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Concomitant Boost Radiation Plus Concurrent Cisplatin for Advanced Head and Neck Carcinomas: Radiation Therapy Oncology Group Phase II Trial 99-14

From The University of Texas M.D. Anderson Cancer Center, Houston, TX; Radiation Therapy Oncology Group Statistical Unit, University of South Florida H. Lee Moffitt Cancer Center, Tampa, FL; Radiological Associates of Sacramento, Sacramento, CA; University of Louisville, Louisville, KY; Fox Chase Cancer Center; University of Pennsylvania Medical Center, Philadelphia, PA; University of Alabama at Birmingham, Birmingham, AL; and The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD

Address reprint requests to K. Kian Ang, MD, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 97, Houston, TX 77030; e-mail: kianang{at}mail.mdanderson.org

PURPOSE: To investigate the feasibility of combining concomitant boost accelerated radiation regimen (AFX-C) with cisplatin and to assess its toxicity and the relapse pattern and survival in patients with advanced head and neck carcinoma (HNC).

PATIENTS AND METHODS: Between April and November of 2000, 84 patients with stage III to IV HNC who met the eligibility criteria were enrolled; 76 of these patients were analyzable. Radiation consisted of 72 Gy in 42 fractions over 6 weeks (daily for 3.5 weeks, then twice a day for 2.5 weeks). Cisplatin dose was 100 mg/m² on days 1 and 22. Tumor and clinical status were assessed, and acute late toxicities were graded.

RESULTS: Sixty-five patients (86%) received both radiation and chemotherapy per protocol or with minor variations. The estimated 2-year locoregional relapse and distant metastasis rates were 34.7% and 16.1%, respectively. The estimated 2-year overall survival and disease-free survival rates were 71.6% and 53.5%, respectively. Three patients (4%) died of complications, 19 patients (25%) had acute grade 4 toxicity, and 49 patients (64%) had acute grade 3 toxicity. The 2-year cumulative incidence of late grade 3 to 5 toxicities was 51.3%.

CONCLUSION: These data showed that it was feasible to combine AFX-C with cisplatin. The compliance to therapy was high, and the locoregional control and survival rates achieved compared favorably with AFX-C alone or other concurrent chemoradiation regimens tested by the Radiation Therapy Oncology Group. A phase III trial comparing AFX-C plus cisplatin against standard radiation plus cisplatin is ongoing to determine whether the use of AFX-C in the concurrent chemoradiation setting further improves outcome.

Supported by grant Nos. U10 CA21661, U10 CA37422, U10 CA32115, and CA06294 awarded by the National Cancer Institute (Bethesda, MD) supplemented by the Gilbert H. Fletcher Chair.

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

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