Table 2.
Adjuvant chemotherapy clinical trials focused on older breast cancer patients.
| Trial | Age Cut-Off (Median) | Sample Size, n | Treatment Arms | Tumour Characteristics | Outcomes |
|---|---|---|---|---|---|
| FASG 08 | >65 (69) | 338 | Tam +/− Epi | Node + | No ≠ in DFS; ↑ DFS with Epi + Tam at multivariate analysis |
| CALGB 49907 | >65 | 633 | CMF or AC vs. capecitabine | Stage I-IIIB | ↑ DFS and OS with AC/CMF |
| ELDA | >65 (71) | 299 | CMF vs. weekly docetaxel | Node + or average to high-risk 1 for recurrence (Hormone Receptor −, G 2–3, or T > 2 cm) | Docetaxel no more effective than CMF; worse QoL and more side effects |
| ICE | >65 (71) | 1358 | Ibandronate +/− capecitabine | Node + or high-risk 2 node − | No ≠ in DFS or OS |
| ICE II | >65 | 207 | EC or CMF vs. PX | Increased risk 3 | No ≠ in DFS; EC/CMF better tolerated |
| CASA | >65 | 77 | Nil vs. PLD vs. metronomic CM | Hormone Receptor − | Worse QoL, deterioration of cognitive and physical functioning with PLD |
Tam: Tamoxifen; Epi: Epirubicin; DFS: Disease free survival; OS: Over-all survival; CMF: Cyclophosphamide, methotrexate and fluorouracil; AC; doxorubicin and cyclophosphamide; QoL: Quality of life; EC: Epirubicin + cyclophosphamide; PX: Nab-Paclitaxel + capecitabine; PLD: Pegylated liposomal doxorubicin; CM: Cyclophosphamide + methotrexate; ORR: Over-all response rate; ≠: Difference; >: Greater than; ↑: Improved; G: Grade; T: Tumor size; +/−: With or without; +: Positive; −: Negative. 1 Estrogen and progesterone receptor negative or histologic grading 2–3 or primary tumor >2 cm; 2 Node negative disease with at least 1 other risk factor (tumor size >2 cm, grade 2 or 3, ER and PR negative); 3 As determined by urokinase-type plasminogen activator/plasminogen activator-1 or clinic-pathological risk parameters.