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MO13 - SCLC I (ID 118)
- Event: WCLC 2013
- Type: Mini Oral Abstract Session
- Track: Medical Oncology
- Presentations: 1
- Moderators:C.K. Liam, E.S. Santos
- Coordinates: 10/29/2013, 10:30 - 12:00, Bayside 201 - 203, Level 2
MO13.04 - <strong>A Phase II Trial of second line Pazopanib in Small Cell Lung Cancer (SCLC) patients: Preliminary results in patients with sensitive disease</strong> (ID 2095)
10:30 - 12:00 | Author(s): V. Karavasilis
Pazopanib, a small molecule competitive inhibitor of the tyrosine kinase of VEGFR‑1, VEGFR‑2, VEGFR‑3, PDGF, and c‑kit has been approved for the treatment of renal cell carcinoma and soft tissue sarcoma. Microvessel density and VEGF expression in SCLC tumor samples correlate with development of metastases and poor prognosis. A phase II trial of pazopanib in SCLC patients who have relapsed after, or have refractory disease to front-line chemotherapy was conducted.
This is a two-cohort, non-randomized, two-stage phase II study. Patients with sensitive (cohort A) and resistant/refractory (cohort B) histologically confirmed SCLC are enrolled onto the study. An interim analysis has been planned after enrolment of 19 patients in each cohort. Eligible patients have to have measurable disease (RESIST) and ECOG performance status (PS) 0-2. Up to 1 prior regimen (cisplatin/etoposide) for extended disease is allowed. Treatment consists of daily pazopanib 800 mg given p.o.q28 days, until disease progression. The primary endpoint is progression-free rate with a planned sample size of 39 eligible patients per cohort.
We present the first interim analysis in cohort A. 19 eligible patients have been enrolled with a median age of 67 years (range 46-77); male 16; PS 0, 10 pts; PS 1, 9 pts. Four patients had only local relapse. Four (21%) partial responses and 8 (42%) stable disease were documented which is translated in a disease control rate (DCR) of 63% (95% CI: 41.5- 85%). The median PFS was 4.3 months and the estimated 1-year survival 58%. Grade 4 neutropenia and diarrhea occurted in 1 patient each; other grade 3 adverse events were fatigue (n=2), nausea (n=1); grade 2 hypertransaminasemia occurred in 2 patients, grade 1 hemorrhage (epistaxis) in 3 and hypertension in 2. No deaths related to the study drug were observed.
These preliminary results show that pazopanib is an active and well tolerated drug in patients with sensitive SCLC. Recruitment in both cohorts is ongoing. A biomarker analysis is planned.
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