دورية أكاديمية
Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial.
| العنوان: | Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial. |
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| المؤلفون: | Jones RP; The Royal Liverpool University Hospital, Liverpool, England., Psarelli EE; University of Liverpool, Liverpool, England., Jackson R; University of Liverpool, Liverpool, England., Ghaneh P; The Royal Liverpool University Hospital, Liverpool, England.; University of Liverpool, Liverpool, England., Halloran CM; The Royal Liverpool University Hospital, Liverpool, England.; University of Liverpool, Liverpool, England., Palmer DH; University of Liverpool, Liverpool, England.; The Clatterbridge Cancer Centre, Wirral, England., Campbell F; The Royal Liverpool University Hospital, Liverpool, England., Valle JW; University of Manchester/The Christie, Manchester, England., Faluyi O; The Clatterbridge Cancer Centre, Wirral, England., O'Reilly DA; Manchester University Foundation Trust, Manchester, England., Cunningham D; Royal Marsden Hospital, London, England., Wadsley J; Weston Park Hospital, Sheffield, England., Darby S; Weston Park Hospital, Sheffield, England., Meyer T; Royal Free Hospital, London, England., Gillmore R; Royal Free Hospital, London, England., Anthoney A; St. James's University Hospital, Leeds, England., Lind P; Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden., Glimelius B; Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden., Falk S; Bristol Haematology and Oncology Centre, Bristol, England., Izbicki JR; University of Hamburg Medical Institutions UKE, Hamburg, Germany., Middleton GW; Royal Surrey County Hospital, Guildford, England., Cummins S; Royal Surrey County Hospital, Guildford, England., Ross PJ; Guy's Hospital, London, England., Wasan H; Hammersmith Hospital, London, England., McDonald A; The Beatson West of Scotland Cancer Centre, Glasgow, Scotland., Crosby T; Velindre Hospital, Cardiff, Wales., Ting Y; Queen Elizabeth Hospital, Birmingham, England., Patel K; Churchill Hospital, Oxford, England., Sherriff D; Derriford Hospital, Plymouth, England., Soomal R; Jersey General Hospital, Jersey, England., Borg D; Skåne University Hospital, Lund, Sweden., Sothi S; University Hospital Coventry, Coventry, England., Hammel P; Hôpital Beaujon, Clichy, France., Lerch MM; Greifswald University, Medicine, Greifswald, Germany., Mayerle J; Greifswald University, Medicine, Greifswald, Germany.; University Hospital Munich, Ludwig-Maximilians-University Munich, Germany., Tjaden C; University of Heidelberg, Heidelberg, Germany., Strobel O; University of Heidelberg, Heidelberg, Germany., Hackert T; University of Heidelberg, Heidelberg, Germany., Büchler MW; University of Heidelberg, Heidelberg, Germany., Neoptolemos JP; University of Heidelberg, Heidelberg, Germany. |
| مؤلفون مشاركون: | European Study Group for Pancreatic Cancer |
| المصدر: | JAMA surgery [JAMA Surg] 2019 Nov 01; Vol. 154 (11), pp. 1038-1048. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Medical Association Country of Publication: United States NLM ID: 101589553 Publication Model: Print Cited Medium: Internet ISSN: 2168-6262 (Electronic) Linking ISSN: 21686254 NLM ISO Abbreviation: JAMA Surg Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Chicago, IL : American Medical Association, [2013]- |
| مواضيع طبية MeSH: | Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Carcinoma, Pancreatic Ductal/*surgery , Neoplasm Recurrence, Local/*etiology , Pancreatic Neoplasms/*surgery, Adult ; Aged ; Aged, 80 and over ; Capecitabine/administration & dosage ; Carcinoma, Pancreatic Ductal/drug therapy ; Carcinoma, Pancreatic Ductal/mortality ; Chemotherapy, Adjuvant ; Deoxycytidine/administration & dosage ; Deoxycytidine/analogs & derivatives ; Disease-Free Survival ; Female ; Humans ; Male ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy ; Neoplasm Recurrence, Local/mortality ; Pancreatic Neoplasms/drug therapy ; Pancreatic Neoplasms/mortality ; Prospective Studies ; Treatment Outcome ; Gemcitabine |
| مستخلص: | Importance: The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective: To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants: Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions: Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures: Overall survival, recurrence, and sites of recurrence. Results: Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 and P = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .03). Conclusions and Relevance: There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection. Trial Registration: ClinicalTrials.gov identifier: NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434. |
| التعليقات: | Comment in: JAMA Surg. 2019 Nov 1;154(11):1048. (PMID: 31483455) Comment in: JAMA Surg. 2020 Apr 1;155(4):361-362. (PMID: 31895430) Comment in: JAMA Surg. 2020 Apr 1;155(4):362-363. (PMID: 31895438) Comment in: Int J Radiat Oncol Biol Phys. 2020 Mar 15;106(4):653-662. (PMID: 32092335) |
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| معلومات مُعتمدة: | C245/A8968/A20830 United Kingdom CRUK_ Cancer Research UK; 11883 United Kingdom CRUK_ Cancer Research UK; 16186 United Kingdom CRUK_ Cancer Research UK; 16812 United Kingdom CRUK_ Cancer Research UK; 17680 United Kingdom CRUK_ Cancer Research UK; 08/29/02 United Kingdom DH_ Department of Health; 15957 United Kingdom CRUK_ Cancer Research UK; 8968 United Kingdom CRUK_ Cancer Research UK; 16791 United Kingdom CRUK_ Cancer Research UK |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00058201 EudraCT 2007-004299-38 ISRCTN ISRCTN96397434 |
| المشرفين على المادة: | 0W860991D6 (Deoxycytidine) 6804DJ8Z9U (Capecitabine) 0 (Gemcitabine) |
| تواريخ الأحداث: | Date Created: 20190905 Date Completed: 20200713 Latest Revision: 20240210 |
| رمز التحديث: | 20240210 |
| مُعرف محوري في PubMed: | PMC6727687 |
| DOI: | 10.1001/jamasurg.2019.3337 |
| PMID: | 31483448 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2168-6262 |
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| DOI: | 10.1001/jamasurg.2019.3337 |