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Poster display - Cocktail

804 - Meta-analysis of four Phase 3 RCTs of tamoxifen, versus 3rd generation aromatase inhibitors as 1st Line Endocrine Therapy for HR+ Advanced Breast Cancer

Date

24 Nov 2018

Session

Poster display - Cocktail

Presenters

John Robertson

Citation

Annals of Oncology (2018) 29 (suppl_9): ix13-ix20. 10.1093/annonc/mdy428

Authors

J. Robertson1, C. Campbell2, J. Bogaerts3, R. Parideans4, J. Lichfield5

Author affiliations

  • 1 Graduate Entry Medicine, University of Nottingham, School of Medicine, NG7 2RD - Nottingham/GB
  • 2 Biostatistics, Frontier Science, PH21 1NA - Kincaig/GB
  • 3 Biostatistics, European Organisation for Research and Treatment of Cancer, 1200 - Brussels/BE
  • 4 Medical Oncology, Universitair Ziekenhuis Gasthuisberg, Leuven/BE
  • 5 Global Medicines Development, AstraZeneca, SG8 6HB - Melbourn/GB
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Resources

Abstract 804

Background

Randomised controlled trials (RCTs) in ABC have reported significantly longer progression free survival (PFS) and overall survival (OS) with the SERD, fulvestrant (500mg) in first (versus an AI) and second line settings. In contrast, none of the four RCTs comparing AIs versus Tam (SERM) individually reported a difference in OS. Of note in these trials between 6.8% - 55% of tumours were HR unknown or negative. The present meta-analysis intends therefore to restrict the comparison to HR+ tumours.

Methods

Anonymised, individual patient level data were obtained for three RCTs (EORTC, 0027 & 0030): for the remaining Femara RCT, odds ratios (ORs) with confidence intervals were obtained from the Clinical Study Report &/or publications. Details of the studies, AI used & patient numbers are shown (Table).

Results

ORs for clinical benefit rate (CBR), duration of CB (DoCB), PFS & OS are shown for each individual study & for combined trials grouped 1-4 and 1-3 (with & without Femara). P-values for CBR with ORs>1 favour AIs; P-values for DoCB, PFS & OS with ORs <1 favour AIs.Table: 47P

TreatmentStudyTotal no. of ptsNo of HR+ ptsCBRDoCBPFSOS
Tam vs(n)(n)OROROROR
Exe (1)EORTC3713461.851.020.861.06
Ana (2)00276652981.120.730.841.77
Ana (3)00303533171.710.990.771.0
Let (4)Femara9075991.620.810.701.06
Subtotal (1-4)229615601.560.880.821.1
p-value<0.0010.080.0070.18
Subtotal (1-3)13899611.510.931.2
p-value0.0080.460.26

Conclusions

AIs produce significantly increased CBR than Tam. AIs result in a significantly longer PFS than Tam. The meta-analysis did not show improved OS for AIs compared to Tam. This finding is different from the SERD, fulvestrant (500mg), where significant improvement in CBR & PFS total have been associated with significant improvement in OS.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

University of Nottingham.

Funding

University of Nottingham.

Disclosure

J. Robertson: Consulting/non-CME fees: Novartis, AstraZeneca, Cullinan Oncology; Contracted research: Novartis, AstraZeneca - all payments to author\'s institution; Stock: Oncimmune, Carrick Therapeutics; Expert testimony: AstraZeneca. J. Lichfield: Employee, Share options: AstraZeneca. All other authors have declared no conflicts of interest.

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