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Weekly cisplatin paclitaxel and continuous infusion fluorouracil in patients with recurrent and/or metastatic head and neck squamous cell carcinoma: a phase II study

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Abstract

Background

Cisplatin, paclitaxel and 5-fluorouracil (5-FU) have demonstrated significant activity in patients with advanced squamous head and neck cancer (HNSCC) despite relevant toxicity. A weekly administration of cisplatin and paclitaxel with continuous infusion of 5-FU could offer a better toxicity profile without affecting dose intensity or treatment outcome. We evaluated the toxicity and the activity of weekly cisplatin/paclitaxel with continuous infusion 5-FU in patients with recurrent and/or metastatic HNSCC.

Methods

A total of 44 patients were studied. Treatment consisted of two 6-week cycles with weekly cisplatin 20 mg/m2 and paclitaxel 60 mg/m2 and daily continuous infusion 5-FU 200 mg/m2 from day 1 to 42. Patients were evaluated for toxicity and response.

Results

40 out of 44 patients were evaluable for response. After two cycles we observed seven complete responses (16%) and 12 partial responses (27%), with a 43% (95% CI 28–58%) overall response rate. Stable disease was seen in 13 patients (29%) and progressive disease in 12 patients (27%). Toxicity was mild in treated patients: we observed less than 10% of grade 3/4 hematological and gastroenteric toxicity.

Conclusions

A weekly schedule of cisplatin and paclitaxel associated with continuous infusion 5-FU showed low toxicity in the treatment of advanced HNSCC while significant activity was conserved.

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Authors and Affiliations

  1. Department of Medical Oncology, Azienda Ospedaliera San Giovanni Battista, Via Cherasco 15, 10126, Turin, Italy

    M. Schena, C. Barone, N. Birocco, D. Dongiovanni & O. Bertetto

  2. Department of Medical Oncology, Ospedale S Croce, Cuneo, Italy

    G. Numico & I. Colantonio

Authors
  1. M. Schena
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  2. C. Barone
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  3. N. Birocco
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  4. D. Dongiovanni
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  5. G. Numico
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  6. I. Colantonio
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  7. O. Bertetto
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Correspondence to M. Schena.

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Schena, M., Barone, C., Birocco, N. et al. Weekly cisplatin paclitaxel and continuous infusion fluorouracil in patients with recurrent and/or metastatic head and neck squamous cell carcinoma: a phase II study. Cancer Chemother Pharmacol 55, 271–276 (2005). https://doi.org/10.1007/s00280-004-0875-1

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  • DOI: https://doi.org/10.1007/s00280-004-0875-1

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