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. 2022 Apr 27:12:842281.
doi: 10.3389/fonc.2022.842281. eCollection 2022.

A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin

Zhiyuan Xu  1   2 , Li Yang  2 , Wai-Tong Ng  2   3 , Aya El Helali  2   3 , Victor Ho-Fun Lee  2   3 , Lingyu Ma  2 , Qin Liu  2 , Jishi Li  2 , Lin Shen  2 , Jijie Huang  2 , Jiandong Zha  2 , Cheng Zhou  1 , Anne W M Lee  2   3 , Longhua Chen  1
Affiliations

A Single-Arm Phase 2 Trial on Induction Chemotherapy Followed by Concurrent Chemoradiation in Nasopharyngeal Carcinoma Using a Reduced Cumulative Dose of Cisplatin

Zhiyuan Xu et al. Front Oncol. .

Abstract

Background: We conducted this study to evaluate if a reduced cumulative dose of induction and concurrent cisplatin conferred similar favorable outcomes when compared to trial NPC-0501.

Methods: Newly diagnosed nasopharyngeal carcinoma (NPC) with stage III-IVA were prospectively recruited from January 2015 to September 2019. Induction chemotherapy (IC) consisted of cisplatin 80mg/m2 on day 1 and capecitabine 1000mg/m2 twice daily from day 1 to 14 every 3 weeks for 3 cycles followed by concurrent chemoradiotherapy (CCRT) with 2 cycles of cisplatin 100mg/m2 given every 3 weeks. Tumor response was evaluated according to RECIST v1.1. Acute and late adverse events (AEs) were graded with CTCAE v4.0 and Late Radiation Morbidity Scoring of the RTOG, respectively.

Results: 135 patients were recruited. At 16 weeks after CCRT, all 130 patients who completed the entire course of radiotherapy (RT) had a complete response upon final assessment. With a median follow-up of 36.2 months, 22 treatment failures and 8 deaths were observed. The 3-year progression-free survival, overall survival, locoregional recurrence-free survival, and distant recurrence-free survival were 83.7%, 94.1%, 94.1%, and 85.9%, respectively. Our survival data outcomes were similar to those reported in the cisplatin and capecitabine (PX) induction arm of the 0501 trial. 103 patients (76.3%) reported acute grade 3-4 AEs. Two patients (1.5%) had late grade 3-4 complications, numerically fewer than those reported in the NPC-0501 trial.

Conclusions: Induction PX and concurrent cisplatin with a reduced cumulative cisplatin dose yield survival outcomes comparable to those reported in the NPC-0501 trial with excellent tolerability. Therefore, a reduced cumulative dose of cisplatin is a promising treatment scheme for nasopharyngeal carcinoma.

Keywords: capecitabine; cisplatin; induction chemotherapy; nasopharyngeal carcinoma; progression-free survival.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Enrollment and Follow-up.
Figure 2
Figure 2
(A-D) Kaplan–Meier Analysis of survival outcomes in intention-to-treat population.
Figure 3
Figure 3
Univariate and multivariate Cox regression on PFS.
See this image and copyright information in PMC

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