Objectives: The aim of this study was to conduct a review of health technology assessments (HTAs) in cervical cancer screening to highlight the most common metrics HTA agencies use to evaluate and recommend cervical cancer screening technologies. Methods: The Center for Reviews and Dissemination (CRD), MedLine, and national HTA agency databases were searched using keywords (“cervical cancer screening” OR “cervical cancer” OR “cervical screening”) and “HTA” from January 2000 to October 2014. Non-English language reports without English summaries, non-HTA reports, HTAs unrelated to a screening intervention and HTAs without sufficient summaries available online were excluded. We used various National Institute for Health and Care Excellence (NICE) methods to extract key assessment criteria and to determine whether a change in screening practice was recommended. Results: One hundred and ten unique HTA reports were identified; forty-four HTAs from seventeen countries met inclusion criteria. All reports evaluated technologies for use among women. Ten cervical screening technologies were identified either as an intervention or a comparator. The most common outcome metric evaluated was diagnostic accuracy, followed by economic effectiveness. Additional outcome metrics such as the use of adjunct testing, screening intervals, and age-specific testing were commonly evaluated. Nearly one-third (fifteen of forty-four) of HTAs recommended a change in practice. Conclusions: This review highlights popular metrics used in HTAs for cervical cancer screening. Clinical and economic effectiveness metrics have been consistently assessed in HTAs, while the use of adjunct testing, screening intervals, and age-specific screening became increasingly prevalent from after 2007. Moreover, we observed an increase in optimized recommendations after 2007.
210 Background: With the accumulation of RWD in healthcare, CER continues to expand. RWD are becoming increasingly relevant in oncology, particularly since the onset of care pathways and CMS’ Oncology Care Model pilot program; yet, CER in oncology presents several challenges as disease biology differs by cancer type and many RWD sources do not capture clinical response, progression or survival. This review examined common endpoints reported in RWD studies on CER and TxP in MBC, focusing on HER2-negative and Triple Negative (TN) MBC. Methods: PubMed (2006-January 2016) and 4 conferences (2011-January 2016)—ASCO and SABC meetings/symposiums—were searched using MeSH/keywords, e.g., metastatic breast cancer, treatment, and comparative effectiveness. RWD CER and TxP studies in U.S. patients with HER2-negative or TNMBC were included; clinical trials were excluded. Results: Of1,782 total records, 17 articles and 9 conference abstracts were included. Studies using RWD increased over time with 2 studies published in 2010, 1 in 2012, 6 in 2013, 6 in 2014, 10 in 2015, and 1 as of January 2016. Of these, 8 were CER and 18 examined TxP. Most studies were retrospective chart reviews (7 CER; 10 TxP studies), others were retrospective secondary database analyses (1 CER; 6 TxP) and physician surveys (2 TxP). RWD sources included commercial insurance claims, SEER-Medicare, and California Cancer Registry data. Nineteen studies reported results in patients with HER2-negative MBC and 7 reported in TNMBC patients. Primary endpoints included overall survival (OS), progression-free survival (PFS), and treatment duration (TD). CER studies most commonly reported TD and survival outcomes (e.g., OS, PFS), each reported in 75% of the studies. TxP studies also most commonly examined survival outcomes (61% of studies), in addition to various treatment patterns and duration outcomes. Conclusions: This literature review indicates that in parallel to the availability of RWD, published CER studies and analysis of treatment patterns have grown in the last 5 years. The most commonly reported outcomes include OS, TD and PFS.
429 Background: Based on a randomized clinical trial (RCT), nab-P+G had superior overall survival (OS) compared to G for the treatment of advanced PDAC, but limited data is available comparing the effectiveness of these treatment options in a real-world setting. The objective of this study is to compare treatment patterns of patients receiving nab-P+G versus G for first-line treatment of PDAC. Methods: A retrospective cohort study was performed using fully de-identified data from a nationally representative electronic medical record platform of 1,300 community oncology physicians. Patients diagnosed with advanced PDAC between September 2013 and October 2014 who received first-line therapy with either nab-P+G or Gm were included in the analysis. We calculated the median time to treatment discontinuation (TTD) and database persistence (DP), a proxy for OS, using the Kaplan Meier method, and assessed supportive care usage with Poisson regression. Results: Out of 851 patients, 168 met eligibility criteria for the analysis (nab-P+G, n=122; G, n=46). Patients in the nab-P+G arm were younger (mean age 67.0 v 72.0; p <0.01) and mostly males (60% v 44%). Other baseline characteristics were comparable. Patients treated with nab-P+G had a statistically significant longer median TTD (3.4 v 2.2 mos; p <0.01) and median DP (8.6 v 5.3 mos; p=0.03). Patients receiving nab-P+G had fewer AEs-related to discontinuation (18% v 26%); but they utilized more doses of granulocyte-colony stimulating factor (2.02 v 0.73 doses, p<0.01), erythropoietin-stimulating agents (0.90 v 0.54, p<0.01) and steroids (7.89 v 0.58 doses, p<0.01) per 100 days compared to patients receiving G. Conclusions: Similar to the RCT comparing nab-P+G with G,patients receiving nab-P+G experienced significantly longer TTD and DP in this real-world analysis compared to patients receiving G. Additionally, patients receiving nab-P+G had fewer AEs leading to discontinuation compared to patients receiving G. More supportive care may have been used in the nab-P+G group due to longer treatment duration.
376 Background: nab-Paclitaxel plus gemcitabine ( nab-P+G) and FOLFIRINOX (FFX) are among the most common first-line (1L) therapies for metastatic adenocarcinoma of the pancreas (mPC), yet there is no head-to-head trial comparing their efficacy and real-world data is limited. As new second-line (2L) therapies become available, it is important to understand the real-world effectiveness associated with different treatment sequences. Methods: This retrospective cohort study compared the efficacy and safety of 1L nab-P+G vs. FFX, overall and under specific treatment sequences. Medical records were reviewed by 215 physicians across the US who provided information for mPC patients who initiated 1L with nab-P+G or FFX between 04/01/2015-12/31/2015. The outcomes of interest were overall survival (OS) and tolerability. OS was evaluated using Kaplan-Meier curves, and compared between cohorts using Cox proportional hazards model adjusting for baseline characteristics. Results: Medical records were reviewed for 654 patients receiving nab-P+G (n = 337) or FFX (n = 317) as 1L therapy for mPC. Patients in the nab-P+G cohort were older, less likely to have ECOG ≤ 1 and had more comorbidities than patients in the FFX cohort. There was no statistically significant difference in OS (adjusted HR = 0.99, p = 0.96), with median OS (mOS) being 12.1 and 13.8 months for nab-P+G and FFX, respectively. Among the subgroup of patients with ECOG ≤ 1, mOS was 14.1 and 13.7 months, respectively (adjusted HR = 1.00, p = 0.99). Among patients with 1L nab-P+G and FFX, 36.1% and 41.3% received 2L therapy and experienced mOS of 16.3 and 16.6 months, respectively (HR = 1.04, p = 0.76). Among commonly observed adverse events (AEs) (≥ 5% of patients in both cohorts), the rates of diarrhea, fatigue, mucositis, nausea and vomiting were higher in the FFX than nab-P+G cohort (all p < 0.05). Conclusions: In a nationwide sample of mPC patients, real-world survival outcomes were similar between patients receiving 1L nab-P+G or FFX. both overall and among patients who went on to receive active 2L treatments. In addition, nab-P+G was associated with significantly lower rates of common AEs compared with FFX.
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