A phase II, randomized study of aprepitant in the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapies in colorectal cancer patients.

The present study aimed to study the efficacy of aprepitant in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) for colorectal cancer (CRC), and comprised a multicenter, phase II, open-label, randomized, parallel comparative study conducted as part of the Kagoshima aprepitant study for colon cancer in Japan. Patients with advanced or recurrent CRC were treated with standard MEC regimens (FOLFOX, XELOX or FOLFIRI) and received either standard chemotherapy [5-hydroxytryptamine-3 receptor antagonist (5-HT3RA) + dexamethasone] or aprepitant regimen chemotherapy (5-HT3 RA + reduced-dose dexamethasone + aprepitant). The primary endpoint of the present study was the proportion of patients who achieved a complete response (CR) during the overall, acute, and delayed phases of the first planned chemotherapy cycle. Secondary endpoints were complete protection, the proportions of patients without emetic episodes or nausea, patients with no more than moderate nausea during the overall, acute and delayed phases, and the time to treatment failure. The CR rates in the overall, acute and delayed phases were similar in the aprepitant and the standard-regimen groups. Additionally, there were no significant differences in secondary endpoints between the two groups. In summary, aprepitant in combination with 5-HT3 RA and reduced-dose corticosteroids was well tolerated and effective in preventing CINV associated with moderately emetogenic antitumor agents in Japanese patients with CRC.

Bone marrow micrometastasis detected by RT-PCR in esophageal squamous cell carcinoma.

The clinical implications of bone marrow micrometastases (BMM) detected by RT-PCR in esophageal squamous cell carcinoma (ESCC) have not been elucidated. We evaluated the relation between the presence of BMM, both before and after surgery, and clinicopathologic findings in patients with ESCC. Bone marrow samples from 48 patients with ESCC were obtained from the iliac crest before and after surgery. After total RNA was extracted from each bone marrow sample, carcinoembryonic antigen (CEA)-specific RT-PCR was performed. BMM was detected by RT-PCR in 10 of the 48 patients. Four patients each had positive signals only before or only after surgery and 2 patients had positive signals both before and after surgery. There were no significant differences in clinicopathologic factors, including neoadjuvant therapy, between patients with BMM and without BMM. To date, the rates of recurrent disease in patients with BMM and without BMM are 80% (8/10) and 50% (19/38), respectively, a difference which is not significant. The 4-year survival rates of patients with BMM and without BMM are 10.0% and 47.3%, respectively. Recurrence and survival rates were poorer in patients with RT-PCR positivity, although the differences were not significant. A larger study is required to clarify the clinical impact of BMM.

Biological properties of biopsy specimens are useful for predicting lymph node micrometastasis in esophageal carcinoma.

BACKGROUND: Some studies have reported on lymph node micrometastasis (MM) by RT-PCR. We attempted to predict MM by biological means using preoperative biopsy specimens. MATERIALS AND METHODS: Lymph nodes from 60 patients with esophageal carcinoma were examined by routine histological examination and CEA-specific RT-PCR. The biopsy specimens were immunohistochemically examined using p53, cyclin D1 (CD1) and desmoglein 1 (DG1) antibodies. RESULTS: Of 659 lymph nodes, 53 (8.0%) nodes were positive according to histological examination and 158 (24.0%) had MM by RT-PCR. The percentage of patients with lymph node metastasis according to histological examination and RT-PCR was 65.0% and 81.7%, respectively. CD1 and DG1 expression correlated with MM, whereas p53 expression did not. MM was frequently detected in the tumors with CD1-positive, DG1-negative or reduced expression. CONCLUSION: The expression of CD1 and DG1 in biopsy specimens may offer useful information on lymph node metastasis, including MM in esophageal carcinoma.

Paraaortic lymph node micrometastasis and tumor cell microinvolvement in advanced gastric carcinoma.

BACKGROUND: Paraaortic lymph node dissection in advanced gastric carcinoma is controversial. The purpose of this study was to investigate the incidence and significance of micrometastasis (MM) or tumor cell microinvolvement (TCM) in these critical lymph nodes.METHODS: A total of 2339 lymph nodes, including 390 paraaortic nodes, obtained from 47 patients with advanced gastric carcinoma were examined immunohistochemically, using cytokeratin antibody.RESULTS: Lymph node metastasis was found in 95 of the 390 paraaortic nodes of 14 patients by routine histological examination. MM or TCM was immunohistochemically detected in 45 of the 295 negative paraaortic lymph nodes from 15 of 33 patients (MM, n = 5; TCM, n = 10). The 5-year-survival rate in the paraaortic node-negative group and cytokeratin-positive group was significantly higher that that of the hematoxilin and eosin-positive group. The total number of lymph node metastases by hematoxylin and eosin staining and the pathological lymph node compartments, by cytokeratin-positive nodes, were prognostic factors by multivariate analysis.CONCLUSIONS: We demonstrated a high rate of MM or TCM in the paraaortic lymph nodes and suggest that such harbored metastases are related to the prognosis of patients with advanced gastric carcinoma. On the basis of this study, a multi-institutional study should be considered.