Table 3.
Clinical questions for MBC
| SoR | SoE | Consensus rate | ||
|---|---|---|---|---|
| CQ.18 | What is recommended as first-line ET for premenopausal patients with HR-positive, HER2-negative MBC? | |||
| Recommendation | OFS in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor and a nonsteroidal aromatase inhibitor (NSAI) is recommended | 1–2 | Weak |
1: 53% 2: 47% |
| The combination of OFS and ET alone is weakly recommended | ||||
| The combination of OFS and tamoxifen is weakly recommended | 2 | Moderate | 95% | |
| The combination of OFS and a NSAI is weakly recommended | 2 | Weak | 100% | |
| CQ.19 | What is recommended as second-line or subsequent ET for premenopausal patients with HR-positive, HER2-negative MBC? | |||
| Recommendation | Fulvestrant and a CDK4/6 inhibitor in combination with a LH-RH agonist is strongly recommended | 1 | Moderate | 97% |
| OFS in conjunction with an AI or other ET used for postmenopausal patients is weakly recommended | 2 | Weak | 97% | |
| CQ.20 | What is recommended as ET for postmenopausal patients with HR-positive, HER2-negative MBC? | |||
| Recommendation | The combination of a NSAI and a CDK4/6 inhibitor is strongly recommended | 1 | Strong | 100% |
| Fulvestrant alone is weakly recommended | 2 | Weak | 97% | |
| An AI alone is weakly recommended | 2 | Moderate | 91% | |
| CQ.21 | What is recommended as second-line ET when an AI is administered as first-line therapy for postmenopausal patients with HR-positive, HER2-negative MBC? | |||
| Recommendation | The combination of fulvestrant and a CDK4/6 inhibitor is strongly recommended | 1 | Strong | 100% |
| CQ.22 | What is recommended as third-line or later ET for postmenopausal patients with HR-positive, HER2-negative MBC? | |||
| Recommendation | The combination of exemestane and everolimus is weakly recommended for NSAI-refractory MBC | 2 | Weak | 98% |
| CQ.23 | Is bevacizumab in combination with chemotherapy recommended as first- or second-line chemotherapy for patients with HER2-negative MBC? | |||
| Recommendation | Bevacizumab in combination with chemotherapy is weakly recommended | 2 | Strong | 97% |
| CQ.24 | Are oral fluoropyrimidines recommended as first- or second-line chemotherapy for patients with HER2-negative MBC? | |||
| First-line chemotherapy: | ||||
| Recommendation | S-1 is weakly recommended | 2 | Moderate | 86% |
| Capecitabine is weakly recommended | 2 | Weak | 86% | |
| Second-line chemotherapy: | ||||
| Recommendation | S-1 or capecitabine is weakly recommended | 2 | Weak | 100% |
| CQ.25 | Is eribulin recommended as first- or second-line chemotherapy for patients with HER2-negative MBC? | |||
| Recommendation | Eribulin is weakly recommended for patients previously treated with anthracycline- and taxane-based chemotherapy, including in neoadjuvant/adjuvant therapy | 2 | Weak | 92% |
| CQ.26 | Is trastuzumab + pertuzumab + taxane recommended as first-line therapy for patients with HER2-positive MBC? | |||
| Recommendation | The combination of trastuzumab + pertuzumab + docetaxel is strongly recommended | 1 | Strong | 100% |
| The combination of trastuzumab + pertuzumab + paclitaxel is weakly recommended | 2 | Moderate | 97% | |
| CQ.27 | Is trastuzumab emtansine recommended as first-line therapy for patients with HER2-positive MBC? | |||
| Recommendation | Trastuzumab emtansine is weakly not recommended | 3 | Weak | 79% |
| CQ.28 | Is trastuzumab deruxtecan (T-DXd) recommended as second-line therapy for patients with HER2-positive MBC? | |||
| Recommendation | T-DXd is strongly recommended as second-line therapy for patients with HER2-positive MBC that has progressed during or after the combination of trastuzumab, pertuzumab and chemotherapy | 1 | Moderate | 90% |
| CQ.29 | Is ET alone or in combination with anti-HER2 therapy recommended for patients with HER2-positive, HR-positive MBC? | |||
| Recommendation | Anti-HER2 therapy in combination with ET is weakly recommended for patients with HER2-positive, HR-positive MBC that is unsuitable for chemotherapy | 2 | Moderate | 88% |
| ET alone is weakly not recommended for patients with HER2-positive, HR-positive MBC that is unsuitable for chemotherapy | 3 | Moderate | 76% | |
| CQ.30 | Is platinum-based chemotherapy recommended for patients with triple-negative MBC? | |||
| Recommendation | Platinum-based chemotherapy is weakly recommended | 2 | Weak | 98% |
| CQ.31 | Are PD-1/PD-L1 inhibitors recommended for patients with MBC? | |||
| Recommendation | Atezolizumab in combination with nanoparticle albumin-bound paclitaxel is strongly recommended for patients with PD-L1-positive triple-negative breast cancer | 1 | Moderate | 94% |
| Pembrolizumab in combination with chemotherapy (nanoparticle albumin-bound paclitaxel, paclitaxel, carboplatin plus gemcitabine) is strongly recommended for patients with PD-L1-positive triple-negative breast cancer | 1 | Moderate | 97% | |
| CQ.32 | Are PARP inhibitors recommended for MBC patients with germline BRCA1/2 pathogenic variants? | |||
| Recommendation | Monotherapy with a PARP inhibitor is strongly recommended for patients with anthracycline- and taxane-based chemotherapy | 1 | Strong | 88% |