Late Phase II Clinical Study of RP56976 (Docetaxel) in Patients with Advanced/Recurrent Head and Neck Cancer.
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Accession number;99A0203861
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| Title;Late Phase II Clinical Study of RP56976 (Docetaxel) in Patients with Advanced/Recurrent Head and Neck Cancer. |
| Author;
INUYAMA YUKIO
(Hokkaido Univ., Sch. of Med.)
KATAURA AKIKATSU
(Sapporo Med. Coll.)
TOGAWA KIYOSHI
(Akita Univ., Sch. of Med.)
SAIJO SHIGERU
(Miyagi Cancer Center)
KIDA AKINORI
(Nihon Univ., Surugadai Hosp.)
KONO NAOYUKI
(Juntendo Univ., Sch. of Med.)
KAMATA SHIN'ETSU
(Cancer Inst. Hosp., Jpn. Found. for Cancer Res.)
HORIUCHI MASATOSHI
(Tokai Univ., Sch. of Med.)
KOMIYAMA SOTARO
(Kyushu Univ., Fac. of Med.)
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Journal Title;Japanese Journal of Cancer and Chemotherapy
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Journal Code:Z0938A
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ISSN:0385-0684
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VOL.26;NO.1;PAGE.107-116(1999)
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| Figure&Table&Reference;FIG.1, TBL.5, REF.25 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;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 60mg/m2 every 3 to 4 weeks. Of 63 patients wligible in this study, 59 were judged as complete cases. Complete response(CR) was observed in 1 patient, partial response(PR) in 13, no change(NC) in 25, and progressive disease(PD) in 20, for an overall response rate of 22.2% (14/63, 95% CI: 12.7-34.5%) in eligible cases, and 23.7% (14/59, 95% CI: 13.6-36.6%) in complete cases. Previously treated patients showed a 17.9% (10/56) response rate, whereas treatment-naive patients showed a 57.1% (4/7) response rate. Among 46 patients who received prior chemotherapy, one CR and 7PR were observed with a 17.4% response rate. Major hematological toxicities were leucopenia in 95.1% (.GEQ.grade 3, 59.7%) and neutropenia in 90.3% (.GEQ.grade 3, 79.0%). Other severe toxicities (.GEQ.grade 3) included anorexia in 9.7% (6 cases), diarrhea in 3.2% (2 cases), dyspnea in 3.2% (2 cases), and fatigue in 3.2% (2 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. (author abst.) |
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