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      Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial

      1 , 2 , 3 , 3 , 4 , 5 , 6 , 4 , 7 , 8 , 9 , 10 , 11 , 2 , 12 , 9 , 13 , 14 , 15 , 16 , 17 , 18 , 19 ,   20 , 21 , 22 , 22 , 22 , 2 , 1 , for the Dutch Pancreatic Cancer Group
      Journal of Clinical Oncology
      American Society of Clinical Oncology (ASCO)

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          Abstract

          PURPOSE

          Preoperative chemoradiotherapy may improve the radical resection rate for resectable or borderline resectable pancreatic cancer, but the overall benefit is unproven.

          PATIENTS AND METHODS

          In this randomized phase III trial in 16 centers, patients with resectable or borderline resectable pancreatic cancer were randomly assigned to receive preoperative chemoradiotherapy, which consisted of 3 courses of gemcitabine, the second combined with 15 × 2.4 Gy radiotherapy, followed by surgery and 4 courses of adjuvant gemcitabine or to immediate surgery and 6 courses of adjuvant gemcitabine. The primary end point was overall survival by intention to treat.

          RESULTS

          Between April 2013 and July 2017, 246 eligible patients were randomly assigned; 119 were assigned to preoperative chemoradiotherapy and 127 to immediate surgery. Median overall survival by intention to treat was 16.0 months with preoperative chemoradiotherapy and 14.3 months with immediate surgery (hazard ratio, 0.78; 95% CI, 0.58 to 1.05; P = .096). The resection rate was 61% and 72% ( P = .058). The R0 resection rate was 71% (51 of 72) in patients who received preoperative chemoradiotherapy and 40% (37 of 92) in patients assigned to immediate surgery ( P < .001). Preoperative chemoradiotherapy was associated with significantly better disease-free survival and locoregional failure-free interval as well as with significantly lower rates of pathologic lymph nodes, perineural invasion, and venous invasion. Survival analysis of patients who underwent tumor resection and started adjuvant chemotherapy showed improved survival with preoperative chemoradiotherapy (35.2 v 19.8 months; P = .029). The proportion of patients who suffered serious adverse events was 52% versus 41% ( P = .096).

          CONCLUSION

          Preoperative chemoradiotherapy for resectable or borderline resectable pancreatic cancer did not show a significant overall survival benefit. Although the outcomes of the secondary end points and predefined subgroup analyses suggest an advantage of the neoadjuvant approach, additional evidence is required.

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          Most cited references16

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          Comparison of adjuvant gemcitabine and capecitabine with gemcitabine monotherapy in patients with resected pancreatic cancer (ESPAC-4): a multicentre, open-label, randomised, phase 3 trial.

          The ESPAC-3 trial showed that adjuvant gemcitabine is the standard of care based on similar survival to and less toxicity than adjuvant 5-fluorouracil/folinic acid in patients with resected pancreatic cancer. Other clinical trials have shown better survival and tumour response with gemcitabine and capecitabine than with gemcitabine alone in advanced or metastatic pancreatic cancer. We aimed to determine the efficacy and safety of gemcitabine and capecitabine compared with gemcitabine monotherapy for resected pancreatic cancer.
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            Definition of a standard lymphadenectomy in surgery for pancreatic ductal adenocarcinoma: a consensus statement by the International Study Group on Pancreatic Surgery (ISGPS).

            The lymph node (Ln) status of patients with resectable pancreatic ductal adenocarcinoma is an important predictor of survival. The survival benefit of extended lymphadenectomy during pancreatectomy is, however, disputed, and there is no true definition of the optimal extent of the lymphadenectomy. The aim of this study was to formulate a definition for standard lymphadenectomy during pancreatectomy.
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              Redefining the R1 resection in pancreatic cancer.

              Resection margin (RM) status in pancreatic head adenocarcinoma is assessed histologically, but pathological examination is not standardized. The aim of this study was to assess the influence of standardized pathological examination on the reporting of RM status. A standardized protocol (SP) for pancreaticoduodenectomy specimen examination, involving multicolour margin staining, axial slicing and extensive tissue sampling, was developed. R1 resection was defined as tumour within 1 mm of the RM. A prospective series reported according to this protocol (SP series, n = 54) was compared with a historical matched series in which a non-standardized protocol was used (NSP series, n = 48). Implementation of the SP resulted in a higher R1 rate overall, and for pancreatic (22 of 26 85 per cent) compared with ampullary (four of 15) and bile duct (six of 13) cancer. Sampling of the circumferential RM was more extensive in the SP series and correlated with RM status. RM involvement was often multifocal (14 of 32), affecting the posterior RM most frequently (21 of 32). Survival correlated with RM status for the entire SP series (P < 0.001), but not for the NSP series. There was a trend towards better median and actuarial 5-year survival after R0 resection in the SP pancreatic cancer subgroup. Standardized examination influences the reporting of RM status.
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                Author and article information

                Journal
                Journal of Clinical Oncology
                JCO
                American Society of Clinical Oncology (ASCO)
                0732-183X
                1527-7755
                February 27 2020
                : JCO.19.02274
                Affiliations
                [1 ]Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
                [2 ]Department of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
                [3 ]Clinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL), Nijmegen, the Netherlands
                [4 ]Department of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
                [5 ]Department of Surgery, Leiden University Medical Center, Leiden, the Netherlands
                [6 ]Department of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, the Netherlands
                [7 ]Department of Medical Oncology, Catharina Hospital, Eindhoven, the Netherlands
                [8 ]Department of Surgery, Division of Hepato-Pancreato-Biliary & Oncology, European Surgery Center Aachen Maastricht, Maastricht UMC+, Maastricht, the Netherlands
                [9 ]Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
                [10 ]Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
                [11 ]Department of Medical Oncology, Isala Oncology Centre, Zwolle, the Netherlands
                [12 ]Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands
                [13 ]Department of Gastroenterology and Hepatology, Cancer Centre Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
                [14 ]Department of Medical Oncology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands
                [15 ]Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands
                [16 ]Department of Radiation Oncology, Leiden University Medical Center, Leiden, the Netherlands
                [17 ]Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands
                [18 ]Department of Radiation Oncology, Isala Oncology Center, Zwolle, the Netherlands
                [19 ]Department of Surgery, Isala Oncology Center, Zwolle, the Netherlands
                [20 ]Department of Radiation Oncology, Catharina Hospital, Eindhoven, the Netherlands
                [21 ]Department of Internal Medicine, Division of Medical Oncology, GROW School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the Netherlands
                [22 ]Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands
                Article
                10.1200/JCO.19.02274
                32105518
                eafe8602-8edc-4bed-8c96-d0b25a30f1a4
                © 2020
                History

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