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Multicenter phase II trial of adjuvant therapy for resected pancreatic cancer using cisplatin, 5-fluorouracil, and interferon-alfa-2b-based chemoradiation: ACOSOG Trial Z05031.
- Source :
-
Annals of oncology : official journal of the European Society for Medical Oncology [Ann Oncol] 2011 Feb; Vol. 22 (2), pp. 348-54. Date of Electronic Publication: 2010 Jul 29. - Publication Year :
- 2011
-
Abstract
- Background: The American College of Surgeons Oncology Group sought to confirm the efficacy of a novel interferon-based chemoradiation regimen in a multicenter phase II trial.<br />Patients and Methods: Patients with resected (R0/R1) adenocarcinoma of the pancreatic head were treated with adjuvant interferon-alfa-2b (3 million units s.c. on days 1, 3, and 5 of each week for 5.5 weeks), cisplatin (30 mg/m(2) i.v. weekly for 6 weeks), and continuous infusion 5-fluorouracil (5-FU; 175 mg·m(2)/day for 38 days) concurrently with external-beam radiation (50.4 Gy). Chemoradiation was followed by two 6-week courses of continuous infusion 5-FU (200 mg·m(2)/day). The primary study end point was 18-month overall survival from protocol enrollment (OS18); an OS18 ≥65% was considered a positive study outcome.<br />Results: Eighty-nine patients were enrolled. Eighty-four patients were assessable for toxicity. The all-cause grade ≥3 toxicity rate was 95% (80 patients) during therapy. No long-term toxicity or toxicity-related deaths were noted. At 36-month median follow-up, the OS18 was 69% [95% confidence interval (CI) 60% to 80%]; the median disease-free survival and overall survival were 14.1 months (95% CI 11.0-20.1 months) and 25.4 months (95% CI 23.4-34.1 months), respectively.<br />Conclusions: Notwithstanding promising multi-institutional efficacy results, further development of this regimen will require additional modifications to mitigate toxic effects.
- Subjects :
- Adult
Aged
Aged, 80 and over
Chemotherapy, Adjuvant
Cisplatin administration & dosage
Combined Modality Therapy
Female
Fluorouracil administration & dosage
Humans
Interferon alpha-2
Interferon-alpha administration & dosage
Male
Middle Aged
Pancreatic Neoplasms radiotherapy
Pancreatic Neoplasms surgery
Recombinant Proteins
Survival Analysis
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Pancreatic Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1569-8041
- Volume :
- 22
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Annals of oncology : official journal of the European Society for Medical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 20670978
- Full Text :
- https://doi.org/10.1093/annonc/mdq384