scholarly journals Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set

ESMO Open ◽  
2018 ◽  
Vol 3 (3) ◽  
pp. e000347 ◽  
Author(s):  
Axel Grothey ◽  
Takayuki Yoshino ◽  
Gyorgy Bodoky ◽  
Tudor Ciuleanu ◽  
Rocio Garcia-Carbonero ◽  
...  

BackgroundIn the RAISE trial, ramucirumab+leucovorin/fluorouracil/irinotecan (FOLFIRI) improved the median overall survival (mOS) of patients with previously treated metastatic colorectal cancer versus patients treated with placebo+FOLFIRI but had a higher incidence of neutropaenia, leading to more chemotherapy dose modifications and discontinuations. Thus, we conducted an exploratory post-hoc analysis of RAISE and a retrospective, observational analysis of electronic medical record (EMR) data to determine and verify the association of neutropaenia, baseline absolute neutrophil count (ANC) and survival.MethodsThe RAISE analysis used the study safety population (n=1057). IMS Health Oncology Database (IMS EMR) was the source for the real-world data set (n=617).ResultsRAISE patients with treatment-emergent neutropaenia had improved mOS compared with those without (ramucirumab arm: 16.1 vs 10.7 months, HR=0.57, p<0.0001; placebo arm: 12.7 vs 10.7 months, HR=0.76, p=0.0065). RAISE patients with low ANC versus high baseline ANC also had longer mOS (ramucirumab arm: 15.2 vs 8.9 months, HR=0.49, p<0.0001; placebo arm: 13.2 vs 7.3 months, HR=0.50, p<0.0001). The results were similar for IMS EMR low versus high baseline ANC (bevacizumab+FOLFIRI patients: 14.9 vs 7.7 months, HR=0.59, p<0.0001; FOLFIRI alone: 14.6 vs 5.4 months, HR=0.37, p<0.0001). Patients in the RAISE trial with low baseline ANC were more likely to develop neutropaenia (OR: ramucirumab arm=2.62, p<0.0001; placebo arm=2.16, p=0.0003).ConclusionNeutropaenia during treatment, and subsequent dose modifications or discontinuations, do not compromise treatment efficacy. Baseline ANC is a strong prognostic factor for survival and is associated with treatment-emergent neutropaenia in the analysed population.Trial registration numberNCT01183780, Results.

2021 ◽  
Vol 28 (3) ◽  
pp. 2260-2269
Author(s):  
Daniel Tong ◽  
Lei Wang ◽  
Jeewaka Mendis ◽  
Sharadah Essapen

In the UK, Trifluridine-tipiracil (Lonsurf) is used to treat metastatic colorectal cancer in the third-line setting, after prior exposure to fluoropyrimidine-based regimes. Current data on the real-world use of Lonsurf lack long-term follow-up data. A retrospective evaluation of patients receiving Lonsurf at our Cancer Centre in 2016–2017 was performed, all with a minimum of two-year follow-up. Fifty-six patients were included in the review. The median number of cycles of Lonsurf administered was 3. Median follow-up was 6.0 months, with all patients deceased at the time of analysis. Median progression-free survival (PFS) was 3.2 months, and overall survival (OS) was 5.8 months. The median interval from Lonsurf discontinuation to death was two months, but seven patients received further systemic treatment and median OS gained was 12 months. Lonsurf offered a slightly better PFS but inferior OS to that of the RECOURSE trial, with PFS similar to real-world data previously presented. Interestingly, 12.5% had a PFS > 9 months, and this cohort had primarily left-sided and RAS wild-type disease. A subset received further systemic treatment on Lonsurf discontinuation with good additional OS benefit. Lonsurf may alter the course of disease for a subset of patients, and further treatment on progression can be considered in carefully selected patients.


2015 ◽  
Vol 2 (2) ◽  
pp. 82
Author(s):  
Monica Alvarado ◽  
Hilary Kershberg ◽  
George Tiller ◽  
Patty Miller ◽  
Ivan Lizarraga ◽  
...  

2018 ◽  
Vol 103 (6) ◽  
pp. 837-843 ◽  
Author(s):  
Alastair K Denniston ◽  
Aaron Y Lee ◽  
Cecilia S Lee ◽  
David P Crabb ◽  
Clare Bailey ◽  
...  

AimTo assess the impact of deprivation on diabetic retinopathy presentation and related treatment interventions, as observed within the UK hospital eye service.MethodsThis is a multicentre, national diabetic retinopathy database study with anonymised data extraction across 22 centres from an electronic medical record system. The following were the inclusion criteria: all patients with diabetes and a recorded, structured diabetic retinopathy grade. The minimum data set included, for baseline, age and Index of Multiple Deprivation, based on residential postcode; and for all time points, visual acuity, ETDRS grading of retinopathy and maculopathy, and interventions (laser, intravitreal therapies and surgery). The main  outcome measures were (1) visual acuity and binocular visual state, and (2) presence of sight-threatening complications and need for early treatment.Results79 775 patients met the inclusion criteria. Deprivation was associated with later presentation in patients with diabetic eye disease: the OR of being sight-impaired at entry into the hospital eye service (defined as 6/18 to better than 3/60 in the better seeing eye) was 1.29 (95% CI 1.20 to 1.39) for the most deprived decile vs 0.77 (95% CI 0.70 to 0.86) for the least deprived decile; the OR for being severely sight-impaired (3/60 or worse in the better seeing eye) was 1.17 (95% CI 0.90 to 1.55) for the most deprived decile vs 0.88 (95% CI 0.61 to 1.27) for the least deprived decile (reference=fifth decile in all cases). There is also variation in sight-threatening complications at presentation and treatment undertaken: the least deprived deciles had lower chance of having a tractional retinal detachment (OR=0.48 and 0.58 for deciles 9 and 10, 95% CI 0.24 to 0.90 and 0.29 to 1.09, respectively); in terms of accessing treatment, the rate of having a vitrectomy was lowest in the most deprived cohort (OR=0.34, 95% CI 0.19 to 0.58).ConclusionsThis large real-world study suggests that first presentation at a hospital eye clinic with visual loss or sight-threatening diabetic eye disease is associated with deprivation. These initial hospital visits represent the first opportunities to receive treatment and to formally engage with support services. Such patients are more likely to be sight-impaired or severely sight-impaired at presentation, and may need additional resources to engage with the hospital eye services over complex treatment schedules.


Author(s):  
M Tonelli ◽  
M Scaldaferri ◽  
S Bustreo ◽  
L Fanchini ◽  
G Ritorto ◽  
...  

Cancers ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 844 ◽  
Author(s):  
Kei Muro ◽  
Taylor Salinardi ◽  
Arvind Rup Singh ◽  
Teresa Macarulla

Background: Metastatic colorectal cancer (mCRC) represents a substantial health burden globally and an increasing challenge in Asian countries. Treatment options include chemotherapy plus a vascular endothelial growth factor (VEGF) inhibitor (such as bevacizumab, aflibercept or ramucirumab), or anti-epidermal growth factor receptor (EGFR) therapies. Aflibercept, a recombinant fusion protein, has been approved for treatment of mCRC in combination with FOLFIRI for patients whose disease progresses during or after treatment with an oxaliplatin-containing regimen, based on its efficacy and tolerability profile in clinical trials. This report aims to provide an overview of both clinical and real-world evidence and experience on the use of aflibercept in routine clinical practice, with a focus on European, American and Asian populations. Methods: A literature search was conducted in PubMed (on 28th February 2019) using the search terms ("aflibercept") and ("Colorectal"OR"CRC") to identify publications containing information on aflibercept-containing regimens. Results: The adverse events (AE) profile was similar between geographical locations. Across trials, real-world and retrospective studies, grade ≥ 3 hypertension and proteinuria were amongst the most frequently reported AEs. Conclusions: The safety profile of aflibercept is generally manageable and comparable across various geographic locations.


2017 ◽  
Vol 11 (9) ◽  
pp. 751-760 ◽  
Author(s):  
George Kafatos ◽  
Daniela Niepel ◽  
Kimberley Lowe ◽  
Sophie Jenkins-Anderson ◽  
Hal Westhead ◽  
...  

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 24-24
Author(s):  
Chinelo C. Orji ◽  
Carolyn M. Brown ◽  
J. Russell Hoverman ◽  
Kristin M. Richards

24 Background: Current American Society of Clinical Oncology (ASCO) guidelines recommend prophylactic use of colony stimulating factors (CSF) for prevention of febrile neutropenia among cancer patients. ASCO also recommends chemotherapy dose reduction as a viable alternative to CSF administration, which may result in cost savings to patients and payers, but adherence to these guidelines has been less than ideal. The objectives of this study were i.) to determine the prevalence and prescribing patterns of CSF and dose reduction in metastatic colorectal cancer patients and ii.) to evaluate the impact of a program initiative on CSF prescribing patterns and on compliance to ASCO guidelines. Methods: In this retrospective study, we utilized data from the electronic health records of metastatic colorectal cancer patients who received care at a multi-center oncology practice network during two time periods: July 2013 to December 2014 and July to December 2017. In 2016, a site-wide program initiative that involved educational materials, appropriate non-use recommendations and prior authorization was introduced in the oncology practice network with an aim of reducing CSF overutilization. Descriptive statistics and chi squared tests were employed to explore CSF utilization across patient age, gender, disease, year of diagnosis, febrile neutropenia risk, line of therapy and duration of treatment. Results: There were 3426 chemotherapy regimens corresponding to 2968 patients. There was a total of 3095 CSF administrations and the CSF administered was pegfilgrastim. There were 343 (10%) CSF users. Among subjects who had data on dose reduction (N = 508), 58.7% received dose reduction. CSF use was significantly lower in the post-period, compared to the pre-period (p < 0.0001). Compliance to guidelines was significantly higher in the post-period, compared to the pre-period (p < 0.0001). Conclusions: Our results demonstrate that program initiatives have the potential to positively impact CSF prescription patterns. These findings could help prescribers adopt a cost-effective approach for this population, leading to enhanced clinical practice and value-based care.


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