BACKGROUND: For several decades, both preoperative intra-arterial chemotherapy and preoperative irradiation have been accepted treatments for patients with tumors of the head and neck. Unfortunately, arguments have often been put forward in favor of one or other of the two methods, but without the performance of an objective, randomized investigation. To resolve this situation, the authors have carried out a multicenter, randomized prospective study of selected patients with a view to deciding which method affords better results in complex tumor therapy from the aspects of survival and postoperative quality of life. METHODS:One hundred thirty-one patients with operable sublingual or lingual squamous cell carcinoma in stages T2NXM0 to T4MXM0 were randomized into 2 groups: 1 group participated in preoperative chemotherapy with cisplatin and epirubicin (total doses: 200 mg cisplatin, 120 mg epirubicin) via the external carotid artery, whereas the other group received preoperative radiation therapy (46 grays). Following subsequent radical surgery, the patients received regular follow-up for 5 years. RESULTS: By the end of the 5 years, 95 of the 131 patients had conformed to the protocol. Of those 95, 47 had received preoperative chemotherapy and 48 preoperative irradiation. After 5 years, 18 of the 47 patients who received chemotherapy and 15 of the 48 patients who received irradiation were still alive and tumor free. A few more patients had died of recurrence or regional metastasis in the chemotherapy group (23 patients) than in the irradiation group (20 patients). Occurrence of a second carcinoma was 3 times as frequent in the irradiation group (9 patients) as in the chemotherapy group (3 patients). Overall, the survival rates were by-and-large the same for the two groups. Regarding postoperative quality of life, the chemotherapy group presented a more favorable picture. CONCLUSIONS: The long term survival results subsequent to preoperative intra-arterial chemotherapy or preoperative radiotherapy were practically the same. Regarding postoperative quality of life, patients who underwent intra-arterial chemotherapy appeared to be in a slightly more favorable situation. The authors consider it important to stress these findings, as they are not aware of a similar randomized study of patients with tumors of the oral cavity. Copyright 1999 American Cancer Society.
RCT Entities:
BACKGROUND: For several decades, both preoperative intra-arterial chemotherapy and preoperative irradiation have been accepted treatments for patients with tumors of the head and neck. Unfortunately, arguments have often been put forward in favor of one or other of the two methods, but without the performance of an objective, randomized investigation. To resolve this situation, the authors have carried out a multicenter, randomized prospective study of selected patients with a view to deciding which method affords better results in complex tumor therapy from the aspects of survival and postoperative quality of life. METHODS: One hundred thirty-one patients with operable sublingual or lingual squamous cell carcinoma in stages T2NXM0 to T4MXM0 were randomized into 2 groups: 1 group participated in preoperative chemotherapy with cisplatin and epirubicin (total doses: 200 mg cisplatin, 120 mg epirubicin) via the external carotid artery, whereas the other group received preoperative radiation therapy (46 grays). Following subsequent radical surgery, the patients received regular follow-up for 5 years. RESULTS: By the end of the 5 years, 95 of the 131 patients had conformed to the protocol. Of those 95, 47 had received preoperative chemotherapy and 48 preoperative irradiation. After 5 years, 18 of the 47 patients who received chemotherapy and 15 of the 48 patients who received irradiation were still alive and tumor free. A few more patients had died of recurrence or regional metastasis in the chemotherapy group (23 patients) than in the irradiation group (20 patients). Occurrence of a second carcinoma was 3 times as frequent in the irradiation group (9 patients) as in the chemotherapy group (3 patients). Overall, the survival rates were by-and-large the same for the two groups. Regarding postoperative quality of life, the chemotherapy group presented a more favorable picture. CONCLUSIONS: The long term survival results subsequent to preoperative intra-arterial chemotherapy or preoperative radiotherapy were practically the same. Regarding postoperative quality of life, patients who underwent intra-arterial chemotherapy appeared to be in a slightly more favorable situation. The authors consider it important to stress these findings, as they are not aware of a similar randomized study of patients with tumors of the oral cavity. Copyright 1999 American Cancer Society.
Authors: Maximilian Moergel; Philipp Meurer; Katharina Ingel; Thomas G Wendt; Bilal Al-Nawas Journal: Strahlenther Onkol Date: 2011-05-16 Impact factor: 3.621
Authors: Ambika Parmar; Michaelina Macluskey; Niall Mc Goldrick; David I Conway; Anne-Marie Glenny; Janet E Clarkson; Helen V Worthington; Kelvin Kw Chan Journal: Cochrane Database Syst Rev Date: 2021-12-20
Authors: Vishal M Bulsara; Helen V Worthington; Anne-Marie Glenny; Janet E Clarkson; David I Conway; Michaelina Macluskey Journal: Cochrane Database Syst Rev Date: 2018-12-24