CHICAGO, IL—Patients with locally advanced nasopharyngeal cancer (NPC) do not benefit from the addition of neoadjuvant gemcitabine, carboplatin, and paclitaxel (GCP) to cisplatin chemoradiation, according to findings from a randomized phase 3 open-label clinical trial presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting.
“Neoadjuvant chemotherapy with GCP did not improve survival in locally advanced NPC and concurrent chemoradiotherapy remains the standard of care,” concluded lead study author Terence Tan, FRCR, of the National Cancer Center Singapore, in Singapore.
A total of 180 patients were randomly assigned between 2004 and 2012 to receive chemoradiotherapy alone or following a neoadjuvant GCP regimen: gemcitabine 1000 mg/m2, cisplatin AUC 2.5, and paclitaxel 70 mg/m2 on days 1 and 8 every 3 weeks for three cycles. Radiotherapy (RT) was delivered by intensity-modulated RT (IMRT) or tomotherapy. Participants were stratified by N stage (N0-1 or N2-3). Most participants were male (78%); the ethnicity of most patients was Chinese (96%).
Data analysis included 86 patients from each study arm. At a median follow-up of 3.25 years, overall survival was not significantly different between the two study arms (median OS for GCP group: 74.8 months, compared with 77.6 months for the control-group; hazard ratio [HR], 1.05; 95% CI: 0-2.19; P = 0.494). Therefore, the trial was halted, Tan reported.
Patients in the GCP study arm suffered higher rates of grades 3/4 leukopenia (52% vs. 37% for chemoradiation only), neutropenia (24% vs. 12%), thrombocytopenia (14% vs. 0%), and fatigue (14% vs. 2%). During concurrent treatment, patients receiving GCP also suffered significantly more swallow dysfunction (median dyspnea score: 24 compared to 15 in the control group; P = 0.014) and diarrhea (15.2% vs 9.3%; P = 0.018).
Global quality of life scores were not significantly different between the study arms.
“No phase 3 trial has so far demonstrated a survival benefit for induction,” Dr. Tan said—raising questions about whether or not it will prove “possible to further improve survival over concurrent chemoradiation.”
The study was funded partly by Eli Lilly.
- Tan T, Lim WT, Fong KW et al. Abstract 6003. Presented at: 2014 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30-June 3, 2014; Chicago, IL.