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Bending the Curve Trial by Trial
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Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma

Needs review

Phase 3N = 362NCT01528618

Population
Recurrent or metastatic nasopharyngeal carcinoma, recruited at 22 hospitals in China
Design
Multicentre, randomised, open-label phase 3 trial at 22 hospitals in China. 362 patients with recurrent or metastatic nasopharyngeal carcinoma (ECOG performance status 0 or 1, adequate organ function, measurable lesions by RECIST 1.1) were randomly assigned 1:1 to gemcitabine 1 g per square metre on days 1 and 8 plus cisplatin 80 mg per square metre, or fluorouracil 4 g per square metre by continuous infusion over 96 hours plus cisplatin 80 mg per square metre, every 3 weeks for up to six cycles. The primary endpoint was progression-free survival assessed by an independent image committee in the intention-to-treat population.
Primary endpoint
PFS
Arms
  • Gemcitabine plus cisplatin (experimental, n = 181): Gemcitabine 1 g per square metre days 1 and 8 plus cisplatin 80 mg per square metre every 3 weeks, up to six cycles
  • Fluorouracil plus cisplatin (control, n = 181): Fluorouracil 4 g per square metre over 96 hours plus cisplatin 80 mg per square metre every 3 weeks, up to six cycles
People
Zhang L, senior author Zhao C
PFSHR 0.55 (95% CI 0.44–0.68)Δ median PFS+1.4 months
Show the numbers
Results reported for Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma
EndpointAnalysisGemcitabine plus cisplatinFluorouracil plus cisplatinEffect
PFSprimarymedian follow-up 19.4 monthsZhang 2016median 7 monthsmedian 5.6 monthsHR 0.55 (95% CI 0.44–0.68)P<0.0001The abstract gives intervals beside the medians (4.4-10.9 and 3.0-7.0 months) without labelling them, so they are not entered as 95% CIs. Progression-free survival was assessed by the independent image committee.
Results reported for Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma
EndpointAnalysisGemcitabine plus cisplatinFluorouracil plus cisplatinEffect
PFSprimarymedian follow-up 19.4 monthsZhang 2016median 7 monthsmedian 5.6 monthsHR 0.55 (95% CI 0.44–0.68)P<0.0001The abstract gives intervals beside the medians (4.4-10.9 and 3.0-7.0 months) without labelling them, so they are not entered as 95% CIs. Progression-free survival was assessed by the independent image committee.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.550.44–0.68
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%051015Months (modelled)
  • Gemcitabine plus cisplatin (experimental)
  • Fluorouracil plus cisplatin (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsGemcitabine plus cisplatinFluorouracil plus cisplatin
0100.0%100.0%
467.3%61.0%
941.0%32.8%
1327.6%20.0%
1816.8%10.8%
Primary publication: Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016;388(10054):1883-1892. PubMedDOI

Appears in

Sources

  1. Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, et al. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma: a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016;388(10054):1883-1892.

    PubMedDOI