title: A phase II/III study comparing intravenous ZD9331 with gemcitabine in patients with pancreatic cancer.
abstract: ZD9331 is a novel antifolate inhibitor of thymidylate synthase (TS). This multicentre, randomised, phase II/III study compared the efficacy and safety of ZD9331 with gemcitabine in 55 patients with chemonai;ve, locally advanced or metastatic pancreatic cancer. Patients received intravenous (i.v.) ZD9331 (n=30), on days 1 and 8 of a 3-week cycle or i.v. gemcitabine (n=25), once a week for 7 weeks followed by a 1-week rest, then on days 1, 8 and 15 of a 4-week cycle. Objective tumour response and clinical benefit response (CBR) were similar for both groups. More ZD9331 patients were alive at the data cut-off point compared with gemcitabine patients (13 and 8%, respectively). Median survival (152 versus 109 days, respectively) and time to progression (70 versus 58 days, respectively) were longer in the ZD9331 group. Nausea and vomiting (grade 1/2) were the most common toxicities in both groups. These results suggest that, in pancreatic cancer, ZD9331 is equivalent to gemcitabine and may offer a promising alternative to current therapies.
authors.affiliation: Clatterbridge Centre for Oncology, Clatterbridge Road, Bebington, Wirral, Cheshire CH63 4JY, UK. daves@ccotrust.co.uk
authors.forename: D
authors.initials: D
authors.lastname: Smith
authors.forename: N
authors.initials: N
authors.lastname: Gallagher
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D011799:Quinazolines; C094299:ZD 9331; D003841:Deoxycytidine; D000093542:Gemcitabine