Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Apr 1999
Clinical Trial[Development of Japanese version of QOL questionnaire for bladder and prostate cancer patients using FACT-Bl and P: pilot study].
Quality of life (QOL) has been known to be a prognostic factor as well as the endpoint of treatment efficacy in many clinical fields. We have begun a US-Japan collaborative project introducing a QOL questionnaire, the FACT (Functional Assessment of Cancer Therapy), into Japan. We report on the translation process, results of the pilot study, and future plans for translating the Japanese version of the FACT subscales, FACT-Bl (for bladder cancer) and FACT-P (for prostate cancer). ⋯ There was satisfactorily high internal consistency of FACT-G of both bladder and prostate cancer patients. FACT-Bl study included patients having undergone radical cystectomy as well as those who had not. Because not all items were answered by all patients, the Cronbach's alpha coefficient for the FACT-Bl subscale could not be computed. Further evaluation of the FACT-Bl concerning the surgical procedures affecting QOL is needed. We are currently planning to make the further refinement of the questionnaire in order to make it more suitable for bladder cancer patients. FACT-P subscale had an alpha coefficient of 0.82 and was determined to be useful in its present form.
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Gan To Kagaku Ryoho · Mar 1999
Multicenter Study Clinical Trial[A late phase II clinical study of RP56976 (docetaxel) in patients with advanced or recurrent gastric cancer: a cooperative study group trial (group B)].
A late phase II clinical study of RP56976 (docetaxel) in patients with advanced or recurrent gastric cancer was performed to evaluate the anti-tumor activity and clinical toxicity as a multicenter cooperative trial. Docetaxel was administered intravenously at a dose of 60 mg/m2 every 3-4 weeks. Of 72 patients enrolled, 63 patients were eligible and 59 patients were evaluable for response. ⋯ Leukocytopenia and neutrocytopenia were also observed with a high incidence, but they recovered after 8 days from the nadir. The results show that docetaxel is an effective anti-tumor agent for advanced or recurrent gastric cancer. It is necessary to conduct another clinical trial by concomitant administration with other anti-tumor agents.
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Gan To Kagaku Ryoho · Feb 1999
ReviewBasic research supported developments of chemotherapy in nonresectable isolated colorectal liver metastases to a protocol of hepatic artery infusion using mitoxantrone, 5-FU + folinic acid and mitomycin C.
Since the developments in systemic chemotherapy of metastasized colorectal cancer have not resulted in substantial gains in survival times, we wished to improve the course of isolated nonresectable colorectal liver metastases (CPLM) by hepatic arterial infusion treatment. ⋯ Our learning curve to achieve optimal treatment of CRLM resulted in a protocol using HAI with MFFM. The results of this protocol (E) including the high remission rate, long median survival time, good port function, high quality of life, and, most interestingly, the possibility to downstage and resect primarily nonresectable metastases, seem to be superior to HAI with 5-FUDR of 5-FU + FA and to systemic chemotherapy with 5-FU + FA. This hypothesis is currently examined in a phase III study (HAI with MFFM vs. 5-FU + FA i.v.).
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It is necessary for us to reform the infrastructure for clinical trials in Japan in this new GCP era. Medical institutions for clinical trials should prepare to implement monitoring and auditing procedures for quality control and quality assurance of clinical trials. It is also necessary to ease the burden and improve the benefits of participating in clinical trials by subjects. Although there has been no effort to educate and train CRC/SC staff at all in Japan, future improvement in this area is needed to bring the quality of Japan's clinical trials up to international standards.
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Gan To Kagaku Ryoho · Jan 1999
Clinical Trial[Effect of ondansetron hydrochloride injection and tablet against nausea and vomiting in lung cancer patients receiving carboplatin].
We investigated the efficacy of combination of ondansetron hydrochloride injection and tablet against nausea and vomiting in 22 lung cancer patients (total number of chemotherapy courses: 23) receiving chemotherapy of single-dose carboplatin (CBDCA) at a dose of 302.2 +/- 31.9 mg/m2. For suppressing emesis, the patients were given 4 mg of ondansetron injection on the day of CBDCA injection (Day 1), and 4 mg/day of ondansetron tablet for Days 2 to 5. ⋯ A complete nausea suppression rate was seen in 91.3%, 81.0%, 71.4%, 63.6% and 71.4% from Day 1 to Day 5, respectively. 2) Control of vomiting graded 'Major' control or better was achieved in 95% or more of all cases, for each day. The complete vomiting suppression rate observed from Day 1 to Day 5 was 91.3%, 78.3%, 65.2%, 69.6% and 91.3%, respectively. 3) Inhibitory effect on nausea and vomiting for each day of Days 1 to 5 graded as 'Effective' or better was shown in 90% or higher of all cases; based on overall judgement for Days 1 to 5, all cases were graded as 'Effective' or better. 4) The proportion of cases which was evaluated as 'Can eat most of the meal' was 88.0%, 73.9%, 50.7%, 50.7% and 65.2% from Days 1 to 5, respectively, against 95.7% prior to the start of chemotherapy. 5) No adverse drug reaction or abnormal clinical laboratory values were seen along with ondansetron. 6) In conclusion, combined treatment with ondansetron injection and tablet was considered clinically useful in control of nausea and vomiting during administration of carboplatin, and may also be useful for out-patient chemotherapy.