[Determination of the Effect of Aprepitant and Fosaprepitant for Nausea in Patients with Oral Cancer Receiving Combination Chemotherapy with TPF].

The objective of this study was to determine the effect of aprepitant(from days 1 to 3, po)and fosaprepitant(day 1, iv) for nausea in patients with oral cancer receiving combination chemotherapy with docetaxel, nedaplatin, or cisplatin(divided doses for 5 days), and 5-fluorouracil(TPF).The incidence rate of nausea in the aprepitant group was 60%(6/10), and that in the fosaprepitant group was 90%(9/10).The incidence rate of continuous nausea for more than 2 days was significantly lower in the aprepitant group than in the fosaprepitant group(40%[4/10]vs 90%[9/10], p=0.02; c 2 test).In addition, the mean area under the curve of the chronological changes in the grade of nausea tended to be lower in the aprepitant group than in the fosaprepitant group.In both groups, 3 cases(30%)of vomiting were observed.However, the incidence of continued daily vomiting tended to be lower in the aprepitant group than in the fosaprepitant group.These results suggest that aprepitant is more effective than fosaprepitant for nausea induced by TPF.

[A Case of Cervical Lymph Node Metastasis from an Unknown Primary Cancer Controlled with Immunotherapy, Chemotherapy, and Surgery].

We present a case of cervical lymph node metastasis from an unknown primary cancer that was controlled with immunotherapy, chemotherapy, and surgery. The patient, a 61-year-old man, was referred to our department for treatment of a lesion in the left cervical lateral area. At the initial visit, the mass was covered by reddened skin and was elastic, hard, and immobile on palpation. The presence of a malignant disease such as malignant lymphoma or lymphadenitis because of infection by tubercle bacillus or Epstein-Barr virus was suspected on the basis of the clinical and magnetic resonance imaging findings. Biopsy and resection of the cervical mass was performed under general anesthesia. Because the pathological diagnosis during surgery indicated squamous cell carcinoma, the surgical approach was changed to neck dissection. Head, neck, and thoracic computed tomography and other examinations were performed to locate the primary cancer, but its origin remained unknown. Postoperative therapy consisted of chemotherapy and immunotherapy. The patient has been followed up for 4 years and 10 months without any evidence of recurrence.

[Determination of the Appropriate Timing of Aprepitant Administration for Nausea in Patients with Head and Neck Cancer Receiving Combination Chemotherapy with Docetaxel, Nedaplatin（Divided Doses for 5 Days), and 5-fluorouracil].

The objective of this study was to determine the appropriate timing of aprepitant administration in patients with oral cancer by comparing the antiemetic effect of aprepitant administered on the first day (first-day group) and third day (third-day group) of combination chemotherapy with docetaxel, nedaplatin (divided doses for 5 days), and 5-fluorouracil. 1. In both groups, very few cases of vomiting were observed. Therefore, we could not compare the incidence of vomiting. 2. The mean highest grade of nausea in the third-day group was significantly higher than that in the first-day group (2.33±0.71 vs 0.78±0.22, p=0.002; U-test). 3. In addition, the mean area under the curve of the chronological changes in the grade of nausea in the third-day group was significantly higher than that in the first-day group (13.44±9.58 vs 3.11±3.59, p=0.019; U-test). 4. The incidence of nausea of grade 2 or higher in the first-day group was significantly lower than that in the third-day group (11.1% [1/9] vs 88.9% [8/9], p<0.001; c 2 test). These results indicate that initiation of aprepitant administration on the first day of combination chemotherapy with docetaxel, nedaplatin, and 5-fluorouracil successfully prevented the development of nausea in patients with oral cancer.

[Clinical Investigation of the Effects of Filgrastim BS1 on Neutropenia Following Oral Cancer Chemotherapy (TPF Therapy)].

The time for the neutrophil count to recover after subcutaneous injection of filgrastim BS1 or lenograstim was studied in patients suffering from neutropenia following preoperative combined chemotherapy using docetaxel, nedaplatin, or cisplatin (in divided doses for 5 days)and 5-fluorouracil for oral cancer. 1. There was no significant difference in the minimum leukocyte and neutrophil counts after chemotherapy. 2. There was no significant difference in the maximum leukocyte and neutrophil counts after chemotherapy. 3. Time for leukocytes to recover from their minimum count(>4,000/mm3)or for neutrophils to recover from their minimum count(>2,000/mm3)and the number of days on which treatment was administered tended to be shorter in the filgrastim BS1 group. Thus, it was concluded that filgrastim BS1 is just as effective as other prior G-CSF agents in treating patients suffering from neutropenia following chemotherapy(TPF therapy).

Factors associated with dry mouth in dependent Japanese elderly.

OBJECTIVES: To identify factors associated with dry mouth. BACKGROUND: Dry mouth adversely affects oropharyngeal health, particularly in elderly, and can lead to pneumonia. A better understanding of the epidemiology of dry mouth is therefore important in improving treatment strategies and oral health in high-risk elderly patients. METHODS: We conducted a cross-sectional study involving 383 dependent Japanese elderly individuals (65-84 [n = 167] and ≥85 [n = 216] years) at eight long-term care facilities and hospitals. Thirty-four potential factors associated with dry mouth were examined by multiple logistic regression analysis. The primary outcome was dry mouth, as diagnosed by tongue dorsum moisture. RESULTS: We identified that body mass index and severity of physical disability were identified as a potential factors associated with dry mouth in the super-elderly (≥85 years) group, whereas severity of physical disability, outcome measurement time, high daily water consumption, mouth breathing, use of antidepressants and diuretics, and high frequency of daily brushing (≥2 times per day; Odds ratio: 5.56; 95% Confidence Interval: 1.52-20.00) were associated with dry mouth in the 65- to 84-year-old group. CONCLUSION: To our knowledge, this is the first study to identify a link between frequency of daily brushing and dry mouth and suggests that tooth brushing should be encouraged in high-risk dependent Japanese elderly (65-84 years), particularly those taking antidepressants and/or diuretics.

Digestive symptoms as side effects of combination chemotherapy of docetaxel, nedaplatin and 5-fluorouracil for head and neck cancer.

BACKGROUND: The study was performed to determine the frequency of digestive symptoms in combination therapy of docetaxel, nedaplatin and 5-fluorouracil for head and neck cancer. METHODS: Frequencies of digestive symptoms were retrospectively investigated in 91 patients. Data for 203 treatment courses were evaluated using the JCOG/JSCO National Cancer Institute-Common Terminology Criteria for Adverse Events(v 4.0 in Japanese). RESULTS: The percentages of patients with nausea, vomiting, stomatitis, constipation, and diarrhea in the first course were 74%, 16%, 42%, 42%, and 13%, respectively. Nausea, vomiting and constipation started mostly on day 2 or 3 and peaked between day 5 and 7. Diarrhea and stomatitis began later and peaked between day 8 and 11. Nausea showed the highest frequencies, and in the late phase(day 6 to 14)of chemotherapy rather than the acute phase(day 1 to 5). Stratified analysis based on the occurrence of nausea and vomiting in previous course showed no significant influence in the frequency of nausea.And then, another stratified analyses showed higher frequency of vomiting and diarrhea in females, nausea in patients aged B65 years old. CONCLUSION: Nausea occurred at an unexpectedly high frequency in the late phase of chemotherapy with docetaxel, nedaplatin and 5-fluorouracil.

[Phase I/II clinical trial of induction chemotherapy with nedaplatin (CDGP), docetaxel (DOC) and 5-fluorouracil (5-FU) for squamous cell carcinoma of head and neck].

In a phase I study, we determined the maximum tolerated dose (MTD) and the recommended dose (RD) of nedaplatin (CDGP) in combination chemotherapy with Docetaxel (DOC) and 5-fluorouracil (5-FU) for treatment of carcinoma of the head and neck. Then, in a phase II study, we examined the efficacy and safety of the RD of chemotherapy. Fresh patients with squamous cell carcinoma of the head and neck were enrolled in the study. The dosage of chemotherapy was as follows: DOC 60 mg/m(2) on day 1 by infusion over 2 hours; CDGP 20-30 mg/m(2)/day on day 1 to 5 by infusion over 1 hour, and 5-FU 600 mg/m(2)/day on day 1 to 5 by 5 days continuous infusion. For CDGP, an initial dose level was set at 20 mg/m(2), and 3 patients were enrolled for each level of dose escalation. The DLT was defined here as grade 4 neutropenia or grade> or =3 non-hematotoxic reactions. The dose at which DLT was observed in overall 33% cases was taken as MTD. The RD for phase II study was estimated to be DOC 60 mg/m(2), CDGP 20 mg/m(2)/day, 5-FU 600 mg/m(2)/day. Forty patients were enrolled in the phase II study. DLT of neutropenia was noted in 2 of 38 cases. DLT of non-hematotoxic reactions was found in less than 33% of the cases; 17 cases showed CR, and 12 cases showed PR. The response rate was 76.3%. The overall response rate in histological assessment was 55.3%. The combination chemotherapy with Low-Divided Dose of CDGP, DOC and 5-FU was suggested to be safe and effective.