Colitis associated with docetaxel-based chemotherapy in patients with metastatic breast cancer

Background Docetaxel and vinorelbine as combined treatment for metastatic b reast cancer can have the dose-limiting toxic effects of mucositis and neut ropenic fever. We report unexpected ischaemic colitis in six patients assoc iated with docetaxel-based therapy, three of whom were treated in a phase I study designed to establish the maximum tolerated dose of this combination with the prophylactic use of granulocyte-colony-stimulating factor. Methods Between August, 1997, and December, 1998, 14 patients with metastat ic breast cancer were treated with vinorelbine, docetaxel, and granulocyte- colony-stimulating factor in a phase I study. Three patients developed coli tis similar to that seen in typhlitis. Three additional patients were ident ified during scheduled review of toxic effects in patients participating in clinical trials involving docetaxel. Findings Three patients on combined vinorelbine and docetaxel developed col itis-like symptoms. Two patients died, one from necrotic bower and the othe r from neutropenic fever and colitis, Two of the patients presented on day 7 and day 8 of chemotherapy, respectively, with neutropenic fever and abdom inal pain; the third patient developed neutropenia without fever and abdomi nal pain on day 8. The other three patients were treated with docetaxel, do cetaxel and pamidronate disodium, or docetaxel and cyclophosphamide. All th ree patients presented with abdominal pain on days 10, 5, and 4, respective ly. One had non-neutropenic fever, another had neutropenic fever, and the t hird was afebrile and nonneutropenic at the time of presentation with abdom inal pain. Three patients had blood in their diarrhoea, abdominal tendernes s, or both. Computed tomography of the abdomen and pelvis showed features o f colitis in three patients. Interpretation This serious complication may result from the use of docetax el and may be exacerbated by its combination with vinorelbine. Study of hos pital-based patients treated with taxane-based chemotherapy is underway to find out the frequency of such complications.