Esophageal 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 esophageal cancer page for regimens that include active anticancer treatment.

Last updated on 2024-12-02:
4 regimens on this page
4 variants on this page


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 shorter OS1
OS60: 17.1% vs 23%
(HR 1.19, 95% CI 1.02-1.39)
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 Shorter OS
OS120: 25% vs 38%
(HR 1.43, 95% CI 1.12-1.82)

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

  1. 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
    1. 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
  2. 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
  3. 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
    1. 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
  4. 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
  5. 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
  6. 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
    1. 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
    2. 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
  7. 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 Shorter DFS
Median DFS: 11 vs 22.4 mo
(HR 1.45, 96.4% CI 1.16-1.79)

No active antineoplastic treatment.

Preceding treatment

References

  1. 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, first-line

Best supportive care

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Noronha et al. 2024 2016-05 to 2020-12 Phase 3 (C) Paclitaxel Shorter OS
Median OS: 4.2 vs 9.2 mo
(HR 2.04, 95% CI 1.56-2.56)

Palliative interventions only.

References

  1. Noronha V, Patil VM, Menon N, Goud S, Singh A, Shah M, More S, Shah S, Yadav A, Sonawane S, Nawale K, Chowdhury OR, Kaushal RK, Ghosh-Laskar S, Agarwal JP, Yadav S, Pai T, Janu A, Mahajan A, Purandare N, Banavali S, Badwe R, Prabhash K. Phase III randomized trial comparing palliative systemic therapy to best supportive care in advanced esophageal/GEJ cancer. Int J Cancer. 2024 Dec 15;155(12):2232-2245. Epub 2024 Aug 2. link to original article PubMed CTRI/2016/01/006474


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

  1. 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


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