Baas P et al. - In a study to assess the efficacy and toxicity of DJ-927 in pts with recurrent, advanced non-small cell lung cancer (NSCLC), it was found that when administered once every 3 weeks, DJ-927 was well-absorbed with a long terminal half-life of 167 +/- 77 hours. DJ-927 has antitumor activity against NSCLC when given as second-line monotherapy Methods
Pts who were treated with 1 prior taxane-free chemotherapy regimen were eligible
A single oral dose of DJ-927 (27 mg/m2) was given every 3 weeks
In case of good tolerance, 1 dose escalation to 35 mg/m2 was allowed
Response and toxicity were measured and plasma pharmacokinetic analysis was performed during the first course
Results
36 pts gave informed consent and 34 received medication
The majority of pts were pretreated with combination cisplatin and gemcitabine
12 pts died on study of which 8 were due to disease progression
In 4 pts with preexisting cardiac disease, toxicity led to cardiac worsening and subsequent death
Grade 3 and 4 toxicities were neutropenia in 18 pts, anemia in 6 pts, nausea and fatigue in 2 pts, febrile neutropenia and neurotoxicity in 1 pt
Overall response rate for all pts was 5.6%
Percentage of pts with stabilization for >6 weeks was 47%; median time to progression was 97 days; and median survival time was 120 days for the ITT group
Since only 3 pts tolerated the higher drug dose, this dose was omitted because of hematological toxicity
See all
