Anti-epidermal growth factor receptor monoclonal antibody cetuximab plus doxorubicin in the treatment of metastatic castration-resistant prostate cancer Journal Article
| Authors: | Slovin, S. F.; Kelly, W. K.; Wilton, A.; Kattan, M.; Myskowski, P.; Mendelsohn, J.; Scher, H. I. |
| Article Title: | Anti-epidermal growth factor receptor monoclonal antibody cetuximab plus doxorubicin in the treatment of metastatic castration-resistant prostate cancer |
| Abstract: | Purpose: An open-label, dose-escalating phase Ib/IIa trial was performed to establish a safety profile of ascending doses of cetuximab (IMC C225) in combination with doxorubicin administered weekly for 6 treatments in patients with metastatic castration-resistant prostate cancer. The secondary endpoint was to assess the efficacy of cetuximab in combination with doxorubicin as well as to determine the optimal biologic dose and the maximum tolerated dose. Patients and Methods: Patients in 8 groups received escalating doses of cetuximab 20-300 mg/m<sup>2</sup> plus doxorubicin 15 or 20 mg/m<sup>2</sup> given intravenously weekly for 6 consecutive weeks, followed by a 1-week observation period. A treatment response was defined as a > 50% decline in prostate-specific antigen (PSA) or regression of radiographically measurable disease. Results: Of the 36 treated patients, 25% had grade 2 neutropenia, 39% had leukopenia, and 44% had stomatitis at doxorubicin 20 mg/m<sup>2</sup>. Erythematous skin exanthema was seen in 38% of the patients. There was no significant regression of bone or soft tissue disease, but stable disease was observed in 20 (65%) of the 31 patients with bone disease and 14 (61%) of the 23 patients with lymph node disease. Declines in PSA were modest in the 36 patients, with 1 (2.7%) with an 80% decline from baseline, 2 (5.6%) with > 50% to < 80% declines, and 14 (39%) with progression. Median survival was approximately 18 months. Conclusion: In a heavily pretreated population of men with metastatic castration-resistant prostate cancer, this study of cetuximab/doxorubicin was associated with minimal PSA declines posttherapy, though median survival was longer compared to historical control groups. Further studies with cetuximab combined with more contemporary chemotherapy for castration-resistant prostate cancer might be warranted. |
| Keywords: | adult; cancer survival; clinical article; controlled study; treatment outcome; treatment response; aged; survival rate; clinical trial; fatigue; neutropenia; doxorubicin; cancer combination chemotherapy; cancer growth; drug efficacy; drug safety; bone metastasis; lymph node metastasis; neoplasm staging; prostate specific antigen; cancer immunotherapy; drug eruption; multiple cycle treatment; phase 2 clinical trial; bone marrow suppression; nausea; stomatitis; antineoplastic combined chemotherapy protocols; dose-response relationship, drug; cetuximab; monoclonal antibody; drug dose escalation; drug fever; hyperglycemia; nail disease; prostate cancer; prostate-specific antigen; prostatic neoplasms; chemotherapy induced emesis; malaise; survival time; cancer regression; antibodies, monoclonal; drug response; acne; neoplasm metastasis; maximum tolerated dose; orchiectomy; exanthema; castration resistant prostate cancer; pyoderma; pyoderma granulomata; soft tissue metastasis |
| Journal Title: | Clinical Genitourinary Cancer |
| Volume: | 7 |
| Issue: | 3 |
| ISSN: | 1558-7673 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2009-10-01 |
| Start Page: | E77 |
| End Page: | E82 |
| Language: | English |
| DOI: | 10.3816/CGC.2009.n.028 |
| PUBMED: | 19815486 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 2" - "Export Date: 30 November 2010" - "Source: Scopus" |
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