Adjuvant Chemotherapy with Etoposide, Adriamycin and Cisplatin Compared with Surgery Alone in the Treatment of Gastric Cancer: A Phase III Randomized, Multicenter, Clinical Trial

Abstract

Objective: The aim of this study was to evaluate the efficacy of adjuvant chemotherapy with etoposide, Adriamycin and cisplatin (EAP) after potentially curative resections for gastric cancer. Methods: After surgery, patients were randomly assigned to the EAP or control arm. Chemotherapy included 3 courses, administered every 28 days. Each cycle consisted of doxorubicin (20 mg/m²) on days 1 and 7, cisplatin (40 mg/m²) on days 2 and 8, and etoposide (120 mg/m²) on days 4, 5, and 6. Results: Of 309 eligible patients, 141 were allocated to chemotherapy and 154 to the supportive care group. Four (2.8%) treatment-related deaths were recorded, including 3 due to septic complications of myelosuppression and 1 due to cardiocirculatory failure. Grade 3 or 4 toxicities were found in 17 (22%) patients. According to the intention-to-treat analysis, the median survival was 41.3 months (95% confidence interval, 24.5–58.2) and 35.9 months (95% confidence interval, 25.5–46.3) in the chemotherapy and control group, respectively (p = 0.398). Subgroup analysis revealed survival benefit from chemotherapy in patients with tumors infiltrating the serosa and in those with 7–15 metastatic lymph nodes. Conclusion: Three cycles of EAP regimen postoperatively offer no survival advantage in gastric cancer patients.

Neoadjuvant or adjuvant therapy for resectable gastric cancer: a systematic review and practice guideline for North America

“…The literature search identified 11 trial reports, representing 12 RCTs that compared postoperative chemotherapy with surgery alone [12][13][14][15][16][17][18][19][20][21][22]. All of these studies, except for one very recently published trial [22], were part of the meta-analyses described above and will not be discussed further.…”

“…All of these studies, except for one very recently published trial [22], were part of the meta-analyses described above and will not be discussed further. Kulig et al [22] compared postoperative chemotherapy (etoposide, adriamycin, and cisplatin) to surgery alone. They reported no survival advantage in the chemotherapy arm.…”

A retrospective study on intensity-modulated radiation therapy combined with chemotherapy after D2 radical surgery for gastric carcinoma

“…The prognosis with surgery alone is poor for patients with locally advanced gastric carcinoma, while the 5-year survival rate is only ~8-34% (8). In order to improve the survival rate of patients with gastric carcinoma and reduce the recurrence rate, adjuvant therapy following gastrectomy has become a consensus (9). However, chemotherapy alone after surgery did not confer an obvious survival benefit to such patients in the majority of studies (9,10).…”

Impact of Adjuvant Chemotherapy Cycles on Prognosis of Resectable Stomach Cancer: A Retrospective Analysis

“…There is no defined standard that addresses the number of cycles of adjuvant chemotherapy that are required for the maximal response after gastric cancer resection. Previous studies have reported that patients with stomach cancer had no survival benefit from 3 to 5 courses of adjuvant chemotherapy after radical gastrectomy (De Vita et al, 2007;Di Costanzo et al, 2008;Kulig et al, 2010). Neri et al (2001) investigated whether 7 cycles of adjuvant chemotherapy led to a longer median survival time than the surgery-only group.…”