158P_PR - Intermittent versus continuous chemotherapy beyond first-line for patients with HER2-negative advanced breast cancer (BOOG 2010-02)

Date 03 May 2019
Event ESMO Breast Cancer 2019
Session Poster lunch
Topics Anticancer Agents
Breast Cancer
Presenter Frans Erdkamp
Citation Annals of Oncology (2019) 30 (suppl_3): iii47-iii64. 10.1093/annonc/mdz100
Authors F.L.G. Erdkamp1, A.K.M. Claessens1, M. Lopez-Yurda2, J.M. Bouma3, H. van Tinteren2, J.M. Rademaker-Lakhai4, A.H. Honkoop5, H. de Graaf6, V.C.G. Tjan-Heijnen7, M.M.E.M. Bos8
  • 1Internal Medicine - Oncology, Zuyderland Medical Center - Sittard-Geleen, 6162 BG - Sittard-Geleen/NL
  • 2Biometrics, Netherlands Cancer Institute, 1066 CX - Amsterdam/NL
  • 3Trial Registation, Comprehensive Cancer Centre the Netherlands, 3011 BN - Rotterdam/NL
  • 4Boog Study Center, Dutch Breast Cancer Research Group, 1076 CV - Amsterdam/NL
  • 5Medical Oncology, Isala Klinieken, 8025 AB - Zwolle/NL
  • 6Medical Oncology, Medical Center Leeuwarden, 8901 BR - Leeuwarden/NL
  • 7Medical Oncology, Maastricht University Medical Center+ (MUMC+), 6202 AZ - Maastricht/NL
  • 8Medical Oncology, Erasmus University Medical Center, 3015 CE - Rotterdam/NL

Abstract

Background

This study investigates efficacy and safety of intermittent versus continuous scheduling of chemotherapy over two treatment lines for patients within the Stop & Go trial.

Methods

Participants were randomized to two sets of four cycles (intermittent) or eight consecutive cycles (continuous) of chemotherapy in two treatment lines. First-line consisted of paclitaxel plus bevacizumab, second-line of capecitabine or non-pegylated liposomal doxorubicin. The primary endpoint of the present study was progression-free survival (PFS) of second-line treatment.

Results

Characteristics at randomization were well-balanced. Patients with a good baseline performance status, only non-visceral metastasis, longer disease-free-interval, and HR-positive disease more often started second-line study treatment. For patients who started second line study treatment (n = 270; 131 vs. 139 in intermittent vs. continuous arm) median PFS in second-line was respectively 3.5 vs. 5.0 months with a Hazard Ratio (HR) of 1.04 (95%CI 0.69-1.57), and median OS in second-line was 10.6 vs.12.0 months, with a HR of 1.64 (95%CI 1.08 – 2.48). The median combined first- and second-line PFS for this population was 14.6 vs. 16.6 months with a HR of 1.59 (95%CI 1.04 – 2.45), and median OS measured from randomization was 20.3 vs. 23.0 months with a HR of 1.93 (95%CI 1.26 – 2.95). For all randomized patients (n = 420) median combined first- and second-line PFS was 12.7 vs. 13.9 months, with a HR of 1.21 (95%CI 0.9 – 1.63), and OS measured from randomization was 17.1 vs. 20.9 months with a HR of 1.37 (95%CI 1.03 - 1.54) for intermittent vs. continuous scheduling respectively. Selected baseline characteristics and first-line PFS duration were not significantly associated with second-line PFS in exploratory analyses. However, patients with longer first-line PFS more often started second-line study treatment (odds ratio 2.13; 95%CI 1.20 – 3.78) compared to patients with shorter first-line PFS. Details on safety will be presented at the meeting.

Conclusions

In conclusion, considering the overall survival benefits of continuous scheduling in both first- and second-line chemotherapy, we recommend this strategy for treatment of advanced breast cancer.

Editorial acknowledgement

Clinical trial identification

EudraCT 2010-021519-18; BOOG 2010-02.

Legal entity responsible for the study

Dutch Breast Cancer Research Group (BOOG).

Funding

F. Hoffmann-La Roche Ltd, The Netherlands TEVA Nederland, B.V.

Disclosure

F.L.G. Erdkamp: Honoraria, consulting/advisory role: Roche, Novartis. V.C.G. Tjan-Heijnen: Honoraria: E. Lilly, Pfizer; Funding for her institution: E. Lilly, Roche, Eisai, Pfizer, Novartis; Travel expenses: E. Lilly, Pfizer, Novartis, Roche; Consulting or advisory role: E. Lilly, Pfizer, Roche. All other authors have declared no conflicts of interest.