A randomized study of adjuvant chemotherapy for cancer of the upper aerodigestive tract

Abstract A prospective, randomized trial of induction chemotherapy in advanced squamous cell carcinomas of the upper aerodigestive tract (UAD) was conducted between July 1979 and September 1982. Eighty-three patients with locally advanced Stage III–IV tumors received standard treatment (STD RX; defined as preoperative irradiation and radical excision or irradiation alone), or induction chemotherapy (CTX) followed by STD RX. Chemotherapy consisted of two cycles of bleomycin (30 units/day by continuous infusions Days 1–4), cyclophosphamide (200 mg/m 2 IV Days 1–5), methotrexate (30 mg/m 2 Days 1 + 5), and 5-fluorouracil (400 mg/m 2 IV Days 1–5). Response to CTX was complete in 2 and partial (>50% reduction) in 27; the overall response rate was 68%. Tumor clearance was documented in 3040 STD RX patients at completion of irradiation and/or surgery and in 2443 CTX patients (1729 responders, 714 non-responders). Freedom from local-regional disease was noted at 2 years in 53% STD RX and 35% CTX patients ( p