5-fluorouracile and cisplatinum combination chemotherapy for metastatic squamous-cell anal cancer

Anal cancers (AC) represent rare gastrointestinal tumors and there ave only a few studies dealing with the treatment of AC at the metastatic stage. We report here the results of one chemotherapy regimen bared on the experienc e of the Gustave-Roussy institute. Between 1985 and 1996, 19 patients: 3 ma les, 16 females, have been treated with a combination of 5-fluorouracil (5F U) and cisplatinum (CDDP) (FUP regimen). Their median age was 58, their per formance status (WHO grade: G) was G0-1 in 68% and G2 in 32% of the cases. Metastasis were synchroneous in 6 cases and metachroneous in 13 cases. Meta static sites were the liver (10 cases), the lymph nodes 11 cases (paraaorti c 5, iliac 4 and inguinal 2) and pulmonary in 3 cases; in 3 cases the lymph nodes metastasis were isolated in 7 cases the liver metastasis were isolat ed. One patient received FUP as an adjuvant treatment has been only conside red for toxicity and survival The FUP regimen combined an IV 5FU continuous infusion (1 g/m(2)/d (5 days) and a short infusion of CDDP (100 mg/m(2)) o n day 2, every 4 weeks: 10 patients received further local treatment Accord ing to WHO criteria, 18 patients were evaluable for the efficacy and 19 for the tolerance. The median number of cycles was 4. The response rate was 66 % (standard error: 22%) with 1 complete response and 11 partial response; t here were also 4 stabilisations and 2 progressions. Toxicity rate was neutr openia grade (G) 3-4 in 13% of the patients without febrile neutropenia, G3 nausea in 30%, no G2 or 3 mucositis or diarrhoea, and 2 patients experienc ed a nephrotoxicity G1-2. The actuarial survival was 62.2% at 1 year and 32 .2% at 5 years and the median survival was 34.5 months. Three patients are still alive at 4, 5 and 7 years and benefited from additional local treatme nt (the patient treated with adjuvant chemotherapy after hepatic resection and 2 patients treated after response to the FUP regimen, by surgery or rad iotherapy). The FUP combination gave a high response rate with an acceptabl e toxicity in patients with metastatic anal cancer Combined with local trea tment it does allow prolonged survivals for some patients.