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A Phase II study of docetaxel and carboplatin as neoadjuvant therapy for nasopharyngeal carcinoma with early T status and advanced N status
Article first published online: 30 JAN 2004
Copyright © 2004 American Cancer Society
Volume 100, Issue 5, pages 991–998, 1 March 2004
How to Cite
Johnson, F. M., Garden, A., Palmer, J. L., Kies, M., Clayman, G., Brumfield, B., Khuri, F. R., Morrison, W., Papadimitrakopoulou, V., Diaz, E. M. and Glisson, B. S. (2004), A Phase II study of docetaxel and carboplatin as neoadjuvant therapy for nasopharyngeal carcinoma with early T status and advanced N status. Cancer, 100: 991–998. doi: 10.1002/cncr.20079
- Issue published online: 18 FEB 2004
- Article first published online: 30 JAN 2004
- Manuscript Accepted: 3 DEC 2003
- Manuscript Revised: 24 NOV 2003
- Manuscript Received: 2 OCT 2003
- Aventis Pharmaceuticals (Bridgewater, NJ)
- National Institutes of Health. Grant Number: NIH CA09666
- nasopharyngeal carcinoma;
- neoadjuvant therapy;
- locally advanced
Promising results from a Phase II trial of induction chemotherapy and sequential radiotherapy for advanced nasopharyngeal carcinoma (NPC) at The University of Texas M. D. Anderson Cancer Center (Houston, TX) and two retrospective reviews of the authors' historical experience with NPC demonstrated that distant failure was directly correlated with advanced lymph node status. Furthermore, local control was excellent for patients with T1–3 disease that was managed with radiation alone or with a sequential approach involving chemotherapy. Neoadjuvant chemotherapy (primarily with cisplatin + 5-fluorouracil) was associated with a significantly decreased risk of distant metastasis and with improved survival. Based on these findings, the authors evaluated a novel induction regimen involving docetaxel and carboplatin for patients with previously untreated T1–2N2–3M0 NPC.
Docetaxel (80 mg/m2 on Day 1) and carboplatin (to an area under the time-concentration curve of 6 on Day 1) were administered every 21 days for 3 cycles, after which radiotherapy was administered. NPC was restaged with magnetic resonance imaging and nasopharyngoscopy 3 weeks after the completion of chemotherapy and 6 weeks after the completion of radiotherapy.
Over 5 years, 18 patients were enrolled in the study. Grade 4 neutropenia and Grade 2 fatigue were observed in 51% and 28% of chemotherapy courses, respectively. After chemotherapy, 2 patients had complete responses, 14 had partial responses, 1 had a minor response, and 1 had progressive disease. The latter two patients and one patient who had a partial response underwent off-study chemoradiotherapy. After radiotherapy or chemoradiotherapy, 12 patients had complete responses and 6 had partial responses. Seven patients had recurrent disease; two had local recurrences, and five had distant metastases.
Although unlikely to be superior to cisplatin + 5-fluorouracil, the trial regimen could be administered quickly in the outpatient setting, was logistically more convenient for the patient, and was devoid of serious nonhematologic toxic effects. We believe that the risk-based approach examined in the current study merits further investigation. Cancer 2004;100:991–8. © 2004 American Cancer Society.