| Autor: |
Sharman JP; Willamette Valley Cancer Institute and Research Center/US Oncology Research, 520 Country Club Rd., Eugene, OR, 97401, USA. Jeff.Sharman@usoncology.com.; US Oncology Research, Houston, TX, USA. Jeff.Sharman@usoncology.com., Wheler JJ; The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX, 77030, USA., Einhorn L; Indiana University Division of Hematology and Oncology, 535 Barnhill Dr, Indianapolis, IN, 46202, USA., Dowlati A; Department of Medicine - Hematology and Oncology, University Hospitals Case Medical Center, 11100 Euclid Ave., Cleveland, OH, 44106, USA., Shapiro GI; Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA., Hilton J; Dana-Farber Cancer Institute, 450 Brookline Ave., Boston, MA, 02215, USA.; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, 501 Smyth Road, Ottawa, Ontario, K1H 8L6, Canada.; Ottawa Hospital Research Institute, 501 Smyth, Box 511, Ottawa, Ontario, K1H 8L6, Canada., Burke JM; US Oncology Research, Houston, TX, USA.; Rocky Mountain Cancer Centers, 1700 South Potomac St., Aurora, CO, 80012, USA., Siddiqi T; City of Hope National Medical Center, 1500 East Duarte Rd., Duarte, CA, 91010, USA., Whiting N; Seattle Genetics, Inc., 21823 30th Dr. SE, Bothell, WA, 98021, USA., Jalal SI; Indiana University Division of Hematology and Oncology, 535 Barnhill Dr, Indianapolis, IN, 46202, USA. |
| Abstrakt: |
Purpose Brentuximab vedotin (BV) is an anti-CD30 antibody-drug conjugate used in the treatment of several types of lymphomas. Expression of the target antigen has also been reported on a variety of malignant tumors of nonlymphoid origin. This phase 2, open-label study evaluated the safety and antitumor activity of BV in patients with CD30-expressing nonlymphomatous malignancies. Methods Patients were dosed with 1.8 or 2.4 mg/kg BV once every three weeks. Antitumor activity was assessed at Cycles 2, 4, and every 4 cycles thereafter. Patients with stable disease or better were eligible to continue treatment until disease progression, unacceptable toxicity, or study closure. Results Of the 2693 patients screened, 3.8% had solid tumors with CD30 expression and 63 eligible patients with solid tumors enrolled in this study. The most common CD30 positive solid tumors were testicular cancer and mesothelioma. Both subtypes had more than one patient with an objective response. The median duration of BV exposure was 6.1 weeks. The disease control rate, defined as achieving stable disease or better at any point during the study, was 55%. The objective response rate was 11%, with a median duration of response of 2.92 months. The most common adverse events reported were fatigue (57%), nausea (33%), and decreased appetite (32%). Conclusion The safety profile of BV in patients with solid tumors was similar to the known safety profile of BV. In solid tumors, BV had modest activity as a single agent, which was similar to other second-line treatments already available to patients. |
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