were treated with 2Gy fractions using an IMRT technique up to a total dose of 78Gy. Gastrointestinal (GI) and genitourinary (GU) toxicity were recorded during treatment and at 3, 6 and 12 months following irradiation by using the RTOG/EORTC criteria. Proctoscopy was performed 12 months after treatment and the results were scored using the Vienna Rectoscopy Score (VRS). Results: A prostate to rectal wall distance (mean±standard deviation) of 10±6mm at midgland level resulted after hydrogel injection, remaining stable at the end of treatment (11±6mm) and decreasing to 3±4mm three
Materials and Methods: Between 1998 and 2004, 258 selected, low-risk breast cancer patients were randomized after breast-conserving surgery to receive 50 Gy WBI (n=130) or PBI (n=128). The latter consisted of either 7 x 5.2 Gy high-dose-rate multicatheter brachytherapy (PBI-HDR; n=88) or 50 Gy electron beam irradiation (PBI-ELE; n=40). Late radiation side effects were scored by the RTOG/EORTC late radiation morbidity scoring scheme. Follow-up mammograms were reviewed searching for visible signs of fat necrosis. Cosmetic results were evaluated using the Harvard criteria. At the time of analysis median follow-up time was 10.2 years (range 1.5-13.5 years). Results: The rate of subcutaneous and parenchymal fibrosis (any grade) was 49.4%, 22.5%, and 42.7% after PBI-HDR, PBI-ELE, and WBI, respectively (pHDR vs WBI =NS, pHDR vs ELE =0.0034, pELE vs WBI =0.0166). The respective rate of grade 3 fibrosis was only 2.4%, 0%, and 0.9%; p=NS). Skin side effect (any grade) occurred in 12.9%, 40.0%, and 20.5% after PBI-HDR, PBI-ELE, and WBI, respectively (pHDR vs WBI =NS, pHDR vs ELE =0.0009, pELE vs WBI =NS). The respective rate of grade 3 telangiectasia was 0%, 7.5%, and 2.6% (pHDR vs WBI =NS, pHDR vs ELE =0.0311, pELE vs WBI =NS). Fat necrosis was detected on follow-up mammograms in 58.1%, 30.0%, and 52.1%, respectively (pHDR vs WBI =NS, pHDR vs ELE =0.0019, pELE vs WBI =0.0119). Only one patient (1.2%) in the PBI-HDR group developed fat necrosis requiring surgical intervention. The overall rate of grade 3 late toxicities was 2.4%, 7.5%, and 3.4% after PBI-HDR, PBI-ELE, and WBI, respectively (p=NS). The rate of excellent-good cosmetic result was 81.2% in the PBIHDR, 75.0% in the PBI-ELE, and 62.1% in the control group (pHDR vs WBI =0.0003, pHDR vs ELE =NS, pELE vs WBI =0.0972). Conclusions: Both WBI and PBI (either with HDR or ELE) are well tolerated and severe late side effects are minimal. Slightly more skin side effects occur after external beam PBI and WBI. On the contrary, parenchymal side effects occur more frequently after PBI-HDR. Significantly better cosmetic outcome can be achieved with carefully designed PBI-HDR multicatheter implants compared with the outcome after PBI-ELE or WBI. OC-0161 Is it possible to deliver efficacious and high quality APBI treatment outside a clinical trial? E. Gruszczynska1, M. Dabkowski2, A. Kulik2, M. Kawczynska1, M. Bijok1, A. Kasprowicz2, A. Zolciak-Siwinska2