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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
OncoLink
Ultima Vez Modificado: 31 de mayo del 2003

Presenter: FM Johnson
Presenter's Affiliation: The University of Texas M.D. Anderson Cancer Center
Type of Session: Poster

Background

• 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

Results

• 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%).

Author's Conclusions

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.

Clinical/Scientific Implications

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.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.