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Review
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Korean J Med. 2006;71(1):176-176.
- Phase II trial of Genexol-PM, a cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced NSCLC
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Dong-Wan Kim, Si-Young Kim, Hoon-Kyo Kim, Sang-We Kim, Sang Won Shin, Jun Suk Kim, Keunchil Park, and Dae Seog Heo
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- Phase II trial of Genexol-PM, a cremophor-free, polymeric micelle formulation of paclitaxel, with cisplatin in patients with advanced NSCLC
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국립의료원 내과
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- Abstract
- Background : Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This multicenter phase
II study was designed to evaluate the efficacy and safety of the combination of Genexol-PM and cisplatin for the treatment of
advanced non-small cell lung cancer (NSCLC). Methods : Patients with locally advanced, metastatic, or recurrent NSCLC and
no prior chemotherapy exposure were eligible. Patients received Genexol-PM 230 mg/m2 (IV over 3 hours) and cisplatin 60
mg/m2 (IV with adequate hydration) on day 1 of a 3-week cycle until disease progression or intolerance. A maximum of 6 cycles
was recommended. Intrapatient dose escalation of Genexol-PM to 300 mg/m2 was done from second cycle when pre-specified
grade of hematologic or nonhematologic toxicities were not observed after first cycle of treatment. Results : Sixty-nine patients
were enrolled in this study. A total of 282 cycles was administered, with a median of 4 cycles per patient (range, 1-7).
Genexol-PM dose escalation to 300 mg/m2 was done in 46% of patients. Overall response rate was 37.7% (95% CI, 26.3-49.1)
with 0 complete response and 26 partial responses. The median time to progression was 5.8 months and the median survival
period was 21.7 months. The major non-hematologic toxicities included grade 3 peripheral sensory neuropathy (13.0%), grade
3 myalgia (5.8%), and grade 3 and 4 arthralgia (7.3%). Four patients (5.8%) experienced grade 3 and 4 hypersensitivity reactions.
The major hematologic toxicities were grade 3 and 4 neutropenia (29.0 and 17.4%, respectively). Grade 3 and 4 thrombocytopenia
was not observed. Grade 3 and 4 febrile neutropenia was observed in only 1 patient. Conclusions : Genexol-PM plus cisplatin
combination chemotherapy showed significant anti-tumor activity with low incidence of grade 3 and 4 hematologic toxicity in
patients with advanced NSCLC.
Keywords :
