Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study

Kawazoe, Hitoshi; Môri, N.; Ido, Shizuka; Uozumi, Ryuji; Tsuneoka, Kikue; Takeuchi, Akane; Matsuo, Mayumi; Yamauchi, Misako; Nakai, Masaki; Sumikawa, Satomi; Nakamura, Tomonori; Yakushijin, Yoshihiro

doi:10.1016/j.clinthera.2020.02.010

Cited by 7 publications

(13 citation statements)

References 16 publications

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“…The dose of gemcitabine and the concentration of gemcitabine administered were identified as relevant factors for the development of gemcitabine-associated vascular pain. Consistent with our results, Kawazoe et al 13 reported that a dose increase of gemcitabine was significantly associated with an increased risk of venous pain induced by gemcitabine-based chemotherapy. In general, increasing the dose of a drug increases its concentration in a solution.…”

Section: Discussionsupporting

confidence: 93%

“…There were no significant differences in the regular use of analgesic drugs (ie, NSAIDs and opioids), age, or sex between the groups with and without vascular pain. With regard to the analgesic drugs, the results of this study were similar to those previously reported for gemcitabine 13 and oxaliplatin. 19 Sex-related differences in the experience of both clinical and experimentally induced pain have been widely reported, 26 and pain sensitivity is also thought to decrease with aging.…”

Section: Discussionsupporting

confidence: 89%

“…In contrast, it has been reported that the use of a hot compress was not associated with venous pain derived from gemcitabine-based chemotherapy. 13 This discrepancy might be a result of differences in gemcitabine chemotherapy regimens (single agent or in combination with other antineoplastic drugs), vehicle of gemcitabine (normal saline or 5% glucose solution), course number of chemotherapy (first course only or multiple), and condition of hot pack use. Further studies are needed to clarify this issue.…”

Section: Discussionmentioning

confidence: 99%

“…The potential explanatory variables for analysis in this study were selected with reference to previous reports. 13,19,20 These were as follows: age, sex, body mass index (BMI), body surface area (BSA), dose of gemcitabine, dose of gemcitabine per BSA, concentration of gemcitabine, history of prior chemotherapy, and use of a hot pack, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids.…”

Section: Data Collectionmentioning

confidence: 99%

“…8 Whereas the cases of vasculitis induced by gemcitabine are frequently mentioned in the literature, [9][10][11][12] vascular pain at the injection site has not been quantified sufficiently. Recently, Kawazoe et al 13 reported that venous pain occurred in 10.0% of treatment courses and in 34.8% of patients treated with gemcitabinebased chemotherapy regimens (ie, gemcitabine alone or gemcitabine and other antineoplastic drugs). Conversely, the incidence of vascular pain derived from gemcitabine alone is still unknown.…”

Section: Introductionmentioning

confidence: 99%

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Risk Factors for Gemcitabine-Induced Vascular Pain in Patients With Pancreatic Cancer

et al. 2020

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Background: Peripheral intravenous injection of gemcitabine often causes vascular pain; however, preventive measures have not yet been established. Objectives: This study focused on identifying predictive factors for gemcitabine-induced vascular pain. Methods: We retrospectively analyzed risk factors for developing vascular pain in patients with pancreatic cancer receiving gemcitabine infusions at our institution. Infusions were divided into groups according to presence or absence of vascular pain symptoms, and variables were compared. Odds ratios for risk factors were calculated using logistic regression analyses. Results: Overall, 272 patients with pancreatic cancer were subjected to 725 gemcitabine infusions, and of these, 18.4% (n = 50) experienced vascular pain. There were significant differences in the gemcitabine dose ( P = 0.025), dose of gemcitabine/body surface area (BSA; P = 0.004), concentration of gemcitabine ( P = 0.025), and hot pack use ( P = 0.011) between the vascular pain and no vascular pain groups. Multivariable analyses indicated that gemcitabine dose/BSA and lack of hot pack use were risk factors for developing vascular pain. Moreover, on administration of a higher dosage (>930 mg/m2), the incidence of vascular pain in patients using a hot pack (6.7%) was significantly lower than that in patients not provided a hot pack (16.2%). Conclusions and Relevance: High gemcitabine dosages and lack of hot pack use were predictive factors for gemcitabine-induced vascular pain in patients with pancreatic cancer. Patients receiving gemcitabine treatment should apply a hot pack to the injection site. Scrupulous clinical attention is required for patients presenting with these risk factors to improve pain management.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 99%

Section: Data Collectionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Risk Factors for Gemcitabine-Induced Vascular Pain in Patients With Pancreatic Cancer

et al. 2020

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Oral Delivery of Photopolymerizable Nanogels Loaded with Gemcitabine for Pancreatic Cancer Therapy: Formulation Design, and in vitro and in vivo Evaluations

Yugatama,

Huang,

Hsu

et al. 2024

IJN

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Background Gemcitabine (GEM) faces challenges of poor oral bioavailability and extensive first-pass metabolism. Currently, only injectable formulations are available for clinical use. Hence, there is an urgent demand for the development of advanced, efficacious, and user-friendly dosage forms to maintain its status as the primary treatment for pancreatic ductal adenocarcinoma (PDAC). Nanogels (NGs) offer a novel oral drug delivery system, ideal for hydrophilic compounds like GEM. This study aims to develop NGs tailored for GEM delivery, with the goal of enhancing cellular uptake and gastrointestinal permeability for improved administration in PDAC patients. Methods We developed cross-linked NGs via photopolymerization of methacryloyl for drug delivery of GEM. We reveal characterization, cytotoxicity, and cellular uptake studies in Caco-2 and MIA PaCa-2 cells. In addition, studies of in vitro permeability and pharmacokinetics were carried out to evaluate the bioavailability of the drug. Results Our results show NGs, formed via photopolymerization of methacryloyl, had a spherical shape with a size of 233.91±7.75 nm. Gemcitabine-loaded NGs (NGs-GEM) with 5% GelMA exhibited efficient drug loading (particle size: 244.07±19.52 nm). In vitro drug release from NGs-GEM was slower at pH 1.2 than pH 6.8. Cellular uptake studies indicated significantly enhanced uptake in both MIA PaCa-2 and Caco-2 cells. While there was no significant difference in GEM’s AUC and Cmax between NGs-GEM and free-GEM groups, NGs-GEM showed markedly lower dFdU content (10.07 hr∙μg/mL) compared to oral free-GEM (19.04 hr∙μg/mL) after oral administration (p<0.01), highlighting NGs’ efficacy in impeding rapid drug metabolism and enhancing retention. Conclusion In summary, NGs enhance cellular uptake, inhibit rapid metabolic degradation of GEM, and prolong retention after oral administration. These findings suggest NGs-GEM as a promising candidate for clinical use in oral pancreatic cancer therapy.

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A 5% Glucose Solution for the Liquid Formulation Gemcitabine Solvent Decreases Gemcitabine-induced Vascular Pain

et al. 2021

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Background/Aim: Gemcitabine (GEM)-induced vascular pain often occurs in patients. A 5% glucose solution for the lyophilized formulation of GEM solvent is known to decrease the frequency of GEM-induced vascular pain compared with saline. In this study, we aimed to examine the availability of glucose for a liquid formulation GEM solvent for the prevention of GEM-induced vascular pain. Patients and Methods: In total, 214 patients with bile tract or pancreatic cancer, who received GEM-containing regimens, were enrolled in this retrospective study. The patients were divided into a glucose group, which was administered the liquid formation GEM diluted with glucose, and a saline group. The frequency of GEM-induced vascular pain was compared between them. Results: Glucose significantly decreased the frequency of GEM-induced vascular pain during the first GEM administration (36% vs. 55%, p=0.005). Conclusion: Switching the solution for liquid formulation GEM from saline to glucose significantly decreased the frequency of vascular pain.

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Liquid Formulation of Gemcitabine Increases Venous Pain in Patients With Cancer: A Retrospective Study

Cited by 7 publications

References 16 publications

Risk Factors for Gemcitabine-Induced Vascular Pain in Patients With Pancreatic Cancer

Risk Factors for Gemcitabine-Induced Vascular Pain in Patients With Pancreatic Cancer

Oral Delivery of Photopolymerizable Nanogels Loaded with Gemcitabine for Pancreatic Cancer Therapy: Formulation Design, and in vitro and in vivo Evaluations

A 5% Glucose Solution for the Liquid Formulation Gemcitabine Solvent Decreases Gemcitabine-induced Vascular Pain

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