Preoperative gemcitabine-based chemoradiation for patients with resectable adenocarcinoma of the pancreatic head.
OBJECTIVE
We conducted a phase II trial to assess the outcomes of patients who received preoperative gemcitabine-based chemoradiation and pancreaticoduodenectomy (PD) for stage I/II pancreatic adenocarcinoma.


METHODS
Eligible patients with pancreatic head/uncinate process adenocarcinoma and radiographically defined potentially resectable disease received chemoradiation with 7 weekly intravenous (IV) infusions of gemcitabine (400 mg/m(2) IV over 30 minutes) plus radiation therapy (30 Gy in 10 fractions over 2 weeks). Patients underwent restaging 4 to 6 weeks after completion of chemoradiation and, in the absence of disease progression, were taken to surgery.


RESULTS
The study enrolled 86 patients. At the time of restaging, disease progression or a decline in performance status precluded 13 patients from surgery. Seventy-three (85%) of 86 patients were taken to surgery, extrapancreatic disease was found in nine, and 64 (74%) of 86 underwent a successful PD. Median overall survival (86 patients) was 22.7 months with a 27% 5-year survival. Median survival was 34 months for the 64 patients who underwent PD and 7 months for the 22 unresected patients (P < .001). The 5-year survival for those who did and did not undergo PD was 36% and 0%, respectively.


CONCLUSIONS
Preoperative gemcitabine-based chemoradiation followed by restaging and evaluation for surgery separated the study population into two different subsets: patients likely to benefit from PD (n = 64) and those in whom surgery would be unlikely to provide clinical benefit (n = 22). Furthermore, the encouraging overall survival observed in this large trial supports the continued investigation of gemcitabine-based preoperative therapy in resectable pancreatic cancer.
Evans
Douglas B
DB
Department of Surgical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA. devans@mdanderson.org
Varadhachary
Gauri R
GR
Crane
Christopher H
CH
Sun
Charlotte C
CC
Lee
Jeffrey E
JE
Pisters
Peter W T
PW
Vauthey
Jean-Nicolas
JN
Wang
Huamin
H
Cleary
Karen R
KR
Staerkel
Gregg A
GA
Charnsangavej
Chusilp
C
Lano
Elizabeth A
EA
Ho
Linus
L
Lenzi
Renato
R
Abbruzzese
James L
JL
Wolff
Robert A
RA
D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods*; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016577:Pancreaticoduodenectomy; D011300:Preoperative Care / Q000379:methods*; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects / Q000379:methods; D000093542:Gemcitabine
D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000093542:Gemcitabine