Konference: 2012 37th Congress ESMO – účast ČR
Téma: Proffered Papers, Breast Cancer, metastatic
Číslo abstraktu: 317O
Autoři: Prof. Dr. Christoph C. Zielinski; Prof. Dr. István Lang; Prof. Moshe Inbar; MD Zsuzsanna Kahan, PhD.; MD Richard Greil, Ph.D.; Dr. Semir Beslija; Dr. Salomon M. Stemmer; MD Bella Kaufman; Dr. Zaneta Zvirbule; Prof. MD Günther Steger; prof. MUDr. Bohuslav Melichar, Ph.D.; Dr. Tadeusz Pienkowski; Dr. Daniela Sirbu; prof. MUDr. Luboš Petruželka, CSc.; Dr. Alexandru Eniu; Bella Nisenbaum; Magdolna V. Dank; Rodica Anghel; Diethelm Messinger, MSc; prof. MD Thomas Brodowicz
Background
TURANDOT is the first prospective trial to compare BEV combined with either paclitaxel (PAC) or capecitabine (CAP). We report the planned interim analysis (IA) of efficacy.
Methods
Patients with HER2-negative mBC who had received no prior chemotherapy for mBC were randomised to receive either BEV–PAC (BEV 10 mg/kg d1 & 15 + PAC 90 mg/m d1, 8 & 15 q4w) or BEV–CAP (BEV 15 mg/kg d1 + CAP 1000 mg/m bid d1–14 q3w) until disease progression or unacceptable toxicity. The primary objective is to demonstrate non-inferior overall survival (OS) with BEV–CAP vs BEV–PAC. Interim and final OS analyses were planned after 175 and 389 deaths, respectively, in the per-protocol (PP) population to reject the null hypothesis of inferiority (hazard ratio [HR] ≥1.33) with 80% power and overall α = 0.025. Secondary endpoints include response rate (RR), progression-free survival (PFS), safety and quality of life.
Results
Median follow-up was 19 months at data cut-off for this IA (1 Sep 2011). Baseline characteristics were generally similar in the 2 treatment arms.
| BEV-PAC (n = 285) | BEV–CAP (n = 279) | |
|---|---|---|
| Median age, years | 59 | 59 |
| Visceral metastases, % | 65 | 73 |
| Prior (neo)adjuvant taxane, % | 20 | 18 |
| OSa | ||
| Events, % | 33 | 35 |
| 1-year OS rate, %b | 81 | 79 |
| HR (97.5% RCIc)for non-inferiority | 1.04 (−∞ to 1.69)p = 0.0593d | |
| RR | ||
| Overall, % | 44 | 27 |
| CMH test (superiority) | p < 0.0001 | |
| PFS | ||
| Events, % | 62 | 77 |
| Median, months | 11.0 | 8.1 |
| HR (95% CI) | 1.36 (1.09 to 1.68) | |
| Log-rank (superiority) | p = 0.0052 | |
RCI = repeated confidence interval
aPP population (n = 533)
bKaplan–Meier estimate
cUsing O'Brien–Fleming boundaries
dNon-inferiority not shown as p > 0.00105 (α at IA) AEs were consistent with the known safety profiles of BEV, PAC and CAP. The most common grade ≥3 AEs were neutropenia (18%), peripheral neuropathy (14%) and leucopenia (7%) with BEV–PAC and hand-foot syndrome (16%), hypertension (6%) and diarrhoea (5%) with BEV–CAP.
Conclusion
In this planned IA, the non-inferiority criterion has not been met but OS results do not indicate relevant differences. Final results are expected in 2014. PFS and RR were better with BEV–PAC and very similar to previous data for BEV–PAC (E2100) and BEV–CAP (RIBBON-1).
Disclosure
R. Greil: RG has received research support and honoraria from Roche.
S. Beslija: SB has received research support and honoraria from Roche.
D. Messinger: Employee of IST GmbH, CRO which is providing various services and consultancies for Hoffmann-La Roche and CECOG.
T. Brodowicz: TB has received honoraria from Roche.
All other authors have declared no conflicts of interest.
Datum přednesení příspěvku: 1. 10. 2012
