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Age-related Toxicities and QOL in ATEMPT Study of T-DM1 vs Paclitaxel/TH

March, 03, 2023 | Breast Cancer

KEY TAKEAWAYS

  • The ATEMPT trial compared T-DM1 to paclitaxel plus trastuzumab (TH) for stage I HER2-positive breast cancer.
  • Among the eligible participants randomized in a 3:1 ratio to T-DM1 or TH, T-DM1 discontinuation was higher among women over 50 compared to those under 50, with 23% versus 9% discontinuing treatment, respectively.
  • Superior QOL was observed among women under 50 who received T-DM1 compared to those who received TH.
  • Among women over 50, T-DM1 was associated with superior physical well-being and less activity impairment, with no differences in global QOL.
  • De-escalated treatment regimens for HER2-positive breast cancer may have an age-varying impact on treatment tolerance, toxicities, and subsequent QOL.

Patient-reported outcomes (PROs) for stage I HER2-positive breast cancer increased with adjuvant trastuzumab emtansine (T-DM1) compared to paclitaxel plus trastuzumab (TH) in the ATEMPT study, while retaining excellent disease outcomes. Using multivariable models, we evaluate patient-reported toxicity and quality of life (QOL) 18 months after enrolment among 366 eligible participants randomly assigned in a 3:1 ratio to T-DM1 or TH.

They also report treatment discontinuation. Fisher’s Exact test revealed that T-DM1 discontinuation was more common in women over 50 compared to women under 50 (23% vs. 9%, p = 0.003), with older patients quitting medication at rates of 4%, 8%, and 17% by 3, 6 and 9 months, respectively. With an estimated mean difference of 6.48 (95% confidence interval (CI) 0.51-12.46) and driven by improved social/family well-being and breast cancer-specific sub-scores, women under 50 were found to have better QOL with T-DM1 vs. TH. T-DM1 was linked to better physical health and less activity impairment in women over 50, but there were no differences in overall QOL.

With T-DM1 compared to TH, neuropathy in older women decreased. When choosing therapy alternatives, it is important to remember that de-escalated treatment regimens for HER2-positive breast cancer may have age-varying effects on treatment tolerance, toxicities, and future QOL.

Source: https://pubmed.ncbi.nlm.nih.gov/36450763/

Clinical trial: https://clinicaltrials.gov/ct2/show/NCT01853748

Sella, T., Zheng, Y., Tayob, N., Ruddy, K.J., Freedman, R.A., Dang, C., Yardley, D., Isakoff, S.J., Valero, V., DeMeo, M., Burstein, H.J., Winer, E.P., Wolff, A.C., Krop, I., Partridge, A.H. and Tolaney, S.M. (2022). Treatment discontinuation, patient-reported toxicities, and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT). npj Breast Cancer, 8(1). doi:https://doi.org/10.1038/s41523-022-00495-x.

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