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9043 Background: One of the most burdensome complications of advanced cancer is the development of malignant ascites, impacting quality of life (QoL), gastrointestinal function, survival, and overall management costs. Recent studies have shown that malignant effusions arise in part from increased production and activity of vascular endothelial growth factors (VEGFs). VEGFs increase vascular permeability and establish an ideal environment for accumulation of malignant effusions. Methods: A pilot trial evaluating safety and efficacy of intraperitoneal administration of bevacizumab at 5 mg/kg monthly for as long as no disease progression or unacceptable toxicities are encountered. Patients with cytologically documented malignant ascites from any primary tumor refractory to standard therapy of diuretics, repeated paracentesis, and/or intraperitoneal chemotherapy were eligible. Patients were either off systemic therapy or had not had any changes in their systemic therapy for at least 4 weeks at the time of enrollment. Results: Between July 2006 and November 2006, 9 patients with refractory malignant ascites from colon cancer (3 pts), breast cancer (3 pts), uterine cancer (2 pts) and ovarian cancer (1 pt). Prior therapy included systemic chemotherapy and large volume paracentesis. Patients with ovarian and uterine cancer also received intraperitoneal cisplatin. All patients had rapid re-accumulation within 2 weeks of paracentesis before treatment. Patients were given intraperitoneal bevacizumab at 5 mg/kg monthly. Complications included grade I nausea in one patient, grade I abdominal pain in one patient, and partial small bowel obstruction in one patient that was managed conservatively. Malignant ascites resolved without reaccumulation or repeat paracentresis in 9/9 after a single intraperitoneal dose of bevacizumab over a median observation period of over two months. No objective tumor responses were observed. QoL assessment, pharmacokinetic studies of intraperitoneal Bevacizumab and pharmacodynamic studies on serum and ascites fluid VEGF are ongoing and will be reported. Conclusions: Intraperitoneal bevacizumab is a relatively safe and highly efficacious way to palliate the symptoms of refractory malignant ascites. No significant financial relationships to disclose.

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Breast cancer in men accounts for approximately 1% of all breast cancers. Breast cancer trials have routinely excluded men. The aim of this analysis was to determine the effect of different treatment factors, in particular, postoperative radiation therapy (RT) on long-term outcomes. Methods and Materials: Seventy-one patients with male breast cancer treated in 5 closely cooperating institutions between 2003 and 2019 were analyzed. Results: Almost all patients (95%) underwent surgical resection. Forty-two patients (59%) received chemotherapy, and 59 (83%) received adjuvant hormonal therapy. Of the 71 patients, 52 (73%) were treated with RT. The rate of recurrence was 20% in the whole cohort, with a locoregional recurrence rate of 3%. In the entire group, the 5-year local control (LC) was 95%, whereas 5-year progressionfree survival (PFS) and 5-year overall survival (OS) were 62% and 96%, respectively. There was a lower rate of relapses after adjuvant RT (19% vs 32%, P Z .05) without in-field relapse after postoperative RT (0%) versus 10% in patients without RT (P Z .02). In the Sources of support: none. Research data are stored in an institutional repository and will be shared upon request to the corresponding author. Disclosures: We declare no conflict of interest.

Background: Central neurocytoma (CN) is a rare tumor accounting for <0.5% of all intracranial tumors. Surgery ± radiotherapy is the mainstay treatment. This international multicentric study aims to evaluate the outcomes of CNs patients after multimodal therapies and identify predictive factors. Patients and methods: We retrospectively identified 33 patients with CN treated between 2005 and 2019. Treatment characteristics and outcomes were assessed. Results: All patients with CN underwent surgical resection. Radiotherapy was delivered in 19 patients. The median radiation dose was 54 Gy (range, 50–60 Gy). The median follow-up time was 56 months. The 5-year OS and 5-year PFS were 90% and 76%, respectively. Patients who received radiotherapy had a significantly longer PFS than patients without RT (p = 0.004) and a trend towards longer OS. In addition, complete response after treatments was associated with longer PFS (p = 0.07). Conclusions: Using RT seems to be associated with longer survival rates with an acceptable toxicity profile.

Intracavitary MRI PDR-IGBT boost after CRT is a feasible, tolerable, and effective treatment modality for patients with stages IB2 and II cervical cancer.

Objective: Although local definitive radiotherapy (RT) is considered the standard of care for solitary plasmacytoma (SP), the optimal RT parameters for SP patients have not been defined. The aim of this retrospective study is to analyze the effectiveness of various RT doses, volumes, and techniques, as well as to define the relevant prognostic factors in SP. Methods: Between 2000 and 2019, 84 patients, including 54 with solitary bone plasmacytoma (SBP) and 30 with extramedullary plasmacytoma (EMP), underwent RT at six institutions. Results: The overall RT median dose was 42 Gy (range, 36.0–59.4). The median follow-up period was 46 months. Overall, the local control (LC) rate was 96%, while the complete remission (CR) rate was 46%. The 5-year local relapse-free survival (LRFS), multiple myeloma-free survival (MMFS), progression-free survival (PFS), and overall survival (OS) rates were 89%, 71%, 55%, and 93%, respectively. Using an RT dose above 40 Gy was associated with a higher complete remission (CR) rate and a lower rate of local relapse. Modern irradiation techniques were associated with a trend toward a higher LC rate (98% vs. 87% for conventional, p = 0.09) and a significantly lower local relapse rate (6% vs. 25% for conventional, p = 0.04). However, RT dose escalation and technique did not lead to a significant effect on MMFS, PFS, and OS. Univariate analyses identified several patient characteristics as potentially relevant prognostic factors. In SBP patients, systemic therapy administration was associated significantly with MMFS and PFS rates. Conclusion: Using an RT dose >40 Gy and modern RT techniques may improve the local control and reduce the rate of relapse, without a significant impact on survival rates. The addition of systemic therapies may improve the MMFS and PFS rates of SBP patients.

Background Everolimus (EVE), an mTOR inhibitor has shown activity in HER2+ advanced breast cancer (ABC) in both preclinical and clinical studies. In the pivotal BOLERO-1 trial (NCT00876395), the progression-free survival (PFS) was not significantly different between the EVE + trastuzumab (TRAS) + paclitaxel (PAC) combination and placebo (PBO) + TRAS + PAC in the full HER2+ population (EVE, 15.0 mo vs PBO, 14.5 mo; HR=0.89; 95% CI: 0.73-1.08; p=0.1166). Although not reaching protocol defined level for statistical significance, the hormone receptor negative (HR-) subpopulation appeared to benefit from EVE, with a 7.2 mo PFS benefit vs PBO arm (EVE, 20.3 mo vs PBO, 13.1 mo; HR=0.66; 95% CI: 0.48-0.91; p=0.0049). The final exploratory overall survival (OS) analysis from the study is presented here. Methods In this phase 3 randomized trial, 719 women with HER2+ ABC without prior TRAS or chemotherapy in the metastatic setting were randomized 2:1 to receive either EVE (10 mg/d) or placebo (PBO) and weekly PAC+TRAS, stratified by visceral metastasis (lung, liver, peritoneal or pleural: yes vs no) and prior adjuvant or neo-adjuvant treatment with TRAS (yes vs no). As the primary objectives (PFS on full population and on HR- subpopulation) of BOLERO-1 were not met, the key secondary endpoint of OS was not formally statistically tested. However, given the results of PFS, in particular in the HR- subpopulation, a change to the OS analysis plan was made by introducing one final exploratory OS analysis at the time of study termination. Results At data cutoff (Dec 31, 2015), the median duration of exposure was 40.8 weeks (range: 0.6-320.4) in the EVE arm and 48.1 weeks (range: 1.1-308.0) in the PBO arm. After a median follow-up of 60.3 mo, 350 deaths were recorded in the full population, 238 (49.6%) in the EVE arm and 112 (46.9%) pts in the PBO arm. In the full population, the median OS was comparable in the EVE vs PBO arms (48.6 mo vs 50.0 mo respectively; HR = 1.13; 95% CI: 0.90-1.42). In the HR- subpopulation, 138 deaths were recorded; 88 (42.3%) pts in the EVE arm and 50 (48.5%) pts in the PBO arm. In the HR- subpopulation, the median OS in the EVE arm was longer compared to PBO arm (57.0 mo vs 41.6 mo respectively; HR = 0.83; 95% CI: 0.59-1.18). Stomatitis, diarrhea, alopecia, cough, rash, pyrexia, neutropenia, and fatigue were the most frequent adverse events (AEs) reported in EVE arm (≥35%). AEs leading to dose interruption and/or change were reported in 441 (93.4%) pts in EVE arm and 165 (69.3%) pts in the PBO arm respectively. Overall, AEs leading to treatment discontinuation were reported in 262 (55.5%) pts in EVE arm and 98 (41.2%) pts in PBO arm. Serious AEs were reported in 171 (36.2%) pts in the EVE arm and 40 (16.8%) pts in the PBO arm respectively. On treatment AE related deaths were reported for 3.6% pts in the EVE arm and 0% pts in the PBO arm. Conclusions The median OS was similar in the EVE vs PBO arms for overall population. However, a prolongation of 15.4 mo in median OS of HR- subpopulation was observed in the EVE arm vs PBO arm in this exploratory analysis. Pts in the EVE arm had a manageable safety, consistent with the safety profile of EVE and no new safety signals were identified. Citation Format: Yardley D, Hurvitz S, Jiang Z-f, Toi M, Burris H, Buyse M, Slamon D, Makhson A, Elsaid A, Lerzo G, Hellerstedt B, Nuzzo F, Sohn J, Manzyuk L, Cabaribere D, Lincy J, Weimann A, Noel-Baron F, Pacaud L, Andre F. Everolimus plus trastuzumab and paclitaxel as first-line therapy in women with HER2+ advanced breast cancer: Overall survival results from BOLERO-1 [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P4-22-13.