Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)

Ruddy, Kathryn J.; Zheng, Yue; Tayob, Nabihah; Hu, Jiani; Dang, Chau T.; Yardley, Denise A.; Isakoff, Steven J.; Valero, Vicente; Faggen, Meredith; Mulvey, Therese M.; Bose, Ron; Sella, Tal; Weckstein, Douglas; Wolff, Antonio C.; Reeder‐Hayes, Katherine E.; Rugo, Hope S.; Ramaswamy, Bhuvaneswari; Zuckerman, Dan Sayam; Hart, Lowell L.; Gadi, Vijayakrishna K.; Constantine, Michael; Cheng, Kit; Briccetti, Frederick; Schneider, Bryan P.; Garrett, A. Merrill; Marcom, P. Kelly; Albain, Kathy S.; DeFusco, Patricia; Tung, Nadine; Ardman, Blair; Nanda, Rita; Jankowitz, Rachel C.; Rimawi, Mothaffar F.; Abramson, Vandana G.; Pohlmann, Paula Raffin; Poznak, Catherine Van; Forero‐Torres, Andres; Liu, Minetta C.; Rosenberg, Shoshana M.; DeMeo, Michelle K.; Burstein, Harold J.; Winer, Eric P.; Krop, Ian E.; Partridge, Ann H.; Tolaney, Sara M.

doi:10.1007/s10549-021-06267-8

Cited by 26 publications

(13 citation statements)

References 12 publications

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“…Specific to younger women, treatment-related menopause is a toxicity with more long-term effects, which may in part explain our findings. In a preplanned sub-study, among premenopausal women enrolled to ATEMPT, 18-month chemotherapy-related amenorrhea was significantly lower with T-DM1 vs. TH (24% vs. 50%) 25 . Treatment-related menopause is associated with physiologic symptoms such as night sweats, hot flashes, vaginal dryness, and weight gain, which can adversely affect patients’ psychosocial QOL 26 , 27 .…”

Section: Discussionmentioning

confidence: 91%

Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)

et al. 2022

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In the ATEMPT trial, adjuvant trastuzumab emtansine (T-DM1) compared to paclitaxel plus trastuzumab (TH) for stage I HER2-positive breast cancer improved patient-reported outcomes (PROs), while maintaining excellent disease outcomes. We report treatment discontinuation and use multivariable models to compare, patient-reported toxicity and quality-of-life (QOL) by age (≤50, >50) and treatment arm at 18 months post-enrollment among 366 eligible participants randomized in a 3:1 ratio to T-DM1 or TH. T-DM1 discontinuation was higher among women >50 vs. ≤50 (23% vs. 9%, p = 0.003, Fisher’s Exact test) with 4%, 8%, and 17% of older patients discontinuing treatment by 3, 6, and 9 months, respectively. Superior QOL with T-DM1 vs. TH was observed among women ≤50 with estimated mean difference of 6.48 (95% confidence interval (CI) 0.51–12.46) and driven by better social/family well-being and breast cancer-specific sub-scores. Among women >50, T-DM1 was associated with superior physical well-being and less activity impairment, with no differences in global QOL. Older women had decreased neuropathy with T-DM1 vs. TH. De-escalated treatment regimens for HER2 positive breast cancer may have age-varying impact on treatment tolerance, toxicities and subsequent QOL, which should be considered when selecting therapy options.Clinical Trial Registration: ClinicalTrials.gov, NCT01853748

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Section: Discussionmentioning

confidence: 91%

Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)

et al. 2022

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“…Two other analyses have reported on post‐treatment amenorrhoea rates in premenopausal women receiving anti‐HER2 therapies without prior exposure to anthracycline‐ and cyclophosphamide‐based chemotherapy. As compared to what is expected for standard breast cancer chemotherapy, lower rates of post‐treatment amenorrhoea were observed in premenopausal women who were treated with weekly paclitaxel and trastuzumab in the APT trial 10 and in those that received T‐DM1 alone as adjuvant anti‐HER2 therapy in the ATEMPT trial 11 …”

Section: Figurementioning

confidence: 88%

“…T‐DM1: see ref. 11. A, anthracycline‐based chemotherapy; H, trastuzumab; L, lapatinib; P, paclitaxel; T, taxane‐based chemotherapy…”

Section: Figurementioning

confidence: 99%

“…As compared to what is expected for standard breast cancer chemotherapy, lower rates of post-treatment amenorrhoea were observed in premenopausal women who were treated with weekly paclitaxel and trastuzumab in the APT trial 10 and in those that received T-DM1 alone as adjuvant anti-HER2 therapy in the ATEMPT trial. 11 Nevertheless, these studies were mostly retrospective analyses characterized by a small sample size, and treatment-induced gonadotoxicity was assessed using amenorrhoea as marker of ovarian damage, thus preventing an accurate analysis of the real impact of anti-HER2-targeted agents on patients' ovarian reserve and subsequent chances of conception.…”

Section: Risk Of Gonadotoxicity With Immunotherapy and Targeted Agent...mentioning

confidence: 99%

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Risk of gonadotoxicity with immunotherapy and targeted agents remains an unsolved but crucial issue

Lambertini

Marrocco

Spinaci

et al. 2022

Eur J Clin Investigation

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“…Over the past few years, Mem Sloan Kettering Canc Ctr conducted clinical trials in various solid cancers, including epithelial cancer, ovarian cancer, urothelial carcinoma, and early-stage HER2-positive breast cancer. The results of the IMMU-132-01 trial, FORWARD I trial, EV-201 trial, and ATEMPT trial were disclosed in 2021 ( Bardia et al, 2021 ; Moore et al, 2021 ; Ruddy et al, 2021 ; Yu et al, 2021 ). Furthermore, the most cited paper published by Mem Sloan Kettering Canc Ctr was the clinical reports of the DESTINY-Breast01 trial ( Modi et al, 2020 ).…”

Section: Discussionmentioning

confidence: 99%

Research Trend of Publications Concerning Antibody-Drug Conjugate in Solid Cancer: A Bibliometric Study

Liu

et al. 2022

Front. Pharmacol.

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Background: Antibody-drug conjugate (ADC) is a promising therapy for solid cancer that has raised global concern. Although several papers have reviewed the current state of ADCs in different solid cancers, a quantitative analysis of the publications in this field is scarce.Methods: Publications related to ADC in the field of solid cancer were obtained from the Web of Science Core Collection. Data analyses were performed with VOSviewer 1.6.9, HistCite 2.1, CiteSpace V and R package Bibliometrix.Results: A total of 3,482 records were obtained in the holistic field and 1,197 in the clinical field. Steady growth in the number of publications was observed. The United States was the leading contributor in this field. Krop IE was the most influential author. The most productive institution was Genentech Inc., while Mem Sloan Kettering Canc Ctr was the most cited one. The most impactful journal was the Journal of Clinical Oncology. A total of 37 burst references and five burst references were identified between 2017–2022 in the holistic and clinical fields, respectively. Keywords analysis indicated that ADCs research mainly involved breast cancer, triple-negative breast cancer, ovarian cancer, small cell lung cancer, prostate cancer, gastric cancer, and urothelial carcinoma. ADC agents including trastuzumab emtansine, trastuzumab deruxtecan, sacituzumab govitecan, enfortumab vedotin, and rovalpituzumab tesirine were highly studied. Targets including HER2, trophoblast cell-surface antigen, mesothelin, delta-like ligand 3, and nectin-4 were the major concerns.Conclusion: This study analyzed publications concerning ADCs in the field of solid cancer with bibliometric analysis. Further clinical trials of ADCs and designs of the next generation of ADCs are the current focuses of the field. Acquired resistance of ADCs and biomarkers for ADC therapy efficacy monitoring are future concerns.

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Chemotherapy-related amenorrhea (CRA) after adjuvant ado-trastuzumab emtansine (T-DM1) compared to paclitaxel in combination with trastuzumab (TH) (TBCRC033: ATEMPT Trial)

Cited by 26 publications

References 12 publications

Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)

Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT)

Risk of gonadotoxicity with immunotherapy and targeted agents remains an unsolved but crucial issue

Research Trend of Publications Concerning Antibody-Drug Conjugate in Solid Cancer: A Bibliometric Study

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