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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There are many things that we can learn from the clinical trials conducted in the U. S. They move ahead based on explicit basic principles regarding various matters such as the method for setting up the clinical trial system, selection of CRO, selection of investigators, monitoring activities that are mainly based on their direct access to source documents and sponsor's action when a lack of compliance with GCP occurs. ⋯ It is evident that compliance with these standards is ensured in the U. S. by the activities of study coordinators who take greater part in the clinical studies themselves. In order to expedite introduction of the study coordinator system in Japan even just a little, sponsors should consider providing medical institutions with relevant information as well as a chance to educate and train their study coordinators to optimize the function.
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Gan To Kagaku Ryoho · Jan 1999
Multicenter Study Clinical Trial[Late phase II clinical study of RP56976 (docetaxel) in patients with advanced/recurrent head and neck cancer].
A late phase II clinical study of RP56976 (docetaxel), a new anticancer agent for advanced/recurrent head and neck cancer, was conducted in 29 institutions all over Japan as a multi-institutional cooperative study. Docetaxel was administered by 1 to 2-hour intravenous infusion at a dose of 60 mg/m2 every 3 to 4 weeks. Of 63 patients eligible in this study, 59 were judged as complete cases. ⋯ One patient had a grade 3 interstitial pneumonia; however, symptoms were resolved by the administration of corticosteroids. During this study, one patient died due to multiple organ failure (MOF) caused by disseminated intravascular coagulation (DIC), and this case was reported as a therapy-related death. Based on these results, docetaxel is an active agent for treatment of head and neck cancer.