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One Patient, who died under neoadjuvant chemotherapy, was excluded. In total, 64 patients with advanced gastric carcinoma staged UICC Ib-III were included in the study. 26 of these received preoperative CTx followed by surgical resection. The other 38 patients received resection only. Patient characteristics were well balanced in both groups (Table 1). Median age was 67.86 years. There were 21 women and 43 men. Stage Ib was diagnosed in 12 patients (19%), stage II in 20 (31%) and stage III in 32 (50%). The tumor was located in the proximal stomach in 46 patients. Most frequently, an poorly differentiated (G3) intestinal Lauren type (36/64) tumor was found. All 64 patients underwent surgical Resection. 56 patients received total gastrectomy with D2-lymphadenectomy, 8 patients received subtotal gastrectomy in cases of early tumor stages and intestinal-type tumors with distal localization. The overall curative resection rate (R0) was 75% (n = 48/64). Thus by definition, 16 patients received not curative resection (R1).
Preoperative CTx was administered in 26 and completed in 18 patients. In 8 cases, CTx was aborted due to gastrointestinal toxicity, i.e. nausea, vomiting and diarrhea (n = 3/26), hematologic toxicity, i.e. neutropenia (n = 2/26), complete early tumor regression in one case and tumor progression in 2 further patients. We observed a histological response rate of 77% (n = 20/26), 5 patients showing complete and 15 patients displaying partial response. No histological benefit was detected in 6 patients (23%). In respect of the regression grade 75% showed submucosal subtotal cicatrisation, which complies with regressiongrade 2; the examination of the resected tissue of the remaining patients showed complete necrosis. (Regression grade was examined by JRSGC). The histological response was particularly significant among patients staged UICC III. Table 2 illustrates pre- versus postoperative tumor staging in both groups. The curative resection rate after neoadjuvant CTx was 77% (n = 20/26) and was accomplished in 17 responders and 3 non-responders. R1-resection was diagnosed in 6 cases (3 responders and 3 non-responders).
Postoperative complications developed in 35 of 64 patients. The complication rate was 39% in the group with chemotherapy (n = 10/26) and 66% after surgical resection only (n = 25/38). Common complications like pneumonia (7/64), pulmonary embolism (2/64) and urinary infection (1/64) occurred more frequently in the group without neodjuvant CTx. Complication like deep vein thrombosis appeared in both groups with the same frequency (2/64). Between the two groups, there was no difference with respect to the surgical complication rate, which arose in 8 of 26 patients subsequent to CTx and 15 of 38 patients after resection only. Anastomotic leakage occurred in 12% after CTx and 11% after resection only. Also intestinal obstruction (3/64), delayed nourishment (5/64) and wound infection (8/64) weren't more frequent in the group with CTx (Table 3).
Overall recurrence rate was 52% (n = 33/64). CTx reduced the overall recurrence rate and was 39% in the neoadjuvant group versus 63% in the only surgery group (Table 4). Especially locoregional recurrence was reduced after chemotherapy and occurred in 12% versus 26% after resection only. Lymph node metastases merely occurred in only resected patients. However, peritoneal recurrence or distant metastases couldn't be prevented by CTx.
The overall survival was not improved by CTx (Figure 1). The 5-year survival rate was 38% after CTx versus 42% after surgery only. Not even a subgroup analysis comparing responders with only resected patients showed a benefit of CTx. The 5-year survival rate of responders was 44% versus the above mentioned 42% after surgery only. Non-responders to CTx had a worse survival rate of 20% (Figure 2).
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Figure 1.
Survival of patients with preoperative chemotherapy versus surgery alone (Log rank p = 0,580).
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Figure 2.
Survival of responders, non-responders and only resected patients (Log rank p = 0,283).
A subgroup analysis of patients with preoperative stage III tumors showed a significantly improved survival in responders to chemotherapy compared to patients without response (p = 0.002) (Figure 3).
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Figure 3.
Survival curves of responders, patients without neoadjuvant chemotherapy and non-responders to neoadjuvant chemotherapy with stage III UICC only (log rank p = 0,002).
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