Morbidity and Quality of life (QOL) assessment in a phase III trial of surgical treatment for gastric cardia cancer, comparing a left thoraco-abdominal (LT) with abdominal and transhiatal approach (AT) (JCOG9502)
Mitsuru Sasako, MD*, Ken-ichi Yoshimura, Ph.D.*, Takeshi Sano, MD*, Motonori Sairenji, MD*, Seiichiro Yamamoto, PhD*, Kuniyoshi Arai, MD*, Taira Kinoshita, MD*
National Cancer Center Hospital, Tokyo, Japan
Sponsored by: Murray Brennan, MD
OBJECTIVE(S): It is not known whether LT is superior to AT for cardia cancer. We carried out a randomized trial in 167 patients. We evaluated the change in respiratory function and QOL after surgery.
METHODS: Patients with T2-4 cardia cancer with esophageal invasion of <3 cm were randomly assigned to LT or AT. The primary endpoint was overall survival. Respiratory function and body weight (BW) were measured pre-op and after 1 and 6 months. Aspects of QOL including appetite, meal volume, passage, pain were evaluated at 6 and 12 months and dichotomized (good =1 or fair =0). All items were evaluated by marginal models fit via generalized estimating equations and the group means were compared at each point.
RESULTS: There was no survival difference between LT and AT; 5-year survival rates were 49% and 36% in the AT and LT group respectively (P=NS) (ASCO 2004). Vital capacity at 1 and 6 months (both p<0.0001) and PaO2 at 1 month after surgery (p=0.004) were significantly better in AT. There was no difference in relative BW. Significantly higher scores for return to work, meal volume, pain and dyspnea were seen in the AT group at 6 months, but only for meal volume and dyspnea at 1 year.
CONCLUSIONS: This RCT demonstrated that AT gives better QOL after surgery, mainly within 6 months but some after 1 year. Without any benefit in survival or QOL, LT is not the standard approach for cardia cancer with esophageal invasion of 3 cm or less.
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