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Preoperative imaging by Computed Tomographic Angiography (CTA) has been promoted a gold standard tool for perforator mapping in abdominally based microsurgical breast reconstruction, while Color Doppler Ultrasound (CDU) has lost its popularity. As the CTA X-ray exposure might have long-term consequences for patients, CDU has regained importance for preoperative workup in our center. Our aim was to revisit the role of CDU by comparing the reliability of CDU and CTA in predicting intraoperative perforator selection. We performed a retrospective chart review study of patients who underwent microsurgical breast reconstructions with DIEP flaps at our institution. Both CTA and CDU were performed prior to the surgery, and both imaging entities were thoroughly examined by the surgical team. Perforator identification, number, size, and location were assessed and correlated with CTA and CDU data and with intraoperative findings. We identified 98 patients who received 125 DIEP flap surgeries. A significantly stronger correlation was found between CDU and intraoperative findings of perforator detection and size (p <0.0001) and selection (r = 0.9987, CI 0.9981–0.9991, p < 0.0001 and r = 0.01, CI -0.18–0.2, p = 0.91, respectively), when compared with CTA data. If none of the preoperative imaging studies matched intraoperative perforator selection, an association with a higher incidence of flap loss (Odds ratio 4.483, CI 0.5068–39.65, p = 0.2171) was found. Our data suggests that CDU might regain relevance as a safe and reliable preoperative imaging study, without the risk and potential consequences of X-ray exposure. Preoperative imaging tools like CDU and CTA should be considered part of the gold standard in abdominally based free flap breast reconstruction. [ABSTRACT FROM AUTHOR]

Abstract: Adjuvant clinical trials (CTs) usually compare a standard treatment regime versus an innovative new substance or regimen. Participation in CT however, is available for only few patients and exclusion criteria are usually very strict. Therefore we used an unselected patient cohort to investigate the following questions: [(1)] Is participation in adjuvant CT associated with improved survival in breast cancer (BC)? [(2)] What is the impact of guideline conform therapy on survival in BC compared to that of participants in CT? Does guideline-conform adjuvant treatment provide an equal impact? Material and methods: This German retrospective multi-centre cohort study included 9433 patients with primary breast cancer recruited from 1992 to 2008. Results: One thousand two hundred and fifty-five (13.3%) patients participated in adjuvant clinical trials (PA) and 8178 (86.7%) did not (NPA). RFS was higher among participants (PA) than among non-participants (NPA) [p =0.006], but differences in overall survival (OAS) were not significant [p =0.15]. When stratified for guideline adherence, the outcome was not different for guideline conform NPA [RFS: p =0.88] [OAS: p =0.37] compared to PA. Survival parameters however, were significantly poorer in non-guideline conform PA [RFS: p <0.001] [OAS: p <0.001] and non-guideline conform NPA [RFS: p <0.001] [OAS: p <0.001] as compared to guideline adherent PA. Discussion: There is a strong association between guideline adherence in adjuvant treatment in BC and survival. PA in clinical trials tended to higher survival rates, but only if guideline-adherent treatment was applied. Patients who do not have access to clinical trials may profit substantially from guideline-adherent adjuvant treatment. [Copyright &y& Elsevier]

Background: Randomized, phase III trial to evaluate safety and efficacy of topotecan and carboplatin (TC) compared with standard platinum-based combinations in platinum-sensitive recurrent ovarian cancer (ROC). Patients and methods: Patients were randomly assigned in a 1:1 ratio to the experimental TC arm (topotecan 0.75 mg/m²/days 1-3 and carboplatin AUC 5 on day 3 every 3 weeks) or to one of the standard regimes [(PC) paclitaxel plus carboplatin; (GC) gemcitabine plus carboplatin; (PLDC) pegylated liposomal doxorubicin and carboplatin] which could be chosen by individual preference but before randomization. The primary end point was progression-free survival (PFS) after 12 months. Overall survival (OS), response rate, toxicity, quality of life and treatment preference regarding standard treatment were defined as secondary end points. Results: A total of 550 patients were recruited. The PFS rate after 12 months was 37.0% for TC compared with 40.2% in the standard combinations (P = 0.470). The overall response rate was 73.1% for TC versus 75.1% for standard combinations (P = 0.149). After a median follow-up of 20 months, the median PFS was 10 months [95% confidence interval (CI) 9.4-10.6] and did not differ between both arms (P = 0.414). The median OS was 25 months in the TC arm versus 31 months in the standard arm (95% CI: 22.4-27.6 resp. 26.0-36.0; P = 0.163). Severe hematologic toxicities (grade 3/4) were rare in the experimental arm (P < 0.001), with 17.4% leucopenia, 27.8% neutropenia and 15.9% thrombopenia. Conclusion: The combination of carboplatin and topotecan was well tolerated with significant lower rates of severe hematological toxicities but did not improve PFS or OS in platinum-sensitive relapsed ovarian cancer compared with established standard regimens. [ABSTRACT FROM AUTHOR]

Background Recurrent platinum-resistant ovarian cancer usually has a poor outcome with conventional chemotherapeutic therapy and new treatment modalities are warranted. This phase II study was conducted to evaluate sunitinib, an oral antiangiogenic multitargeted tyrosin kinase inhibitor, in this setting. Material and methods The primary end point of this randomized phase II trial was the objective response rate according to RECIST criteria and/or Gynecologic Cancer InterGroup CA125 response criteria to sunitinib in patients with recurrent platinum-resistant ovarian cancer who were pretreated with up to three chemotherapies. A selection design was employed to compare two schedules of sunitinib (arm 1: 50 mg sunitinib daily orally for 28 days followed by 14 days off drug; and arm 2: 37.5 mg sunitinib administered daily continuously). Results Of 73 patients enrolled, 36 patients were randomly allocated to the noncontinuous treatment arm (arm 1) and 37 patients were randomly allocated to the continuous treatment arm (arm 2). The mean age was 58.8 and 58.5 years, respectively. We observed six responders (complete response + partial response) in arm 1 (16.7%) and 2 responders in arm 2 (5.4%). The median progression-free survival (arm 1: 4.8 [2.9–8.1] months; arm 2: 2.9 [2.9–5.1] months) and the median overall survival (arm 1: 13.6 [7.0–23.2] months; arm 2: 13.7 [8.4–25.6] months) revealed no significant difference. Adverse events included fatigue as well as cardiovascular, gastrointestinal and abdominal symptoms, hematologic and hepatic laboratory abnormalities. Pattern and frequency of adverse events revealed no substantial differences between both treatment groups. Conclusions Sunitinib treatment is feasible and moderately active in relapsed platinum-resistant ovarian cancer. The noncontinuous treatment schedule should be chosen for further studies in ovarian cancer. [ABSTRACT FROM PUBLISHER]

Background: The objective of this study was to compare the effect of dose-intensified neoadjuvant chemotherapy with that of standard epirubicin plus cyclophosphamide followed by paclitaxel in combination with or without darbepoetin on survival in primary breast cancer.Patients and methods: A total of 733 patients received either four cycles of neoadjuvant epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks followed by four cycles of paclitaxel 175 mg/m2 every 3 weeks (EC→T), or three cycles of epirubicin 150 mg/m2 every 2 weeks followed by three cycles of paclitaxel 225 mg/m2 every 2 weeks followed by three cycles of combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (Edd→Tdd→CMF). The patients were randomly assigned to receive darbepoetin or none. The primary objective was to demonstrate a superior disease-free survival (DFS) of Edd→Tdd→CMF compared with EC→T.Results: Estimated 3-year DFS was 75.8% with EC→T versus 78.8% with Edd→Tdd→CMF [hazard ratio (HR) 1.14; P = 0.37] and overall survival (OS) 88.4% versus 91.5% (HR 1.26; P = 0.237). Three-year DFS was 74.3% with darbepoetin versus 80.0% without (HR 1.31; P = 0.061) and OS 88.0% versus 91.8% (HR 1.33; P = 0.139). Patients with a pathologically documented complete response [pathological complete response (pCR)] had a significantly better DFS compared with those without achieving a pCR (estimated 3-year DFS: 89.2% versus 74.9%; HR 2.27; P = 0.001).Conclusion: Neoadjuvant dose-intensified chemotherapy compared with standard chemotherapy did not improve DFS, whereas the addition of darbepoetin might have detrimental effects on DFS. [ABSTRACT FROM AUTHOR]

Background: Preoperative chemotherapy is a recommended treatment of both primary operable and locally advanced breast cancer. Strategies to improve efficacy include the use of anthracyclines, taxanes, and intensified dose with bone marrow support.Patients and methods: Patients received neoadjuvant epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 followed by paclitaxel 175 mg/m2 (EC→T), each 3-weekly for four cycles (n = 370), or epirubicin 150 mg/m2 followed by paclitaxel 225 mg/m2 with pegfilgrastim followed by CMF (cyclophosphamide 500 mg/m2, methotrexate 40 mg/m2, fluorouracil 600 mg/m2) on days 1 and 8 (Edd→Tdd→CMF), each 2-weekly and for three cycles (n = 363). Patients were randomly allocated to either simultaneous darbepoetin alfa (DA) (n = 356) or none (n = 377).Results: Pathological complete response (pCR) rate (breast) was higher with Edd→Tdd→CMF, 18.7% versus 13.2% with EC→T; P = 0.043, ypT0/Tis; ypN0 was reported in 20.9% versus 14.3% respectively; P = 0.019. Patients with grade 3 tumors and negative hormone receptor status had a significantly higher pCR rate. Mean hemoglobin values maintained higher with DA (13.6 versus 12.6 g/dl). Edd→Tdd→CMF regimen showed more grade 3–4 mucositis, sensory neuropathy, and neurological complaints. Thromboembolic events were more frequent on DA (3% versus 6%; P = 0.055).Conclusion: Dose-dense and -intensified neoadjuvant chemotherapy with Edd→Tdd→CMF was potentially superior to EC→T in terms of pCR. Primary use of DA did not affect pCR. [ABSTRACT FROM AUTHOR]

Background: Standard treatment of patients with breast cancer decreases with age and older persons are mostly excluded from clinical trials. We hypothesized that non-adherence to treatment guidelines occurs for women aged ≥70 years and changes overall survival (OAS) and disease-free survival (DFS). [ABSTRACT FROM PUBLISHER]