Table.
GRADE evaluation of interventions for breast cancer (non-metastatic)
| Important outcomes | Treatment success, mortality, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of interventions after breast-conserving surgery for ductal carcinoma in situ? | |||||||||
| 3, 1 paper (2862) | Treatment success | Radiotherapy v no radiotherapy | 4 | 0 | 0 | 0 | 0 | High | |
| 3, 1 paper (2862) | Mortality | Radiotherapy v no radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1, 1 paper (1804) | Treatment success | Tamoxifen plus radiotherapy v placebo | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1, 1 paper (1804) | Mortality | Tamoxifen plus radiotherapy v placebo | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (523) | Treatment success | Tamoxifen plus radiotherapy v radiothera py | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| What are the effects of treatments for primary operable breast cancer? | |||||||||
| 1 (5187 | Mortality | Adjuvant aromatase inhibitors v placebo | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2, 2 papers (14068) | Treatment success | Adjuvant aromatase inhibitors v tamoxifen | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2, 2 papers (14068) | Mortality | Adjuvant aromatase inhibitors v tamoxifen | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 47 (18000) | Treatment success | Adjuvant combination chemotherapy v no chemotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 47 (18000) | Mortality | Adjuvant combination chemotherapy v no chemotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| not reported (3454) | Treatment success | Different treatment durations compared with each other ( prolonged adjuvant combination chemotherapy) | 4 | 0 | 0 | 0 | 0 | High | |
| not reported (3454) | Mortality | Different treatment durations compared with each other ( prolonged adjuvant combination chemotherapy) | 4 | 0 | 0 | 0 | 0 | High | |
| 2 (3877) | Treatment success | Different doses compared with each other (enhancedose regimens of adjuvant combination chemotherapy) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (3877) | Mortality | Different doses compared with each other (enhancedose regimens of adjuvant combination chemotherapy) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 11 (5942) | Treatment success | Anthracycline regimens compared with standard CMF regimens | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 11 (5942) | Mortality | Anthracycline regimens compared with standard CMF regimens | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 55 (37000) | Treatment success | Adjuvant tamoxifen v placebo | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 55 (37000) | Mortality | Adjuvant tamoxifen v placebo | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (3887) | Treatment success | Durations of treatment compared with each other (adjuvant tamoxifen) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (3887) | Mortality | Durations of treatment compared with each other (adjuvant tamoxifen) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (3387) | Treatment success | Trastuzumab v observation (after chemotherapy) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (3387) | Mortality | Trastuzumab v observation (after chemotherapy) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (3351) | Treatment success | Trastuzumab v observation (during chemotherapy) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (3351) | Mortality | Trastuzumab v observation (during chemotherapy) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 6 (at least 3490 women) | Treatment success | Adjuvant taxoid regimens v standard anthracycline based regimens | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 6 (at least 3490 women) | Mortality | Adjuvant taxoid regimens v standard anthracycline based regimens | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 5 (2090) | Mortality | Supraradical, radical, and total mastectomy compared with each other | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 4 (1296) | Mortality | Radical/total mastectomy v simple mastectomy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (1079) | Mortality | Radical mastectomy v total mastectomy with or without axillary radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 6 (3107) | Treatment success | Mastectomy v breast conservation | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 6 (4438) | Mortality | Mastectomy v breast conservation | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (701) | Mortality | Radical mastectomy v quandrantectomy plus radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (1851) | Mortality | Lumpectomy with or without radiotherapy v total mastectomy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (237) | Mortality | Modified radical mastectomy v lumpectomy plus axillary dissection plus radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (705) | Treatment success | Different extents of local excision compared with each other | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 12 (2102) | Treatment success | Ovarian ablation v no ablation | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 12 (2102) | Mortality | Ovarian ablation v no ablation | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 10 (7311) | Treatment success | Breast-conserving surgery plus radiotherapy v breast-conserving surgery alone | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 10 (7311) | Mortality | Breast-conserving surgery plus radiotherapy v breast-conserving surgery alone | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 8 (3531) | Treatment success | Breast-conserving surgery plus radiotherapy v mastectomy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 7 (3294) | Mortality | Breast-conserving surgery plus radiotherapy v mastectomy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 3 (2073) | Treatment success | Breast-conserving surgery plus radiotherapy v breast-conserving surgery plus tamoxifen | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 3 (2071) | Mortality | Radiotherapy plus tamoxifen v tamoxifen alone (after breast-conserving surgery) | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 36 (10982) | Treatment success | Radiotherapy after mastectomy v mastectomy alone (in women at high risk of local recurrence) | 4 | −1 | −1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for heterogeneity between RCTs |
| 36 (10982) | Mortality | Radiotherapy after mastectomy v mastectomy alone (in women at high risk of local recurrence) | 4 | −1 | −1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for heterogeneity between RCTs |
| 36 (5195) | Treatment success | Radiotherapy after mastectomy v mastectomy alone (in women not at high risk of local recurrence) | 4 | −1 | −1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for heterogeneity between RCTs |
| 36 (5195) | Mortality | Radiotherapy after mastectomy v mastectomy alone (in women not at high risk of local recurrence) | 4 | −1 | −1 | 0 | 0 | Low | Quality point deducted for incomplete reporting of results. Consistency point deducted for heterogeneity between RCTs |
| 4 (2802) | Treatment success | Primary chemotherapy v adjuvant chemotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 5 (3216) | Mortality | Primary chemotherapy v adjuvant chemotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 26 (not reported) | Treatment success | Radiotherapy after mastectomy v mastectomy alone in women at high risk of local recurrence | 4 | −2 | −1 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and for inclusion of RCTs without total nodal radiation. Consistency point deducted for heterogeneity between RCTs |
| 26 (not reported) | Mortality | Radiotherapy after mastectomy v mastectomy alone in women at high risk of local recurrence | 4 | −2 | −2 | 0 | 0 | Very low | Quality points deducted for incomplete reporting of results and for inclusion of RCTs without total nodal radiation. Consistency point deducted for conflicting results and for heterogeneity between RCTs |
| 1 (466) | Mortality | Axillary clearance v axillary sampling | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 8 (4370) | Treatment success | Axillary clearance v axillary radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 8 (4370) | Mortality | Axillary clearance v axillary radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (448) | Treatment success | Standard v dose intensified anthracycline based regimens | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (448) | Mortality | Standard v dose intensified anthracycline based regimens | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (174) | Treatment success | FAC regimen (fluorouracil, adriamycin [doxorubicin], and cyclophosphamide) v single agent paclitaxel | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (174) | Mortality | FAC regimen (fluorouracil, adriamycin [doxorubicin], and cyclophosphamide) v single agent paclitaxel | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (101) | Treatment success | MPEMi (methotrexate, cisplatin, etoposide, mitomycin C), MPEpiE (methotrexate, cisplatin, epirubicin, etoposide), and MPEpiV (methotrexate, cisplatin, epirubicin, vincristine) regimens v each other | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 2 (2515) | Treatment success | Sequencing of anthracycline based chemotherapy and docetaxel | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and for no long term results |
| 1 (73) | Treatment success | Intra-arterial v intravenous administration | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 2 (876) | Treatment success | Less than whole-breast radiotherapy v whole breast radiotherapy | 4 | 0 | −1 | 0 | 0 | Moderate | Consistency point deducted for conflicting results |
| 1 (168) | Mortality | Less than whole-breast radiotherapy v whole breast radiotherapy | 4 | −1 | −1 | 0 | 0 | Moderate | Quality point deducted for sparse data and conflicting results |
| 1 (270) | Treatment success | Radiotherapy to the internal mammary chain v nointernal mammary chain irradiation | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (270) | Mortality | Radiotherapy to the internal mammary chain v nointernal mammary chain irradiation | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (1375) | Treatment success | Radiotherapy v no radiotherapy to the ipsilateral supraclavicular fossa | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (498) | Treatment success | Sentinel node biopsy plus total axillary dissection v with sentinel node biopsy alone | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and for uncertainty about follow-up |
| 1 (200) | Mortality | Sentinel node biopsy plus total axillary dissection v with sentinel node biopsy alone | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for incomplete reporting of results and for uncertainty about follow-up |
| at least 6 RCTs (at least 3015 women) | Mortality | High-dose chemotherapy plus autologous stem cell transplantation v conventional chemotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 13 (5064) | Adverse effects | High-dose chemotherapy plus autologous stem cell transplantation v conventional chemotherapy | 4 | 0 | 0 | 0 | +2 | High | Effect size points added for RR greater than 5 |
| What are the effects of interventions in locally advanced breast cancer (stage III B)? | |||||||||
| 4 (3599) | Treatment success | Post-operative radiotherapy (in women also receiving postoperative systemic treatment) v no radiotherapy | 4 | −2 | 0 | −1 | 0 | Low | Quality poinst deducted for incomplete reporting of results and for weak methods. Directness points deducted for inclusion of women with different disease severities |
| 4 (3599) | Mortality | Post-operative radiotherapy (in women also receiving postoperative systemic treatment) v no radiotherapy | 4 | −2 | 0 | −1 | 0 | Low | Quality poinst deducted for incomplete reporting of results and for weak methods. Directness points deducted for inclusion of women with different disease severities |
| 2 (219) | Treatment success | Surgery alone v radiotherapy alone | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 2 (219) | Mortality | Surgery v radiotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting of results |
| 1 (143) | Mortality | Low-dose radiotherapy v tamoxifen | 4 | −2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 3 (580) | Treatment success | Systemic treatment plus radiotherapy v radiotherapy | 4 | −1 | −1 | −1 | 0 | Very low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results. Directness points deducted for inclusion of women with less locally advanced breast cancer |
| 3 (580) | Mortality | Systemic treatment plus radiotherapy v radiotherapy | 4 | −1 | −1 | −1 | 0 | Very low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results. Directness points deducted for inclusion of women with less locally advanced breast cancer |
| 1, 1 publication (107) | Treatment success | Multimodal treatment v hormone treatment | 4 | −1 | −1 | 0 | +1 | Moderate | Quality point deducted for sparse data. Consistency point deducted for different results at different end points. Effect size point added for OR 2–5 |
| 1 (101) | Mortality | Adjuvant chemotherapy v primary plus adjuvant chemotherapy | 4 | −1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
Type of evidence: 4 = RCT; 2 = Observational Consistency: similarity of results across studies Directness: generalisability of population or outcomes Effect size: based on relative risk or odds ratio