title: Long-term analysis of gemcitabine-based chemoradiation after surgical resection for pancreatic adenocarcinoma.
abstract: OBJECTIVE
  To evaluate the efficacy in terms of local control (LC) of 24 h infusion of gemcitabine plus radiotherapy after surgery for pancreatic cancer.
  
  
  METHODS
  Weekly gemcitabine (100 mg/m(2)) was provided as a 24-hour infusion during the course of radiotherapy (50.4 Gy to the tumor, 39.6 Gy to the nodes). Patients subsequently received five cycles of gemcitabine monochemotherapy (1,000 mg/m(2) 1, 8, q21). The primary end point of the study was to achieve a 2-year LC rate of ≥80 % with type I and II errors of 5 and 20 %. The study was designed to accrue a maximum sample size of 35 patients. Secondary end points were toxicity evaluation, metastasis-free survival (MFS), and overall survival (OS).
  
  
  RESULTS
  Data of 35 patients were available. Most of the patients (n = 27; 77.1 %) had duodeno-cephalo-pancreatectomy, 5 (14.3 %) distal pancreatectomy, and 3 (8.6 %) total pancreatectomy. The pathological stages were T1-T2 (n = 7; 20.0 %), T3-T4 (n = 28; 80.0 %), N0 (n = 17; 48.6 %), and N1 (n = 18; 51.4 %). Thirty patients (85.7 %) completed chemoradiation. Twenty-three patients (65.7 %) received further sequential chemotherapy. Acute toxicity was acceptable. No late toxicity occurred. The median follow-up period was 64 (range 24-118) months, and 2-year crude rate of LC was 83 (median not reached). Median MFS and OS were 26.5 and 22.5 months, respectively.
  
  
  CONCLUSIONS
  The rate of LC met the main goal of the study. The regimen resulted in a high LC rate but failed to show a benefit in terms of OS or MFS, thus suggesting the need for a more intensified multimodal approach.
authors.affiliation: Department of Radiotherapy, Policlinico Universitario "Agostino Gemelli", Catholic University, Rome, Italy.
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Mattiucci
authors.forename: Edy
authors.initials: E
authors.lastname: Ippolito
authors.forename: Giuseppe Roberto
authors.initials: GR
authors.lastname: D'Agostino
authors.forename: Sergio
authors.initials: S
authors.lastname: Alfieri
authors.forename: Armando
authors.initials: A
authors.lastname: Antinori
authors.forename: Antonio
authors.initials: A
authors.lastname: Crucitti
authors.forename: Mario
authors.initials: M
authors.lastname: Balducci
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.forename: Stefano
authors.initials: S
authors.lastname: Luzi
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.forename: Daniela
authors.initials: D
authors.lastname: Smaniotto
authors.forename: Alessio Giuseppe
authors.initials: AG
authors.lastname: Morganti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D059248:Chemoradiotherapy; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D011379:Prognosis; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine