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.
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.
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)|
|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%)|
|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%).
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).
Novartis Pharma S.A.S. (France).
Florence Arts and Jérôme Leemans; Keyrus Biopharma, Belgium.
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.