A multicenter randomized, controlled clinical trial of adjuvant sintilimab for esophageal squamous cell carcinoma

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

• 1. Sung H, Ferlay J, Siegel RL et al. Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 71(3), 209–249 (2021).
  MedlineGoogle Scholar
• 2. Sjoquist KM, Burmeister BH, Smithers BM et al. Survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 12(7), 681–692 (2011).
  MedlineGoogle Scholar
• 3. Ajani JA, D'amico TA, Bentrem DJ et al. Esophageal and Esophagogastric Junction Cancers, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J. Natl Compr. Cancer Netw. 17(7), 855–883 (2019).
  CASGoogle Scholar
• 4. Kitagawa Y, Uno T, Oyama T et al. Esophageal cancer practice guidelines 2017 edited by the Japan Esophageal Society: part 1. Esophagus 16(1), 1–24 (2019).
  MedlineGoogle Scholar
• 5. Van Hagen P, Hulshof MC, Van Lanschot JJ et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N. Engl. J. Med. 366(22), 2074–2084 (2012). • Provides an important reference for the selection of neoadjuvant therapy regimen for esophageal cancer in Asia.
  Medline CASGoogle Scholar
• 6. Ando N, Kato H, Igaki H et al. A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus (JCOG9907). Ann. Surg. Oncol. 19(1), 68–74 (2012).
  MedlineGoogle Scholar
• 7. Blum Murphy M, Xiao L, Patel VR et al. Pathological complete response in patients with esophageal cancer after the trimodality approach: the association with baseline variables and survival – The University of Texas MD Anderson Cancer Center experience. Cancer 123(21), 4106–4113 (2017).
  MedlineGoogle Scholar
• 8. Samson P, Puri V, Lockhart AC et al. Adjuvant chemotherapy for patients with pathologic node-positive esophageal cancer after induction chemotherapy is associated with improved survival. J. Thorac. Cardiovasc. Surg. 156(4), 1725–1735 (2018).
  MedlineGoogle Scholar
• 9. Semenkovich TR, Subramanian M, Yan Y et al. Adjuvant therapy for node-positive esophageal cancer after induction and surgery: a multisite study. Ann. Thorac. Surg. 108(3), 828–836 (2019). •• The first global, randomized, double-blind, placebo-controlled phase III trial to evaluate a checkpoint inhibitor as adjuvant therapy in patients with esophageal or gastroesophageal junction cancer, which provides an important reference for the application of immunotherapy in the clinical treatment of esophageal cancer.
  MedlineGoogle Scholar
• 10. Kelly RJ, Ajani JA, Kuzdzal J et al. Adjuvant nivolumab in resected esophageal or gastroesophageal junction cancer. N. Engl. J. Med. 384(13), 1191–1203 (2021).
  Medline CASGoogle Scholar
• 11. Lordick F, Mariette C, Haustermans K, Obermannova R, Arnold D, Committee EG. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann. Oncol. 27(Suppl. 5), v50–v57 (2016).
  Medline CASGoogle Scholar
• 12. Shin S, Kim HK, Choi YS, Kim K, Shim YM. Clinical stage T1–T2N0M0 oesophageal cancer: accuracy of clinical staging and predictive factors for lymph node metastasis. Eur. J. Cardiothorac. Surg. 46(2), 274–279; discussion 279 (2014).
  MedlineGoogle Scholar
• 13. Crabtree TD, Yacoub WN, Puri V et al. Endoscopic ultrasound for early stage esophageal adenocarcinoma: implications for staging and survival. Ann. Thorac. Surg. 91(5), 1509–1515; discussion 1515–1506 (2011).
  MedlineGoogle Scholar
• 14. Crabtree TD, Kosinski AS, Puri V et al. Evaluation of the reliability of clinical staging of T2 N0 esophageal cancer: a review of the Society of Thoracic Surgeons database. Ann. Thorac. Surg. 96(2), 382–390 (2013).
  MedlineGoogle Scholar
• 15. Haque W, Verma V, Bernicker E, Butler EB, Teh BS. Management of pathologic node-positive disease following initial surgery for clinical T1–2 N0 esophageal cancer: patterns of care and outcomes from the national cancer data base. Acta Oncol. 57(6), 782–789 (2018).
  MedlineGoogle Scholar
• 16. Feng SK, Liu XB, Xing WQ et al. Adjuvant chemotherapy for node-positive esophageal squamous cell carcinoma improves survival. Ann. Thorac. Surg. 114(4), 1205–1213 (2022).
  MedlineGoogle Scholar
• 17. Gao SJ, Park HS, Corso CD, Rutter CE, Kim AW, Johung KL. Role of adjuvant treatment in esophageal cancer with incidental pathologic node positivity. Ann. Thorac. Surg. 104(1), 267–274 (2017).
  MedlineGoogle Scholar
• 18. Rice TW, Ishwaran H, Ferguson MK, Blackstone EH, Goldstraw P. Cancer of the esophagus and esophagogastric junction: an eighth edition staging primer. J. Thorac. Oncol. 12(1), 36–42 (2017). • Provides an important reference for patient selection and statistical analysis in clinical studies of esophageal cancer.
  MedlineGoogle Scholar
• 19. Sun HB, Xing WQ, Liu XB et al. Neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for locally advanced oesophageal squamous cell carcinoma: a single-centre, open-label, randomized, controlled, clinical trial (HCHTOG1903). BMC Cancer 20(1), 303 (2020).
  Medline CASGoogle Scholar
• 20. World Medical Association I. Declaration of Helsinki. Ethical principles for medical research involving human subjects. J. Indian Med. Assoc. 107(6), 403–405 (2009).
  MedlineGoogle Scholar
• 21. Obermannova R, Alsina M, Cervantes A et al. Oesophageal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann. Oncol. 33(10), 992–1004 (2022).
  Medline CASGoogle Scholar
• 22. Shah MA, Kennedy EB, Catenacci DV et al. Treatment of locally advanced esophageal carcinoma: ASCO guideline. J. Clin. Oncol. 38(23), 2677–2694 (2020).
  MedlineGoogle Scholar
• 23. Toh Y, Yamamoto H, Miyata H et al. Significance of the board-certified surgeon systems and clinical practice guideline adherence to surgical treatment of esophageal cancer in Japan: a questionnaire survey of departments registered in the National Clinical Database. Esophagus. 16(4), 362–370 (2019).
  MedlineGoogle Scholar
• 24. Weber J, Mandala M, Del Vecchio M et al. Adjuvant Nivolumab versus ipilimumab in resected stage III or IV melanoma. N. Engl. J. Med. 377(19), 1824–1835 (2017).
  Medline CASGoogle Scholar
• 25. Speicher PJ, Ganapathi AM, Englum BR et al. Induction therapy does not improve survival for clinical stage T2N0 esophageal cancer. J. Thorac. Oncol. 9(8), 1195–1201 (2014).
  Medline CASGoogle Scholar
• 26. Stiles BM, Mirza F, Coppolino A et al. Clinical T2–T3N0M0 esophageal cancer: the risk of node positive disease. Ann. Thorac. Surg. 92(2), 491–496; discussion 496–498 (2011).
  MedlineGoogle Scholar
• 27. Wang J, Fei K, Jing H et al. Durable blockade of PD-1 signaling links preclinical efficacy of sintilimab to its clinical benefit. MAbs 11(8), 1443–1451 (2019).
  Medline CASGoogle Scholar
• 28. Zhang L, Mai W, Jiang W, Geng Q. Sintilimab: a promising anti-tumor PD-1 antibody. Front. Oncol. 10, 594558 (2020).
  MedlineGoogle Scholar
• 29. Lu Z, Wang J, Shu Y et al. Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial. BMJ 377, e068714 (2022).
  MedlineGoogle Scholar
• 30. Kojima T, Shah MA, Muro K et al. Randomized phase III KEYNOTE-181 study of pembrolizumab versus chemotherapy in advanced esophageal cancer. J. Clin. Oncol. 38(35), 4138–4148 (2020).
  Medline CASGoogle Scholar
• 31. Doki Y, Ajani JA, Kato K et al. Nivolumab combination therapy in advanced esophageal squamous-cell carcinoma. N. Engl. J. Med. 386(5), 449–462 (2022).
  Medline CASGoogle Scholar
• 32. Luo H, Lu J, Bai Y et al. Effect of camrelizumab vs placebo added to chemotherapy on survival and progression-free survival in patients with advanced or metastatic esophageal squamous cell carcinoma: the ESCORT-1st randomized clinical trial. JAMA 326(10), 916–925 (2021).
  Medline CASGoogle Scholar
• 33. Doi T, Piha-Paul SA, Jalal SI et al. Safety and antitumor activity of the anti-programmed death-1 antibody pembrolizumab in patients with advanced esophageal carcinoma. J. Clin. Oncol. 36(1), 61–67 (2018).
  Medline CASGoogle Scholar
• 34. Patel MA, Kratz JD, Lubner SJ, Loconte NK, Uboha NV. Esophagogastric cancers: integrating immunotherapy therapy into current practice. J. Clin. Oncol. 40(24), 2751–2762 (2022).
  Medline CASGoogle Scholar