Seit 2002 werden in der multizentrischen Phase III TARGIT-A Studie Patientinnen mit kleinem Mammakarzinom mit IORT (20Gy) während der brusterhaltenden Operation (Arm A) oder postoperativer WBI (56/2Gy; Arm B) randomisiert behandelt. Bei Arm A Patientinnen mit Risikofaktoren am Resektionspräparat wird die gesamte Brust postoperativ nachbestrahlt (46-50/2Gy; WBI). Erste Ergebnisse zeigen eine Äquivalenz von IORT und WBI in Bezug auf Gesamtüberleben, Rezidivfreiheit und Toxizität (Vaidya et al. Lancet 2010;376:91-102). Die vorliegende Arbeit untersucht strahlentherapeutisch relevante Lebensqualitätsaspekte der ersten 123 an der Universitätsmedizin Mannheim im Rahmen der TARGIT-A Studie therapierten Patientinnen.

Erfassung der Lebensqualität nach IORT Boost und Vergleich mit einer altersadjustierten deutschen Normstichprobe. Materialen und Methoden: Zwischen Februar 2002 und Dezember 2006 erhielten 142 Patientinnen (medianes Alter 63 Jahre) einen IORT Boost (20Gy; INTRABEAM System). Nach abgeschlossener Wundheilung und/oder Chemotherapie wurde mit der EBRT begonnen (46–50Gy). Die Lebensqualitätserhebung erfolgte im Median nach 34 Monaten mittels der standardisierten EORTC Fragebögen QLQ-C-30 und QLQ-BR-23 nach Ende der EBRT bei 121 Patientinnen. Der Rücklauf betrug 85% (103/121). Alle 6–12 Monate fand eine klinische Nachsorge mit Erhebung von Spättoxizitäten (LENT SOMA) statt. Ergebnisse: Nach im Median 32 Monaten Nachbeobachtungszeit zeigten sich (sehr) gute Ergebnisse nach IORT Boost (Spättoxizität + Lebensqualität). Die allgemeine Lebensqualität unterschied sich nicht klinisch relevant (>10 Punkte Unterschied) von einer altersadjustierten deutschen Normstichprobe bei statistisch signifikant niedrigerem Mittelwert (58,66 vs. 64,77 Punkte; p=0,016). Patientinnen mit höhergradigen Toxizitäten hatten signifikant mehr Emesis/Nausea (p=0,018), Obstipation (p=0,002), Brust- (p=0,008) und Armsymptome (p=0,013) und eine gering schlechtere allgemeine Lebensqualität (60,58 vs. 56,74 Punkte). Den stärksten Einfluss hatten Schmerzen > °II. Zufriedene Patientinnen (89%) hatten signifikant weniger Brust- und Armsymptome (p<0,001) bei weniger höhergradigen Spättoxizitäten (p=0,004). Zusammenfassung: Patientinnen mit IORT Boost haben eine gute Lebensqualität nach 32 Monaten medianer Nachsorgezeit. Diese ist zwar signifikant niedriger im Vergleich zu einer altersadjustierten Normstichprobe, jedoch klinisch nicht relevant (Unterschied <10 Punkte). Höhergradige Toxizitäten übten in nur wenigen Bereichen einen negativen Einfluss auf die Lebensqualität aus.

626 Background: Recently, the concept of IORT during BCS has been introduced using linear accelerators, brachytherapy or dedicated mobile IORT devices generating fast electrons or low energy X-rays. Here, we report the first 5 years of a single center experience after introduction of a novel approach to deliver IORT as a tumor bed boost during BCS for breast cancer. Methods: 155 breast cancers in 154 women (median age 63 yrs, range 30 - 83 yrs, T1/T2 = 110/45, N0/N+ = 104/51) were treated between February 2002 and December 2007 at the University Medical Center Mannheim/University of Heidelberg, in whom IORT as tumor bed boost was applied using 50 kV X rays (20 Gy, INTRABEAM, Carl Zeiss Oberkochen, additional OR time about 45 - 60 min) followed by 46 - 50 Gy external beam whole breast radiotherapy (EBRT). Chemotherapy was given before EBRT. The median interval between BCS+IORT and EBRT was 10 wks. Median follow-up was 34 mon (max 79.6 mon, 1 pt lost to f/u). Overall survival (OS), local relapse free survival (LRFS) and disease free survival (DFS) were calculated at 5 yrs using the Kaplan Meier method. 81 patients were evaluated at 3 yr f/u for normal tissue effects using the LENT SOMA scoring system. Results: Ten patients have died, 2 pts suffered from in breast relapse and 8 pts developed distant metastases yielding a 5yr OS of 87.0%, a 5yr LRFS of 98.4% and a 5 yr DFS of 73.9%. Grade 3 fibroses of the tumor bed were detected in 6% of the patients after 3 yrs. Skin toxicity was mild (teleangiectases and hyperpigmentations in 6% each). Conclusions: IORT as a tumor bed boost using the INTRABEAM system yields low recurrence and toxicity rates when followed by external beam whole breast radiotherapy. [Table: see text]

Zielsetzung: Vergleich von Lebensqualität (LQ) und Patientenzufriedenheit nach brusterhaltender Operation (BET) mit (a) Intraoperativer Radiotherapie (IORT) als alleiniger strahlentherapeutischer Behandlung oder (b) IORT als vorgezogener Boostbestrahlung gefolgt von einer externen Radiotherapie (IORT+EBRT) oder (c) konventioneller externer Nachbestrahlung (EBRT).

BACKGROUND:Intraoperative radiotherapy (IORT) is currently being evaluated as a novel approach during breast-conserving surgery (BCS). IORT can be used either as a tumor bed boost followed by external-beam radiotherapy (EBRT) or as a single treatment. In a matched-pair study, we assessed quality of life (QoL) in 69 patients with early breast cancer treated with BCS and/or IORT and/or EBRT.METHODS:Patients were matched for age and time since BCS. IORT was provided with 50 kV x-rays (Intrabeam) delivering 20 Gy at the applicator surface. EBRT (46 to 50 Gy in 2-Gy fractions in the IORT with EBRT group, and 56 Gy in 2-Gy fractions in the EBRT group) was initiated after completion of wound healing and/or chemotherapy. The mailed questionnaires included the European Organization for the Research and Treatment of Cancer QLQ-C30 and BR23, FACT-F, HADS, Body Image Scale, and Rosenberg Self-Esteem Scale. At 18 to 70 months' follow-up (median 47 months), all patients were disease free.RESULTS:We found only a few differences between the three groups. There was a trend toward more pain (mean ± standard deviation; 42.8 ± 32.9 vs. 27.5 ± 34.7) and reduced QoL (57.6 ± 20.7 vs. 70.3 ± 23.9) after IORT with EBRT compared with EBRT, respectively. IORT patients reported comparable QoL (70.3 ± 23.0), and less breast symptoms and body image concerns compared to EBRT (8.6 ± 12.3 vs. 19.2 ± 23.8, and 1.7 ± 3.3 vs. 3.4 ± 4.4, respectively). IORT alone resulted in significantly fewer breast symptoms (8.6 ± 12.3; P = 0.012) and less pain (23.9 ± 24.5, P = 0.041) compared with IORT with EBRT (26.1 ± 27.6; 42.8 ± 32.9, respectively).CONCLUSIONS:Patients with early breast cancer after BCS and IORT with or without EBRT present with comparable QoL like patients receiving EBRT without a boost. IORT patients show the lowest rate of breast symptoms.

Volumetric modulated arc therapy (VMAT) has the potential to deliver dose distributions comparable to the established intensity-modulated radiotherapy techniques for a multitude of target paradigms. Prior to implementing VMAT into their clinical routine in December 2008, the authors evaluated the dose calculation/delivery accuracy of 24 sample VMAT plans (prostate and anal cancer target paradigms) with film and ionization dosimetry. After the start of the clinical program, in vivo measurements with a rectal probe were performed.

Vertebral column is the most prevalent location of bone metastases. Patients with instable and painful spinal metastases receive surgery for stabilization followed by fractionated radiotherapy over 2-4 weeks to control the underlying malignant process. Many patients with bone metastases simultaneously present visceral metastases and require urgent systemic therapy. However, due to increased toxicity, concurrent chemotherapy and irradiation is rarely possible. We have therefore established a novel method for intraoperative radiotherapy (IORT) during kyphoplasty which enables immediate stability, sterilization of the metastasis and immediate initiation of chemotherapy. The kyphoplasty conformed to standard procedure with minor modifications. For intraoperative radiotherapy the INTRABEAM system (Carl Zeiss Surgical, Oberkochen, Germany) was used. After choosing a bipendicular approach specially designed metallic sleeves were inserted to guide the drift tube of the INTRABEAM system. Correct position of the sleeves was verified using biplanar X-rays. Then the applicator (including the drift tube) was guided through the sleeve into the center of the metastasis. There a single dose of 8 Gy in 5 mm distance using 50 kV x-rays was delivered within 2 minutes. After removal of the INTRABEAM system the kyphoplasty balloon was inflated and PMMA cement was injected. The total treatment lasted less than 90 minutes. Since August 2009 14 lesions in 12 patients were treated. There were five males and seven female patients with a median age of 65, 5 years. The primary histological diagnoses included: breast cancer (6), prostate cancer (2), rectum cancer, lung cancer, gastric cancer and hepatocellular carcinoma (respectively 1). No radiation induced skin reaction or neuropathy was seen. There were only a few procedure-related complications in two patients (asymptomatic extravertebral cement leak, asymptomatic pulmonary cement extravasation). Pain improved in all patients on day one. To date there have been no local failures with a median follow-up of two months (> 6 months in 2 patients). The combination of kyphoplasty and IORT is technically feasible with high patient acceptance. As survival in patients with cancer increases this new treatment method may become a valuable option for patients with spinal metastases providing immediate stability and sterilization of the metastasis.

To investigate whether a dose reduction to CT-enlarged but FDG-PET-negative (([18F]-fluoro-2-deoxy-D-glucose positron emission tomography) inguinal lymph nodes in radiochemotherapy of anal cancer is safe.

Purpose/Objective(s)Intraoperative radiotherapy (IORT) during breast conserving surgery (BCS) has been introduced into clinical practice using linear accelerators, brachytherapy or dedicated mobile IORT devices generating fast electrons or low energy X-rays. Here, we report the first five years of a single center experience after introduction of a novel approach to deliver IORT with the INTRABEAM system as a tumor bed boost during BCS for breast cancer.Materials/Methods155 breast cancers in 153 women (median age 63 yrs, range 30 - 83 yrs, T1/T2 = 100/55, N0/N+ = 108/47) were treated between 02/2002 and 12/2007 at the University Medical Center Mannheim/University of Heidelberg, in whom IORT as tumor bed boost was applied using 50 kV X rays (20 Gy, INTRABEAM, Carl Zeiss Oberkochen, additional OR time about 45 - 60 min) followed by 46 - 50 Gy external beam whole breast radiotherapy (EBRT). Chemotherapy was given before EBRT. The median interval between BCS+IORT and EBRT was 10 wks. Median follow-up was 34 months (max 80 months, 1 patient was lost to follow-up). Overall survival (OS) and local relapse free survival (LRFS) were calculated at 5 yrs using the Kaplan Meier method. 79 patients were evaluated at 3 yr f/u for normal tissue effects using the LENT SOMA scoring system.ResultsTen patients have died, 2 pts suffered from in breast relapse and 8 pts developed distant metastases yielding a 5yr OS of 87.0%, a 5yr LRFS of 98.5%. Grade 3 fibroses of the tumor bed were detected in 5% of the patients after 3 yrs in general restricted to the tumor bed. There was one secondary mastectomy due to whole breast fibrosis. Skin toxicity was mild (telangiectases and hyperpigmentation in 6% each).ConclusionsIORT as a tumor bed boost using the INTRABEAM system yields low recurrence and toxicity rates when followed by 46 - 50 Gy external beam whole breast radiotherapy. Purpose/Objective(s)Intraoperative radiotherapy (IORT) during breast conserving surgery (BCS) has been introduced into clinical practice using linear accelerators, brachytherapy or dedicated mobile IORT devices generating fast electrons or low energy X-rays. Here, we report the first five years of a single center experience after introduction of a novel approach to deliver IORT with the INTRABEAM system as a tumor bed boost during BCS for breast cancer. Intraoperative radiotherapy (IORT) during breast conserving surgery (BCS) has been introduced into clinical practice using linear accelerators, brachytherapy or dedicated mobile IORT devices generating fast electrons or low energy X-rays. Here, we report the first five years of a single center experience after introduction of a novel approach to deliver IORT with the INTRABEAM system as a tumor bed boost during BCS for breast cancer. Materials/Methods155 breast cancers in 153 women (median age 63 yrs, range 30 - 83 yrs, T1/T2 = 100/55, N0/N+ = 108/47) were treated between 02/2002 and 12/2007 at the University Medical Center Mannheim/University of Heidelberg, in whom IORT as tumor bed boost was applied using 50 kV X rays (20 Gy, INTRABEAM, Carl Zeiss Oberkochen, additional OR time about 45 - 60 min) followed by 46 - 50 Gy external beam whole breast radiotherapy (EBRT). Chemotherapy was given before EBRT. The median interval between BCS+IORT and EBRT was 10 wks. Median follow-up was 34 months (max 80 months, 1 patient was lost to follow-up). Overall survival (OS) and local relapse free survival (LRFS) were calculated at 5 yrs using the Kaplan Meier method. 79 patients were evaluated at 3 yr f/u for normal tissue effects using the LENT SOMA scoring system. 155 breast cancers in 153 women (median age 63 yrs, range 30 - 83 yrs, T1/T2 = 100/55, N0/N+ = 108/47) were treated between 02/2002 and 12/2007 at the University Medical Center Mannheim/University of Heidelberg, in whom IORT as tumor bed boost was applied using 50 kV X rays (20 Gy, INTRABEAM, Carl Zeiss Oberkochen, additional OR time about 45 - 60 min) followed by 46 - 50 Gy external beam whole breast radiotherapy (EBRT). Chemotherapy was given before EBRT. The median interval between BCS+IORT and EBRT was 10 wks. Median follow-up was 34 months (max 80 months, 1 patient was lost to follow-up). Overall survival (OS) and local relapse free survival (LRFS) were calculated at 5 yrs using the Kaplan Meier method. 79 patients were evaluated at 3 yr f/u for normal tissue effects using the LENT SOMA scoring system. ResultsTen patients have died, 2 pts suffered from in breast relapse and 8 pts developed distant metastases yielding a 5yr OS of 87.0%, a 5yr LRFS of 98.5%. Grade 3 fibroses of the tumor bed were detected in 5% of the patients after 3 yrs in general restricted to the tumor bed. There was one secondary mastectomy due to whole breast fibrosis. Skin toxicity was mild (telangiectases and hyperpigmentation in 6% each). Ten patients have died, 2 pts suffered from in breast relapse and 8 pts developed distant metastases yielding a 5yr OS of 87.0%, a 5yr LRFS of 98.5%. Grade 3 fibroses of the tumor bed were detected in 5% of the patients after 3 yrs in general restricted to the tumor bed. There was one secondary mastectomy due to whole breast fibrosis. Skin toxicity was mild (telangiectases and hyperpigmentation in 6% each). ConclusionsIORT as a tumor bed boost using the INTRABEAM system yields low recurrence and toxicity rates when followed by 46 - 50 Gy external beam whole breast radiotherapy. IORT as a tumor bed boost using the INTRABEAM system yields low recurrence and toxicity rates when followed by 46 - 50 Gy external beam whole breast radiotherapy.

Purpose: To determine the frequency and volume of seroma after breast-conserving surgery (BCS) with or without intraoperative radiotherapy (IORT).Methods and Materials: Seventy-one patients with 73 breast cancers (IORT group) treated with IORT (20 Gy Intrabeam) as a boost during BCS were compared with 86 patients with 88 breast tumors (NO-IORT group) treated without IORT. Clinical examination and measurement of seroma volume on treatment-planning CT (CT-seroma) was done at median interval of 35 days after BCS.Results: Seroma were found on palpation in 37 patients (23%) and on CT in 105 patients (65%; median volume, 26.3 mL). Interval between BCS and CT was significantly shorter in patients with palpable seroma (median, 33 days) or CT-seroma (33 days) compared with those with no palpable seroma (36.5 days; p = 0.027) or CT-seroma (52 days, p <0.001). The rate of palpable seroma was not different (TORT it = 17, 23%; NO-IORT n = 20, 23%; p = 0.933), whereas fewer patients required puncture in the TORT group [3 (4%) vs. 10 (11 %)]. In contrast, more patients showed CT-seroma after IORT (IORT n = 59, 81%; NO-TORT n = 46, 52%; p < 0.001). The interval between BCS and CT was significantly shorter in patients with IORT as compared with the NO-IORT patients (median, 33 days vs. 41.5 days; p = 0.036).Conclusion: Intraoperative radiotherapy with low-kilovoltage X-rays during BCS is not associated with an increased rate of palpable seroma or seroma requiring treatment. The rate of seroma formation on CT was higher after IORT compared with the NO-IORT group, which might be because of the shorter interval between BCS and CT. (C) 2010 Elsevier Inc.

Volumetric modulated arc therapy (VMAT) provides the possibility to deliver comparable dose distributions to the established IMRT techniques. In the case of VMAT, the treatment efficiency can be increased due to the available degrees of freedom (like gantry speed, collimator angle, dose rate and leaf position). Before implementing VMAT into our clinical routine, we compared data consisting of 9 patients with prostate cancer between calculated VMAT plans, film and ionization dosimetry. In addition the first patients also received rectal in-vivo measurements. The VMAT plans were generated with the treatment planning system (TPS) ERGO++ (ELEKTA, Crawley/UK) for the 9 prostate cancer patients. On each patient CT dataset, two plans (1 rotation vs. 1.5rotations) were calculated. The verification was made by the use of films- (edr2, KODAK) and ionization dosimetry (0.125cm3/ PTW Freiburg) in a homogeneous phantom. The complete Dicom Export from ERGGO++ to the record and verify system Mosaiq (Impac, Elekta) and to the Elekta Synergy machine was verified. The resulting dose distribution of the irradiated films were analyzed by profiles and γ-index analysis. An appropriate ion chamber of type 23323 (PTW Freiburg, Germany) for the in-vivo measurements was used. The plans were transferred from ERGO++ to the R&V system and further to the linac without any deviations. The mean monitor units for prescription dose of 2Gy were 312±20MU. The deviations noticed with the ionization dosimetry for the 1.5 rotations were less than 2% (0,69±0.43%). The plans with just one rotation showed deviations less than 3% (2.59±0.8%), except 2 plans with measurements close to the high gradient region, had a deviation between 3% and 4%. The γ-index analysis of the film dosimetry showed no plan with a deviation higher than 3%/3mm in high dose region. The analysis of the high- and low dose region in the γ-index showed that 40.9±8.7% met the requirements for the γ-index criteria of 1%/1mm, 84.8±8% for 3%/3mm and 97.2±2.7% for 5%/5mm. The in-vivo measurements showed a good agreement between calculated and treated dose (1.76±0.47%). VMAT plans can be planned and treated reproducible in high quality after the commissioning the complete chain from TPS over R&V system to the linac. The results of the individual plan verification meet the general published requirements. The first in-vivo measurements confirm the precision of the delivered dose.