Table 1.
Trial | Year of First Accrual | Year of Publication | Total No. of Patients | Follow-Up (years) | Median Age (years) | Induction Regimen | HDC Regimen | Control Regimen | SDI |
SDIP |
||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
HDC | Control | Difference | HDC | Control | Difference | |||||||||
MDACC | 1990 | 2000,7 200634 | 48* | 7 | 46 | 1,000 F, 50 D, 500 C | 5,250 C, 1,200 Et, 165 P over 3 days 2 cycles | No additional chemotherapy | 2.32 | 2.07 | 0.25 | 70 | 50 | 20 |
Dutch1 | 1991 | 1998,8 200235 | 81 | 6 | 47 | 500 F, 120 E, 500 C | 6,000 C, 480 T, 1,600 Cb over 4 days | No additional chemotherapy | 3.13 | 2.10 | 1.03 | 47 | 25 | 22 |
ECOG | 1991 | 20039 | 540 | 7 | 44 | 1,400 C, 60 D, 1,000 F | 6,000 C, 800 T over 4 days | No additional chemotherapy | 2.25 | 2.10 | 0.15 | 68 | 50 | 18 |
CALGB | 1991 | 200510 | 785 | 9 | 45 | 600 C, 60 D, 1,200 F | 5,625 C, 165 P, 600 BCNU over 3 days | 900 C, 90 P, 90 BCNU over 3 days | 2.16 | 1.90 | 0.26 | 52 | 36 | 16 |
MCG | 1993 | 200111 | 398 | 7 | 44 | — | 7,000 C, 8,000 Mt, 240 E, 600 T, 160-180 A | 120 E 3 cycles then 600 C, 40 Mt, 600 F 6 cycles | 2.76 | 1.81 | 0.95 | 50 | 60 | −10 |
NKI | 1993 | 200312 | 885 | 8 | 46 | 500 F, 90 E, 500 C | 6,000 C, 480 T, 1,600 Cb over 4 days | 500 F, 90 E, 500 C (1 additional cycle) | 2.72 | 1.70 | 1.02 | 49 | 25 | 24 |
GABG | 1993 | 2004,13 200836 | 302 | 5 | 48 | 90 E, 600 C | 6,000 C, 600 T, 40 M over 4 days | 1,000 C, 80 Mt, 1,200 F 3 cycles (28 days) | 2.23 | 1.66 | 0.57 | 41 | 40 | 1 |
ICCG | 1993 | 200514 | 281 | 4 | 47 | cycle 1: 600 F, 50 E, 600 C; cycles 2 and 3: 1,200 F, 50 E, 1200 C | 6,000 C, 500 T, 800 Cb | 1,200 F, 50 E, 1,200 C 2 additional cycles (28 days) | 2.21 | 1.39 | 0.82 | 38 | 33 | 5 |
JCOG | 1993 | 200815 | 97 | 7 | 47 | 500 C, 40 D, 500 F | 6,000 C, 600 T | No additional chemotherapy | 1.80 | 1.56 | 0.24 | 43 | 28 | 15 |
SBG | 1994 | 200016 200737 | 525 | 6 | 48 | HDC only: 600 C, 60 E, 600 F 3 cycles | 6,000 C, 500 T, 800 Cb over 4 days | Doses individually tailored, 6 plans. Start dose: 600 F, 75 E, 900 C, 9 cycles (21 days) | 2.33 | 1.86 | 0.47 | 35 | 50 | −15 |
PEGASE 01 | 1994 | 200517 | 314 | 5 | 48 | 500 F, 100 E, 500 C | 120 mg/kg C, 45 M, 140 A | No additional chemotherapy | 2.98 | 1.82 | 1.16 | 54 | 22 | 32 |
WSG | 1995 | 200518 | 403 | 5 | 49 | 90 E, 600 C | 3,000 C, 90 E 400 T every 28 days | 600 C, 40 Mt, 600 F 3 cycles (14 days) | 2.78 | 2.10 | 0.68 | 33 | 29 | 4 |
ACCOG | 1995 | 200419 | 605 | 6 | 45 | 75 D | 4,000 C single dose then 6,000 C, 800 T over 4 days | 600 C, 50 Mt, 600 F 8 cycles (21 days) | 2.48 | 1.62 | 0.86 | 47 | 58 | −11 |
IBCSG | 1995 | 2006,20 200938 | 344 | 5 | 47 | — | 4,000 C, 200 E 3 cycles (21 days) | 600 C, 90 E or 60 D 4 cycles (21 days), then 1,400 C, 1,200 F, 80 Mt over 14 days 3 cycles (28 days) | 4.73 | 1.84 | 2.89 | 42 | 44 | −2 |
SWOG | 1996 | 200721 | 602 | 8 | 46 | HDC only: 80 D, 600 C | STAMP I: C, P, BCNU or STAMP V: C, Cb, T | 80 D: 3 cycles (14 days) then 200 Pac: cycles (14 days) then 3,000 C 3 cycles (14 days) | 3.00 | 2.50 | 0.50 | 36 | 45 | −9 |
Total | 6,210 | 7 | 2.66 | 1.87 | 0.79 | 47 | 39.7 | 7.3 |
Abbreviations: A, melphalan; ACCOG, Anglo-Celtic Cooperative Oncology Group; BCNU, carmustine; C, cyclophosphamide; CALGB, Cancer and Leukemia Group B; Cb, carboplatin; D, doxorubicin; E, epirubicin; ECOG, Eastern Cooperative Oncology Group; Et, etoposide; F, fluorouracil; GABG, German Adjuvant Breast Cancer Study Group; HDC, high-dose chemotherapy; IBCSG, International Breast Cancer Study Group; ICCG, International Collaborative Cancer Group; JCOG, Japan Clinical Oncology Group; M, mitoxantrone; MCG, Michelangelo Cooperative Group; MDACC, MD Anderson Cancer Center; Mt, methotrexate; NKI, the Netherlands Cancer Institute; P, cisplatin; Pac, paclitaxel; PEGASE01, Programme d'évalution des greffes autologues dans le cancer du sein; SBG, Scandinavian Breast Group; SDI, summation dose intensity; SDIP, summation dose intensity product; STAMP I, Solid Tumor Autologous Marrow Transplant Program regimen I (C 1.85 g/m2/d and P 55 mg/m2/d, each for 3 days [days −6, −5, and −4], followed by BCNU 600 mg/m2 [day−3]); STAMP V, Solid Tumor Autologous Marrow Transplant Program regimen V (C 1.5 g/m2/d, Cb 200 mg/m2/d, and T 125 mg/m2/d for 4 days (days −7 through −4); SWOG, Southwest Oncology Group; T, thiotepa; WSG, West German Study Group.
Of the 78 total patients enrolled on this trial, 30 were randomly assigned to receive neoadjuvant therapy rather than adjuvant therapy; these patients were not included in the meta-analysis.