Originally published as JCO Early Release 10.1200/JCO.2008.18.1545 on December 8 2008

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Randomized Phase II Trial of Concurrent Cisplatin-Radiotherapy With or Without Neoadjuvant Docetaxel and Cisplatin in Advanced Nasopharyngeal Carcinoma

Edwin P. Hui, Brigette B. Ma, Sing F. Leung, Ann D. King, Frankie Mo, Michael K. Kam, Brian K. Yu, Samuel K. Chiu, Wing H. Kwan, Rosalie Ho, Iris Chan, Anil T. Ahuja, Benny C. Zee, Anthony T. Chan

From the Department of Clinical Oncology; Department of Diagnostic Radiology and Organ Imaging, Prince of Wales Hospital; State Key Laboratory in Oncology in South China, Sir Y.K. Pao Centre for Cancer, Hong Kong Cancer Institute; Center for Clinical Trials, School of Public Health, The Chinese University of Hong Kong; and Sanofi-aventis Hong Kong, Hong Kong SAR, China

Corresponding author: Anthony T. Chan, MD, FRCP, Department of Clinical Oncology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, New Territories, Hong Kong SAR, China; e-mail: anthonytcchan{at}cuhk.edu.hk

Purpose To compare the toxicities, tumor control, survival, and quality of life of nasopharyngeal cancer (NPC) patients treated with sequential neoadjuvant chemotherapy followed by concurrent cisplatin-radiotherapy (CRT) or CRT alone.

Patients and Methods Previously untreated stage III to IVB NPC were randomly assigned to (1) neoadjuvant docetaxel 75 mg/m² and cisplatin 75 mg/m² every 3 weeks for two cycles, followed by cisplatin 40 mg/m²/wk concurrent with radiotherapy, or (2) CRT alone. Planned accrual was 30 patients per arm to detect 20% difference of toxicities based on 95% CIs.

Results From November 2002 to November 2004, 65 eligible patients were randomly assigned to neoadjuvant chemotherapy followed by CRT (n = 34) or CRT alone (n = 31). There was a high rate of grade 3/4 neutropenia (97%) but not neutropenic fever (12%) during neoadjuvant chemotherapy. No significant differences in rates of acute toxicities were observed between the two arms during CRT. Dose intensities of concurrent cisplatin, late RT toxicities and quality of life scores were comparable in both arms. The 3-year progression-free survival for neoadjuvant versus control arm was 88.2% and 59.5% (hazard ratio = 0.49; 95% CI, 0.20 to 1.19; P = .12). The 3-year overall survival for neoadjuvant versus control arm was 94.1% and 67.7% (hazard ratio = 0.24; 95% CI, 0.078 to 0.73; P = .012).

Conclusion Neoadjuvant docetaxel-cisplatin followed by CRT was well tolerated with a manageable toxicity profile that allowed subsequent delivery of full-dose CRT. Preliminary results suggested a positive impact on survival. A phase III study to definitively test this neoadjuvant-concurrent strategy is warranted.

published online ahead of print at www.jco.org on December 8, 2008

Supported in part by a research grant from Sanofi-aventis Hong Kong Limited.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL; the 13th European Cancer Conference, October 30-November 3, 2006, Paris, France; and the 43rd Annual Meeting of the American Society of Clinical Oncology, June 2-5, 2007, Chicago, IL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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