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Long-Term Outcomes of Laparoscopic Radical Gastrectomy for Highly Advanced Gastric Cancer: Final Report of a Prospective Phase II Trial (KUGC04)

  • Gastrointestinal Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

This is the final report evaluating the long-term outcomes of a single-arm phase II clinical trial that demonstrated the short-term efficacy of laparoscopic gastrectomy (LG) for highly advanced gastric cancer (AGC) [KUGC04].

Patients and Methods

Seventy-three patients with histologically confirmed gastric adenocarcinoma and diagnosed with clinical stage II or higher, who potentially underwent curative resection between August 2009 and November 2014, were prospectively enrolled. Long-term outcomes with 5-year progression-free survival (PFS) and 5-year overall survival (OS) were evaluated according to clinical or pathological stages. Recurrence and progression patterns were also investigated. These outcomes were compared with those of previous reports to assess the applicability of LG for highly advanced gastric cancer (HAGC).

Results

The median observation period of all surviving patients was 75.1 months. The 5-year PFS and 5-year OS of all patients was 47.4% and 54.4%, respectively. Clinical stage-specific 5-year PFS and 5-year OS was 75.0, 69.1, 53.9, 39.4, 40.0 and 9.1, and 75.0, 68.8, 61.5, 45.0, 60.0 and 27.3, respectively, in stages IIA, IIB, IIIA, IIIB, IIIC, and IV, respectively. Pathological stage-specific 5-year PFS and 5-year OS, including ypStage with preoperative chemotherapy, was 100, 80.0, 100, 62.5, 80.0, 51.3, 16.7, 22.2 and 12.5, and 100, 80.0, 100, 75.0, 80.0, 64.2, 25.0, 33.3 and 12.5, respectively, in stage X (no residual tumor with preoperative chemotherapy), IA, IB, IIA, IIB, IIIA, IIIB, IIIC, and IV, respectively. Recurrence or progression was observed in 30 patients (41.1%).

Conclusion

LG for HAGC performed by experienced surgeons is safe and oncologically acceptable.

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References

  1. Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer 2017;20:1–19.

  2. Katai H, Mizusawa J, Katayama H, et al. Survival outcomes after laparoscopy-assisted distal gastrectomy versus open distal gastrectomy with nodal dissection for clinical stage IA or IB gastric cancer (JCOG0912): a multicentre, non-inferiority, phase 3 randomised controlled trial. Lancet Gastroenterol Hepatol. 2020;5:142–51.

    Article  Google Scholar 

  3. Kim HH, Han SU, Kim MC, et al. Effect of laparoscopic distal gastrectomy vs open distal gastrectomy on long-term survival among patients with stage I gastric cancer: The KLASS-01 randomized clinical trial. JAMA Oncol. 2019;5:506–13.

    Article  Google Scholar 

  4. Inokuchi M, Nakagawa M, Tanioka T, et al. Long- and short-term outcomes of laparoscopic gastrectomy versus open gastrectomy in patients with clinically and pathological locally advanced gastric cancer: a propensity-score matching analysis. Surg Endosc. 2018;32:735–42.

    Article  Google Scholar 

  5. Kinoshita T, Uyama I, Terashima M, et al. Long-term outcomes of laparoscopic versus open surgery for clinical stage II/III gastric cancer: A multicenter cohort study in Japan (LOC-A Study). Ann Surg. 2019;269:887–94.

    Article  Google Scholar 

  6. Lee H, Kim W, Lee J. Long-term outcomes of laparoscopic versus open total gastrectomy for advanced gastric cancer: A propensity score-matched analysis. Dig Surg. 2020;37:220–8.

    Article  CAS  Google Scholar 

  7. Beyer K, Baukloh AK, Kamphues C, et al. Laparoscopic versus open gastrectomy for locally advanced gastric cancer: a systematic review and meta-analysis of randomized controlled studies. World J Surg Oncol. 2019;17:68.

    Article  Google Scholar 

  8. Yu J, Huang C, Sun Y, et al. Effect of laparoscopic vs open distal gastrectomy on 3-year disease-free survival in patients with locally advanced gastric cancer: The CLASS-01 randomized clinical trial. JAMA. 2019;321:1983–92.

    Article  Google Scholar 

  9. Hyung WJ, Yang HK, Park YK, et al. Long-term outcomes of laparoscopic distal gastrectomy for locally advanced gastric cancer: The KLASS-02-RCT randomized clinical trial. J Clin Oncol. 2020;38:3304–13.

    Article  Google Scholar 

  10. Cunningham D, Allum WH, Stenning SP, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355:11–20.

    Article  CAS  Google Scholar 

  11. Al-Batran SE, Homann N, Pauligk C, et al. Perioperative chemotherapy with fluorouracil plus leucovorin, oxaliplatin, and docetaxel versus fluorouracil or capecitabine plus cisplatin and epirubicin for locally advanced, resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4): a randomised, phase 2/3 trial. Lancet. 2019;393:1948–57.

    Article  Google Scholar 

  12. Iwasaki Y, Terashima M, Mizusawa J, et al. Randomized phase III trial of gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer: Japan clinical oncology group study (JCOG0501). J Clin Oncol. 2019;22:1044–52.

    Google Scholar 

  13. Tokunaga M, Mizusawa J, Machida N et al. Phase III trial to evaluate the efficacy of neoadjuvant chemotherapy with S-1 plus oxaliplatin followed by D2 gastrectomy with adjuvant S-1 in locally advanced gastric cancer: Japan Clinical Oncology Group study JCOG1509 (NAGISA trial). Journal of Clinical Oncology 2017;35(15 Suppl).

  14. Okabe H, Tsunoda S, Obama K, et al. Feasibility of laparoscopic radical gastrectomy for gastric cancer of clinical stage II or higher: early outcomes in a phase II study (KUGC04). Ann Surg Oncol. 2016;23:516–23.

    Article  Google Scholar 

  15. Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer 2011;14:101–112.

  16. Hosogi H, Shinohara H, Tsunoda S, et al. Staging laparoscopy for advanced gastric cancer: significance of preoperative clinicopathological factors. Langenbecks Arch Surg. 2017;402:33–9.

    Article  Google Scholar 

  17. Okabe H, Hata H, Hosogi H, et al. A phase 2 study of induction chemotherapy using docetaxel, cisplatin, and S-1 for gastric cancer with peritoneal metastasis (KUGC06). Ann Surg Oncol. 2019;26:1779–86.

    Article  Google Scholar 

  18. Bang YJ, Van Cutsem E, Feyereislova A, et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010;376:687–97.

    Article  CAS  Google Scholar 

  19. Tanigawa N, Lee SW, Kimura T, et al. The Endoscopic Surgical Skill Qualification System for gastric surgery in Japan. Asian J Endosc Surg. 2011;4:112–5.

    Article  CAS  Google Scholar 

  20. Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer 2011;14:113–123.

  21. Amin MB, Edge S, Greene F, Byrd DR, Brookland RK, Washington MK, et al. AJCC cancer staging manual. 8th edn. New York: Springer; 2017.

    Book  Google Scholar 

  22. Sano T, Coit DG, Kim HH, et al. Proposal of a new stage grou** of gastric cancer for TNM classification: International Gastric Cancer Association staging project. Gastric Cancer. 2017;20:217–25.

    Article  Google Scholar 

  23. Ahn SH, Kang SH, Lee Y, et al. Long-term survival outcomes of laparoscopic gastrectomy for advanced gastric cancer: five-year results of a phase II prospective clinical trial. J Gastric Cancer. 2019;19:102–10.

    Article  Google Scholar 

  24. Sakuramoto S, Sasako M, Yamaguchi T, et al. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007;357:1810–20.

    Article  CAS  Google Scholar 

  25. An JY, Kim KM, Kim YM, et al. Surgical complications in gastric cancer patients preoperatively treated with chemotherapy: their risk factors and clinical relevance. Ann Surg Oncol. 2012;19:2452–8.

    Article  Google Scholar 

  26. Lin JX, Huang YQ, **e JW, et al. Age-adjusted Charlson Comorbidity Index (ACCI) is a significant factor for predicting survival after radical gastrectomy in patients with gastric cancer. BMC Surg. 2019;19:53.

    Article  Google Scholar 

  27. Tsunoda S, Okabe H, Obama K, et al. Short-term outcomes of totally laparoscopic total gastrectomy: experience with the first consecutive 112 cases. World J Surg. 2014;38:2662–7.

    Article  Google Scholar 

  28. Sasako M, Sakuramoto S, Katai H, et al. Five-year outcomes of a randomized phase III trial comparing adjuvant chemotherapy with S-1 versus surgery alone in stage II or III gastric cancer. J Clin Oncol. 2011;29:4387–93.

    Article  CAS  Google Scholar 

  29. Ikoma N, Chen HC, Wang X, et al. Patterns of initial recurrence in gastric adenocarcinoma in the era of preoperative therapy. Ann Surg Oncol. 2017;24:2679–87.

    Article  Google Scholar 

  30. Li C, Oh SJ, Kim S, et al. Macroscopic Borrmann type as a simple prognostic indicator in patients with advanced gastric cancer. Oncology. 2009;77:197–204.

    Article  Google Scholar 

  31. Liang C, Chen G, Zhao B, et al. Borrmann type IV gastric cancer: focus on the role of gastrectomy. J Gastrointest Surg. 2020;24:1026–32.

    Article  Google Scholar 

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Funding

No funding was received for this study.

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Correspondence to Shigeo Hisamori MD, PhD.

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Shigeo Hisamori, Hiroshi Okabe, Shigeru Tsunoda, Tatsuto Nishigori, Riki Ganeko, Yudai Fukui, Ryosuke Okamura, Hisatsugu Maekawa, Yoshiharu Sakai, and Kazutaka Obama declare they have no conflicts of interest.

Ethical standards

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions.

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Informed consent to be included in the study or equivalent was obtained from all patients.

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Hisamori, S., Okabe, H., Tsunoda, S. et al. Long-Term Outcomes of Laparoscopic Radical Gastrectomy for Highly Advanced Gastric Cancer: Final Report of a Prospective Phase II Trial (KUGC04). Ann Surg Oncol 28, 8962–8972 (2021). https://doi.org/10.1245/s10434-021-10373-8

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