Triweekly TPF and PF induction chemotherapy (IndCT) are the most popular and effective regimen for locally advanced squamous cell carcinoma of the head and neck (SCCHN). However, significant ethnic differences in susceptibility to the effects and toxicities exist. We designed a novel weekly CDFLEM IndCT and compared treatment outcome with TPF/PF from literature in locally advanced SCCHN.
A four-drug regimen (C-D-FL-EM) consisting of (1) cisplatin 60 mg/m2, day 1, (2) docetaxel 50 mg/m2, day 8, (3) 5-fluorouracil 2500 mg/m2 + leucovorin 250 mg/m2, day 15, (4) epirubicin 30 mg/m2 + methotrexate 30 mg/m2, day 22, were alternatively delivered once per week, 4 weeks per cycle. From September 2011 to December 2013, 78 patients with stage III/IV SCCHN received 3-4 cycles IndCT of CDFLEM, followed by local therapy (including surgery, radiotherapy, concurrent chemoradiotherapy, or bio-radiotherapy).
Baseline characteristics of 78 patients are as follows: primary of oral cavity/oropharynx/hypophayrnx/larynx = 23/26/24/5; stage III/IV = 10/68; median age = 51 (range 33-77); male/female = 73/5; performance status ECOG 0-1/2 = 75/3. Synchronous second or triple primary tumors were also noted in 10 patients. We obtained an overall response rate of 97.3% (CR 39.2% + PR 58.1%) for 74 evaluable patients. The Overall response rate in the TAX-323 trial was 53.6% (CR 6.6% + PR 47.0%) for the PF and 67.8% (CR 8.5% + PR 59.3%) for the TPF regimens, respectively. The corresponding figures in the TAX-324 trial was 64% (CR 15% + PR 49%) and 72% (CR 17% + PR 55%), respectively. Gr 3/4 mucositis occurred in 7.7% for our weekly CDFLEM, 11.2% and 4.6% for PF and TPF in the TAX-323, 27% and 22% for PF and TPF in the TAX-324. Gr 3/4 leucopenia was 38.4% for our CDFLEM, 22.9% and 41.6% for PF and TPF in the TAX-323, 56% and 83% for PF and TPF inf the TAX-324.
IndCT with our weekly CDFLEM regimen has a higher response rate and a lower Gr 3/4 mucositis/neutropenia than triweekly PF/TPF in patients with locally advanced SCCHN.
Clinical trial identification
JF11153A of the Taichung Veterans General Hospital
Legal entity responsible for the study
Department of Radiation Oncology, Taichung Veterans General Hospital, Taiwan
Sanofi, Taiwan branch
All authors have declared no conflicts of interest.