P3-14-01: Panitumumab in Combination with FEC 100 (5-Fluorouracile, Epirubicin, Cyclophosphamide) Followed by Docetaxel (T) in Patients with Operable, Triple Negative Breast Cancer (TNBC): Final Results of a Multicentre Neoadjuvant Pilot Phase II Study

• Published in: Cancer research (Chicago, Ill.) Vol. 71; no. 24_Supplement; pp. P3 - P3-14-01
• Main Authors: Nabholtz, J-M, Weber, B, Gligorov, J, Mouret-Reynier, M-A, Tredan, O, Vanlemmens, L, Petit, T, Mayer, F, Van, Praagh-Doreau I, Dubray-Longeras, P, Nayl, B, Ferriere, J-P, Jouannaud, C, Devaud, H, Tubiana-Mathieu, N, Abrial, C, Kwiatkowski, F, Planchat, E, Chalabi, N, Penault-Llorca, F, Chollet, P
• Format: Journal Article
• Language: English
• Published: 15.12.2011
• ISSN: 0008-5472; 1538-7445
• DOI: 10.1158/0008-5472.SABCS11-P3-14-01

Abstract Background: Panitumumab is an antibody targeting the epidermal growth factor receptor (EGFR) to which a role has been suggested in TNBC. Consequently, we evaluated the combination of a standard chemotherapy (FEC 100 followed by T) with panitumumab as neoadjuvant therapy of oprable TNBC. Methods: 60 patients with stage II-IIIA disease were prospectively included in this multicentre pilot study. Systemic therapy (ST) consisted of 4 cycles of FEC 100 (500/100/500 mg/m2) q.3 weeks followed by 4 cycles of T (100 mg/m2) q.3 weeks, in combination with panitumumab (9 mg/kg) for 8 cycles q.3 weeks. All patients underwent surgery at completion of ST. Complete pathologic response (pCR) was the primary endpoint (Sataloff/J Am Coll Surg 1995; Chevallier: Am J Clin Oncol 1993), with toxicity and biologic ancillary studies as secondary endpoints. Results: Patients characteristics are as follows: mean age 47 [27-72]; T2: 74%, T3: 26%, (mean tumor size: 40 mm [20-120]); N0: 65%, N1: 28% and N2: 7%; invasive ductal carcinoma: 96%; Scarff-Bloom-Richardson Grade III: 72%, grade II: 28%. The median number of cycles was: FEC 100: 4 [2-4], T: 4 [0-4], Panitumumab: 7 [1-8]. Pathological response showed a pCR according to Sataloff's classification of 57.1% [95% IC: 40.7−73.5] and according to Chevallier's classification of 51.4% [95% IC: 34.8−68.0] with an overall clinical response rate of 60% (29% CR) [95% IC: 43.8−76.2]. Conservative surgery was performed in 79% of cases. Skin toxicity was the main side-effect: Cutaneous toxicity grade IV: 12%, grade III: 26%, grade II: 23%. No ocular complications have been reported. Neutropenia grade IV: 23.7%; febrile neutropenia: 4.2%. Infection: 0%. Hand-foot syndrome grade III: 4%. Ungueal toxicity grade IV: 2.5%, grade II: 25 .5%. Conclusions: These results suggest that Panitumumab in combination with FEC100 followed by T appears efficacious with acceptable toxicity in the neoadjuvant therapy of operable TNBC. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P3-14-01.