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Conrad Notes
a timely medical meeting newsletter
ADJUVANT THERAPY OF COLON CANCER
Research pearls
D.G. Haller, MD, Univ of Pennsylvania Cancer Center, Philadelphia, reviewed recently published data, outlined a proposed evidence-based surveillance program to follow colon cancer surgery, and identified two promising therapies. Interim results from Study INT 0089 and other trials support a 6-month regimen of 5-fluorouracil (5-FU) and leucovorin (LV) for stage III colon cancer, compared to 12 months' of 5-FU with levamisole (LEV). Pelvic radiation therapy, given either before or after surgery in high-risk rectal cancer patients, awaits results from ongoing studies.

Study INT 0089 compared four FU-based regimens in nearly 3800 high-risk stage II and stage III colon cancer patients. One group received postoperatively 12 months' treatment with 5-FU and levamisole (LEV). The 6 months' group had one of three regimens, 5-FU with low dose leucovorin (5-FU/LDLV), 5-FU with high dose leucovorin (5-FU/HDLV), or 5-FU/LDLV/LEV.

Based on a recent interim analysis (Proc ASCO 1997; 16:211, Abst No. 940), 6 months of 5-FU/LV seems as effective as 12 months of 5-FU/LEV. A final analysis is planned for mid-1997.

As seen below, grade 3/4 granulocytopenia and stomatitis occurred less frequently in patients treated with 5-FU/HDLV:

Percent Reported
5-FU-Based
Granulocytopenia
Stomatitis
Diarrhea

LDLV
25


18


22

HDLV
5


2


30

LEV
20


5


10

LDLV/LEV
30


23


17

Age-related infection and toxicity

Haller reported unpublished safety data on patients treated with the adjuvant regimens given in INT-0089:


Percent Reported
Age(y)
No.
Infection
Diarrhea
Stomatitis
Leukopenia
<40
161

1.2

19

4

2
40-70
2580

2.2

20

10

8
>70
898

4.4

23

16

14


p value
<0.05
0.32
0.001
<0.001

The >70 year-old group showed significantly higher percentages of infection, stomatitis and leukopenia, but were able to complete therapy in the same proportion as younger individuals.

Innovations in chemotherapy

The treatment of colon cancer has made a significant advance with the evaluation of 5-FU. Buyse et al conducted a meta-analysis on the results from controlled trials on 5-FU alone or combined with other drugs (JAMA 1988; 259:3571-3578). The analysis covered English language reports published up to 1987. Using 5-FU alone or in combination led to a survival advantage of 2.3% compared with surgery alone. This advantage later rose to 12% to 15% from the combination of 5-FU with LEV, according to Haller, owing to improved administration techniques and quality of clinical studies.

Therapies in research range from monoclonal antibody 17-1a which mimics IgG antibodies to tegafur (prodrug or precursor of 5-FU) with uracil.

Eugene A. Conrad

Presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) on May 17-20, 1997
CONRAD NOTES, © 1997 All Rights Reserved
Eugene A. Conrad, PhD, MPH / ISSN 1078 / June 1997

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