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Alternating Chemo-Radiotherapy Versus Partly Accelerated Radiotherapy in Advanced Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Randomized Trial

Joel W. Goldwein, MD
OncoLink Founder
Last Modified: May 20, 2000

Presenter: M. Benasso
Affiliation: Inst Nazionale per la Ricera sul Cancro and affiliated centers, Genoa, Italy

Background:
It has previously been shown that alternating chemo-radiotherapy (ALT) has improved outcome compared with conventional RT in advanced-stage Squamous cell carcinoma of the head and neck. This study compared the alternating chemo-RT regimen with a partly accelerated radiotherapy (PA-RT) regimen without chemotherapy in a similar patient population.

Materials and Methods:

• 136 patients with unfavorable Stage II or Stage III, IV Squamous Cell Carcinoma were randomized to either of 2 regimens, n=70 for ALT and n=60 for PA-RT; 69 were eligible for ALT, 64 for PA-RT
• ALT=3 splits of 20Gy each of RT with CDDP + 5- FU
• PA-RT=60Gy/30fx/6wks and 15gy/10fx during last 2 weeks of treatment

Results:

• The study was closed early due to poor accrual.
• The CR rate was 51% in the ALT and 39% in PA- RT arms (p=NS).
• The failure rates were 27% vs. 24% in ALT vs. PA-RT arms (p=NS)
• The 3-year PFS was 34% and 255, and the 3- year OS was 37% and 29% in the ALT and PA-RT arms
• Significantly more dermatitis and grade 2 late toxicities were seen in the PA-RT patients compared with ALT-treated patients

Authors' Conclusions

• No significant difference in response or survival was seen between the 2 regimens.
• PA-RT was associated with significantly more dermatitis and grade 2 late toxicicity.
• Low accrual may have contributed to this outcome.

Clinical/Scientific Implications:

• A more toxic regimen was, in this case, not associated with a better survival
• The ALT regimen will continue to be the standard therapy against which new regimens will be compared at this institution.