BACKGROUND: Data on preoperative chemotherapy in resectable oral cavity cancer are conflicting. We present the long-term results of a randomized trial of induction chemotherapy in resectable oral cavity cancer. PATIENTS AND METHODS: A randomized, parallel, multicentre trial evaluated the impact of three cycles of cisplatin 100 mg/m2 and fluorouracil 1000 mg/m2 (120-h infusion administered every 21 days) in stage T2-T4, N0-N2, previously untreated patients with advanced disease. Control group received upfront surgery. Postoperative radiation was offered to both arms when pathologic risk features were identified. The co-primary end points were the occurrence of locoregional or distant tumour relapse, and death. RESULTS: Among the 198 enrolled patients, with a median follow-up of 11.5 years, there was no difference in the incidence of locoregional relapse between chemotherapy and control group (P=0.6337), nor in distant metastasis development (P=0.1527). There was also no difference between groups in overall survival (P=0.3402). Patients with a pathological complete response (pCR) had higher probability of survival than those without (10-year OS: 76.2% versus 41.3%, P=0.0004). Late toxicities in patients with a minimum follow-up of 60 months (42 in each group) were similar between arms, except from fibrosis (cumulative incidence 40% versus 22% in chemotherapy arm) and grade 2 dysphagia (14% versus 5%). CONCLUSIONS: Long-term follow-up of this randomized trial confirmed the absence of survival benefit with preoperative chemotherapy in oral cavity cancer. Late toxicity was similar in the two arms except for fibrosis and dysphagia, which were less in the chemotherapy arm. The survival benefit for patients achieving a pCR was maintained.
RCT Entities:
BACKGROUND: Data on preoperative chemotherapy in resectable oral cavity cancer are conflicting. We present the long-term results of a randomized trial of induction chemotherapy in resectable oral cavity cancer. PATIENTS AND METHODS: A randomized, parallel, multicentre trial evaluated the impact of three cycles of cisplatin 100 mg/m2 and fluorouracil 1000 mg/m2 (120-h infusion administered every 21 days) in stage T2-T4, N0-N2, previously untreated patients with advanced disease. Control group received upfront surgery. Postoperative radiation was offered to both arms when pathologic risk features were identified. The co-primary end points were the occurrence of locoregional or distant tumour relapse, and death. RESULTS: Among the 198 enrolled patients, with a median follow-up of 11.5 years, there was no difference in the incidence of locoregional relapse between chemotherapy and control group (P=0.6337), nor in distant metastasis development (P=0.1527). There was also no difference between groups in overall survival (P=0.3402). Patients with a pathological complete response (pCR) had higher probability of survival than those without (10-year OS: 76.2% versus 41.3%, P=0.0004). Late toxicities in patients with a minimum follow-up of 60 months (42 in each group) were similar between arms, except from fibrosis (cumulative incidence 40% versus 22% in chemotherapy arm) and grade 2 dysphagia (14% versus 5%). CONCLUSIONS: Long-term follow-up of this randomized trial confirmed the absence of survival benefit with preoperative chemotherapy in oral cavity cancer. Late toxicity was similar in the two arms except for fibrosis and dysphagia, which were less in the chemotherapy arm. The survival benefit for patients achieving a pCR was maintained.
Authors: Thaís Bianca Brandão; Karina Morais-Faria; Ana Carolina Prado Ribeiro; César Rivera; João Victor Salvajoli; Marcio Ajudarte Lopes; Joel B Epstein; Praveen R Arany; Gilberto de Castro; Cesar Augusto Migliorati; Alan Roger Santos-Silva Journal: Support Care Cancer Date: 2018-02-08 Impact factor: 3.603
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Authors: A H Rudresha; Tamojit Chaudhuri; K C Lakshmaiah; K Govind Babu; Lokanatha Dasappa; Linu Abraham Jacob; M C Suresh Babu; K N Lokesh; L K Rajeev Journal: Indian J Med Paediatr Oncol Date: 2017 Oct-Dec
Authors: Jung Julie Kang; Richard J Wong; Eric J Sherman; Alisa Rybkin; Sean M McBride; Nadeem Riaz; C Jillian Tsai; Yao Yu; Linda Chen; Kaveh Zakeri; Daphna Y Gelblum; Erin F Gillespie; Marc A Cohen; Jennifer R Cracchiolo; Ian Ganly; Snehal Patel; Bhuvanesh Singh; Jay O Boyle; Benjamin R Roman; Luc G Morris; Ashok R Shaha; Lara A Dunn; Alan L Ho; James V Fetten; Jatin P Shah; David G Pfister; Nancy Y Lee Journal: Cancer Date: 2020-07-08 Impact factor: 6.921