Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: long-term results of a phase III multicentre randomised controlled trial.
Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results.
Our trial was a randomised, open-label phase III trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m2 d1) and fluorouracil (800 mg/m2 d1-5) every 3 weeks for two cycles before CCRT. Both groups were treated with 80 mg/m2 cisplatin every 3 weeks concurrently with radiotherapy. The primary end-points were DFS and DMFS. We did efficacy analyses in the 476 randomised patients (intention-to-treat population).
After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval [CI] 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (p = 0.007). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, p = 0.014). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (p = 0.040). The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029).
IC followed by CCRT provides long-term DFS, DMFS and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients.
Yang Q
，Cao SM
，Guo L
，Hua YJ
，Huang PY
，Zhang XL
，Lin M
，You R
，Zou X
，Liu YP
，Xie YL
，Wang ZQ
，Mai HQ
，Chen QY
，Tang LQ
，Mo HY
，Cao KJ
，Qian CN
，Zhao C
，Xiang YQ
，Zhang XP
，Lin ZX
，Li WX
，Liu Q
，Li JB
，Ling L
，Guo X
，Hong MH
，Chen MY
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Comparison of therapeutic efficacy and toxicity of docetaxel, cisplatin, and fluorouracil (TPF)-based induction chemotherapy plus concurrent chemoradiotherapy and chemoradiotherapy alone in locally advanced nasopharyngeal carcinoma.
In recent years, docetaxel, cisplatin, and fluorouracil (TPF)-based induction chemotherapy plus concurrent chemoradiotherapy (CCRT) has been commonly applied for locally advanced nasopharyngeal carcinoma (LA-NPC). However, whether TPF+CCRT regimen is the best choice for LA-NPC remains unclear. This meta-analysis aims to elucidate and compare the efficacy and toxicity of TPF+CCRT versus CCRT alone for LA-NPC.
Two investigators independently and systematically searched relevant studies available on PubMed, Embase, Cochrane Library, and Web of Science published before January 7, 2021. Data were extracted from eligible studies for assessing their qualities, and calculating pooled hazard ratios (HR), odds ratio (OR) and 95% confidence intervals (CI) using Review Manager software 5.3 (RevMan 5.3).
Five studies involving 759 LA-NPC patients were analyzed in the meta-analysis. Compared to CCRT alone, TPF-based IC plus CCRT significantly improved overall survival (OS) (HR = 0.53, 95% CI: 0.35-0.81, P = .003), progression-free survival (PFS) (HR = 0.63, 95% CI: 0.46-0.86, P = .004), distant metastasis-free survival (DMFS) (HR = 0.58, 95% CI: 0.39-0.86, P = .008), and locoregional failure-free survival (LRFFS) (HR 0.62, 95% CI: 0.43-0.90, P = .01). In addition, TPF-based IC plus CCRT mainly increased risks of grade 3/4 acute hematological toxicity and non-hematological toxicities like leukopenia (OR = 1.84, 95% CI: 0.42-8.03, P = .42), neutropenia (OR = 1.78, 95% CI: 0.23-13.82, P = .58), thrombocytopenia (OR = 1.76, 95% CI: 0.53-5.81, P = .35), febrile neutropenia (OR = 2.76, 95% CI: 0.07-101.89, P = .58), vomiting (OR = 18.94, 95% CI: 0.99-362.02, P = .05) and dry mouth (OR = 2.23, 95% CI: 0.22-22.57, P = .50), which were uncomplicated and manageable.
TPF + CCRT is superb than CCRT alone for the management of LA-NPC. However, TPF+CCRT increases the incidences of grade 3/4 acute hematological toxicity and some non-hematological toxicities.
Chen R
，Lu Y
，Zhang Y
，He R
，Tang F
，Yuan W
，Li Y
，Zhang X
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ResearchGate
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