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Fluorouracil (5 - FU) / Mitomycin C / XRT
Abstract: Epidermoid anal cancer: results from the UKCCCR
randomised trial of radiotherapy alone versus radiotherapy,
5-fluorouracil, and mitomycin. UKCCCR Anal Cancer Trial Working
Party. UK Co-ordinating Committee on Cancer Research.
BACKGROUND: Non-surgical management of anal cancer by radiotherapy alone or
combined with chemotherapy has, in uncontrolled studies, yielded similar local
tumour control and survival rates to surgery. However, whether the addition of
chemotherapy improves outcome without adding to morbidity is not known. Our
trial was designed to compare combined modality therapy (CMT) with radiotherapy
alone in patients with epidermoid anal cancer. METHODS: From 856 patients
considered for entry to our multicentre trial,
585 patients were
randomised to receive initially either 45 Gy radiotherapy in twenty or
twenty-five fractions over 4-5 weeks (290 patients) or the same regimen of
radiotherapy combined with 5-fluorouracil (1000 mg/m2 for 4 days or 750 mg/m2
for 5 days) by continuous infusion during the first and the final weeks of
radiotherapy and mitomycin (12 mg/m2) on day 1 of the first course (295
patients). We assessed clinical response 6 weeks after initial treatment: good
responders were recommended for boost radiotherapy and poor responders for
salvage surgery. The main endpoint was local-failure rate (> or = 6 weeks after
initial treatment); secondary endpoints were overall and cause-specific
survival. Analysis was by intention-to-treat. FINDINGS: In the radiotherapy and
CMT arms, respectively, five and three were ineligible, and six and nine died 6
weeks after initial treatment. After a median follow-up of 42 months (interquartile
range 28-62), 164 of 279 (59%)
radiotherapy patients had a local failure compared with 101 of 283 (36%)
CMT patients. This gave a 46% reduction in the risk of local failure in the
patients receiving CMT (relative risk 0.54, 95% CI 0.42-0.69, p < 0.0001). The
risk of death from anal cancer was also reduced in the CMT arm (0.71, 0.53-0.95,
p = 0.02). There was
no overall survival advantage
(0.86, 0.67-1.11, p = 0.25). Early morbidity was significantly more frequent in
the CMT arm (p = 0.03), but late morbidity occurred at similar rates.
INTERPRETATION: Our trial shows that the standard treatment for most patients
with epidermoid anal cancer should be a combination of radiotherapy and infused
5-fluorouracil and mitomycin, with surgery reserved for those who fall on this
regimen.
References
UKCCCR Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer
Research. Epidermoid anal cancer: results from the UKCCCR randomised trial of
radiotherapy alone versus radiotherapy, 5-fluorouracil, and mitomycin. UKCCCR
Anal Cancer Trial Working Party. UK Co-ordinating Committee on Cancer Research.
Lancet; 348(9034):1049-54
1996
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| Regimen |
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5 - FU 1000 mg / M2 / d CIV (X 4 days) days 1 - 4 & 29 - 32
Mitomycin C 10 mg / M2 IV days 1,29
- maximum dose of mitomycin C is 20 mg
- given concurrently with XRT to 45 Gy over 5 weeks
If residual tumor is present on post - therapy biopsy:
5 - FU 1000 mg / M2 / d CIV (X 4 days) days 1 - 4
Cisplatin 100 mg / M2 IV day 2
- given with XRT boost of 9 Gy over 5 days |
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Summary |
Randomized
trial of radiotherapy vs. radiotherapy + 5FU + Mitomycin C for anal cancer. |
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Local failure rate |
36% for CMT vs.
59% for radiotherapy alone |
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Overall Survival |
No difference |
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Toxicity |
Early morbidity
was significantly more frequent in the CMT arm, but late morbidity occurred
at similar rates. |
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