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Metronomic chemotherapy (mCHT) refers to the minimum biologically effective dose of a chemotherapy agent given as a continuous dosing regimen, with no prolonged drug-free breaks, that leads to antitumor activity. Aim of the present study is to describe the use of mCHT in a retrospective cohort of metastatic breast cancer (MBC) patients in order to collect data regarding the different types and regimens of drugs employed, their efficacy and safety. Between January 2011 and December 2016, data of 584 metastatic breast cancer patients treated with mCHT were collected. The use of VRL-based regimens increased during the time of observation (2011: 16.8% - 2016: 29.8%), as well as CTX-based ones (2011: 17.1% - 2016: 25.6%), whereas CAPE-based and MTX-based regimens remained stable. In the 1st-line setting, the highest ORR and DCR were observed for VRL-based regimens (single agent: 44% and 88%; combination: 36.7% and 82.4%, respectively). Assuming VRL-single agent as the referee treatment (median PFS: 7.2 months, 95% CI: 5.3–10.3), the longest median PFS were observed in VRL-combination regimens (9.5, 95%CI 88.8–11.3, HR = 0.72) and in CAPE-single agent (10.7, 95%CI 8.3–15.8, HR = 0.70). The VICTOR-6 study provides new data coming from the real-life setting, by adding new information regarding the use of mCHT as an option of treatment for MBC patients.

Aim: Eribulin (E) is a non taxane microtubule inhibitor indicated for treatment of MBC. To evaluate its tolerability, impact on Quality of Life (QoL) and symptoms improvement in MBC pts, from April 2012, we conducted a prospective observational study. Methods: Pts pretreated with anthracyclines (A) and taxanes (T) who have received 2 CHT lines for MBC, scheduled to be treated with E, were considered eligible. Pts completed ESAS at each cycle and FACT-B every 2 cycles. Outcome of QoL included the FACT-B total score, FACT-General (FACT-G) score and the Trial Outcome Index (TOI) score. Paired data were analyzed with non parametric Wilcoxon, McNemar and Friedman tests. Kaplan-Meier method was used for survival calculation. Results: 50 consecutive MBC pts entered the study. Median age 64 (range 31-85), 83% of pts had PS (ECOG) 0-1, 23% had triple-negative MBC, 75% ER/PgR positive and 63% HER2 positive. All pts were pretreated with A and T, 19 (76%) also with capecitabine. Median E cycles administered was 5 (range 1-17), 31% of pts received more than 6 cycles. Main side effects G2-G3 were: 42% alopecia, 38% asthenia, 15% peripheral neuropathy,16% neutropenia. At a median follow-up of 7 months (mo) (range 2-21), 17% (CI 95% 6-28) of pts achieved partial response (PR), 39% stable disease (SD) and 44% progressive disease; disease control rate (PR + SD ≥ 6 mo) occurred in 40% of pts. Median PFS is 4 mo (95% CI, 3-5); median OS is 9 mo (CI 95% 2-16); 1-yr overall survival is 49%. Items in ESAS which at baseline had score more than >5 in at least 25% of pts were anorexia, drowsy, anxiety, loss of activity and wellbeing; all these symptoms not worsened in subsequent evaluations. Data of ESAS and QoL are reported in table. ESAS and QoL assessments were adjusted for response, PS and age. Conclusions: Our results shows that treatment with E is associated with a good maintenance of QoL and ESAS scores with expected and manageable toxicities. Basal median score(range) Final median score (range) P value ESAS 30 (3-63) 28 (3-60) 0.91 FACT- B 79 (55-117) 81(45-119) 0.36 FACT-G 59 (40-88) 60 (30-93) 0.98 TOI 53 (33-78) 52 (29-78) 0.23 Disclosure: All authors have declared no conflicts of interest.

Background PST with taxanes, anthracycline-containing regimens and T showed a high percentage of pathologic complete response (pCR); T administered concurrently with chemotherapy is more effective, but the combination with anthracyclines may be at risk of cardiotoxicity. The present study evaluates efficacy and toxicity of T administered concurrently with a sequential regimen of D followed by EC in neoadjuvant setting. Materials and methods This phase II single stage trial is enrolling pts with cT2-T4, N0-2, M0, Her-2 positive (IHC 3+ or 2+ amplified) breast cancer. A core biopsy is required prior treatment start to evaluate hormonal receptors, Ki67, topoisomerase II, Her-2, with re-evaluation of these parameters, whenever possible, at definite surgery. LVEF is evaluated before and during treatment. Blood samples are collected at baseline for evaluation of 9 genetic polymorphisms related to higher risk of developing cardiac toxicity. We are quantitatively evaluating gene copy number by multiple ligand probe amplification (MLPA), PTEN, p-Akt, p-MAPK, and PIK3CA mutations. Pts receive 4 cycles of D (100mg/m2) plus T (loading dose 8mg/kg followed by 6mg/kg), followed by 4 cycles of EC (120/600mg/m2) plus T, every 3 weeks. Definite surgery is planned at the end of PST, and standard radiotherapy and hormonal adjuvant treatment in case of positive hormonal receptors are given; adjuvant T is given for 6 months. The primary objective of the trial is pCR (absence of invasive tumor cells in the breast and axilla); secondary objectives are cardiac safety, toxicity, disease-free survival. The planned sample size is 42 pts. Results To date, 29 pts have been enrolled; median age is 45 years, pre/postmenopausal 22/7, ER and/or PgR positive in 16 pts. 27 pts are evaluable for pathological response: we observed 20 pCR (74%, 95%C.I, 57.5-90.6). Grade 3-4 neutropenia was the most frequent toxicity, encountered in 75% of the pts, other toxicities were mild to moderate. No clinical cardiotoxicity was observed. Conclusions At preliminary analysis, PST with sequential administration of D followed by EC, given concurrently with T, appears to be very active and safe in stage II-III breast cancer pts. Disclosure All authors have declared no conflicts of interest.