[Comparative clinical studies for head and neck cancer in Japan]

Very few large multi-institutional comparative clinical studies for head and neck cancer are reported in Japan. Many studies for organ-preservation with better QOL have been reported around the world, and comparative clinical studies are also necessary in Japan to evaluate organ-preservation treatment. I reviewed comparative clinical studies for head and neck cancer in Japan. Inuyama et al. reported a multi-institutional randomized clinical trial (RCT) that compared the efficacy of CBDCA + PEP and CDDP + PEP. Comparative clinical studies for combination chemotherapy, CDDP + PEP + MTX (PPM) vs. CDDP + PEP + 5-FU (PPF), and PPM vs. CDDP + PEP (PP) are reported. Effects and toxicity are different with each regimen, but the differences are not statistically significant. An RCT of neoadjuvant chemotherapy (NAC) for nasopharyngeal cancer with a small sample size was reported. Three-year survival was significantly better for the NAC group. An RCT of concurrent chemo-radiotherapy with CDDP vs. CBDCA was also reported. CBDCA with radiation was significantly better in terms of 2- and 5-year survival. This result is interesting but the low-dose CDDP with radiation 4 times per week is not standard. A large nationwide RCT with 560 cases investigating adjuvant chemotherapy with UFT was conducted in 1987. The differences in 3-year survival and 3-year disease-free survival with or without UFT adjuvant were not statistically significant, but the incidence of distant metastasis was significantly lower in the UFT adjuvant group. Comparative clinical studies of 5-HT3 antagonists for chemotherapy including CDDP are reported. We conducted a crossover comparative clinical study on the combination of azasetron and dexamethasone. The combination with dexamethasone significantly prevented acute emesis induced by CDDP. Comparative clinical studies of head and neck cancer have not provided good evidence, with the exception of an RCT of adjuvant chemotherapy with UFT, in the past. Well-designed comparative clinical studies with the cooperation of head and neck surgeons, radio-oncologists, and medical oncologists should be considered in order to acquire high-level evidence.