J Clin Oncol: Gemcitabine combined with cisplatin improves the prognosis of patients with recurrent or metastatic nasopharyngeal carcinoma compared with fluorouracil combined with cisplatin: Phase III study GEM20110714 final OS analysis

GEM20110714 (NCT01528618) is the first randomized phase III study to evaluate the efficacy of systemic chemotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC)
.

The preliminary analysis of the study showed that gemcitabine + cisplatin (GP) significantly improved the progression-free survival of patients compared with fluorouracil + cisplatin (FP) (HR=0.

GEM20110714 (NCT01528618) is the first randomized phase III study to evaluate the efficacy of systemic chemotherapy for recurrent or metastatic nasopharyngeal carcinoma (NPC)

From February 2012 to October 2015, 362 patients were randomly assigned to receive GP (gemcitabine 1 g/m2, once a day, on days 1 and 8; cisplatin 80 mg/m2, once a day, Day 1; n = 181) or FP (fluorouracil 4 g/m2 continuous intravenous infusion for more than 96 hours, cisplatin 80 mg/m2 once a day, on day 1; n = 181), a course of treatment every 21 days
.

The primary study endpoint is progression-free survival (PFS), which has been reported previously; overall survival (OS) is the secondary endpoint

From February 2012 to October 2015, 362 patients were randomly assigned to receive GP (gemcitabine 1 g/m2, once a day, on days 1 and 8; cisplatin 80 mg/m2, once a day, Day 1; n = 181) or FP (fluorouracil 4 g/m2 continuous intravenous infusion for more than 96 hours, cisplatin 80 mg/m2 once a day, on day 1; n = 181), a course of treatment every 21 days

The median follow-up time was 69.

OS and PFS

OS and PFS

The 1-, 3-, and 5-year PFS rates of the GP and FP groups were 21.
2% (15.
5 to 27.
6) vs 6.
0% (95% CI, 3.
1 to 10.
3), 8.
5% (95% CI, 4.
6 to 13.
9) vs.
1.
1% (95% CI, 0.
1 to 4.
8), and 7.
6% (95% CI, 3.
9 to 12.
9) vs 0%, there are statistical differences (p=0.
001)
.

The 1-, 3-, and 5-year PFS rates of the GP and FP groups were 21.
2% (15.
5 to 27.
6) vs 6.
0% (95% CI, 3.
1 to 10.
3), 8.
5% (95% CI, 4.
6 to 13.
9) vs.
1.
1% (95% CI, 0.
1 to 4.
8), and 7.
6% (95% CI, 3.
9 to 12.
9) vs 0%, there are statistical differences (p=0.
001)
.

The 1-, 3-, and 5-year PFS rates of the GP and FP groups were 21.

The ORR of the GP group was 20.

              Subgroup analysis

Subgroup analysis

Multivariate analysis showed that the factors related to the improved prognosis were the GP treatment group (P=0.
008), better ECOG PS score (P<0.
001), no liver metastasis (P=0.
05), and lower baseline EBV load (P<0.
05)
.

Multivariate analysis showed that the factors related to the improved prognosis were the GP treatment group (P=0.
008), better ECOG PS score (P<0.
001), no liver metastasis (P=0.
05), and lower baseline EBV load (P<0.
05)
.

Factors related to improved prognosis include the GP treatment group (P=0.

In summary, for patients with recurrent or metastatic nasopharyngeal carcinoma, first-line GP (gemcitabine + cisplatin) improves the OS of patients compared with FP (fluorouracil + cisplatin)

Original source:

Hong S, Zhang Y, Yu G, et al.

Hong S, Zhang Y, Yu G, et al.
Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study.
J Clin Oncol.
2021 Aug 11:JCO2100396 .
doi: 10.
1200/JCO.
21.
00396.
Epub ahead of print.
PMID: 34379443.
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