Neoadjuvant chemotherapy (CT) and postoperative chemoradiation (PCRT) in locally advanced, resectable, gastric cancer (LAGC). Preliminary results of a pilot study

Abstract

15078 Background: Curative surgery is achieved in fewer than 50% of patients (pts) in LAGC. PCRT has shown significant improvement in disease control and survival but a limited impact on metastatic disease. To improve this results, a combined modality approach, including IORT, was planned. Methods: Pts with resectable LAGC (stage T3–4 and/or N+) were eligible. EGDS, EUS, abdomen CT were used for staging. 3 cycles of ECF (Epirubicin 50mg/mq, q 3wks; Cisplatin 60mg/mq, q 3wks and 21-day c.i. 5-FU 200mg/mq/day) were planned before radical surgery. IORT (10–15 Gy) included the high risk area defined at surgery. Postop RT included gastric area, anastomosis, duodenal stump and draining lymph node stations. RT (41.4–45 Gy in 23–25 fractions) and concurrent c.i. 5-FU (200 mg/mq/day) were administered. An oral caloric intake >= 1500 Kcal was provided. Results: From June 2001 to December 2006, 22 pts (13 M and 9 F), median age 64 yrs (41–74), with uT3N1 (21pts) and uT2N1 (1pt), entered the study. Tumor location was proximal in 10, lower in 8 and middle in 4 pts, respectively. All pts underwent the planned neoadjuvant ECF with a median of 3 cycles (range 3–5). Toxicity was moderate (<= grade 3) without toxic deaths: nausea and vomiting in 3%, mucositis in 3%, hematological in 7%. Twenty/22 pts underwent surgery (in progress in 2 pts) and 15 (75%) had R0 resection. Tumor downstaging was reported in 9/20 (45%) pts (8 pT2, 1pT1). IORT with 12.5 Gy (10–15 Gy) was given to 12 pts and 12 pts had PCRT. Eight pts were excluded from PCRT for postop complications (2 pts), disease progression (3 pts) or pN3 (3 pts). All 12 pts completed RT with a median dose of 41.4 Gy (41.4–56Gy), but 3 (25%) required RT interruption and 5 pts (40%) also definitive 5-FU interruption (overall PCRT compliance of 60%). Major toxicity from PCRT consisted of G3 asthenia and anorexia, requiring parenteral nutrition. Conclusions: Neoadjuvant CT confirmed feasible in LAGC and resulted in a substantial downstaging with a favourable R0 resection rate. Combined modality approach with IORT and PCRT appears attractive, but limited compliance to PCRT was observed. A definitive evaluation and data on disease control and survival will be reported. No significant financial relationships to disclose.