Unique ID issued by UMIN | UMIN000054267 |
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Receipt number | R000061609 |
Scientific Title | Pegfilgrastim subcutaneous injection 3.6mg Drug use results survey -Prevention of chemotherapy-induced febrile neutropenia- |
Date of disclosure of the study information | 2024/04/27 |
Last modified on | 2024/05/08 06:42:06 |
Pegfilgrastim subcutaneous injection 3.6mg Drug use results survey
-Prevention of chemotherapy-induced febrile neutropenia-
Pegfilgrastim subcutaneous injection 3.6mg Drug use results survey
-Prevention of chemotherapy-induced febrile neutropenia-
Pegfilgrastim subcutaneous injection 3.6mg Drug use results survey
-Prevention of chemotherapy-induced febrile neutropenia-
Pegfilgrastim subcutaneous injection 3.6mg Drug use results survey
-Prevention of chemotherapy-induced febrile neutropenia-
Japan |
Patients who received pegfilgrastim for the first time to prevent of chemotherapy-induced febrile neutropenia
Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
Hematology and clinical oncology | Nephrology | Obstetrics and Gynecology |
Pediatrics | Dermatology | Urology |
Malignancy
NO
The objective of this survey was to confirm the safety and efficacy of peg-filgrastim administered to prevent FN after cancer chemotherapy in a real world clinical practice setting.
Safety,Efficacy
Consider the following safety issues
-Side effects/infectious diseases (types, incidence, etc.)
-Factors that may affect safety
-Serious adverse events
-Safety specifications
Consider the following effectiveness issues
-Febrile neutropenia
-Changes in neutrophil count
-Examination of factors thought to influence changes in neutrophil count and the onset of febrile neutropenia
Observational
Not applicable |
Not applicable |
Male and Female
Patients who received pegfilgrastim for the first time to prevent of chemotherapy-induced febrile neutropenia
-If a contract with the facility has not been concluded
-If the start date of Pegfilgrastim administration is outside the contract period
-If there are duplicate registered cases (already registered)
-If the number of registrations exceeds the number of contracted cases
-If the case is registered after Pegfilgrastim administration
-If registered by a doctor other than the contracted doctor
1500
1st name | Nobuhiro |
Middle name | |
Last name | Shibata |
Kansai Medical University Hospital
Cancer Treatment Center
573-1191
3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan
+81(0)72-804-0101
shibanob@hirakata.kmu.ac.jp
1st name | Hiroshi |
Middle name | |
Last name | Kuwazawa |
Kyowa Kirin Co., Ltd.
Pharmacovigilance Division
100-0004
Otemachi Financial City Grand Cube 1-9-2 Otemachi, Chiyoda-ku, Tokyo
07031439628
hiroshi.kuwazawa.wd@kyowakirin.com
Kyowa Kirin Co., Ltd.
Hiroshi Kuwazawa
Kyowa Kirin Co., Ltd.
Profit organization
Research Ethical Review Committee of Kyowa Kirin Co., Ltd.
Otemachi Financial City Grand Cube 1-9-2 Otemachi, Chiyoda-ku, Tokyo
03-5205-7202
researchethics.fj@kyowakirin.com
NO
2024 | Year | 04 | Month | 27 | Day |
https://www.pmda.go.jp/drugs_reexam/2023/P20231226001/index.html
Unpublished
https://www.pmda.go.jp/drugs_reexam/2023/P20231226001/index.html
1531
1531 patients were included in the safety and 1523 were included in the efficacy analysis set.ADRs were 18.88%, and the main ADRs were "back pain" 3.59%, "fever" 3.14%, "arthralgia" 2.16%, "Hepatic functional abnormality" 1.50%, "muscle pain" 1.31%, and "bone pain" 1.18%.FN due to cancer chemotherapy after administration of pegfilgrastim can be suppressed in both "primary preventive administration" and "secondary preventive administration" from cycle 1 (first administration of pegfilgrastim).
2024 | Year | 04 | Month | 26 | Day |
The patient backgrounds of the 1531 patients included in the safety analysis set were shown in below.
The main diseases were breast cancer in 52.25% (800/1531 patients), NHL in 25.21% (386/1531 patients), and lung cancer in 11.03% (169/1531 patients) [NSCLC 5.94% (91 /1531 patients), SCLC 5.09% (78/1531 patients)].
Regarding gender, 29.92% (458/1531 patients) were male and 70.08% (1073/1531 patients) were female.
The mean age (standard deviation) at the start of pegfilgrastim administration was 60.9 years (13.1 years), with 0-14 years (children) at 0.07% (1 /1531 patients) and 15-64 years at 53.49% (819/1531 patients). 46.44% (711 /1531 patients) were aged 65 years or older (elderly).
Most treatments were performed on an outpatient basis, accounting for (62.83% (962/1531 patients)), and most of the performance status (PS) was 0, 69.11% (1058/1531 patients).
The main cancer chemotherapy regimens for 800 patients of breast cancer were FEC therapy in 28.00% (224/800 patients), TC therapy in 27.50% (220/800 patients), and EC therapy in 18.00% (144/800 patients).
The main cancer chemotherapy regimens for 386 patients of NHL were R-CHOP therapy in 38.60% (149/386 patients) and CHOP therapy in 11.66% (45/386 patients).
The main cancer chemotherapy regimens for 91 patients of lung cancer (NSCLC) were DTX single therapy in 23.08% (21/91 patients), DTX/RAM therapy in 12.09% (11/91 patients), and CBDCA/PEM/BV therapy in 10.99% (10/91 patients), and Lung cancer (SCLC) were 78 patients, CBDCA/VP-16 therapy in 38.46% (30/78 patients), AMR monotherapy in 29.49% (23/78 patients) and CDDP/VP-16 therapy in 19.23% (15/78 patients).
Pegfilgrastim was administered almost according to the package insert for all cycles.
The average time to start administration of pegfilgrastim in each cycle of up to 6 cycles was 3.4 to 4.0 days from the start date of cancer chemotherapy (day 1).
Furthermore, the average number of days from administration of pegfilgrastim to the start of the next cancer chemotherapy was 20.4 to 21.8 days, and the average number of days from the end of cancer chemotherapy to administration of pegfilgrastim was 2.0 to 2.2 days.
In the safety analysis set, 18.88% (289/1531 patients) had ADRs, 3.27% (50/1531 patients) had serious ADRs, and 0.07% (1/1531 patients) had ADRs reported with fatal outcome, but there was no reasonable possibility of a causal relationship indicated between the event and pegfilgrastim.
During this survey, ADRs unexpected from "Precautions" (unexpected ADRs) were collected from 69 patients. Unexpected ADRs experienced by at least 0.20% (3 patients) were as follows: "Febrile neutropenia"in 0.78% (12/1531 patients) "Neuropathy peripheral" and "Blast cell count increased" in 0.26% (4/1531 patients) each and"Cystitis" "Renal impairment" and "Platelet count increased"in 0.20% (3/1531 patients) each.
Furthermore, based on results from this survey, the necessity of additional risk minimization activities was examined for the priority survey items and the safety specifications (including adverse events other than safety specifications): "interstitial lung disease" "splenomegaly and/or splenic rupture" "anaphylactic shock" "acute respiratory distress syndrome" "blast cell count increased""capillary leak syndrome" "events relating to bone pain/back pain/etc" "Sweet's syndrome" "cutaneous vasculitis" "febrile neutropenia" "thrombocytopenia" "secondary malignancy" "large-vessel vasculitis" and "antibody expression." After evaluating the current risk minimization activities, the company determines that no additional measures are currently required.
Among patients whose indication for use of pegfilgrastim (company`s assessment) was "primary prophylactic administration," febrile neutropenia was observed in 13.85% of patients (18 /130 patients) who received chemotherapy (including regimens different from those administered with pegfilgrastim) within the last 3 months before the first dose of pegfilgrastim, whereas the overall incidence of febrile neutropenia after pegfilgrastim administration was 5.67% (44 /776 patients). Among patients whose indication for use of pegfilgrastim (company`s assessment) was "secondary prophylactic administration," febrile neutropenia was observed in 40.29% of patients (301 /747 patients) who received chemotherapy (including regimens different from those administered with pegfilgrastim) within the last 3 months before the first dose of pegfilgrastim, whereas the overall incidence of febrile neutropenia after pegfilgrastim administration was 4.28% (32 /747 patients).
Completed
2015 | Year | 06 | Month | 10 | Day |
2021 | Year | 06 | Month | 30 | Day |
2015 | Year | 08 | Month | 26 | Day |
2017 | Year | 11 | Month | 10 | Day |
2019 | Year | 12 | Month | 17 | Day |
Drug use results survey based on the ministerial ordinance on implementation of Good Post-marketing Study Practice
2024 | Year | 04 | Month | 26 | Day |
2024 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061609
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