Effective consolidative chemoradiation (CRT) regimens are lacking. In this phase 1 trial, we evaluated the safety and efficacy of nab-paclitaxel, capecitabine, and radiation therapy after induction chemotherapy in patients with locally advanced and borderline-resectable pancreatic cancer (LAPC and BRPC). Also, we evaluated a computed tomography (CT)-based biomarker of response.Eligible patients had pathologically confirmed pancreatic ductal adenocarcinoma, underwent computed tomography-imaging, received a diagnosis of LAPC or BRPC, and received induction chemotherapy. Standard 3 + 3 study design was used, with 3 escalating nab-paclitaxel dose levels (50, 75, and 100 mg/m2) with concurrent capecitabine and RT in cohort sizes of 3 starting at the lowest dose. Dose limiting toxicity was defined as grade 3 or higher toxicity. Patients were restaged 4 to 6 weeks post-CRT completion, and surgical resection was offered to those with stable/responsive disease. We scored the tumor interface response (IR) postchemotherapy and post-CRT into type I (remained/became more defined) and type II (became less defined). Overall survival (OS) and progression-free survival (PFS) from time of CRT were estimated using Kaplan-Meier method. P ≤ .05 was considered significant.Twenty-three patients started and finished on protocol (LAPC = 14, BRPC = 9). No grade 3 and 4 toxicities were reported in level 1 (n = 3) or level 2 (n = 3) initial groups. Two patients in the initial level 3 group developed dose limiting toxicity, establishing level 2 dose as the maximal tolerated dose. Level 2 group was expanded for additional 15 patients (for a total of 23 on trial), 5 of whom developed grade 3 toxicities. Seven patients underwent surgical resection. Median OS and PFS were 21.2 and 8.1 months, respectively. Type I IR was associated with better OS (P = .004) and PFS (P = .03) compared with type II IR.We established the maximum tolerated dose for nab-paclitaxel in a consolidative CRT regimen for pancreatic ductal adenocarcinoma. Preliminary efficacy results warrant phase 2 trial evaluation. IR may be used for personalized treatment. 

Nab-Paclitaxel, Capecitabine, and Radiation Therapy Following Induction Chemotherapy in Treating Patients with Locally Advanced and Borderline Resectable Pancreatic Cancer: Phase I Trial and Imaging-based Biomarker Validation.

Pancreatic ductal adenocarcinoma (PDAC) is one of the most lethal human cancers. Innovative treatment concepts may enhance oncological outcome. Clinically relevant tumor models are essential in developing new therapeutic strategies. In the present study, we used two human PDAC cell lines for an orthotopic xenograft mouse model and compared treatment characteristics between this in vivo tumor model and PDAC patients. Tumor-bearing mice received stereotactic high-precision irradiation using arc technique after 3D-treatment planning. Induction of DNA damage in tumors and organs at risk (OARs) was histopathologically analyzed by the DNA damage marker γH2AX and compared with results after unprecise whole-abdomen irradiation. Our mouse model and preclinical setup reflect the characteristics of PDAC patients and clinical RT. It was feasible to perform stereotactic high-precision RT after defining tumor and OARs by CT imaging. After stereotactic RT, a high rate of DNA damage was mainly observed in the tumor but not in OARs. The calculated dose distributions and the extent of the irradiation field correlate with histopathological staining and the clinical example. We established and validated 3D-planned stereotactic RT in an orthotopic PDAC mouse model, which reflects the human RT. The efficacy of the whole workflow of imaging, treatment planning, and high-precision RT was proven by longitudinal analysis showing a significant improved survival. Importantly, this model can be used to analyze tumor regression and therapy-related toxicity in one model and will allow drawing clinically relevant conclusions.

Histopathological Tumor and Normal Tissue Responses after 3D-Planned Arc Radiotherapy in an Orthotopic Xenograft Mouse Model of Human Pancreatic Cancer

ASO Author Reflections: Accelerating the Learning Curve of Robotic Pancreatectomy and Gastrectomy Through a Composite Robotic Foregut Surgical Oncology Program.

Minimalinvasive Resektionstechniken zur Behandlung verschiedener Pathologien des Pankreas sind potenziell vorteilhaft für die behandelten Patienten in Bezug auf Rekonvaleszenzzeit und
 postoperative Morbidität, stellen jedoch eine besondere technische Herausforderung für den behandelnden Chirurgen dar. Der Einzug der robotischen Technik in die Viszeralchirurgie bietet eine
 prinzipielle Möglichkeit zur weitreichenden Verbreitung minimalinvasiver Verfahren in der Pankreaschirurgie.Ziel dieser Arbeit war es, die Entwicklungsmöglichkeiten der robotischen Pankreaschirurgie in Deutschland zu überprüfen. Datengrundlage sind die Qualitätsberichte der Krankenhäuser der
 Jahre 2015–2019 kombiniert mit einer selektiven Literaturrecherche.Die Anzahl der vorliegenden Qualitätsberichte reduzierte sich von 2015 bis 2019 von 1635 auf 1594. Im Median führten 96 Kliniken 11–20, 56 Kliniken 21–50 und 15 Kliniken mehr als 50
 Pankreaskopfresektionen jährlich durch. Bei den Linksresektionen waren es 35 Kliniken mit 11–20, 14 Kliniken mit 21–50 und 2 Kliniken mit mehr als 50 Eingriffen. Unter Berücksichtigung aller
 Kliniken, die 5 oder mehr Linksresektionen pro Jahr durchführen, wurden an nur 29 Kliniken minimalinvasive Verfahren eingesetzt. Der Anteil an laparoskopischen Linksresektionen über 50%
 wurde an nur 7 Kliniken beschrieben.Nach Datenlage in der Literatur divergieren die Lernkurven für die robotische Pankreaslinks- und Pankreaskopfresektion. Während die Lernkurve für die robotische Pankreaslinksresektion nach
 etwa 20 Eingriffen durchlaufen ist, hat die Lernkurve für die robotische Pankreaskopfresektion mehrere Plateaus, die etwa nach 30, 100 und 250 Eingriffen erreicht werden.Aufgrund der dezentralen Struktur der Pankreaschirurgie in Deutschland scheint ein flächendeckendes Angebot robotischer Verfahren aktuell in weiter Ferne. Insbesondere die Etablierung der
 robotischen Pankreaskopfresektion wird zunächst Zentren mit entsprechend hoher Fallzahl vorbehalten bleiben.

Robotische Pankreaschirurgie – Lernkurve und Etablierung

Minimally invasive resection techniques for the treatment of various pathologies of the pancreas are potentially advantageous for the treated patients in terms of restitution time and postoperative morbidity, but are a technical challenge for the responsible surgeon. The introduction of robotic assistance in visceral surgery offers a possibility for further distribution of minimally invasive procedures in pancreatic surgery.The aim of this study was to examine the possibilities for developing robotic pancreatic surgery in Germany. The data are based on the quality reports of the hospitals for the years 2015-2019 combined with a selective literature search.The number of quality reports available decreased from 1635 to 1594 between 2015 and 2019. A median of 96 clinics performed 11-20, 56 clinics 21-50 and 15 clinics more than 50 pancreaticoduodenectomies. For distal resections, there were 35 clinics with 11-20, 14 clinics with 21-50 and two clinics with more than 50 procedures. In relation to all clinics with at least five distal resections per year, minimally invasive procedures were performed at only 29 clinics; a ratio to laparoscopic left resections of over 50% was reported in only seven clinics.According to the literature, the learning curves for robotic pancreatic distal resection and pancreaticoduodenectomy diverge. While the learning curve for robotic distal resection is completed after around 20 procedures, the learning curve for robotic pancreaticoduodenectomy has several plateaus, which are reached after around 30, 100 and 250 procedures.Due to the decentralised structure of pancreatic surgery in Germany, a nationwide introduction of robotic pancreatic surgery is unlikely. The routine use of robotic pancreaticoduodenectomy will probably be restricted to high volume centres in the foreseeable future.

[Robotic Pancreatic Surgery - Learning Curve and Implementation].

Over the past few decades, robotic surgery techniques required to resect gastric and pancreatic malignancies have evolved remarkably; however, the safety and generalizability of robotic pancreatoduodenectomy remain unknown. At our cancer center, gastrectomies and pancreatectomies are performed in a combined foregut minimally-invasive surgery program; this effectively increases the composite case volume and shortens the learning curve for any individual surgeon. In this video, we demonstrate the shared steps in pancreatoduodenectomy and gastrectomy and explain how the skills gained through robotic gastrectomy can be used during robotic pancreatoduodenectomy. During the initial 2-year period of our robotic foregut surgery program, we performed 120 pancreatic and gastric operations, including 22 pancreatoduodenectomies and 37 gastrectomies. Our first robotic pancreatoduodenectomy was performed following successful completion of 45 other robotic foregut operations. Of those 22 patients who underwent robotic pancreatoduodenectomy, the median hospital stay was 4 days (range 3-17 days) and the readmission rate was 14% (3/22). The rate of grade B/C pancreatic fistula was 9% (2/22) and there was no 90-day mortality. In conclusion, the presented video showing the shared steps in robotic pancreatoduodenectomy and gastrectomy demonstrates the potential for a combined robotic surgery program to increase composite case volumes and to shorten the learning curve. At our cancer center, implementation of this approach has been helpful in accelerating the development of our new robotic pancreatectomy program, especially in honing the skills necessary to perform robotic pancreatoduodenectomy.

/pdf/early-experience-of-a-robotic-foregut-surgery-program-at-a-2l7421jeve.pdf

Early Experience of a Robotic Foregut Surgery Program at a Cancer Center: Video of Shared Steps in Robotic Pancreatoduodenectomy and Gastrectomy.

Neutrophil-Lymphocyte Ratio and Tumor Interface Response as Predictors of Outcomes for Prospective Cohort of Patients with Pancreatic Ductal Adenocarcinoma

PURPOSE/OBJECTIVE(S) Patients with pancreatic cancer often receive radiation therapy before undergoing surgical resection. We compared the clinical outcomes differences between SBRT and 3D/IMRT after receiving current, modern standard-of-care chemotherapy. MATERIALS/METHODS We retrospectively identified patients with borderline resectable or locally advanced pancreatic cancer treated with neoadjuvant SBRT (median: 36.0Gy/5fx), 3D-CRT (median: 50.4Gy/28fx) or IMRT (median: 50.4Gy/28fx) at one institution 2015-2020. Overall survival (OS) and progression-free survival (PFS) were analyzed using COX regression. RESULTS In total, 111 patients were included. Sixty patients (54.1%) were treated with SBRT, and 51 patients (45.9%) were treated with 3D/IMRT. Patients in the SBRT group were slightly older (median age: 70.0 vs 62.7 in the 3D/IMRT group). Both groups had similar proportions of patients with locally advanced pancreatic cancer (SBRT: 32, 53.3%; 3D/IMRT: 27, 52.9%). All patients were treated with chemotherapy. Patients in the SBRT group underwent slightly more surgical resection when compared to the 3D/IMRT group (36.7% vs 21.6%, respectively, P = 0.08). At a median follow-up of 22 months, a total of 65 patients (58.6%) died: 28 (28/60, 46.7%) in the SBRT group, and 37 (37/51, 72.5%) in the 3D/IMRT group. Median OS was slightly higher in the SBRT group (28.7 months vs 24.2 months in the 3D/IMRT group). On multivariable COX regression, the choice of radiation therapy technique was not associated with differences in OS (aHR = 0.6, 95% CI [0.3-1.1], P = 0.10). Moreover, patients that underwent surgical resection had better OS (aHR = 0.3, P = 0.003). Furthermore, PFS was also similar between patients treated with SBRT and those treated with 3D/IMRT (aHR = 0.8, P = 0.31). CONCLUSION SBRT was associated with similar clinical outcomes when compared to conventional radiation techniques, despite being delivered over a shorter period of time which would spare patients prolonged treatment burden. Future prospective data are still needed to better assess the role of SBRT in patients with pancreatic cancer.

Stereotactic vs. Conventional Radiation Therapy in Patients With Pancreatic Cancer.

Risk-stratified use of perioperative pasireotide does not decrease post-operative pancreatic fistula in high-risk pancreatectomy patients

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Early Experience of a Robotic Foregut Surgery Program at a Cancer Center: Video of Shared Steps in Robotic Pancreatoduodenectomy and Gastrectomy.

Neutrophil-Lymphocyte Ratio and Tumor Interface Response as Predictors of Outcomes for Prospective Cohort of Patients with Pancreatic Ductal Adenocarcinoma

Stereotactic vs. Conventional Radiation Therapy in Patients With Pancreatic Cancer.

Risk-stratified use of perioperative pasireotide does not decrease post-operative pancreatic fistula in high-risk pancreatectomy patients