September 2021: iDFS and safety results of the randomized phase III GAIN-2 trial

The GAIN-2 trial was designed to identify a superior intense dose-dense strategy for high-risk patients with early breast cancer. Here, we report an interim analysis, at which the predefined futility boundary was crossed.

Highlights:

• Adjuvant dose-dense regimens and survival in high-risk breast cancer
• Tailored dose-dense compared to intense dose-dense chemotherapy in high-risk breast cancer
• Tailored dose-dense chemotherapy is superior in HR+/HER2-, lobular cancer and ≤50 years of age
• High-grade toxicity was significantly higher with intense dose-dense regimen
•  GAIN-2 results support the EBCTCG metaanalysis of increasing the dose intensity

Conclusion: iDFS is equal in both regimens, but tailoring dose-dense chemotherapy improved outcomes in HR+/HER2-, lobular cancer and patients ≤50 years.

Möbus V, Lück HJ, Ladda E, et al. Phase III randomised trial comparing intense dose-dense chemotherapy to tailored dose-dense chemotherapy in high-risk early breast cancer (GAIN-2). Eur J Cancer. 2021;156:138-148.

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