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Highly frequent and enhanced injection site reaction induced by peripheral venous injection of fosaprepitant in anthracycline-treated patients.

Sato Y, Kondo M, Inagaki A, Komatsu H, Okada C, Naruse K, Sahashi T, Kuroda J, Ogura H, Uegaki S, Yoshida T, Mori Y, Sawada H, Watanabe S, Sugiura H, Endo Y, Yoshimoto N, Toyama T, Iida S, Yamada K, Kimura K, Wakita A - J Cancer (2014)

Bottom Line: We conducted this retrospective study to clarify the incidence and symptoms of fosaprepitant-associated ISR in patients treated with anthracycline.By multivariate analysis, fosaprepitant injection was found to be a significant independent variable correlated with ISR risk.ISR occurred more frequently and severely when fosaprepitant was injected through the peripheral vein in patients treated with anthracyclines compared to those without fosaprepitant.

View Article: PubMed Central - PubMed

Affiliation: 1. Department of Pharmacy, Nagoya City West Medical Center.

ABSTRACT

Background: Fosaprepitant-associated injection site reaction (ISR) has been reported in patients treated with cisplatin, an irritant drug. We conducted this retrospective study to clarify the incidence and symptoms of fosaprepitant-associated ISR in patients treated with anthracycline.

Patients and methods: Fifty six patients receiving 159 injections administering doxorubicin/cyclophosphamide (AC), fluorouracil/epirubicin/cyclophosphamide (FEC), or rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone (R-)CHOP regimen through a peripheral vein at ambulatory treatment centers reviewed for this study from patients' medical records. Incidence of ISR was compared between 24 patients with fosaprepitant injection (fosaprepitant group) and 32 patients without fosaprepitant (control group). Frequency and symptoms of ISR per injection were also compared between 61 injections with fosaprepitant and 98 injections without fosaprepitant.

Results: Both the ISR incidence rate per patient and per injection were significantly higher in the fosaprepitant group than in the control group (67% vs. 16%; P=0.0002, 34% vs. 8.2%; P<0.0001, respectively). By multivariate analysis, fosaprepitant injection was found to be a significant independent variable correlated with ISR risk. Symptoms observed in 61 injections of fosaprepitant were pain (n=14, 23%), erythema (n=10, 16%), swelling (n=6, 10%), and delayed drip infusion (n=6, 10%). After the observation period, no ISR occurred when the administration route was changed to central venous injection or oral aprepitant was administered despite the continuation of chemotherapy.

Conclusion: ISR occurred more frequently and severely when fosaprepitant was injected through the peripheral vein in patients treated with anthracyclines compared to those without fosaprepitant.

No MeSH data available.


Related in: MedlinePlus

Schema of treatment regimen. Fosaprepitant, 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body), and/or dexamethasone 9.9 mg/body were administered to patients (fosaprepitant group), while only 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body were administered to the control group via peripheral venous route for premedication of a particular chemotherapy (AC, FEC or (R-)CHOP). fAPR, fosaprepitant; NS, normal saline; 5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; DEX, dexamethasone; EPI, epirubicin; DXR, doxorubicin; VCR, vincristine; iv, intravenous injection; CPA, cyclophosphamide; and 5-FU, 5-fluorouracil.
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Figure 1: Schema of treatment regimen. Fosaprepitant, 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body), and/or dexamethasone 9.9 mg/body were administered to patients (fosaprepitant group), while only 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body were administered to the control group via peripheral venous route for premedication of a particular chemotherapy (AC, FEC or (R-)CHOP). fAPR, fosaprepitant; NS, normal saline; 5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; DEX, dexamethasone; EPI, epirubicin; DXR, doxorubicin; VCR, vincristine; iv, intravenous injection; CPA, cyclophosphamide; and 5-FU, 5-fluorouracil.

Mentions: All patients underwent one of the following three regimens: doxorubicin/cyclophosphamide (AC), fluorouracil/epirubicin/cyclophosphamide (FEC), or rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone [(R-)CHOP]. The schedules of FEC, AC and (R-)CHOP regimens are shown in Figure 1. In the fosaprepitant group, fosaprepitant was dissolved in 100 mL of normal saline (1.5 mg/mL), and subsequently, the solution was administered by drip into a peripheral vein for 30 minutes. Following fosaprepitant injection, 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body was administered via the same peripheral venous route for premedication of a particular chemotherapy. In contrast, in the control group, fosaprepitant was not administered and only 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body were administered for premedication before each chemotherapy treatment. All chemotherapy drugs including anthracycline were administered via the peripheral vein in addition to antiemetic drugs.


Highly frequent and enhanced injection site reaction induced by peripheral venous injection of fosaprepitant in anthracycline-treated patients.

Sato Y, Kondo M, Inagaki A, Komatsu H, Okada C, Naruse K, Sahashi T, Kuroda J, Ogura H, Uegaki S, Yoshida T, Mori Y, Sawada H, Watanabe S, Sugiura H, Endo Y, Yoshimoto N, Toyama T, Iida S, Yamada K, Kimura K, Wakita A - J Cancer (2014)

Schema of treatment regimen. Fosaprepitant, 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body), and/or dexamethasone 9.9 mg/body were administered to patients (fosaprepitant group), while only 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body were administered to the control group via peripheral venous route for premedication of a particular chemotherapy (AC, FEC or (R-)CHOP). fAPR, fosaprepitant; NS, normal saline; 5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; DEX, dexamethasone; EPI, epirubicin; DXR, doxorubicin; VCR, vincristine; iv, intravenous injection; CPA, cyclophosphamide; and 5-FU, 5-fluorouracil.
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Related In: Results  -  Collection

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Figure 1: Schema of treatment regimen. Fosaprepitant, 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body), and/or dexamethasone 9.9 mg/body were administered to patients (fosaprepitant group), while only 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body were administered to the control group via peripheral venous route for premedication of a particular chemotherapy (AC, FEC or (R-)CHOP). fAPR, fosaprepitant; NS, normal saline; 5-HT3RA, 5-hydroxytryptamine-3 receptor antagonist; DEX, dexamethasone; EPI, epirubicin; DXR, doxorubicin; VCR, vincristine; iv, intravenous injection; CPA, cyclophosphamide; and 5-FU, 5-fluorouracil.
Mentions: All patients underwent one of the following three regimens: doxorubicin/cyclophosphamide (AC), fluorouracil/epirubicin/cyclophosphamide (FEC), or rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone [(R-)CHOP]. The schedules of FEC, AC and (R-)CHOP regimens are shown in Figure 1. In the fosaprepitant group, fosaprepitant was dissolved in 100 mL of normal saline (1.5 mg/mL), and subsequently, the solution was administered by drip into a peripheral vein for 30 minutes. Following fosaprepitant injection, 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body was administered via the same peripheral venous route for premedication of a particular chemotherapy. In contrast, in the control group, fosaprepitant was not administered and only 5-HT3RA (FEC, AC: palonosetron 0.75 mg/body, (R-)CHOP: granisetron 3 mg/body) and/or dexamethasone 9.9 mg/body were administered for premedication before each chemotherapy treatment. All chemotherapy drugs including anthracycline were administered via the peripheral vein in addition to antiemetic drugs.

Bottom Line: We conducted this retrospective study to clarify the incidence and symptoms of fosaprepitant-associated ISR in patients treated with anthracycline.By multivariate analysis, fosaprepitant injection was found to be a significant independent variable correlated with ISR risk.ISR occurred more frequently and severely when fosaprepitant was injected through the peripheral vein in patients treated with anthracyclines compared to those without fosaprepitant.

View Article: PubMed Central - PubMed

Affiliation: 1. Department of Pharmacy, Nagoya City West Medical Center.

ABSTRACT

Background: Fosaprepitant-associated injection site reaction (ISR) has been reported in patients treated with cisplatin, an irritant drug. We conducted this retrospective study to clarify the incidence and symptoms of fosaprepitant-associated ISR in patients treated with anthracycline.

Patients and methods: Fifty six patients receiving 159 injections administering doxorubicin/cyclophosphamide (AC), fluorouracil/epirubicin/cyclophosphamide (FEC), or rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone (R-)CHOP regimen through a peripheral vein at ambulatory treatment centers reviewed for this study from patients' medical records. Incidence of ISR was compared between 24 patients with fosaprepitant injection (fosaprepitant group) and 32 patients without fosaprepitant (control group). Frequency and symptoms of ISR per injection were also compared between 61 injections with fosaprepitant and 98 injections without fosaprepitant.

Results: Both the ISR incidence rate per patient and per injection were significantly higher in the fosaprepitant group than in the control group (67% vs. 16%; P=0.0002, 34% vs. 8.2%; P<0.0001, respectively). By multivariate analysis, fosaprepitant injection was found to be a significant independent variable correlated with ISR risk. Symptoms observed in 61 injections of fosaprepitant were pain (n=14, 23%), erythema (n=10, 16%), swelling (n=6, 10%), and delayed drip infusion (n=6, 10%). After the observation period, no ISR occurred when the administration route was changed to central venous injection or oral aprepitant was administered despite the continuation of chemotherapy.

Conclusion: ISR occurred more frequently and severely when fosaprepitant was injected through the peripheral vein in patients treated with anthracyclines compared to those without fosaprepitant.

No MeSH data available.


Related in: MedlinePlus