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This trial shows that FEC with epirubicin at 100 mg/m2 can be administered for repeated cycles without bone marrow support with increased, though acceptable, toxicity and with a significant increase of antitumor effect (especially in visceral and/or high-burden disease), but no increased survival.

LV and LG seem to be active combinations in patients with HER2(+) MBC after taxane failure. The overall toxicity was manageable in all regimens.

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Background: Lapatinib-Capecitabine (LC) is approved for the treatment of advanced or metastatic breast cancer (MBC) whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane (T), and trastuzumab (H). LACOG 0801 evaluated different L-based chemotherapies as first and second-line treatments in MBC. Methods: This is a randomized, open label, multicenter, phase II trial of L 1250 mg BID given continuously in combination with C 2000 mg/m2 d1-14 (LC), or Vinorelbine (V) 25mg/m2 d1 and 8 (LV) or Gemcitabine (G) 1000 mg/m2 d1 and 8 (LG), in 21 days cycles. Primary endpoint was ORR (RECIST). Secondary endpoints included progression free survival (PFS), overall survival, tolerability and safety. Patients with HER2 positive MBC who had failed a T-based treatment and who had ≤1 chemotherapy regimen in the metastatic setting were included. Prior therapy with H was not mandatory. Patients were stratified by the presence of liver metastasis, previous use of H, and T administered in the neo/adjuvant or the metastatic setting. With an expected ORR of 23% in the control arm (LC), we hypothesized an absolute increase of 12% in the experimental arms using Simon's design. Results: A total of 142 pts from Argentina, Brazil and Peru were included from 2009-2012. Patient baseline characteristics were well balanced between the three arms. Median age was 51y, 58% postmenopausal, 65% ECOG 1, 49% had visceral disease (32% liver metastasis), 57% hormone receptor negative and only 47% had received prior H. Median number of administered cycles was 6 (LC = 5; LV = 7; LG = 6). ORR was 47.1% (95%CI 38.5; 67.1), 55.6% (95%CI 29.6; 60.0) and 41.3% (95%CI 43.2; 73.0) in LC, LV and LG, respectively. Median PFS was 9.1m (95%CI 6.1; 14.7), 7.0m (95%CI 5.0; 9.9) and 6.8m (95%CI 5.8; 9.9) in LC, LV and LG arms respectively. Survival data will be updated. The proportion of patients with at least one adverse event (AE) was 96% in all arms. Most common all grade AE were diarrhea (76%), hand-foot syndrome (HFS) (45%) and vomiting (39%) in LC; diarrhea (71%), neutropenia (68%) and nausea (43%) in LV; diarrhea (64%), neutropenia (60%), anemia and increased ALT both 44% in LG. The most frequent grade 3 and 4 AEs were HFS (18%), diarrhea (6%) and increased ALT/AST (4%) in LC; neutropenia (36%), diarrhea (9%) and febrile neutropenia (6%) in LV; and neutropenia (47%), ALT/AST elevation (13%) and rash (4%) in LG. Discontinuation due to toxicity occurred in 16%, 7% and 20% of patients in arms LC, LV and LG respectively. Conclusion: LV and LG seems to be active combinations in patients with HER2 positive MBC after T failure. The high ORR observed in this study might be explained, among other factors, by the inclusion of patients with less prior treatment exposure. No new safety signals where reported with these two novel Lapatinib/chemotherapy combinations. The different side effect profile may help in selecting the most appropriate regimen for a particular patient. Sponsor: Latin American Cooperative Oncology Group (LACOG) with support from GlaxoSmithKline. ClinicalTrials.gov number NCT01050322. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-12-26.

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10725 Background: To evaluate the efficacy of the Epirubicin as a part of the FEC60 AdCT in operable BrC patients in a Brazilian single-center. Methods: We verified retrospectively our experience with FEC 60 as AdCT in pre and postmenopausal, node positive and negative, pathologic stage I, II and III patients with BrC. Pts were submitted after surgery to receive Fluorouracil 600 mg/m2, Epirubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 28 days for 6 cycles. Pts who were ER+ and/or PR+ received Tamoxifen (TMX) 20 mg/day for 5 years after AdCT. Radiotherapy was also offered at the end of AdCT if indicated. All patients were evaluated in terms of 10 year (y) Disease Free Survival (DFS) and Overall Survival (OS). The most common toxicities (acute and chronic) and metastatic sites will also be reported. Results: Between July 1983 and December 1995 a total of 752 patients (ranging from 22 to 77 years old - median 47.7) were encountered and all of them were evaluated to 10 year (y) DFS and OS. Approximately 61% of these patients received adjuvant TMX. Pts in premenopausal and postmenopausal represented 62.5% and 37.5% respectively. 72 (11%) pts had pathological stage I; 353 (46%) pts had stage II and 327 (43%) had stage III. The 10y DFS was 70%, 46% and 19% for stage I, II and III respectively. The 10y OS after a minimal follow-up of 122.98 months was 74%, 48% and 20% for stage I, II and III respectively. Conclusions: Our results demonstrated that FEC 60 regimen is active and well tolerated in the adjuvant treatment for BrC pts. We had about 89% of stage II and III pts and in this population FEC60 regimen add benefit. Nevertheless, the randomized studies indicate that the greatest anticancer effect of Epirubicin requires doses ranging from 75 to 120 mg/m2, but due to economic reasons (we integrate the brazilian public healthy system) we could not offer dosages greater than 60 mg/m2. FEC 60 was feasible and offered reasonable results in our population in terms of 10y DFS and OS. No significant financial relationships to disclose.