Response
The duration from the initial treatment of AI regimen to subsequent PD
was 0.5 to 12 months (median, 3.5months).
Prior to the treatment of AI regimen, the 16 enrolled patients had
either progression at local site(N=2) or metastasis (N=9, all the
metastasis sites were lung) or both of local site and metastasis (N=5).
Following several courses of this regimen, 14 patients were assessable
for response: 2 CR, 5 PR, 2 SD, 5 PD (Table 2). Overall, 7 out of 14
patients (50%) were alive at last follow-up, ranging from 2.6 to 32.4
months.
Both of two patients achieved CR were alive at last follow-up (Patient#
6 who reached CR after 6 courses of AI regimen showed tumor relapse
after 5 months, then received other salvage chemotherapy including
topotecan and cyclophosphamide, and alive with disease for 28.8 months
at last follow-up; patient #12 achieved CR after 8 cycles of AI regimen
and alive at last follow-up, showing no evidence of disease for 9.2
months). Of 5 patients achieved PR (received 4 to 6 courses of AI
regimen), 4 patients achieved CR after further clinical
management(patients #3 and patient# 5 received surgery and radiation
of pulmonary lesions, patients#13 and patient #14 received whole lung
radiation), and 1 patient (patient#8) achieved PR after 4 courses of
AI regimen but PD after 6 courses and then received other salvage
therapy. Both of two patients achieved SD (2 to 3 courses) changed to
further salvage chemotherapy regimen but died of tumor progression at
last follow-up. Of 5 patients reached PR after AI regimen, 3 patients
alive without disease, 1 patient alive with disease and 1 patient died
of disease at last follow-up. Both of two patients achieved SD after AI
regimen died of disease at last follow-up. Of the five patients achieved
PD, patient #7 were performed to remove of the lung lesions and then
received radiation of the whole lung and alive at last follow-up for 3.7
months, the other four patients (patient#1, patient #9, patient #10,
patient #11) died of disease progression at last follow-up.
The disease control rate (DCR) was 64% (2 CR, 5 PR, and 2 SD), and the
objective response rate (ORR) was 50% (2 CR, 5 PR). The median
progression-free survival was 3.5 months (range 0.5-12 months), and the
median survival duration was 8 months (range 1-28 months) (Figure 1 and
table 3).