Bevacizumab combined with chemotherapy significantly improves pathologic complete response in patients with operable or locally advanced breast cancer.

Abstract

Abstract Abstract #5114 Bevacizumab (B) improved progression free survival in metastatic breast cancer (BC) when added to chemotherapy (CT) and was relatively safe in the adjuvant setting. This study evaluated pathologic complete response (pCR) and safety of B with CT in the neoadjuvant setting.
 Methods: This is a single arm, single institution phase II trial. Patients (Pts) eligible for the study were women with proven BC (T1-4 and/or positive axillary LN -excluding inflammatory BC). Pts received CT with docetaxel (T, 75 mg/m2), cyclophosphamide (C, 500 mg/m2) and B (15 mg/kg), TCB every 3 wks x 4 cycles followed by doxorubicin (A, 60 mg/m2) every 3 wks for 4 cycles. After CT, Pts were evaluated clinically (clinical complete or partial response cCR or cPR), by mammogram and for their heart function by MUGA. Breast conserving surgery was considered if the response was deemed satisfactory, otherwise mastectomy was performed and pCR was evaluated. 28 to 84 days after surgery and after documented healing of the operative incision, B was restarted at 15 mg/kg x 9 cycles. XRT, herceptin and endocrine therapy were given as indicated concurrently with B.
 Results: As planned, 40 Pts were enrolled. Average age 46 (range 27-73). One patient withdrew consent after 2 cycles of TCB. Average tumor size was 5.26 cm (range 1.8 - 15 cm). Lobular 7/ductal 32. Grade I/II/III: 3/12/24. ER +/PR +: 11; ER+/PR-8; ER-/ PR +: 3, ER-/PR-:17. HER2 +: 8. Triple negative: 14. Lymph nodes were + in 25 patients. 32 Pts completed all pre-op CT cycles. One Pt died after 2 cycles of TCB of bilateral PE, 4 Pts received a truncated doxorubicin course due to side effects, 2 Pt received TCB x 2 followed by A x 4. The most common grade 3/4 AEs (#): diarrhea (4), febrile neutropenia (4), musculoskeletal pain (10), fatigue (8), mucositis (3), nausea (2), hypertension (5), syncope (2) infection (3). No clinically significant change in LVEF was noticed (Pre-CT EF 63.3% (55-76%); post-CT EF 61.2% (49-72%)). 4 Pts had a decrease of EF > 10. 21 cCR and 16 cPR were seen.1 Pt had progression and 1 Pt had no change. 38 Pts underwent surgery. 10 had lumpectomy (average pre-CT size 4.8 cm) and 28 had mastectomy (average pre-CT size 6.1 cm). One Pt had infusaport infection and another had breast implant infection, both required device removal and had delayed wound healing. 16 pCR/39 in the breast and 13 pCR/39 in the breast and axilla were seen (pCR breast 41%, pCR breast and axilla 33%). Several Pts had near pCR. Post-operative B safety data will be presented.
 Conclusions: When added to CT, B improved pCR in a poor prognostic BC Pts and was associated with manageable toxicity. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 5114.