D2 lymphadenectomy alone or with para-aortic nodal dissection for gastric cancer.
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.)
Sasako
Mitsuru
M
Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan. msasako@hyo-med.ac.jp
Sano
Takeshi
T
Yamamoto
Seiichiro
S
Kurokawa
Yukinori
Y
Nashimoto
Atsushi
A
Kurita
Akira
A
Hiratsuka
Masahiro
M
Tsujinaka
Toshimasa
T
Kinoshita
Taira
T
Arai
Kuniyoshi
K
Yamamura
Yoshitaka
Y
Okajima
Kunio
K
D000328:Adult; D000368:Aged; D001011:Aorta; D005260:Female; D005743:Gastrectomy; D006801:Humans; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008197:Lymph Node Excision / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000453:epidemiology; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D015996:Survival Rate