Texas Oncology/US Oncology Research, Houston, TX
Frankie Ann Holmes , Melissa Brammer , Renard Dubois , Feng Xu , Bin Yao , Deepa Lalla
Background: Disease-free survival (DFS) in patients with EBC has improved over time. Trials of systemic agents for adj rx of HER2+ BC, including chemotherapies (CT), endocrine, and HER2-targeted agents have reported improved DFS. This review is a high-level overview describing DFS improvements in adj rx HER2+ BC. Methods: Therapeutic agents listed in NCCN guidelines for adj rx HER2+ BC were evaluated for relative and absolute improvements in DFS. Information was derived from US product labels and publications. Hazard ratios, 95% CI, p-values, and DFS differences at 2 and 5 years (if available) are reported. Results: At 2−3 years, adj rx of HER2+ BC with CT and HER2 treatments reported DFS improvements of 4−5% and 0.9−11.3%, respectively. For hormone receptor positive (HR+) BC, unselected by HER2 status, extended adj letrozole had a 1.9% DFS improvement at 2 years; in HR+ HER2+ BC, extended adj neratinib had 4.5% DFS at 2 years. Conclusions: Relative and absolute improvements in DFS in the adj rx BC setting have been largely incremental and cumulative. Absolute improvements in DFS were 0.9−11.3% with CT, HER2 agents, and AIs. In the subset of HR+ / HER2-positive patients, neratinib showed higher DFS improvement compared to non-steroidal AIs. Similar hazard ratios did not always correspond to similar DFS improvements, possibly reflecting differences in baseline risks in the study populations.
Agent | Year, Trial | HR (95% CI) | p−value | DFS difference (%) at 2 yr | DFS difference (%) at 5 yr |
---|---|---|---|---|---|
Docetaxel | 1995 BCIRG 001 | 0.74 (0.60, 0.92) | 0.0047 | 5.4 | 5.8 |
Doxorubicin | 2017 ABC trials | 1.23 (1.01, 1.50) | 0.04 | 2.5 (4 yr) | |
Paclitaxel | 1993 CALGB 9913 | 0.78 (0.67, 0.91) | 0.0022 | 4.4 | 5 |
Tamoxifen | 1989 NSABP B−14 | < 0.00001 | 6 (4 yr) | ||
Anastrazole | 1995 ATAC | 0.87 (0.78, 0.97) | 0.0127 | 1.6 | 2.7 |
Letrozole | 1996 MA.17 | 0.62 (0.49, 0.78) | 0.00003 | 1.9 | |
Trastuzumab | 2005 Joint Analysis | 0.48 (0.39, 0.59) | < 0.0001 | 7.2 | 13.0 |
Pertuzumab | 2017 APHINITY | 0.81 (0.66, 1) | 0.045 | 0.9 (3 yr) | |
Neratinib | 2016 ExteNET | 0.66 (0.49, 0.90)* | 0.008* | 2.3* | 2.5* |
0.49 (0.30, 0.78)† | 0.002† | 4.5† | 5.1† | ||
Ado-trastuzumab emtansine | 2018 KATHERINE‡ | 0.50 (0.39, 0.64) | < 0.001 | 11.3 (3 yr) |
*ITT; †HR+ ≤ 1 year from trastuzumab; ‡No pCR
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