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Adjuvant
Neoadjuvant
Locally Adanced Unresectable
Metastatic
Newer agents...

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Resectable Neoadjuvant
5FU 300 mg/m2/day C.I. with radiation (30 Gy 10 fractions 5 days a week).
JCO 16:3843, 1998
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Resectable Adjuvant
5FU 500 mg/m2/day x 6 days with radiation (40 Gy)
Arch Surg 120: 899, 1985
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Unresectable Locally Advanced
5FU 200 mg/m2 C.I. per 24 hrs q Monday to Friday concurrently with XRT.
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Metastatic

SINGLE AGENT GEMCITIBINE

Gemcitibine 1000 mg/m2 weekly for up to 7 weeks
Follow by 1 rest week
Then Weekly X 3 Q4weeks until progression

J Clin Oncol 15:2403-13, 1997

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other approaches...

IRINOTECAN + GEMZAR (IRINOGEM)
(Phase I & II complete, Phase III started)

Irinotecan 100 mg/m2 DAYS 1 & 8 of 21 cycle
Gemcitibine 1000 mg/m2 DAYS 1 & 8 of 21 cycle


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TWICE-WEEKLY GEMCITBINE + XRT
(phase I)
Gemcitabine 40 mg/m2 by 30-minute intravenous infusion each Monday and Thursday for 5 weeks
concurrent with 50.4 Gy of radiation to the pancreas

J Clin Oncol 1999 Jul;17(7):2208-12
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PEF-G Regimen (Phase II)

CISPLATIN 40 mg/m2 day 1
EPIRUBICIN 40 mg/m2 day 1
GEMCITABINE 600 mg/m2 over 1 hour days 1, 8 Q 4 weeks
5FU 200 mg/m2 QD as a protracted venous infusion

JCO 19:2679, 2001
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Multicenter Randomized Phase III Trial Comparing Protracted Venous Infusion (PVI) Fluorouracil (5-FU) With PVI 5-FU Plus Mitomycin in Inoperable Pancreatic Cancer

PURPOSE: To compare protracted venous infusion (PVI) fluorouracil (5-FU) with PVI 5-FU plus mitomycin (MMC) in patients with advanced pancreatic cancer in a multicenter, prospectively randomized study.

PATIENTS AND METHODS: Two hundred eight patients were randomized to PVI 5-FU (300 mg/m2/d for a maximum of 24 weeks) or PVI 5-FU plus MMC (7 mg/m2 every 6 weeks for four courses). The major end points were tumor response, survival, toxicity, and quality of life (QOL).

RESULTS: The two treatment groups were balanced for baseline demographic factors, and 62% had metastatic disease. The overall response rate was 8.4% (95% confidence interval [CI]) 3.2% to 13.7% for patients treated with PVI 5-FU alone compared with 17.6%; 95% CI 10.3% to 25.1% for PVI 5-FU plus MMC (P = .04). Median failure-free survival was 2.8 months for PVI 5-FU and 3.8 months for PVI 5-FU plus MMC (P = .14). Median survival was 5.1 months for PVI 5-FU and 6.5 months for PVI 5-FU plus MMC (P = .34). Toxicities in both arms were mild. There was an increased incidence of neutropenia in the 5-FU plus MMC arm (P < .01), although no differences in infection were seen. No patients developed hemolytic uremic syndrome. Global QOL improved significantly after 24 weeks of treatment compared with baseline for patients receiving 5-FU plus MMC, although there was no statistically significant difference in QOL between arms.

CONCLUSION: PVI 5-FU plus MMC resulted in a superior response rate in comparison with PVI 5-FU alone in advanced pancreatic cancer, but this did not translate into a survival advantage. These results emphasize the importance of chemotherapy in this setting and the continuing value of the fluoropyrimidines in pancreatic cancer.

T1 2 cm or less
T2 more than 2 cm
T3 extends to duodenum, bile duct, peripancreatic tissue
T4 extends to stomach, spleen, colon, adjacent large vessels

STAGE
I T1-2 N0
II T3 N0
III T1-3 N1
IVA T4 any N
IVB M1