279P - Real-World Everolimus Experience in Postmenopausal HR+ HER2- Advanced Breast Cancer Women – Treat ER+ight Canadian Prospective Observational Study...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Metastatic
Breast Cancer
Presenter Catherine Doyle
Citation Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365
Authors C. Doyle1, N. Califaretti2, S. Dent3, E. Chouinard4, S.R. Perri5, S. Chia6
  • 1Oncology, Centre des Maladies du Sein Deschênes-Fabia, G1S 4L8 - Quebec/CA
  • 2Medical Oncology, Grand River Regional Cancer Center, Kitchener/CA
  • 3Medical Oncology, Ottawa Hospital Cancer Center, K1H 8L6 - Ottawa/CA
  • 4Oncology, Cambridge Memorial Hospital, Cambridge/CA
  • 5Medical Affairs, Novartis Pharmaceuticals Canada Inc., H9S1A9 - Dorval/CA
  • 6Medical Oncology, BC Cancer Agency - Vancouver Cancer Center, Vancouver/CA

Abstract

Background

Treat ER+ight is the 1st Canadian real-world study enrolling patients (pts) previously exposed to letrozole or anastrozole and currently receiving endocrine therapy (ET) alone or in combination with targeted therapy.

Methods

At data cut-off (13 Mar '17), 35 pts were enrolled in the everolimus + exemestane (EVE+EXE) subgroup out of 100 total enrolled pts since Mar '16 from 24 active sites. This sub-analysis describes baseline characteristics, treatment duration and stomatitis prevention outcomes in EVE+EXE pts.

Results

Baseline characteristics: median age – 65 (39-80); family history of breast cancer (BC) – 37%; ECOG 0-1 – 83%; median time since primary BC diagnosis – 6 yrs (2-12); median time since advanced BC diagnosis – 1 yr (0-3.5). Sites of metastases (%): bone (B) only – 26; visceral (V) only – 43; B+V – 23. Line (L) of metastatic therapy (%): 17 - 1L, 51 - 2L, 31 - 3L. EVE start dose (%): 10mg (80), 7.5mg (3), 5mg (17). Therapy ongoing n (%): 23 (66) (78% 1L & 2L). Therapy discontinued n (%): 12 (34) (50% 3L). Reason for discontinuation n (%): 9 (75) progression, 2 (17) adverse event, 1 (8) death. Median follow-up time at data cut-off 3.4 mths (0.5-9.1). Median time to treatment discontinuation (TTD) 7.0 mths (95% CI, 3.4-NR) in overall subgroup. Median TTD NR (95% CI, 2.4-NR) in 20 (57%) pts receiving prophylactic/proactive mouthwash (P/P MW) compared to 5.7 mths (95% CI, 3.2-NR) in 15 (43%) pts receiving reactive/no MW (p = 0.140, Log-rank). 1st stomatitis event related to EVE n (%): overall subgroup 10 (29) – any Grade (Gr), 7 (20) – Gr 1, 2 (6) – Gr 2, 1 (3) – Gr 3 and in P/P MW subgroup 3 (15) – any Gr. Median time to 1st stomatitis event in P/P MW subgroup (mths) NR (95% CI, 1.64-NR) and NR (95% CI, 0.33-NR) in reactive/no MW subgroup (p = 0.334, Log-rank) with majority of stomatitis events occurring early within the 1st 2 months of therapy.

Conclusions

Compared to BOLERO-2, EVE+EXE pts in Treat ER+ight had lower ECOG 0-1 (83 vs 96%), more V disease (66 vs 56%), 20% received lower EVE start dose, similar treatment duration (7.0 mths median TTD vs 7.8 mths median PFS) and lower any Gr stomatitis (29 vs 59%). This represents the 1st observation of a trend toward improved TTD in pts receiving P/P MW upon EVE initiation.

Clinical trial identification

NCT02753686

Legal entity responsible for the study

Novartis Pharmaceuticals Canada Inc.

Funding

Novartis Pharmaceuticals Canada Inc.

Disclosure

E. Chouinard: Research support received from Novartis. S.R. Perri: Employee of Novartis Pharmaceuticals Canada Inc. S. Chia: Honorarium from Novartis and Pfizer. All other authors have declared no conflicts of interest.