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A trial of gemcitabine (gems) in combination with cisplatin for treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)



A trial of gemcitabine (gems) in combination with cisplatin for treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC)



Journal of Clinical Oncology 24(18_Suppl): 15505-15505



NlmCategory="UNASSIGNED">15505 Aims: To determine the efficacy of gemcitabine in combination with cisplatin, and to assess the safety profile of the regimen as the first-line treatment in patients with recurrent/metastatic HNSCC. An open-label, non-comparative, multi-center phase II study for patients with histologically proven recurrent/metastatic HNSCC without prior treatment for their recurrent/metastatic disease. In this trial, 1250 mg/m2 gemcitabine was administered alone on day 1 and day 8 and 80 mg/m2 cisplatin would follow gemcitabine on day 8, to be repeated in cycles of 21 days until disease progression, intolerable toxicity, or consent withdrawal. Between 04/2004 and 09/2005, 34 patients were enrolled in this study. 33 patients have completed the study treatment. Characteristics of the 33 patients: male- 33; median age- 51 years (range 38-65); 30 pts had a performance status (PS) of 0 or 1 and 3 had a PS of 2 (ECOG scale); histology: recurrent/metastatic HNSCC in all cases. Of the 33 patients, 25 were evaluable for response assessment. Partial response was observed in 8, stable disease in 10, and progressive disease in 7 patients. Overall response rate was 32% (95% Confidence interval 12%-52%). Grade 3/4 hematological toxicities included neutropenia in 12 pts, leukopenia in 11 pts, thrombocytopenia in 2 pts and anemia in 8 pts. Grade 3/4 nausea or vomiting was observed in 2 pts. Other toxicity was mild in the treatment. Patient treatment and follow-up are still ongoing. This study, with an overall response rate of 32% and a rate of stable disease of 40%, has shown a good activity with mild and acceptable toxicities of gemcitabine/cisplatin regimen in patients with recurrent/metastatic HNSCC. Survival and response analyses will be presented at the meeting. No significant financial relationships to disclose.

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Accession: 057104948

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PMID: 27955247


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