PURPOSE: With improved antiretroviral therapy, HIV-positive patients are ac
hieving a longer life expectancy. An increased incidence of anal squamous c
ell carcinomas has been noted in these patients. The purpose of this study
was to determine the outcome of HIV-positive patients with anal squamous ce
ll carcinomas. METHODS: We conducted a review based on our tumor registry f
rom 1980 through 1999. We identified 73 patients with anal squamous cell. c
arcinoma treated at the University of Texas Southwestern Medical Center aff
iliated hospitals; 23 were HIV positive (18 had AIDS). In the HIV-positive
group, 9 had in situ squamous carcinomas and 14 had invasive squamous cell
carcinomas. Data collected included age, CD4 count, treatment, complication
s, and survival; these data were analyzed by Student's t-test. RESULTS: All
patients were male. Those with squamous cell cancer of the anus were offer
ed radiation therapy and chemotherapy. Beginning in 1998, all patients rece
ived highly active antiretroviral therapy before treatment. Seven of 14 ana
l squamous cell carcinoma patients had their therapy adjusted owing to toxi
city. Morbidity included proctocolitis and diarrhea (n = 2) requiring diver
sion (n = 1), hemorrhagic cystitis (n = 1), neutropenic fever (n = 3), bone
marrow suppression (n = 1), and urethral stricture (n = 1). Mean age was 4
2 years for anal squamous cell carcinoma patients and 36 years for squamous
cell carcinoma in situ patients (P = 0.05). Mean CD4 count was 222 cells/m
l in patients with infiltrating carcinoma and 200 in the in situ patients (
P = NS). One-year and five-year mortality rates, respectively, were 40 perc
ent and 80 percent for infiltrating carcinoma patients and 17 per cent and
50 percent for the in situ patients. Both of the in situ patients who died
had CD4 counts <20 cells/ml at diagnosis, whereas the rest had CD4 counts >
100 cells/ml and are currently without anal disease. Mean CD4 count at diag
nosis for all patients who died was 133 cells/ml, whereas for those survivi
ng, it was 261 cells/ml (P = 0.03). Eight (all with infiltrating carcinoma)
of the 10 patients who died had persistent anal disease, but none had meta
stasis. CONCLUSION: HIV-positive patients with in situ carcino mas present
at an earlier age than those with infiltrating lesions. In situ patients wi
th CD4 counts as low as 105 cells/ml do well with local excision. A low CD4
count at diagnosis without highly active antiretroviral therapy predicts a
poor prognosis. Because these patients appear to succumb to their HIV stat
us and not the and disease, anal squamous cell carcinoma should be included
with cervical squamous cell carcinoma as an AIDS-defining illness. HIV-pos
itive patients, particularly AIDS patients, with invasive anal cancers and
without effective antiretroviral therapy obtain little benefit and signific
ant toxicity from current radiation therapy and chemotherapy. Initiation of
highly active antiretroviral therapy in HIV-positive patients before radia
tion therapy and chemotherapy are begun may decrease toxicity and improve s
urvival. Additional clinical trials are warranted to test this theory.