ABSTRACT
PURPOSE: Based on the results of first-line chemotherapy for advanced pancreatic cancer, S-1 was confirmed to be non-inferior to gemcitabine. However, the recommended regimen of 4 weeks of administration followed by 2 weeks of drug withdrawal frequently causes adverse effects. On the other hand, we experienced in clinical practice that alternate-day administration of S-1 reduced adverse effects and were tolerable for advanced pancreatic cancer patients unwilling to continue the standard daily administration. We therefore conducted a multicenter cooperative prospective study to compare daily with alternate-day administration of S-1 for advanced pancreatic cancer. METHODS: Patients with advanced pancreatic cancer were eligible for enrollment in this trial. S-1 was administered at a dose of 40-60 mg twice daily, calculated according to body surface area, on Monday, Wednesday, Friday, and Sunday. Each treatment cycle was 42 days. The primary end point was overall survival (OS). Secondary end points were safety, response rate (RR), progression-free survival (PFS), and time to treatment failure (TTF). RESULTS: Forty-eight patients were evaluable for response. OS as the primary end point was 8.4 months (95 % CI 5.4-10.8), and the 1-year survival rate was 29.2 %. PFS was 5.5 months, and TTF was 3.9 months. RR was 10.4 %, and the disease control rate was 79.2 %. Grade 3/4 hematological and non-hematological toxicities were minor. All of these adverse reactions were tolerable and reversible. CONCLUSIONS: The current data demonstrate the mitigation of adverse effects with alternate-day administration of S-1, and this appears to be a more sustainable option for advanced pancreatic cancer.
Subject(s)
Antimetabolites, Antineoplastic/administration & dosage , Oxonic Acid/administration & dosage , Pancreatic Neoplasms/drug therapy , Tegafur/administration & dosage , Administration, Oral , Adult , Aged , Drug Combinations , Female , Humans , Male , Middle Aged , Neoplasm Metastasis , Oxonic Acid/adverse effects , Pancreatic Neoplasms/mortality , Pancreatic Neoplasms/pathology , Prospective Studies , Tegafur/adverse effectsABSTRACT
PURPOSE: Although the susceptibility to chemotherapy of unresectable/advanced pancreatic cancer is very poor, the usefulness of new anticancer drugs, such as S-1, has been reported in recent years. We clinically investigated whether or not S-1 would prolong survival in this study. OBJECTIVE: 17 unresectable pancreatic cancer patients who came for consultation between November 2001 and August 2008 (ten men, seven women). The average age was 72.5 years and performance statuses before medical treatment were 0-2. METHOD: A group of 8 patients did not use S-1 (non-S-1 group) and a group of a patients (S-1 group)did. The average survival period, one-year survival rate, and hospitalization rate were examined. RESULT: The average survival period of the non-S-1 group was 173.1 days, and its one-year survival rate was 12.5%, compared to 435.1 days and 55.6% in the S-1 group. The hospitalization rate was 25.6% in the S-1 group, against 53.1% in the non-S-1 group. DISCUSSION: S-1 treatment for unresectable/advanced pancreatic cancer served to prolong the survival period, suggesting it enabled extension of the recuperation-at-home period.
