The European Society for Medical Oncology (ESMO) Congress 2022 was held in Paris, France, from September 9th to September 13th. Leading oncology experts from around the world gathered at this event to present and discuss the most recent data and cancer trial updates. The following are three key points from ESMO 2022 on breast cancer.
#1: Extending aromatase inhibition beyond 5 years of sequential therapy should not be recommended to all postmenopausal women with hormone receptor-positive breast cancer, but it may be considered in patients with node-positive, ER- and PR-positive tumours, according to the final results of the DATA phase III trial.[1]
In the DATA phase III study, 1912 postmenopausal women with hormone receptor-positive breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen received anastrozole (aromatase inhibitor) 1 mg/day for either 3 or 6 years.[1]
The median adapted follow-up time was 10.1 years. The 10-year adapted disease-free survival (aDFS) was 69% (95% CI: 66%-72%) in the 6-year group and 66% (95% CI: 63%-69%) in the 3-year group (HR 0.86; 95% CI: 0.72-1.01). There was no difference in adapted overall survival (aOS) (HR 0.93; 95% CI: 0.75-1.16).[1]
The effect of extended treatment on aDFS was different between patients with tumours expressing both oestrogen receptors (ER) and progesterone receptors (PR) (HR 0.77; 95% CI: 0.63-0.94), and patients with tumours expressing only one receptor (HR 1.22; 95% CI: 0.86-1.73).[1]
For patients with node-positive, ER- and PR-positive tumours (n=849), the 10-year aDFS was 69% (95% CI: 64%-73%) in the 6-year group and 61% (95% CI: 56%-65%) in the 3-year group (HR 0.74; 95% CI: 0.59-0.93). There was no significant difference in aOS (HR 0.84; 95% CI: 0.62-1.12).[1]
Anastrozole benefits are dependent on tumour characteristics.[1]
More information about this trial can be found here.
#2: The DAWNA-2 phase III study supports dalpiciclib plus letrozole or anastrozole as a new first-line treatment option for patients with locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer.[2]
he DAWNA-2 phase III trial randomized 456 patients with untreated HR+/HER2- locally recurrent or metastatic breast cancer and any menopausal status to the dalpiciclib plus letrozole/anastrozole arm (n=303) or the placebo plus letrozole/anastrozole arm (n=153). Dalpiciclib 150 mg was administered to patients on days 1-21 of each four-week cycle, along with letrozole 2.5 mg/day or anastrozole 1.0 mg/day.[2]
The progression-free survival (PFS) was significantly improved in the dalpiciclib plus letrozole/anastrozole arm compared to the placebo arm (median, 30.6 months [95% CI 30.6-NR] versus 18.2 months [16.5-22.5]; HR 0.51 [95% CI 0.38-0.69]).[2]
The objective response rate (ORR) and the duration of response (DoR) favoured the dalpiciclib arm as well. The ORR in the dalpiciclib arm was 57.4%, the clinical benefit rate was 86.8%, and the DoR was unreached. For the placebo arm, the corresponding values were 47.7%, 79.7%, and 15.0 months, respectively.[2]
Adding dalpiciclib to letrozole or anastrozole significantly prolonged PFS in patients with HR+/HER2- advanced breast cancer with manageable toxicities.[2]
More information about this trial can be found here.
#3: The TROPiCS-02 phase III study’s findings support the use of sacituzumab as a novel therapy for patients with HR+, HER2- metastatic breast cancer.[3]
In the TROPiCS-02 phase III study 543 patients with HR+/HER2- metastatic breast cancer were randomized to receive sacituzumab govitecan 10 mg/kg on days 1 and 8 of every 21-day cycle (n=272) or a physician’s choice of capecitabine, vinorelbine, gemcitabine, or eribulin (n=271).[3]
At the data cut-off on July 1, 2022, the median follow-up was 12.5 months and 390 overall survival (OS) events occurred. Sacituzumab govitecan significantly improved OS. The median OS durations were 14.4 and 11.2 months for sacituzumab govitecan and chemotherapy, respectively (HR=0.70; 95% Cl). The objective response rate (ORR) was significantly higher in the sacituzumab govitecan than the chemotherapy group, at 21% versus 14%. The median durations of response were 8.1 and 5.6 months, respectively.[3]
Sacituzumab govitecan showed statistically significant and clinically meaningful improvement in OS and ORR with manageable safety in patients with ET-resistant HR+/HER2- metastatic breast cancer.[3]
More information about this trial can be found here.
REFERENCE:
- https://oncologypro.esmo.org/meeting-resources/esmo-congress/extended-adjuvant-aromatase-inhibition-after-sequential-endocrine-therapy-final-results-of-the-phase-iii-data-trial
- https://oncologypro.esmo.org/meeting-resources/esmo-congress/dalpiciclib-plus-letrozole-or-anastrozole-as-first-line-treatment-for-hr-her2-advanced-breast-cancer-dawna-2-a-phase-iii-trial
- https://oncologypro.esmo.org/meeting-resources/esmo-congress/overall-survival-os-results-from-the-phase-iii-tropics-02-study-of-sacituzumab-govitecan-sg-vs-treatment-of-physician-s-choice-tpc-in-patient