Single-agent paclitaxel in advanced anal cancer after failure of cisplatin and 5-fluorouracil chemotherapy.

Squamous cell cancer of the anal canal (anal cancer) is a rare disease but with worldwide increasing incidence. While combined therapy of 5-fluorouracil (5-FU), mitomycin, and radiation is the treatment of choice for locoregional anal cancer, the treatment of metastatic disease is less established. 5-FU and cisplatin combination has been adopted as the first-line treatment of choice for metastatic disease based on several phase II studies. However, no standard therapy has been established for stage IV anal cancer after the failure of this combination. Paclitaxel, a microtubule-stabilizing chemotherapeutic agent, has established clinical activity in squamous cell cancer of the head and neck. One prior report described the activity of paclitaxel in five patients with anal cancer. In this report, we describe our experience using this agent in seven patients suffering from metastatic anal cancer with prior progression on cisplatin and 5-FU. Four patients had an objective response and one patient experienced stable disease. Our results confirm activity of weekly-paclitaxel in patients with 5-FU and cisplatin-resistant metastatic anal cancer.