Oxaliplatin and capecitabine in the treatment of patients with recurrent or refractory carcinoma of unknown primary site

BACKGROUND: Despite the widespread use of oxaliplatin‐based regimens for colorectal and other gastrointestinal cancers, there is surprisingly little information regarding their empiric use for the treatment of carcinoma of unknown primary site (CUP). In the current study, the combination of oxaliplatin and capecitabine in patients with recurrent and refractory CUP was examined. METHODS: Patients with CUP who had received at least 1 previous chemotherapy regimen were treated with oxaliplatin (130 mg/m2 intravenously on Day 1) and capecitabine (1000 mg/m2 orally twice daily on Days 1‐14). Treatment cycles were repeated every 21 days. Patients with objective response or stable disease after 2 cycles continued treatment for 6 cycles or until disease progression. RESULTS: Nine of 48 patients (19%) had objective responses to treatment; an additional 22 patients had stable disease at the time of first re‒evaluation. After a median follow‐up of 17 months, the median progression‐free and overall survivals were 3.7 months and 9.7 months, respectively. This regimen was reasonably well tolerated by most patients. CONCLUSIONS: The combination of oxaliplatin and capecitabine was found to have activity as a salvage treatment for patients with CUP. This regimen should be considered in patients with clinical and pathologic features suggesting a primary site in the gastrointestinal tract. Further development of the regimen as a first‐line therapy, or with bevacizumab added, is indicated. Cancer 2010. © 2010 American Cancer Society. Oxaliplatin‐based regimens are routinely used in the treatment of gastrointestinal cancers, but to the authors' knowledge, their empiric use in carcinoma of an unknown primary site (CUP) has not been evaluated. In this multicenter, community‐based phase 2 trial, the combination of oxaliplatin and capecitabine was found to have significant activity as a salvage treatment in patients with recurrent and refractory CUP and should be considered in patients with clinical and pathologic features suggesting a primary site in the gastrointestinal tract.