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Table 2 Summary of study and patient characteristics from RCTs with overall survival results

From: Herceptin® (trastuzumab) in HER2-positive early breast cancer: a systematic review and cumulative network meta-analysis

Study (primary publication) Treatments Node name in network Median follow-up (months) N total Median age (years) Tumor Size > 2 cm (%) Node + (%) HR+ (%) HER2+ (%)
RCTs with 100% HER2+ early breast cancer patients
ALTTO (Piccart-Gebhart 2016) [66] Anthracycline and/or taxane → trastuzumab IV (52 weeks) AC-TH52 weeks 54 2097 51 49 51 57 100
Anthracycline and/or taxane → lapatinib (52 weeks) AC-TL52 weeks 54 2100 51 51 52 57 100
Anthracycline and/or taxane → trastuzumab IV (12 weeks) → lapatinib (34 weeks) AC-TL34 weeks-H12 weeks 54 2091 51 50 52 58 100
Anthracycline and/or taxane → trastuzumab IV (52 weeks) + lapatinib (52 weeks) AC-TL52 weeks-H52 weeks 54 2093 51 50 51 57 100
BCIRG 006 (Slamon 2011) [44] Doxorubicin + cyclophosphamide → docetaxel AC-T 65 1073 NR 59 71 54 100
Doxorubicin + cyclophosphamide → docetaxel + trastuzumab IV (52 weeks) AC-TH52 weeks 65 1074 NR 62 71 54 100
Docetaxel + carboplatin + trastuzumab IV (52 weeks) TCH52 weeks 65 1075 NR 59 72 54 100
FNCLCC-PACS 04 (Spielmann 2009) [67] FEC or ED (epirubicin + docetaxel) → trastuzumab IV (52 weeks) AC-TH52 weeks 47 260 48 59·1 100 58 100
FEC or ED (epirubicin + docetaxel) AC-T 47 268 49 50·6 100 61 100
HannaH (Jackisch 2016) [68] Docetaxel → FEC + trastuzumab IV → trastuzumab IV (52 weeks) AC-TH52 weeks 40·6 297 50 NR 79·1 49·8 100
Docetaxel → FEC + trastuzumab SC → trastuzumab SC (52 weeks) AC-THSC,52 weeks 40·3 294 50 NR 75·8 52·4 100
HERA (Goldhirsch 2013) [64] Anthracycline or taxane → trastuzumab IV (104 weeks) AC-TH104 weeks 96 1700 NR 49·5 56·5 51·4 100
Anthracycline or taxane → trastuzumab IV (52 weeks) AC-TH52 weeks 96 1702 49 48·4 56·4 50·9 100
Anthracycline or taxane AC-T 96 1697 49 NR NR NR 100
HORG (Mavroudis 2015) [70] FEC → docetaxel + trastuzumab IV (52 weeks) AC-TH52 weeks 47 241 54 NR 74·7 64·7 100
FEC → docetaxel + trastuzumab IV (26 weeks) AC-TH26 weeks 51 240 56 NR 83·3 68·8 100
NCCTG N9831 and NSABP B-31 (Perez 2014) [51] Doxorubicin + cyclophosphamide → paclitaxel AC-T 99·6 2018 ~ 50 59·2 92·6 54·8 100
Doxorubicin + cyclophosphamide → paclitaxel + trastuzumab IV (52 weeks) AC-TH52 weeks 100·8 2028 ~ 50 61.8 93·4 54·7 100
NeoALTTO (de Azambuja 2014) [72] Paclitaxel → FEC → lapatinib (52 weeks) AC-TL52 weeks 45 154 50 100 > 16·2 51·9 100
Paclitaxel → FEC → trastuzumab IV (52 weeks) AC-TH52 weeks 45 149 49 100 > 15·4 50·3 100
Paclitaxel + → FEC → lapatinib (52 weeks) + trastuzumab IV (52 weeks) AC-TL52 weeks-H52 weeks 45 152 50 100 > 15·8 50·7 100
NOAH (Gianni 2014) [20] Paclitaxel + doxorubicin → paclitaxel → CMF AC-T 64·8 118 NR NR 84 36 100
[Paclitaxel + doxorubicin → paclitaxel → CMF → trastuzumab IV (52 weeks) AC-TH52 weeks 64·8 117 NR NR 86 36 100
NSABP B-41 (Robidoux 2013b) [94] Doxorubicin + cyclophosphamide → paclitaxel → trastuzumab IV (52 weeks) AC-TH52 weeks 22·8 181 NR 100 51 67 100
Doxorubicin + cyclophosphamide → paclitaxel + lapatinib (12 weeks) → trastuzumab IV (34 weeks) AC → T-L12 weeks-H34 weeks 22·8 174 NR 100 52 58 100
Doxorubicin + cyclophosphamide → paclitaxel + lapatinib (12 weeks) + trastuzumab IV → trastuzumab IV (52 weeks) AC → T-L12 weeks-H52 weeks 22·8 174 NR 100 49 62 100
PHARE (Pivot 2013) [75] Anthracycline + taxane + trastuzumab IV → trastuzumab IV (52 weeks) AC-TH52 weeks 42·5 1690 54 45.3 44·6 60·4 100
Anthracycline + taxane + trastuzumab IV → trastuzumab IV (26 weeks) AC-TH26 weeks 42·5 1690 55 47·6 45.3 61·5 100
RCTs with subgroup data of HER2+ early breast cancer patients
BCIRG 001 (Mackey 2013) [76] Docetaxel + doxorubicin + cyclophosphamide AC-T 124 745 49 61 100 76·1 21
Fluorouracil + doxorubicin + cyclophosphamide AC 123 746 49 57 100 75·7 22
Boccardo 2010 [77] Epirubicin → cyclophosphamide + methotrexate + fluorouracil AC 102 122 53·0 47·5 100 79·5 31·1
Paclitaxel → epirubicin + vinorelbine T → AV 102 122 54·5 64.8 100 79·5 28·7
BR9601 and NEAT (Earl 2012) [78] Epirubicin → CMF AC 88·8 1189 NR 56 72 ≥59 21
Cyclophosphamide + methotrexate + fluorouracil CMF 88·8 1202 NR 56 72 ≥59 20
Colozza 2005 [79] Cyclophosphamide + methotrexate + fluorouracil CMF 96 133 NR 51 80 ≥63 69
Epirubicin E 96 133 NR 48 78 ≥63 77
Del Mastro 2015 [80] Epirubicin + cyclophosphamide → paclitaxel (q3w) AC-T 84 545 51 48 100 77 23
FEC → paclitaxel (q3w) AC-T 84 544 53 52 100 81 24
Epirubicin + cyclophosphamide → paclitaxel (q2w) Dose dense 84 502 53 48 100 81 21
FEC → paclitaxel (q2w) Dose dense 84 500 51 49 100 80 24
E1199 (Sparano 2015c) [95] Doxorubicin + cyclophosphamide → paclitaxel (weekly) Dose dense 145·2 1232 51 63.8 87.8 70·2 19·2
Doxorubicin + cyclophosphamide → paclitaxel (q3w) AC-T 145·2 1253 51 60.7 87.8 71·0 20·6
E2198 (Schneider 2015) [82] Paclitaxel + trastuzumab IV (10 weeks) → doxorubicin + cyclophosphamide AC-TH9–10 weeks 77 115 49 NR 100 60 53
Paclitaxel + trastuzumab IV (10 weeks) → doxorubicin + cyclophosphamide + trastuzumab IV (52 weeks total) AC-TH52 weeks 77 112 48 NR 100 63
FinHer (Joensuu 2009) [83] Docetaxel → FEC AC-T 62 58 49·9 70 78 ≥44 100a
Docetaxel + trastuzumab IV (9 weeks) → FEC AC-TH9–10 weeks 62 54 51·4 59 90 ≥50 100a
Vinorelbine → FEC AC-V 62 58 49·9 70 78 ≥44 100a
Vinorelbine + trastuzumab IV (9 weeks) → FEC AC-VH9 weeks 62 62 51·4 59 90 ≥50 100a
FinXX (Joensuu 2014) [84] Capecitabine + docetaxel → cyclophosphamide + epirubicin + capecitabine → trastuzumab IV (52 weeks); or docetaxel → FEC → trastuzumab IV (52 weeks) AC-TH52 weeks 80·4 176 52·2 NR 84·6 60·2 100a
Capecitabine + docetaxel → cyclophosphamide + epirubicin + capecitabine; or docetaxel → FEC AC-T 80·4 108 50·5 NR 81·4 51·9 100a
GeparTrio (von Minckwitz 2013) [85] Docetaxel + doxorubicin + cyclophosphamide → vinorelbine + capecitabine (in non-responders) AC-T → VX 62 987 NR NR 54·7 65·6 29·1
Docetaxel + doxorubicin + cyclophosphamide AC-T 62 1025 NR NR 55·3 63·2 30·5
GONO-MIG-1 (Del Mastro 2005) [86] FEC (q3w) AC 80·4 53 54 NR 61·2 ≥27·2 100a
FEC (q2w) Dose dense 80·4 50 54 NR 61·2 ≥27·2 100a
Miles 1999 [87] Cyclophosphamide + methotrexate + fluorouracil CMF 159·6 129 NR 78 100 ≥77·5 30
No treatment No Tx 159.6 145 NR 78 100 ≥77·5 30
Rocca 2014 [88] Epirubicin → CMF, or CMF → epirubicin AC 69 545 53 NR 48·3 ≥64·0 34·1
Cyclophosphamide + methotrexate + fluorouracil CMF 69 160 51 NR 47·5 ≥56·9 30·0
TEACH (Goss 2013) [89] Lapatinib (52 weeks) + anthracycline/taxane AC-TL52 weeks 47.4 1571 51 NR 54 59 78
Placebo (52 weeks) + anthracycline/taxane AC-T 48·3 1576 52 NR 54 59 80
UNICANCER-PACS01 (Coudert 2012) [90] FEC AC 92·8 996 NR 57·8 100 78 9·4
FEC → docetaxel AC-T 92·8 1003 NR
Non-randomized studies with 100% HER2+ early breast cancer patients
Bayraktar 2012 [91] Paclitaxel + trastuzumab → FEC + trastuzumab (52 weeks) AC-TH52 weeks 29 235 49 NR 81·5 ≥53·8 100
Docetaxel + carboplatin + trastuzumab (52 weeks) TCH52 weeks 18 65 53 NR 80.0 ≥55·6 100
Gonzalez-Angulo 2015 [92] Adjuvant trastuzumab: paclitaxel + trastuzumab → FEC + trastuzumab (52 weeks) AC-TH52 weeks 45 480 ~ 50 NR 19·4 61·1 100
No adjuvant trastuzumab: paclitaxel + trastuzumab (26 weeks) → FEC AC-TH26 weeks 45 109 ~ 50 NR 15·6 53·2 100
Seferina 2015 [93] Anthracycline/taxane-containing chemotherapy + trastuzumab (52 weeks) AC-TH52 weeks 60 230 51 > 56 56·0 62 100
Endocrine therapy and radiotherapy, no chemotherapy No chemo 60 246 65 NR NR NR 100
  1. Data were extracted from the most recent full-text publications, when available
  2. aPatient characteristics were available for the HER2+ subgroup population. Therefore, the percentage of HER2+ patients in the HER2+ subgroup is 100%, even though it is a non-randomized subset of the RCT
  3. bPatient characteristics for NSABP B-41 were extracted from Robidoux 2013; [94] OS results were extracted from Robidoux 2016. [74]
  4. cPatient characteristics for E1199 were extracted from Sparano 2015; [95] OS results were extracted from Sparano 2008. [81]
  5. AC anthracycline (doxorubicin, epirubicin) + cyclophosphamide, AV anthracycline + vinorelbine, CMF cyclophosphamide + methotrexate + fluorouracil, Dose dense AC → T, or AC, either weekly or biweekly, E epirubicin, ED epirubicin + docetaxel, ER+ estrogen receptor-positive, FEC fluorouracil + epirubicin + cyclophosphamide, H Herceptin® intravenous (IV), HER2+ human epidermal growth factor receptor 2-positive, HR+ hormone receptor-positive, HSC Herceptin® subcutaneous (SC), IV intravenous, L lapatinib, No Chemo no chemotherapy (includes endocrine therapy and radiotherapy), No Tx no treatment, NR not reported, OS overall survival, PBO placebo, PgR+ progesterone receptor-positive, q2w once every 2 weeks, q3w once every 3 weeks, RCT randomized controlled trial, T taxane (docetaxel, paclitaxel), TCH docetaxel + carboplatin + Herceptin® IV, V vinorelbine, X capecitabine