Gemcitabine improves survival in patients with recurrent or metastatic nasopharyngeal carcinoma

Hong, Shaodong; Zhang, Li

doi:10.1186/s40880-016-0163-6

Cited by 6 publications

(3 citation statements)

References 8 publications

(7 reference statements)

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“…The GEM20110714 trial was the first randomized, phase III trial of palliative chemotherapy in RM-NPC. 4 , 5 This trial compared the efficacy and safety of gemcitabine plus cisplatin (GP) with that of fluorouracil plus cisplatin (FP) in first-line treatment of RM-NPC.…”

Section: Introductionmentioning

confidence: 99%

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

Hong

Zhang

et al. 2021

JCO

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PURPOSE GEM20110714 (ClinicalTrials.gov identifier: NCT01528618 ), the first randomized, phase III study of systemic chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC), reported significant progression-free survival improvement with gemcitabine plus cisplatin (GP) versus fluorouracil plus cisplatin (FP; hazard ratio, 0.55; 95% CI, 0.44 to 0.68; P < .001). Data from the final analysis of overall survival (OS) are presented here. METHODS From February 2012 to October 2015, 362 patients were randomly assigned to receive either GP (gemcitabine 1 g/m2 once daily on days 1 and 8 and cisplatin 80 mg/m2 once daily on day 1; n = 181) or FP (fluorouracil 4 g/m2 in continuous intravenous infusion over 96 hours and cisplatin 80 mg/m2 once daily on day 1; n = 181) once every 21 days. The primary end point was progression-free survival, which has been previously reported; OS was a secondary end point. RESULTS After a median follow-up time of 69.5 months with GP and 69.7 months with FP, 148 (81.8%) and 166 (91.7%) deaths occurred in the GP and FP arms, respectively. The estimated hazard ratio for OS was 0.72 (95% CI, 0.58 to 0.90; two-sided P = .004). The median OS was 22.1 months (95% CI, 19.2 to 25.0 months) with GP versus 18.6 months (95% CI, 15.4 to 21.7 months) with FP. The OS probabilities at 1, 3, and 5 years were 79.9% versus 71.8%, 31.0% versus 20.4%, and 19.2% versus 7.8%, respectively. Poststudy therapy was administered in 51.9% and 55.2% of patients in the GP and FP arms, respectively. CONCLUSION Among patients with previously untreated advanced nasopharyngeal carcinoma, those who receive GP have longer OS than those receive FP. Gemcitabine plus cisplatin should be considered a preferred front-line option for these patients.

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Section: Introductionmentioning

confidence: 99%

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

Hong

Zhang

et al. 2021

JCO

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“…The majority (223/266, 83.8%) of toxicities and adverse events was judged on Grades1/2. About one-third of patients with NPC suffer of distant metastases and resultant treatment failure [15]. Liver metastasis is the second common metastasis site, which accounts for 30% of such cases, following bone metastasis (70%) and followed by lung metastasis (18%) [16], but has the worst prognosis (with reported mOS of 3-5 months) [6,7].…”

Section: Discussionmentioning

confidence: 99%

Hepatic artery infusion pump for nasopharyngeal carcinoma with liver metastasis

Peng

Zhou

et al. 2019

Clin Exp Metastasis

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To evaluate the benefits and risks of hepatic artery infusion (HAI) gemcitabine and floxuridine (FUDR) in patients with nasopharyngeal carcinoma liver metastases. HAI catheter systems were implanted under the guide of digital subtract angiography (DSA) in 16 patients with unresectable nasopharyngeal carcinoma liver metastases. HAI gemcitabine and FUDR in combination with radiotherapy and systemic chemotherapy were delivered. Disease control rate (DCR) of intrahepatic lesions is 100%, objective response rate (ORR) of intrahepatic lesions is 87.5%, including 4 patients (25%) with complete response (CR), 10 patients (62.5%) with partial response (PR) and 2 patients (12.5%) with stable disease (SD). The median overall survival (mOS) was 30 months. There was no significant difference between patients with < 9 intrahepatic lesions and patients with ≥ 9 intrahepatic lesions (31 months vs. 24 months, P = 0.562). Patients without extrahepatic metastases has longer survival than patients with extrahepatic metastases (31 months vs. 17 months, P = 0.005). In all 72 cycles of HAI, the main grade 3/4 toxicities related to HAI include: leukopenia occur in 8 cycles (11.1%), thrombocytopenia in 5 cycles (6.9%), AST/ALT elevation in 12 cycles (16.7). Catheter related complications occurred in 2 patients (12.5%). HAI gemcitabine and FUDR is effective to improve DCR of intrahepatic lesions and prolong mOS for patients with nasopharyngeal carcinoma liver metastases, and is associated with a relative low rate of toxicity.

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“…The preliminary result of phase 2 trial with tislelizumab (an anti-PD-1) which was presented in ASCO 2019 meeting showed 43% objective response rate and 10.4 months of progression-free survival (PFS) in those with advanced metastatic or recurrent nasopharyngeal cancer. This was shown to confer longer PFS compared to historical control (PFS of 7 months) with second-line chemotherapy [41]. However, the survival benefit is yet to be proven in phase 3 study.…”

Section: Current Work In Progress For Potential Immune-related Targementioning

confidence: 99%

Current Immune-Related Molecular Approach in Combating Nasopharyngeal Cancer

et al. 2019

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Nasopharyngeal cancer is a cancer closely related to Epstein-Barr virus (EBV) infection. EBV protein has been shown to be related to various oncogenic development. Suppression of tumor suppressor genes, upregulating molecules to prevent immune attack, downregulating pro-apoptotic proteins, and stimulating local immune suppressive environment are among some roles that EBV proteins can exert on host cells. All those factors combined together with underlying genetic susceptibility of host cells further increase the chance of nasopharyngeal cancer development. Approach targeting those carcinogenesis pathways has been tested with marginal benefit. A newer approach boosting immune cells to increase recognition of tumor antigen and promoting cytotoxic T cell attack has shown promising clinical benefit. Further combination of those immunotherapies with other modality, in particular radiotherapy, has resulted in amplification of cancer killing.

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Gemcitabine improves survival in patients with recurrent or metastatic nasopharyngeal carcinoma

Cited by 6 publications

References 8 publications

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

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

Hepatic artery infusion pump for nasopharyngeal carcinoma with liver metastasis

Current Immune-Related Molecular Approach in Combating Nasopharyngeal Cancer

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