Faculty Collaboration Database

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. J Clin Oncol 2009 Oct 01;27(28):4727-32

Date

09/02/2009

Pubmed ID

19720915

Pubmed Central ID

PMC2754914

DOI

10.1200/JCO.2008.21.4197

Scopus ID

2-s2.0-70350433284 (requires institutional sign-in at Scopus site)   35 Citations

Abstract

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/m(2)) was given once weekly during postoperative weeks 2, 3, and 4 and was given before radiation therapy (RT). Paclitaxel (30 mg/m(2)) and cisplatin (20 mg/m(2)) 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/m(2) 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.

Author List

Rosenthal DI, Harris J, Forastiere AA, Weber RS, Ridge JA, Myers JN, Garden AS, Kuettel MR, Sidhu K, Schultz CJ, Trotti A, Ang KK

Author

Christopher J. Schultz MD Chair, Professor in the Radiation Oncology department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adult
Aged
Antineoplastic Combined Chemotherapy Protocols
Carcinoma, Squamous Cell
Cisplatin
Combined Modality Therapy
Feasibility Studies
Female
Follow-Up Studies
Head and Neck Neoplasms
Humans
Kaplan-Meier Estimate
Male
Middle Aged
Paclitaxel
Radiotherapy
Skin Diseases
Time Factors
Treatment Outcome