The chemotherapy agent Abraxane (paclitaxel protein-bound particles) is highly effective and well tolerated as initial therapy for metastatic breast cancer.
Paclitaxel is a chemotherapy agent that is commonly used in the treatment of breast cancer. Patients with cancer that has recurred following previous therapy and/or has spread to distant sites in the body are often treated with paclitaxel. The formulation of paclitaxel includes agents that allow for the proper storage and administration of the drug. These agents, however, are also responsible for of many side effects associated with paclitaxel.
Abraxane is a form of paclitaxel that is bound with albumin, a type of protein normally found in the human body. This form of paclitaxel delivers high concentrations of the active ingredient into the cancer cells and, compared to the original form of the drug, reduces the incidence of side effects.
Abraxane has been directly compared to Taxol for the treatment of advanced breast cancer and found to improve overall survival with fewer side effects.5 Based on the results of several clinical trials the National Comprehensive Cancer Network added Abraxane to its treatment guidelines in 2005.2,36,9
In addition, Abraxane tends to be better tolerated than Taxol, administration times are shorter, and there are no premedication requirements (as with Taxol). The FDA has approved Abraxane for the treatment of patients with breast cancer.4
Abraxane vs Taxotere
Researchers conducted a randomized Phase II clinical trial to directly compare Abraxane to Taxotere (docetaxel) in the initial treatment of metastatic breast cancer. In addition researchers evaluated different doses and schedules of Abraxane.7
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This trial included over 300 women who had not received prior therapy. Study participants were assigned to one of four treatment groups: 1) Abraxane 300 mg/m2 every three weeks; 2) Abraxane 100 mg/m2 weekly for three weeks out of four; 3) Abraxane 150 mg/m2 weekly for three weeks out of four; 4) Taxotere (100 mg/m2) every three weeks.
- Response rates (the rate of partial or complete disappearance of detectable cancer) were 72% better among patients treated with Abraxane 150 mg/m2 weekly than among patients treated with Taxotere.
- Response rates were 61% better among patients treated with Abraxane 100 mg/m2 weekly than among patients treated with Taxotere.
- Response rates were better among patients who received Abraxane every week than among patients who received Abraxane every three weeks.
- Progression-free survival from all three Abraxane groups was better than in the Taxotere group, although additional follow-up is necessary.
- Grade 4 neutropenia (low white blood cell count) occurred in 74% of patients treated with Taxotere, compared to only 3%–4% of patients treated with weekly Abraxane.
- Febrile neutropenia (neutropenia accompanied by fever) occurred in 7% of patients treated with Taxotere, compared with only 1% of patients treated with Abraxane.
- Grades 1–2 mucositis/stomatitis (sores or inflammation in the mouth) occurred in 20% of patients treated with Taxotere, compared with 3% or less of patients treated with Abraxane.
Researchers have evaluate the combination of Abraxane and Xeloda in the treatment of metastatic breast cancer.8 Results from this trial demonstrated the following:
- Complete responses (complete disappearances of detectable cancer) were achieved in nearly 9% of patients.
- Partial responses (partial regression of cancer) were achieved in 44% of patients.
- Disease stabilization was achieved in 32.4% of patients.
- Overall, this treatment regimen was generally well tolerated.
The researchers concluded that, although these results are preliminary, it appears that treatment with Abraxane and Xeloda may be effective for patients with metastatic breast cancer. Longer follow-up is necessary to confirm the effectiveness of this treatment regimen, and the researchers stated that a future clinical trial further evaluating Abraxane and Xeloda for these patients is warranted.
- Ibrahim N, Samuels B, Page R, et al. Multicenter Phase II Trial of ABI-007, an Albumin-Bound Paclitaxel, in Women With Metastatic Breast Cancer. Journal of Clinical Oncology 2005:23;6019–6026.
- Desai N, et al. ABI-007 (ABRAXANE), a nanoparticle albumin-bound (NAB) paclitaxel demonstrates superior efficacy vs. Taxol in MBC: a phase III trial. Proceedings from the 2003 San Antonio Breast Cancer Symposium. San Antonio TX. 2003. Abstract #44.
- Perez E. New antitubulin agents. Proceedings from the 22nd annual Miami Breast Cancer Conference. MiamiFL. 2005
- Abraxane Prescribing Information. Available at: Accessed August 2005.
- American Pharmaceutical Partners. American Pharmaceutical Partners Announces Presentation of ABRAXANE Survival Data at 22nd Annual Miami Breast Cancer Conference. Available at: . Accessed June 2005.
National Comprehensive Cancer Network. Practice Oncology Guidelines- Invasive Breast Cancer. Available at: http://www.nccn.com/professionals/physician_gls/PDF/breast.pdf. Accessed December 2005.
Gradishar W, Krasnojon D, Cheporov S, et al. A randomized Phase 2 study of weekly (W) or every-3-week (Q3W) ABI-007 (ABX) versus every-3-week docetaxel as first-line therapy in patients with metastatic breast cancer. Proceedings from the 2006 annual San Antonio Breast Cancer Symposium (SABCS). Oral presentation December 17, 2006. Abstract #46.
Schwartzberg L, et al. Phase II trial of nanoparticle albumin-bound paclitaxel (ABX) + capecitabine (XEL) in first-line treatment of metastatic breast cancer (MBC): interim results. Proceedings from the 2006 Annual San Antonio Breast Cancer Symposium. December 2006. Abstract 1096.
New Antitubulin Agents. Proceedings from the 22nd annual Miami Breast Cancer Conference. Presented by Dr. Perez. Friday February 25, 2005. 2:45 pm. Miami, Florida.
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