Study design and participants
undifferentiated nonkeratinizing carcinoma, allergies, Cancer
METASTASIS, MALIGNANT TUMOURS, MAY, ALLERGIES, ONCOLOGY, CANCER
This was a multicentre, open-label, randomized controlled study involving metastatic NPC patients recruited from May 2015 to May 2019 at the Cancer Treatment Center of the Fourth Affiliated Hospital of Guangxi Medical University, Chemotherapy Department of the First Affiliated Hospital of Guangxi Medical University, Oncology Department of the Affiliated Hospital of Guilin Medical University, Oncology Department of the Third Affiliated Hospital of Guangxi Medical University, and Oncology Department of the Liuzhou Traditional Chinese Medicine Hospital. The study was reviewed and approved by the Institutional Review Board of the Fourth Affiliated Hospital of Guangxi Medical University (PJK2015221). The clinical trial registration number is ChiCTR-IOR-16007939. Written informed consent was obtained from all participants prior to any study-related procedures. The study was conducted according to the tenets of the Declaration of Helsinki and Good Clinical Practice.The inclusion criteria were (1) pathologically diagnosed nasopharyngeal undifferentiated nonkeratinizing carcinoma, (2) prior potentially curative treatment, (3) clinically/pathologically diagnosed distant metastasis, with at least one measurable lesion, (4) first-line chemotherapy with ≥ 4 cycles, and efficacy evaluation of clinical benefit based on the DC, (5) Eastern Cooperative Oncology Group (ECOG) score < 2 points, and (6) giving written consent to participate in the study. The exclusion criteria were (1) other malignant tumours, (2) chemotherapy contraindications, (3) allergies to any of the drugs in the regimen, or (4) inability to take oral drugs or attend the follow-up visits.