A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer

Hasegawa, Rikiya; Okuwaki, Kosuke; Kida, Mitsuhiro; Yamauchi, Hiroshi; Kawaguchi, Yusuke; Matsumoto, Takaaki; Kaneko, Toru; Miyata, Eiji; Uehara, Kazuho; Iwai, Tomohisa; Watanabe, Masafumi; Kurosu, Takahiro; Inoue, Hiroshi; Ohno, Takashi; Koizumi, Wasaburo

doi:10.1007/s10147-019-01511-0

Cited by 25 publications

(15 citation statements)

References 14 publications

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“…However, gemcitabine monotherapy offers limited effectiveness at this stage. The ECOG PS is known as a statistically significant independent predictor of survival [11,22,23]; however, real-world evidence suggests that age by itself should not be considered a limiting factor in treatment selection for elderly patients with mPC [10e12, 14,18], thus claiming accurate selection of non-frail subjects, careful monitoring and adequate dose adjustments of nab-paclitaxel/ gemcitabine in intermediate and frail patients with mPC.…”

Section: Discussionmentioning

confidence: 99%

“…A number of studies examined nab-paclitaxel/ gemcitabine efficacy for elderly patients with mPC, either using the MPACT schedule [9e14] or dose-modified regimens [15e17]. However, except for a few prospective trials [12,17,18], most available data originate from retrospective analyses in diverse, small cohorts of patients with PC [9e11, 13,15,19]. None of them reported prospective, non-interventional evidence with first-line nabpaclitaxel/gemcitabine from a comparably large cohort of elderly patients with mPC.…”

Section: Introductionmentioning

confidence: 99%

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Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study

Prager

Oehler

Gerger

et al. 2021

European Journal of Cancer

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study

Prager

Oehler

Gerger

et al. 2021

European Journal of Cancer

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“…Finally, we confirmed the lesser efficacy of the gemcitabine alone regimen among older adults with mPC. However, our study results should be taken with caution since, due to the retrospective design of our study, the dose-intensity related feasibility of each regimen was not known [ 32 ].…”

Section: Discussionmentioning

confidence: 99%

Overall Survival and Prognostic Factors among Older Patients with Metastatic Pancreatic Cancer: A Retrospective Analysis Using a Hospital Database

Conti

Pamoukdjian

Aparicio

et al. 2022

Cancers

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Pre-therapeutic factors associated with overall survival (OS) among older patients ≥70 years with metastatic pancreatic cancer (mPC) are not known. This was a retrospective single-centre cohort study in Paris including 159 consecutive older patients with mPC between 2000 and 2018. Alongside geriatric parameters, specific comorbidities, cancer-related data and chemotherapy regimens were retrieved. Cox multivariate models were run to assess predictors for OS. The median age was 80 years, 52% were women, 21.5% had diabetes, and 48% had pancreatic head cancer and 72% liver metastases. 62% of the patients (n = 99) received chemotherapy, among which the gemcitabine + nab-paclitaxel (GnP) regimen was the most frequent (72%). Median OS [95%CI] was 7.40 [5.60–10.0] and 1.40 [0.90–2.20] months respectively for patients with and without chemotherapy. The GnP regimen (aHR [95%CI] = 0.47 [0.25–0.89], p = 0.02) and diabetes (aHR = 0.44 [0.24–0.77], p = 0.004) (or anti-diabetic therapy) were multivariate protective factors for death, while ECOG-PS, liver metastases, and the neutrophil cell count were multivariate risk factors for death. In the chemotherapy group, ECOG-PS, number of metastatic sites and the GnP remained significantly associated with OS. Our study confirms the feasibility and efficacy of chemotherapy and the protective effects of diabetes among older patients with mPC.

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“…Furthermore, most of the previous studies focused on patients older than 65 years and not on very elderly patients older than 75 years. One Japanese study[ 12 ] demonstrated the efficacy of the GA regimen in patients older than 75 years; they suggested that the GA regimen is feasible with appropriate dose reductions provided treatment-related decisions are managed appropriately. However, in the study, only 48% of patients completed two cycles of the GA regimen.…”

Section: Discussionmentioning

confidence: 99%

First-line chemotherapy in very elderly patients with metastatic pancreatic cancer: Gemcitabine monotherapy vs combination chemotherapy

Han

Kim

Seol

et al. 2020

WJCC

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BACKGROUND Combination chemotherapy (gemcitabine plus nab-paclitaxel and FOLFIRINOX) is widely used as the standard first-line treatment for pancreatic cancer. Considering the severe toxicities of combination chemotherapy, gemcitabine monotherapy (G mono) could be used as a first-line treatment in very elderly patients or those with a low Eastern Cooperative Oncology Group status. However, reports on the efficacy of G mono in patients older than 75 years are limited. AIM To evaluate the efficacy of G mono and combination chemotherapy by comparing their clinical outcomes in very elderly patients with pancreatic cancer. METHODS We retrospectively analyzed 104 older patients with pancreatic cancer who underwent chemotherapy with G mono ( n = 45) or combination therapy ( n = 59) as a first-line treatment between 2011 and 2019. All patients were histologically diagnosed with ductal adenocarcinoma. Primary outcomes were progression-free survival and overall survival. We also analyzed subgroups according to age [65-74 years (elderly) and ≥ 75 years (very elderly)]. Propensity score matching was performed to compare the outcomes between the two chemotherapy groups. RESULTS The baseline characteristics were significantly different between the two chemotherapy groups, especially regarding age, ratio of multiple metastases, tumor burden, and Eastern Cooperative Oncology Group performance status. After propensity score matching, the baseline characteristics were not significantly different between the chemotherapy groups in elderly and very elderly patients. In the elderly patients, the median progression-free survival (62 d vs 206 d, P = 0.000) and overall survival (102 d vs 302 d, P = 0.000) were longer in the combination chemotherapy group. However, in the very elderly patients, the median progression-free survival (147 d and 174 d, respectively, P = 0.796) and overall survival (227 d and 211 d, respectively, P = 0.739) were comparable between the G mono and combination chemotherapy groups. Adverse events occurred more frequently in the combination chemotherapy group than in the G mono group, especially thromboembolism (G mono vs nab-paclitaxel vs FOLFIRINOX; 8.9% vs 5.9% vs 28%, P = 0.041), neutropenia (40.0% vs 76.5% vs 84.0%, P = 0.000), and neuropathy (0% vs 61.8% vs 28.0%, P = 0.006). CONCLUSION In elderly patients, combination therapy is more effective than G mono. However, G mono i...

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A clinical trial to assess the feasibility and efficacy of nab-paclitaxel plus gemcitabine for elderly patients with unresectable advanced pancreatic cancer

Cited by 25 publications

References 14 publications

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study

Comparison of nab-paclitaxel plus gemcitabine in elderly versus younger patients with metastatic pancreatic cancer: Analysis of a multicentre, prospective, non-interventional study

Overall Survival and Prognostic Factors among Older Patients with Metastatic Pancreatic Cancer: A Retrospective Analysis Using a Hospital Database

First-line chemotherapy in very elderly patients with metastatic pancreatic cancer: Gemcitabine monotherapy vs combination chemotherapy

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