Abstract | PURPOSE: EXPERIMENTAL DESIGN: Two phase II, multicenter, single-arm, open-label studies enrolled chemorefractory patients with tumors expressing low/negative (1-9%/<1%; Low/Negative EGFR study) or high (> or =10%; High EGFR study) levels of EGFR. Patients received panitumumab 6 mg/kg every two weeks until disease progression or intolerance. End points included objective response rate (per response evaluation criteria in solid tumors), progression-free survival (PFS), overall survival (OS), and safety. Exploratory analyses by tumor KRAS status were carried out. RESULTS: A total of 203 patients (Low/Negative EGFR) and 185 patients (High EGFR) enrolled in the studies. The overall response rate was 5.7% [95% confidence interval (95% CI), 2.6-10.5] in patients with low/negative EGFR and 4.2% (95% CI, 1.6-9.0) in patients with high EGFR; the response rate at week 16 was 4% in both studies (all partial responses). Median PFS times were 8.1 weeks (95% CI, 7.1-12.6), 8.1 weeks (95% CI, 7.4-11.1), and 7.3 weeks (95% CI, 7.1-7.6) in patients with negative, low, and high levels of EGFR expression, respectively. PFS and OS were longer in patients with wild-type KRAS than those with mutant KRAS. As expected, most adverse events were skin related. CONCLUSIONS: These studies confirm previous reports that tumor EGFR expression levels are not associated with efficacy with an anti-EGFR antibody and that anti-EGFR antibody therapy should be limited to those patients whose tumors express wild-type KRAS.
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Authors | J Randolph Hecht, Edith Mitchell, Marcus A Neubauer, Howard A Burris 3rd, Paul Swanson, Timothy Lopez, Glenn Buchanan, Maureen Reiner, Jennifer Gansert, Jordan Berlin |
Journal | Clinical cancer research : an official journal of the American Association for Cancer Research
(Clin Cancer Res)
Vol. 16
Issue 7
Pg. 2205-13
(Apr 01 2010)
ISSN: 1557-3265 [Electronic] United States |
PMID | 20332321
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2010 AACR. |
Chemical References |
- Antibodies, Monoclonal
- Antineoplastic Agents
- Biomarkers, Tumor
- Panitumumab
- ErbB Receptors
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(adverse effects, therapeutic use)
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Biomarkers, Tumor
(metabolism)
- Carcinoma
(diagnosis, drug therapy, metabolism, pathology)
- Colorectal Neoplasms
(diagnosis, drug therapy, metabolism, pathology)
- ErbB Receptors
(metabolism)
- Female
- Humans
- Male
- Middle Aged
- Neoplasm Metastasis
- Panitumumab
- Predictive Value of Tests
- Prognosis
- Treatment Outcome
- Young Adult
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