title: Prospective phase II study of neoadjuvant doxorubicin followed by cisplatin/docetaxel in locally advanced breast cancer.
abstract: The objective of this study is to evaluate the efficacy and safety profile of the doxorubicin followed by cisplatin/docetaxel as primary chemotherapy for patients with locally advanced breast cancer (LABC). For this evaluation, 59 patients with LABC (T2-T4, N0-N2, M0) received three cycles of doxorubicin, followed by three cycles of cisplatin/docetaxel and followed by definitive surgery and locoregional radiotherapy with or without tamoxifen. The primary end point was pathologic complete response (pCR) in breast and axilla. Fifty-nine patients were evaluable for analysis: median age: 41 years, premenopausal: 68%, median tumor size: 6.0 cm (4-10), Stage IIB: 32% and IIIA/IIIB: 68%, both ER/PR positive: 53%, Her2/neu (3+) by IHC staining: 29%. Clinical complete response was seen in 44%, and clinical partial response was seen in 56%. Breast conserving surgery was performed in 44%, and MRM in 56%. pCR in the breast was 30.5%, in axilla was 37%, and pCR in both breast and axilla was 24%. Overall at follow-up of 60 months, the disease-free (DFS) and overall survival (OS) were 70 and 82%, respectively. The DFS and OS of patients who achieved complete pathologic response in breast and axilla were 78 and 100%, respectively, while 14 patients relapsed of which 46% were Her2 positive. Sequential combination of doxorubicin followed by docetaxel/cisplatin is a safe, feasible, and active combination, which offers the possibility of conservative surgery and is associated with high clinical and pathologic response rates, with promising and encouraging survival outcomes.
authors.affiliation: Department of Medical Oncology, King Faisal Specialist Hospital and Research Centre, Oncology Centre, MBC 64, P.O. Box 3354, Riyadh, 11211, Kingdom of Saudi Arabia. ttwegieri@kfshrc.edu.sa
authors.forename: Taher A
authors.initials: TA
authors.lastname: Al-Tweigeri
authors.forename: Dahish S
authors.initials: DS
authors.lastname: Ajarim
authors.forename: Adher A
authors.initials: AA
authors.lastname: Alsayed
authors.forename: Mohamed M
authors.initials: MM
authors.lastname: Rahal
authors.forename: Mohamed O
authors.initials: MO
authors.lastname: Alshabanah
authors.forename: Asma M
authors.initials: AM
authors.lastname: Tulbah
authors.forename: Osama A
authors.initials: OA
authors.lastname: Al-Malik
authors.forename: Doha M
authors.initials: DM
authors.lastname: Fatani
authors.forename: Gamal A
authors.initials: GA
authors.lastname: El-Husseiny
authors.forename: Naser B
authors.initials: NB
authors.lastname: Elkum
authors.forename: Adnan A
authors.initials: AA
authors.lastname: Ezzat
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D004967:Estrogens; D005260:Female; D018734:Genes, erbB-2; D006801:Humans; D053208:Kaplan-Meier Estimate; D008207:Lymphatic Metastasis; D015411:Mastectomy, Modified Radical; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009376:Neoplasms, Hormone-Dependent / Q000188:drug therapy / Q000473:pathology; D011374:Progesterone; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D013629:Tamoxifen / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004967:Estrogens; D043823:Taxoids; D013629:Tamoxifen; D000077143:Docetaxel; D011374:Progesterone; D004317:Doxorubicin; D002945:Cisplatin