TY - JOUR
T1 - Long-term analysis of gemcitabine-based chemoradiation after surgical resection for pancreatic adenocarcinoma
AU - Mattiucci, Gian Carlo
AU - Ippolito, Edy
AU - D'Agostino, Giuseppe Roberto
AU - Alfieri, Sergio
AU - Antinori, Armando
AU - Crucitti, Antonio
AU - Balducci, Mario
AU - Deodato, Francesco
AU - Luzi, Stefano
AU - Macchia, Gabriella
AU - Smaniotto, Daniela
AU - Morganti, Alessio Giuseppe
AU - Valentini, Vincenzo
PY - 2013/2
Y1 - 2013/2
N2 - Purpose: 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/m2) 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/m2 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.
AB - Purpose: 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/m2) 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/m2 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.
UR - http://www.scopus.com/inward/record.url?scp=84878865946&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84878865946&partnerID=8YFLogxK
U2 - 10.1245/s10434-012-2767-7
DO - 10.1245/s10434-012-2767-7
M3 - Article
C2 - 23208130
AN - SCOPUS:84878865946
VL - 20
SP - 423
EP - 429
JO - Annals of Surgical Oncology
JF - Annals of Surgical Oncology
SN - 1068-9265
IS - 2
ER -