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A Phase III Comparison of Standard Radiation Therapy (RT) Versus RT Plus Concurrent Cisplatin (CDDP) Versus Split-Course RT Plus ConcurrentCDDPP and 5-Flourouracil (5-FU) in Patients with Unresectable Squamous Cell Head and Neck Cancer (SCHNC): An Intergroup Study

James Metz, MD
OncoLink Associate Editor
Ultima Vez Modificado: 20 de mayo del 2000

Presenter: DJ Adelstein
Affiliation: ECOG & SWOG

Background:
Unresectable squamous cell carcinoma of the head and neck region conotates a very poor prognosis overall. Recent Phase II trials have suggested the addition of concurrent chemotherapy to radiation therapy may improve survival. This study was performed to compare standard radiation therapy to concurrent chemotherapy and radiation therapy for unresectable squamous cell carcinoma of the head and neck.

Materials and Methods:

• Head and neck Intergroup trial of patients with Stage III and IV unresectable squamous cell carcinoma of the head and neck (nasopharynx, paranasal sinus, and parotid primaries excluded.
• There were three treatment arms:
  • Arm A - Since daily fractionated RT (70 Gy/day @ 2 Gy/day)
  • Arm B - Identical Radiation with concurrent CDDP (100mg/m² x 3 q 3 wk
  • Arm C - Split course of RT and 3 cycle of concurrent chemotherapy, 30 Gy given with the first and 30-40 Gy given with the third cycle (chemo q 4 weeks 75 mg/m² DDP & 5-FU 1000 mg/m²/day X 4)
• Due to declining accrual, the study was prematurely closed after 295 of planted 369 patients were enrolled. There were 273 patients eligible for evaluation. The median follow up was 25 months.

• Grade 3 toxicity of worse occurred in 54% Arm A patients versus 87% Arm B, and 77% Arm C (p < 0.001)
• 3 year projected survivals are 20% Arm A, 36% Arm B, and 28% Arm C
• Median survivals are 12.6 months Arm A, 18.8 months Arm B, and 14.0 months Arm C
• A significant improvement in survival was found only for Arm B (p = 0.02)

• In poor prognosis unresectable Squamous Cell Carcinoma of the head and neck:
  1. Concurrent chemotherapy and RT can be safely administered with acceptable toxicity
  2. The addition of concurrent high-dose single- agent DDP to conventional standard Rt significantly improved survival
  3. The use of multi-agent chemotherapy does not offset the loss of efficacy resulting from split- course RT