A Phase II Study of Docetaxel and Carboplatin as Neoadjuvant Therapy for Patients with Early T and Advanced N Stage Nasopharyngeal Carcinoma(NPC)
Reviewer: Tracy d'Entremont, MD
Last Modified: May 31, 2003
Presenter: FM Johnson
Presenter's Affiliation: The University of Texas M.D. Anderson Cancer Center
Type of Session: Poster
- Historically, early stage NPC has been treated successfully with radiation therapy.
- Radiation therapy alone provides excellent locoregional control, but poor systemic control.
- Concurrent cisplatin and radiation followed by adjuvant cisplatin and 5-flurouracil has become standard of care for locally advanced NPC in North America based on survival benefit seen in the Intergroup 0099 Trial.
- The authors proposed a study of a selected population of patients, T1-2 but advanced N, who may benefit from neoadjuvant chemotherapy to address micrometases followed by definitive radiation without the morbidity of concurrent chemoradiation.
- The taxanes are the most active single agents identified yet in squamous cell carcinoma of the head and neck.
- The primary objective was to assess response to induction therapy and to treatment overall and to estimate progression-free and overall survival rates.
Materials and Methods
- Eighteen Patients with T1-2, N2-3, M0 histologically proven NPC were enrolled.
- No prior chemotherapy
- ECOG PS 0-1
- Docetaxel 80mg/m2 and Carboplatin AUC=6 were given on D1 q 21 days x 3 cycles.
- Followed by 9 weeks of rest
- CT or MRI was then conducted to evaluate response to chemotherapy
- The radiation portion of the treatment was 6600-7000 cGy for 7 weeks.
- The radiation was followed by another 6 week break and final evaluation was again conducted with CT or MRI.
- The majority of patients were T2N2c
- 11/18 patients were alive without evidence of disease at the conclusion of the study with a median follow up of 90 weeks.
- There were 2 local recurrences and 5 distant recurrences (including 2 deaths).
- The estimated 3-year survival rate was 74%
- With this induction chemotherapy, only one patient progressed after the neoadjuvant phase of the trial.
- This study was closed after completing accrual to the first stage of the trial. Because the regimen was unlikely to prove superior to cisplatin/5-FU based historical CR rate of 20%.
- The regimen was well tolerated, with asymptomatic grade 4 neutropenia as the most common toxicity (78%).
- It required 5 years to complete the first stage of accrual to this trial. This demonstrates the low feasibility of studying this specific sub-group of patients with NPC in a geographic area of sporadic incidence.
- The author's continue to believe that this risk-based approach for early T/advanced N stage NPC has merit and deserves further study. Given the slow accrual to this study future efforts will need to include patients with primaries in other head and neck sites.
- Although it is clear that standard 5-FU/cisplatin based chemoradiotherapy for NPC is cumbersome to give and not without side effects, it should not be replaced with this experimental regimen.
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