Konference: 2008 33st Congress ESMO - účast ČR
Kategorie: Zhoubné nádory prsu
Téma: Breast cancer, advanced
Číslo abstraktu: 151P
Autoři: A. T. C. Chan; V. Ganju; D. Becquart; P.F. Conte; M. Gil Gil; prof. MUDr. Luboš Petruželka, CSc.; G. Bernardo; G. Villanova; N. Tubiana-Mathieu
Background: CT plus H is the standard treatment of
HER2-positive MBC. Combination therapy of H plus vinorelbine is an
active and safe regimen in this setting. All-oral combination of
NVBo and X has been reported as an active and safe regimen in MBC.
We report efficacy and safety information from an updated analysis
of all 50 patients included in this trial with a median follow-up
of 28.5 months.
Materials and methods: In this multicentre trial, main eligibility criteria included: HER2-positive disease (defined as IHC 3+ or FISH+), documented measurable metastatic disease previously untreated by CT, relapse ‡ 6 months after the end of neoadjuvant or adjuvant CT, Karnofsky PS ‡70. NVBo was given as a 60 mg/m2 (cycle 1) or 80 mg/m2 (from cycle 2) dose D1 & D8 every 3 weeks, X at 1000 (750 if ‡ 65 y) mg/m2 bid D1-D14 every 3 weeks, H at 4 mg/kg on D1 as a loading dose then 2 mg/kg i.v. weekly starting on D8. Treatment was continued until progression.
Results: Median age: 53.5y (18% ‡ 65y); prior (neo)adjuvant CT 27 pts (54%); visceral involvement 41 pts (82%), > 2 metastatic sites 17 pts (34%); Median number of cycles: 10 (range 1-56); Median relative dose intensity: NVBo 75%, X 77%, H 96%; NVBo escalated to the recommended dose of 80 mg/m2: 84%; G3/4 NCI CTC v2 adverse events per pt: (n=49) neutropenia 69%, (n=50) febrile neutropenia 8%, infection without neutropenia 4%, stomatitis 4%, nausea 4%, vomiting 12%,diarrhoea 16%, hand-foot syndrome 20%, asthenia 8%, LVEF decline 6%, alopecia (grade 2) 14%; Efficacy (n=44 evaluable patients): objective response rate (RECIST) 77% (95% CI [62-89]), CR 18%, PR 59%, SD 18%, PD 5%, disease control (CR+PR+SD ‡6 months) 93% (95% CI [81-99]), Median duration of response was 14.3 months (95% CI [10-17]), median progression-free survival was 12.8 months (95% CI [11-17]), overall survival results are not mature yet. Treatment is ongoing in 5 pts.
Conclusion: This trial results show, in patients with HER-2 positive MBC, a high efficacy of the combination of NVBo and X plus H. This regimen can be safely administered for this patient population.
Materials and methods: In this multicentre trial, main eligibility criteria included: HER2-positive disease (defined as IHC 3+ or FISH+), documented measurable metastatic disease previously untreated by CT, relapse ‡ 6 months after the end of neoadjuvant or adjuvant CT, Karnofsky PS ‡70. NVBo was given as a 60 mg/m2 (cycle 1) or 80 mg/m2 (from cycle 2) dose D1 & D8 every 3 weeks, X at 1000 (750 if ‡ 65 y) mg/m2 bid D1-D14 every 3 weeks, H at 4 mg/kg on D1 as a loading dose then 2 mg/kg i.v. weekly starting on D8. Treatment was continued until progression.
Results: Median age: 53.5y (18% ‡ 65y); prior (neo)adjuvant CT 27 pts (54%); visceral involvement 41 pts (82%), > 2 metastatic sites 17 pts (34%); Median number of cycles: 10 (range 1-56); Median relative dose intensity: NVBo 75%, X 77%, H 96%; NVBo escalated to the recommended dose of 80 mg/m2: 84%; G3/4 NCI CTC v2 adverse events per pt: (n=49) neutropenia 69%, (n=50) febrile neutropenia 8%, infection without neutropenia 4%, stomatitis 4%, nausea 4%, vomiting 12%,diarrhoea 16%, hand-foot syndrome 20%, asthenia 8%, LVEF decline 6%, alopecia (grade 2) 14%; Efficacy (n=44 evaluable patients): objective response rate (RECIST) 77% (95% CI [62-89]), CR 18%, PR 59%, SD 18%, PD 5%, disease control (CR+PR+SD ‡6 months) 93% (95% CI [81-99]), Median duration of response was 14.3 months (95% CI [10-17]), median progression-free survival was 12.8 months (95% CI [11-17]), overall survival results are not mature yet. Treatment is ongoing in 5 pts.
Conclusion: This trial results show, in patients with HER-2 positive MBC, a high efficacy of the combination of NVBo and X plus H. This regimen can be safely administered for this patient population.
Datum přednesení příspěvku: 12. 9. 2008
