Docetaxel (T) + capecitabine (X) with or without trastuzumab (H) neoadjuvant therapy for locally advanced breast cancer (BC): Phase II study
| Autor: | Willem Lybaert, R. Drijkoningen, Frédéric Amant, Robert Paridaens, Caroline Weltens, G Debrock, H. Wildiers, E. Van Limbergen, Patrick Neven, M-R Christiaens |
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| Rok vydání: | 2007 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 25:11042-11042 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2007.25.18_suppl.11042 |
| Popis: | 11042 Background: In MBC, adding X to T improves RR, TTP and OS; adding X to TH improves TTP. XT±H is appealing in early BC because H serum concentrations fall during the peri-operative period, potentially reducing the risk of overlapping cardiac toxicity with adjuvant anthracyclines. Methods: Pts with newly diagnosed invasive stage III inoperable BC (cT4 and/or cN2–3) received six 21d cycles of oral X 900 mg/m2 bid d1–14 + iv T 36 mg/m2 d1&8 (+ H on d1 in pts with HER2+ [IHC 3+/FISH+] tumors: 8 mg/kg cycle 1, 6 mg/kg cycles 2–6). After surgery, pts received 4–6 cycles of FEC100 and radiotherapy (+ hormone therapy and H when indicated). Clinical response was assessed after cycles 3 and 6, safety after each cycle, and pathological complete response (pCR: no residual invasive tumor in breast and axilla) after surgery. Results: 71 of 89 planned pts have completed XT±H (Table); 64 have undergone surgery (53 mastectomies, 9 wide excisions, 2 axillary lymph node dissections only). 51 pts are evaluable for safety. The most common treatment-related adverse events (AEs; G1- 2/G3) were stomatitis (61%/8%), nausea (61%/6%), diarrhea (41%/22%), fatigue (57%/4%), neuropathy (59%/0), lacrimation (57%/0) and hand- foot syndrome (33%/16%). Other G3 AEs were anorexia (14%) and vomiting (10%); neutropenic fever occurred in 4 pts (8%). 24 pts had a dose reduction for G2–3 AEs (X 47%, T 27%). 7 pts stopped therapy prematurely for AEs. No unexpected AEs occurred with anthracycline-based adjuvant therapy. Conclusions: Although all pts experienced at least one AE, toxicity was predictable and manageable with dose reduction. Based on the encouraging efficacy of XT+H in HER2+ pts, we are expanding this arm. [Table: see text] No significant financial relationships to disclose. |
| Databáze: | OpenAIRE |
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