Background:We aimed to identify molecular epidermal growth factor receptor (EGFR) tissue biomarkers in pancreatic cancer (PC) patients treated with the anti-EGFR agent erlotinib within the phase 3 randomised AIO-PK0104 study.Methods:AIO-PK0104 was a multicenter trial comparing gemcitabine/erlotinib followed by capecitabine with capecitabine/erlotinib followed by gemcitabine in advanced PC; primary study end point was the time-to-treatment failure after first- and second-line therapy (TTF2). Translational analyses were performed for KRAS exon 2 mutations, EGFR expression, PTEN expression, the EGFR intron 1 and exon 13 R497K polymorphism (PM). Biomarker data were correlated with TTF, overall survival (OS) and skin rash.Results:Archival tumour tissue was available from 208 (74%) of the randomised patients. The KRAS mutations were found in 70% (121 out of 173) of patients and exclusively occurred in codon 12. The EGFR overexpression was detected in 89 out of 181 patients (49%) by immunohistochemistry (IHC), and 77 out of 166 patients (46%) had an EGFR gene amplification by fluorescence in-situ hybridisation (FISH); 30 out of 171 patients (18%) had a loss of PTEN expression, which was associated with an inferior TTF1 (first-line therapy; HR 0.61, P=0.02) and TTF2 (HR 0.66, P=0.04). The KRAS wild-type status was associated with improved OS (HR 1.68, P=0.005); no significant OS correlation was found for EGFR–IHC (HR 0.96), EGFR–FISH (HR 1.22), PTEN–IHC (HR 0.77), intron 1 (HR 0.91) or exon 13 R497K PM (HR 0.83). None of the six biomarkers correlated with the occurrence of skin rash.Conclusion:The KRAS wild-type was associated with an improved OS in erlotinib-treated PC patients in this phase 3 study; it remains to be defined whether this association is prognostic or predictive.

This post hoc analysis of AIO-PK0104 supports the assumption that KRAS is rather a prognostic than a predictive biomarker in PC.

Main aim of this study is to assess the effect of a structured, interdisciplinary, surgical, team-training protocol in robotic gynecologic surgery, with the gradual integration of an advanced nurse practitioner. Data from all robotic surgical procedures were prospectively acquired. The surgical team consisted of one experienced surgeon and two surgical fellows and the scrub nurse team from three advance nurse practitioners, specialized in robotic surgery. The training was performed in a four-phase manner over 4 years and included theoretical training, hands-on training and team-communication skills enhancement. Scrub nurses increasingly adopted an active role during surgery. For a period of 4 years, 175 patients could be included in the analysis. All of them underwent a robotic gynecologic procedure. Mean docking time decreased from 45.3 to 27.3 min (p < 0.001), mean operating time from 235 to 179 min (p = 0.0071) and costs per case from 17,891 to 14,731 Swiss Francs (p = 0.035). There were no statistically significant changes in perioperative complications and conversions to laparotomy. An interdisciplinary long-term training protocol for high specialized robotic surgery within a “fixed” team with the gradually addition of an advanced study nurse improves the efficacy of the procedure in terms of time and costs. Although the surgery is performed quicker, the same performance and quality of surgical care could be reached.

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