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Capecitabine and oxaliplatin as second-line treatment in patients with carcinoma of unknown primary site

Abstract Background. Treatment of patients with carcinoma of unknown primary site (CUP) remains a challenge, and no effective second-line treatment has been identified. In CUP patients who are non-responsive or relapse early after first-line platinum/taxane-based regimens, it is likely that gastrointestinal (GI) tract tumours may be overrepresented. These patients could be candidates for GI tract-directed therapy. We here report the results obtained with oxaliplatin and capecitabine as second-line therapy in 25 recurrent/refractory CUP patients following first-line treatment with paclitaxel, cisplatin and gemcitabine. Patients and methods. Patients received capecitabine orally (1000 mg/m2) twice daily, days 1–14, and oxaliplatin (130 mg/m2) intravenously on day 1 in a three-week schedule. Results. Twenty-five CUP patients received a median of three cycles of capecitabine and oxaliplatin as second-line treatment. Histopathological assessments suggested the primary site to be of GI tract origin in the majority of the patients (76%). We found an objective response rate of 13%, a median progression-free survival and overall survival rate of 2.3 and 3.9 months, respectively, and 32% of patients alive at one year after initiation of second-line therapy. The regimen was well tolerated by most patients. Conclusions. This study, demonstrates that there is still a significant need for improved second-line therapy in CUP patients.