Purpose: To determine the efficacy and tolerance of a standardized protocol of chemotherapy and low-dose radiotherapy in the treatment of anal cancer in human immunodeficiency virus (HIV)-infected patients.
Methods and materials: Between 1987 and 1995, eight HIV-positive patients with squamous cell carcinoma of the anal canal, four of whom had acquired immunodeficiency syndrome (AIDS), received therapy at the Kaiser Permanente Medical Center. All patients were treated using a combined modality approach consisting of low-dose radiotherapy (30 Gy in 15 fractions delivered 5 days/week), and chemotherapy [1000 mg/m2 of 5-fluorouracil (5-FU) delivered on days 1-4 and 29-32 as a continuous infusion over 96 h, and 10 mg/m2 of mitomycin C delivered as a bolus injection on day 1]. Patients have been followed from 4 to 81 months (mean 41, median 38).
Results: All eight patients completed the therapy with minor variations to the protocol, and all have attained a clinical complete response. Four patients are alive and free of disease, and four died as a result of complications of AIDS, but remained free of anal carcinoma. There were no mortalities from the protocol and the morbidity was acceptable. Only one patient each was noted to have Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer Grade 4 hematologic and gastrointestinal acute toxicity, and no Grade 4 skin toxicity was noted.
Conclusion: This combined therapy is effective for HIV-infected patients and appears to be tolerable with acceptable toxicities. It is best applied to patients who are HIV positive, or who have AIDS without concurrent major opportunistic infections. This approach is reasonable and affords patients a reasonably good chance at sphincter preservation by avoiding abdominoperineal resection. The optimal therapy for HIV-positive patients with advanced AIDS remains less well defined.