Patient characteristics, treatment patterns and clinical outcomes among patients with previously treated recurrent or metastatic cervical cancer: a community oncology-based real-world analysis

2021 ◽  
Vol 162 ◽  
pp. S227-S228
Author(s):  
Zachary Alholm ◽  
Bradley Monk ◽  
Jie Ting ◽  
Sonia Pulgar ◽  
Marley Boyd ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Clinical Outcomes ◽  
Real World ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Community Oncology ◽  
Previously Treated

scholarly journals Treatment patterns and clinical outcomes with palbociclib-based therapy received in US community oncology practices

2020 ◽  
Author(s):  
Junji Lin ◽  
Lynn McRoy ◽  
Maxine D Fisher ◽  
Nan Hu ◽  
Cralen Davis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Outcomes ◽  
Real World ◽  
Medical Records ◽  
Metastatic Breast ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Community Oncology ◽  
Label Indication ◽  
Free Rate

Background: Limited studies have evaluated palbociclib-based therapy use in patients with advanced/metastatic breast cancer in the real world. This retrospective study used medical records from US community oncology practices to address the gap. Materials & methods: Eligible patients receiving palbociclib-based therapy per label indication from 3 February 2015 to 31 December 2017 were included. Descriptive analyses were conducted for patient characteristics, treatment patterns and clinical outcomes. Results: The study included 233 patients who received palbociclib + aromatase inhibitor (P+AI) and 48 who received palbociclib + fulvestrant (P+F). Real-world progression-free rate for P+AI was 69.8% (46.8%) at 12 (24) months (P+F: 43.5% [39.9%]) months. Real-world survival rate was 89.8% (71.4%) at 12 (24) months (P+F: 76.3% [65.0%]). Conclusion: The study findings are consistent with previous studies of palbociclib-based therapy.

scholarly journals Treatment Patterns and Outcomes of Relapsed/Refractory Peripheral T-Cell Lymphoma (RR-PTCL) Patients Treated in the Community Oncology Setting

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1656-1656
Author(s):  
Chadi Nabhan ◽  
Jalyna Laney ◽  
Joseph Feliciano ◽  
Choo Hyung Lee ◽  
Andrew J Klink
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Novel Therapies ◽  
Employment Equity ◽  
The Real ◽  
Community Oncology ◽  
The Us ◽  
Equity Ownership

Abstract Introduction: The majority of PTCL cases are pathologically heterogeneous, aggressive and chemorefractory; nearly 70% of patients who undergo induction chemotherapy develop RR disease. Data on how RR-PTCL patients are managed outside of clinical trials and academic settings have not been adequately studied. Understanding how PTCL patients are treated in the real world allows better design of future clinical trials and refined development of novel therapies. This study aimed to describe contemporary treatment patterns, clinical characteristics, and overall survival (OS) among RR-PTCL patients treated in the US community oncology setting. Methods: We conducted a retrospective, observational cohort study of RR-PTCL patients treated between 1/1/2010-12/31/2016. Data were collected from patient medical records abstracted from 30 community oncologists across all geographic areas in the US (38% South, 22% West, 7% Midwest, 26% Northeast, and 7% unknown). Patient characteristics, treatment patterns, adverse events (AEs), physician-reported response to first- and second-line (1L, 2L) treatments, and date of death were collected. Descriptive statistics were calculated to summarize patient characteristics and study outcomes. Median (95% confidence interval [CI]) OS from RR disease was calculated by the Kaplan-Meier method. Results: We analyzed 200 RR PTCL patients (71% received CHOP, 20% received CHOEP, and 9% received another regimen as 1L systemic therapy). The majority (58%) were PTCL not otherwise specified (NOS), 61% were males, and median age was 62 years (range: 20-90) (Table). Overall response rate (ORR) to 1L treatment was 80% (CR, 54%; PR, 26%), and ORR to 2L treatment was 55% (CR, 31%, PR, 24%). Among all PTCL patients and among those with PTCL NOS, the OS (95% CI) from RR disease was 13.0 months (95% 7.0-not estimable) and 9.0 months (95% 6.0-not estimable), respectively (Figure). Median time to RR disease from 1L initiation was 12.9 months. Median durations of 1L and 2L treatments were 4.4 months and 3.7 months, respectively. Among those who continued to 2L therapy, 27% received brentuximab vedotin (2% in combination), 19% received ICE (carboplatin/cisplatin, ifosfamide, etoposide), 13% received romidepsin (2% in combination with pralatrexate), 10% received pralatrexate monotherapy, 7% received GEMOX (gemcitabine, oxaliplatin), and the rest (22%) received other 2L regimens or an unknown regimen (2%). After 1L initiation, only 14/200 (7%) received hematopoietic stem cell transplant (HSCT) and 28/151 (19%) after 2L. AEs resulting in a dose reduction, discontinuation, or hospitalization during 1L treatment and occurring among ≥10% included anemia (39%), thrombocytopenia (27%), neutropenia (23%), mouth sores (16%), diarrhea (15%), neuropathy (14%), febrile neutropenia (13%), and vomiting (10%). Conclusions: While response to 1L treatment in this cohort was high (80%), all developed RR disease (or died), for whom the prognosis remains poor. Very few patients underwent HSCT in any line of therapy. Our data demonstrate the unmet medical need for RR-PTCL patients and the need for novel therapies in the 1L setting. It also underscores the need to better understand factors leading to treatment selection and optimal treatment sequencing in the real world. Disclosures Nabhan: Cardinal Health: Employment, Equity Ownership. Laney:Cardinal Health: Employment, Equity Ownership. Feliciano:Seattle Genetics: Employment, Equity Ownership. Lee:Cardinal Health: Employment. Klink:Cardinal Health: Employment, Equity Ownership.

scholarly journals Real-World Patient Characteristics, Treatment Patterns and Outcomes for Patients with Atypical Hemolytic Uremic Syndrome Who Have Switched from Eculizumab to Ravulizumab in the USA

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 5003-5003
Author(s):  
Yan Wang ◽  
Imad Al-Dakkak ◽  
Katherine Garlo ◽  
Moh-Lim Ong ◽  
Ioannis Tomazos ◽  
...  
Keyword(s):  
Hemolytic Uremic Syndrome ◽  
Clinical Outcomes ◽  
Real World ◽  
Atypical Hemolytic Uremic Syndrome ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Real World Data ◽  
Before And After ◽  
The Usa ◽  
Uremic Syndrome

Abstract Introduction Atypical hemolytic uremic syndrome (aHUS) is a rare disease that can cause irreversible organ damage or death. Ravulizumab is a long-acting complement C5 inhibitor approved in the USA, Europe, and Japan for the treatment of aHUS. Ravulizumab was engineered from eculizumab to leverage its clinical benefits and safety profile while reducing dosing frequency. This study assessed real-world patient characteristics, treatment patterns, and clinical outcomes for adult and pediatric patients with aHUS in the USA who switched from eculizumab to ravulizumab. Methods This retrospective, non-interventional study evaluated the period from January 1, 2012 to March 22, 2021, using US claims data from the Decision Resources Group Real World Data repository. Eligible patients had ≥ 1 medical claim with an aHUS-related International Classification of Diseases 9/10 diagnosis code and ≥ 1 medical or pharmacy claim for treatment with eculizumab or ravulizumab. Patients with evidence of paroxysmal nocturnal hemoglobinuria, myasthenia gravis, neuromyelitis optical spectrum disorder or Shiga toxin Escherichia coli-related hemolytic uremic syndrome in the 3 months prior to their first aHUS-related treatment were excluded. A patient was classified as 'switched' if they had ≥ 1 claim for eculizumab followed by an initial claim for ravulizumab from 14 to 30 days after the last eculizumab claim. Patients were required to have ≥ 3 months of continuous enrollment in the database prior to their first ravulizumab claim. Ravulizumab treatment was considered to be continuous if all treatment intervals were ≤ 63 days. Data extracted included: demographics and clinical characteristics at the time of switching to ravulizumab; treatment patterns (including service setting, treatment history before switching to ravulizumab, and subsequent adherence); and clinical outcomes (dialysis, plasma exchange [PE], kidney transplant, and utilization of other end-stage renal disease [ESRD] services) in the 6 months before and after switching to ravulizumab. Data were summarized using descriptive statistics. Results Overall, 2101 patients had ≥ 1 eculizumab or ravulizumab claim and an aHUS-related diagnosis. Of these patients, 227 had claims for both eculizumab and ravulizumab with ≥ 3 months of continuous enrollment data before the first ravulizumab claim. The median (lower quartile, upper quartile) treatment interval between the last eculizumab claim and the first ravulizumab claim was 15 (14, 41) days. In total, 131 patients met the 'switched' criteria. Table 1 presents patient characteristics at the time of switching from eculizumab to ravulizumab. Outpatient facilities were the most common places of service for initiation of switch to ravulizumab (n = 41/89 patients [46%]); private practice facilities were the most common sites for administration of ravulizumab maintenance treatment (n = 84/213 claims [39%]). Prior to switching to ravulizumab, the median (lower quartile, upper quartile) duration between the first and last eculizumab claim was 788 (252, 1719) days. Among the 95 patients with ≥ 6 months of continuous enrollment after switching to ravulizumab, 73 (77%) patients were treated with ravulizumab continuously for ≥ 6 months. Selected clinical outcomes in the 6 months before and after switching to ravulizumab treatment are presented in Table 2. Although no inferential statistical comparisons were made, data show that fewer switched patients underwent dialysis or utilized other ESRD services in the 6-month post-switch period (with no recorded cases of PE or kidney transplant) compared with the 6-month pre-switch period. Discussion and conclusions This study provides real-world data on clinical characteristics and treatment patterns for patients with aHUS who have switched from eculizumab to ravulizumab. The majority of patients switching to ravulizumab were treated continuously for ≥ 6 months according to the treatment schedule in the prescribing information. Ongoing analyses with longer follow-up time will provide inferential assessment of the clinical and economic impacts of switching to ravulizumab. Figure 1 Figure 1. Disclosures Wang: Alexion: Current Employment; AstraZeneca: Current Employment. Al-Dakkak: Alexion: Current Employment; AstraZeneca: Current Employment. Garlo: Alexion: Current Employment; AstraZeneca: Current Employment. Ong: Alexion: Current Employment; AstraZeneca: Current Employment. Tomazos: Alexion, AstraZeneca Rare Disease: Current Employment. Mahajerin: Alexion: Consultancy; AstraZeneca: Current Employment.

Real-world treatment patterns and clinical outcomes in patients receiving second-line (2L) treatment for advanced or metastatic gastric cancer (GC).

2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 102-102
Author(s):  
Mayur Amonkar ◽  
David Gomez-Ulloa ◽  
Smita Kothari ◽  
Winson Y. Cheung ◽  
Ian Chau ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Clinical Outcomes ◽  
Real World ◽  
Retrospective Chart Review ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Patient Characteristics ◽  
Metastatic Gastric Cancer ◽  
Treatment Patterns ◽  
Randomised Controlled

102 Background: Despite increased survival demonstrated for patients with advanced / metastatic GC due to 2L chemotherapy, different standard of care options exist. This study aims to describe RW treatment patterns and clinical outcomes in patients with advanced / metastatic GC receiving 2L treatment. Methods: Retrospective chart review study conducted in Australia, Canada, Italy and UK. Patients diagnosed with metastatic / unresectable GC receiving 2L treatment between January 2013 and July 2015 were enrolled. Patient characteristics, treatment patterns and clinical outcomes were captured for 12 months from the start of 2L treatment or until death. Results: 280 patients were included (mean age 60.9 years, 68.9% male). Half of the patients (51.8%) received monotherapy in 2L. Among these, taxanes were most prescribed (69.0%) followed by irinotecan (22.1%). Doublet chemotherapy was the most common combination therapy in 2L (75.6%) with fluoropyrimidine + irinotecan (33.3%) being the most used, followed by fluoropyrimidine + platinum (17.8%). Less than a third of patients (29.3%) received subsequent third-line (3L) treatment; 62.7% received monotherapy [mainly taxanes (69.2%) or irinotecan (19.2%)]. Most 3L patients who had combination therapy received a doublet (86.7%), most frequently fluoropyrimidine combined with irinotecan (53.3%) or platinum (20.0%). The majority of 2L patients (93.6%) had received combination therapy as first-line treatment, of whom 67.9% had received triplet chemotherapy, most commonly anthracycline + fluoropyrimidine + platinum (51.1%). Estimated median real-world progression free survival (PFS) and overall survival (OS) after 2L treatment initiation was 3.09 (95% CI: 2.76-3.68) and 6.54 (5.29-7.76) months, respectively, and estimated probability of PFS and OS at 12 months was 8% and 26%, respectively. Conclusions: The clinical management of advanced / metastatic GC patients in 2L treatment commonly involves taxanes or irinotecan as monotherapy, or irinotecan or platinum-based combinations with fluoropyrimidines. RW clinical outcomes for 2L treatment are similar to randomised controlled trials but remain poor.

Real-world evidence of cancer immunotherapy (CIT) combination treatment in first-line (1L) extensive-stage small cell lung cancer (ES-SCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8561-8561
Author(s):  
Eric S. Nadler ◽  
Anupama Vasudevan ◽  
Kalatu Davies ◽  
Yunfei Wang ◽  
Ann Johnson ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Real World ◽  
Performance Status ◽  
Descriptive Analysis ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Combination Regimen ◽  
Duration Of Treatment ◽  
The Real

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]

Evolution of standard of care therapies used for recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC): A real-world analysis of patient health records from 2016 to 2019.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18728-e18728
Author(s):  
Nabil F. Saba ◽  
Soham Shukla ◽  
Kathleen M. Aguilar ◽  
Marc S. Ballas ◽  
Kelly Bell ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Real World ◽  
Data Extraction ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Treatment Discontinuation ◽  
Health Records ◽  
Treatment Regimens ◽  
Community Oncology ◽  
Oncology Practice

e18728 Background: The R/M HNSCC treatment landscape has evolved significantly in recent years, notably with the approval of 2 immuno-oncology agents (IO), pembrolizumab (second-line [2L] approval, 2016; first-line [1L] approval, 2019) and nivolumab (2L approval, 2016). Review of the literature suggests there is limited real-world (rw) data on clinical outcomes and safety associated with chemotherapy (chemo) and IO in R/M HNSCC. These analyses present a review of patient charts to assess rw clinical outcomes and safety in R/M HNSCC, stratified by patient factors. Methods: Data were derived via structured data extraction and manual review of electronic health records (EHRs; January 1, 2016–December 31, 2019) for patients with R/M HNSCC and who initiated systemic treatment at a community oncology practice in The US Oncology Network. Time-to-event endpoints were assessed by unadjusted Kaplan–Meier analyses and included death (rw overall survival [OS]), provider-assessed progression (rw progression-free survival [PFS]), rw duration of response (DoR), and treatment discontinuation (rw time-to-discontinuation [TTD]). Treatment sequences were evaluated following R/M HNSCC diagnosis. Provider-assessed response rates and adverse events (AEs) as captured in the EHRs were reported. Results: Overall, 257 patients who received 1L treatment were included in these analyses; median age was 64 years (range: 21, 90+); the majority of patients were male (77.4%) and white (74.7%), and 17.5% had evaluable PD-L1 status. The most common 1L treatment regimens were nivolumab (18.3%), carboplatin + paclitaxel (16.0%), and pembrolizumab (14.8%). Median follow-up time from treatment initiation was 7.9 months (range: 0.2, 45.9). Of the 174 patients with evaluable response to 1L treatment, overall response rate was 48.5% (95% CI: 38.3, 58.8) for chemo and 40.0% (95% CI: 28.9, 52.0) for IO. Median rwDoR was 7.6 months (95% CI: 5.8, 11.2). Median rwOS was 12.1 months (95% CI: 10.5, 16.6), and median rwPFS was 5.9 months (95% CI: 4.7, 6.8). Median rwTTD was 2.3 months (95% CI: 2.0, 3.2). The top reason for treatment discontinuation was treatment completion (38.5%) for chemo and progression (46.6.%) for IO. The most commonly reported AEs were rash (17.5%), fatigue (14.4%), and nausea (14.4%) for chemo and fatigue (12.4%), rash (7.2%), and anemia (5.2%) for IO. The percentage of AEs that did not require any intervention was 34.4% for chemo and 20.6% for IO. Conclusions: These analyses present rw clinical outcomes for patients with R/M HNSCC in community oncology practices. The proven role of IO continues to evolve, and continued work is needed to best demarcate the use of these agents, in addition to exploration of additional therapeutics for use in R/M HNSCC. Study funding: GlaxoSmithKline (GSK Study 207139).

Sign in / Sign up

Export Citation Format

Share Document