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).