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 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 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

Risk factors of chemotherapy-induced nausea and vomiting in patients with advanced pancreatic cancer receiving modified FOLFIRINOX.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 344-344
Author(s):  
Akira Shinohara ◽  
Masafumi Ikeda ◽  
Ai Irisawa ◽  
Misaki Kobayashi ◽  
Ryoko Udagawa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Pancreatic Cancer ◽  
Adverse Events ◽  
Treatment Cycle ◽  
Advanced Pancreatic Cancer ◽  
Incidence Rates ◽  
Nausea And Vomiting ◽  
Cancer Center ◽  
Younger Age ◽  
Delayed Cinv

344 Background: Modified FOLFIRINOX (mFFX) has been reported to be a high incidence of chemotherapy-induced nausea and vomiting (CINV). However, CINV is difficult to adequately control in patients receiving treatment with mFFX. The aim of this study is to evaluate the incidence of delayed CINV and to identify as risk factors for CINV in patients receiving treatment with mFFX. Methods: The study subjects were patients with advanced pancreatic cancer treated with mFFX from December 2013 to June 2015 at National Cancer Center Hospital East. The mFFX regimen consisted of oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, l-leucovorin 200 mg/m2 and a 46-h continuous infusion of fluorouracil 2400 mg/m2. The antiemetic prophylaxis consisted of aprepitant (125 mg on day1 and 80 mg on day 2-3), palonosetron (0.75 mg on day1) and dexamethasone (12 mg on day1 and 8 mg on day 2-3). All adverse events, including nausea and vomiting were graded according to the Common Toxicity Criteria for Adverse Events (CTCAE version 4.0). Results: A total of 115 patients were enrolled in this study. The incidence rates of nausea and vomiting of any grade during the first treatment cycle were 45.2% and 5.2%, respectively. Grade 2-3 of nausea and vomiting were observed in 13.9% and 0.9% of the patients, respectively. Any grade of CINV occurred frequently during days 4 to 7 for the first treatment cycle. Univariate and multivariate analyses identified female and younger age ( < 50 years) as significant independent factors associated with the incidence of any grade of CINV on days 4 to 7 for the first treatment cycle (Odds ratio [OR], 7.44; 95%CI, 2.21 to 25.1; p = 0.001; OR, 4.57; 95% CI, 1.04 to 20.1; p = 0.044). Conclusions: The risk factors of delayed CINV for the first treatment cycle were identified as female and younger age in patients treated with mFFX. Therefore, in patients with these risk factors, additional dexamethasone should be considered as an antiemetic treatment on day 4-5.

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.

scholarly journals Risk factors for severe neutropenia in pancreatic cancer patients treated with gemcitabine/nab-paclitaxel combination therapy

PLoS ONE ◽  
2021 ◽  
Vol 16 (7) ◽  
pp. e0254726
Author(s):  
Genta Ito ◽  
Kazuyoshi Kawakami ◽  
Takeshi Aoyama ◽  
Takashi Yokokawa ◽  
Masashi Nakamura ◽  
...  
Keyword(s):  
Risk Factors ◽  
Pancreatic Cancer ◽  
Combination Therapy ◽  
Cancer Patients ◽  
Clinical Data ◽  
Multivariate Logistic Regression Analysis ◽  
Severe Neutropenia ◽  
Reference Ranges ◽  
Laboratory Values ◽  
Grade 3

Aim Combination therapy with gemcitabine and nanoparticle albumin-bound paclitaxel (nab-paclitaxel), known as GnP therapy, significantly prolongs the survival of pancreatic cancer patients compared with gemcitabine monotherapy. However, it may cause severe neutropenia, requiring discontinuation of treatment. This study aimed to clarify the risk factors for Grade 3/4 neutropenia during GnP therapy. Methods Clinical data of pancreatic cancer patients who underwent GnP therapy at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research from December 2014 to December 2016 were retrospectively collected. The relationship of Grade 3/4 neutropenia onset to laboratory values and patient background factors was investigated by multivariate logistic regression analysis. Results Clinical data of 222 patients were analyzed. Grade 3/4 neutropenia occurred in 118 patients (53.2%) in the first cycle of GnP therapy. Multivariate analysis identified low absolute neutrophil count (ANC), high total bilirubin (T-Bil), and low C-reactive protein (CRP) as risk factors for Grade 3/4 neutropenia. Age was not a risk factor. The incidence of neutropenia was 85.7% in patients with all three risk factors, but only 27.7% in patients with none of them. Conclusion Low ANC, high T-Bil, and low CRP may be risk factors for Grade 3/4 neutropenia in patients receiving GnP therapy, even if these laboratory values are within normal reference ranges. Patients with these risk factors should be carefully monitored for adverse events.

Risk factors for severe neutropenia among pancreatic cancer patients receiving nab-paclitaxel and gemcitabine combination therapy.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 684-684
Author(s):  
Kazuyoshi Kawakami ◽  
Genta Ito ◽  
Takeshi Aoyama ◽  
Takashi Yokokawa ◽  
Masashi Nakamura ◽  
...  
Keyword(s):  
Risk Factors ◽  
Pancreatic Cancer ◽  
Combination Therapy ◽  
Significant Risk ◽  
Multivariate Logistic Regression Analysis ◽  
Previous Treatment ◽  
Severe Neutropenia ◽  
Limiting Factor ◽  
Clinical Settings ◽  
Grade 3

684 Background: Albumin-bound paclitaxel (nab-paclitaxel) and gemcitabine combination therapy (GnP therapy) significantly extends overall survival in patients with metastatic pancreatic cancer, compared to conventional gemcitabine monotherapy. However, severe neutropenia (Grade ≥ 3) occurred in 67.6% of patients in the Japanese phase I/II trials of GnP therapy, and is often a limiting factor. The purpose of this study was to identify the risk factors for severe neutropenia in pancreatic patients receiving GnP therapy in clinical settings. Methods: A retrospective study of 222 consecutive patients with pancreatic cancer who received GnP therapy at the Cancer Institute Hospital from December 2014 to December 2016 was conducted. Univariate and multivariate analyses were used to compare blood test values and patients’ characteristics between patients with no neutropenia or Grade 1/2 (non-serious) neutropenia and those with Grade ≥ 3 (severe) neutropenia. Results: There were 19 patients (8.6%) with modified FOLFIRINOX in the previous treatment history. The median doses of nab-paclitaxel and gemcitabine were 192.5 mg (range 134-277.5) and 1,545 mg (range 1,000-2,220), respectively. Severe neutropenia and febrile neutropenia occurred in 118 patients (53.2%) and 15 patients (6.8%), respectively. Multivariate logistic regression analysis indicated that ANC (absolute neutrophil count) < 3.03 x 103 /μL (OR: 4.806, 95% CI: 2.416-9.558, p = 0.000), T-Bil ≥ 0.6 mg/dl (OR: 1.964, 95% CI: 1.040-3.708, p = 0.037) and CRP < 0.13 mg/dl (OR: 2.607, 95% CI: 1.331-5.106, p = 0.005) were significant risk factors for severe neutropenia. The incidence rate of severe neutropenia was 85.7% (18/21) in patients with all three identified factors, while it was 27.7% (13/47) in patients with none of them. Age was not a risk factor in either univariate or multivariate analysis. Conclusions: Low ANC, high T-Bil, and low CRP were found to be risk factors for severe neutropenia in patients receiving GnP therapy. It would be desirable to monitor patients with these risk factors carefully, even if their values are within the standard ranges.

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.

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