Difference between revisions of "Esophageal cancer - null regimens"
Warner-admin (talk | contribs) m (Text replacement - "#Cisplatin.2C_Fluorouracil.2C_" to "#Cisplatin_.26_Fluorouracil_.28CF.29_.26_") Tags: mobile edit mobile web edit |
m |
||
(63 intermediate revisions by 3 users not shown) | |||
Line 1: | Line 1: | ||
− | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | <span id="BackToTop"></span> |
+ | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | ||
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | 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 [[Esophageal cancer|main esophageal cancer page]] for regimens that include active anticancer treatment. | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
Line 5: | Line 9: | ||
=Neoadjuvant induction therapy= | =Neoadjuvant induction therapy= | ||
==No neoadjuvant therapy== | ==No neoadjuvant therapy== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 19: | Line 20: | ||
|[https://doi.org/10.1200/JCO.2001.19.2.305 Urba et al. 2001] | |[https://doi.org/10.1200/JCO.2001.19.2.305 Urba et al. 2001] | ||
|1989-1994 | |1989-1994 | ||
− | | style="background-color:#1a9851" |Randomized Phase | + | | style="background-color:#1a9851" |Randomized Phase 2 (C) |
− | |Cisplatin, 5-FU, Vinblastine, RT | + | |[[#Cisplatin.2C_Fluorouracil.2C_Vinblastine.2C_RT_999|Cisplatin, 5-FU, Vinblastine, RT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1056/NEJM199812313392704 Kelsen et al. 1998 (RTOG 8911)] |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|1990-1995 | |1990-1995 | ||
− | | style="background-color:#1a9851" | | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | + | |[[Esophageal_cancer#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] | |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |[[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] | ||
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S0140-6736(02)08651-8 Girling et al. 2002 (UK MRC OE02)] |
|1992-1998 | |1992-1998 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |[[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] | + | |[[Esophageal_cancer#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] |
| style="background-color:#fc8d59" |Seems to have inferior OS<sup>1</sup> | | style="background-color:#fc8d59" |Seems to have inferior OS<sup>1</sup> | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(05)70288-6 Burmeister et al. 2005] |
|1994-2000 | |1994-2000 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |[[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | + | |[[Esophageal_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | | style="background-color:#ffffbf" |Did not meet primary endpoint of PFS | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5126644/ Tepper et al. 2008 (CALGB 9781)] | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5126644/ Tepper et al. 2008 (CALGB 9781)] | ||
|1997-2000 | |1997-2000 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |[[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | + | |[[Esophageal_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] |
| style="background-color:#d73027" |Inferior OS | | style="background-color:#d73027" |Inferior OS | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|[https://doi.org/10.1200/JCO.2013.53.6532 Mariette et al. 2014 (FFCD 9901)] | |[https://doi.org/10.1200/JCO.2013.53.6532 Mariette et al. 2014 (FFCD 9901)] | ||
|2000-2009 | |2000-2009 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |[[#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | + | |[[Esophageal_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1056/NEJMoa1112088 van Hagen et al. 2012 (CROSS)] |
|2004-2008 | |2004-2008 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |[[#Carboplatin_.26_Paclitaxel_.28CP.29_.26_RT|Carboplatin, Paclitaxel, RT]] | + | |[[Esophageal_cancer#Carboplatin_.26_Paclitaxel_.28CP.29_.26_RT|Carboplatin, Paclitaxel, RT]] |
| style="background-color:#d73027" |Inferior OS | | style="background-color:#d73027" |Inferior OS | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|- | |- | ||
|} | |} | ||
Line 111: | Line 64: | ||
''Surgery as primary therapy; i.e., no induction chemotherapy or chemoradiotherapy, and no adjuvant therapy.'' | ''Surgery as primary therapy; i.e., no induction chemotherapy or chemoradiotherapy, and no adjuvant therapy.'' | ||
− | |||
− | |||
''CALGB 9781 patients: 75% adenocarcinoma, 25% squamous cell histology. 5% with ECOG PS of 2.'' | ''CALGB 9781 patients: 75% adenocarcinoma, 25% squamous cell histology. 5% with ECOG PS of 2.'' | ||
''CROSS patients: 75% adenocarcinoma, 23% squamous cell, 2% other. 24% gastroesophageal junction.'' | ''CROSS patients: 75% adenocarcinoma, 23% squamous cell, 2% other. 24% gastroesophageal junction.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Subsequent treatment==== | ====Subsequent treatment==== | ||
*[[Surgery#Esophagectomy|Surgery]] | *[[Surgery#Esophagectomy|Surgery]] | ||
− | + | </div></div> | |
===References=== | ===References=== | ||
− | + | #'''RTOG 8911:''' Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. [https://doi.org/10.1056/NEJM199812313392704 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9869669/ PubMed] | |
− | # | + | ##'''Update:''' Kelsen DP, Winter KA, Gunderson LL, Mortimer J, Estes NC, Haller DG, Ajani JA, Kocha W, Minsky BD, Roth JA, Willett CG; Radiation Therapy Oncology Group; USA Intergroup. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer. J Clin Oncol. 2007 Aug 20;25(24):3719-25. [https://doi.org/10.1200/JCO.2006.10.4760 link to original article] [https://pubmed.ncbi.nlm.nih.gov/17704421/ PubMed] |
− | # | + | #Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13. [https://doi.org/10.1200/JCO.2001.19.2.305 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11208820/ PubMed] |
− | # | + | #'''UK MRC OE02:''' Girling DJ, Bancewicz J, Clark PI, Smith DB, Donnelly RJ, Fayers PM, Weeden S, Hutchinson T, Harvey A, Lyddiard J; Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. [https://doi.org/10.1016/S0140-6736(02)08651-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12049861/ PubMed] |
− | + | ##'''Update:''' Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. Epub 2009 Sep 21. [https://doi.org/10.1200/JCO.2009.22.2083 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19770374/ PubMed] | |
− | # | + | #Burmeister BH, Smithers BM, Gebski V, Fitzgerald L, Simes RJ, Devitt P, Ackland S, Gotley DC, Joseph D, Millar J, North J, Walpole ET, Denham JW; Trans-Tasman Radiation Oncology Group; Australasian Gastro-Intestinal Trials Group. Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial. Lancet Oncol. 2005 Sep;6(9):659-68. [https://doi.org/10.1016/S1470-2045(05)70288-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16129366/ PubMed] |
− | # | + | #'''CALGB 9781:''' Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. [https://doi.org/10.1200/jco.2007.12.9593 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5126644/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/18309943/ PubMed] [https://clinicaltrials.gov/study/NCT00003118 NCT00003118] |
− | #''' | + | #'''CROSS:''' van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. [https://doi.org/10.1056/NEJMoa1112088 link to original article] [https://www.nejm.org/doi/suppl/10.1056/NEJMoa1112088/suppl_file/nejmoa1112088_appendix.pdf link to supplement] [https://pubmed.ncbi.nlm.nih.gov/22646630/ PubMed] NTR487 |
− | + | ##'''Update:''' Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. Epub 2015 Aug 5. [https://doi.org/10.1016/S1470-2045(15)00040-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26254683/ PubMed] | |
− | + | ##'''Update:''' Eyck BM, van Lanschot JJB, Hulshof MCCM, van der Wilk BJ, Shapiro J, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch OR, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Spillenaar Bilgen EJ, van der Sangen MJC, Rozema T, Ten Kate FJW, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS Study Group. Ten-Year Outcome of Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: The Randomized Controlled CROSS Trial. J Clin Oncol. 2021 Jun 20;39(18):1995-2004. Epub 2021 Apr 23. [https://doi.org/10.1200/jco.20.03614 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33891478/ PubMed] | |
− | # | + | #'''FFCD 9901:''' Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. Epub 2014 Jun 30. [https://doi.org/10.1200/JCO.2013.53.6532 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24982463/ PubMed] [https://clinicaltrials.gov/study/NCT00047112 NCT00047112] |
− | #''' | ||
− | #''' | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
=Adjuvant therapy= | =Adjuvant therapy= | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
Line 219: | Line 100: | ||
|[https://doi.org/10.1056/nejmoa2032125 Kelly et al. 2021 (CheckMate 577)] | |[https://doi.org/10.1056/nejmoa2032125 Kelly et al. 2021 (CheckMate 577)] | ||
|2016-2019 | |2016-2019 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
|[[Esophageal_cancer#Nivolumab_monotherapy|Nivolumab]] | |[[Esophageal_cancer#Nivolumab_monotherapy|Nivolumab]] | ||
| style="background-color:#d73027" |Inferior DFS | | style="background-color:#d73027" |Inferior DFS | ||
Line 225: | Line 106: | ||
|} | |} | ||
''No active antineoplastic treatment.'' | ''No active antineoplastic treatment.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *Neoadjuvant chemoradiotherapy (not specified), then [[Surgery#Esophageal_cancer_surgery|Surgery]], with residual pathologic disease | + | *Neoadjuvant [[Regimen_classes#Chemoradiotherapy-based_regimen|chemoradiotherapy (not specified)]], then [[Surgery#Esophageal_cancer_surgery|Surgery]], with residual pathologic disease |
− | + | </div></div> | |
===References=== | ===References=== | ||
− | #'''CheckMate 577:''' Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lièvre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. [https://doi.org/10.1056/nejmoa2032125 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33789008/ PubMed] NCT02743494 | + | #'''CheckMate 577:''' Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lièvre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. [https://doi.org/10.1056/nejmoa2032125 link to original article] [https://pubmed.ncbi.nlm.nih.gov/33789008/ PubMed] [https://clinicaltrials.gov/study/NCT02743494 NCT02743494] |
=Metastatic or locally advanced disease, subsequent lines of therapy= | =Metastatic or locally advanced disease, subsequent lines of therapy= | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
==Placebo== | ==Placebo== | ||
− | + | <div class="toccolours" style="background-color:#eeeeee"> | |
− | |||
− | |||
− | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
− | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
|- | |- | ||
− | |[https:// | + | |[https://doi.org/10.1016/S1470-2045(14)70024-5 Dutton et al. 2014 (COG-esoph)] |
|2009-2011 | |2009-2011 | ||
− | | style="background-color:#1a9851" |Phase | + | | style="background-color:#1a9851" |Phase 3 (C) |
− | |Gefitinib | + | |[[#Gefitinib_monotherapy_999|Gefitinib]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS | | style="background-color:#ffffbf" |Did not meet primary endpoint of OS | ||
|- | |- | ||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
|} | |} | ||
− | ''Note: | + | ''Note: COG is renamed as COG-esoph so as not to confuse with the Children's Oncology Group.'' |
− | ''No active antineoplastic | + | ''No active antineoplastic treatment.'' |
− | |||
− | |||
− | |||
− | |||
− | |||
− | |||
− | '' | + | ''COG-esoph patients: 24% squamous cell, 76% adenocarcinoma histology. 78% esophageal, 22% gastroesophageal junction'' |
+ | </div> | ||
===References=== | ===References=== | ||
− | + | #'''COG-esoph:''' Dutton SJ, Ferry DR, Blazeby JM, Abbas H, Dahle-Smith A, Mansoor W, Thompson J, Harrison M, Chatterjee A, Falk S, Garcia-Alonso A, Fyfe DW, Hubner RA, Gamble T, Peachey L, Davoudianfar M, Pearson SR, Julier P, Jankowski J, Kerr R, Petty RD. Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial. Lancet Oncol. 2014 Jul;15(8):894-904. Epub 2014 Jun 17. [https://doi.org/10.1016/S1470-2045(14)70024-5 link to original article] [https://pubmed.ncbi.nlm.nih.gov/24950987/ PubMed] [https://clinicaltrials.gov/study/NCT01243398 NCT01243398] | |
− | #''' | ||
− | |||
− | |||
− | |||
− | |||
[[Category:Esophageal cancer regimens]] | [[Category:Esophageal cancer regimens]] |
Latest revision as of 00:54, 27 January 2024
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 esophageal cancer page for regimens that include active anticancer treatment.
Neoadjuvant induction therapy
No neoadjuvant therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Urba et al. 2001 | 1989-1994 | Randomized Phase 2 (C) | Cisplatin, 5-FU, Vinblastine, RT | Did not meet primary endpoint of OS |
Kelsen et al. 1998 (RTOG 8911) | 1990-1995 | Phase 3 (C) | CF | Did not meet primary endpoint of OS |
Girling et al. 2002 (UK MRC OE02) | 1992-1998 | Phase 3 (C) | CF | Seems to have inferior OS1 |
Burmeister et al. 2005 | 1994-2000 | Phase 3 (C) | CF & RT | Did not meet primary endpoint of PFS |
Tepper et al. 2008 (CALGB 9781) | 1997-2000 | Phase 3 (C) | CF & RT | Inferior OS |
Mariette et al. 2014 (FFCD 9901) | 2000-2009 | Phase 3 (C) | CF & RT | Did not meet primary endpoint of OS |
van Hagen et al. 2012 (CROSS) | 2004-2008 | Phase 3 (C) | Carboplatin, Paclitaxel, RT | Inferior OS |
1Reported efficacy for UK MRC OE02 is based on the 2009 update.
Surgery as primary therapy; i.e., no induction chemotherapy or chemoradiotherapy, and no adjuvant therapy.
CALGB 9781 patients: 75% adenocarcinoma, 25% squamous cell histology. 5% with ECOG PS of 2.
CROSS patients: 75% adenocarcinoma, 23% squamous cell, 2% other. 24% gastroesophageal junction.
Subsequent treatment
References
- RTOG 8911: Kelsen DP, Ginsberg R, Pajak TF, Sheahan DG, Gunderson L, Mortimer J, Estes N, Haller DG, Ajani J, Kocha W, Minsky BD, Roth JA. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998 Dec 31;339(27):1979-84. link to original article PubMed
- Update: Kelsen DP, Winter KA, Gunderson LL, Mortimer J, Estes NC, Haller DG, Ajani JA, Kocha W, Minsky BD, Roth JA, Willett CG; Radiation Therapy Oncology Group; USA Intergroup. Long-term results of RTOG trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer. J Clin Oncol. 2007 Aug 20;25(24):3719-25. link to original article PubMed
- Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001 Jan 15;19(2):305-13. link to original article PubMed
- UK MRC OE02: Girling DJ, Bancewicz J, Clark PI, Smith DB, Donnelly RJ, Fayers PM, Weeden S, Hutchinson T, Harvey A, Lyddiard J; Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. link to original article PubMed
- Update: Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009 Oct 20;27(30):5062-7. Epub 2009 Sep 21. link to original article PubMed
- Burmeister BH, Smithers BM, Gebski V, Fitzgerald L, Simes RJ, Devitt P, Ackland S, Gotley DC, Joseph D, Millar J, North J, Walpole ET, Denham JW; Trans-Tasman Radiation Oncology Group; Australasian Gastro-Intestinal Trials Group. Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the oesophagus: a randomised controlled phase III trial. Lancet Oncol. 2005 Sep;6(9):659-68. link to original article PubMed
- CALGB 9781: Tepper J, Krasna MJ, Niedzwiecki D, Hollis D, Reed CE, Goldberg R, Kiel K, Willett C, Sugarbaker D, Mayer R. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008 Mar 1;26(7):1086-92. link to original article link to PMC article PubMed NCT00003118
- CROSS: van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. link to original article link to supplement PubMed NTR487
- Update: Shapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. Epub 2015 Aug 5. link to original article PubMed
- Update: Eyck BM, van Lanschot JJB, Hulshof MCCM, van der Wilk BJ, Shapiro J, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch OR, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Spillenaar Bilgen EJ, van der Sangen MJC, Rozema T, Ten Kate FJW, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS Study Group. Ten-Year Outcome of Neoadjuvant Chemoradiotherapy Plus Surgery for Esophageal Cancer: The Randomized Controlled CROSS Trial. J Clin Oncol. 2021 Jun 20;39(18):1995-2004. Epub 2021 Apr 23. link to original article PubMed
- FFCD 9901: Mariette C, Dahan L, Mornex F, Maillard E, Thomas PA, Meunier B, Boige V, Pezet D, Robb WB, Le Brun-Ly V, Bosset JF, Mabrut JY, Triboulet JP, Bedenne L, Seitz JF. Surgery alone versus chemoradiotherapy followed by surgery for stage I and II esophageal cancer: final analysis of randomized controlled phase III trial FFCD 9901. J Clin Oncol. 2014 Aug 10;32(23):2416-22. Epub 2014 Jun 30. link to original article PubMed NCT00047112
Adjuvant therapy
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Kelly et al. 2021 (CheckMate 577) | 2016-2019 | Phase 3 (C) | Nivolumab | Inferior DFS |
No active antineoplastic treatment.
Preceding treatment
- Neoadjuvant chemoradiotherapy (not specified), then Surgery, with residual pathologic disease
References
- CheckMate 577: Kelly RJ, Ajani JA, Kuzdzal J, Zander T, Van Cutsem E, Piessen G, Mendez G, Feliciano J, Motoyama S, Lièvre A, Uronis H, Elimova E, Grootscholten C, Geboes K, Zafar S, Snow S, Ko AH, Feeney K, Schenker M, Kocon P, Zhang J, Zhu L, Lei M, Singh P, Kondo K, Cleary JM, Moehler M; CheckMate 577 Investigators. Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer. N Engl J Med. 2021 Apr 1;384(13):1191-1203. link to original article PubMed NCT02743494
Metastatic or locally advanced disease, subsequent lines of therapy
Placebo
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Dutton et al. 2014 (COG-esoph) | 2009-2011 | Phase 3 (C) | Gefitinib | Did not meet primary endpoint of OS |
Note: COG is renamed as COG-esoph so as not to confuse with the Children's Oncology Group.
No active antineoplastic treatment.
COG-esoph patients: 24% squamous cell, 76% adenocarcinoma histology. 78% esophageal, 22% gastroesophageal junction
References
- COG-esoph: Dutton SJ, Ferry DR, Blazeby JM, Abbas H, Dahle-Smith A, Mansoor W, Thompson J, Harrison M, Chatterjee A, Falk S, Garcia-Alonso A, Fyfe DW, Hubner RA, Gamble T, Peachey L, Davoudianfar M, Pearson SR, Julier P, Jankowski J, Kerr R, Petty RD. Gefitinib for oesophageal cancer progressing after chemotherapy (COG): a phase 3, multicentre, double-blind, placebo-controlled randomised trial. Lancet Oncol. 2014 Jul;15(8):894-904. Epub 2014 Jun 17. link to original article PubMed NCT01243398