Induction chemotherapy with nab-paclitaxel and cisplatin versus docetaxel, cisplatin, and fluorouracil followed by chemoradiotherapy in patients with stage III–IVA nasopharyngeal carcinoma
Description
This open-label, non-inferiority, multicentre, phase 3 randomised controlled trial (ChiCTR1800019922) compared induction chemotherapy with nanoparticle albumin-bound paclitaxel plus cisplatin (nab-TP) with docetaxel, cisplatin, and fluorouracil (TPF), both followed by concurrent chemoradiotherapy, in treatment-naive patients aged 18–70 years with pathologically confirmed WHO type II or III, stage III–IVA nasopharyngeal carcinoma according to the eighth edition of the AJCC staging system. The primary endpoint was the 3-year failure-free survival rate in the intention-to-treat population, defined as the interval from randomisation to locoregional recurrence, distant metastasis, death from any cause, or last follow-up. Conducted at five tertiary hospitals in southern China, this trial randomly assigned 515 patients to receive nab-TP (n=259) or TPF (n=256). Nab-TP met the prespecified criterion for non-inferiority in 3-year failure-free survival rate, while objective response, overall survival, locoregional recurrence-free survival, and distant metastasis-free survival were comparable between the groups. Nab-TP was associated with lower rates of leucopenia, neutropenia, hyponatraemia, and diarrhoea, and no treatment-related deaths occurred. These findings support nab-TP as an effective and better-tolerated alternative to TPF for patients with locoregionally advanced nasopharyngeal carcinoma.
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Institutions
- Sun Yat-sen University Cancer CenterGuangdong, Guangzhou
- Fifth Affiliated Hospital of Sun Yat-sen UniversityGuangdong, Zhuhai
- Guangzhou Medical University Cancer HospitalGuangdong, Guangzhou
- University of South ChinaHunan, Hengyang
- First Affiliated Hospital of Guangzhou Medical UniversityGuangdong, Guangzhou
- The First Affiliated Hospital, Sun Yat-sen UniversityGuangdong, Guangzhou
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Funders
- Natural Science Foundation of Guangdong ProvinceGrant ID: No. 2023B1515020044