Department of Radiation Oncology, Hospital Sírio-Libanês and Instituto do Câncer do Estado de São Paulo - Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
Brazilian Cochrane Center and Discipline of Emergency Medicine and Evidence-Based Medicine Universidade Federal de São Paulo - Escola Paulista de Medicina (UNIFESP-PM), São Paulo, Brazil.
Eur J Cancer. 2015 Nov;51(17):2596-603. doi: 10.1016/j.ejca.2015.08.007. Epub 2015 Aug 26.
Locoregionally advanced oral cavity cancers are aggressive tumours with high risk of relapse after definitive treatment. This study was performed to assess the effectiveness and safety of induction chemotherapy prior to surgery for untreated oral cavity cancer patients.
Only prospective phase III randomised studies comparing induction chemotherapy followed by surgery with or without postoperative radiotherapy (Chemo Group) compared with surgery with or without postoperative radiotherapy (Control Group) were eligible. Two of the authors independently selected and assessed the studies regarding eligibility criteria and risk of bias.
Two studies were selected. A total of 451 patients were randomly assigned to Chemo Group (n=226) versus Control Group (n=225). Most patients had tumours at clinical stages III/IV (89.1%). Both trials were classified as having low risk of bias. No significant overall benefit in favour of induction chemotherapy was found regarding loco-regional recurrence, disease-free survival and overall survival. A subgroup analysis of individual data from cN2 patients showed statistically significant overall survival benefit in favour of induction chemotherapy. The included studies did not directly compare toxicity between the groups and no statistical analysis was performed regarding safety outcomes.
Based on the available studies, induction chemotherapy when administered before surgery with curative intent did not improve clinical outcomes in locoregionally advanced oral cavity cancer patients. Clinically assessed N2 patients might benefit from induction chemotherapy.
局部晚期口腔癌是具有高复发风险的侵袭性肿瘤,根治性治疗后复发风险较高。本研究旨在评估诱导化疗在未经治疗的口腔癌患者手术前的有效性和安全性。
仅符合条件的前瞻性 III 期随机研究比较了诱导化疗后手术联合或不联合术后放疗(化疗组)与手术联合或不联合术后放疗(对照组)。两名作者独立选择和评估了符合纳入标准和偏倚风险的研究。
共纳入 2 项研究,451 例患者被随机分配至化疗组(n=226)和对照组(n=225)。大多数患者肿瘤处于临床分期 III/IV 期(89.1%)。这两项试验均被归类为低偏倚风险。诱导化疗在局部区域复发、无病生存率和总生存率方面均未显示出总体获益。对 cN2 患者的个体数据进行亚组分析显示,诱导化疗在总生存率方面具有统计学显著优势。纳入的研究并未直接比较两组之间的毒性,也未对安全性结局进行统计学分析。
基于现有研究,在根治性手术前给予诱导化疗并不能改善局部晚期口腔癌患者的临床结局。经临床评估的 N2 患者可能从诱导化疗中获益。