No abstract

46 Background: We previously reported results of a randomized study showing that CX is equally active to ECX in terms of progression-free survival (PFS) (Yun et al. Eur J Cancer. 2010). Here we report updated overall survival (OS) results with an additional 12 months' follow-up. Methods: Ninety-one chemotherapy-naïve patients with histologically-confirmed, measurable AGC were randomized to receive CX (cisplatin 75 mg/m2 iv on day 1 and capecitabine 1,000 mg/m2 bid po on days 1-14, n=45) or ECX (epirubicin 50 mg/m2 plus CX, n=44) every 3 weeks. After CX or ECX had failed, second-line chemotherapy (SLC) was recommended for all patients if their performance status was preserved. Results: Treatment duration was similar for both arms (4.4 for CX v 4.2 months for ECX). There was no relevant difference in the occurrence of overall grade 3 or 4 toxicities between the CX and ECX arms (80% v 78%, respectively; p=0.516). However, none in the CX and 12% in the ECX arm discontinued treatment because of toxicity. There were no significant differences in therapeutic efficacy between CX and ECX with respect to the response rate (38% v 37%, respectively), PFS (6.4 v 6.5 months), as well as OS (12.7 v 13.8 months; p=0.51). After failure, 60% of patients (26 CX and 28 ECX patients) received SLC. However, OS was not differed whether a patient was treated with SLC or not (13.1 v 11.2 months; p=0.94). Conclusions: The present analysis confirms previous findings that both CX and ECX appear to be comparatively active as first-line chemotherapy for AGC. Furthermore, the role of SLC in AGC warrants further evaluation. No significant financial relationships to disclose.

No abstract

e15558 Background: We evaluated safety and efficacy of concurrent chemoradiotherapy (CCRT) with capecitabine in patients with locally advanced pancreatic cancer (LAPC). We also tried to devise a prognostic model for LAPC undergoing definitive CCRT. Methods: Between January 2004 and January 2008, 39 patients with LAPC treated with capecitabine CCRT were reviewed. Capecitabine was administered at 850 mg/m2 bid every day for 5 weeks. Radiotherapy was given 5 days per week, at 1.8 Gy fractions, over the 5 weeks. Results: Thirty seven (94.8%) patients completed CCRT, and 2 patients removed during the treatment for toxicity issues. Of the 36 evaluable patients, 15 (41.7 %) patients achieved partial response, and 13 (36.1 %) had a stable disease with 77.8% of disease control rate. Among the 28 patients who had achieved disease control after CCRT, 8 patients (21.6 %) received gemcitabine-based post-CCRT chemotherapy without dose reduction or delay. With median 1.8 years of follow- up, the overall survival was 14.3 months (95% confidence interval [CI]; 10.6–17.9 months). Median progression free survival was 11.1 (95% CI 7.2–15.1) for all patients, and 7.9 months (95% CI 6.6–9.2) for those not received post-CCRT chemotherapy. No patient had grade 4 hematologic or non-hematologic toxicity. Eight patients (21.6%) had severe grade 3 toxicities, 7 (18.9%) with gastrointestinal toxicity and 1 (2.7%) with hematologic toxicity. Prognostic factors for survival were serum albumin (P=0.014; relative risk [RR], 3.4; 95% CI, 1.4, 8.6), and adjuvant gemcitabine treatment (P = 0.005; RR, 3.5; 95% CI, 1.2, 10.6). The prognostic grouping resulted in three groups with significantly different prognosis: group 1 (0 adverse factor; n=8; 1-year survival, 87.5%), group 2 (1 adverse factor; n=23; 1-year survival, 52.9%) and group 3 (2 adverse factors; n=8; 1-year survival, 25.0%). Conclusions: Combined therapy with capecitabine CCRT was well tolerated. Capecitabine seems to be a promising regimen in the treatment of LAPC, in terms of response, survival, and tolerable adverse effects. No significant financial relationships to disclose.