The Head and Neck Intergroup conducted a phase III randomised trial to test the benefit of adding chemotherapy to radiation in patients with unresectable squamous cell head and neck cancer. Eligible patients were randomly assigned between arm A (the control), single daily fractionated radiation (70 Gy at 2 Gy/day); arm B, identical radiation therapy with concurrent bolus cisplatin, given on days 1, 22, and 43; and arm C, a split course of single daily fractionated radiation and three cycles of concurrent infusional fluorouracil and bolus cisplatin chemotherapy, 30 Gy given with the first cycle and 30 to 40 Gy given with the third cycle. Surgical resection was encouraged if possible after the second chemotherapy cycle on arm C and, if necessary, as salvage therapy on all three treatment arms. Survival data were compared between each experimental arm and the control arm using a one-sided log-rank test.
It was concluded that the addition of concurrent high-dose, single-agent cisplatin to conventional single daily fractionated radiation significantly improves survival, although it also increases toxicity. The loss of efficacy resulting from split-course radiation was not offset by either multiagent chemotherapy or the possibility of midcourse surgery.r
Kaplan-Meier of overall survivalr
© Journal of Clinical Oncology 2003
|Projected 3 year survival
|Median survival (months)
NR: not reported
Grade 3 or worse toxicity occurred with 52% of arm 1 (RT alone) compared with 89% of arm 2 (RT plus cisplatin) (p <0.0001).
Grade 3 to 5
Radiotherapy plus cisplatin