Harumichi Ikegami

Double-blind randomized control trial of the effect of recombinant human erythropoietin on chemotherapy-induced anemia in patients with non-small cell lung cancer

AbstractBackground. We studied the clinical effect of recombinant human erythropoietin (r-huEPO) on anemia induced by two courses of cisplatin-based chemotherapy in patients with non-small cell lung cancer (NSCLC). Methods. Seventy-two patients with NSCLC were randomized into three groups, receiving 100, or 200 IU/kg of r-huEPO, or placebo. The r-huEPO and placebo were administered subcutaneously three times a week for 6 weeks, starting 2 weeks after the initiation of chemotherapy. Results. In the 53 evaluable patients, hemoglobin (Hb) levels at the nadir after the second cycle of chemotherapy were significantly elevated compared with the nadir after the first cycle in both r-huEPO treated groups, while this level was decreased in the placebo group. Hb levels at the end of the second course of chemotherapy (week 8) in both r-huEPO groups were higher than that in the placebo groups. No adverse drug reaction attributable to r-huEPO was observed. Serum erythropoietin levels after the administration of r-huEPO were higher than those after placebo administration. Conclusions. r-huEPO had an effect in preventing anemia in patients with NSCLC who had cisplatin-based chemotherapy.

Placebo-controlled double-blind comparative study on the preventive efficacy of mesna against ifosfamide-induced urinary disorders

SummaryIn order to evaluate the preventive efficacy, safety and usefulness of mesna (Sodium 2-mercaptoethane sulfonate) against ifosfamide-induced urinary disorders, a placebo-controlled double-blind comparative study was performed. Ifosfamide was administered by intravenous drip infusion at a daily dose of 2 g/m2 for 5 consecutive days, and mesna was intravenously administered at 20% of the ifosfamide dose, three times daily for 5 consecutive days. The results obtained are as follows. (a) Of 101 accrued patients, 91 patients were evaluated consisting of 45 for the mesna group and 46 for the placebo group. There was no intergroup difference in the number of the evaluated cases and patient characteristics. (b) Micturition pain and feeling of residual urine graded as moderate or severe were not observed for the mesna group, but were observed for the placebo group with incidences of 19.6% (9/46) for micturition pain and 15.2% (7/46) for feeling of residual urine; the intergroup differences in the appearance of these urinary symptoms were statistically significant (P=0.0003 for micturition pain;P=0.0009 for feeling of residual urine). The incidence of hematuria graded as moderate or severe was 6.7% (3/45) in the mesna group, which was significantly lower than the 32.6% (15/46) in the placebo group (P=0.0008). (c) No side-effect attributable to mesna was observed. (d) A judgment of “useful” was obtained in 80.0% (36/45) of the patients treated with mesna, which was significantly higher than the 34.8% (16/46) of the patients treated with placebo (P= near 0). On the basis of the above results, we conclude that the preventive efficacy, safety and usefulness of mesna against ifosfamide-induced urinary disorders have been well demonstrated in this study.

Dose escalation study of carboplatin with fixed-dose etoposide plus granulocyte-colony stimulating factor in patients with small cell lung carcinoma: A study of the lung cancer study group of west Japan

We performed a Phase I‐II trial to determine the maximum tolerated dose of carboplatin (CBDCA) with a fixed dose of VP‐16 and granulocyte‐colony stimulating factor (G‐CSF) in small cell lung cancer (SCLC) patients.

Cytologic characteristics of oat‐cell carcinoma of the lung in relation to the effect of chemotherapy

The cytologic study of the effect of chemotherapy was performed in oat‐cell carcinoma of the lung. Cellular characteristics of tumor cells obtained by brushing via bronchoscopy were compared between responders (13 patients in complete and partial regressions) and nonresponders (13 patients with no response) treated with cyclophosphamide. The tumor cells in the responders more frequently showed finely granular chromatin evenly distributed throughout the nuclei. The tumor cells in nonresponders showed predominantly either deeply stained nuclei with coarsely granular chromatin distributed evenly or pale nuclei with unevenly distributed chromatin. These findings were also applied in the evaluation of the effect of combination chemotherapy. The nuclear chromatin pattern from oat‐cell carcinoma of the lung may be an indicator to predict the degree of response to chemotherapy.

Survival Rates of Adenocarcinoma of the Lung According to Histological Subtype and the Grade of Morphological Differentiation in Resected Cases

Postoperative survival rates in 393 patients with adenocarcinoma of the lung were studied according to histological subtype, the grade of differentiation, clinical stage, size of tumor and the mode of operation.Regardless of histological subtypes better survival rates were achieved in the cases with well-differentiated adenocarcinoma. Stage I cases and curatively operated cases also showed good prognosis. There was no difference in post-operative survival rates between papillary type and tubular-cribriform type of adenocarcinoma, irrespective of the grade of morphological differentiation. This suggests the necessity of a new device for subtyping adenocarcinoma of the lung.Combination chemotherapy with cyclophosphamide, mitomycin C and 5 -fluorouracil was found to be the best postoperative adjuvant chemotherapy in this study.