Randomized clinical trial of adjuvant chemotherapy with intraperitoneal and intravenous cisplatin followed by oral fluorouracil (UFT) in serosa-positive gastric cancer versus curative resection alone: final results of the Japan Clinical Oncology Group trial JCOG9206-2

• Published in: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association Vol. 14; no. 3; pp. 212 - 218
• Main Authors: Miyashiro, Isao, Furukawa, Hiroshi, Sasako, Mitsuru, Yamamoto, Seiichiro, Nashimoto, Atsushi, Nakajima, Toshifusa, Kinoshita, Taira, Kobayashi, Osamu, Arai, Kuniyoshi
• Format: Journal Article
• Language: English
• Published: Tokyo Springer Japan 01-08-2011; Springer Nature B.V
• Subjects: Abdominal Surgery; Adenocarcinoma - drug therapy; Adenocarcinoma - pathology; Adenocarcinoma - surgery; Administration, Oral; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Cancer Research; Chemotherapy, Adjuvant; Cisplatin - administration & dosage; Cohort Studies; Female; Fluorouracil - administration & dosage; Follow-Up Studies; Gastrectomy; Gastric cancer; Gastroenterology; Humans; Injections, Intraperitoneal; Injections, Intravenous; Japan; Liver Neoplasms - drug therapy; Liver Neoplasms - secondary; Liver Neoplasms - surgery; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Article; Prospective Studies; Serous Membrane - drug effects; Serous Membrane - pathology; Serous Membrane - surgery; Stomach Neoplasms - drug therapy; Stomach Neoplasms - pathology; Stomach Neoplasms - surgery; Surgical Oncology; Survival Rate; Treatment Outcome; Japan; Adjuvant chemotherapy; Randomized clinical trial; Serosa-positive gastric cancer; Intraperitoneal chemotherapy
• ISSN: 1436-3291; 1436-3305
• DOI: 10.1007/s10120-011-0027-3

Purpose
To evaluate the survival benefit of adjuvant chemotherapy after curative resection in serosa-positive gastric cancer, a multicenter phase III clinical trial was conducted in Japan.
Patients and methods
From January 1993 to March 1998, 268 patients were randomized to adjuvant chemotherapy (135 patients) or surgery alone (133 patients). All patients underwent gastrectomy with D2 or greater lymph node dissection. The chemotherapy regimen consisted of intraperitoneal cisplatin soon after abdominal closure, postoperative intravenous cisplatin (day 14) and 5-fluorouracil (day 14–16), and daily oral FU (UFT) starting 4 weeks after surgery for 12 months. The primary endpoint was overall survival. Relapse-free survival and site of recurrence were secondary endpoints.
Results
Fifty-two patients (38.5%) in the adjuvant chemotherapy arm completed the chemotherapy regimen. There were 4 (1.49%) treatment-related deaths, 1 in the surgery-alone and 3 in the adjuvant chemotherapy arm (2 did not receive chemotherapy). Grade 4 toxicity was observed in 3 patients in the surgery-alone and 2 patients in the adjuvant chemotherapy arm. There was no significant difference in 5-year overall survival (62.0% adjuvant chemotherapy vs. 60.9% surgery-alone,
P
 = 0.482) and 5-year relapse-free survival rates (57.5% adjuvant chemotherapy vs. 55.6% surgery-alone;
P
 = 0.512).
Conclusion
There was no benefit in overall and relapse-free survival with this adjuvant chemotherapy regimen for patients with macroscopically serosa-positive gastric cancer after curative resection.