Abstract | PURPOSE: PATIENTS AND METHODS: Patients received pertuzumab every 3 weeks. All castration-resistant patients had experienced progression after at least one taxane-based regimen. Patients received a loading dose of 840 mg pertuzumab (cycle 1) followed by 420 mg for subsequent cycles. The primary end point was overall response and safety. A separate retrospective analysis of actual survival time versus predicted survival time for a patient population with comparable prognostic features was performed. RESULTS: Patients were enrolled (N = 42) and treated (n = 41). No patients had complete or partial response (as defined by Response Evaluation Criteria in Solid Tumors Group or 50% decline in prostate-specific antigen). Of 30 efficacy-assessable patients, five had stable disease (SD) for at least 23 weeks; one of five had SD for 36 weeks. Pertuzumab was well tolerated; diarrhea was the most common adverse effect (61.0%, grades 1 to 3). Retrospective analysis of survival using a validated nomogram suggested that survival was prolonged with pertuzumab treatment, compared with historic controls with similar baseline prognostic features. CONCLUSION:
Pertuzumab was well tolerated and resulted in no objective responses, but several patients had SD more than 23 weeks from a heavily pretreated population. Retrospective analysis suggested prolonged median survival time with pertuzumab compared with historical controls. Thus, inhibition of HER dimerization may have clinical utility in CRPC patients.
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Authors | David B Agus, Christopher J Sweeney, Michael J Morris, David S Mendelson, Douglas G McNeel, Frederick R Ahmann, Jin Wang, Mika K Derynck, Kimmie Ng, Benjamin Lyons, David E Allison, Michael W Kattan, Howard I Scher |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 25
Issue 6
Pg. 675-81
(Feb 20 2007)
ISSN: 1527-7755 [Electronic] United States |
PMID | 17308272
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Bridged-Ring Compounds
- Taxoids
- taxane
- Receptor, ErbB-2
- pertuzumab
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Topics |
- Aged
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Humanized
- Bridged-Ring Compounds
(adverse effects, therapeutic use)
- Disease Progression
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Drug Resistance, Neoplasm
- Humans
- Male
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy, pathology)
- Orchiectomy
- Probability
- Prognosis
- Prostatic Neoplasms
(drug therapy, mortality, pathology, surgery)
- Receptor, ErbB-2
(administration & dosage, antagonists & inhibitors)
- Risk Assessment
- Single-Blind Method
- Survival Analysis
- Taxoids
(adverse effects, therapeutic use)
- Treatment Outcome
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