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  1. Article ; Online: Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial.

    Versteijne, Eva / van Dam, Jacob L / Suker, Mustafa / Janssen, Quisette P / Groothuis, Karin / Akkermans-Vogelaar, Janine M / Besselink, Marc G / Bonsing, Bert A / Buijsen, Jeroen / Busch, Olivier R / Creemers, Geert-Jan M / van Dam, Ronald M / Eskens, Ferry A L M / Festen, Sebastiaan / de Groot, Jan Willem B / Groot Koerkamp, Bas / de Hingh, Ignace H / Homs, Marjolein Y V / van Hooft, Jeanin E /
    Kerver, Emile D / Luelmo, Saskia A C / Neelis, Karen J / Nuyttens, Joost / Paardekooper, Gabriel M R M / Patijn, Gijs A / van der Sangen, Maurice J C / de Vos-Geelen, Judith / Wilmink, Johanna W / Zwinderman, Aeilko H / Punt, Cornelis J / van Tienhoven, Geertjan / van Eijck, Casper H J

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2022  Volume 40, Issue 11, Page(s) 1220–1230

    Abstract: Purpose: The benefit of neoadjuvant chemoradiotherapy in resectable and borderline resectable pancreatic cancer remains controversial. Initial results of the PREOPANC trial failed to demonstrate a statistically significant overall survival (OS) benefit. ...

    Abstract Purpose: The benefit of neoadjuvant chemoradiotherapy in resectable and borderline resectable pancreatic cancer remains controversial. Initial results of the PREOPANC trial failed to demonstrate a statistically significant overall survival (OS) benefit. The long-term results are reported.
    Methods: In this multicenter, phase III trial, patients with resectable and borderline resectable pancreatic cancer were randomly assigned (1:1) to neoadjuvant chemoradiotherapy or upfront surgery in 16 Dutch centers. Neoadjuvant chemoradiotherapy consisted of three cycles of gemcitabine combined with 36 Gy radiotherapy in 15 fractions during the second cycle. After restaging, patients underwent surgery followed by four cycles of adjuvant gemcitabine. Patients in the upfront surgery group underwent surgery followed by six cycles of adjuvant gemcitabine. The primary outcome was OS by intention-to-treat. No safety data were collected beyond the initial report of the trial.
    Results: Between April 24, 2013, and July 25, 2017, 246 eligible patients were randomly assigned to neoadjuvant chemoradiotherapy (n = 119) and upfront surgery (n = 127). At a median follow-up of 59 months, the OS was better in the neoadjuvant chemoradiotherapy group than in the upfront surgery group (hazard ratio, 0.73; 95% CI, 0.56 to 0.96;
    Conclusion: Neoadjuvant gemcitabine-based chemoradiotherapy followed by surgery and adjuvant gemcitabine improves OS compared with upfront surgery and adjuvant gemcitabine in resectable and borderline resectable pancreatic cancer.
    MeSH term(s) Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Chemoradiotherapy/methods ; Humans ; Neoadjuvant Therapy ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/surgery ; Survival Rate ; Pancreatic Neoplasms
    Language English
    Publishing date 2022-01-27
    Publishing country United States
    Document type Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.21.02233
    Database MEDical Literature Analysis and Retrieval System OnLINE

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

    Versteijne, Eva / Suker, Mustafa / Groothuis, Karin / Akkermans-Vogelaar, Janine M / Besselink, Marc G / Bonsing, Bert A / Buijsen, Jeroen / Busch, Olivier R / Creemers, Geert-Jan M / van Dam, Ronald M / Eskens, Ferry A L M / Festen, Sebastiaan / de Groot, Jan Willem B / Groot Koerkamp, Bas / de Hingh, Ignace H / Homs, Marjolein Y V / van Hooft, Jeanin E / Kerver, Emile D / Luelmo, Saskia A C /
    Neelis, Karen J / Nuyttens, Joost / Paardekooper, Gabriel M R M / Patijn, Gijs A / van der Sangen, Maurice J C / de Vos-Geelen, Judith / Wilmink, Johanna W / Zwinderman, Aeilko H / Punt, Cornelis J / van Eijck, Casper H / van Tienhoven, Geertjan

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2020  Volume 38, Issue 16, Page(s) 1763–1773

    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, ... ...

    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;
    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.
    MeSH term(s) Aged ; Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/adverse effects ; Carcinoma, Pancreatic Ductal/mortality ; Carcinoma, Pancreatic Ductal/pathology ; Carcinoma, Pancreatic Ductal/therapy ; Chemoradiotherapy, Adjuvant/adverse effects ; Chemoradiotherapy, Adjuvant/mortality ; Deoxycytidine/administration & dosage ; Deoxycytidine/adverse effects ; Deoxycytidine/analogs & derivatives ; Disease Progression ; Disease-Free Survival ; Dose Fractionation, Radiation ; Female ; Humans ; Male ; Middle Aged ; Neoadjuvant Therapy/adverse effects ; Neoadjuvant Therapy/mortality ; Neoplasm Recurrence, Local ; Netherlands ; Pancreatectomy/adverse effects ; Pancreatectomy/mortality ; Pancreatic Neoplasms/mortality ; Pancreatic Neoplasms/pathology ; Pancreatic Neoplasms/therapy ; Pancreaticoduodenectomy/adverse effects ; Pancreaticoduodenectomy/mortality ; Time Factors ; Gemcitabine
    Chemical Substances Antimetabolites, Antineoplastic ; Deoxycytidine (0W860991D6) ; Gemcitabine
    Language English
    Publishing date 2020-02-27
    Publishing country United States
    Document type Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.19.02274
    Database MEDical Literature Analysis and Retrieval System OnLINE

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