Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Gemcitabine plus cisplatin provides benefits over 5-fluorouracil plus cisplatin as adjuvant treatment for nasopharyngeal carcinoma, according to research presented at the ASCO Annual Meeting 2023.1
Patients who received gemcitabine and cisplatin had improvements in progression-free survival (PFS), loco-regional relapse-free survival (LRFS), and distant metastasis-free survival (DMFS) when compared to patients who received 5-fluorouracil plus cisplatin.
“We highly recommend adjuvant GP [gemcitabine and cisplatin] therapy for patients with locoregionally advanced nasopharyngeal carcinoma, but a long-term follow-up time is required to confirm whether GP adjuvant chemotherapy will benefit the overall survival,” said study presenter Lin-Quan Tang, MD, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China.
Dr Tang and colleagues conducted this phase 3 trial (ClinicalTrials.gov Identifier: NCT03321539) in 240 patients with stage T1–4N2–3 nasopharyngeal carcinoma.
All patients received cisplatin (100 mg/m2) on days 1, 22, and 43 of radiotherapy. Patients were then randomly assigned to receive gemcitabine (1 g/m2 on days 1 and 8) and cisplatin (80 mg/m2 on day 1) once every 3 weeks (n=120) or 5-fluorouracil (4 g/m2 continuously over 96 hours) and cisplatin (80 mg/m2 on day 1) once every 4 weeks for 3 cycles (n=120).
Baseline characteristics were well balanced between the arms. The median follow-up was 40 months.
Response rates were similar between the arms. The overall response rate was 97.5% for the 5-fluorouracil arm and 96.7% for the gemcitabine arm.
However, the rate of progression was lower in the gemcitabine arm than in the 5-fluorouracil arm (17.5% and 30.8%, respectively). The same was true for distant failure (10.8% vs 20.8%) and locoregional failure (4.2% vs 12.5%).
The 3-year PFS rate was significantly higher in the gemcitabine arm than in the 5-fluorouracil arm — 83.9% and 71.5%, respectively (hazard ratio [HR], 0.54; 95% CI, 0.32-0.93; P =.023).
LRFS was significantly higher in the gemcitabine arm than in the 5-fluorouracil arm as well (HR, 0.33; 95% CI, 0.12-0.90; P =.03). The same was true for DMFS (HR, 0.50; 95% CI, 0.26-0.98; P =.042).
There was no significant difference in overall survival between the arms (HR, 1.17; 95% CI, 0.51-2.66; P =.71).
Grade 3 or higher hematologic toxicity occurred more frequently in the gemcitabine arm than in the 5-fluorouracil arm. The rate of grade 3 or higher leukopenia was 52.1% in the gemcitabine arm and 29.3% in the 5-fluorouracil arm (P =.00039). The rate of grade 3 or higher neutropenia was 31.6% and 16.4%, respectively (P =.01). The hematologic toxicity should be carefully managed, Dr Tang said.
This research was also published in The Lancet Oncology.2
Disclosures: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
References
1. Tang L-Q, Liu L-T, Liu H, et al. Concurrent chemoradiotherapy followed by adjuvant cisplatin-gemcitabine versus cisplatin-5-fluorouracil chemotherapy for N2-3 nasopharyngeal carcinoma: A multicentre, open-label, randomised, controlled, phase 3 trial. ASCO 2023. June 2-6, 2023. Abstract 6000.
2. Liu L-T, Liu H, Huang Y, et al. Concurrent chemoradiotherapy followed by adjuvant cisplatin–gemcitabine versus cisplatin–fluorouracil chemotherapy for N2–3 nasopharyngeal carcinoma: A multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. Published online June 5, 2023. doi:10.1016/S1470-2045(23)00232-2
