Highlights
- •IC followed by CCRT improved not only DMFS and DFS, but also OS at 5 years in patients with locoregionally advanced NPC.
- •The addition of cisplatin and fluorouracil induction chemotherapy did not significantly increase late toxicities.
- •IC followed by CCRT can be recommended for patients with locoregionally advanced NPC.
Abstract
Background
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.
Patients and methods
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).
Results
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).
Conclusion
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.
Keywords
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Article info
Publication history
Published online: August 16, 2019
Accepted:
July 4,
2019
Received in revised form:
June 23,
2019
Received:
January 9,
2019
Identification
Copyright
© 2019 Elsevier Ltd. All rights reserved.
