Panitumumab - Abstract 1123:
Panitumumab, a fully human antibody, combined with paclitaxel and carboplatin versus paclitaxel and carboplatin alone for first line advanced non-small cell lung cancer (NSCLC): a primary analysis
Citation: European Journal of Cancer Supplements Volume 3, No. 2, October 2005, Page 324
J. Crawford1, P. Swanson2, D. Prager3, P. Schwarzenberger4, A. Sandler5, J. Schiller6, D. Johnson5, L. Navale7, S. Moss7, S. Jerian7
1Duke University Medical Center, Durham, NC, USA
2Hematology Oncology Associates, Port S Lucie, FL, USA
3UCLA Medical Center, Los Angeles, CA, USA
4Louisiana State University Health Science Center, New
Orleans, LA, USA
5Vanderbilt-Ingram Cancer Center, Nashville, TN, USA
6University of Wisconsin School of Medicine, Madison, WI, USA
7Amgen Inc., Thousand Oaks, CA, USA
Background:
Panitumumab is a fully human monoclonal antibody directed against the epidermal growth factor receptor (EGFr).
In part 1 of this 2-part phase 2 trial in patients (pts) with advanced NSCLC, panitumumab could be safely combined with standard paclitaxel (P; 200 mg/m2) and carboplatin (C; 6 mg/min/mL) (Crawford, ASCO 2004).
Methods:
In Part 2, pts (stage IIIB or IV NSCLC, EGFr expression =1+ in 10% of tumor cells, ECOG <2) were randomized 2:1 to receive panitumumab 2.5 mg/kg QW plus PC Q3W (Arm 1) or PC alone Q3W (Arm 2).
PC was continued until PD or up to a maximum of 6 cycles, panitumumab was continued until PD or intolerability. Tumor response (RECIST) was evaluated Q6W.
The primary study objective was to compre time to PD (TTP) with panitumumab + PC vs PC alone; secondary objectives were to compare additional measures of efficacy and safety. The primary analysis was performed when 113 PD events occurred and had 65% power at the p = 0.10 level to detect a 50% improvement in TTP.
Results:
of 175 pts enrolled,
166 treated pts (112 in Arm 1; 54 in Arm 2) were included in this analysis.
Baseline demographics and disease characteristics were similar between arms.
The study included 94 men and 72 women (mean [SD] age of 61.5 [10.4] yrs, ECOG of 0 [n = 52] or 1 [n = 112]).
Two percent were Asian; 10% never smoked.
Most (62%) had adenocarcinoma; 21% had squamous cell carcinoma. Median TTP (95% CI) was 4.2 (3.1, 5.4) mos for Arm 1 and 5.3 (3.6, 5.6) mos for Arm 2 (log-rank p = 0.55).
Objective response rates were 15.2% for Arm 1 and 11.1% for Arm 2 (p = 0.63).
Median (95% CI) survival times were 8.5 (7.1, 12.0) mos for Arm 1
and 8.0 (6.7, 11.8) mos for Arm 2 (p = 0.81).
Adverse events (Arm 1 vs Arm 2) more frequently seen in the panitumumab arm included rash (59% vs 17%), dry skin (20% vs 4%) dermatitis acneiform (21% vs 0%), pruritus (18% vs 6%), diarrhea (48% vs 26%), vomiting (44% vs 31%), stomatitis (33% vs 9%), dizziness (21% vs 11%).
Neutropenia was not significantly different (24% vs 28%). No panitumumab-induced human anti-human antibodies were detected in 110 pts tested post baseline.
Conclusions:
Results from this phase 2 study indicate that panitumumab + PC is well tolerated with similar efficacy as PC alone in an unselected NSCLC population.
Retrospective assessment of tumors for biomarkers may define subpopulations more likely to benefit from panitumumab.
Clinical studies of panitumumab in NSCLC are ongoing with other novel combinations of targeted agents.
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