[en] A prospective study to assess toxicity and survival outcomes after intensity-modulated whole-abdominal irradiation (IM-WAI) following surgery and adjuvant intravenous carboplatin/taxane chemotherapy in advanced FIGO stage III ovarian cancer. Between 2006 and 2009, 16 patients with optimally resected FIGO stage III ovarian cancer, who had received six cycles of adjuvant carboplatin/taxane chemotherapy were treated with consolidation IM-WAI. Radiotherapy was delivered to a total dose of 30 Gy in 1.5-Gy fractions, using step-and-shoot (n = 3) or helical tomotherapy (n = 13). The first 10 patients were treated within a phase I trial; the following patients received the same treatment modality. The target volume included the entire peritoneal cavity, the diaphragm, the liver capsule, and the pelvic and para-aortic node regions. Organs at risk were kidneys, liver, heart, and bone marrow. Median follow-up was 44 months (range 19.2-67.2 months). No grade 4 toxicities occurred during IM-WAI. Common Toxicity Criteria for Adverse Events (CTCAE) grade 3 toxicities were: diarrhea (25 %), leucopenia (19 %), nausea/vomiting (6 %), and thrombocytopenia (6 %). No toxicity-related treatment break was necessary. Small bowel obstruction occurred in a total of 6 patients: in 3 cases (19 %) due to postsurgical adhesions and in 3 cases due to local tumor recurrence (19 %). Median recurrence-free survival (RFS) was 27.6 months (95 % confidence interval, CI = 24-44 months) and median overall survival (OS) was 42.1 months (95 %CI = 17-68 months). The peritoneal cavity was the most frequent site of initial failure. Consolidation IM-WAI following surgery and adjuvant chemotherapy is feasible and can be performed with manageable acute and late toxicity. The favorable RFS outcome is promising and justifies further clinical trials. (orig.)
[de]
Es wurden Akut- und Langzeittoxizitaet sowie Ueberlebensdaten der konsolidierenden intensitaetsmodulierten Ganzabdomenbestrahlung (''intensity-modulated whole-abdominal irradiation'', IM-WAI) nach adjuvanter Chemotherapie beim Ovarialkarzinom im Stadium FIGO III prospektiv untersucht. Zwischen 2006 und 2009 wurden 16 Patientinnen mit optimal reseziertem Ovarialkarzinom im Stadium FIGO III mittels konsolidierender IM-WAI nach 6 Zyklen adjuvanter Carboplatin-/Taxane-Chemotherapie behandelt. Die ersten 10 Patientinnen wurden im Rahmen einer prospektiven Phase-I-Studie behandelt, danach wurden 6 Patientinnen analog zu dem Studienprotokoll behandelt. Bestrahlt wurde bis zu einer Gesamtdosis von 30 Gy in 1,5 Gy Fraktionen mittels ''step-and-shoot'' (n = 3) oder helikaler Tomotherapietechnik (n = 13). Das Zielvolumen umfasste die gesamte Peritonealhoehle, die Zwerchfellkuppeln, die Leberkapsel und die paraaortalen und pelvinen Lymphabflusswege. Risikoorgane waren die Nieren, das Leberparenchym, Herz und Knochen. Das mediane Follow-up betrug 44 Monate (Spanne 19,2-67,2 Monate). Unter Bestrahlung traten keine CTC-Grad-IV-Toxizitaeten auf und es fanden keine toxizitaetsbedingten Unterbrechungen statt. Beobachtete Grad-III-Akuttoxizitaeten waren Diarrhoe (25 %), Leukopenie (19 %), Uebelkeit/Erbrechen (6 %) und Thrombozytopenie (6 %). Insgesamt erlitten 6 Patientinnen einen Darmverschluss im spaeteren Verlauf (37 %). Die Ursachen dafuer waren postoperative Briden (19 %) und Peritonealkarzinose (19 %). Das mediane rezidivfreie Ueberleben (RFS) betrug 27,6 Monate (95 %-KI 24-44 Monate) und das mediane Gesamtueberleben betrug 42,1 Monate (95 %-KI 17-68 Monate). Die Peritonealhoehle war die haeufigste Rezidivstelle. Die konsolidierende IM-WAI ist machbar und klinisch gut vertraeglich. Die Daten zum RFS sind vielversprechend und rechtfertigen die Einleitung weiterer klinischer Studien. (orig.)Journal
[en] The main study objectives were: to establish a nationwide voluntary collaborative network of breast centres with independent data analysis; to define suitable quality indicators (QIs) for benchmarking the quality of breast cancer (BC) care; to demonstrate existing differences in BC care quality; and to show that BC care quality improved with benchmarking from 2003 to 2007. BC centres participated voluntarily in a scientific benchmarking procedure. A generic XML-based data set was developed and used for data collection. Nine guideline-based quality targets serving as rate-based QIs were initially defined, reviewed annually and modified or expanded accordingly. QI changes over time were analysed descriptively. During 2003–2007, respective increases in participating breast centres and postoperatively confirmed BCs were from 59 to 220 and from 5,994 to 31,656 (> 60% of new BCs/year in Germany). Starting from 9 process QIs, 12 QIs were developed by 2007 as surrogates for long-term outcome. Results for most QIs increased. From 2003 to 2007, the most notable increases seen were for preoperative histological confirmation of diagnosis (58% (in 2003) to 88% (in 2007)), appropriate endocrine therapy in hormone receptor-positive patients (27 to 93%), appropriate radiotherapy after breast-conserving therapy (20 to 79%) and appropriate radiotherapy after mastectomy (8 to 65%). Nationwide external benchmarking of BC care is feasible and successful. The benchmarking system described allows both comparisons among participating institutions as well as the tracking of changes in average quality of care over time for the network as a whole. Marked QI increases indicate improved quality of BC care
Journal
BMC Cancer (Online); ISSN 1471-2407; 
; v. 8; p. 358
; v. 8; p. 358