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 Cytotoxic agents
Breast Cancer
Therapy
Biological therapy
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.