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Background Gastrectomy with D2 lymphadenectomy is the standard treatment for curable gastric cancer in eastern Asia. Whether the addition of para-aortic nodal dissection (PAND) to D2 lymphadenectomy for stage T2, T3, or T4 tumors improves survival is controversial. We conducted a randomized, controlled trial at 24 hospitals in Japan to compare D2 lymphadenectomy alone with D2 lymphadenectomy plus PAND in patients undergoing gastrectomy for curable gastric cancer.
Methods Between July 1995 and April 2001, 523 patients with curable stage T2b, T3, or T4 gastric cancer were randomly assigned during surgery to D2 lymphadenectomy alone (263 patients) or to D2 lymphadenectomy plus PAND (260 patients). We did not permit any adjuvant therapy before the recurrence of cancer. The primary end point was overall survival.
Results The rates of surgery-related complications among patients assigned to D2 lymphadenectomy alone and those assigned to D2 lymphadenectomy plus PAND were 20.9% and 28.1%, respectively (P=0.07). There were no significant differences between the two groups in the frequencies of anastomotic leakage, pancreatic fistula, abdominal abscess, pneumonia, or death from any cause within 30 days after surgery (the rate of death was 0.8% in each group). The median operation time was 63 minutes longer and the median blood loss was 230 ml greater in the group assigned to D2 lymphadenectomy plus PAND. The 5-year overall survival rate was 69.2% for the group assigned to D2 lymphadenectomy alone and 70.3% for the group assigned to D2 lymphadenectomy plus PAND; the hazard ratio for death was 1.03 (95% confidence interval [CI], 0.77 to 1.37; P=0.85). There were no significant differences in recurrence-free survival between the two groups; the hazard ratio for recurrence was 1.08 (95% CI, 0.83 to 1.42; P=0.56).
Conclusions As compared with D2 lymphadenectomy alone, treatment with D2 lymphadenectomy plus PAND does not improve the survival rate in curable gastric cancer. (ClinicalTrials.gov number, NCT00149279
[ClinicalTrials.gov]
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Source Information
From the Gastric Surgery Division, National Cancer Center Hospital, Tokyo (M.S., T.S.); the Japan Clinical Oncology Group Data Center, National Cancer Center, Tokyo (S.Y., Y.K.); the Department of Surgery, Niigata Cancer Center Hospital, Niigata (A.N.); the Department of Surgery, National Shikoku Cancer Center, Matsuyama (A.K.); the Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka (M.H.); the Department of Surgery, Osaka National Hospital, Osaka (T.T.); the Department of Surgery, National Cancer Center Hospital East, Kashiwa (T.K.); the Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo (K.A.); the Department of Surgery, Aichi Cancer Center, Nagoya (Y.Y.); and Osaka Medical College, Osaka (K.O.) — all in Japan.
Address reprint requests to Dr. Sasako at the Department of Surgery, Hyogo College of Medicine, 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan, or at msasako{at}hyo-med.ac.jp.
Related Letters:
Nodal Dissection for Gastric Cancer
Barreto S. G., Shukla P. J., Ramadori G., Triebel J., Hundahl S. A., Sasako M., Kurokawa Y., Yamamoto S.
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N Engl J Med 2008;
359:2392-2393, Nov 27, 2008.
Correspondence
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