Summary Recommendation
The following taxane containing regimens are considered reasonable treatment options for the target population:
- Six cycles of three-weekly docetaxel, doxorubicin, and cyclophosphamide (TAC) (75/50/500mg/m2)
- Four cycles of doxorubicin and cyclophosphamide (AC) (60/600mg/m2) followed by four cycles of paclitaxel (175mg/m2 or 225mg/m2 every three weeks or 175 mg/m2 every two weeks with granulocyte colony-stimulating factor [G-CSF]).
- Three cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC)-100 followed by three cycles of docetaxel (100 mg/m2)
These regimens are recommended over their non-taxane containing counterparts (six cycles of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC), four cycles of AC, and six cycles of FEC-100), as they have been shown to be superior in efficacy. Taxane-containing counterparts to other commonly used non-taxane anthracycline regimens (e.g., cyclophosphamide, epirubicin, 5-fluorouracil [CEF]) have not yet been evaluated by randomized clinical trials. However, these non-taxane-containing regimens remain reasonable treatment options.
Question #1: Compared with a Standard Anthracycline-Based Regimen, Does a Concurrent Taxane-Anthracycline Regimen Improve Clinically Meaningful Outcomes?
- Women in the target population are recommended to receive six cycles of three-weekly docetaxel, doxorubicin, and cyclophosphamide over six-cycles of three-weekly 5-fluorouracil, doxorubicin, and cyclophosphamide (500/50/500mg/m2).
Question #2: Compared with an Anthracycline-Based Regimen, Does a Sequential Taxane-Anthracycline Regimen Improve Clinically Meaningful Outcomes?
- For women in the target population, four cycles of three-weekly AC (60/600mg/m2) followed by four cycles of three-weekly paclitaxel (175mg/m2 or 225mg/m2) is recommended over four cycles of three-weekly AC alone (60/600mg/m2).
- For women in the target population, three cycles of FEC-100 followed by three cycles of docetaxel (100 mg/m2) is recommended over six cycles of FEC-100 alone.
Question #3: Compared with a Standard (Three-Weekly) Anthracycline-Taxane Regimen, Does a Dose-Dense (Two-Weekly) Regimen Improve Clinically Meaningful Outcomes?
- Women in the target population should be considered for dose-dense therapy. In practice, four cycles of two-weekly AC (60/600mg/m2) followed by four cycles of two-weekly paclitaxel (175mg/m2) (AC followed by docetaxel [T]) is more commonly used due to a shorter duration of treatment.
- Granulocyte colony-stimulating factor (days three to 10 of each cycle [a total of seven doses] at 5 micrograms /kg rounded to either 300 micrograms or 480 micrograms total dose) should be given in combination with four cycles of two-weekly AC followed by docetaxel to prevent neutropenia.
Question #4: Compared with an Anthracycline-Based Regimen, Does a Non-Anthracycline Taxane Regimen Improve Clinically Meaningful Outcomes?
- There is insufficient evidence at this time to make any evidence-based recommendations regarding non-anthracycline taxane regimens versus anthracycline-based regimens.
Question #5: What are the Harms Associated with Adjuvant Taxane Regimens?
- Women receiving an adjuvant anthracycline-taxane regimen should be closely monitored for febrile neutropenia. In those who experience febrile neutropenia while receiving TAC, granulocyte colony-stimulating factor (days three to ten of each cycle [a total of seven doses] at 5 micrograms/kg rounded to either 300 micrograms or 480 micrograms total dose) should be administered with subsequent docetaxel infusions. Alternatively, a dose reduction should be considered.
- Women receiving an anthracycline-taxane regimen should also be monitored for other toxicities, including diarrhea, stomatitis, amenorrhea, asthenia, myalgia, paresthesia, and leukopenia.
- Women receiving docetaxel and cyclophosphamide (TC) should be monitored for paresthesia, edema, weight gain, rash, and arthralgia.
