Adjuvant and neoadjuvant therapies in resectable pancreatic cancer: a systematic review of randomized controlled trials

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• 作者：Francesco A. D'Angelo ; Laura Antolino ; Mara La Rocca…
• 关键词：Resectable pancreatic cancer ; Neoadjuvant therapy ; Adjuvant therapy ; Systematic review ; Pancreas surgery ; Ductal pancreatic adenocarcinoma
• 刊名：Medical Oncology
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：33
• 期：3
• 全文大小：494 KB
• 参考文献：1.Surveillance Research Program, NCI. SEER Stat Fact Sheets: Pancreas Cancer. 2015. http://​seer.​cancer.​gov/​statfacts/​html/​pancreas.​html .
  2.Evans DB, Ritch PS, Erickson BA. Neoadjuvant therapy for localized pancreatic cancer. Ann Surg. 2015;261(1):18–20.CrossRef PubMed
  3.Kleeff J, Michalski CW, Friess H, Büchler MW. Surgical treatment of pancreatic cancer: the role of adjuvant and multimodal therapies. Eur J Surg Oncol. 2007;33(7):817–23.CrossRef PubMed
  4.WMA Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects. http://​www.​wma.​net/​en/​30publications/​10policies/​b3/​ . Last Accessed 31 Mar 2015.
  5.Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. PLoS Med. 2009; 6(7):e1000100. doi:10.​1371/​journal.​pmed.​1000100 .
  6.Higgins JPT, Altma DG. Chapter 8: assessing risk of bias in included studies [updated February 2008]. In: Higgins JPT, Green S, editors. Cochrane handbook for systematic reviews of interventions version 5.0.0, The Cochrane Collaboration. 2008. http://​www.​cochrane-handbook.​org/​ . Accessed 26 May 2009.
  7.Kalser MH, Ellenberg SS. Pancreatic cancer. Adjuvant combined radiation and chemotherapy following curative resection. Arch Surg. 1985;120(8):899–903.CrossRef PubMed
  8.Neoptolemos JP, Stocken DD, Friess H, European Study Group for Pancreatic Cancer, et al. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004;350(12):1200–10.CrossRef PubMed
  9.Kosuge T, Kiuchi T, Mukai K, Kakizoe K, Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer (JSAP). A multicenter randomized controlled trial to evaluate the effect of adjuvant cisplatin and 5-fluorouracil therapy after curative resection in cases of pancreatic cancer. Jpn J Clin Oncol. 2006;36(3):159–65.CrossRef PubMed
  10.Palmer DH, Stocken DD, Hewitt H, et al. A randomized phase 2 trial of neoadjuvant chemotherapy in resectable pancreatic cancer: gemcitabine alone versus gemcitabine combined with cisplatin. Ann Surg Oncol. 2007;14(7):2088–96.CrossRef PubMed
  11.Yoshitomi H, Togawa A, Kimura F, Pancreatic Cancer Chemotherapy Program of the Chiba University Department of General Surgery Affiliated Hospital Group, et al. A randomized phase II trial of adjuvant chemotherapy with uracil/tegafur and gemcitabine versus gemcitabine alone in patients with resected pancreatic cancer. Cancer. 2008;113(9):2448–56.CrossRef PubMed
  12.Ueno H, Kosuge T, Matsuyama Y, et al. A randomised phase III trial comparing gemcitabine with surgery-only in patients with resected pancreatic cancer: Japanese Study Group of Adjuvant Therapy for Pancreatic Cancer. Br J Cancer. 2009;101(6):908–15.PubMedCentral CrossRef PubMed
  13.Landry J, Catalano PJ, Staley C, et al. Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma. J Surg Oncol. 2010;101(7):587–92.PubMedCentral CrossRef PubMed
  14.Neoptolemos JP, Stocken DD, Bassi C, European Study Group for Pancreatic Cancer, et al. Adjuvant chemotherapy with fluorouracil plus folinic acid vs gemcitabine following pancreatic cancer resection: a randomized controlled trial. JAMA. 2010;304(10):1073–81.CrossRef PubMed
  15.Van Laethem JL, Hammel P, Mornex F, et al. Adjuvant gemcitabine alone versus gemcitabine-based chemoradiotherapy after curative resection for pancreatic cancer: a randomized EORTC-40013-22012/FFCD-9203/GERCOR phase II study. J Clin Oncol. 2010;28(29):4450–6.PubMedCentral CrossRef PubMed
  16.Regine WF, Winter KA, Abrams R, et al. Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the U.S. Intergroup/RTOG 9704 phase III trial. Ann Surg Oncol. 2011;18(5):1319–26.PubMedCentral CrossRef PubMed
  17.Reni M, Balzano G, Aprile G, et al. Adjuvant PEFG (cisplatin, epirubicin, 5-fluorouracil, gemcitabine) or gemcitabine followed by chemoradiation in pancreatic cancer: a randomized phase II trial. Ann Surg Oncol. 2012;19(7):2256–63.CrossRef PubMed
  18.Schmidt J, Abel U, Debus J, et al. Open-label, multicenter, randomized phase III trial of adjuvant chemoradiation plus interferon Alfa-2b versus fluorouracil and folinic acid for patients with resected pancreatic adenocarcinoma. J Clin Oncol. 2012;30(33):4077–83.CrossRef PubMed
  19.Oettle H, Neuhaus P, Hochhaus A, et al. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013;310(14):1473–81.CrossRef PubMed
  20.Golcher H, Brunner TB, Witzigmann H, et al. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial. Strahlenther Onkol. 2015;191(1):7–16.PubMedCentral CrossRef PubMed
  21.NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Pancreatic Adenocarcinoma Version 1.2015. http://​www.​nccn.​org/​professionals/​physician_​gls/​f_​guidelines.​asp . Last Accessed 31 Mar 2015.
  22.Callery MP, Chang KJ, Fishman EK, Talamonti MS, William Traverso L, Linehan DC. Pretreatment assessment of resectable and borderline resectable pancreatic cancer: expert consensus statement. Ann Surg Oncol. 2009;16(7):1727–33.CrossRef PubMed
  23.Allen VB, Gurusamy KS, Takwoingi Y, Kalia A, Davidson BR. Diagnostic accuracy of laparoscopy following computed tomography (CT) scanning for assessing the resectability with curative intent in pancreatic and periampullary cancer. Cochrane Database Syst Rev. 2013; 11:CD009323. doi:10.​1002/​14651858.​CD009323.​pub2 .
  24.Emanuel EJ, Miller FG. The ethics of placebo-controlled trials—a middle ground. N Engl J Med. 2001;345(12):915–9.CrossRef PubMed
  25.Xu CP, Xue XJ, Liang N, Xu DG, Liu FJ, Yu XS, Zhang JD. Effect of chemoradiotherapy and neoadjuvant chemoradiotherapy in resectable pancreatic cancer: a systematic review and meta-analysis. J Cancer Res Clin Oncol. 2014;140:549–59.CrossRef PubMed
  26.Tempero MA, Malafa MP, Behrman SW, Benson AB III, Casper ES, et al. Pancreatic adenocarcinoma, version 2 2014. JNCCN. 2014;12(8):1083–93.PubMed
  27.Bockhorn M, Uzunoglu FG, Adham M, Imrie C, Milicevic M, et al. Borderline resectable pancreatic cancer: a consensus statement by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2014;155(6):977–88.CrossRef PubMed
  28.Tachezy M, Gebauer F, Petersen C, et al. Sequential neoadjuvant chemoradiotherapy (CRT) followed by curative surgery vs. primary surgery alone for resectable, non-metastasized pancreatic adenocarcinoma: NEOPA—a randomized multicenter phase III study (NCT01900327, DRKS00003893, ISRCTN82191749). BMC Cancer. 2014;14:411.PubMedCentral CrossRef PubMed
  
• 作者单位：Francesco A. D’Angelo (1)
  Laura Antolino (1)
  Mara La Rocca (1)
  Niccolò Petrucciani (1)
  Paolo Magistri (1)
  Paolo Aurello (1)
  Giovanni Ramacciato (1)
  
  1. Division of General Surgery, St Andrea Hospital, Faculty of Medicine and Psychology, Sapienza - Università di Roma, Rome, Italy
  
• 刊物主题：Oncology; Hematology; Pathology; Internal Medicine;
• 出版者：Springer US
• ISSN：1559-131X

文摘

The timing of surgery and antineoplastic therapies in patients with resectable non-metastatic pancreatic cancer is still a controversial matter of debate, with special regard to neoadjuvant approaches. Following the criteria of the PRISMA statement, a literature search was conducted looking for RCTs focusing on adjuvant and neoadjuvant therapies in resectable pancreatic cancer. The quality of the available evidence was assessed using the Cochrane Collaboration’s tool for assessing risk of bias. Data extraction was carried out by two independent investigators. The search led to the identification of 2830 papers of which 14 RCTs focusing on adjuvant and neoadjuvant treatment of resectable pancreatic cancer eligible for the systematic review. Risk of bias was estimated “unclear” in 3 studies and “high” in 5 studies. Median age ranged between 53 and 66. Overall survival in the surgery-only arms ranged between 11 and 20.2 months; in the adjuvant treatment arms 12.5–29.8 months; and in the neoadjuvant setting 9.9–19.4 months. Neoadjuvant protocols should be offered only in randomized clinical trials comparing the standard of care (surgery followed by adjuvant treatments) to a neoadjuvant approach followed by surgery and adjuvant treatment.