Real-world treatment and outcomes of frontline chemotherapy in patients with metastatic pancreatic cancer.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16249-e16249
Author(s):  
Salwan Al Mutar ◽  
Muhammad Shaalan Beg ◽  
Eric Hansen ◽  
Andrew J. Belli ◽  
Maegan Vaz ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Real World ◽  
Univariate Analysis ◽  
The United States ◽  
Metastatic Pancreatic Cancer ◽  
Future Research ◽  
Real World Data ◽  
The Real ◽  
The Impact

e16249 Background: The difference between the FOLFIRINOX and gemcitabine/nab-paclitaxel (GnP) regimens’ clinical trial designs limit the ability to generate cross-study comparisons. Therefore, there is a significant need to understand the impact of various demographic and clinical characteristics on the effectiveness of these systemic therapies in the real-world treatment setting. This study seeks to compare the real-world outcomes of patients with metastatic pancreatic cancer treated with frontline FOLFIRINOX or GnP. Methods: Patients with primary metastatic pancreatic cancer who received first-line (1L) FOLFIRINOX or GnP were identified in the COTA real-world database. The COTA database is a de-identified database of real-world data (RWD) derived from the electronic health records of healthcare providers in the United States. Real-world overall response rate (rwORR) was calculated as the proportion of patients achieving complete response (CR) or partial response (PR). Overall survival (OS) was calculated using the Kaplan-Meier method and multivariate analyses utilized Cox proportional hazards. Results: The overall qualified cohort (n=236) was stratified by 1L FOLFIRINOX (n=109) or GnP (n=127). Select patient characteristics are shown in table. Patients treated with 1L FOLFIRINOX showed greater rwORR as compared to those treated with GnP (68.8% vs. 55.9%, p=0.04). Additionally, patients treated with 1L FOLFIRINOX had longer median OS (14.4 vs 11.4 mos, respectively). In univariate analysis, patients treated with GnP had a greater chance of mortality (HR: 1.3, 95% CI: 1.0, 1.8, p=0.05). This relationship strengthened in multivariate analysis (GnP treated HR: 1.6, 95% CI: 1.1, 2.1, p=0.01). Conclusions: Due to lack of enrollment of representative patients in clinical trials and in the absence of a comparative clinical trial, real-world experience with chemotherapy regimens provide critical insights on the outcome of treatments. In our cohort, patients treated with frontline GnP had a significantly greater chance of mortality as compared to patients treated with frontline FOLFIRINOX. The FOLFIRINOX cohort also showed greater rwORR. Future research will continue to expand on treatment patterns in subsequent lines of therapy, as well as emerging therapy types, in order to better understand the optimal treatment sequence in metastatic pancreatic cancer.[Table: see text]

scholarly journals Improvement of Treatment Outcomes for Metastatic Pancreatic Cancer: A Real-world Data Analysis

In Vivo ◽  
2018 ◽  
Vol 33 (1) ◽  
pp. 271-276 ◽  
Author(s):  
TAKASHI SASAKI ◽  
RYO KANATA ◽  
IKUHIRO YAMADA ◽  
MASATO MATSUYAMA ◽  
MASATO OZAKA ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Data Analysis ◽  
Treatment Outcomes ◽  
Real World ◽  
Metastatic Pancreatic Cancer ◽  
Real World Data ◽  
World Data

Neoadjuvant chemoradiation (NCRT) for esophageal (EC) or gastroesophageal junction cancer (GEJC): A Canadian single institution real-world experience using the CROSS trial regimen.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 25-25
Author(s):  
Sidra Khalid ◽  
Wilma M. Hopman ◽  
Beatrice Preti ◽  
Anna T. Tomiak ◽  
Kiran Virik
Keyword(s):  
Clinical Trial ◽  
Real World ◽  
Gastroesophageal Junction ◽  
Trial Protocol ◽  
Single Institution ◽  
Real World Data ◽  
Trimodality Therapy ◽  
World Data ◽  
The Real ◽  
The Cross

25 Background: NCRT followed by surgery per the CROSS trial regimen is an accepted standard of care in the treatment of EC and GEJC. When treatments are used in the real-world setting, there are often patient, treatment and potential outcome differences compared to the original clinical trial. The study aim was to assess the real-world application and outcomes of the CROSS trial protocol. Methods: A retrospective chart review was undertaken of 83 patients (pts) with EC or GEJC who were treated from June 2012 to June 2018 with CRT. 65 pts were with NCRT intent to proceed to surgery. Pts’ demographics, clinical, pathological, treatment and surgical characteristics were assessed and exploratory analyses were conducted to review these factors and outcomes. Analyses included Chi-square, t-tests and Kaplan-Meier. Results: For pts who underwent NCRT (n = 65): median age was 68 yrs (range 52-80), male 79%, adenocarcinoma 82%, median (m) tumor length 5 cm, GERD 43%, clinical stage II/III 95%, and BMI > 30 in 37%. 80% completed CRT with RT ≥ 41.4 Gy; of these 88% had ≥ 50.4 Gy. Delay/interruption in chemotherapy occurred in 46% and in RT 37%. Pts who underwent surgery were younger (p = 0.04) and weighed more (p = 0.05). mOS was 37 months (M) v 14 M in those who started CRT ≤ 8 weeks (w) from diagnosis v > 8 w (p = 0.10). The median time from CRT to surgery was 8.9 w. 40 pts had surgery with a complete response in 38% and a R0 resection in 98%. Postoperative major and minor complications occurred in 67%. Those < 75 yrs v ≥ 75 yrs had a mOS of 32 M v 15 M respectively (log rank p = 0.46). 25 pts did not get surgery; 28% was due to death/progression. Pts who proceeded to surgery had a mOS of 35 M v 12 M in pts who did not go to surgery (log rank p = 0.002). Further correlative outcome data will be presented. Conclusions: Real-world data in our center showed patient, tumor and treatment differences compared to the CROSS trial protocol. Despite the broadening of eligibility and treatment criteria, survival in a single institution setting is maintained with trimodality therapy compared to NCRT alone. Real-world data is of value in the assessment of therapeutic validity of clinical trial data.

Use of a real-world data approach to rapidly generate outcomes data following a case study of a novel treatment combination in pancreatic adenocarcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16735-e16735
Author(s):  
Lola Rahib ◽  
Karen Chen ◽  
Allyson J. Ocean ◽  
Changqing Xie ◽  
Austin Duffy ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Partial Response ◽  
Median Time ◽  
Real World ◽  
Clinical Benefit ◽  
Progressive Disease ◽  
Metastatic Pancreatic Cancer ◽  
Precision Oncology ◽  
Real World Data ◽  
World Data

e16735 Background: We use a real-world data approach to report on safety and benefits on metastatic pancreatic cancer pts who were treated with a MEK inhibitor plus hydroxychloroquine (HCQ) after exhausting all other treatment options. MEK inhibition acts on the KRAS pathway, which in turn increases autophagy as a resistance mechanism, furthermore, HCQ inhibits autophagy causing a cytotoxic effect. This combination was shown to diminish tumor volume in xenograft mouse models and a partial response in one heavily pre-treated patients was reported. Methods: XCELSIOR is an IRB approved, patient-centric, real-world data and outcomes registry for developing operational and analytic methods in precision oncology. Searching the XCELSIOR database, we identified 14 pts for whom this regimen had been considered. As part of their participation in XCELSIOR, these patients shared access to their full medical records, which were collected, processed, and abstracted into a 21 CFR 11 compliant database for analysis. We additionally collected de-identified data on 12 pts treated with this combination from five academic centers. Three more patients are expected to start treatment soon. Results: Between March 2018 and January 2020, 15 patients treated with the trametinib/HCQ combination and 3 patients treated with cobimetinib/HCQ were identified in XCELSIOR and five academic institutions. The median age at diagnosis was 64 (range 43-74) and 56% were male. For patients treated with trametinib/HCQ, the median time on treatment was 67 days (range 5-172 days), 11 patients were treated for more than 30 days (median time 97 days). The median PFS for this group was 2.9 months and the median OS was 7.4 months. The clinical benefit rate was 60% for the 10 evaluable patients treated with trametinib/HCQ, 1 patient had a partial response (previously published), 5 had stable disease (for at least 8 weeks) and 4 had progressive disease (physician reported). 2/3 patients treated with cobimetinib/HCQ were on treatment for more than 30 days and all three had progressive disease within 7 weeks. The most common side effects were Grade 1 fatigue and Grade 1/2 rash for both combinations. An additional 3 patients will start treatment soon and will be included in the analysis. Conclusions: Combinatorial MEK and autophagy inhibition was well tolerated in heavily treated metastatic pancreatic cancer patients. Trametinib/HCQ demonstrates some clinical benefit for this group. We demonstrate the feasibility of utilizing real-world data in precision oncology. Clinical trial information: NCT03793088 .

Observational retrospective evaluation of treatment with liposomal irinotecan plus fluorouracil/leucovorin for metastatic pancreatic cancer patients: An Italian large real-world analysis.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 660-660 ◽  
Author(s):  
Antonio Pellino ◽  
Chiara Manai ◽  
Valeria Merz ◽  
Mario Scartozzi ◽  
Michele Milella ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Real World ◽  
Cox Regression ◽  
Phase Iii ◽  
Metastatic Pancreatic Cancer ◽  
Rank Test ◽  
Efficacy And Safety ◽  
Real World Data ◽  
Liposomal Irinotecan ◽  
Ecog Ps

660 Background: In the NAPOLI I phase III trial, Nanoliposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) showed better outcome compared to 5FU/LV in patients with metastatic Pancreatic Cancer (MPC) progressed to 1st- line gemcitabine-based therapy. Aim of this study is to explore the real-world efficacy and safety of 5FU/LV-nal-IRI by a compassionate use programme and to identify potential prognostic factors that could affect survival in this setting. Methods: This is a retrospective multi-center analysis including patients with MPC who received 5FU/LV-nal-IRI after failure of a gemcitabine-based therapy. Survival analyses were carried out by the Kaplan-Meier method. Univariate and multivariate analyses were performed by using the log-rank test and the Cox regression. Results: A total of 296 pts (median age, 69 years, range 30-82; 50% male; ECOG PS 0, 44%) were treated at 11 Italian institutions from June 2016 and November 2018. 34% of the pts have been previously resected on their primary tumor, and 76% received gemcitabine-nabpaclitaxel as 1st - line treatment. 5FU/LV-nal-IRI has been administered as 2nd - line in 72% of the pts, while in 23% of the cases as 3rd - line or more. The median OS was 7.1 months [95% confidence interval (CI) 6.1 - 8.1] and the median PFS was 3.3 months (95% CI 2.9 - 3.6). At six months, OS and PFS rate were 53.4% and 31.4% respectively. ORR was 12% and DCR was 40%. 52% of pts received more than 4 cycle with dose reduction in 148 pts (50%). Most common grade 3 toxicities were neutropenia (14%), diarrhea (11%), anemia (3%), nausea (3%), fatigue (3%), mucositis (2%) and vomiting (1%). Baseline characteristics associated with better OS were ECOG PS 0, normal CEA, neutrophil-to-lymphocyte ratio ≤5 and haemoglobin ≥11 g/dL. Conclusions: These real-world data confirm the efficacy and safety of 5FU/LV-nal-IRI in patients with MPC progressed to a gemcitabine-based therapy, with outcome comparable to NAPOLI-1 even in a less selected population and with more active 1st - line combination therapy. In this cohort, well known prognostic markers has been confirmed, as expected.

Real-world data on usage of scalp cooling for chemotherapy associated alopecia in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18739-e18739
Author(s):  
Nicole Olivia Williams ◽  
Richard Paxman ◽  
Emma Thornhill ◽  
Mahmoud Kassem ◽  
Michael Grimm ◽  
...  
Keyword(s):  
Hair Loss ◽  
Real World ◽  
The United States ◽  
Scalp Cooling ◽  
Real World Data ◽  
The Real ◽  
System A ◽  
The Usa ◽  
Number Of Cycles ◽  
Cancer Network

e18739 Background: Hair loss is a well-known side effect of chemotherapy. The Paxman Hair Loss Prevention System, a scalp cooling device, has been shown to be effective in reducing chemotherapy induced alopecia in patients receiving chemotherapy (Nangia, JAMA, 2017). The National Comprehensive Cancer Network and the European Society for Medical Oncology guidelines have recommended scalp cooling as category 2A and 2B options, respectively. Methods: The real world use of scalp cooling using the Paxman device, as documented by orders through the Paxman Hub during the years of 2017-2020 was summarized. Descriptive statistics were used to summarize demographics and utilization. Results: Data from 6649 patients who used scalp cooling were reviewed. Patients with breast cancer were the most common users of scalp cooling (78%, n=5197) followed by gynecology (12%, n=775), gastrointestinal (3%, n=201), lung (1%, n=81) and genitourinary (1%, n=52). The majority of patients were between the ages of 45-65 (55%), followed by 65-74 (18%), older than 75 (5%), and 25-44 (2%). Average number (#) of cycles of cooling completed was 6.53 (range of average # of cycles 4.50-12). Scalp cooling with this device was commonly used in 39 out of 50 states. Conclusions: This is the largest report of scalp cooling usage in the real world setting in the USA, including scalp cooling usage in older adults. Uptake of scalp cooling across various cancers has not been uniform and this deserves further study.

scholarly journals Clinical significance of site-specific metastases in pancreatic cancer: a study based on both clinical trial and real-world data

2021 ◽  
Vol 12 (6) ◽  
pp. 1715-1721
Author(s):  
Lixia Wu ◽  
Lina Zhu ◽  
Kequn Xu ◽  
Siyuan Zhou ◽  
Yang Zhou ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Clinical Trial ◽  
Clinical Significance ◽  
Real World ◽  
Real World Data ◽  
Site Specific ◽  
World Data

Patient characteristics and pre-existing chronic diseases with COVID-19 related outcomes: a real-world experience (Preprint)

2020 ◽  
Author(s):  
Hua Zhao ◽  
Bernard Fuemmeler ◽  
Tilahun Adera ◽  
EVAN Leung ◽  
Silviu-Alin Bacanu ◽  
...  
Keyword(s):  
United States ◽  
Chronic Diseases ◽  
Real World ◽  
Black Male ◽  
Kidney Diseases ◽  
Univariate Analysis ◽  
Patient Characteristics ◽  
The United States ◽  
Real World Data ◽  
Increased Risk

BACKGROUND Significant variations in experience of the COVID-19 pandemic have been observed in the United States. However, there is currently no published study which comprehensively examines the relationship between patient characteristics and COVID-19 related health outcomes. OBJECTIVE In this study, using aggregated real-world data extracted from TriNetx electronic medical record data from 34 hospitals around United States, we intended to fill the gap. METHODS A total of 12,555 patients aged 18-80 years old who contracted COVID-19 were identified from January 20th to April 20th, 2020. RESULTS First, in the univariate analysis, we found that patients who were older (age 51-80), Black, male, and had pre-existing chronic diseases (e.g. obesity, diabetes, hypertension, and chronic kidney diseases (CKD)) had increased risk ratio (RR) of exhibiting severe outcomes, including increased C-reactive protein (CRP), decreased oxygen saturation, hospitalization, use of ventilator, and ultimately death. Next, we applied propensity score matching to match the patients based on their characteristics. We found that patients who were older, Black, male, and diagnosed with CKD had 3.69, 1.77, 1.75, and 1,61-fold increased RR of death. On the other hand, while obesity, diabetes, and hypertension had no direct relationship with death, they were associated with other severe outcomes. In further analysis by including CRP as a matching variable, death disparity by age group, race, gender, and CKD was reduced, particularly for race and CKD where a significant disparity was no longer observed. CONCLUSIONS In summary, our data show significant disparities in COVID-19 related outcomes by patient characteristics and further suggest that acute inflammation plays an important role in the disparity in COVID-19 death.

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