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Adjuvant cisplatin-gemcitabine significantly improves progression-free survival (PFS) over standard cisplatin-fluorouracil in N2-3 nasopharyngeal carcinoma.


  • The study included patients aged 18–65 years with untreated, nonkeratinizing, stage T1-4 N2-3 M0 nasopharyngeal carcinoma who were treated in a randomized trial at four cancer centers in China.

  • Four weeks after upfront chemoradiation therapy, 120 patients received gemcitabine (1 g/m2 intravenously on days 1 and 8) and cisplatin (80 mg/m2 intravenously on day 1) once every 3 weeks for three cycles.

  • Another 120 patients received fluorouracil (4 g/m2 in continuous intravenous infusion) and cisplatin (80 mg/m2 intravenously on day 1) once every 4 weeks for three cycles.

  • Nearly 62% of patients in the cisplatin-gemcitabine group completed all three cycles, as did 77% in the cisplatin-fluorouracil arm. The median follow-up was 40 months.


  • Overall, 3-year PFS was 83.9% (19 cases of disease progression, fansidar discontinued 11 deaths) with cisplatin-gemcitabine, vs 71.5% (34 cases of disease progression, seven deaths) with cisplatin-fluorouracil (hazard ratio, 0.54; P = .023).

  • The 3-year cumulative incidence of locoregional relapse was 2.6% with cisplatin-gemcitabine, vs 13.6% with cisplatin-fluorouracil. The 3-year cumulative incidence of distant metastasis was 10.9%, vs 22.3%.

  • The most common acute grade 3+ adverse events were leukopenia (52% with cisplatin-gemcitabine, vs 29% with cisplatin-fluorouracil), neutropenia (32% vs 16%), and mucositis (23% vs 28%).

  • Hearing loss was the most common grade 3+ late adverse event (5% with cisplatin-gemcitabine, vs 9%). One treatment-related death occurred in the cisplatin-gemcitabine arm. The cause of death was septic shock.


  • “These results support the potential role of adjuvant therapy with cisplatin-gemcitabine chemotherapy for the treatment of nasopharyngeal carcinoma,” the study authors conclude.


  • The study was led by Li-Ting Liu, MD, of the Sun Yat-sen University Cancer Center, Guangzhou, and was published June 5 in The Lancet Oncology.


  • The study was conducted in an endemic area; it is not known whether the results apply elsewhere.

  • The effect of adjuvant cisplatin-gemcitabine on early overall survival was not significant; longer follow-up is needed.

  • Baseline PET/CT was not required; as a result, occult distant metastases may have been missed.

  • Further studies are needed in a more globally diverse population to confirm the findings.


  • The study was funded by the National Key Research and Development Program of China, the National Natural Science Foundation of China, and others.

  • The investigators reported no relevant financial relationships.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: [email protected].

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