Abstract 4632
Background
Adjuvant dose-dense chemotherapy improves breast cancer (BC) outcomes compared to standard chemotherapy, with no increase in chemotherapy-induced amenorrhea (CIA). However, the impact of menopausal status and the contribution of CIA to outcomes per subtype remain unclear.
Methods
PANTHER is a phase 3 trial comparing tailored, according to hematologic nadirs, and dose-dense (tdd) epirubicin/cyclophosphamide (EC) and docetaxel (D) versus standard interval FEC/D. The primary endpoint of the trial is relapse-free survival (BCRFS). This exploratory secondary analysis aimed to evaluate whether there was differential efficacy of tdd therapy according to menopausal status and if differences in CIA, defined as amenorrhea at 2 years following treatment, may contribute to its efficacy.
Results
Baseline menopause status was available for 1913 women; 1036 premenopausal and 877 postmenopausal. Median follow-up was 5.3 years. The administration of tdd EC/D was associated with a non-statistically significant improvement in BCRFS in both premenopausal (HR = 0.83, 95% CI 0.59 – 1.16, p = 0.265) and postmenopausal patients (HR = 0.74, 95% CI 0.51 – 1.06, p = 0.102; pinteraction0.658). On the contrary, a significant interaction was noticed in women with triple negative BC (TNBC, p = 0.043). Tdd EC/D improved BCRFS in postmenopausal women (HR = 0.44, 95% CI 0.19 – 1.03, p = 0.06) but had a trend to opposite effect among premenopausal women (HR = 1.29, 95% CI 0.69 – 2.40, p = 0.426). There was no difference in CIA rates between the two treatment groups (OR = 1.04, 95% CI 0.77 – 1.39).
Conclusions
Tdd EC/D was associated with non-significant improvements in BCRFS, regardless of menopause status, without increasing rates of CIA. Negative effect on TNBC could be a chance finding due to low number of patients but the results warrant caution and necessitate further investigation.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Swedish Cancer Society, Swedish Breast Cancer Association (BRO), Radiumhemmet Research funds, Amgen, Roche, Sanofi-Aventis.
Disclosure
G. Steger: Honoraria (self): Amgen. R. Greil: Honoraria (self): Amgen; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self): MSD; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Celgene; Honoraria (self): BMS; Travel / Accommodation / Expenses: Roche; Travel / Accommodation / Expenses: Amgen; Travel / Accommodation / Expenses: AstraZeneca; Travel / Accommodation / Expenses: Janssen; Research grant / Funding (self): Roche; Research grant / Funding (self): BMS; Research grant / Funding (self): AstraZeneca. S. Loibl: Research grant / Funding (institution): Vigor; Honoraria (institution): AstraZeneca; Honoraria (institution): Amgen; Honoraria (institution): Pfizer; Honoraria (institution): Roche; Honoraria (institution): Puma; Honoraria (institution): Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Amgen; Advisory / Consultancy: Novartis; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Roche; Advisory / Consultancy: Puma; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Celgene; Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Teva. M. Gnant: Honoraria (self), Travel / Accommodation / Expenses: Amgen; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Celgene; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Lilly; Honoraria (self): Invectys; Honoraria (self), Travel / Accommodation / Expenses: Pfizer; Honoraria (self): Nano string; Honoraria (self): Novartis; Honoraria (self), Travel / Accommodation / Expenses: Roche; Honoraria (self): Medison; Travel / Accommodation / Expenses: Ipsen; Travel / Accommodation / Expenses: Medison. V. Moebus: Honoraria (self): Amgen; Honoraria (self): Celgene; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Myelotherapeutics; Honoraria (self): AstraZeneca. T. Foukakis: Honoraria (self), Research grant / Funding (institution): Roche; Honoraria (self), Research grant / Funding (institution): Pfizer; Honoraria (self): Novartis; Honoraria (self): UptoDate. J. Bergh: Research grant / Funding (institution): Merck; Research grant / Funding (institution): Amgen; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Sanofi-Aventis; Honoraria (self): Uptodate. All other authors have declared no conflicts of interest.
Resources from the same session
3191 - The efficacy and safety of lenvatinib in patients who did not meet the inclusion criteria of the phase 3 trial (REFLECT trial) and those with BCLC Stage B hepatocellular carcinoma - A nationwide multicenter study in Japan-
Presenter: Azusa Sakamoto
Session: Poster Display session 2
Resources:
Abstract
1529 - Prognostic and predictive value of baseline alpha-fetoprotein (AFP) in patients with advanced hepatocellular carcinoma (HCC) treated with ramucirumab from two phase 3 studies (REACH, REACH-2)
Presenter: Andrew Zhu
Session: Poster Display session 2
Resources:
Abstract
2767 - Effect of second-line cabozantinib on health states for patients with advanced hepatocellular carcinoma (aHCC) after sorafenib: QTWiST analysis from the CELESTIAL study
Presenter: Nicholas Freemantle
Session: Poster Display session 2
Resources:
Abstract
2150 - Alpha-fetoprotein (AFP) response in patients with unresectable hepatocellular carcinoma (HCC) in the phase 3 RESORCE trial
Presenter: Jordi Bruix
Session: Poster Display session 2
Resources:
Abstract
3437 - Phase I/II trial of NBTXR3 activated by SBRT in patients with hepatocellular carcinoma or liver metastasis
Presenter: Marc Pracht
Session: Poster Display session 2
Resources:
Abstract
1758 - Efficacy and safety of ramucirumab (RAM) for advanced hepatocellular carcinoma (HCC) with elevated alpha-fetoprotein (AFP) following first-line sorafenib across age subgroups in two global phase 3 trials (REACH and REACH-2)
Presenter: Masatoshi Kudo
Session: Poster Display session 2
Resources:
Abstract
1192 - Ramucirumab in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha fetoprotein (AFP): An exposure–response analysis
Presenter: Josep Llovet
Session: Poster Display session 2
Resources:
Abstract
1600 - Outcomes of Hepatocellular Carcinoma (HCC) Patients Treated with Nivolumab: The Mount Sinai Hospital Experience.
Presenter: Sirish Dharmapuri
Session: Poster Display session 2
Resources:
Abstract
2364 - Pembrolizumab vs Chemotherapy in Patients With Advanced/Metastatic Adenocarcinoma (AC) or Squamous Cell Carcinoma (SCC) of the Esophagus as Second-Line Therapy: Analysis of the Chinese Subgroup in KEYNOTE-181
Presenter: Jia Chen
Session: Poster Display session 2
Resources:
Abstract
1933 - A national comparative effectiveness study to assess definitive chemoradiation regimens in proximal oesophageal squamous cell cancer
Presenter: Judith de Vos-Geelen
Session: Poster Display session 2
Resources:
Abstract