PMID- 29744672 OWN - NLM STAT- MEDLINE DCOM- 20190325 LR - 20190325 IS - 1179-1918 (Electronic) IS - 1173-2563 (Linking) VI - 38 IP - 7 DP - 2018 Jul TI - Efficacy and Safety of Neoadjuvant Treatment with Bevacizumab, Liposomal Doxorubicin, Cyclophosphamide and Paclitaxel Combination in Locally/Regionally Advanced, HER2-Negative, Grade III at Premenopausal Status Breast Cancer: A Phase II Study. PG - 639-648 LID - 10.1007/s40261-018-0655-z [doi] AB - BACKGROUND: In the era of personalized therapy, targeted treatment in specific patient populations is mandated. OBJECTIVE: We evaluated the efficacy and safety of neoadjuvant treatment on locally advanced breast cancer (LABC) with a monoclonal agent against vascular endothelial growth factor (VEGF), bevacizumab plus chemotherapy combination of liposomal doxorubicin, cyclophosphamide and paclitaxel (PLAC-B). METHODS: Patients enrolled were at premenopausal status and characterized by human epidermal growth factor receptor 2 (HER2)-negative, hormone-receptor positive (estrogen receptor/progesterone receptor-positive [ER/PR+]) or triple-negative (TNBC), LABC (T > 3 cm), with high-grade ductal carcinoma. Patients had to have a measurable disease and Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, with adequate hematologic, renal, and hepatic function. Patients received intravenous liposomal doxorubicin 30 mg/m(2), cyclophosphamide 600 mg/m(2), paclitaxel 120 mg/m(2), and bevacizumab 8 mg/kg on day 1 of 15-day cycles for four cycles (four administrations as neoadjuvant treatment). The primary endpoint was complete clinical (cCR) and pathologic (pCR) response rates, while secondary endpoints included safety, breast-conserving surgery (BCS) conversion rate, and disease-free survival (DFS). RESULTS: Sixty-two women were enrolled; 20 were ER/PR+ and 42 had TNBC. All underwent surgery, six received mastectomy, and 56 (90.3%) received BCS, with an equal conversion rate from initial indication for mastectomy. cCR was 25.8%. pCR in the breast and axilla occurred in 24 patients (38.7%). pCR was 42.9% for TNBC and 30% for ER/PR+. Hematologic adverse events (AEs) included neutropenia (74.2% total; 22.6% grade 3 [G3]) and febrile neutropenia (6.5% G3); non-hematologic G3 AEs included nausea (6.5%), mucositis (9.7%), and infection (3.2%), all of which were managed without negative sequelae. Over a 3-year follow-up, all patients were alive and DFS was 87.1%. CONCLUSION: PLAC-B as neoadjuvant treatment of this subpopulation with TNBC and ER/PR+ patients is effective and safe. Further studies are necessitated. FAU - Tampaki, Ekaterini C AU - Tampaki EC AD - Second Department Propaedeutic Surgery, "Laikon" General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece. FAU - Tampakis, Athanasios AU - Tampakis A AD - Second Department Propaedeutic Surgery, "Laikon" General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece. AD - Department of Visceral Surgery, Basel University Hospital, Basel, Switzerland. FAU - Alifieris, Constantinos E AU - Alifieris CE AD - Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias, Goudi, 11527, Athens, Greece. alifieris.k@gmail.com. AD - Department of Medical Oncology, "Henry Dunant" Hospital Center, Athens, Greece. alifieris.k@gmail.com. AD - Department of Surgery, General Hospital of Nea Ionia "Agia Olga-Konstantopouleion", Athens, Greece. alifieris.k@gmail.com. FAU - Krikelis, Dimitrios AU - Krikelis D AD - Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias, Goudi, 11527, Athens, Greece. FAU - Pazaiti, Anastasia AU - Pazaiti A AD - Breast Unit, 'Bioclinic' General Clinic of Athens, Athens, Greece. FAU - Kontos, Michalis AU - Kontos M AD - First Department of Surgery, "Laikon" General Hospital of Athens, National and Kapodistrian University of Athens, Athens, Greece. FAU - Trafalis, Dimitrios T AU - Trafalis DT AD - Department of Pharmacology, Medical School, National and Kapodistrian University of Athens, 75 Mikras Asias, Goudi, 11527, Athens, Greece. AD - Department of Medical Oncology, "Henry Dunant" Hospital Center, Athens, Greece. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PL - New Zealand TA - Clin Drug Investig JT - Clinical drug investigation JID - 9504817 RN - 0 (liposomal doxorubicin) RN - 2S9ZZM9Q9V (Bevacizumab) RN - 3WJQ0SDW1A (Polyethylene Glycols) RN - 80168379AG (Doxorubicin) RN - 8N3DW7272P (Cyclophosphamide) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Adult MH - Antineoplastic Combined Chemotherapy Protocols/*administration & dosage MH - Bevacizumab/administration & dosage MH - Breast Neoplasms/diagnostic imaging/*drug therapy MH - Cyclophosphamide/administration & dosage MH - Doxorubicin/administration & dosage/analogs & derivatives MH - Female MH - Humans MH - Middle Aged MH - Neoadjuvant Therapy/*methods MH - Neoplasm Grading/methods MH - Paclitaxel/administration & dosage MH - Polyethylene Glycols/administration & dosage MH - Premenopause/*drug effects MH - *Receptor, ErbB-2 MH - Treatment Outcome EDAT- 2018/05/11 06:00 MHDA- 2019/03/26 06:00 CRDT- 2018/05/11 06:00 PHST- 2018/05/11 06:00 [pubmed] PHST- 2019/03/26 06:00 [medline] PHST- 2018/05/11 06:00 [entrez] AID - 10.1007/s40261-018-0655-z [pii] AID - 10.1007/s40261-018-0655-z [doi] PST - ppublish SO - Clin Drug Investig. 2018 Jul;38(7):639-648. doi: 10.1007/s40261-018-0655-z.