Radiation therapy alone or with concurrent low-dose daily either cisplatin or carboplatin in locally advanced unresectable squamous cell carcinoma of the head and neck: a prospective randomized trial

• Published in: Radiotherapy and oncology Vol. 43; no. 1; pp. 29 - 37
• Main Authors: Jeremic, Branislav, Shibamoto, Yuta, Stanisavljevic, Bozidar, Milojevic, Ljubisa, Milicic, Biljana, Nikolic, Nebojsa
• Format: Journal Article
• Language: English
• Published: Ireland Elsevier Ireland Ltd 01.04.1997
• Subjects: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carboplatin - administration & dosage; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - radiotherapy; Chemotherapy; Cisplatin - administration & dosage; Combined Modality Therapy; Female; Head and neck cancer; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - mortality; Head and Neck Neoplasms - radiotherapy; Humans; Male; Middle Aged; Radiotherapy; Survival Rate; Radiotherapy; Head and neck cancer; Chemotherapy
• ISSN: 0167-8140; 1879-0887
• DOI: 10.1016/S0167-8140(97)00048-0

Between January 1988 and December 1991, 159 patients with Stage III/IV (M0) squamous cell carcinoma of the head and neck were randomized to receive standard fraction RT (70 Gy) (group I) or the same RT plus either 6 mg/m 2 of cisplatin (CDPP) (group II) or 25 mg/ m 2 of carboplatin (CBDCA) both given daily during RT (group III). Patients in groups II and III had significantly higher overall response rates then those in group I ( P = 0.011 and P = 0.0025, respectively) with no difference between groups II and III ( P = 0.60). They also had significantly longer median survival time (MST) and higher 5-year survival rates than those in group I (MST, 32 months (32%) and 30 months (29%) versus 16 months (15%), respectively; P = 0.011 and P = 0.019, respectively), with no difference between the two RT/CHT groups. Median time to local recurrence (MTLR) and 5-year local recurrence-free survival (LRFS) were significantly higher for both RT/ CHT when compared to RT alone (MTLR, not attained yet and 30 months versus 10 months, respectively; 5-year LRFS, 51% and 48% versus 27%, respectively; P = 0.018 and P = 0.040, respectively) with no difference between the two RT/CHT groups. There was no difference between the three treatment groups regarding regional lymph node and distant metastasis control. Apart from acute high grade (≥3) hematological toxicity that was significantly more frequent in the two RT/CHT groups and no different between the two RT/CHT groups, other acute high grade toxicity was similar between the three treatment groups. Late high grade toxicity was infrequent and similar between the three treatment groups.