Purpose Increasing new cancer cases and approval of effective but expensive new drugs extending survival have led to unsustainable cancer care costs. Potential cost savings by a hypothetical dose down-rounding project of monoclonal antibodies at a community-based cancer center is presented. Methods From October 2014 through October 2015, metastatic cancer patients receiving monoclonal antibodies at CHI-Health St Francis Cancer Treatment Center in Grand Island, Nebraska, were identified through electronic health records. A total of 11 different types of monoclonal antibodies that were administered during the study period were identified. Trastuzumab, ofatumumab, and obinutuzumab did not require dose-rounding; thus, they were excluded from the analyses. Available vial size(s) and costs per milligram per average wholesale price for each monoclonal antibody were recorded. Costs of actual amounts prescribed were compared to the costs of theoretically reduced ≤5% and ≤10% doses rounded to the nearest vial sizes. Reduced doses resulting in a decreased number of opened vials qualified for meaningful dose down-rounding and were included in the analysis. Average actual dose reduction percentage resulting in cost savings for both groups was also calculated. Results A total of 728 doses of eight monoclonal antibodies suitable for dose down-rounding were identified. Vial sizes of pembrolizumab and ipilimumab did not allow for a meaningful dose down-rounding. At the ≤5% dose down-rounding, 255 of 728 doses (35%) qualified with a potential annual cost savings of $220,793.80. At the ≤10% dose down-rounding, 526 of 728 doses (72%) qualified with a potential annual cost savings of $454,461.00. The average actual dose reduction was 2.4% for the ≤5% dose reduction group and 4.9% for the ≤10% dose reduction group. Overall average cost savings per qualifying dose reduction was around $865.00. More doses qualified for cost savings in the ≤10% dose reduction group. Significant differences between different monoclonal antibodies for dose rounding at either ≤5% (p = 0.002) or ≤10% (p < 0.001) were observed. Conclusion A practical dose down-rounding procedure may allow significant cost reduction in metastatic cancer setting, where the cure is not the goal. Drug waste can be avoided by convenient vial sizes or can even be eliminated by lyophilized forms like in trastuzumab. Our data reflect the monoclonal antibody use and potential cost savings with the proposed dose down-rounding approach in a community-based cancer program.

6616 Background: Increasing new cancer cases and approval of expensive drugs extending survival has led to unsustainable cancer care costs. Potential cost savings by a dose rounding practice for mABs is presented. Methods: Using EHR, Oct 2014 - Oct 2015, metastatic cancer patients receiving mABs at CHI-Health St Francis in Grand Island Nebraska were identified. Trastuzumab, ofatumumab, obinutuzumab did not require dose rounding and excluded. Available vial size(s) and cost/mg (per acquisition costs) for each mAB recorded. Costs of actual amount prescribed compared to hypothetical ≤ 5% and ≤ 10% reduced doses rounded to nearest vial sizes. Doses resulting in decreased number of used vials qualified and included in analysis. Average actual dose reduction (%) resulting in cost-savings for both groups was also calculated. Results: 728 doses of 8 mABs identified. Vial sizes of pembrolizumab and ipilimumab did not allow meaningful dose rounding. At ≤ 5% dose rounding 255/728 doses (35%) qualified, with potential annual cost savings(PACS) of $ 220,793. At ≤ 10% dose rounding 526/728 doses (72%) qualified, with a PACS s of $ 454,461.The average actual dose reduction was 2.4% and 4.9% at 5 and 10 % groups respectively. Overall average cost savings per qualifying dose reduction was around $ 865.Significant differences among different mABs for dose rounding at either 5% (p = 0.002) or 10% (p < 0.001) were observed. Overall more doses qualified for cost savings at 10%. Conclusions: A pragmatic dose rounding project may reduce cost in metastatic cancer when cure is not the goal. Drug waste may be avoided/eliminated by convenient vial sizes or lyophilized forms like in trastuzumab. Our data reflect mAB use and potential cost savings in a community cancer setting. Drug ≤ 5% Reduction # % Savings ≤ 10% Reduction # % Savings Reduction 5% vs 10% P Cost 5% vs 10% P Bev 136/323 42 $ 113,288 250/323 77 $ 208,250 < 0.001 < 0.001 Ritux 62/232 26 $ 55,614 169/232 72 $ 151,593 < 0.001 < 0.001 Cetux 12/46 26 $ 7,632 18/46 39 $ 11,448 0.267 0.017 Panitum 19/40 47 $ 23,465 26/40 65 $ 32,110 0.176 0.089 Ramu 13/42 31 $ 13,312 33/42 78 $ 33,792 < 0.001 < 0.001 Ipi 0/7 0 $ 0 0/7 0 $ 0 Pembro 0/2 0 $ 0 0/2 0 $ 0 Nivo 13/36 36 $ 7,482 30/36 83 $ 17,268 < 0.001 0.001 Total 255/728 35 $ 220,793 526/728 72 $ 454,461

Background Although oral iron therapy is often the initial approach for the treatment of iron deficiency anemia (IDA) many patients fail to respond and tolerate. Approved parenteral iron treatment options have inconvenient dosing schedules, safety warnings and require an infusion center. Since the availability of parenteral Ferumoxytol (FER) more and more patients have been treated with this drug in the community setting.

n engl j med 369;20 nejm.org november 14, 2013 1968 The authors Reply: In response to Walsh: the outcomes according to Gleason score in our recent report, with scores of 2 to 6 indicating lowgrade tumors and scores of 7 to 10 indicating high-grade tumors, were consistent with those in our initial 2003 report.1 Table 1 shows postdiagnostic Kaplan–Meier survival estimates for patients with Gleason scores between 8 and 10. In this small subset of men from the PCPT, confidence intervals are wide and overlap. Modeling the time from randomization to death with the use of time-dependent covariates to account for the time at which the diagnosis of prostate cancer occurred (an approach that is less biased than one incorporating postdiagnostic survival), we calculated the between-group difference in the hazard ratios for death when Gleason scores of 8 to 10 rather than 7 to 10 were used to indicate high-grade cancer. After adjusting for age and race, we found that the P value for the comparison was 0.59, indicating that there was no statistically significant difference in survival. However, this test is also underpowered and represents another reason why we chose not to highlight this subset in our article. Revannasiddaiah and Susheela ask about the incidence of male breast cancer in the PCPT trial. With 141,009 person-years of follow-up, there have been two cases, one in each of the two study groups.

9110 Background: Pegfilgrastim reduces neutropenia risk in patients (pts) on cytotoxic chemotherapy. A single 6 mg dose per chemotherapy cycle commonly causes bone pain and leukocytosis. While half-dose pegfilgrastim has been shown to be safe and effective in breast cancer pts, there is no data on half-dose pegfilgrastim in general oncology pts. Methods: We evaluated the efficacy and safety of half-dose pegfilgrastim in general oncology pts on cytotoxic chemotherapy at St Francis Cancer Center. Pts who received at least one dose of 6 mg pegfilgrastim and developed NCI-CTCAE grade 2 or more bone pain and/or leukocytosis (WBC>10,000/ml) were given 3 mg dose pegfilgrastim on their following chemotherapy cycles. Pt demographics, type/number of chemotherapy regimens, efficacy, side effects and complications were evaluated. McNemar’s test, logistic regression analysis and ANOVA were used for statistical analysis. Results: Twenty-six pts (3 males, 23 females, all Caucasian) with median age 55 (range 34-86) received a total of eighty-three 3 mg doses of pegfilgrastim. Cancers treated were breast (N=16), colorectal (N=7), head and neck (N=1), non-Hodgkin lymphoma (N=1) and non-small cell lung cancer (N=1). Chemotherapy received was anthracycline (N=9), taxane (N=7), 5-FU/oxaliplatin (N=7), 5-FU/cisplatin (N=1), gemcitabine/oxaliplatin (N=1), pemetrexed/carboplatin (N=1). No neutropenia or chemotherapy dose modifications occurred on half-dose pegfilgrastim. In the 26 pts we report, bone pain occurred in 23 pts at 6 mg and 14 pts at 3 mg dose. Leukocytosis occurred in 23 pts at 6 mg and only 2 pts at 3 mg dose (McNemar’s test, P<0.01). While older age and full-dose pegfilgrastim were predictive of bone pain, more than one line of chemotherapy and half-dose pegfilgrastim were predictive of lack of leukocytosis (logistic regression analysis/ANOVA, P<0.01). Conclusions: Half-dose pegfilgrastim in general oncology pts receiving cytotoxic chemotherapy seems to be safe and effective with less bone pain and leukocytosis without resultant neutropenia or need for chemo modification. Larger prospective studies of half-dose pegfilgrastim in this setting are needed to further understand the feasibility of this approach.

e11137 Background: Preclinical data show that complete estrogen blockade, by down regulating ER and inhibiting estrogen synthesis, has greater effect on tumor growth than either treatment alone. Combination of an aromatase inhibitor (AI) and F may be an optimal second-line therapy by preventing activation of growth factor pathways and possible cross talk with ER. One clinical study has shown no benefit of adding anastrozole (A) to F at first relapse. No clinical data on combination L and F in the second line or more MBC is available. Methods: ER+, progesterone receptor(PgR) + or negative (-) MBC patients (pts) with prior chemo and/or non-AI endocrine(E) therapy were treated with L and F. Pts with complete/partial response, or stable disease were considered to have clinical benefit (CR+PR+SD). The predictive effect of age, number of prior regimens, ER/PgR status, and lobular histology were examined using Chi-square test. Results: 32 pts received L (2.5 mg/d po) plus F (250 mg/month, im). Mean age was 70 (Range: 35-92), median number of prior treatments was 2 (range1-6). 25 pts had ER+/PgR+, 7 pts had ER+/PgR- tumors. 25 pts had prior non-AI E therapy. 8 pts had lobular histology. Overall clinical benefit rate was 71% (3 CR, 7 PR, 13 SD). Mean duration of the clinical benefit was 15 months (range 2-38). 8 pts progressed under therapy. Age > 65 vs younger (89% vs 46%, p=0.007), prior treatments< 4 vs more (87% vs 25%, p=0.0007) and ER+/PgR+ vs ER+/PgR- (84% vs 42%, p<0.05) were predictive of clinical benefit; lobular histology and prior E therapy did not have any effect on clinical benefit (p>0.05). Conclusions: In pretreated MBC, combination of L and F can be effective with mean clinical benefit duration of 15 months. Older age, < 4 prior lines of therapy, and expression of both ER/PgR are predictive of clinical benefit while lobular histology and prior E therapy are not. L and F combination can be a reasonable option in selected group of MBC pts and should be further evaluated in larger studies using high dose F schedule.