Originally published as JCO Early Release 10.1200/JCO.2008.21.4197 on August 31 2009

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Early Postoperative Paclitaxel Followed by Concurrent Paclitaxel and Cisplatin With Radiation Therapy for Patients With Resected High-Risk Head and Neck Squamous Cell Carcinoma: Report of the Phase II Trial RTOG 0024

From the Departments of Radiation Oncology and Head and Neck Surgery, The University of Texas M. D. Anderson Cancer Center, Houston, TX; Department of Statistics, American College of Radiology, Reston, VA; Head and Neck Section, Fox Chase Cancer Center; Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA; Department of Oncology, Johns Hopkins University School of Medicine, Baltimore, MD; Department of Radiation Medicine, Roswell Park Cancer Institute, Buffalo, NY; Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI; and H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.

Corresponding author: David I. Rosenthal, MD, Department of Radiation Oncology, Unit 97, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: dirosenthal{at}mdanderson.org.

Purpose We sought to improve outcomes for patients with high-risk head and neck squamous cell cancer (HNSCC) after surgical resection by testing the feasibility and safety of early postoperative chemotherapy followed by concurrent chemoradiotherapy.

Patients and Methods Eligible patients had resected, stages III to IV HNSCC with positive margins, extracapsular nodal extension, or multiple positive nodes. Paclitaxel (80 mg/m²) was given once weekly during postoperative weeks 2, 3, and 4 and was given before radiation therapy (RT). Paclitaxel (30 mg/m²) and cisplatin (20 mg/m²) were given once weekly during the last 3 weeks of RT (60 Gy over 6 weeks, beginning 4 to 5 weeks after surgery). The primary end points were treatment safety and tolerability compared with concurrent cisplatin (100 mg/m² every 3 weeks) and RT, as tested in Radiation Therapy Oncology Group trial RTOG 9501.

Results The median follow-up time for the 70 patients enrolled was 3.3 years (range, 0.6 to 4.4 years) for surviving patients. Tolerability of all treatment components was comparable to that of RTOG 9501 treatment, which is the current standard of care (compliance rate, 75%; 95% CI, 63% to 85%). One patient died, and seven patients experienced grade 4 nonhematologic toxicities. Rates of locoregional control, disease-free survival, and overall survival exceeded those of RTOG 9501 after adjustment for important prognostic variables (ie, positive margins, extracapsular extension, primary site, and performance status).

Conclusion Chemotherapy soon after surgery followed by concurrent chemoradiotherapy therapy was feasible; tolerance was in line with standard postoperative chemoradiotherapy; and this regimen led to excellent rates of locoregional control and disease-free survival.

Supported by Grants No. RTOG U10 CA21661, CCOP U10 CA37422, and Stat U10 CA32115 from the National Cancer Institute.

This manuscript's contents are the sole responsibility of the authors and do not necessarily represent the official views of the NCI.

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

Clinical Trials repository link available on JCO.org.

Clinical trial information can be found for the following: NCT00011999 [ClinicalTrials.gov] .

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