A phase III trial (RTOG 0129) of two radiation-cisplatin regimens for head and neck carcinomas (HNC): Impact of radiation and cisplatin intensity on outcome.

Abstract

5507 Background: Data of patients with stage III-IV HNC accrued in a phase III trial of cisplatin (CDDP) plus an accelerated concomitant boost (AFX-C, 72 Gy/6 W) versus standard fractionation (SFX, 70 Gy//7 W) was analyzed with emphasis on the impact of radiotherapy (RT) and CDDP intensity. Methods: Patients had good status (Zubrod 0-1) and predefined blood chemistry range. Therapies were AFX-C + CDDP x2 or SFX + CDDP x3 (100 mg/m2, q3W). Results: Of 743 enrolled, 721 were analyzable. There was no difference in the primary endpoint (5-Y survival: 59% vs. 56%; HR: 0.90, 0.72-1.13; p=0.18). Other endpoints were assessed in 656 patients (AFX-C: 333; SFX: 323) receiving 64-76 Gy in 35-63 days and 1-3 CDDP doses. Table shows the combined effects of RT and CDDP regimens on outcome and toxicity. As a continuous variable, each day of RT delay compromised OS, PFS, and LRP by 5%, 4%, and 4% (p=0.001, 0.006, and 0.02), respectively. Conclusions: RT duration and CDDP dose affected survival significantly. CDDP improve...