Survival Benefits of Chemotherapy for Patients with Advanced Pancreatic Cancer in A Clinical Real-World Cohort

Kordes, Maximilian; Yu, Jingru; Malgerud, Oscar; Liljefors, Maria; Löhr, Matthias

doi:10.3390/cancers11091326

Cited by 28 publications

(29 citation statements)

References 27 publications

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“…The limited effect on survival on population level probably originates from differences in patient selection compared to clinical trials. Another study [24] including patients with advanced pancreatic cancer from a single institution showed that survival could achieve benefits as shown in randomized clinical trials, but that this differed between treatment regimens. Moreover, the study demonstrated protocol adherence to be one of the explanations for differences between real-world outcomes and results in randomized controlled trials.…”

Section: Discussionmentioning

confidence: 99%

Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis

et al. 2020

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2020) Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis, Acta Oncologica, 59:6, 705-712, ABSTRACT Background: Positive results of randomized trials led to the introduction of FOLFIRINOX in 2012 and gemcitabine with nab-paclitaxel in 2015 for patients with metastatic pancreatic ductal adenocarcinoma. It is unknown to which extent these new chemotherapeutic regimens have been implemented in clinical practice and what the impact has been on overall survival. Material and methods: Patients diagnosed with metastatic pancreatic ductal adenocarcinoma between 2007-2016 were included from the population-based Netherlands Cancer Registry. Multilevel logistic regression and Cox regression analyses, adjusting for patient, tumor, and hospital characteristics, were used to analyze variation of chemotherapy use. Results: In total, 8726 patients were included. The use of chemotherapy increased from 31% in 2007-2011 to 37% in 2012-2016 (p < .001). Variation in the use of any chemotherapy between centers decreased (adjusted range 2007-2011: 12-67%, 2012-2016: 20-54%) whereas overall survival increased from 5.6 months to 6.4 months (p < .001) for patients treated with chemotherapy. Use of FOLFIRINOX and gemcitabine with nab-paclitaxel varied widely in 2015-2016, but both showed a more favorable overall survival compared to gemcitabine monotherapy (median 8.0 vs. 7.0 vs. 3.8 months, respectively). In the period 2015-2016, FOLFIRINOX was used in 60%, gemcitabine with nab-paclitaxel in 9.7% and gemcitabine monotherapy in 25% of patients receiving chemotherapy. Conclusion: Nationwide variation in the use of chemotherapy decreased after the implementation of FOLFIRINOX and gemcitabine with nab-paclitaxel. Still a considerable proportion of patients receives gemcitabine monotherapy. Overall survival did improve, but not clinically relevant. These results emphasize the need for a structured implementation of new chemotherapeutic regimens. ARTICLE HISTORYmedian overall survival) [4]. Over the years, several combination chemotherapy regimens have been investigated without any gain of survival [5,6]. More recently, FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) was associated with a survival benefit compared to gemcitabine (11.1 vs. 6.8 months median overall survival) in patients with a good performance status [7]. The phase III MPACT trial revealed a

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Section: Discussionmentioning

confidence: 99%

Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis

et al. 2020

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“…They did not find a significant difference to the sequence FOLFIRINOX followed by Gem/NabP and FP/Nal-IRI (mOS 25.5 months) [29]. Furthermore, in the previously mentioned study by Kordes et al patients who received FOLFIRINOX had a shorter median OS (9.9 months, 95% CI; 8.1-11.7) than previously reported [21]. In that respect and in light of no head-to-head prospective comparison trials, there is still no evidence that FOLFIRINOX in the palliative setting is associated with increased survival compared to Gem/NabP.…”

Section: Discussionmentioning

confidence: 75%

“…Our hypothesis is strengthened by other reports. A recent study by Kordes M et al reported that the sequence of gemcitabine-based therapy after 5-FU/oxaliplatin with or without irinotecan was associated with poorer outcomes than a 5-FU-based treatment after a gemcitabine-based doublet therapy [21]. Another study by Caparello and colleagues reports for the subgroup of patients who received Gem/NabP after the failure of first line FOLFIRINOX disappointing results in terms of both activity (RR: 7%; DCR: 23%) and survival (median PFS: 1.95 months; median OS: 5.4 months) [22].…”

Section: Discussionmentioning

confidence: 99%

Impact of New Chemotherapy Regimens on the Treatment Landscape and Survival of Locally Advanced and Metastatic Pancreatic Cancer Patients

Kieler

Unseld

Bianconi

et al. 2020

JCM

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Background: New chemotherapy regimens for the treatment of metastatic pancreatic cancer have changed the therapy paradigm. We aimed to assess their impact on the treatment landscape and clinical outcome at our academic institution. Methods: In this single institutional posthoc registry analysis, we assessed characteristics and survival rates from all patients with locally advanced and metastatic pancreatic cancer who started a systemic treatment between 01/2011 and 12/2017. Survival analyses were performed by Kaplan-Meier and Cox proportional hazards model. Results: A total of 301 patients started a systemic treatment in the observation period. In the first line treatment, we observed a shift from the four different main regimens (gemcitabine/nab-paclitaxel, modified FOLFIRINOX, gemcitabine/oxaliplatin +/− erlotinib or gemcitabine alone) to gemcitabine/nab-paclitaxel and modified FOLFIRINOX that add up to more than 80% of administered first line treatments in each of the time cohorts (2011–2013 vs. 2014–2017). The rate for first line modified FOLFIRINOX treatment was balanced between the two groups (19% and 15%). Median overall survival differed significantly between the two time cohorts (8.89 versus 11.9 months, p = 0.035). Survival rates for different first to second line treatment sequences (modified FOLFIRINOX to gemcitabine/nab-paclitaxel, gemcitabine/nab-paclitaxel to fluoropyrimidines plus nanoliposomal irinotecan, or gemcitabine/nab-paclitaxel to fluoropyrimidines plus oxaliplatin) were not significantly different and median overall survival ranged from 14.27 to 15.64 months. Conclusion: Our study provides real-world evidence for the effectiveness of the new chemotherapy regimens and underscores the importance of the choice of the front-line regimen when considering different sequencing strategies.

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“…For patients with lower performance status and comorbidity, best supportive care or palliative chemotherapy with milder regimes such as gemcitabine monotherapy remain the only therapeutic options. In these groups of patients, survival is usually limited to around 1-2 [9] and 6 months respectively, the latter which appears similar in randomised controlled trials and real-world populations [7][8][9]11].…”

Section: Background and Rationale {6a}mentioning

confidence: 74%

“…In patients with adequate Eastern Cooperative Oncology Group (ECOG) performance status zero to two and acceptable organ functions, palliative chemotherapy may prolong life and reduce disease related symptomatic burden. For reasonably 'fit' patients treated with chemotherapy combination regimens such as gemcitabine/nab-paclitaxel or FOLFIRINOX, overall survival is usually between 8-11 months [7][8][9][10]. For patients with lower performance status and comorbidity, best supportive care or palliative chemotherapy with milder regimes such as gemcitabine monotherapy remain the only therapeutic options.…”

Section: Background and Rationale {6a}mentioning

confidence: 99%

Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multi-centre, parallel group, double-blind, randomised controlled clinical trial (MISTRAL)

Wode

Nordberg

Kienle³

et al. 2020

Preprint

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Background Most pancreatic cancer patients present with advanced stage at diagnosis with extremely short expected survival and few treatment options. A multimodal palliative approach is necessary for symptom relief and optimisation of health-related quality of life. In a recent open-label trial of mistletoe extract for advanced pancreatic cancer patients not eligible for chemotherapy, promising results on improved overall survival and better health-related quality of life were reported. The objective of the present study is to assess the value of mistletoe extract as a complement to standard 18 treatment (palliative chemotherapy or best supportive care) in advanced pancreatic cancer patients with 19 regard to overall survival and health-related quality of life. Methods The trial is prospective, randomised, double-blind, multicentre, parallel group and placebo-controlled. In total 290 participants are randomly assigned to placebo or mistletoe extract given subcutaneously in increasing dosage from 0.01mg to 20mg three times per week for nine months. Stratification is performed for site and palliative chemotherapy. Main inclusion criteria are advanced pancreatic cancer and Eastern Cooperative Oncology Group performance status zero to two; main exclusion criteria are life expectancy less than four weeks and neuroendocrine tumour of the pancreas. Two ancillary studies on sub-sets of participants are nested in the trial: a biomarker study collecting blood samples and a cross-sectional qualitative study with semi-structured face-to-face interviews. Discussion To our knowledge, this is the first placebo-controlled randomised trial assessing the impact of mistletoe extract as a complement to standard treatment on overall survival and health-related quality of life in patients with advanced pancreatic cancer. The presented trial with its two nested ancillary studies exploring biomarkers and patient experiences is expected to give new insights into the treatment of advanced pancreatic cancer. Trial registration EU Clinical Trial Register, EudraCT Number 2014-004552-64. Registered 19 January 2016, https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004552-64/SE

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Survival Benefits of Chemotherapy for Patients with Advanced Pancreatic Cancer in A Clinical Real-World Cohort

Cited by 28 publications

References 27 publications

Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis

Implementation of contemporary chemotherapy for patients with metastatic pancreatic ductal adenocarcinoma: a population-based analysis

Impact of New Chemotherapy Regimens on the Treatment Landscape and Survival of Locally Advanced and Metastatic Pancreatic Cancer Patients

Efficacy of mistletoe extract as a complement to standard treatment in advanced pancreatic cancer: study protocol for a multi-centre, parallel group, double-blind, randomised controlled clinical trial (MISTRAL)

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