Clin Cancer Res: Evaluation of the efficacy and safety of two different administration methods of cisplatin in patients with locally advanced nasopharyngeal carcinoma: a randomized controlled clinical study

Nasopharyngeal carcinoma (NPC) is a common malignant tumor in southern China and southern Asia
.

For patients with locally advanced nasopharyngeal carcinoma (LANPC), cisplatin-based concurrent chemoradiation is the main treatment

Nasopharyngeal carcinoma (NPC) is a common malignant tumor in southern China and southern Asia

This is a randomized, open-label, non-inferiority III study.
The main research endpoint is FFS, which is defined as the time from the beginning of random allocation to local recurrence, distant metastasis or death from any cause (whichever comes first)
.

Secondary endpoints include overall survival (OS), survival without distant metastasis (DMFS), localized FFS (LRFS), response rate of treatment and toxic effects

This is a randomized, open-label, non-inferiority III study.

A total of 510 eligible patients (357 men and 153 women; median age, 44 years; range, 19-65 years) were randomly assigned to cisplatin every 3 weeks (n=260) or once a week (n=250)

Research Overview

Research Overview

There was no statistical difference in the response rate of the once every 3 weeks group and the once every week group after 3 months of treatment, which were 99.
2% and 99.
6%, respectively
.

There was no statistical difference in the response rate of the once every 3 weeks group and the once every week group after 3 months of treatment, which were 99.
2% and 99.
6%, respectively
.

Response to 3 months of treatment

Response to 3 months of treatment

The median follow-up time was 58.
3 months (IQR, 47.
8-79.
9)
.

The 3-year FFS rates of the once every 3 weeks group and once a week group were 85.

The median follow-up time was 58.

                Comparison of survival analysis between the two groups

Comparison of survival analysis between the two groups

The incidence of grade 3-4 acute toxicity in the once every 3 weeks group was 55.
8%, while that in the once a week group was 66.
2%.
There was a statistical difference between the two groups ((P=0.
015)
.

The two groups were grade 3-4 ) The incidence of leukopenia was 16.

The incidence of grade 3-4 acute toxicity in the once every 3 weeks group was 55.

In summary, in the treatment of locally advanced nasopharyngeal carcinoma, cisplatin combined with radiotherapy once every 3 weeks (100 mg/m 2) is not inferior to once a week (40 mg/m 2) combined with radiotherapy

Original source;

Wei-Xiong Xia, Xing Lv, Hu Liang, et al.

Wei-Xiong Xia, Xing Lv, Hu Liang, et al.
A Randomized Controlled Trial Comparing Two Different Schedules for Cisplatin Treatment in Patients with Locoregionally Advanced Nasopharyngeal Cancer.
Clin Cancer Res.
2021 Jun 3.
doi: 10.
1158/1078-0432.
CCR -20-4532.
Online ahead of print.
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