Couplelinks is an original, professionally facilitated online intervention tailored to the unique challenges facing young women with breast cancer and their male partners. The purpose of this evaluation was to determine the feasibility and acceptability of the intervention and areas for improvement. Sixteen couples were sequentially enrolled over an 18-month period. Couples provided feedback via a treatment satisfaction survey, and post-treatment interviews with a sub-group of participants. Qualitative information was analysed for themes relevant to the program's acceptability, perceived benefits and limitations, and directions for improvement. Of the 16 couples who enrolled, six completed four modules or less, and 10 completed the entire program. Completers reported satisfaction with the program overall, as well as with the website useability and professional facilitation. Reported benefits were: enhanced communication and self-other knowledge; creation of opportunities for meaningful, cancer-related discussion; affirmation of relationship strengths; and a greater sense of closeness between partners. The main reported limitation was how program participation disrupted the couple's usual routine. Themes related to non-completion suggest that partners with particularly elevated relational or illness-related distress, or with differential levels of motivation, are less likely to finish. These findings have led to targeted improvements to the website and intervention protocol.

1065 Background: Cell culture and xenograft studies suggest a synergistic interaction between histone deacetylase inhibitors (HDACi) and topoisomerase (topo) inhibitors, as well as other DNA targeting agents. Methods: In this phase I/II study, we determined the effects of escalating doses of VPA on the clinical efficacy and tolerability of epirubicin. The phase I part was open to patients will all solid tumors. A limited phase II part at the maximum tolerated dose (MTD) of VPA enrolled 10 breast cancer patients and incorporated the breast cancer regimen FEC100 (5-fluorouracil, epirubicin, cyclophosphamide (600/100/600 mg/m2)). VPA was given on days 1–3 prior to epirubicin/FEC100 in 3-week cycles. HDAC expression, histone acetylation and topo II expression were evaluated in pre-and post-VPA peripheral blood mononuclear cells and tumor samples. Results: Fifty-four (44 in phase I and 10 in phase II) patients [median age 55 (39–78)] received VPA (mg/kg/day): 15, 30, 45, 60, 75, 90, 100, 120, 140 and 160. Tumor types included: breast (10+10), melanoma (11), lung (6), sarcoma (2), GYN (2), GI (5) and others (8). Dose-limiting toxicities included somnolence, confusion and febrile neutropenia. No exacerbation of FEC100/epirubicin-related toxicities was observed. Objective responses in the phase I part 9/41 (22%) were seen across different tumor types despite a median number of 3 (0–6) prior regimens with stable disease/minor response in 16/41 (39%). In the breast-specific phase II part, partial responses to date were seen in 4/8 (50%) and stable disease in 2/8 (25%), progression in 1/8 (12.5%), 1/8 (12.5%) patients withdrew consent. All breast cancer patients with a response/stable disease received the maximal number of seven cycles. VPA plasma concentrations correlated with VPA dose. There was a positive correlation between histone acetylation and VPA dose as well as plasma levels in PBMC and further correlated with those in tumors. Conclusion: A sequence-specific combination of VPA and FEC100 in breast cancer is highly active without exacerbation of chemotherapy-induced toxicities. A neoadjuvant phase II trial using VPA (120 mg/kg) -> FEC100 in patients with early stage breast cancer is ongoing. [Table: see text]