Their median age was 57 years, and 42 of 45 patients (93.3%) had a good performance status (ECOG www.selleckchem.com/products/Trichostatin-A.html 0 or 1). Ten patients had recurrent disease after previous curative gastrectomy and nine had previous adjuvant chemotherapy (three FAM, five doxifluridine or 5-FU plus cisplatin, and one doxifluridine plus mitomycin-C). The median disease-free interval of relapsed patients was 33.0 months (range=16.4�C55.6 months). Twenty-six patients (57.8%) had multiple metastases involving two or more organs, with the abdominal lymph nodes and liver being the most common sites of metastases. Table 1 Patient characteristics (n=45) Efficacy and survival A total of 43 patients were assessable for response (Table 2).

Of the two patients not assessable, one was lost to follow-up after the first cycle of treatment, and the other died after the first cycle of unknown cause, although brain metastasis was suspected. Of the 43 assessable patients, 2 achieved CR and 20 achieved PR, giving an overall response rate of 48.9% (95% CI=30.3�C63.5%) in the ITT population. Table 2 Antitumour activity There was no difference in overall response rate between patients who were pretreated and who were not with adjuvant chemotherapy (33.3 vs 52.8%, P=0.459 by Fisher’s exact test). The median duration of response in the 22 responding patients was 6.1 months (range=2.9�C12.4 months). The median follow-up period was 42.2 months (range=31.2�C54.3 months). The median TTP for all patients was 5.6 months (95% CI=3.9�C7.2 months) (Figure 1), and the median OS was 11.3 months (95% CI=8.1�C14.

4 months) (Figure 2), with a 1-year survival rate of 46.0% (95% CI=31.4�C60.6%). Figure 1 Time to progression for all patients. Figure 2 Overall survival for all patients. Poststudy treatment After disease progression, 28 patients (62.2%). received second-line chemotherapy, most commonly with irinotecan (21 patients; 75%) in combination with cisplatin/mitomycin-C or 5-FU/LV. Two patients (7.1%) achieved PR and 5 (17.9%) had stable disease in response to second-line chemotherapy, the median TTP was 1.5 months (95% CI=1.3�C1.8 months). Batimastat Three patients (6.7%) received palliative radiotherapy, and one patient underwent total gastrectomy due to cancer bleeding. Adverse events A total of 248 treatment cycles (median=6; range=1�C9 cycles) were administered, with 246 cycles and 43 patients assessable for safety. The frequencies of haematological and non-haematological adverse events are shown in Table 3 and and4,4, respectively. The most common haematological adverse event was neutropaenia, which occurred at grade 3 or 4 intensity in 20 patients (46.5%) and during 51 cycles (20.7%). No patient experienced febrile neutropaenia. There were no treatment-related deaths.