[Clinical evaluation of rhG-CSF in patients with neutropenia induced by chemotherapy for multiple myeloma].

A randomized controlled study of patients with multiple myeloma was performed to evaluate the efficacy and safety of recombinant human granulocyte colony-stimulating factor (rhG-CSF:KW-2228) in treating neutropenia induced by chemotherapy, and its influence on the dose intensity of, and response rate to, chemotherapy. As a rule, 3 courses of chemotherapy at intervals of 4 weeks were administered both to the untreated and KW-2228-treated groups. Among 98 eligible patients evaluated for neutrophil recovery, a markedly reduced duration of neutropenia was observed during each course in the KW-2228 treated group. No significant difference distinguished the two groups in terms of incidence or duration of infection. However, febrile neutropenia appeared only in the untreated group. There was no significant difference in terms of response rate or dose intensity. However, only patients in the untreated group withdrew from the study due to protracted neutropenia. These results demonstrated that KW-2228 is effective and safe, and has a significant effect on the acceleration of neutrophil recovery in patients with neutropenia induced by chemotherapy for multiple myeloma, and is useful for the completion of chemotherapy regimens.

[An overview of clinical trials in endocrine therapy for cancer].

To obtain information for published clinical trials in endocrine therapy for cancer in Japan, a computerized literature search of MEDLINE, EMBASE and IGAKU-CHUO-ZASSHI (CD-ROM) was done. We found four articles on randomized trials for prostate cancer and two for breast cancer. In order to obtain information for ongoing randomized phase III trials in endocrine therapy for cancer in the United States and Europe, a search of PDQ (Physician's Data Query) was done. In PDQ, 13 active trials started after January 1990 in endocrine therapy for breast cancer and six active trials started after January 1990 in endocrine therapy for prostate cancer were registered. Out of 13 trials for breast cancer, projected sample sizes were over 1,000 in eight trials, and QOL was selected as an end point in six trials. Out of six trials for prostate cancer, projected sample sizes were over 500 in three trials, and QOL or sexual function was selected as an end point in three trials.

[Ocular murine cytomegalovirus infection in immunocompromised hosts].

Cytomegalovirus (CMV) chorioretinitis is one of the commonest complications in immunocompromised hosts. However, the entire scope of ocular involvement during generalized CMV infection in immunocompromised hosts is yet to be elucidated. Balb/c nude mice were inoculated intraperitoneally with Smith strain of salivary gland passaged murine cytomegalovirus. Eight days after infection, they were sacrificed and the pathological features of virus spread were studied by immunofluorescence method. Subconjunctival tissues, corneal stroma, outer ocular muscles and occasional choroidal tissue are the site of positive fluorescence in the eye. At the same time, viral antigens were detected in the various organs such as spleen, liver, salivary glands, etc. Balb/c nude mice were injected intraperitoneally with silica three days and one day prior to virus infection to suppress their macrophages. The localization of viral antigens in the silica-treated mice was similar to that in untreated mice. When the peripheral blood obtained from the nude mice infected for 8 days was titrated for the virus, cell-free virus and blood-cell-associated virus was detected. These results indicated that cell-free virus is the major source of its spread.

bcr/abl mRNA in leukemic blasts of an unusual patient with acute lymphoblastic leukemia followed after 5-year remission by chronic myelogenous leukemia in blast crisis.

A 13-year-old boy without any previous illness was diagnosed as suffering from acute lymphoblastic leukemia (ALL). After a period of apparent complete remission until 17 years of age, the presence of Ph1 positive cells in bone marrow was demonstrated by karyotype analysis. This finding suggested chronic myelogenous leukemia (CML) because of the absence of blastic changes in bone marrow but mild leukocytosis with basophilia at that time. Six months later he had a relapse (blast crisis) with the appearance of peroxidase negative lymphoid blasts and myeloid surface markers. To make differential diagnosis, leukemia blasts at onset and relapse were examined for rearrangement of immunoglobulin JH gene and bcr/abl fusion mRNA, and were found to have the same JH gene rearrangement pattern and the same bcr/abl mRNA of bcr exon 2/abl exon 2. These results indicate an unusual case of CML which appeared in blast crisis at onset, followed by a long-term remission.

[Clinical evaluation of CGS16949A in advanced or recurrent breast cancer--a multi-institutional late phase II clinical trial].

A multi-institutional late-phase II clinical trial of CGS 16949A was conducted at the dose of 1 mg twice daily in postmenopausal patients with advanced or recurrent breast cancer. Seventy patients entered into the study; 65 were eligible and 53 were complete cases. There were 3 CR, 11 PR, 10 long-NC, 14 NC and 25 PD with an overall response rate of 22.2% in 63 evaluable cases. The median period of overall duration of responses was 327.5 days. There were 22 cases that drug was found useful or better, and global usefulness rate was 33.8%. Forty six (76.7%) of patients experienced no side effects in this therapy. Grade 2 toxicities included anorexia (1 pt.), feeling of distension of abdomen (1 pt.), vomiting (1 pt.), fatigue (1 pt.), and only one patient experienced Grade 3 toxicity (anorexia). Grade 2 laboratory abnormalities were confirmed in two patients; one with elevated gamma-GTP and another with elevated LDH, and both were in the absence of liver metastasis. From these results, it is concluded that CGS16949A seemed to be a useful hormonal agent in the treatment of postmenopausal breast cancer.