BackgroundRapidly evolving understanding of cancer biology has presented novel opportunities to translate that understanding into clinically relevant therapy. Palbociclib, a novel, first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor was approved in the USA in February 2015 for the treatment of advanced/metastatic breast cancer. We examined real-world evidence in the first year post approval to understand the clinical and demographic characteristics of patients treated with palbociclib in community oncology practices and the dosing, treatment, and complete blood count (CBC) monitoring patterns.MethodsThis was a retrospective observational study of structured data from a US electronic medical record (EMR) database. Female patients receiving palbociclib after 31 January 2015 were followed through 31 March 2016. Our methodological rules were constructed to aggregate drugs received according to the order in which they are given, i.e., identify the line of therapy as first, second, or third line, etc., using treatment order and course description fields from the EMR.ResultsThere were 763 patients initiating palbociclib who met the selection criteria. Of those, 612 (80.2%) received palbociclib concomitantly with letrozole. Mean follow up was 6.4 months and mean age at palbociclib initiation was 64 years. Of patients with a known starting dose (n = 417), 79.9% started on palbociclib 125 mg. Dose reductions were observed in 20.1% of patients. Percentages of patients according to line of therapy at initiation of palbociclib were first-line, 39.5%; second-line, 15.7%; third-line, 13.1%; and fourth-line therapy or later, 31.7%. On average, two CBC tests were conducted during the first cycle of palbociclib treatment. Overall, 74.6% of patients had a neutropenic event during follow up including 47.3% and 8.0% of patients with a grade 3 or 4 occurrence, respectively.ConclusionsReal-world palbociclib use one year post US approval demonstrates a more heterogeneous patient population than that studied in the clinical trials with more than half of the patients receiving palbociclib plus letrozole in later lines of therapy. CBC testing rates suggested good provider compliance with monitoring guidelines in the USA prescribing information. The occurrence of grade 3 and 4 neutropenia (based on laboratory results) was consistent with the rates of grade 3 and 4 neutropenia in two phase-III studies (PALOMA-2, 56% and 10%; PALOMA-3, 55% and 11%, respectively). Understanding palbociclib utilization in real-world patients and how drug dosing and monitoring are performed aids in the understanding of safe and effective use of the drug.Electronic supplementary materialThe online version of this article (10.1186/s13058-018-0958-2) contains supplementary material, which is available to authorized users.

IntroductionReal‐world data are critical to demonstrate the consistency of evidence and external generalizability of randomized controlled trials (RCTs). This study examined characteristics and outcomes of metastatic triple‐negative breast cancer (mTNBC) patients treated with eribulin mesylate at community oncology practices in the United States.MethodsPhysicians identified mTNBC patients initiating eribulin between 1 January 2011 and 1 January 2014 and abstracted data into an electronic case report form (eCRF). Eribulin treatment in the metastatic setting was categorized as early use (EU, first‐/second‐line) and late use (LU, third‐line or later). Patient characteristics, overall survival (OS), disease response (per treating physician), and adverse events (AEs) rates in each group, respectively, are reported.ResultsOverall 252 eCRFs were completed: 125 (49.6%) EU and 127 (50.4%) LU. The median age at metastatic diagnosis was 53 years and 42.1% were stage IV at their initial diagnosis. The median duration of follow‐up from the initiation of first‐line treatment was 24 months. Rates of disease response (complete or partial per treating physician) were 69.9% in the EU group and 48.8% in the LU group. The five most commonly reported adverse events during eribulin were as follows: fatigue (65.1%), weakness (40.1%), decreased appetite (32.5%), neutropenia (31.0%), and leukopenia (27.4%). Discontinuation of eribulin due to AE was observed in 4.0% of patients. Median OS from initiation of eribulin was 23.0 months (95% CI: 18.7‐27.3) among EU and 14.7 (95% CI: 12.6‐16.9) among LU.ConclusionIn the real‐world eribulin‐treated mTNBC, patients have more sites of metastatic disease and exposure to greater numbers of prior therapies compared to RCTs. The median OS of 14.7 months among LU patients is consistent with, and slightly longer than the 13.1 months and 14.4 months reported in the EMBRACE and Study 301 clinical trials, respectively.

IntroductionReal-world comparative effectiveness, safety, and supportive care use of nab-paclitaxel plus carboplatin vs gemcitabine plus platinum were analyzed in patients with advanced or metastatic squamous cell non-small cell lung cancer (NSCLC).Materials and methodsPatients who received ≥ 1 cycle of first-line nab-paclitaxel plus carboplatin or gemcitabine plus platinum were identified from the Navigating Cancer database. Clinical effectiveness endpoints included overall survival (OS) and time to treatment discontinuation (TTD). Other endpoints included safety and utilization of supportive care. Cox proportional hazards models were used to control for potential confounding effects of baseline characteristics.ResultsIn total, 193 patients were included (nab-paclitaxel plus carboplatin, n = 61; gemcitabine plus platinum, n = 132). Baseline characteristics were generally similar between the cohorts. Patients receiving nab-paclitaxel plus carboplatin had a significantly longer OS than those receiving gemcitabine plus carboplatin (median, 12.8 vs 9.0 months; P = 0.03). However, the adjusted difference was not statistically significant (adjusted HR 1.55; 95% CI, 0.99–2.42; P = 0.06). nab-Paclitaxel plus carboplatin-treated patients had significantly longer TTD than gemcitabine plus carboplatin-treated patients (median, 4.3 vs 3.5 months; P = 0.03; adjusted HR 1.39; 95% CI, 1.01–1.90; P = 0.04). Grade 3 or 4 anemia and neutropenia were significantly lower in patients treated with nab-paclitaxel plus carboplatin vs gemcitabine plus carboplatin. Nausea and neuropathy (grade not specified) were significantly higher in the nab-paclitaxel plus carboplatin than the gemcitabine plus carboplatin group. No differences in supportive care use were observed between the cohorts.ConclusionThese real-world data support the effectiveness and safety of nab-paclitaxel plus carboplatin for first-line treatment of advanced squamous cell NSCLC.

5579 Background: Approximately 1% of US women will be diagnosed with epithelial OC during their lifetime. OC patients who achieve a response to platinum-based chemotherapy may benefit from maintenance therapy, with the goal of inducing a lasting remission or extending the time interval before progression without any deleterious impact on quality of life1. This analysis, based on real world data sourced from US community oncology practices, was designed to assess the current utilization of maintenance therapy among maintenance eligible patients. Methods: This analysis utilized the Integra Data Exchange (DTX) database, a deidentified data source from community oncology practice systems (EMR, practice management, paid claims). This retrospective study included 3,629 OC patients with at least two visits between 7/16/16 and 4/16/18. 398 patients who completed 2nd line or later platinum-based chemotherapy for 4-9 cycles and/or had a complete/partial response between 1/1/17 and 7/31/18 were included. Potential maintenance therapy options were monotherapy of PARP inhibitors, bevacizumab, and non-platinum-chemotherapy agents. Rate of maintenance therapy after platinum-based treatment was assessed. Results: Our real-world analysis found that 49% of 398 maintenance eligible patients received maintenance therapy at least once following response to 2nd line or later platinum chemotherapy. Among those that received maintenance, 46% received PARPi, 28% bevacizumab, and 26% non-platinum chemotherapy. Further, 56% of women with BRCA mutations received maintenance treatment, compared with 49% of women without BRCA mutations. Conclusions: Though there are several options available, 51% of OC women studied who could potentially benefit from maintenance treatment did not receive maintenance. Only 56% of BRCA mutation carriers were targeted for maintenance in the real world. Among patients that receive maintenance therapy following 2nd line or later platinum chemotherapy 46% received a PARPi based regimen. 1) Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomized controlled trial. Lancet Oncol. 2018 Aug;19(8).

Background Palbociclib was approved in the U.S. in February 2015 for the treatment of advanced/metastatic breast cancer (MBC) in combination with letrozole as initial endocrine based therapy for post-menopausal women with ER+/HER2- disease. We examined the demographic, clinical characteristics and treatment patterns of patients initiating palbociclib (PAL) + letrozole (LET) in real-world, community oncology practices. Methods This was a retrospective observational study of female breast cancer patients identified in the Navigating Cancer (NC) EMR database. The NC database collects EMR data, in both structured and unstructured fields (patient/clinical progress notes), from over 975 oncology and hematology providers across more than 50 locations in 25 states. Female patients with record of treatment with PAL after 01/31/2015 were selected. Combination treatment with LET was defined as having a record for LET within 30 days of the PAL prescription. Line of therapy (LOT) was assessed from the date of metastatic diagnosis and assigned by evaluating treatment plans pre-and post PAL initiation. Bi-monthly cohorts were constructed based on the month of initiation of PAL from 02/01/2015-01/31/2016. Interim results are presented; data from an additional three months of follow-up (through 03/31/2016) are pending. Results Overall, 931 unique patients were identified as having initiated PAL treatment. Of those, 608 (65.3%) received PAL + LET. Mean follow-up was relatively short at 5.4 mo (SD=3.5). Confirmed ER+/HER2- was observed in 71.6% of patients and 50.3% were age ≥65, mean age was 64.3 yrs. Of patients with available ECOG-PS at treatment initiation (n=424): 0/1=78.5%, 2=17.5% and 3=4.0%. Of patients with a known starting dose (n=418), 69.9% initiated with PAL 125mg, 22.0% at 100mg and 8.1% at 75mg. Compared to women < 65, women ≥ 65 were more often started with 100mg (25.4% vs. 18.9%) and 75mg (10.0% vs 6.5%). Any dose reductions were observed in 20.6% of patients (21.5% of patients receiving 125mg). During the year following approval, 39.8% of patients initiated PAL + LET at LOT1, 15.6% at LOT2, 13.0% at LOT3 and 31.6% at LOT4+, following MBC diagnosis. Over time the proportion of late use (LOT4+) declined from 39.7% in Feb/Mar '15 to 23.9% in Dec '15/Jan '16 with more patients utilizing in LOT3 (from 7.9% in Feb/Mar '15 to 19.5% in Dec '15/Jan '16). Number of Patients Initiating PAL + LET by LOT and Month. AllFeb/Mar '15Apr/May '15Jun/Jul '15Aug/Sep '15Oct/Nov '15Dec'15/Jan '16N (%)608(100)63(10.4)108(17.8)125(20.6)108(17.8)91(14.5)113(18.6)LOT1 (%)242(39.8)23(36.5)45(41.7)53(42.4)45(41.7)33(36.3)43(38.1)LOT2 (%)95(15.6)10(15.9)12(11.1)19(15.2)15(13.9)18(19.8)21(18.6)LOT3 (%)79(13.0)5(7.9)10(9.3)18(14.4)12(11.1)12(13.2)22(19.5)LOT4+ (%)192(31.6)25(39.7)41(38.0)35(28.0)36(33.3)28(30.8)27(23.9) Conclusions There was a trend toward earlier utilization of PAL + LET from Feb-Jul '15, an increase in later use during Aug/Sep '15, and a return towards earlier use in subsequent cohorts reaching the lowest proportion of LOT 4+ use observed in Dec '15/Jan '16. After a mean follow-up of 5.4 mo, 21.5% of patients receiving the 125 mg dose had a dose reduction. Final results, with additional follow-up, will be presented at conference. Citation Format: Kish JK, Ward MA, Garofalo D, Ahmed HV, McRoy L, Laney J, Zanotti G, Yu H-T, Feinberg BA. Early utilization pattern of palbociclib 1 year post-approval in the United States [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 P6-16-05.