In patients with metastatic CRC, the FOLFOX4 regimen was superior to LV5FU2 with a higher response rate and time to disease progression. FOLFOX4 is an effective regimen even after disease progression on two previous chemotherapy regimens with fluoropyrimidines and irinotecan.

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Epithelioid Hemangioendothelioma (EH) is a rare soft-tissue tumor which may present as an isolated tumor or can spread to affect internal organs. The course of EH varies, based on the tissue of origin. This case report describes a young woman who developed cutaneous EH with concurrent intracranial disease during pregnancy. After resection, the lesions returned. Even after several courses of chemotherapy and radiotherapy, the patient developed multifocal disease including pulmonary, skeletal, and liver disease. She now exhibits stable disease after approximately 6 years of therapy with lenalidomide.

2806 Background: Current first-line immuno-chemotherapy for diffuse large B-cell lymphoma (DLBCL) is highly effective, curing 50–90% of patients, depending on staging and prognostic factors. Relapsed or refractory patients who are ineligible for transplant or who relapse after transplant generally have a poor prognosis. Aggressive salvage regimens for DLBCL are frequently intolerable and may involve hospitalization for this population of patients. Bendamustine (B) has demonstrated activity as a single-agent and in combination therapy for indolent lymphomas, however data about its activity in DLBCL and other aggressive lymphomas are limited. Based on the favorable toxicity profile and demonstrated synergy of bendamustine with rituximab (R), this study of combination BR is being conducted for subjects with relapsed or refractory DLBCL. Methods: Patients who have failed at least one prior therapy and have at least one measurable lesion were given bendamustine (120 mg/m2) on days 1 and 2, and rituximab (375 mg/m2) on day 1 for up to six 28-day cycles. A Simon two-stage design was used (a=0.1,b=0.2,P0=50%, P1=70%), in which at least 8 of the first 15 patients enrolled achieved a complete or partial response to allow the study to continue until 43 patients in the modified intent-to-treat (MITT) population are evaluable for efficacy. The MITT cohort includes enrolled patients who have received at least one response evaluation. Safety is assessed weekly, and disease status measured by the Revised Response Criteria for Malignant Lymphoma is evaluated at completion of every two cycles, the first assessment at approximately eight weeks after enrollment. Results: Enrollment in the trial is ongoing, with 43 subjects enrolled currently. These patients have a median age of 74 (range 54–90), ECOG status at baseline of 0 (n=18, 42%), 1 (n=23, 53%), and 2 (n=2, 5%), baseline R-IPI score very good/good (n=13, 30%) and poor (n=30, 70%) and have been administered a sum of 130 cycles, with a median of 3 cycles per subject. Efficacy data from 33 evaluable subjects to date (MITT population) demonstrate an ORR of 51.6% (CR: n=5, 15.2%; PR: n=12, 36.4%), with SD (n=7, 21.2%) and PD (n=9, 27.2%). Four patients are considered non-evaluable due to removal from the study prior to the first efficacy evaluation (three withdrew consent prior to cycle 1 and one progressed during cycle 1); four patients have yet to complete their first efficacy evaluations. Grade 3/4 treatment-related AEs include neutropenia (10), anemia (4), thrombocytopenia (4), leukopenia (3), hepatic failure (1), disseminated herpes zoster (1), diarrhea (1), elevated liver functions (1), mucositis (1), dehydration (1), anorexia (1), and weight loss (1). Grade 1/2 AEs have been consistent with treatment and anticipated co-morbidities of the DLBCL patient population. Conclusions: Data from our ongoing trial suggest that BR may have a role in the treatment of relapsed/refractory DLBCL, particularly for older patients who are not candidates for transplant and who may not tolerate aggressive therapy associated with higher toxicity. Disclosures: No relevant conflicts of interest to declare.

BackgroundLapatinib in combination with capecitabine is approved for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress the human epidermal growth factor receptor 2 (HER2) and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. Based on our phase I trial, we conducted a single arm, multicenter phase II study of lapatinib in combination with vinorelbine.Patient and methodsWomen with HER2-positive advanced breast cancer, who had received up to one prior regimen for metastatic disease, were eligible. Prior trastuzumab was allowed. Patients received daily lapatinib 1500 mg orally and vinorelbine 20 mg/m2 intravenously on days 1, 8 and 15 of a 28-day cycle. The primary endpoint was overall response rate (ORR).ResultsForty-four patients received the combination treatment, including 48% as second-line therapy. The ORR was 41% (95% confidence interval [CI] 26–55%), including 9% with a complete response. Median progression-free survival was 24.1 weeks (95% CI 17–37 weeks) and median duration of response was 32 weeks (95% CI 18–42 weeks). Nearly 80% of patients did not require a dose reduction in lapatinib, although most patients required one dose reduction of vinorelbine secondary to neutropenia. The most common toxicities were grade 1 and 2 diarrhea, nausea, fatigue and rash, and grade 3 and 4 neutropenia. One case of grade 3 asymptomatic decreased left ventricular ejection fraction event was reported.ConclusionThe combination of lapatinib and vinorelbine was active, feasible and well tolerated in patients with HER2-positive advanced breast cancer.Electronic supplementary materialThe online version of this article (doi:10.1186/2193-1801-3-108) contains supplementary material, which is available to authorized users.

621 Background: Lapatinib (L), an inhibitor of epidermal growth factor receptor and human epidermal growth factor receptor 2 (HER2) is approved in combination with capecitabine for second-line treatment of HER2+ metastatic breast cancer (MBC). Vinorelbine (V)is a semi-synthetic vinca alkaloid approved for use in patients (pts) with MBC. A previous phase I trial provided a maximum tolerated dose of L plus V. Methods: This was a multicenter, phase II study (LPT111110; NCT00709618) to evaluate the efficacy and safety of L plus V in women with histologically confirmed stage IV HER2+ MBC, ≤1 prior chemotherapeutic regimen (no prior L or V was allowed; prior trastuzumab was permitted) and a Zubrod performance status of 0-2. Pts received L (1500 mg daily) plus V (20 mg/m2IV on Days 1, 8, 15) in a 4-week treatment cycle until disease progression or study withdrawal. Primary endpoint: overall response rate (ORR). Secondary endpoints: progression-free survival (PFS), overall survival, time to response (TTR), duration of response (DOR), time to progression, and safety assessments. Results: The study was terminated after three years due to slow enrollment; 60 pts were planned and 44 enrolled and were treated. The ORR was 41% (95% CI: 26.4%-55.4%; 4 complete responses, 14 partial responses). Investigator-assessed median (95% CI) PFS, TTR, and DOR were 24.1 (16.9-36.7), 7.5 (7.1–8.1), and 32.0 (18.0-42.3) weeks, respectively. Survival data are not available since data collection was terminated after discontinuation of study treatment. All pts experienced at least 1 adverse event (AE). Conclusions: The combination of L plus V resulted in a 41% ORR and was generally well tolerated. However, definitive conclusions could not be drawn as the study was terminated early and not powered for inference testing. Further exploration of L plus V is warranted to clearly define the role of this novel combination in the treatment of HER2+ MBC. Clinical trial information: NCT00709618. [Table: see text]