Table 6 Randomized Controlled Trials of Chemotherapy +/- Glucocorticoids in Advanced Breast Cancer

Brambilla et al [17], 1974

Postmenopausal

adriamycin 40–75 IV mg/m² day 1, vincristine IV 1.4 mg/m² days 1 and 8 every 3 weeks for 8 cycles (20/15) vs same + prednisone 100 po mg/m²/day days 1–5 (22/21)

2

response rates of 50% vs. 55%

Ramirez et al [16], 1975

5-fluorouracil (5-FU) 10 mg/kg/week IV, methotrexate 0.5 mg/kg/week IV, vincristine 0.02 mg/kg/week IV, cyclophosphamide 2 mg/kg/day po (NR/52) vs. same + prednisone po 45 mg/day for 2 weeks, then 30 mg/day for 2 weeks then 15 mg/day (NR/48); treatment until PD

2

response rates of 44.2% vs. 62.5% (p = 0.075), no significant difference in response duration or survival

Rossi et al [25], 1976

Pre or postmenopausal, no previous chemotherapy

L-phenylalanine 4 mg/m² po/day + 5-FU 300 mg/m² po/day each days 1–5 every 28 days (16/14) vs. same except 5-FU IV (18/18) vs. same as first except 5-FU IV + prednisone 30 mg/m²/day days 1–5 (17/15)

1

response rates of 7% vs. 22% vs. 40% (ns)

Tormey et al [21], 1982

Pre or postmenopausal, no previous chemotherapy or prednisone therapy

CMF (NR/79) vs. CMFP (NR/86) vs. AV (NR/166); after 6 months or if progressive disease prior to then, switched to nonglucocorticoid containing chemotherapy

1

response rates of 57% vs. 63% vs. 56% (p > 0.10), response durations of 4.5 months vs. 8.4 months vs. 7.7 months (p = 0.05), time to treatment failure of 5.3 months vs. 9.1 months vs. 5.7 months (p = 0.04), overall survival of 14.5 months vs. 16.4 months vs. 13.7 months (p = 0.03)

Tormey et al [48], 1983

Pre or postmenopausal, no previous chemotherapy or prednisone therapy

CMF (NR/47) vs. CMFP (NR/47) vs. rotation every 2 cycles between CMF and AV (NR/50); treatment for 6 months followed by nonglucocorticoid containing therapy

2

response rates of 55% vs. 70% vs. 58% (ns), response duration of CMF less than CMFP (p = 0.39); time to treatment failure of CMF 5.6 months and CMFP 7.0 months (p = 0.16); median survival of CMF 12.5 months and CMFP 18.0 months

Gercovich et al [31], 1989

Untreated

5-FU + cyclophosphamide + mitoxantrone vs. same + prednisone 80 mg po days 1–5 (53/50 in total)

1

no difference in response rates

Tashiro & Nomura [40], 1995

resistant to or relapsed after adriamycin treatment, pre or postmenopausal

mitomycin C 4 mg/m² + methotrexate 35 mg/m² IV + vincristine 0.7 mg/m² IV days 1 and 8 every 21 days (21/21) (MMV) vs. same + prednisolone 10 mg po per day (MMVP) (43/41) vs. same as first + MPA 1200 mg po per day (MMVM) (44/40); treatment until PD

2

response rates of 9.5% vs. 29% vs. 37.5% (p = 0.0784 comparing MMV to MMVP); median duration of response of 12 vs. 16 vs. 34 weeks (ns); time to progression for MMVM longer than MMVP which was longer than MMV (p = 0.0256); survival differences (p = 0.382)

Piccart et al [28], 1997

One previous chemotherapy regimen for advanced or metastatic breast cancer

docetaxel 50 mg/m² IV days 1 and 8 every 3 weeks (42/41) vs. same + methylprednisolone 40 mg po on days -1,0,1,7,8 and 9 (41/39)

2

no significant differences in median response duration, median time to progression or median survival