Gemcitabine-based combination chemotherapy followed by radiation with capecitabine as adjuvant therapy for resected pancreas cancer.
OBJECTIVE
To report outcomes for patients with resected pancreas cancer treated with an adjuvant regimen consisting of gemcitabine-based combination chemotherapy followed by capecitabine and radiation.


METHODS
We performed a retrospective review of a series of patients treated at a single institution with a common postoperative adjuvant program. Between January 2002 and August 2006, 43 resected pancreas cancer patients were offered treatment consisting of 4, 21-day cycles of gemcitabine 1 g/m(2) intravenously over 30 min on Days 1 and 8, with either cisplatin 35 mg/m(2) intravenously on Days 1 and 8 or capecitabine 1500 mg/m(2) orally in divided doses on Days 1-14. After completion of combination chemotherapy, patients received a course of radiotherapy (54 Gy) with concurrent capecitabine (1330 mg/m(2) orally in divided doses) day 1 to treatment completion.


RESULTS
Forty-one patients were treated. Median progression-free survival for the entire group was 21.7 months (95% confidence interval 13.9-34.5 months), and median overall survival was 45.9 months. In multivariate analysis a postoperative CA 19-9 level of >or=180 U/mL predicted relapse and death. Toxicity was mild, with only two hospitalizations during adjuvant therapy.


CONCLUSIONS
A postoperative adjuvant program using combination chemotherapy with gemcitabine and either cisplatin or capecitabine followed by radiotherapy with capecitabine is tolerable and efficacious and should be considered for Phase III testing in this group of patients.
Desai
Sameer
S
Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48109-0934, USA.
Ben-Josef
Edgar
E
Griffith
Kent A
KA
Simeone
Diane
D
Greenson
Joel K
JK
Francis
Isaac R
IR
Hampton
Janet
J
Colletti
Lisa
L
Chang
Alfred E
AE
Lawrence
Theodore S
TS
Zalupski
Mark M
MM
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy*; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D018714:Radiotherapy, Adjuvant; D012044:Regression Analysis; D012189:Retrospective Studies; D016896:Treatment Outcome; D000093542:Gemcitabine
D003841:Deoxycytidine; D000069287:Capecitabine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine