Lung Cancer.pdf

Treatment of Patients with Advanced Non–Small Cell Lung Cancer 177
Table 9–9. Docetaxel as Second-Line Therapy
Median 1-Year
Study and No. of Response Survival Survival P for
Treatment Regimen Patients Rate Time Rate Survival
(TAX 320) (Fossella, 2000)
Docetaxel 100 mg/m2 125 10.8% 7 months 21% NR
Docetaxel 75 mg/m2 125 6.7% 5.7 months 32% .025*
Vinorelbine or ifosfamide
(TAX 317) (Shepherd, 2000)
123 0.8% 5.6 months 19%
BSC 51 4.9 months 28% .780
Docetaxel 100 mg/m2 BSC 49 6% 5.9 months 19%
BSC 49 4.6 months 12% .010
Docetaxel 75 mg/m2 BSC 55 6% 7.5 months 37%
* For docetaxel 75 mg/m 2 versus vinorelbine or ifosfamide.
In TAX 317, patients were initially randomly assigned to treatment
with docetaxel 100 mg/m 2 every 3 weeks or BSC. Eligibility requirements
included receipt of at least 1 previous platinum-based regimen
and PS score of 0 to 2. Patients who had previously been treated with a
taxane were excluded. The initial docetaxel dose was too toxic as observed
in the first 49 patients treated. The dose was then reduced to 75
mg/m 2 for the rest of the patients. For all patients, treatment with docetaxel
was associated with a survival advantage (P .047). However, this
survival advantage was especially pronounced in patients treated at 75
mg/m 2 , in whom median survival time and 1-year survival rates were
7.5 months and 37%, versus 4.6 months and 11% for BSC (P .01 for
overall survival). In addition, treatment with docetaxel improved quality
of life as compared to BSC.
The TAX 320 study differed from the TAX 317 study in the following
ways: the control arm was either vinorelbine or ifosfamide, determined
by the treating physician; the patients were randomly assigned to either
75 mg/m 2 or 100 mg/m 2 ; and previous paclitaxel exposure was permitted.
Patients who received 75 mg/m 2 had a significantly improved 1-year
survival rate as compared to the rate in patients in both control arms.
Previous paclitaxel exposure did not affect the likelihood of response or
survival. Patients treated at 75 mg/m 2 who had disease that was refractory
to platinum compounds had survival similar to that of patients who
had disease not refractory to platinum compounds. In the 100 mg/m 2
and vinorelbine and ifosfamide treatment groups, there was a trend to-