Abstract |
We conducted a multi-institutional (11 facilities), early phase II study of BMS-181339 ( paclitaxel), a novel anti- cancer drug, for non-small cell lung cancer (NSCLC). The 150 mg/m2 dose of paclitaxel was given by intravenous infusion over 24 hours every three weeks. When fifteen patients were accumulated, the interim review revealed that three of 15 eligible patients had a partial response for a response rate of 20%. The most common toxic effects were grade 3 or 4 leukopenia seen in 73.3% (11/15), and grade 4 neutropenia in 93.3% (14/15). One patient with neutropenia had suspected septic shock, which could be managed by G-CSF and antibiotics. No serious hypersensitivity reaction was seen with premedication of anti-allergic drugs, although mild allergic reactions such as skin rash and flush, were observed in 20.0% (3/15). Other adverse reactions, including alopecia, fever, arthralgia, myalgia and peripheral neuropathy, were mild in most cases. We conclude that it is relevant to proceed to a late phase II study for NSCLC.
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Authors | S Yoneda, Y Nishiwaki, H Niitani, Y Kurita, Y Ariyoshi, H Ikegami, K Furuse, M Fukuoka, I Kimura, N Hara, N Saijo |
Journal | Gan to kagaku ryoho. Cancer & chemotherapy
(Gan To Kagaku Ryoho)
Vol. 23
Issue 6
Pg. 695-701
(May 1996)
ISSN: 0385-0684 [Print] Japan |
PMID | 8645020
(Publication Type: Clinical Trial, Clinical Trial, Phase II, English Abstract, Journal Article, Multicenter Study)
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Chemical References |
- Antineoplastic Agents, Phytogenic
- BMS 181339
- Taxoids
- Paclitaxel
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Topics |
- Adult
- Aged
- Antineoplastic Agents, Phytogenic
(administration & dosage, adverse effects, therapeutic use)
- Carcinoma, Non-Small-Cell Lung
(drug therapy)
- Drug Administration Schedule
- Drug Hypersensitivity
(etiology)
- Female
- Humans
- Infusions, Intravenous
- Japan
- Leukopenia
(chemically induced)
- Lung Neoplasms
(drug therapy)
- Male
- Middle Aged
- Paclitaxel
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Remission Induction
- Taxoids
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