scholarly journals Severe Neutropenia is Associated with Better Clinical Outcomes in Patients with Advanced Pancreatic Cancer Who Receive Modified FOLFIRINOX Therapy

Cancers ◽  
2018 ◽  
Vol 10 (11) ◽  
pp. 454 ◽  
Author(s):  
Yunami Yamada ◽  
Hironori Fujii ◽  
Daichi Watanabe ◽  
Hiroko Kato-Hayashi ◽  
Koichi Ohata ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Bolus Injection ◽  
Advanced Pancreatic Cancer ◽  
Significant Risk ◽  
Total Bilirubin Level ◽  
Severe Neutropenia ◽  
Prior History

While modified FOLFIRINOX therapy is effective for treating advanced pancreatic cancer, it frequently causes severe neutropenia. The present study investigated the effect of severe neutropenia on clinical outcomes in advanced pancreatic cancer patients who received modified FOLFIRINOX. The study subjects were 51 patients (30 males and 21 females) with advanced pancreatic cancer who received modified FOLFIRINOX (2h bolus injection of oxaliplatin at 85 mg/m2, 2 h bolus injection of L-leucovorin at 200 mg/m2, 90min bolus injection of irinotecan at 150 mg/m2, followed by continuous infusion of 5-fluorouracil for 46 h at 2400 mg/m2 without bolus 5-fluorouracil) during the period from January 2014 to May 2018. No patients had prior history of chemotherapy. Adverse events, including neutropenia, were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Median overall survival (OS) was the primary endpoint, while median time to treatment failure (TTF), overall response rate (ORR), and the incidence of other adverse events were secondary endpoints. Severe neutropenia (grade ≥3) occurred in 39 patients (76.4%), and Cox proportional hazard analysis identified high total bilirubin level as a significant risk factor. Median duration of OS was significantly longer in patients with severe neutropenia than in those without it (21.3 months versus 8.9 months, p = 0.020). Moreover, there was a significant correlation between OS and the grade of neutropenia (r = 0.306, p = 0.029). ORR tended to be higher, though not significantly, in patients with severe neutropenia. In contrast, the incidence rates of other adverse events were not different between the two groups. Severe neutropenia is an independent predictor of prognosis in advanced pancreatic cancer patients received modified FOLFIRINOX therapy.

scholarly journals Severe neutropenia is associated with better clinical outcomes in patients with advanced pancreatic cancer who received modified FOLFIRINOX therapy

2018 ◽  
Author(s):  
Yunami Yamada ◽  
Hironori Fujii ◽  
Daichi Watanabe ◽  
Hiroko Kato-Hayashi ◽  
Koichi Ohata ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Advanced Pancreatic Cancer ◽  
Significant Risk ◽  
Multivariate Logistic Regression Analysis ◽  
Incidence Rates ◽  
Severe Neutropenia ◽  
High Level

Modified FOLFIRINOX is effective for advanced pancreatic cancer but frequently causes severe neutropenia. The present study was designed to investigate the influence of severe neutropenia on clinical outcomes in advanced pancreatic cancer patients receiving modified FOLFIRINOX. Fifty-one advanced pancreatic cancer patients who received modified FOLFIRINOX during January 2014 and May 2018 were subjects of the present study. Adverse events, including neutropenia, were graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Median overall survival (OS) was determined as the primary endpoint, while median time to treatment failure (TTF), overall response rate (ORR), and the incidence of other adverse events were measured as secondary endpoints. Severe neutropenia (grade≥3) occurred in 39 patients (76.4%), in which high level of total bilirubin (>0.6mg/dL) was a significant risk as assessed by a multivariate logistic regression analysis. Median duration of OS was significantly longer in patients with severe neutropenia than in those without it (15.2 months versus 7.2 months, P=0.032). Moreover, there was a significant correlation between OS and the grade of neutropenia (R=0.306, P=0.029). ORR tended to be higher, though not significantly, in patients with severe neutropenia. In contrast, the incidence rates of other adverse events were not different between the two groups. Severe neutropenia is an independent predictor of prognosis in advanced pancreatic cancer patients received modified FOLFIRNOX therapy.

scholarly journals P31-7 Clinical outcomes of cerebral infarction associated with Trousseau’s syndrome in advanced pancreatic cancer patients

2021 ◽  
Vol 32 ◽  
pp. S350
Author(s):  
Tomoyo Oguri ◽  
Hiroyuki Takeda ◽  
Kumiko Umemoto ◽  
Ayako Doi ◽  
Hiroyuki Arai ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cerebral Infarction ◽  
Cancer Patients ◽  
Clinical Outcomes ◽  
Advanced Pancreatic Cancer ◽  
Trousseau’S Syndrome

scholarly journals Identification of a Predictive Biomarker for Hematologic Toxicities of Gemcitabine

2009 ◽  
Vol 27 (13) ◽  
pp. 2261-2268 ◽  
Author(s):  
Junichi Matsubara ◽  
Masaya Ono ◽  
Ayako Negishi ◽  
Hideki Ueno ◽  
Takuji Okusaka ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Statistical Significance ◽  
Advanced Pancreatic Cancer ◽  
Area Under The Curve ◽  
Predictive Ability ◽  
Predictive Biomarker ◽  
Severe Neutropenia ◽  
Current Standard ◽  
Grade 3

PurposeGemcitabine monotherapy is the current standard for patients with advanced pancreatic cancer, but the occurrence of severe neutropenia and thrombocytopenia can sometimes be life threatening. This study aimed to discover a new diagnostic method for predicting the hematologic toxicities of gemcitabine.Patients and MethodsUsing quantitative mass spectrometry (MS), we compared the baseline plasma proteomes of 25 patients who had developed severe hematologic adverse events (grade 3 to 4 neutropenia and/or grade 2 to 4 thrombocytopenia) within the first two cycles of gemcitabine with those of 22 patients who had not (grade 0).ResultsWe identified 757 peptide peaks whose intensities were significantly different (P < .001, Welch t test) among a total of 60,888. The MS peak with the highest statistical significance (P = .0000282) was revealed to be derived from haptoglobin by tandem MS. A scoring system (nomogram) based on the values of haptoglobin, haptoglobin phenotype, neutrophil count, platelet count, and body-surface area was constructed to estimate the risk of hematologic adverse events (grade 3 to 4 neutropenia and/or grade 2 to 4 thrombocytopenia) with an area under curve value of 0.782 in a cohort of 166 patients with pancreatic cancer. Predictive ability of the system was confirmed in two independent validation cohorts consisting of 87 and 52 patients with area under the curve values of 0.655 and 0.747, respectively.ConclusionAlthough the precise mechanism responsible for the correlation of haptoglobin with the future onset of hematologic toxicities remains to be clarified, our prediction model seems to have high practical utility for tailoring the treatment of patients receiving gemcitabine.

Improving FOLFIRINOX safety in pancreatic cancer patients through multidimensional remote monitoring and proactive care using a domomedecine mobile platform.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. TPS4673-TPS4673
Author(s):  
Mohamed Bouchahda ◽  
Sandra Komarzynski ◽  
Ayhan Ulusakarya ◽  
Amal Attari ◽  
Alban Duprès ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Real Time ◽  
Cancer Patients ◽  
Hospital Admissions ◽  
Performance Status ◽  
Advanced Pancreatic Cancer ◽  
Treatment Compliance ◽  
Critical Parameters ◽  
Severe Adverse Events

TPS4673 Background: Pancreatic cancer is a poor prognosis and fast-growing cancer, whose five-year survival is 6% in Europe and the US. FOLFIRINOX has been established as the reference medical treatment for this disease worldwide, yet it also causes leuko-neutropenia, thrombocytopenia, diarrhea, anorexia, asthenia, weight loss, and peripheral sensory neuropathy. Its indication is usually limited to patients having a WHO performance status of 0 or 1. This treatment is often interrupted once Grade 3-4 clinical or hematological toxicities occur, resulting in poor patient performance status and quality of life. Presently, no prospective study monitor and evaluate the qualitative and quantitative effects of FOLFIRINOX on the daily life of pancreatic cancer patients in real-time. Such monitoring would provide early warning signals for the identification of any improvement or deterioration of the patient condition. Whenever necessary, proactive interventions would be triggered to avoid emergency hospitalization for severe adverse events and to enhance treatment compliance. Methods: Our study involves the use of the mobile e-Health platform PiCADo (JMIR 2018) to track and analyse circadian rhythms, symptoms, and body weight in real time in 45 advanced pancreatic cancer patients at 4 centres. The patients are continuously telemonitored for rest-activity, temperature and 3D-orientation via a BLE sensor during the six weeks following the first FOLFIRINOX course. Patients weigh themselves daily on a BLE scale and self-rate their symptoms using a touchscreen on GPRS tablet. Alerts are generated according to preset yet modifiable thresholds of automatically computed critical parameters. From these data, we will evaluate the rate of emergency hospital admissions and the admission-free survival, the rates of severe adverse events, patients’ symptoms dynamics, and their relations with the disruption of the patients’ circadian rhythm. Patient satisfaction and research experience will also be assessed, since engagement is at the core of the success of the approach. The results will guide a future randomized trial comparing standard pancreatic cancer patient care with a personalized FOLFIRINOX approach, including chronotherapy delivery. Support: Ramsay-Sante, Altran.

scholarly journals Efficacy and Safety of the Combination of Nano-Liposomal Irinotecan and 5-Fluorouracil/L-Leucovorin in Unresectable Advanced Pancreatic Cancer: A Real-World Study

2022 ◽  
Author(s):  
Hidetoshi Yasuoka ◽  
Atsushi Naganuma ◽  
Eishin Kurihara ◽  
Tsutomu Kobatake ◽  
Masashi Ijima ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Real World ◽  
Advanced Pancreatic Cancer ◽  
Gastrointestinal Symptoms ◽  
Significant Risk ◽  
Prognostic Indicators ◽  
Second Line ◽  
Efficacy And Safety ◽  
Liposomal Irinotecan

Abstract Aim: This retrospective study investigated the efficacy and safety of nano-liposomal irinotecan (nal-IRI) plus 5-fluorouracil/l-leucovorin (5-FU/l-LV) treatment in the second-line or later setting for advanced pancreatic cancer under real-world conditions.Methods: Between June 2020 and September 2021, a total of 44 patients with unresectable advanced pancreatic cancer treated with nal-IRI + 5-FU/l-LV in our affiliated hospitals were included. The prognosis, predictive factors (including systemic inflammation-based prognostic indicators), and adverse events were investigated.Results: The median age was 68 (interquartile range [IQR] 62-73) years old, and 22 patients (50.0%) were male. Concerning tumor factors, 9 patients (20.5%) had local advanced disease, and 35 patients (79.5%) had metastases. Twenty-five of the 44 patients were receiving second-line treatment, and 19 were receiving third-line or later treatment. The median overall survival (OS) and progression free survival (PFS) were 9.0 (range, 0.7-15.4) months and 4.4 (range, 0.6-15.4) months, respectively. The overall response rate (ORR) was 5.3%. The disease control rate (DCR) was 44.7%. Patients with a neutrophil-to-lymphocyte ratio (NLR) of >2.7 had a significant risk of a poor OS (HR=0.275, P=0.017). Adverse events were manageable, although gastrointestinal symptoms and neutropenia were observed. The most common grade ≥3 adverse event was neutropenia, which was reported in 20% of patients.Conclusions: Nal-IRI + 5-FU/l-LV therapy was considered to be a useful regimen as second-line or later treatment for unresectable advanced pancreatic cancer, even in clinical practice.

scholarly journals Clinical Outcomes of Digital Cholangioscopy-Guided Procedures for the Diagnosis of Biliary Strictures and Treatment of Difficult Bile Duct Stones: A Single-Center Large Cohort Study

2021 ◽  
Vol 10 (8) ◽  
pp. 1638
Author(s):  
Hirohito Minami ◽  
Shuntaro Mukai ◽  
Atsushi Sofuni ◽  
Takayoshi Tsuchiya ◽  
Kentaro Ishii ◽  
...  
Keyword(s):  
Bile Duct ◽  
Adverse Events ◽  
Clinical Outcomes ◽  
Significant Risk ◽  
Histopathological Analysis ◽  
Bile Duct Stones ◽  
Serious Adverse Events ◽  
Visualization System ◽  
Visual Impression ◽  
Number Of Patients

Although Spy DS (SpyGlass DS Direct Visualization System) is considered to be useful for the diagnosis of bile duct strictures and the treatment of bile duct stones, there is limited data to date validating its efficacy. We hence retrospectively evaluated the clinical outcomes of the use of Spy DS in a large number of patients. A total of 183 patients who underwent Spy DS-guided procedures for indeterminate bile duct strictures (n = 93) and bile duct stones (n = 90) were analyzed retrospectively. All patients (93/93) with bile duct strictures successfully underwent visual observation, and 95.7% (89/93) of these patients successfully underwent direct biopsy. The sensitivity, specificity, and overall accuracy were 94.7%, 83.3%, and 90.3%, respectively, for visual impression; 80.9%, 100%, and 89.2%, respectively, for histopathological analysis of a direct biopsy; and 96.5%, 91.7%, and 94.6%, respectively, for visual impression combined with biopsy. Successful visualization of the stones was achieved in 98.9% (89/90) of the patients, and complete stone removal was achieved in 92.2% (83/90) of the patients, with an average of 3.3 procedures. The adverse events rate was 17.5% (32/183; cholangitis in 15 patients, fever the following day in 25, pancreatitis in 1, hemorrhage in 1, and gastrointestinal perforation in 1). No administration of antibiotics before the procedure was found to be a statistically significant risk factor for the development of fever after the procedure (p < 0.01). Spy DS-guided procedures are effective for the diagnosis and treatment of bile duct lesions and can be performed with a low risk of serious adverse events.

Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy following FOLFIRINOX in Patients with Unresectable Pancreatic Cancer: A Single-Institution, Retrospective Analysis

Chemotherapy ◽  
2021 ◽  
pp. 1-7
Author(s):  
Kotone Hayuka ◽  
Hiroyuki Okuyama ◽  
Akitsu Murakami ◽  
Yoshihiro Okita ◽  
Takamasa Nishiuchi ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Unresectable Pancreatic Cancer ◽  
Line Treatment ◽  
Second Line ◽  
Free Survival ◽  
Common Grade ◽  
Grade 3

<b><i>Introduction:</i></b> Patients with advanced pancreatic cancer have a poor prognosis. FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP) have been established as first-line treatment, but they have not been confirmed as second-line treatment after FFX. The aim of this study was to evaluate the safety and efficacy of GnP as second-line therapy after FFX in patients with unresectable pancreatic cancer. <b><i>Methods:</i></b> Twenty-five patients with unresectable pancreatic cancer were enrolled. The patients were treated with GnP after FFX between September 2015 and September 2019. Tumor response, progression-free survival (PFS), overall survival (OS), and incidence of adverse events were evaluated. <b><i>Results:</i></b> The response rate, disease control rate, median PFS, and median OS were 12%, 96%, 5.3 months, and 15.6 months, respectively. The common grade 3 or 4 adverse events were neutropenia (76%) and anemia (16%). <b><i>Conclusions:</i></b> GnP after FOLFIRINOX is expected to be one of the second-line recommendations for patients with unresectable pancreatic cancer.

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