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Clinical Trial
. 2014 May 1;89(1):13-20.
doi: 10.1016/j.ijrobp.2013.12.027. Epub 2014 Mar 7.

Final results of local-regional control and late toxicity of RTOG 9003: a randomized trial of altered fractionation radiation for locally advanced head and neck cancer

Jonathan J Beitler  1 , Qiang Zhang  2 , Karen K Fu  3 , Andy Trotti  4 , Sharon A Spencer  5 , Christopher U Jones  6 , Adam S Garden  7 , George Shenouda  8 , Jonathan Harris  2 , Kian K Ang  7
Affiliations
Clinical Trial

Final results of local-regional control and late toxicity of RTOG 9003: a randomized trial of altered fractionation radiation for locally advanced head and neck cancer

Jonathan J Beitler et al. Int J Radiat Oncol Biol Phys. .

Abstract

Purpose: To test whether altered radiation fractionation schemes (hyperfractionation [HFX], accelerated fractionation, continuous [AFX-C], and accelerated fractionation with split [AFX-S]) improved local-regional control (LRC) rates for patients with squamous cell cancers (SCC) of the head and neck when compared with standard fractionation (SFX) of 70 Gy.

Methods and materials: Patients with stage III or IV (or stage II base of tongue) SCC (n=1076) were randomized to 4 treatment arms: (1) SFX, 70 Gy/35 daily fractions/7 weeks; (2) HFX, 81.6 Gy/68 twice-daily fractions/7 weeks; (3) AFX-S, 67.2 Gy/42 fractions/6 weeks with a 2-week rest after 38.4 Gy; and (4) AFX-C, 72 Gy/42 fractions/6 weeks. The 3 experimental arms were to be compared with SFX.

Results: With patients censored for LRC at 5 years, only the comparison of HFX with SFX was significantly different: HFX, hazard ratio (HR) 0.79 (95% confidence interval 0.62-1.00), P=.05; AFX-C, 0.82 (95% confidence interval 0.65-1.05), P=.11. With patients censored at 5 years, HFX improved overall survival (HR 0.81, P=.05). Prevalence of any grade 3, 4, or 5 toxicity at 5 years; any feeding tube use after 180 days; or feeding tube use at 1 year did not differ significantly when the experimental arms were compared with SFX. When 7-week treatments were compared with 6-week treatments, accelerated fractionation appeared to increase grade 3, 4 or 5 toxicity at 5 years (P=.06). When the worst toxicity per patient was considered by treatment only, the AFX-C arm seemed to trend worse than the SFX arm when grade 0-2 was compared with grade 3-5 toxicity (P=.09).

Conclusions: At 5 years, only HFX improved LRC and overall survival for patients with locally advanced SCC without increasing late toxicity.

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Figures

Figure 1
Figure 1
Panel A: Cumulative Incidence Estimates of Local-Regional Failure; Panel B: Cumulative Incidence Estimates of Distant Metastasis; Panel C: Cumulative Incidence Estimates of Second Primary Tumor; Panel D: Kaplan-Meier Estimates of Disease-Free Survival; SFX-Standard Fractionation, HFX-Hyperfractionation, AFX-S –Accelerated Fractionation with Split, AFX-C Accelerated Fractionation, Continuous
Figure 2
Figure 2
Kaplan-Meier Estimates of Overall Survival; SFX-Standard Fractionation, HFX-Hyperfractionation, AFX-S –Accelerated Fractionation with Split, AFX-C Accelerated Fractionation, Continuous
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References

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