In this study, patients with advanced nasopharyngeal cancer (cancer of the upper part of the throat behind the nose) received either chemoradiotherapy (chemotherapy and radiotherapy given together) alone, or first received two drugs, gemcitabine and cisplatin, as initial chemotherapy before it. After about 7 years of follow-up, the 5-year survival rate was higher in the group that received initial chemotherapy (about 88% versus 79%), and no more late side effects were seen. In patients whose blood level of Epstein-Barr virus DNA was low before treatment, this extra chemotherapy did not seem to give a clear benefit; of course, the treatment decision should be made by the treating doctor.
Locoregionally advanced non-keratinizing nasopharyngeal cancer; in the trial: T3–4N1 or N2–3 (AJCC 7th edition), M0, KPS ≥70, creatinine clearance ≥60 mL/min, age 18 to 65 years
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Induction: 3 cycles | |||
| Gemcitabine | 1000 mg/m² | IV | Days 1 and 8 |
| Cisplatin | 80 mg/m² | IV | Day 1 |
| Chemoradiotherapy: 3 cycles | |||
| Cisplatin | 100 mg/m² | IV | Every 3 weeks, concurrent with IMRT |
| Chemoradiotherapy | |||
| Intensity-modulated radiotherapy (IMRT) | Per protocol | External beam | |
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Induction: gemcitabine 1000 mg/m² (1 g/m²) IV on days 1 and 8 + cisplatin 80 mg/m² IV on day 1, every 3 weeks, 3 cycles.
Then chemoradiotherapy: IMRT at 2.0 to 2.3 Gy per fraction, 5 fractions a week over 6 to 7 weeks, to a total dose of 66 Gy or more to the primary tumour, with concurrent cisplatin 100 mg/m² every 3 weeks for 3 cycles (242 patients).
IMRT (2.0 to 2.3 Gy per fraction, 5 fractions a week over 6 to 7 weeks, total dose 66 Gy or more to the primary tumour) with concurrent cisplatin 100 mg/m² every 3 weeks for 3 cycles (238 patients).
Source of the regimen details: Regimen of the original trial (Zhang et al., NEJM 2019; this paper is the final overall survival analysis of the same trial and does not give doses): abstract of the original paper and ClinicalTrials.gov NCT01872962
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
(Criteria of the original trial, ClinicalTrials.gov NCT01872962) Patients aged 18 to 65 years with newly diagnosed non-keratinising nasopharyngeal carcinoma, stage T3–4N1 or N2–3 (AJCC 7th edition), without distant metastasis; KPS 70 or higher; leucocytes 4000/µL or more, haemoglobin 90 g/L or more and platelets 100,000/µL or more; creatinine clearance 60 mL/min or more; no prior radiotherapy, chemotherapy or surgery (except diagnostic). The trial was conducted at centres in China.
The initial report of this trial had shown a significant improvement in failure-free survival. This paper presents the final analysis of overall survival (OS). It also examines late toxicities, the association between the depth of tumour response to induction chemotherapy and survival, and the role of pre-treatment plasma cell-free Epstein-Barr virus (EBV) DNA load.
The risk of grade ≥3 late toxicities was comparable in the two groups (11.3% in the induction chemotherapy group versus 11.4%). Other safety data are not given in the abstract.
This final analysis shows that adding induction chemotherapy with gemcitabine and cisplatin before concurrent chemoradiotherapy, in addition to the improvement in failure-free survival in the earlier report, also improves overall survival in locally advanced nasopharyngeal carcinoma, without increasing late toxicities. Tumour response to induction chemotherapy and the pre-treatment EBV DNA load may help individualise treatment; these findings are exploratory. The status of this regimen in current reliable clinical guidelines should be checked separately, as it is not mentioned in the abstract.
Based on the abstract, the findings on tumour response and cell-free EBV DNA (including the lack of a survival difference with a low EBV load) are expressed as "may" and need confirmation. Other limitations are not given in the abstract and should be checked in the full text of the paper.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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