BACKGROUND: Advanced pancreatic cancer has limited treatment options. 5-fluorouracil (5-FU) is frequently used in the treatment of pancreatic cancer. Preclinical studies suggest synergism between trimetrexate (TMTX),5-FU, and leucovorin (NFL). AIM: We conducted a phase II trial to evaluate the activity and safety of NFL in pancreatic cancer. METHOD: Eligible patients (n = 21) with untreated advanced pancreatic cancer were treated with 110 mg/m2 intravenous (IV) THTX on day 1 and 200 mg/m2 IV leucovorin prior to 500 mg/m2 IV 5-FU on day 2. Oral leucovorin (15 mg every 6 h for seven doses) started intravenous 24 h later. RESULTS: Treatment was administered for 6 wk followed by a 2-wk rest period. Response was evaluated every 8 wk. All patients were evaluable for response and toxicity. Most patients (80%) had distant metastases. Forty-five cycles of chemotherapy were administered. The most common serious toxicities were Grade 3 diarrhea (23.8%) and nausea and vomiting (14.2%). The response rate was 4.1% (95% CI, 0-23%), median survival was 6.8 mo, and 1-yr survival was 19%. CONCLUSION: Treatment with NFL is well-tolerated in patients with advanced pancreatic cancer. The median survival and 1-yr survival in these patients with poor prognosis compares favorably with other treatment options.
BACKGROUND: Advanced pancreatic cancer has limited treatment options. 5-fluorouracil (5-FU) is frequently used in the treatment of pancreatic cancer. Preclinical studies suggest synergism between trimetrexate (TMTX),5-FU, and leucovorin (NFL). AIM: We conducted a phase II trial to evaluate the activity and safety of NFL in pancreatic cancer. METHOD: Eligible patients (n = 21) with untreated advanced pancreatic cancer were treated with 110 mg/m2 intravenous (IV) THTX on day 1 and 200 mg/m2 IV leucovorin prior to 500 mg/m2 IV 5-FU on day 2. Oral leucovorin (15 mg every 6 h for seven doses) started intravenous 24 h later. RESULTS: Treatment was administered for 6 wk followed by a 2-wk rest period. Response was evaluated every 8 wk. All patients were evaluable for response and toxicity. Most patients (80%) had distant metastases. Forty-five cycles of chemotherapy were administered. The most common serious toxicities were Grade 3 diarrhea (23.8%) and nausea and vomiting (14.2%). The response rate was 4.1% (95% CI, 0-23%), median survival was 6.8 mo, and 1-yr survival was 19%. CONCLUSION: Treatment with NFL is well-tolerated in patients with advanced pancreatic cancer. The median survival and 1-yr survival in these patients with poor prognosis compares favorably with other treatment options.
Authors: M Reni; P Passoni; M G Panucci; R Nicoletti; L Galli; G Balzano; A Zerbi; V Di Carlo; E Villa Journal: J Clin Oncol Date: 2001-05-15 Impact factor: 44.544
Authors: H Oettle; M Arning; U Pelzer; D Arnold; C Stroszczynski; J Langrehr; P Reitzig; M Kindler; J Herrenberger; R Musch; E W Korsten; D Huhn; H Riess Journal: Ann Oncol Date: 2000-10 Impact factor: 32.976
Authors: A Marantz; S Jovtis; E Almira; L Balbiani; J L Castilla; L Fein; D Lewi; G Pasccon; R Pinckevicius; G Uranga; M Abal; M Muiño; M Reale; S Agusto Journal: Semin Oncol Date: 2001-06 Impact factor: 4.929
Authors: Jordan D Berlin; Paul Catalano; James P Thomas; John W Kugler; Daniel G Haller; Al Bowen Benson Journal: J Clin Oncol Date: 2002-08-01 Impact factor: 44.544