The management of high-risk endometrial cancer (HREC) remains controversial. We conducted a prospective multicenter phase-II clinical trial to evaluate an adjuvant chemotherapy (CT) with sequential radiotherapy (RT) in patients with HREC.

Am 09.04.2013 ist das Gesetz zur Weiterentwicklung der Krebsfrüherkennung und Qualitätssicherung durch klinische Krebsregister (KFRG) in Kraft getretenen. Dieses Gesetz sieht bundesweit die Einrichtung klinischer Krebsregister vor. Wichtige gesetzliche Aufgaben sind beispielsweise die Bereitstellung notwendiger Daten zur Herstellung von Versorgungstransparenz sowie die Rückmeldung der Auswertungsergebnisse aus klinischen Krebsregistern an die Leistungserbringer.

Nach Meinung hochkarätiger Experten wird die Nachfrage nach entscheidungsunterstützenden Systemen in der Medizin zukünftig ansteigen. Ein Ziel solcher Systeme ist es, therapeutische Entscheidungen auf der Basis der besten verfügbaren Evidenz transparent und nachvollziehbar zu machen, sowie Abweichungen von der aktuellen Leitlinie nachvollziehbar zu dokumentieren.

Modellierung von clinical workflows mittels BPMN zur transparenten Darstellung medizinischer Prozesse und zur Definition der Schnittstellen für einen (teil-) automatisierten Datenimport in Tumordokumentationssysteme.

5109 Background: To determine the toxicity, tolerability and quality of life (QoL) of adjuvant CT with sequential RT in patients (pts) with high-risk endometrial cancer (hrec). Methods: Pts with hrec from 8 institutions were enrolled. All pts underwent abdominal hysterectomy, bilateral salpingo-oophorectomy, pelvic (100%) and paraaortic (77%) lymphadenectomy and surgical staging. Pts received four cycles of Paclitaxel 175 mg/m² (P) and Carboplatin AUC5 (C) (d1, q21d), subsequent external pelvic radiation therapy (45 Gy: 1.8 Gy/d) and vaginal brachytherapy (15 Gy: 3x 5 Gy). QoL was assessed using the EORTC-QLQ-C30 questionnaire. Primary endpoints: tolerability, toxicity and QoL. Secondary endpoint: progression-free survival (PFS). Results: Thirty-five pts were enrolled from December 2004 through May 2008. Median follow-up was 21 months (range, 3-24 months). Most of the pts (n=30) had an endometroid histology. Distribution of tumor stage (FIGO 2006) was: Ic:9, IIa:2, IIb:5, IIIa:3 and IIIc:16. All pts received 4 cycles of P and C. All pts completed RT. Grade 3/4 hematologic toxicities (in % of all cycles) were mild: leucopenia 6.6%, granulocytopenia 5.9%. Three cycles were delayed because of leucopenia. Darbepoetin alfa was given in 5.1%, G-CSF in 2.9%, blood transfusions in 2.9%. Grade 3/4 non-hematologic toxicities were seldom (< 3%). Only, alopecia occurred in 44.8%. No overall change in QoL occurred during treatment. Median Global Health Score was 50%. 2-year progression-free survival was 77.1%. Conclusions: Adjuvant combination CT with P+C and sequential RT is well tolerated and a feasible regimen in pts with hrec.

5038 Background: To determine the response rate and toxicity of primary concomitant radio-chemotherapy (cRCH) consisting of ifosfamide and carboplatin plus external beam radiotherapy with curative intention in locally advanced primary inoperable stage IIB and IIIB squamous cell cervical cancer (CC). Methods: Patients (pts) with CC from 8 institutions were enrolled. Pts received three cycles of Ifosfamide 1,2 mg/m² (+ Mesna 20%) (d1-3) plus Carboplatin AUC 4 (d1), q21d, and concomitant external beam radiotherapy (50.4 Gy: 1.8 Gy/d). Operability and remission was evaluated by clinical gynecological examination in general anesthesia 4 weeks after 3rd cycle cRCH. If operability was achieved, a radical hysterectomy with pelvic lymphadenectomy was performed within 6 weeks after cRCH. If surgery was not done, because of incomplete remission or preferences, vaginal brachytherapy (BT) (15 Gy: 5 Gy/d) was given additionally. Results: Thirty-nine pts were enrolled from January 2003 through July 2008. Median age was 48 years (range, 30 -73). Distribution of FIGO tumor stage was: IIB: 17, IIIB: 23. Median follow-up was 22 months (range, 1-56). All pts completed cRCH. Grade 3/4 hematologic toxicities (in % of all cycles) were moderate: leucopenia 4.3%, thrombocytopenia 2.6% and anaemia 4.3%. In 8.5%, cycles were delayed because of haematological toxicity. Blood transfusions were given in 23.9%, G-CSF in 35.9%. Grade 3/4 non-hematologic toxicities were seldom (< 6%). Response rate was 89.7% (CR: 35.9%, PR: 53.8%, NC: 5.1%). Operability was achieved in 79.5%. Surgery was performed in 92.8%. Complete histological remission was achieved in 61.5%. Conclusions: cRH is a highly effective and tolerable regimen in CC. Partial remission rate and histological tumour residuals indicate the need for further studies.

5057 Background: The combination of paclitaxel (Taxol) and platinum in a three weeks schedule has emerged as the current standard approach for the adjuvant setting of AOC. Exposition duration of the drug is important for cell death. In animal model additional anti-angionetic effects of low dose paclitaxel infusion was observed. Methods: Based on our phase I study with T and C (ASCO 2000) we conducted a multi-institutional phase II-trial. Following schedule was used after primary radical surgery: first treatment block (6 cycles, q 7d) - 14 d break - second block (6 cycles, q 7d) - 28 d break- third block (3 cycles, q 7d). T was given in a dose of 100mg/m2, C according AUC 2. No primary use of G-CSF was allowed. Eligibility criteria: AOC (FIGO IIb-IV), ECOG performance status 0–2, normal organ function. Results: Between 02/1999 and 02/2003, 130 patients from 12 institutions were enrolled. The median age was 60 years (23–89). FIGO-stages were: II: 6.2%, III: 72.3%, IV: 21.5%. 1676 cycles were analyzed and in median 15 courses were applied (range 3–18). The incidence of non-hematological toxicities was very low. Alopecia (grade 1–3) was the most common side effect (82%). 29.5% of all pts experienced neurotoxicity grade 2, only 2.3 pts grade 3. Nail changes ≥grade 2 occurred in 3.9%. There were no chemotherapy-related fatalities. Grade 3–4 hematological toxicity (% of all pts) included: thrombocytopenia (2.3%), anemia (12.3%), leucopenia (12.3%), neutropenic fever (0.6%). 78% of all pts with initially elevated CA-125 achieved normalization by the end of therapy. After a median follow-up interval of 24 months (range: 1–62) median progression free survival is 21 months and median overall survival 43 months. Conclusions: These mature results suggest that this weekly schedule represents an efficacious and well-tolerated regimen with a favorable therapeutic index for patients with AOC. (Supported by BristolMyers Squibb Germany and AMGEN) No significant financial relationships to disclose.

BACKGROUND Second-line chemotherapy for patients with ovarian cancer who failed platinum and paclitaxel treatment remains a therapeutic challenge. We investigated the toxicity profile and therapeutic efficacy of a novel combination regimen, topotecan plus gemcitabine, in a clinical phase II study. PATIENTS AND METHODS Women with relapsed epithelial ovarian cancer after platinum and paclitaxel treatment were eligible to participate in this trial. Topotecan was given at an initial dose of 0.5 mg/m(2) daily (days 1-5), combined with gemcitabine 800 mg/m(2) and 600 mg/m(2) on days 1 and 8, respectively. Precluding good tolerability, this protocol facilitated subsequent dose increases of topotecan up to 1.0 mg/m(2). The primary objective was to determine the dose-limiting toxicity, whereas secondary objectives comprised measurable and CA-125 response rates, disease-free and overall survival. RESULTS The twenty-one patients (median age 57 years, range 37-70 years) who were allocated to this trial received a total of 94 courses of chemotherapy. Median follow-up was 20.5 months. Topotecan dosage could be escalated to 0.75 mg/m(2) in nine patients and 1 mg/m(2) in another two patients. Dose reduction was not necessary in any case. There were no episodes of neutropenic fever, sepsis or chemotherapy-related fatalities. Only one patient developed CTC grade 4 leukopenia after the first treatment cycle, whereas three patients showed grade 3/4 anaemia. Five patients experienced thrombocytopenia grade 4 without clinical sequelae. Non-hematological toxicities were mild and rare. Eleven patients could be evaluated for clinical tumour response, with three complete, and four partial remissions. Two patients each had stable and progressive diseases. The median progression-free survival rate was 8.8 months [95% confidence interval (CI) 6.3-13.4 months]. The median overall survival rate was 21.1 months (95% CI 14.8-22.1 months). CONCLUSIONS Topotecan combined with gemcitabine has a favourable toxicity profile and encouraging efficacy in patients with recurrent ovarian cancer.