Real-world duration of maintenance therapy in 2nd-line and later ovarian cancer (OC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17103-e17103
Author(s):  
David Garofalo ◽  
Ebru Aydin ◽  
Monica Labrador ◽  
Jennifer Webster ◽  
Joseph Donaldson ◽  
...  
Keyword(s):  
Maintenance Therapy ◽  
Real World ◽  
Data Exchange ◽  
Maintenance Treatment ◽  
Observation Time ◽  
Time Interval ◽  
Real World Data ◽  
Community Oncology ◽  
Significant Difference ◽  
Line Of Therapy

e17103 Background: Recurrent OC patients 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 compare the time to next treatment of available maintenance treatment options in recurrent OC. Methods: This analysis utilized the Integra Data Exchange (DTX) database, a deidentified data source from community oncology practice systems (EMR, claims). This retrospective study included 3,629 OC patients with at least two visits between 7/16/16 and 4/16/18. 1,767 patients started at least one 2nd line or later line of therapy and 577 of these patients had at least one line of maintenance treatment. Maintenance options were monotherapy PARP inhibitors, Bevacizumab, or non-platinum-chemotherapy. Patients who did not receive maintenance were categorized as observation. Time to next treatment (start of maintenance to start of next line of therapy) was compared through ANOVA and paired T-test analyses. Results: A statistically significant difference was seen in time to next treatment between PARPi (n = 151) and bevacizumab maintenance (n = 212) (p = < 0.0125) and between PARPi and cytotoxic maintenance (n = 163) (p = < 0.0001). Bevacizumab and PARPi maintenance had significantly longer duration when compared to observation (n = 1,626) (p = < 0.0001). Cytotoxic maintenance duration was not significantly different than observation (p = 0.93). Conclusions: Our real world analysis found that there was a statistically significant increase in time to subsequent lines of therapy when certain maintenance treatment (PARPi, Bevacizumab) is utilized following 2nd line and later treatment in OC. Further, between available maintenance options, PARPi had the longest time to next treatment when compared to other maintenance options.[Table: see text]

Real-world data analysis of ovarian cancer (OC) maintenance utilization among maintenance eligible patients.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5579-5579 ◽  
Author(s):  
David Garofalo ◽  
Ebru Aydin ◽  
Monica Labrador ◽  
Jennifer Webster ◽  
Greg Brown ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Maintenance Therapy ◽  
Real World ◽  
Maintenance Treatment ◽  
Real World Data ◽  
Brca Mutations ◽  
Community Oncology ◽  
Platinum Based Chemotherapy ◽  
Platinum Chemotherapy

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).

scholarly journals A real-world comparative analysis of carfilzomib and other systemic multiple myeloma chemotherapies in a US community oncology setting

2019 ◽  
Vol 10 ◽  
pp. 204062071881669 ◽  
Author(s):  
Robert M. Rifkin ◽  
Rohan Medhekar ◽  
E. Susan Amirian ◽  
Kathleen M. Aguilar ◽  
Thomas Wilson ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Real World Data ◽  
Kaplan Meier ◽  
Hazard Ratios ◽  
Community Oncology ◽  
First Relapse ◽  
Line Of Therapy

Background: Most multiple myeloma (MM) patients ultimately progress, with remission duration decreasing after first relapse. Recently, novel agents have been approved for the treatment of relapsed MM. There is a paucity of real-world data on these treatments. We sought to compare time to next treatment (TTNT) in MM patients in their second line of therapy (LOT2), treated with common proteasome inhibitor (PI)-based triplets. Methods: Adult MM patients who received carfilzomib (K) between 1 November 2013 and 29 February 2016 at US Oncology Network (USON) clinics utilizing iKnowMed™ electronic health records (EHRs) were identified. Patients were included if they were ⩾18 years of age, not enrolled in clinical trials, had ⩾2 visits at a USON clinic and received LOT2 regimens consisting of: K+lenalidomide with steroid (KRd), bortezomib+lenalidomide with steroid (VRd), or bortezomib+cyclophosphamide with steroid (VCyd). TTNT was estimated from LOT2 initiation to LOT3 initiation using the Kaplan–Meier method, and hazard ratios (HRs) were estimated using Cox modeling. Results: A total of 718 patients received a K-containing regimen sometime during their MM treatment (LOT1 to LOT5). Of these, 156 patients received: KRd ( n = 112; 71.8%), VRd ( n =27; 17.3%), or VCyd ( n = 17; 10.9%). Baseline characteristics were similar between groups (mean age: 64.8 years; 58% male). Median TTNT was longest for KRd [25.3 months; 95% confidence interval (CI): 19.71–NR], versus VRd or VCyd (VRd median TTNT: 10.2 months, 95% CI: 4.24–12.71; VCyd: 6.5 months, 95% CI: 3.02–12.78; log-rank p < 0.0001). The adjusted HR for KRd was 0.19 (95% CI: 0.11–0.37), compared with VRd. Conclusions: Considering the real-world nature of these data, the median TTNT observed with KRd was relatively consistent, with progression-free survival (PFS) for KRd observed in the phase III ASPIRE trial (median PFS: ITT population = 26.3 months; LOT2 = 29.6 months). Patients who received KRd at first relapse had significantly longer TTNT, compared with those on VRd or VCyd, confirming the value of KRd as an important treatment option for relapsed MM.

Recurrence of ovarian cancer in BRCAwt patients without maintenance therapy: Real-world evidence.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5547-5547 ◽  
Author(s):  
Melinda Louie-Gao ◽  
Ebru Aydin ◽  
Premal H. Thaker
Keyword(s):  
Ovarian Cancer ◽  
Data Analysis ◽  
Maintenance Therapy ◽  
Real World ◽  
Maintenance Treatment ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Platinum Resistance ◽  
Real World Data ◽  
World Data

5547 Background: Development of platinum resistance is a major clinical challenge in ovarian cancer (OC) treatment. In the phase 3 ENGOT-OV16/NOVA trial of the poly(ADP-ribose) polymerase inhibitor (PARPi) niraparib, 55% of BRCA wild-type ( BRCAwt) patients (pts) receiving placebo developed platinum resistance after their last platinum-based therapy (ie, progressive disease within 6 months of their last chemotherapy [CT] dose). Niraparib, a PARPi approved for the maintenance treatment of adult pts with recurrent OC following platinum-based CT, significantly prolongs progression-free survival (PFS). This real-world data analysis investigated the risk of platinum eligibility loss for BRCAwt pts who did not receive maintenance therapy after platinum treatment. Methods: This retrospective study identified 5,535 pts with OC from January 2011–October 2018 using data from Flatiron, a longitudinal, demographically and geographically diverse database derived from records of > 265 cancer clinics and > 2 million US cancer pts. BRCAwt pts who had received ≥2 lines of platinum-based CT, had disease progression ≥6 months after their previous line of therapy, and had no maintenance therapy (PARPi, bevacizumab, or CT agents) after their current treatment were included. Kaplan-Meier analysis was used to estimate the probability of pts initiating next treatment or death, whichever occurred first, within 6 months. Results: Of 5,535 pts diagnosed with OC, 147 BRCAwt pts met the inclusion/exclusion criteria of this analysis (similar to ENGOT-OV16/NOVA placebo arm). An estimated 56% of pts received the next treatment or died within 6 months after their last platinum-based therapy. Median time to next therapy or death was 5.1 months (95% confidence interval, 3.1–7.2). Conclusions: Our real-world data analysis shows that 56% of BRCAwt pts who received platinum-based treatment without maintenance therapy had recurrent OC within 6 months, classifying them as platinum resistant. Use of maintenance treatment options, such as niraparib, has been shown to significantly prolong PFS after platinum-based CT and may be beneficial in extending the platinum-free interval, enabling pts to remain eligible for further platinum therapy.

The JPJDF has Synergistic Effect with Fluoropyrimidine in the Maintenance Therapy for Metastatic Colorectal Cancer

2020 ◽  
Vol 15 (3) ◽  
pp. 257-269
Author(s):  
Xiaoling Fu ◽  
Yanbo Zhang ◽  
Lisheng Chang ◽  
Dengcheng Hui ◽  
Ru Jia ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Synergistic Effect ◽  
Maintenance Therapy ◽  
Metastatic Colorectal Cancer ◽  
Maintenance Treatment ◽  
Advanced Colorectal Cancer ◽  
Treated Group ◽  
Induction Treatment ◽  
Chemotherapeutic Regimen ◽  
Significant Difference

Background: Maintenance chemotherapeutic regimen with low toxicity is needed for metastatic colorectal cancer. A recent patent has been issued on the spleen-strengthening and detoxification prescription (JPJDF), a traditional Chinese herbal medicinal formula with anti-angiogenesis effect. The clinical effect of JPJDF on the maintenance treatment of advanced colorectal cancer has not been evaluated. Objective: This study aims to evaluate the effectiveness and safety of JPJDF in combination with fluoropyrimidine compared to fluoropyrimidine alone as maintenance therapy for metastatic colorectal cancer. Methods: We applied a prospective, randomized, double-blinded, single center clinical study design. A total of 137 patients with advanced colorectal cancer were recruited. Patients received either Fluoropyrimidine (Flu-treated group, n = 68), or Fluoropyrimidine plus JPJDF (Flu-F-treated group, n = 69) as maintenance treatment after 6-cycle of FOLFOX4 or FOLFORI induction treatment. The primary endpoints were Progression-Free Survival (PFS) and Overall Survival (OS). The secondary endpoints were safety, Performance Status (PS) score and other symptoms. Results: The endpoint of disease progression was observed in 91.7% of patients. The PFS was 5.0 months and 3.0 months in the Flu-F-treated and Flu-treated groups, respectively. The OS was 15.0 months and 9.0 months in the Flu-F-treated and Flu-treated groups, respectively. Some common symptoms, such as hypodynamia, anepithymia, dizziness and tinnitus and shortness of breath, were improved in the Flu-F-treated group. There was no significant difference in the common adverse reactions between the two groups. Conclusion: JPJDF and fluoropyrimidine have synergistic effect in the maintenance treatment of mCRC.

scholarly journals Role of efficient testing and contact tracing in mitigating the COVID-19 pandemic: a network modelling study

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e045886
Author(s):  
Yiying Hu ◽  
Jianying Guo ◽  
Guanqiao Li ◽  
Xi Lu ◽  
Xiang Li ◽  
...  
Keyword(s):  
Real World ◽  
Case Fatality ◽  
Contact Tracing ◽  
Secondary Outcome ◽  
Time Interval ◽  
Fatality Rate ◽  
Real World Data ◽  
Network Modelling ◽  
World Data ◽  
Quantitative Evidence

ObjectivesThis study quantified how the efficiency of testing and contact tracing impacts the spread of COVID-19. The average time interval between infection and quarantine, whether asymptomatic cases are tested or not, and initial delays to beginning a testing and tracing programme were investigated.SettingWe developed a novel individual-level network model, called CoTECT (Testing Efficiency and Contact Tracing model for COVID-19), using key parameters from recent studies to quantify the impacts of testing and tracing efficiency. The model distinguishes infection from confirmation by integrating a ‘T’ compartment, which represents infections confirmed by testing and quarantine. The compartments of presymptomatic (E), asymptomatic (I), symptomatic (Is), and death with (F) or without (f) test confirmation were also included in the model. Three scenarios were evaluated in a closed population of 3000 individuals to mimic community-level dynamics. Real-world data from four Nordic countries were also analysed.Primary and secondary outcome measuresSimulation result: total/peak daily infections and confirmed cases, total deaths (confirmed/unconfirmed by testing), fatalities and the case fatality rate. Real-world analysis: confirmed cases and deaths per million people.Results(1) Shortening the duration between Is and T from 12 to 4 days reduces infections by 85.2% and deaths by 88.8%. (2) Testing and tracing regardless of symptoms reduce infections by 35.7% and deaths by 46.2% compared with testing only symptomatic cases. (3) Reducing the delay to implementing a testing and tracing programme from 50 to 10 days reduces infections by 35.2% and deaths by 44.6%. These results were robust to sensitivity analysis. An analysis of real-world data showed that tests per case early in the pandemic are critical for reducing confirmed cases and the fatality rate.ConclusionsReducing testing delays will help to contain outbreaks. These results provide policymakers with quantitative evidence of efficiency as a critical value in developing testing and contact tracing strategies.

Real-world utilization and costs with biosimilar and reference filgrastim in patients with breast cancer receiving myelosuppressive chemotherapy in a community oncology setting from 2015 to 2017.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 57-57
Author(s):  
Robert M. Rifkin ◽  
Lisa Herms ◽  
Chuck Wentworth ◽  
Anupama Vasudevan ◽  
Kimberley Campbell ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Real World ◽  
Initial Period ◽  
The United States ◽  
Time Frame ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
Myelosuppressive Chemotherapy ◽  
Community Oncology ◽  
The Us

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.

scholarly journals Comparison of Efficacy in Patients with Metastatic Melanoma Treated with Ipilimumab and Nivolumab Who Did or Did Not Discontinue Treatment Due to Immune-Related Adverse Events: A Real-World Data Study

Cancers ◽  
2021 ◽  
Vol 13 (21) ◽  
pp. 5550
Author(s):  
Morten Fink ◽  
Anders Schwartz Vittrup ◽  
Lars Bastholt ◽  
Inge Marie Svane ◽  
Marco Donia ◽  
...  
Keyword(s):  
Adverse Events ◽  
Metastatic Melanoma ◽  
Real World ◽  
Negative Impact ◽  
Cox Proportional Hazards Model ◽  
Induction Phase ◽  
Discontinue Treatment ◽  
Real World Data ◽  
World Data ◽  
Significant Difference

Immune-related adverse events (irAEs) are very prevalent when treating patients with ipilimumab and nivolumab in combination, and 30–40% of patients discontinue the treatment for this reason. It is of high clinical relevance to investigate the consequences of discontinuing the treatment early since combination therapy with ipilimumab and nivolumab is the first line of treatment for many patients with metastatic melanoma. In this follow-up study, with real-world data from the nationwide DAMMED database, we investigated whether there was a difference in progression-free survival (PFS) and overall survival (OS) for patients who discontinued or did not discontinue treatment within the first four doses of treatment due to irAEs. In total, 448 patients were treated with ipilimumab and nivolumab. Of these, 133 patients discontinued due to irAEs in the induction phase. Using the Cox proportional hazards model, there was no significant difference in PFS when comparing the group that discontinued with the group that did not discontinue. The group that discontinued had a significantly longer OS than the group that received the full length of treatment. Therefore, we conclude that there is no significant negative impact on efficacy for patients who discontinue due to irAEs in the induction phase of combination immunotherapy for metastatic melanoma.

Analyzing treatment patterns and time to the next treatment in chronic lymphocytic leukemia real-world data using automated temporal phenotyping.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e19512-e19512
Author(s):  
Kyeryoung Lee ◽  
Zongzhi Liu ◽  
Meng Ma ◽  
Yun Mai ◽  
Christopher Gilman ◽  
...  
Keyword(s):  
Chronic Lymphocytic Leukemia ◽  
Real World ◽  
Clinical Decision Making ◽  
Single Agent ◽  
Treatment Patterns ◽  
Lymphocytic Leukemia ◽  
Time Interval ◽  
Real World Data ◽  
World Data ◽  
Therapeutic Class

e19512 Background: Targeted therapy is an important treatment for chronic lymphocytic leukemia (CLL). However, optimal strategies for deploying small molecule inhibitors or antibody therapies in the real world are not well understood, largely due to a lack of outcomes data. We implemented a novel temporal phenotyping algorithm pipeline to derive lines of therapy (LOT) and disease progression in CLL patients. Here, the CLL treatment pattern and time to the next treatment (TTNT) were analyzed in real-world data (RWD) using patient electronic health records. Methods: We identified a CLL cohort with LOT from the Mount Sinai Data Warehouse (2003-2020). Each LOT consisted of either a single agent or combinations defined by NCCN CLL guidelines. We developed a natural language processing (NLP)-based temporal phenotyping approach to automatically identify the number of lines and therapeutic regimens. The sequence of treatment and time interval for each patient were derived from the systematic treatment data. Time to event analysis and multivariate (i.e., age, gender, race, other treatment patterns) Cox proportional hazard (CoxPH) models were used to analyze the patterns and predictors of TTNT. Results: Four hundred eleven CLL patients received 1 to 7 LOTs. Ibrutinib was the predominant 1st LOT (40.8% of patients) followed by anti-CD20-based antibody therapies and chemotherapy in 30.6 and 19.2% of patients, respectively, followed by Acalabrutinib, Venetoclax, and Idelalisib in 3.4, 2.7, and 0.7% of patients, respectively (Table 1). The 2nd to 5th LOT showed the same or similar trends. We next analyzed the TTNT in the 1st line of each therapeutic class. Acalabrutinib resulted in a longer median TTNT than Ibrutinib. Both Acalabrutinib and Ibrutinib showed longer TTNT compared to Venetoclax (median TTNTs were 742 and 598 vs. 373 days: HR = 0.23, p=0.015 and HR = 0.48, p=0.03, respectively). In addition, patients with age equal to or older than 65 showed longer TNNT (HR=0.16, p=0.016). Conclusions: Our result shows the potential of RWD usage in clinical decision making as real-world evidence reported here is consistent with results derived from clinical trial data. Linking this study to genetic data and other covariates affecting treatment outcomes may provide additional insights into the optimal sequences of the targeted therapies in CLL. Table 1: Therapeutic class and patient numbers (%) in each line.[Table: see text]

When will it be better? Lenvatinib combined with TACE for unresectable hepatocellular carcinoma: A retrospective analysis of real-world evidence in China.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 281-281
Author(s):  
Lan Zhang ◽  
Yanhong Wang ◽  
Ningling Ge ◽  
Yu-Hong Gan ◽  
ZhengGang Ren ◽  
...  
Keyword(s):  
Combination Treatment ◽  
Real World ◽  
Response Rate ◽  
Objective Response ◽  
Progression Free Survival ◽  
Combination Group ◽  
Optimal Timing ◽  
Real World Data ◽  
Combination Strategy ◽  
Significant Difference

281 Background: TACE and lenvatinib has each shown to prolong overall survival in patients with unresectable HCC, combination of which may also improve clinical outcomes and have been widely used in the real world accordingly. However, the optimal timing of adding on lenvatinb to TACE remains unclear. We are aiming to evaluate the efficacy and safety between two combination strategies. Methods: From Nov 2018 to Jun 2020, 79 consecutive patients had received a combination treatment of lenvatinib and TACE. Patients followed up for more than 2 months were included in this analysis. They were classified as early-combination group(add on lenvatinib before or after the first TACE ) and late-combination group(add on lenvatinib after at least two procedures of TACE ). Tumor response and progression-free survival (PFS,time from the first day of prescribing lenvatinib to progression or death) were assessed according to RECIST1.1 criteria. Liver function were also evaluated at baseline and every 2 months later. AEs were recorded during the combination treatment period according to CTCAE 5.0. Results: A total of 48 u-HCC patients was finally enrolled. Median follow-up in all patients was 9.3(5.3-14.3)months. Patients’ baseline characteristics were similar in two groups. For early-combination group(n=22)and late-combination group(n=26), the mean age was 65±9.7 and 61±11.6years(p=0.2);BCLC stage C HCC was 59% and 54%(p=0.89);and Child-Pugh A proportion was 81.8% and 77%(p=0.73) respectively. The objective response rate(ORR) was 22.9% in total 48 cases. There was no significant difference in response rate (18.2% vs 26.9%, P=0.51) or disease control rate (90.9% vs 92.3%, P=1.00). Median PFS was significantly longer in the early-combination group than that in late-combination group (14.5 vs 8.9 months; p=0.048). The safety profile was similar between two groups. Grade 3/4 adverse events were 3 (13.6%) and 2 cases(7.7%) respectively (P=0.65). Conclusions: This is to date the first real-world data of the combination timing of lenvatinib with TACE in u-HCC patients. Early-combination strategy may be a better option for the u-HCC patients with a longer mPFS.

Real world chart review of adverse event management in patients taking tyrosine kinase inhibitors (TKIs) for metastatic renal cell carcinoma (mRCC) by line of therapy (LoT).

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 521-521
Author(s):  
Sandhya Srinivas ◽  
Dara Stein ◽  
Dana Y Teltsch ◽  
Sunning Tao ◽  
Krishnan Ramaswamy
Keyword(s):  
Real World ◽  
Chart Review ◽  
Kinase Inhibitors ◽  
Drug Regimen ◽  
Patient Demographics ◽  
Community Oncology ◽  
Hand Foot Syndrome ◽  
Impact Patient Care ◽  
Line Of Therapy ◽  
Dose Modifications

521 Background: This is the first real world study to describe adverse events of special interest (AESI) management for all available TKIs by LoT. A better understanding of optimal AE management can positively impact patient care. Methods: A chart review was conducted largely in community oncology practices in Canada and the US. Patients with mRCC were eligible if they started TKI monotherapy between Nov 15, 2010-Nov 15, 2013 and had ≥ 1 of 5 AESI onset ≤ 3 months post TKI start. AESI included fatigue, hypertension, diarrhea, hand-foot syndrome and stomatitis/mucositis. Data on patient demographics, medical history, drug regimen, and AESI management were collected. Results: 220 patients from 27 centers were included. 63% of patients received TKI in 1st, 22% in 2nd and 15% in 3rd LoT. TKIs included axitinib (9%), pazopanib (27%), sorafenib (8%) and sunitinib (55%). 376 AESI occurred in 220 patients; 87% were non-serious. Fatigue (62%), hypertension (37%), diarrhea (31%), stomatitis/mucositis (29%), and hand-foot syndrome (12%) were reported. 55% of AESI resolved/were resolving within 3.5 months of onset. 8% of patients received AESI prophylaxis (Px) and 59% received treatment (Tx). Incidence of stomatitis/mucositis declined as LoT progressed (37%, 16%, 12%). More patients in 1st vs. ≥ 2nd LoT had AESI related TKI discontinuation (17% vs. 12%), interruptions (17% vs. 12%) and reductions (43% vs. 32%). Fewer patients missed doses as LoT progressed (38%, 25%, 18%). Fatigue was the commonest AESI across LoT, and fatigue as a reason for therapy delay/interruption increased across LoT (7%, 14%, 50%). The rates of Tx or Px for fatigue remained low across LoT. Rates of AESI Px were low across the LoT (10%, 0.4%, 0.3%). More patients in 1st (61%) received AESI Tx vs. 2nd (47%) LoT. Conclusions: Most AESI were non-serious, and over half of patients received some form of AESI Tx. Fatigue was the most common yet least frequently Tx AESI. Very few patients received Px across LoT. More patients in 1st versus 2nd LoT experienced dose modifications/discontinuation and received AESI Tx. More emphasis on Px/Tx options for non-serious bothersome AEs is warranted.

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