Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial) Journal Article
| Authors: | Ruddy, K. J.; Zheng, Y.; Tayob, N.; Hu, J.; Dang, C. T.; Yardley, D. A.; Isakoff, S. J.; Valero, V. V.; Faggen, M. G.; Mulvey, T. M.; Bose, R.; Sella, T.; Weckstein, D. J.; Wolff, A. C.; Reeder-Hayes, K. E.; Rugo, H. S.; Ramaswamy, B.; Zuckerman, D. S.; Hart, L. L.; Gadi, V. K.; Constantine, M.; Cheng, K. L.; Briccetti, F. M.; Schneider, B. P.; Garrett, A. M.; Marcom, P. K.; Albain, K. S.; DeFusco, P. A.; Tung, N. M.; Ardman, B. M.; Nanda, R.; Jankowitz, R. C.; Rimawi, M.; Abramson, V.; Pohlmann, P. R.; Van Poznak, C.; Forero-Torres, A.; Liu, M. C.; Rosenberg, S.; DeMeo, M. K.; Burstein, H. J.; Winer, E. P.; Krop, I. E.; Partridge, A. H.; Tolaney, S. M. |
| Article Title: | Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial) |
| Abstract: | Purpose: Chemotherapy-related amenorrhea (CRA) is a surrogate for ovarian toxicity and associated risk of infertility and premature menopause. Here, we compare CRA rate with paclitaxel (T)-trastuzumab (H) to that with ado-trastuzumab emtansine (T-DM1). Methods: Patients with T1N0 HER2 + early-stage breast cancer (eBC) enrolled on the ATEMPT trial and were randomized 3:1 to T-DM1 3.6 mg/kg IV every (q) 3 weeks (w) × 17 vs. T 80 mg/m2 with H IV qw × 12 (4 mg/kg load → 2 mg/kg), followed by H (6 mg/kg IV q3w × 13). Enrollees who self-reported as premenopausal were asked to complete menstrual surveys at baseline and every 6–12 months for 60 months. 18-month CRA (no periods reported during prior 6 months on 18-month survey) was the primary endpoint of this analysis. Results: Of 512 ATEMPT enrollees, 123 who began protocol therapy and answered baseline and at least one follow-up menstrual survey were premenopausal at enrollment. 76 had menstrual data available at 18 months without having received a gonadotropin-releasing hormone agonist or undergone hysterectomy and/or oophorectomy. Median age was 45 (range 23–53) among 18 who had received TH and 46 (range 34–54) among 58 who had received T-DM1. The 18-month rate of CRA was 50% after TH and 24% after T-DM1 (p = 0.045). Conclusion: Amenorrhea at 18 months was less likely in recipients of adjuvant T-DM1 than TH. Future studies are needed to understand how T-DM1 impacts risk of infertility and permanent menopause, and to assess amenorrhea rates when T-DM1 is administered after standard HER2-directed chemotherapy regimens. © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature. |
| Keywords: | controlled study; middle aged; genetics; paclitaxel; chemotherapy; antineoplastic agent; breast cancer; randomized controlled trial; antineoplastic combined chemotherapy protocols; epidermal growth factor receptor 2; breast neoplasms; breast tumor; receptor, erbb-2; trastuzumab; fertility; maytansine; amenorrhea; premenopausal; trastuzumab emtansine; humans; human; female; ado-trastuzumab emtansine |
| Journal Title: | Breast Cancer Research and Treatment |
| Volume: | 189 |
| Issue: | 1 |
| ISSN: | 0167-6806 |
| Publisher: | Springer |
| Date Published: | 2021-08-01 |
| Start Page: | 103 |
| End Page: | 110 |
| Language: | English |
| DOI: | 10.1007/s10549-021-06267-8 |
| PUBMED: | 34120223 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 September 2021 -- Source: Scopus |
