ZEMY, a new software medical device, was developed to improve symptom management and enhance patient and healthcare providers (HCP) interactions. Despite an encouraging connection rate, feasibility has not been demonstrated elsewhere. We report here users and HCP satisfaction and usability. Adult women with breast cancer initiating oral and/or parenteral cancer treatment received a smartphone with ZEMY installed and verbal training. Patients started cancer treatment on Day 1 and were followed for three months. The software made recommendations to patients on the self-management of nine pre-specified symptoms and transmitted automatic messages to HCP, afterwards the relevance of these messages was collected. Global satisfaction and usability were assessed using a 0–10 visual analogue scale and 10 statements. Quality of Life (QoL) was assessed with EQ-5D-5L, EORTC QLQ-C30 and EORTC QLQ-BR23. 54 patients were enrolled in five French sites (June 2018 to January 2019) and 52 (96.3%) completed the study. Verbal training was time consuming for HCP with a median duration of 45min (IQR 30;60). ZEMY patient recommendations and health care team automatic messages were considered relevant for five of the six most reported symptoms (diarrhea, nausea, fatigue, cutaneous and mucosal toxicities, and anxiety/depression). ZEMY satisfaction score was higher and more heterogeneous for patients (median: 7; IQR: 5; 9) than HCP (median: 4; IQR: 4; 5). For all of the 10 usability statements, patients had a more favorable opinion compared to HCP. Regarding QoL, a generally good state of health was observed at enrolment, and the state remains broadly stable until Week 12. Zemy recommendations were considered relevant and patients had a better satisfaction and user experience than HCP despite an unproven feasibility. These results suggest that such e-Health system can be useful for patients monitoring only if it does not interfere excessively the daily work of HCP.

ZEMY is an e-health system that gathers data from a smartphone application companion and a web platform that supports clinician for telemedicine or face-to-face visits. ZEMY has been developed to improve symptom management and enhance patient and healthcare providers (HCP) interactions. We report here feasibility and devices deficiencies (DD). This was a three-month single arm study conducted at five French sites. Adult women with breast cancer initiating oral and/or parenteral cancer treatment received a smartphone with ZEMY installed and verbal training. Patients started cancer treatment on Day 1 and were followed for three months. The ZEMY software made recommendations to patients on the self-management of ten pre-specified symptoms and transmitted automatic messages to HCP. Primary outcome was patient feasibility response at 3 months using a composite endpoint assessing frequency and quality of patients’ connections. Secondary endpoints were description of Symptom Reported Connections (SRC) and DD. 54 patients were enrolled in the study. 31 patients (57.4%) were responders, not significantly higher than the predefined cut-off of 50% (lower limit of the one-sided 95% CI: 45.3%), despite high response rates of its components: ≥3 completed SRC (87.0%); completed SRC ≥60% (66.0%). 3815 SRC were reported by patients, 2979 automatic recommendations were sent back (mostly related to fatigue, pain, anxiety/depression) and 615 (20.6%) led to a message sent to HCP. 95 DD were reported in 37/54 patients (68.5%). Main reasons were inappropriate recommendations (n=51) and device malfunction (n=36). No adverse device effects were reported. The proof of feasibility of ZEMY was not demonstrated instead of an encouraging rate of its two components and a high number of SRC and recommendations. Feasibility of an e-health system is difficult to anticipate in a formally statistical test due to uncertainty of predefined hypothesis. The DD observed indicates the need for user support.

Olaparib was initially approved by the European Medicines Agency (EMA) as maintenance treatment for pts with BRCAm platinum-sensitive relapsed high-grade EOC, following the results of a randomized phase II trial (study 19). The RETROLA study aimed to evaluate whether the outcome observed in this clinical trial are reflected in routine clinical practice, in a real-world cohort of pts. We planned to include 130 pts in this retrospective cohort. French centers (n=28) representative of French regions and of mode of practice were asked to participate. Overall, 251 pts were identified. At each center, up to 6 pts who started olaparib (400 mg bid, capsule formulation) between 03/2014 and 03/2017 were randomly selected and included. Medical records were reviewed for clinic and pathologic characteristics, survival outcomes and safety. Our primary objective was to assess efficacy of olaparib in real-world pts treated upon initial EMA label (ptsEMA) by evaluating progression free survival (PFS) from olaparib initiation. Overall, 128 pts were included in the analysis and 89 were treated according to EMA label. Main reasons to be given olaparib off-label were absence of radiological response following platinum-based chemotherapy (n=22) and non high-grade serous EOC subtype (n=14). BRCA1/2 mutation was present in 126 pts (98%). Most pts (68%) received olaparib after 3 or more lines of platinum-based chemotherapy. Median follow up was 41.8 months. Median PFS in ptsEMA was 17.0 months (95% CI: 14.7-21.3). Median PFS and overall survival (OS) in the whole population were 15.5 months (95% CI: 12.6-18.1) and 33.6 months (95% CI: 28.7; 40.3), respectively. Fourteen (11.2%) pts stopped olaparib for toxicity reason and 75 (58.6%) had at least one dose reduction or one dose interruption. Related myelodysplastic syndrome and second cancers were diagnosed in respectively n=5 and n=1 pts. Number of previous lines of systemic therapy ≤2 was associated with prolonged PFS. With an extended follow-up, efficacy and toxicity of olaparib in real-world cohort of pts are consistent with findings observed in study 19 and SOLO-2 trials.

PURPOSE:The LORHA study described the clinical features of patients and tumours in long-term responders from a subset of breast cancer patients who responded to 1st-line trastuzumab and without disease progression. METHODS:This was an ambispective, multicentre, non-interventional study conducted in 57 centres in France. Eligible patients were women with HER2+metastatic or locally-advanced breast cancer, treated with 1st-line therapy, progression-free for ≥3 years after starting trastuzumab, and followed-up for 12 months. RESULTS:160 patients were recruited, 128 were included in the efficacy analysis subset (median age: 61 years; [34-95 years]). A majority (88%) had invasive ductal carcinoma; 53% had SBR grade III carcinoma, and 58% were positive for hormonal receptors. The median time since diagnosis was 8 years [3-26 years]. The most frequent metastatic sites were the bone, liver, lymph nodes, and lungs in 43%, 35%, 20% and 19% of patients, respectively. The median duration of 1st-line trastuzumab was 4.5 years [0.8-12.1], combined with paclitaxel and docetaxel in 35 and 72 patients, respectively. Median PFS (progression-free survival) was 6.4 years [5.7; Not Reached]. No trastuzumab-related deaths were observed. In the safety analysis subset (N = 134), 3 cardiac adverse events considered related to trastuzumab were recorded in 3 patients (2.2%), and only one prospective congestive cardiac failure was of grade ≥3. CONCLUSIONS:The LORHA study showed that long term responders to 1st-line trastuzumab for locally advanced or metastatic breast cancer could achieve a median PFS of more than 6 years, with an acceptable safety profile.

Depuis plus de 10 ans, le traitement du cancer du sein métastatique (CSm) HER2 positif en 1re ligne est basé sur l’utilisation du trastuzumab (T) associé à un taxane. Dans plusieurs études, il a été observé qu’un sous-groupe de patientes (Ptes) n’avait pas progressé après une 1re ligne de traitement par T [1], [2]. Afin d’identifier cette population, l’étude LORHA a été réalisée.

Le trastuzumab (Herceptin®) est un composant clé du traitement standard des patientes (pts) avec cancer du sein (CS) précoce HER2 positif [1] et est autorisé en administration intraveineuse (IV). La dose de charge initiale (8 mg/kg) est administrée en IV en 90 minutes, suivie par des doses d’entretien de 6 mg/kg/3 sem en 30 minutes. Une nouvelle formulation sous-cutanée (SC) de trastuzumab, avec une dose fixe de 600 mg et pour excipient une hyaluronidase recombinante humaine (rHuPH20), a été développée comme alternative au traitement IV. Cette formulation SC permet une administration rapide (< 5 minutes) améliorant potentiellement la praticabilité et la compliance du traitement.

Abstract Background: A subset of patients with HER2-positive metastatic (mBC) or locally advanced breast cancer (aBC) respond to 1st line trastuzumab-based regimen and have no disease progression for several years. These long-term responders were evaluated in daily practice in the LORHA study. Patients and disease characteristics were presented earlier (ESMO 2012). Material and Methods: Lorha is an ambispective, multicenter, non-interventional study conducted in 57 centers in France. Eligible patients were women aged more than 18 years with HER2-positive mBC or aBC treated with 1st line trastuzumab and progression-free for at least 3 years after starting trastuzumab. The primary objective was to describe clinical and tumor characteristics. Secondary objectives included Progression Free Survival (PFS), Overall Survival (OS), treatment administration and safety. Patients were followed-up for 12 months. Final results are presented here. Results: Overall 160 patients were enrolled; 128 were eligible for efficacy analysis and 154 for safety analysis. Median age was 61 years [34-95]. Tumor characteristics were: invasive ductal carcinoma for 112 patients (88%), positive hormonal receptors in 72 patients (58%). At initial diagnosis, 91 patients (71%) had stage I - II tumors and 37 patients (29%) had de novo mBC or aBC. The main metastatic localizations were bone, liver, lymph nodes and lung in 54 (43%), 44 (35%), 25 (20%) and 24 (19%) patients, respectively. Median 1st line trastuzumab treatment duration was 4.5 years [0.8 - 12.1]. Trastuzumab 1st line was associated with a taxane-based chemotherapy in 104/128 patients (81%). Median PFS was 6.4 years [5.7; - Not reached] and median overall survival was not reached. At 1-year follow-up, 23 deaths (15% of patients) were reported, mainly due to disease progression (21 patients - 91%). No toxic death related to trastuzumab was observed. Grade 3-4 adverse events reported prospectively occurred in 14 patients (10%) and included two patients (1.2%) with grade 3-4 cardiac events related to trastuzumab (congestive cardiac failure and left ventricular dysfunction), both events resolved, one with sequelae. Conclusions: Final results of the LORHA study show that long responding patients receiving first-line trastuzumab-based treatment for aBC or mBC in daily practice, can reach a median PFS of more than 6 years, combined with an acceptable safety profile. Median overall survival is still not reached. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-16-08.

ABSTRACT Background For more than ten years, treatment of HER2-positive mBC patients (Pts) is based on T plus taxane in 1st line therapy. So far, in numerous studies, we have observed few subsets of Pts (long-term responders) who have not experienced disease progression for several years after T-based regimen in 1st line treatment. This study aims to characterise these Pts in the daily practice from a clinical and biological perspective. Material and methods This is an ambispective French multicentre non-interventional study. Eligible Pts were women aged ≥18 years with HER2-positive mBC or aBC treated with T as 1st line and who were progression-free for at least 3 years after starting T. The primary objective was to describe the clinical and tumor characteristics of these Pts. Progression Free Survival (PFS), Overall Survival (OS), data on treatment administration and safety were also collected. An exploratory biomarkers analysis is planned on tumor tissue samples. Here we present some preliminary results based on the interim analysis performed at the end of inclusions. Results 159 Pts were enrolled in 2011 and 110 Pts were eligible for data analysis. Median age was 59 years [34-95]. Tumor characteristics were: invasive ductal carcinoma for 96 Pts (88%), positive hormonal receptors in 63 Pts (58%). At initial diagnosis, presenting stages were I-II for 52 Pts (50%). 36 Pts (33%) had a mBC de novo or an aBC. The main metastatic localisations were bone, liver and lung in 51 (47%), 35 (32%) and 22 (20%) Pts respectively. Median T treatment duration was 4.1 years [0.8 - 11.0] in 1st line. T was associated with a taxane-based chemotherapy in 86 Pts (78%). Median PFS was 6.4 years [4.9; - ]. Median OS was not reached. 13 retrospective adverse events related to T (cardiac or leading to discontinuation) were reported. None of these was serious. Conclusions In this long PFS population treated with a T-based treatment in first line for aBC or mBC Pts, no specific profile in terms of clinical or histological characteristics have been observed. Thus, the exploratory biomarkers analysis will be useful to identify such a profile. Disclosure O. Tredan: Roche consultant. P. Beuzeboc: Roche consultant. D. Coeffic: Roche consultant. M. Fellous: Roche employee. L. Arnould: Roche Consultant. All other authors have declared no conflicts of interest.

CA-125 as a tumour progression criterion in relapsing ovarian cancer (ROC) trials remains controversial. CALYPSO is a large randomised trial incorporating CA-125 (GCIG criteria) and symptomatic deterioration in addition to Response Evaluation Criteria in Solid Tumours (RECIST) criteria (radiological) to determine progression. In all, 976 patients with platinum-sensitive ROC were randomised to carboplatin–paclitaxel (C-P) or carboplatin-pegylated liposomal doxorubicin (C-PLD). CT-scan and CA-125 were performed every 3 months until progression. In all, 832 patients (85%) progressed, with 60% experiencing a first radiological progression, 10% symptomatic progression, and 28% CA-125 progression without evidence of radiological or symptomatic progression. The benefit of C-PLD vs C-P in progression-free survival was not influenced by type of first progression (hazard ratio 0.85 (95% confidence interval (CI): 0.66–1.10) and 0.84 (95% CI: 0.72–0.98) for CA-125 and RECIST, respectively). In patients with CA-125 first progression who subsequently progressed radiologically, a delay of 2.3 months was observed between the two progression types. After CA-125 first progression, median time to new treatment was 2.0 months. In all, 81%of the patients with CA-125 or radiological first progression and 60% with symptomatic first progression received subsequent treatment. CA-125 and radiological tests performed similarly in determining progression with C-PLD or C-P. Additional follow-up with CA-125 measurements was not associated with overtreatment.

TPS646 Background: For patients with early HER2+ breast cancer at diagnosis, addition of trastuzumab (T) to 6 cycles of preoperative docetaxel (D) can reach a pathological complete response (pCR) in ~50% of cases, and a high rate of conservative surgery. pCR can be predicted by changes of Fluorodeoxyglucose (FDG) tumor uptake evaluated by Positon Emission Tomography (PET) after one cycle of therapy. In order to increase this pCR rate, adding an antiangiogenic compound could be considered. Pre-clinical and phase I-II data support that the combination of bevacizumab (B) and T is synergistic and safe when patients are chemotherapy naïve. The neoadjuvant AVATAXHER trial (EUDRACT 2009-013410-26) investigates the potential increase of pCR rate by combining B with T and D for patients with HER2+ breast cancer who are not predicted for pCR by FDG PET. Methods: In this multicenter, open-label, phase II trial, 2 phases are planned after a selection period: phase I: all patients receive two cycles of therapy combining T (8 mg/kg at the first cycle, then 6 mg/kg) and D (100 mg/m2). FDG PET is also performed within 7 days before cycle 1 (baseline) and less than 3 days before cycle 2 in order to calculate changes of the tumor FDG uptake between baseline and after cycle 1 (ΔSUV). Phase 2: if ΔSUV≥70%, patients will continue to receive T and D for (cycles 3 to 6: D 100 mg/m2 + T 6 mg/kg); if ΔSUV<70%, patients are randomized 2:1 to arm A (cycles 3 to 6 D 100 mg/m2 + T 6 mg/kg + B 15 mg/kg) or arm B ( cycles 3 to 6: D 100 mg/m2 + T 6 mg/kg). The primary endpoint is pCR rate evaluated post-surgery 4 to 6 weeks after the last treatment of cycle 6. Enrolment began in May 2010 and 125 patients were to be recruited in 26 sites. According to the hypothesis that 60% of patients will have a ΔSUV<70%, it is presumed that 72 patients will be randomized. There are currently 107 patients included (as of 06 January 2012 ), 95 of them reached the phase 1; 52 of them (55%) showed a ΔSUV<70% and after randomization 34 were included in arm A and 18 in arm B.

BACKGROUND:Very effective trastuzumab-based primary systemic therapy (PST) can be proposed for conservative surgery purpose to human epidermal growth factor receptor 2 (HER2)-positive breast cancer (HER2+BC). Long-term follow-up (LTFU) warrants further data.PATIENTS AND METHODS:LTFU of patients, with stage II/III HER2+BC, treated by trastuzumab associated with docetaxel (Taxotere(®)) and/or carboplatin used as anthracycline-free PST was studied.RESULTS:Among 135 patients, with a median follow-up of 48.3 months [95% confidence interval (CI) 45.3-52.4 months], the relapse-free survival (RFS) rate was 73.2% (95% CI 63.76% to 80.55%) while the overall survival (OS) rate was 91.87% (95% CI 84.23% to 95.90%). Adjuvant trastuzumab favorably influenced RFS in univariate analysis while the pathological nodal invasion unfavorably influenced RFS [Cox multivariate analysis (hazard ratio = 2.80, 95% CI 1.36-5.76, P = 0.0052)] and OS. Cardiac toxicity was minor (2.2% transient, reversible asymptomatic decrease in left ventricular ejection fraction).CONCLUSION:This is the first report of LTFU showing that anthracycline-free trastuzumab-based PST combined either with docetaxel and/or carboplatin can achieve, without cardiac toxicity, very competitive results in terms of pathological complete response, RFS and OS, in HER2+BC. The choice of this schedule could be proposed to patients with vascular contraindication for anthracyclines or because patient's or physician's preference for a taxane-only schedule.

e15509 Background: There is some evidence that BEV, an anti-VEGF monoclonal antibody, is active on OC. The goal of this study was to assess the combination of BEV and chemotherapy in heavily pretreated OC patients (pts) with regard to efficacy and toxicity. Methods: In this retrospective multicentric analysis, heavily pretreated OC pts receiving BEV with chemotherapy were assessed for efficacy with CA125 measurement and CT-scans. Toxicity was assessed according to NCI-CTC V3.0. Results: 43 pts from six oncologic centers were identified and included. The median number of prior chemotherapy regimen was 3 (range 1-13). BEV was combined with paclitaxel in 30 pts (69.7%), docetaxel in 9 (20.9%), and other agents in 4 (9.3%). The median number of treatment cycles was 6 (range 1-29). No toxic death was reported. Grade 3-4 toxic events occurred in 13 (30.2%) pts, including proteinuria, elevated blood pressure, hemorrhage, pelvic abscess and psychiatric disorders. Gastrointestinal perforations (GIP) and fistulas occurred in 3 (7.0%) and 6 (13.9%) pts, respectively. GIP occurred in 7% versus 0% of pts who received 4-7 and 2 prior regimens, respectively. Only 1 (2.3%) patient had venous thrombo-embolic event, whereas no arterial embolic complication was reported. The clinical benefit defined as complete (CR) and partial (PR) responses plus stable disease ≥ 3 months was 65%. The objective response rate was 40%, including 6 (15%) CR and 10 (25%) PR. Median time to progression was 3.8 months (range 0.2 -14.4 months). At last follow-up (Dec. 09), 13 pts (30.2%) were still on BEV treatment, and 31 (72%) were alive. Conclusions: The combination of chemotherapy and BEV in routine practice is feasible and active in heavily pretreated OC pts. Toxicity is manageable, but GIP and fistulas are of concern. Further studies are warranted to assess BEV plus taxanes in advanced OC. No significant financial relationships to disclose.

e11507 Background: Almost 20% of breast cancers over express Her2, which is associated with a more aggressive phenotype and with a decreased survival. Nevertheless, trastuzumab (T) has been a revolutionary step in the adjuvant and in the metastatic treatments of Her2 positive breast cancers. Here, we focus on neoadjuvant T and try to determine the factors correlating with disease free survival and with overall survival in Her2 positive breast cancer treated with T based neoadjuvant chemotherapy. Methods: Data from two published T based neoadjuvant phases II were used: the TAX-HER trial which studied the use of 6 courses of 3 weekly docetaxel with weekly neoadjuvant T (scheme TH) (Coudert et. al. Annals of Oncology 2006) and the GET(N)A-1 trial which studied the use of 6 courses of 3 weekly docetaxel and carboplatin along with weekly neoadjuvant T (scheme TCH) followed by 3 weekly adjuvant T (Coudert et. al. JCO 2007). Moreover, additional patients from our institution and treated by neoadjuvant TH and adjuvant T were included. Survival curves were estimated using Kaplan-Meier methods and compared by log-rank test. Results: Data was available for 128 patients. 62 patients (48.4%) received neoadjuvant TH from whom 39 did not receive adjuvant T. 66 (51.6%) received neoadjuvant TCH and adjuvant T. Tumors characteristics were as followed: 65 (50.7%) SBR 1–2, 54 (42.19%) SBR 3, 49 (38.28%) hormonal receptors (RH) negative and 72 (56.25%) RH positive. The rate of pathological complete response (pCR) (Chevalier 1/2) was 39.6%. Overall survival (OS) for the entire cohort was 74,8 months. Relapse was defined as local, regional, metastatic relapse or death. Survival without relapse (SR) was 74.8 months. No difference was noted in OS and in SR according to the type of chemotherapy, TH or TCH. pCR did significantly influence SR (p = 0. 03) and survival without local recurrence (SLR) (p = 0.04) but neither OS nor survival without metastatic relapse (SMR). Multivariate analysis demonstrated that OS was correlated with node response (as defined by sataloff grade NA or NB) (p=0.0275) and the use of hormonal therapy in RH positive tumors (p=0.0724). [Table: see text]

e20566 Background: Homeopathy used as an adjunct in the treatment of chemotherapy (CT)-induced emesis has rarely been evaluated. Methods: Patients with non-metastatic breast cancer treated with 6 courses of FAC 50, FEC 100 or TAC chemotherapy were randomized to Cocculus/nux vomica/tabacum/petroleum extract (Cocculine, C) or Placebo (P) in a multicentric comparative double-blind phase III study. Anti-emetic treatment was standardized (corticoids + ondansetron). Patients were evaluated after each course. The primary endpoint was nausea measured after the 1st CT course using the FLIE (Functional Living Index for Emesis) with 5-day recall. The planned sample size was 396 evaluable patients based on a minimum expected difference in mean of 0.5 ± 1.6 on a scale from 1 (a lot) to 7 (not at all) with 5% two-sided α error and 85% power. An intent-to-treat analysis was planned. Secondary evaluation criteria were: vomiting measured by the FLIE score, patient self-evaluation (EVA) and investigator recording (NCI-CTC) of nausea and vomiting intensities, and compliance. Results: From September 05 to January 08, 431 patients were randomized (217 to P and 214 to C). Patient characteristics were well balanced between groups. Median age was 53 years, 35% of the patients experienced nausea or vomiting. In total, 403 patients (93.5%) were assessable for the primary endpoint, with few nausea episodes (FLIE nausea scores after the 1st CT course were 6.02 and 6.07 for P and C, respectively) and very good compliance (81% patients complied with the protocol). Adverse events related to nausea occurred in 51% vs. 47% of the patients treated with P and C, respectively (p = 0.48). FLIE and NCI-CTC vomiting scores were similar between the 2 arms (6.91 vs. 6.88, p = 0.47, and 20% vs. 21%, p = 0.73, for P and C, respectively). Grade II-III nausea occurred in 17.6% and 15.7% of patients receiving P and C (p = 0.62). Conclusions: No benefit of homeopathy over standard treatment was noted in this study. But surprisingly we observed lower rates of nausea and vomiting measured by patients and by investigators, than in other studies using identical chemotherapy regimens. The observation and management of emesis could modify the perception and rate of such adverse events. No significant financial relationships to disclose.

Abstract Background: Docetaxel plus capecitabine (DC) combination therapy improves both time to disease progression and overall survival over docetaxel alone in metastatic breast cancer (MBC). The aim of the ERASME-4 trials was to assess the efficacy of DC vs. docetaxel plus epirubicin (DE) combination regimens as first-line therapy for MBC.Material and Methods: Patients with MBC, previously untreated with chemotherapy were randomly assigned to receive either DC (docetaxel 75 mg/m² on day 1 and oral capecitabine 1,000 mg/m² twice daily on days 1 to 14 every 3 weeks) or DE (docetaxel 75 mg/m² and epirubicin 75 mg/m² on day 1 every 3 weeks). The primary endpoint was progression-free rate 6 months after randomization. The planned sample sizes were 106 patients (pts), based on a randomized phase II selection design. The main secondary endpoints were progression-free survival (PFS) and overall survival (OS).Results: Between June 2004 and April 2006, 68 pts were randomized. Slow accrual led to premature termination the study. Final analysis included 33 pts randomized to DC and 35 pts to DE. This sample size allowed to effectively selecting the best arm for non-progression rate with a power of 82%. Patient characteristics were well balanced between the two treatment arms, except for pleural metastasis, alkaline phosphatase and SBR III more present in DE arm or adjuvant hormonotherapy given in more DC patients. Toxicity has been mild or moderate; 62% of patients reported at least one grade 3-4 episode. Hand-foot syndrome grade 3-4 was reported for 18% of DC arm patients, vs. none in the DE arm (p=0.008).Complete/partial response rates were 20/44% in DC and 7/41% in DE (p=0.3). Six months after randomization, 75.8% (95%CI: 57.7-88.9) of pts in the DC arm vs. 65.7% (95%CI: 47.8-80.9) in the DE arm were progression-free (p=0.36). After a median follow-up of 42 months, (95%CI: 32.5-21.1), median PFS was 12 months and 7 months in the DC and DE groups, respectively (p=.004). Median OS was 27 and 37 months for DE and DC respectively (p=0.49).Conclusion: Despite our low accrual, these results show that DC combination therapy is associated with a superior progression-free rate at 6 months and a longer PFS than DE.DC provides a highly active, non-anthracycline-containing, first-line treatment option for MBC patients previously exposed to anthracycline in the adjuvant setting. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 2099.