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Aim: Male patients with anorectal malformations (ARM) are classified according to presence and level of the recto-urinary fistula. This is traditionally established by a preoperative high-pressure distal colostogram that may be variably interpreted by different surgeons. The aim of this study was to evaluate the inter-and intraobserver variation in the assessment by pediatric surgeons of preoperative colostograms with respect to the level of the recto-urinary fistula. Materials and Methods: Sixteen pediatric surgeons from 14 European centers belonging to the ARM-Net Consortium twice scored 130 images of distal colostograms taken in sagittal projection at a median age of 66 days of life (range: 4-1,106 days). Surgeons were asked to classify the fistula in bulbar, prostatic, bladder-neck, no fistula, and "unclear anatomy" example. Their assessments were compared with the intraoperative findings (kappa) for two scoring rounds with an interval of 6 months (intraobserver variation). Agreement among the surgeons' scores (interobserver variation) was also calculated using Krippendorff's alpha. A kappa over 0.75 is considered excellent, between 0.40 and 0.75 fair to good, and below 0.40 poor. Surgeons were asked to score the images in "poor" and "good" quality and to provide their years of experience in ARM treatment. Midrio et al. Colostograms of Recto-Urinary Fistula Results: Agreement between the image-based rating of surgeons and the intraoperative findings ranges from 0.06 to 0.45 (mean 0.31). Interobserver variation is higher (Krippendorff's alpha between 0.40 and 0.45). Years of experience in ARM treatment does not seem to influence the scoring. The mean intraobserver variation between the two rounds is 0.64. Overall, the quality of the images is considered poor. Images categorized as having a good quality result in a statistically significant higher kappa (mean: 0.36 and 0.37 in the first and second round, respectively) than in the group of bad-quality images (mean: 0.25 and 0.23, respectively). Conclusions: There is poor agreement among experienced pediatric colorectal surgeons on preoperative colostograms. Techniques and analyses of images need to be improved in order to generate a homogeneous series of patients and make comparison of outcomes reliable.

Background: The aim of this study was to analyze the impact of tumor size > 2 cm on oncological outcomes of fertility-sparing surgery (FSS) in early cervical cancer in a Spanish cohort. Methods: A multicenter, retrospective cohort study of early cervical cancer (stage IA1 with lymphovascular space invasion -IB1 (FIGO 2009)) patients with gestational desire who underwent FSS at 12 tertiary departments of gynecology oncology between 01/2005 and 01/2019 throughout Spain. Results: A total of 111 patients were included, 82 (73.9%) with tumors < 2 cm and 29 (26.1%) with tumors 2–4 cm. Patients’ characteristics were balanced except from lymphovascular space invasion. All were intraoperative lymph node-negative. Median follow-up was 55.7 and 30.7 months, respectively. Eleven recurrences were diagnosed (9.9%), five (6.0%) and six (21.4%) (p < 0.05). The 3-year progression-free survival (PFS) was 95.7% (95%CI 87.3–98.6) and 76.9% (95% CI 55.2–89.0) (p = 0.011). Only tumor size (<2 cm vs. 2–4 cm was found to be significant for recurrence. After adjusting for the rest of the variables, tumor size 2–4 cm showed a Hazard Ratio of 5.99 (CI 95% 1.01–35.41, p = 0.036). Conclusions: Tumor size ≥ 2 cm is the most important negative prognostic factor in this multicenter cohort of patients with early cervical cancer and gestational desire who underwent FSS in Spain.

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Background: MammaPrint (MP) is a powerful predictor of disease outcome in early stage breast cancer. In addition, TargetPrint (TP), a quality approved microarray-based test that measures the mRNA expression level of ER, PR and HER2 and an 80 gene expression Molecular Subtyping profile BluePrint (BP) were developed. In the present study, MP, BP and TP were measured in a prospective U.S. breast cancer patient cohort. Methods: MP results were evaluated in fresh tumor samples from 141 breast cancer patients (T1-4N0-2; median age 62 [35-97 yr]) collected by core needle biopsy or from a surgical specimen between July 2008 and February 2011. We compared treatment advice as recommended by NCCN guidelines and classification according to MP. In addition, we compared IHC/FISHER, PR and HER2 assessments with TP. The MP and BP results were used to subtype the patients into molecular subgroups. Results: For the group of patients (n=69) for which NCCN recommends the use of a multi-gene signature for determining chemotherapy treatment recommendations, 50 patients were classified as High Risk and 19 as Low Risk by MP. Comparison of TP with IHC/FISH indicated a concordance of 98% for ER, 91% for PR, and 94% for HER2. For a subgroup of 63 patients combined MP and BP results were available; 22 patients were Luminal-type/MP Low Risk, 31 patients were Luminal-type/MP High risk, 1 patient was Her2-type/MP Low Risk, 2 patients were Her2-type/MP High Risk and 7 patients were Basal-type/MP High Risk. Conclusion:The multi-gene signature MammaPrint, as well as BluePrint and TargetPrint provides additional information for treatment guidance. By combining MammaPrint with the BluePrint molecular subtyping profile, specific groups of patients can be recognized that are at high risk of recurrence and that would possibly benefit from specific treatment. This study shows that TargetPrint provides high quality second opinion for local IHC/FISH assessment. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-04-06.