PURPOSE: Patients diagnosed as having anal cancer and human immunodefi
ciency virus (HIV)-positive disease were evaluated for response to tre
atment and its associated toxicity. METHODS: We studied nine HIV-posit
ive patients with squamous-cell carcinoma of the anus. Among them, thr
ee patients had acquired immunodeficiency syndrome (AIDS). The stage o
f disease at presentation included: one Stage 0, two Stage I, two Stag
e II, and four Stage III patients. Seven patients received combined mo
dality treatment, i.e., radiation therapy and chemotherapy, and two pa
tients received radiation therapy alone. The radiation therapy field i
ncluded the pelvis and a conedown boost. Chemotherapy consisted of two
cycles of 5-fluorouracil and mitomycin C. Patients have been followed
from 2 to 42 (median, 8) months. RESULTS: Seven patients achieved a c
omplete response clinically. All Stage I/II patients and one of four S
tage III patients remain alive and have no evidence of disease. Radiat
ion Therapy Oncology Group/European Organization for the Research and
Treatment of Cancer Grades 3 and 4 skin toxicity were noted in six pat
ients, and Grades 2 and 3 myelosuppression were noted in eight patient
s. The response rates achieved are comparable to the experience in non
-HIV patients reported in the literature, but toxicity seems to be inc
reased. CONCLUSION: It would seem reasonable to offer combined modalit
y treatment to early stage, HN-positive patients with good performance
status and a history of minor opportunistic infections. The value of
combined modality in AIDS patients and those who present with advanced
stages of the disease is questionable.