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Intensive concomitant chemoradiotherapy in locally advanced unresectable squamous cell carcinoma of the head and neck: a phase II study of radiotherapy with cisplatin and 7-week continuous infusional fluorouracil



Intensive concomitant chemoradiotherapy in locally advanced unresectable squamous cell carcinoma of the head and neck: a phase II study of radiotherapy with cisplatin and 7-week continuous infusional fluorouracil



Journal of Clinical Oncology 14(4): 1192-1200



Purpose: To evaluate an intensive concomitant chemoradiotherapy protocol of conventional radiotherapy with intermittent cisplatin (CDDP) and continuous-infusion fluorouracil (5-FU) in unresectable, locally advanced squamous cell carcinoma of the head and neck (SCCHN). Patients and Methods: Fifty-seven patients with unresectable stage IV mo disease (international Union Against Cancer (UICC)/American Joint Committee on Cancer (AJCC), 1987) received radiotherapy 70 Gy followed by CDDP 80 mg/m-2 and 5-FU 300 mg/m-2/d. Response was assessed 2 months after treatment completion. Results: Thirty patients (52%) received the full treatment schedule; 53 (93%) received full-dose radiotherapy, while 48 (84%) were given at least 75% of the planned chemotherapy doses. Severe mucositis (World Health Organization (WHO)) grade 3 to 4 was the limiting toxicity and was seen in 79% of patients. The median time for mucositis resolution was 8 weeks. Other toxicities were generally manageable, but there were four treatment-related deaths (7%). Fifty patients were assessable for activity, with an overall response rate of 70% (95% confidence interval (CI), 58% to 82%). Complete response (CR) and partial response (PR) rates were 42% and 28%, respectively. Conclusion: This simultaneous combined-modality regimen was feasible at the cost of severe mucosal toxicity, which required hospitalization with nutritional, parenteral, and hydroelectrolytic support. The high response rate achieved (70%) did not translate into improved survival, probably due to patient eligibility. The likelihood of cure of this high-tumoral-volume patient population remains low ( apprx 10%), despite the association of two therapeutic modalities at full standard therapeutic intensity.

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Accession: 008889916

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PMID: 8648374

DOI: 10.1200/jco.1996.14.4.1192



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