for the German Rectal Cancer Study Group IMPORTANCE Total neoadjuvant therapy has been increasingly adopted for multimodal rectal cancer treatment. The optimal sequence of chemoradiotherapy (CRT) and chemotherapy needs to be established. OBJECTIVE To report the long-term results of the secondary end points prespecified in the Randomized Phase 2 Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy (CAO/ARO/AIO-12 trial) for Locally Advanced Rectal Cancer. DESIGN, SETTING, AND PARTICIPANTS This secondary analysis of a randomized clinical trial included 311 patients who were recruited from the accrued CAO/ARO/AIO-12 trial population
Quantifying cancer and high grade cancer by systematic biopsy and serum PSA concentration are useful preoperative characteristics for predicting organ confined prostate cancer. Side specific analysis of these parameters is a flexible and reliable tool for selecting patients for nerve sparing radical prostatectomy.
Abbreviations & Acronyms AUC = area under the curve CT = computed tomography EAU = European Association of Urology ePLND = extended pelvic lymph node dissection GS = Gleason sum LN = lymph node LNI = lymph node involvement MRI = magnetic resonance imaging PCa = prostate cancer PET = positron emission tomography PLND = pelvic lymph node dissection PSA = prostate-specific antigen SLN = sentinel lymph node sPLND = sentinel-guided pelvic lymph node dissection Objectives: To stratify the rate and prediction of lymph node involvement in prostate cancer patients undergoing sentinel-lymphadenectomy depending on preoperative tumor characteristics, and to compare the outcome with the European Association of Urology Guideline indication for lymphadenectomy. Methods: A total of 1229 patients (median age 66 years) were treated with open sentinel-lymphadenectomy and prostatectomy between 2005 and 2009. Median preoperative prostate-specific antigen was 7.4 ng/mL. The rate of lymph node involvement was analyzed for D'Amico risk groups. Multivariable logistic regression was used to estimate the probability of lymph node involvement. Predictor variables included preoperative prostatespecific antigen, clinical T-category and biopsy Gleason sum. Predictive accuracy has been quantified (area under the curve) and lymph node positive patients were verified under consideration of the recommended European threshold for lymphadenectomy (nomogrampredicted lymph node invasion risk of >7%). Results: The median number of lymph nodes removed was 10 (interquartile range 7-13). Overall, 17.1% of patients had lymph node involvement; 3.2% in low-, 14.8% in intermediate-and 37.4% in high-risk disease. The predicted risk for lymph node involvement ranged from 2% (prostate-specific antigen ≤4 ng/mL, T1, Gleason sum ≤6) to 87% (prostatespecific antigen >20 ng/mL, T3, Gleason sum ≥8). The predictive accuracy was 82.1%. According to the European guidelines, 15.9% of all lymph node involved cases would not have been detected.
Conclusions:The rate of lymph node involvement seems to be higher in the examined sentinel collective than expected according to the European Guideline nomogram. The first sentinel-based lymph node involvement prediction model can assist in deciding on the indication for sentinel-lymphadenectomy. The validation of a corresponding sentinel-based nomogram is still missing.
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