Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Jan 2005
Multicenter Study Clinical Trial[VNCOP-B (etoposide, mitoxantrone, cyclophosphamide, vincristine, predonisolone, bleomycin) therapy in elderly patients with aggressive non-Hodgkin lymphoma--a study of efficacy and safety, final report].
We experienced the VNCOP-B (etoposide, mitoxantrone, cyclophosphamide, vincristine, predonisolone, bleomycin) combination regimen for the treatment of elderly patients with aggressive non-Hodgkin lymphoma (NHL) in a multicenter study by 6 collaborative institutions. Patients were previously untreated > or = 60 years of age and received prophylactic G-CSF. Twenty patients entered this trial, and all of them were evaluated for feasibility, toxicity, and efficacy. ⋯ Our trial was promising and well-tolerated. According to IPI, high/high-intermediate risk was associated with significantly worse OS and PFS than low/low-intermediate risk (2-year OS: 51.8% versus 100.0%, p=0.0118; 2-year PFS: 33.3% versus 80.0%, p=0.0125). Grade 3/4 infections occurred in 3 patients, but no patients experienced it with predonisolone reduced.
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Gan To Kagaku Ryoho · Mar 2004
Multicenter Study[Reliability and validity of the functional assessment of chronic illness therapy-spiritual (FACIT-Sp) Japanese version in cancer patients--a preliminary study].
The reliability and validity of the Functional Assessment of Chronic Illness Therapy-Spiritual well-being (FACIT-Sp), Japanese version, which was developed in the United States for a simple survey of QOL related to spirituality, was evaluated. The survey simultaneously covered FACIT-Sp and HADS, an anxiety and depression scale, using 64 cancer patients as the subjects of the study. ⋯ The correlation with HADS depression and anxiety scales was -0.54 and -0.56, respectively, showing that the emotional and spiritual scales are independent of each other. The findings suggest that The Japanese version of FACIT-Sp is associated with satisfactory reliability and validity and is an effective tool in the study of spirituality among cancer patients.
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Based on reviews of the Japanese clinical trial situation in lung cancer, gastric cancer, prostate cancer and breast cancer, it was clear that much progress has been made in short time. There are considerable differences between Japan and the West and also differences between clinical areas in Japan. For regulatory purposes bridging studies have become increasingly important. ⋯ A critical issue that also need addressing is agreement of centre target recruitment. We need to introduce a new flexible system in Japan if participation in global trial is to be optimised. If we can address these issues Japanese investigators and collaborative groups should be able to initiate and lead global trials in the future.
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Gan To Kagaku Ryoho · Jan 2002
Multicenter Study Clinical Trial[Anti-emetic effects of ondansetron hydrochloride throughout courses of cytotoxic chemotherapy].
Since the emesis induced by cytotoxic drugs is intractable, and is a possible determinant of a patient's QOL during chemotherapy, the control of this adverse event is essential to complete a course of cancer chemotherapy. The anti-emetic effects of a 5-HT3 antagonist, ondansetron hydrochloride (OND), was evaluated during a course of CDDP-containing chemotherapy. Forty-eight patients with gynecologic carcinoma, respiratory malignancy, or urological cancer were followed throughout their treatment courses. ⋯ Adverse events of this anti-emetic treatment were not observed except for mild leukocytosis in one case, and this unexplainable effect abated without any specific treatments. In conclusion, the anti-emetic effects of OND sufficiently prevented the emetogenic action of CDDP throughout the treatment course, with a special importance for successful control in the first treatment course. The additional use of corticosteroid might enhance the effects of OND for female patients.
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Gan To Kagaku Ryoho · Oct 2001
Multicenter Study Comparative Study Clinical Trial[Examination on efficacy and safety of concurrent use of ondansetron hydrochloride and steroid in gynecological cancer patients on cisplatin].
The anti-emetic effect and safety in patients receiving ondansetron hydrochloride (OND group) and ondansetron and dexamethasone (DEX group) concurrently in cases of acute and delayed onset emesis induced by a single high dose of cisplatin, given as a chemotherapy to gynecological cancer patients, were comparatively studied. The study subjects were 139 gynecological cancer patients. The OND group received 4 mg of ondansetron via slow intravenous injection on Day 1, 30 minutes prior to cisplatin, and for Days 2 to 5, the subjects orally received 4 mg ondansetron tablet each day. ⋯ The group also achieved better efficacy in delayed onset of emesis. Adverse reactions were observed in 2 cases (2 reports of headache) in the OND group and 5 cases (2 reports of hiccups, 2 headache, 2 diarrhea, one constipation, one hot facial flushes and one elevation of gamma-GTP) in the DEX group; however, since the symptoms were all mild, we did not consider there was any problem in safety. We conclude from the above findings that concurrent administration of ondansetron hydrochloride and dexamethasone is a clinically useful treatment for acute and delayed onset emesis induced by a single high dose of cisplatin given to gynecological cancer patients.