Vici et al. Journal of Experimental & Clinical Cancer Research 2011, 30:39 http://www.jeccr.com/content/30/1/39 Table 1 Patient and tumor characteristics Characteristics Age, years Median Range Pre/Postmenopausal Median ECOGPS (range) *HR status Positive Negative Unknown HER-2 status Positive Negative Unknown Prior adjuvant chemotherapy** Prior hormonal therapy Adjuvant Advanced Disease free-interval (years) < 1 1-5 >5 Dominant disease site Viscera Bone Soft tissue Number of disease site 1 2 ≥ 3 Arm A(EV) = 54 Arm B(PLD/V) = 50 No. % No. % 63 27-70 10/44 1(0-3) 61 35-69 9/41 1(0-3) 39 13 2 20 35 10 10 30 14 40 11 3 23 23 8 72.2 24.1 3.7 37 64.8 18.5 74.0 20.4 5.6 42.6 42.6 42.6 32 15 3 21 30 11 11 28 11 32 9 9 23 18 9 64.0 30.0 6.0 42 60 22 64.0 18.0 18.0 46.0 36.0 18.0 *HR: hormonal receptor status. **not including anthracyclines or vinka alkaloids. EV: epirubicin/vinorelbine; PLD/V: pegylated liposomal doxorubicin/vinorelbine. Efficacy According to an intent to treat analysis, among 54 patients enrolled in arm A, there were 3 complete response (5.6%) and 20 partial responses (37%), for an overall response rate of 42.6% (95% CI, 29.3-55.9); disease remained stable in 19 (35.2%), and progressive disease was observed in 6 (11.1%) patients. Among 50 patients enrolled in arm B, there were 8 complete responses (16%) and 18 partial responses (36%), for an overall response rate of 52% (95% CI, 38.2-65.8); disease remained stable in 12 (24%), and disease progression occurred in 9 (18%) patients (Table 2a). Six patients of arm A and 3 patients of arm B were not evaluable for response (4 refusal, 5 lost to follow up). Objective response rates in 48 and 47 evaluable patients were 47.9% (95% CI, 33.9-61.9), and 55.3% (95% CI, 41.1-69.4) Page 4 of 8 52.0% 52.0% 55.3% 55.3% Arm B (PLD/V) (50) No. 8 18 12 9 No. 8 18 12 9 77.7 37.5 53.3 % 16.0 36.0 24.0 18.0 % 17.0 38.7 25.5 19.2 Table 2 Objective responses 2a. ITT on all enrolled patients Arm A (EV) (54) 2b. On evaluable patients Arm A (EV) (54) Arm B (PLD/V) (47) CR PR NC PD CR PR NC PD No. 3 20 19 6 No. 3 20 19 6 % 5.6 37.0 35.2 11.1 % 6.3 41.6 39.6 12.5 42.6% 42.6% 47.9% 47.9% 2c. Overall response rates according to disease sites in evaluable patients (%) Arm A (EV) (48) Arm B (PLD/V) (47) Soft tissue Bone Viscera 66.6 33.3 50. Abbreviations: EV = epirubicin, vinorelbine; PLD/V = pegylated liposomal doxorubicin/vinorelbine; ITT = intent to treat; CR = complete response; PR = partial response; NC = no change; PD = progressive disease. in the arm A and B, respectively (Table 2b). Disease con- trol (CRs + PRs + NC) was 87.5% in arm A and 80.8% in arm B, respectively. Responses according to disease sites in evaluable patients are reported in details on Table 2c, and were as follows: arm A/B, soft tissue 66.6%/77.7%; bone 33.3%/37.5%; viscera 50%/53.3%. No relevant differ- ences in response rate was observed according to hormo- nal receptor status, evidencing only a trend of higher response in receptor negative tumors in both arms (53.6% vs 45.7%, arm A; 60% and 53.1% arm B). No dif- ferences in response rates have been observed by Her-2 status in both arms, but numbers are very small: arm A Her-2 neg 54%, Her-2 pos 42.8%; arm B Her-2 neg 64%, Her-2 pos 50%. Median time to response was 2 months in both arms (range, 1 to 4 months). Median progression free survival (Figure 1) was 10.7 months in arm A (95% CI, 8.7-12.6), and 8.8 months in arm B (95% CI 7.1-10.5), median overall survival (Figure 2) was 34.6 months in arm A (95%CI, 19.5-49.8) and 24.8 months in arm B (95% CI, 15.7-33.9). Toxicity Table 3 summarizes treatment-related main toxicities. Overall, both treatment regimens were well tolerated. The dose-limiting toxicity was, as expected, myelosup- pression, with G3-4 neutropenia occurring in 18.5% and 22% of the patients of arm A and B, respectively, with