High efficacy of the combination of oral vinorelbine (NVBo), capecitabine (X) and trastuzumab (H) in HER2-positive metastatic breast cancer (MBC): updated results of an international phase II trial with a median follow-up of 39 months

Konference: 2009 34st Congress ESMO a 15th Congress ECCO - účast ČR

Kategorie: Zhoubné nádory prsu

Téma: Poster Session VI: Breast cancer - Clinical advanced disease

Číslo abstraktu: P-5055

Autoři: A. T. C. Chan; V. Ganju; D. Becquart; P.F. Conte; prof. MUDr. Luboš Petruželka, CSc.; M. Gil-Gil; M. Morand; Nathalie Vaissiere; G. Villanova; N. Tubiana-Mathieu

Background: Chemotherapy (CT) plus H is the standard treatment for HER2-positive MBC. H plus vinorelbine combination therapy is an active and safe regimen in the first-line setting. The all-oral CT combination of NVBo and X has shown activity and good tolerability in MBC. We report the latest results from a multinational phase II study assessing the efficacy and safety of NVBo, X and H in HER2-positive MBC after a median follow-up of 39 months.

Materials and Methods: In this multicenter trial, main eligibility criteria included: HER2-positive disease (3+ IHC or FISH+), documented measurable metastatic disease previously untreated by CT, relapse ˇÝ6 months after the end of neoadjuvant or adjuvant CT, Karnofsky PS ˇÝ70. 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 ˇÝ65 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: Main patient (pt) characteristics in the full population (n = 50): median age: 53.5 years (18% ˇÝ65); 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¨C71); 72% of pts received more than 6 cycles, 58% more than 8 cycles and 32% more than 16 cycles; median number of NVBo administrations: 20 (range:1¨C141); median number of trastuzumab administrations: 30 (range:1¨C218); median relative dose intensity: NVBo 76%, X 78%, H 96%; NVBo dose escalation to 80 mg/m2: 84%. G3/4 NCI CTC v2 adverse events: neutropenia 71%, hand-foot syndrome 20%, diarrhoea 16%, vomiting 12%, asthenia 8%, febrile neutropenia 8%, infection 6%, LVEF decline 4%, stomatitis 4%, nausea 4%, alopecia (grade 2) 14%. Efficacy (n = 44 evaluable patients): objective response rate (RECIST) 77% (95% CI [62¨C89]), CR 21%, PR 57%, SD 18%, PD 5%, disease control (CR+PR+SD ˇÝ6 months) 93% (95% CI [81¨C99]); median duration of response was 13.3 months (95% CI [9.8¨C15.7]) and median progression-free survival was 12.8 months (95% CI [10.8¨C16.9]). With a median follow-up of 39 months, overall survival results are not mature yet. 5 patients are still receiving full study treatment.

Conclusion: Combination chemotherapy with NVBo and X plus H is an active first-line regimen for HER2-positive MBC. Treatment could be continued until disease progression without a pre-planned maximum number of cycles in many patients.

Publikováno v: European Journal of Cancer Supplements, Vol 7 No 2, September 2009, Page 276

Datum přednesení příspěvku: 23. 9. 2009