207P Efficacy and safety of neoadjuvant chemotherapy plus trastuzumab and pertuzumab in non-metastatic HER2-positive breast cancer in real life: NEOPEARL study
M.A. Fabbri1 , A. Botticelli2 , C. Omarini3 , E. Cretella4 , A. Fabi5 , D. Alesini1 , L. Pizzuti5 , G. Piesco6 , A. Vaccaro7 , F. Atzori8 , F. Piacentini3 , L. Moscetti9 , A. Orlandi10 , V. Sini11 , A. Mercanti12 , M.L. Framarino6 , M. Persano13 , R. Ceccherini14 , E.M. Ruggeri15 1
Oncology Department, Belcolle Hospital, Viterbo, Italy,2
Clinical and Molecular Medicine Department, Azienda Ospedaliera St. Andrea, Rome, Italy,3
Oncology Department, Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy, 4
Oncology Department, Ospedale Centrale di Bolzano ASDAA/SABES, Bolzano, Italy, 5
Oncology Department, Istituto Nazionale Tumori Regina Elena, Rome, Italy,6 Oncology Department, Policlinico Umberto I, Rome, Italy,7
Oncology Department, Frosinone, Frosinone, Italy,8
Oncology Department, Azienda Ospedaliero Universitaria di Cagliari, Monserrato, Italy,9
Oncology, Azienda Ospedaliero - Universitaria Policlinico di Modena, Modena, Italy,10
UOC di Oncologia Medica, Policlinico Universitario A. Gemelli, Rome, Italy,11
Oncology Department, Ospedale Santo Spirito, Rome, Italy,12 Oncology Department, Ospedale di Legnago, Legnago, Italy,13
Medical Oncology, Azienda Ospedaliero Universitaria di Cagliari, Cagliari, Italy,14
ASUITS, Centro Sociale Oncologico (CSO), Trieste, Italy,15
Onco-Ematologia, Ospedale Belcolle, Viterbo, Italy
Background:In HER2þ breast cancer (BC) patients (pts) the pathological complete response (pCR) is associated with improved survival. With regimens based on the com-bination of trastuzumab (T), pertuzumab (P) and chemotherapy, pCR rates are slightly over 48%. We conducted a retrospective analysis on HER2þ BC pts to describe the out-comes of neoadjuvant combination of PþT and chemotherapy in the real-life setting. Methods:Our cohort included 64 pts treated between Sept 2015 and Mar 2018 in 15 Italian Cancer Centers. Treatment outcomes were analyzed in terms of pCR (defined as ypT0/Tis, ypN0i-) and toxicities, recorded according to National Cancer Institute Common Toxicity Criteria. Statistical analysis was performed with T di Student test and v2 test.
Results:Overall, in the 55 evaluable pts median age was 50 (range 28-77) and 29 pts (53%) were pre-menopausal. 24 pts (45%) were ER-/PgR-, 12 (21%) ERþ/PgR-, 16 (29%) ERþ/PgRþ, median ki67 was 40. 9% of pts were cT1, 73% cT2, 13% cT3 and 5% cT4; 42 pts (76%) were cNþ. All pts received 4 cycles of T (8 mg/kg loading dose, followed by 6 mg/kg every 3 weeks) and P (loading dose 840 mg, followed by 420 mg every 3 weeks). In 42 pts TþP were administered with docetaxel (75 mg/mq every 3 weeks), in 8 pts with paclitaxel (80 mg/mq) and 5 pts received docetaxel and carbopla-tin (AUC5). In 13 pts also 3 cycles of anthracyclines, according to the FEC scheme, were administered. A pCR was achieved in 29 pts (53%). No significant associations were found between pCR and baseline characteristics or treatments schedule. Seven out of 55 (13%) pts reported G3-G4 toxicities (5 pts neutropenia G3-G4, 1 pt vomiting G3, 1 pt diarrhoea G3, 1 pt anemia G3). Three out of 4 pts treated with docetaxel, carbopla-tin and PþT reported G3/G4 toxicities. A significant association was found between chemotherapy schedule and toxicities (p¼ 0.004).
Conclusions:The association of PþTþchemotherapy improved pCR rate in HER2þ BC pts treated in the real-life setting. Our results showed that the selection of chemo-therapy that will be associated with the dual blockade of HER2 is of paramount impor-tance in order to avoid severe toxicities and increase the compliance with treatment. Legal entity responsible for the study:Department of Oncology, Belcolle Hospital. Funding:Has not received any funding.
Disclosure:All authors have declared no conflicts of interest.
208P Real-world comparison of the impact of adjuvant capecitabine in women with high-risk triple-negative breast cancer after neoadjuvant chemotherapy M.T.S. Vilbert1 , M.P. Corassa2 , R.R. Saleh3 , R.L. Coelho2 , M.R.D.J. Teixeira1 , E. Amir3 1
Clinical Oncology, A. C. Camargo Cancer Center, Sao Paulo, Brazil,2
Medical Oncology, A. C. Camargo Cancer Center, Sao Paulo, Brazil,3
Medical Oncology and Hematology, Princess Margaret Cancer Center, Toronto, ON, Canada
Background: Adjuvant capecitabine (adjC) is recommended for patients with triple-negative breast cancer (TNBC) and poor response to neoadjuvant chemotherapy. Despite evidence of benefit, this therapy is not available in situations of limited resour-ces, such as in the Brazilian public health system.
Methods: A retrospective observational cohort study was conducted in Princess Margaret (PM) Cancer Centre in Toronto, Canada, and in A.C.Camargo Cancer Center (AC) in S~ao Paulo, Brazil. Patients with TNBC who had completed neoadjuvant chemotherapy (taxane and/or anthracycline) followed by surgery, with a high residual cancer burden (RCB-II or RCB-III) and received at least 1 cycle of adjC in PM or had active surveillance (AS) in AC were evaluated. A descriptive comparison was made between PM and AC. Recurrence free survival (RFS), overall survival (OS), and safety profile were explored descriptively. Chi-Square test and Mann-Whitney test were used to assess categorical and continuous variables data, while Kaplan-Meier survival and Cox-regression were used for time-to-event analyses.
Results: From 06/17 to 03/19, 21 patients received adjC in PM and from 04/02 to 03/19, 70 patients had AS in AC. Starting dose of capecitabine was 1000 mg/m2bid. Seven
patients (43.8%) completed 8 cycles, two (12.5%) received 6 cycles and for the remain-ing patients therapy is ongoremain-ing. The median follow-up was 23 months (range 1.9-36
months). At PM 76.2% of the patients were free from recurrence or death and 81% were alive at 3 years. The mean RFS was better in the adjC group (mean 30.8 months vs 20.0 months HR: 0.23; p¼ 0.045). Mean OS was 29 months in adjC group vs 28 months in AS (HR: 1.48; p¼ 0.610). Common adverse events were hand-foot syndrome, fatigue, diarrhea, nausea and anemia. Dose reduction, delay to next chemotherapy cycle or discontinuance of treatment were necessary in 13 (61.9%) patients.
Conclusions: Outcome of patients receiving adjC at PM was better than those on AS in AC, suggesting benefit from this treatment in a real-world setting. AdjC is an inexpensive, widely available and well tolerated oral chemotherapy and should be considered an option for improvement of care even in public health systems of less developed countries. Legal entity responsible for the study: The authors.
Funding: This work has been supported by a UICC Technical Fellowship. Disclosure:E. Amir: Speaker Bureau / Expert testimony: Genentech/Roche; Advisory / Consultancy: Apobiologix; Advisory / Consultancy: Agendia; Advisory / Consultancy: Myriad Genetics. All other authors have declared no conflicts of interest.
209P Influence of age on the indication of adjuvant chemotherapy in early breast cancer using Oncotype DX. An analysis of 240 patients treated in the Institut Catala d’Oncologia (ICO) hospitals
S. Recalde1 , V. Quiroga2 , S. del Barco3 , C. Falo1 , J. Dorca3 , M. Margeli4 , A. Stradella1 , T. Soler5 , I. Teruel Garcıa6 , G. Vi~nas7 , A. Fernandez1 , R. Villanueva Vazquez8 , A. Vethencourt1 , M. Romeo Marin9 , M. Gil-Gil1 1
Medical Oncology, ICO - Institut Catala d’Oncologia Hospital Duran i Reynals, Hospitalet De Llobregat, Barcelona, Spain,2
Department of Oncology, Catalan Institute of Oncology, Badalona, Spain,3
Medical Oncology, ICO Girona, Girona, Spain,4
Medical Oncology, Institut Catala d’Oncologia-Hospital Germans Trias i Pujol, Badalona, Spain,
5
Pathology, Hospital de Bellvitge, Hospitalet De Llobregat, Barcelona, Spain,6
Medical Oncology, Institut Catala d’Oncologia (ICO), Barcelona, Spain,7
Medical Oncology Department, Catalan Institute of Oncology (ICO) and Girona Biomedical Research Institute, Girona, Spain,8
Medical Oncology, Institut Catala d’Oncologia-Hospital Duran i Reynals, Barcelona, Spain,9
Medical Oncology department, Catalan Institute of Oncology (ICO Badalona), Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain Background: Benefit derived from adjuvant chemotherapy (CT) is doubtful in a high percentage of patients (pt) with hormone-receptor–positive HER2 negative early breast cancer. The 21-gene recurrence-score (RS) assay Oncotype DX, provide prognostic and predictive information. Results of the TAYLORx study have confirmed that most of patients with negative node status and RS > 25 can avoid CT without increasing their risk of relapse. However, pt < 50 years (y) and RS > 20 showed benefit with CT. Methods: Aim: To analyse the impact of age using RS test to change the indication of adjuvant CT and the relationship between different clinical pathological factors and the RS value. We analysed 240 cases out of 251 RS test performed in the 3 ICO Centers dur-ing 2017-2018. We compared the adjuvant treatment initially planned accorddur-ing to institutional protocol with the treatment given after RS in the total cohort and in pt < 50 y. We performed a logistical regression analysis of pathological factors and RS. Results: CT was indicated in all pt before knowing the RS results. Only 46 pt (19%) received CT after RS results. 14 out of 88 pt < 50 y received adjuvant CT (15%). 15 pt <50 y had a RS between 21-25, only 5 of them received CT, because in most of them, the RS was performed prior TAILORx results were published. Nowadays, all of these 15 pt would had received CT: 61/240 (25%). Clinical-pathological characteristics of the series are summarized in the Table. Of the risk factors analysed, only Ki67>25 (<0.001) and PR 20% (0.01) showed a statistically significant relationship with a higher probability of RS > 25 in a multivariate analysis.
Table: 209P
Age median (range) 53 (19-76)
<50 y 35.1% 50 y 64.9%
Tumor size median 15 mm
Histological grade G1 23% G2 69.7% G3 4.4% Progesterone receptor 20% 21% >20% 78% Ki67 median (p25-75) 20 (13,28) 14 27% 14-25 41% >25% 31% Nodal status pN0 57% pN1mic 15% pN1a 27%
