Pancreatic cancer - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main pancreatic cancer page for regimens that include active anticancer treatment.
=Neoadjuvant therapy=
==No neoadjuvant therapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Terminated for low accrual (NEOPAC)	2009-2018 	Phase 3 (C)	GemOx 	No results
Versteijne et al. 2020 (PREOPANC) 	2013-2017 	Phase 3 (C)	Gemcitabine & RT	Seems to have shorter OS1
1Reported efficacy is based on the 2022 update.
No treatment prior to surgery.
====Subsequent treatment====
*Surgery
===References===
#PREOPANC: Versteijne E, Suker M, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Eijck CH, van Tienhoven G; Dutch Pancreatic Cancer Group. Preoperative Chemoradiotherapy Versus Immediate Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Results of the Dutch Randomized Phase III PREOPANC Trial. J Clin Oncol. 2020 Jun 1;38(16):1763-1773. Epub 2020 Feb 27. link to original article link to PMC article EuroPMC EudraCT 2012-003181-40
##Update: Versteijne E, van Dam JL, Suker M, Janssen QP, Groothuis K, Akkermans-Vogelaar JM, Besselink MG, Bonsing BA, Buijsen J, Busch OR, Creemers GM, van Dam RM, Eskens FALM, Festen S, de Groot JWB, Groot Koerkamp B, de Hingh IH, Homs MYV, van Hooft JE, Kerver ED, Luelmo SAC, Neelis KJ, Nuyttens J, Paardekooper GMRM, Patijn GA, van der Sangen MJC, de Vos-Geelen J, Wilmink JW, Zwinderman AH, Punt CJ, van Tienhoven G, van Eijck CHJ; Dutch Pancreatic Cancer Group. Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial. J Clin Oncol. 2022 Apr 10;40(11):1220-1230. Epub 2022 Jan 27. link to original article EuroPMC
#NEOPAC: NCT01314027
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Klinkenbijl et al. 1999 (EORTC 40891)	1987-1995 	Phase 3 (C)	5-FU & RT 	Did not meet primary endpoint of OS24
Neoptolemos et al. 2001 (ESPAC-1) 	1994-2000 	Phase 3 (C)	1. FULV 	Shorter OS1
Neoptolemos et al. 2001 (ESPAC-1) 	1994-2000 	Phase 3 (C)	2. 5-FU & RT3. 5-FU & RT/FULV	Seems to have shorter OS
Oettle et al. 2007 (CONKO-001) 	1998-2004 	Phase 3 (C)	Gemcitabine 	Shorter OS2OS60: 10.4% vs 20.7%(HR 1.32, 95% CI 1.05-1.64)
Ueno et al. 2009 (JSAP-02) 	2002-2005 	Phase 3 (C)	Gemcitabine 	Did not meet primary endpoint of OSMedian OS: 18.4 vs 22.3 mo(HR 1.30, 95% CI 0.88-1.96)
1Reported efficacy for ESPAC-1 is based on the 2004 update.
2Reported efficacy for CONKO-001 is based on the 2013 update.
No active antineoplastic treatment.
====Preceding treatment====
*Surgery
===References===
#EORTC 40891: Klinkenbijl JH, Jeekel J, Sahmoud T, van Pel R, Couvreur ML, Veenhof CH, Arnaud JP, Gonzalez DG, de Wit LT, Hennipman A, Wils J. Adjuvant radiotherapy and 5-fluorouracil after curative resection of cancer of the pancreas and periampullary region: phase III trial of the EORTC gastrointestinal tract cancer cooperative group. Ann Surg. 1999 Dec;230(6):776-82. link to original article link to PMC article EuroPMC
##Update: Smeenk HG, van Eijck CH, Hop WC, Erdmann J, Tran KC, Debois M, van Cutsem E, van Dekken H, Klinkenbijl JH, Jeekel J. Long-term survival and metastatic pattern of pancreatic and periampullary cancer after adjuvant chemoradiation or observation: long-term results of EORTC trial 40891. Ann Surg. 2007 Nov;246(5):734-40. link to original article EuroPMC
#ESPAC-1: Neoptolemos JP, Dunn JA, Stocken DD, Almond J, Link K, Beger H, Bassi C, Falconi M, Pederzoli P, Dervenis C, Fernandez-Cruz L, Lacaine F, Pap A, Spooner D, Kerr DJ, Friess H, Büchler MW; European Study Group for Pancreatic Cancer. Adjuvant chemoradiotherapy and chemotherapy in resectable pancreatic cancer: a randomised controlled trial. Lancet. 2001 Nov 10;358(9293):1576-85. link to original article EuroPMC
##Update: Neoptolemos JP, Stocken DD, Friess H, Bassi C, Dunn JA, Hickey H, Beger H, Fernandez-Cruz L, Dervenis C, Lacaine F, Falconi M, Pederzoli P, Pap A, Spooner D, Kerr DJ, Büchler MW; European Study Group for Pancreatic Cancer. A randomized trial of chemoradiotherapy and chemotherapy after resection of pancreatic cancer. N Engl J Med. 2004 Mar 18;350(12):1200-10. link to original article EuroPMC
#CONKO-001: Oettle H, Post S, Neuhaus P, Gellert K, Langrehr J, Ridwelski K, Schramm H, Fahlke J, Zuelke C, Burkart C, Gutberlet K, Kettner E, Schmalenberg H, Weigang-Koehler K, Bechstein WO, Niedergethmann M, Schmidt-Wolf I, Roll L, Doerken B, Riess H. Adjuvant chemotherapy with gemcitabine vs observation in patients undergoing curative-intent resection of pancreatic cancer: a randomized controlled trial. JAMA. 2007 Jan 17;297(3):267-77. link to original article EuroPMC ISRCTN34802808
##Update: Oettle H, Neuhaus P, Hochhaus A, Hartmann JT, Gellert K, Ridwelski K, Niedergethmann M, Zülke C, Fahlke J, Arning MB, Sinn M, Hinke A, Riess H. Adjuvant chemotherapy with gemcitabine and long-term outcomes among patients with resected pancreatic cancer: the CONKO-001 randomized trial. JAMA. 2013 Oct 9;310(14):1473-81. link to original article EuroPMC
#JSAP-02: Ueno H, Kosuge T, Matsuyama Y, Yamamoto J, Nakao A, Egawa S, Doi R, Monden M, Hatori T, Tanaka M, Shimada M, Kanemitsu K. 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 Sep 15;101(6):908-15. Epub 2009 Aug 18. link to original article link to original article EuroPMC
=Metastatic disease, refractory=
==Best supportive care==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Gilliam et al. 2012 (PC6) 	2001-2002 	Phase 3 (C)	G17DT 	Did not meet primary endpoint of OSMedian OS: 82 vs 151 days(aHR 1.33, 95% CI 0.91-1.96)
Pelzer et al. 2011 (CONKO-003) 	2002-12 to 2003-12 	Phase 3 (C)	OFF 	Shorter OSMedian OS: 7.9 vs 9.09 mo(HR 2.00, 95% CI 1.05-3.70)
Ciuleanu et al. 2009 (TH-CR-302)	2004-2006 	Phase 3 (C)	Glufosfamide	Did not meet primary endpoint of OSMedian OS: 84 vs 105 days(HR 1.18, 95% CI 0.93-1.52)
Best supportive care. Placed here because one or more randomized clinical trials included a best supportive care arm in this disease context.
===References===
#PC6: Gilliam AD, Broome P, Topuzov EG, Garin AM, Pulay I, Humphreys J, Whitehead A, Takhar A, Rowlands BJ, Beckingham IJ. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012 Apr;41(3):374-9. link to original article EuroPMC NCT02118077
#TH-CR-302: Ciuleanu TE, Pavlovsky AV, Bodoky G, Garin AM, Langmuir VK, Kroll S, Tidmarsh GT. A randomised Phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009 Jun;45(9):1589-96. Epub 2009 Jan 31. link to original article EuroPMC NCT00099294
#CONKO-003: Pelzer U, Schwaner I, Stieler J, Adler M, Seraphin J, Dörken B, Riess H, Oettle H. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011 Jul;47(11):1676-81. Epub 2011 May 10. link to original article EuroPMC NCT00786058
Category:Pancreatic cancer regimens
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Category:Gastrointestinal cancers
Category:Null regimens