Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4140
© 2005 American Society of Clinical Oncology

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Abstract

Phase II study to evaluate the efficacy and toxicity of oxaliplatin in combination with gemcitabine (GEMOX) in cancer of unknown primary (CUP)

MD Anderson Cancer Ctr, Houston, TX

4140

Background: CUP patients (3–5% of all cancers) show response rates with combination chemotherapy ranging from 20–30% with little impact on median survival. We are evaluating GEMOX in this population since the combination shows synergy in preclinical studies, is well tolerated and is active in pancreatic and lung cancer (common primaries in CUP). Methods: Patients with a metastatic CUP diagnosis who were chemo naive or had received one previous therapy were eligible. Women with axillary only nodes were excluded. Results: 16 patients are enrolled in the study so far. All are evaluable for toxicity and 14 patients who have had at least one post-treatment CT scan are evaluable for response. Median age is 56 yrs. 63% of patients have adenocarcinoma, 6% squamous carcinoma and rest have undifferentiated tumors. 93% of patients have an ECOG performance status of 0–1. 4/16 patients (25%) of the patients have 4 or more organs involved in the metastatic process. 11 patients have received GEMOX first line and 5 patients have received GEMOX second line. The overall response rate is 36% with an additional 7% and 29% showing a minor response and stable disease respectively. Median TTP is 10.3 weeks for the combined group. Grade 3–4 hematologic toxicity was seen in 4/16 (25%) patients (3 patients with neutropenia and 1 patient with thrombocytopenia). The only significant non-hematologic toxicity was grade 3 nausea in 4/16 (25%) patients. 10/16 (63%) patients showed grade 1–2 sensory neuropathy. Conclusions: Preliminary data suggest that Gemcitabine-Oxaliplatin is an active and well-tolerated combination in patients with CUP. Additional patients will be accrued.

No significant financial relationships to disclose.