PURPOSE The standard treatment for postoperative high-risk locally advanced squamous cell carcinoma of the head and neck (LA-SCCHN) is chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ). However, whether chemoradiotherapy with weekly cisplatin (40 mg/m 2 ) yields comparable efficacy with 3-weekly cisplatin in postoperative high-risk LA-SCCHN is unknown. PATIENTS AND METHODS In this multi-institutional open-label phase II/III trial, patients with postoperative high-risk LA-SCCHN were randomly assigned to receive either chemoradiotherapy with 3-weekly cisplatin (100 mg/m 2 ) or with weekly cisplatin (40 mg/m 2 ) to confirm the noninferiority of weekly cisplatin. The primary end point of phase II was the proportion of treatment completion, and that of phase III was overall survival. A noninferiority margin of hazard ratio was set at 1.32. RESULTS Between October 2012 and December 2018, a total of 261 patients were enrolled (3-weekly cisplatin, 132 patients; weekly cisplatin, 129 patients). At the planned third interim analysis in the phase III part, after a median follow-up of 2.2 (interquartile range 1.19-3.56) years, chemoradiotherapy with weekly cisplatin was noninferior to 3-weekly cisplatin in terms of overall survival, with a hazard ratio of 0.69 (99.1% CI, 0.374 to 1.273 [< 1.32], one-sided P for noninferiority = .0027 < .0043). Grade 3 or more neutropenia and infection were less frequent in the weekly arm (3-weekly v weekly, 49% v 35% and 12% v 7%, respectively), as were renal impairment and hearing impairment. No treatment-related death was reported in the 3-weekly arm, and two (1.6%) in the weekly arm. CONCLUSION Chemoradiotherapy with weekly cisplatin is noninferior to 3-weekly cisplatin for patients with postoperative high-risk LA-SCCHN. These findings suggest that chemoradiotherapy with weekly cisplatin can be a possible treatment option for these patients.
Old females are compared to young females for the purpose of studying the difference in comfort caused by the environmental variables of temperature and humidity as well as the form of clothing.Eight experiments were performed in three settings: (a) 30°C R. H. 80%; 30°C R. H. 45%; and 20°C R. H. 45%. The ages of the subjects range from 62 to 68 (Mean=65.17, S. D.=1.68) among old females and from 20 to 23 (Mean=20.83, S. D.=0.76) among young females. The following results were obtained:(1) The young females were sensitive to hot temperatures, while the old females were not. On the other hand, the old females were more sensitive to cold temperatures, under 20°C R. H. 45%, than the young females. In temperatures under 30°C R. H. 80%, the heat radiation from the young females was higher than that of the old females. Under 20°C R. H. 45%, the heat radiation from the old females was higher than from the young females. The old females are thought to decline in physiogenic function due to enduring both hot and cold temperatures.(2) The correlation between the temperature in clothes and comfort among the old females is not different from the same correlation among the young females. This conclusion agrees with previously published studies of the young females.(3) Skin temperature and bloodstream are measured, according to clothing form. As a result, a long skirt is the highest in thermal insulation, long pants the next highest, and a short skirt is the lowest.(4) The effect of thermal insulation provided by a lap robe was tested in both groups. The lap robe was found to be more effective for the older group than the younger in temperatures under 20°C R. H. 45%. Hence, the role of clothes in offsetting for the decline in the thermoregulation function that compensates for environmental change is more important for old females than for young.
Strain difference of responses to acute and long-term benzene inhalations was investigated in male mice of CFW and ddN lines. Observed responses included mortality and lethal time by acute exposure to higher concentrations of benzene, and changes in leucocyte counts and hemoglobin levels after repeated inhalations of lower concentrations. Experiments and results are as follows. 1) Groups of mice aged 5, 7 and 10 weeks for both strains were exposed to 1.5% benzene and mortalities were observed. Mice of 5 and 7 weeks of age did not show any significant strain difference in mortalities. In 10 weeks old mice, however, mortality of ddN was significantly higher than that af CFW. When these data were so arranged that comparison of strains could be made at the same body weight levels instead of the age classes, a significant difference in mortality was found only in the heaviest group of mice, ddN being higher than CFW. 2) Mice of the both strains were exposed, at 10 weeks of age, to 3% and 2% benzene and lethal time was determined for each animal. Mean lethal time of ddN was shorter than that of CFW in both concentrations and the difference was statistically significant in the case of 2%. Variances of lethal time were significantly smaller in ddN than in CFW. 3) After 20-days exposure to 200 ppm benzene, leucopenia was found only in ddN, and a decrease of hemoglobin concentration, on the contrary, was observed in CFW and not in ddN. From these results, it was concluded that the susceptibility of adult mice to the inhaled benzene of higher concentrations was greater in ddN than in CFW, and its variance was smaller in ddN than in CFW. And, consequently, it was noted that ddN was more suited for studying acute response, such as mortality or lethal time, to benzene inhalation in mice.
