Xeloda ® monotherapy in pancreatic cancer: phase II study  42 patients with advanced/metastatic pancreatic cancer received intermittent Xeloda 1,250mg/m 2 twice daily  Three patients (7%) achieved confirmed partial responses  17 patients (40%) achieved disease stabilisation (lasting  12 weeks in 11 patients)  Xeloda provided additional clinical benefit and symptomatic relief –CBR scores were positive in 24%, stable in 38% –pain intensity scores were positive in 29%, stable in 60%  Adverse events included diarrhoea, hand-foot syndrome and nausea Cartwright T. Proc Am Soc Clin Oncol 2000;19:264a (Abst 1026) CBR = Clinical Benefit Response

Xeloda ® plus gemcitabine in pancreatic cancer: phase I study  Xeloda and gemcitabine demonstrated synergistic activity in preclinical studies  Phase I study in 27 patients with previously untreated advanced pancreatic cancer  The dose-limiting toxicities were neutropenia and mucositis  Recommended regimen is a 21-day cycle of –Xeloda 650mg/m 2 twice daily, days 1–14 –i.v. gemcitabine 1,000mg/m 2, days 1 and 8  Objective responses occurred in six (29%) of 21 patients evaluable to date  The regimen will be compared with gemcitabine monotherapy in a phase III trial Herrmann R et al. Proc Am Soc Clin Oncol 2000;19:267a (Abst 1038)

Xeloda ® in pancreatic cancer: summary  Impressive tumour response rates are achieved especially in combination with gemcitabine  Additional clinical benefits include –symptomatic relief (positive CBR score) –reduction in pain intensity  Xeloda is well tolerated as monotherapy and in combination with gemcitabine and warrants further evaluation in patients with pancreatic cancer

Xeloda ® in ovarian cancer: phase II study  Open label phase II trial of intermittent Xeloda 1,250 mg/m 2 twice daily in 21 patients with platinum- and taxane-pretreated ovarian cancer  CA-125 response (according to Rustin criteria) in six (32%) of 19 evaluable patients  Radiologically confirmed tumour responses in two (22%) of 9 patients with measurable disease  No grade 4 adverse events  Further studies are warranted –first-line combination regimens (e.g., platinum, taxanes) –as an alternative to more toxic, i.v. regimens in the palliative setting Vasey PA et al. Ann Oncol 2000;11 (Suppl. 4):84 (Abst 373)

Xeloda ® in renal cell cancer: phase II summary  Overall response rate of 34% –complete response in two patients (7%) –partial response in eight patients (27%)  Stable disease in an additional 12 patients (40%)  No grade 4 adverse events; grade 3 in only two patients (malaise, malaise/nausea/vomiting)  No patients required Xeloda dose modification  A randomised trial has been initiated to further investigate Xeloda in renal cell carcinoma Övermann K et al. Br J Cancer 2000;83:583–7

Xeloda ® monotherapy in renal cell cancer: phase II study  Pilot study of intermittent Xeloda 1,250mg/m 2 twice daily in 22 patients with metastatic renal cell cancer progressing following immunotherapy  At ASCO 2000, response and efficacy data were reported for 12 patients receiving a median of six cycles –one partial response and disease stabilisation in 10 patients for a median >3 months –no grade 4 adverse events –only two grade 3 adverse events (hand-foot syndrome)  Xeloda is clinically active and well tolerated in this setting Wenzel C et al. Proc Am Soc Clin Oncol 2000;19:368a (Abst 1457)

Xeloda ® in other tumour types  Colorectal  Breast  Gastric  Pancreatic  Endocrine  Oesophageal  Head and neck  Ovarian  Cervical  Renal  Prostate  Mesothelioma  Hepatocellular  Biliary tract Worldwide Xeloda monotherapy and combination clinical trials are planned or ongoing in the following tumour types