Abstract 3883
Background
TANGO is a French observational prospective study of women with advanced BC treated with EVE/EXE. The main objective was to describe the management of stomatitis and noninfectious pneumonitis (NIP) in clinical practice. Overall safety, duration of EVE/EXE tx and progression-free survival (PFS) were also assessed.
Methods
Eligible patients (pts) were postmenopausal women ≥18 years with advanced HR+/HER2− BC, for whom EVE/EXE was initiated. Statistical analyses were mainly descriptive. Tx duration and PFS were estimated with Kaplan-Meier methods.
Results
From Nov 2014 to Mar 2016, 596 pts had received EVE/EXE (Pts characteristics: see table).Table: 335P
Pts baseline characteristics at EVE/EXE initiation
| Pts who received EVE/EXE | |
|---|---|
| (N = 596) | |
| Age | |
| Mean (standard deviation) age, years | 65.1 (10.8) |
| Pts aged ≥75 years – n (%) | 131 (22%) |
| Median (range) time since initial BC diagnosis to inclusion, years | 7.5 (0.1 − 44.3) |
| Pts with de novo metastatic BC at diagnosis – n (%) | 145 (24%) |
| Pts with ECOG ≤1 – n (%) | 527 (88%) |
| Metastases | |
| Pts with bone-only metastases – n (%) | 199 (33%) |
| Pts with visceral metastases – n (%) | 290 (49%) |
| Previous lines of tx for metastatic disease | |
| Pts without previous line – n (%) | 113 (19%) |
| Pts with 1 previous line – n (%) | 208 (35%) |
| Pts with 2 previous lines – n (%) | 126 (21%) |
| Pts with ≥3 previous lines – n (%) | 149 (25%) |
| BC relapses relative to adjuvant hormonal tx (N, available data) | 375 |
| <2 years after the beginning of tx – n (%) | 57 (15%) |
| ≥2 years after the beginning of tx and <1 year after the end of tx – n (%) | 165 (44%) |
| ≥1 year after the end of tx – n (%) | 142 (38%) |
305 pts (51%) experienced stomatitis and 80 (13%) experienced NIP (median time to 1st event [range]: 21 [1 − 333] and 104 days [1 − 396], respectively). Most stomatitis (87%) and NIP (91%) were grade 1-2. Stomatitis were mainly treated with mouthwashes (77%), topical analgesics (19%) and antifungals (15%), and NIP with corticosteroids (40%) and antibiotics (10%). 509 pts (85%) had EVE-related adverse events (AE), the most common (excluding stomatitis/NIP) being asthenia (19%), diarrhoea (11%) and rash (10%). 90 pts (15%) had EVE-related serious AE, the most common (excluding stomatitis/NIP) being asthenia (2%). 5 pts (<1%) had EVE-related fatal AE: health deterioration, multiple organ failure, epistaxis, interstitial lung disease, pleural metastases and disorientation. With 562 analysed pts, the median PFS was 6.9 months (95% confidence interval [CI]: 6.2 − 7.8) and median duration of EVE/EXE tx was 5.3 months (95% CI: 4.8 − 6.0). After EVE discontinuation, most pts continued EXE alone (55%) or had chemotherapy (8%).
Conclusions
Results from this real-life observational study reinforce the known safety profile of EVE and better characterize stomatitis and NIP, as well as their management in EVEtreated pts.
Clinical trial identification
EU PAS: EUPAS7325.
Legal entity responsible for the study
Novartis Pharma S.A.S. (France).
Funding
Novartis Pharma S.A.S. (France).
Editorial Acknowledgement
Florence Arts and Jérôme Leemans; Keyrus Biopharma, Belgium.
Disclosure
C. Villanueva, E.-C. Antoine: Investigator and Scientific Committee member on this study sponsored by Novartis Pharma S.A.S. G. Yazbek, P. Beuzeboc, N. Dohollou, E. Luporsi, E. Levy; L.-M. Dourthe, E. Malaurie: Investigator on this study sponsored by Novartis Pharma S.A.S. E. Viel: Investigator on this study sponsored by Novartis Pharma S.A.S; Advisory boards: Bristol-Myers Squibb and Sanofi. J-C. Eymard, M-A. Mouret-Reynier: Investigator on this study sponsored by Novartis Pharma S.A.S; Advisory boards: Novartis Pharma S.A.S. M. Madelenat, A. Denden: Employee: Novartis Pharma S.A.S.
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