Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Reproductive Control Agents

All Drugs and Chemicals

Leuprolide

Antineoplastic Agents, Hormonal

Subcutaneous administration of leuprorelin acetate once every 12 weeks

Leuprorelin acetate SR 11.25 mg for injection

Leuprorelin acetate

Postmarketing Group Manager

The purpose of this survey is to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate SR (slow release) 11.25 milligram (mg) for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).

This survey was designed to examine the safety and efficacy of long-term use (96 weeks) of leuprorelin acetate 3 months depot for injection (Leuplin SR 11.25 mg for Injection) in premenopausal breast cancer patients in daily medical practice, as well as to examine factors that can influence the safety and efficacy of treatment with leuprorelin acetate SR 11.25 mg for injection (Leuplin SR 11.25 mg for Injection).

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

Leuplin SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"

Adverse drug reactions are defined as adverse events (AE) which are in the investigator's opinion of causal relationship to the study treatment. AE are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The event occurred was breast cancer female

Best overall response for a participant is the best observed post-baseline disease response as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria. Objective response was defined as a complete response (CR) or partial response (PR) determined on 2 consecutive occasions greater than or equal to (\>=) 4 weeks apart, using Response Evaluation Criteria in Solid Tumors (RECIST). CR: The disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR: Disappearance of all target lesions and persistence of \>= 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30 percent (%) decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.

Progression-free survival (PFS) was defined as the time from the first day of study treatment to documented disease progression or death on study (ie, death from any cause within 30 days of the last dose of study drug), whichever occurred first. Disease progression was at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. For patients who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS.

Recurrence-free survival was determined in participants who were treated with the drug as adjuvant therapy, and tabulated, based on the date recurrence is confirmed, the presence or absence of recurrence, continued survival or death, and the date of death.

Takeda

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.

Leuprorelin Acetate

20-29 years

30-34 years

35-39 years

40-44 years

45-49 years

50-55 years

Unknown

Age, Customized

Only female participants were enrolled in the study.

Sex/Gender, Customized

T0N0M0

Stage 0

Stage I

Stage IIA

Stage IIB

Stage IIIA

Stage IIIB

Stage IIIC

Stage IV

Unclassifiable

Tumor Node Metastasis (TNM):based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Stage of primary lesion

Experienced recurrence

No recurrence observed

Recurrence prior to start of treatment with leuprorelin acetate 11.25 mg for injection

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair.

Performance Status (at the start of treatment with leuprorelin acetate 11.25 mg for injection)

Safety analysis set was defined as participants who were enrolled and completed the study.

Medical Director

Number of Participants Reporting One or More Adverse Drug Reactions

Number of Participants Reporting One or More Serious Adverse Drug Reactions

Week 24

Week 48

Week 96

The efficacy assessment population was defined as participants with advanced or recurrent breast cancer whose efficacy data at baseline and at least 1 post-baseline time points was available.

Percentage of Participants With Advanced or Recurrent Breast Cancer (Best Response)

Percentage of Participants With Progression Free Survival

Percentage of Participants With Recurrence-free Survival Who Were Treated With the Drug as Adjuvant Therapy

Overall Study

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Hodgkin Disease

Lymphoma, Large-Cell, Anaplastic

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, T-Cell

Lymphosarcoma

Hodgkin Lymphoma

Anaplastic Large Cell Lymphoma

Brentuximab Vedotin

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks

Brentuximab vedotin (recombinant) for IV infusion

Brentuximab vedotin (recombinant)

Study Director

The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.

The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.

The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.

Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

Brentuximab Vedotin (ADCETRIS) IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography \[PET\] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.

OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. For data of "Other Adverse Events", participants may be represented in more than 1 category.

Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks. Participants received interventions as part of routine medical care.

Brentuximab Vedotin Infusion

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Japan

Region of Enrollment

Mean duration between start of study and first time of diagnosis of HL or ALCL was reported.

Duration of Diagnosis of Hodgkin's Lymphoma (HL) or Anaplastic Large Cell Lymphoma (ALCL)

Diagnosis

Recurrent and Refractory or Primary

Number of participants with CD30 Positive

This baseline characteristic was analyzed only in participants who had been diagnosed with ALCL.

ALK Positive or Negative

Lymphoma is classified with following stages. Stage 1; Lymphoma in only 1 group of lymph nodes. Stage 2; Lymphoma in 2 or more groups of lymph nodes. Stage 3; There are lymph nodes that contain lymphoma on both sides of the diaphragm. Stage 4; The most advanced stage of lymphoma and lymphoma cells have spread to at least 1 body organ outside the lymphatic system.

Staging of Lymphoma

B symptom means participants have 1 or more these symptoms as following; Unintentional weight loss (more than 10% in the 6 months before you were diagnosed), Night sweats, Fevers (temperatures above 38 Celsius degrees).

B Symptom

Eastern Cooperative Oncology Group (ECOG) Performance Status

Participants were categorized as outpatient and inpatient.

Healthcare Category

The baseline characteristic was analyzed in participants who had a liability or tendency to suffer from hypersensitivity.

Predisposition to Hypersensitivity

Hepatitis C Virus (HCV) Antibody Positive or Negative

Hepatitis B Surface (HBs) Antigen Positive or Negative

HBs Antibody Positive or Negative

Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Positive or Negative

Medical history defined as a disease or a health condition for each participant before start of the study. Medical history was classified as congenital anomalies, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, GI disorders, hepatic and biliary disorders, renal disease and other medical history. Other medical history included all medical history except for those mentioned above.

Medical History of Lung Disorder

Complications defined as a disease or a health condition for each participant at the start of study. Complications were classified as congenital anomalies, endocrine disorders, hematologic disorders, psychiatric and nervous system disorders, cardiovascular disorders, respiratory disorders, gastrointestinal (GI) disorders, renal disease and other complications. Other complications included all complications except for those mentioned above.

Medical Complications of Lung Disorder

Medical History of Malignant Tumor

Medical Complications of Malignant Tumor

Medical History (Other Than Lung Disorder or Malignant Tumor)

Medical Complications (Other Than Lung Disorder or Malignant Tumor)

Concomitant Hepatic Disorder

Concomitant Renal Disorder

Weight

Body Mass Index = weight (kg)/\[height (m)\^2\]

Smoking Classification

Drug Therapy before Start of Brentuximab Vedotin Administration

Population Analysis Description: This baseline characteristic was analyzed only in participants who had drug therapy before start of Brentuximab Vedotin administration.

Number of Regimens before Start of Brentuximab Vedotin Administration

Time in Days from Last Month of Previous Drug Therapy Regimen to First Cycle of Brentuximab Vendotin

Radiotherapy before Start of Brentuximab Vedotin Administration

Population Analysis Description: This baseline characteristic was analyzed only in participants who had radiotherapy before start of Brentuximab Vedotin administration. The number analyzed is the number of participants with data available for analysis.

Time in Days from Last Month of Most Recent Radiotherapy to First Cycle of Brentuximab Vendotin

Hematopoietic Stem Cell Transplantation before Start of Brentuximab Vedotin Administration

This baseline characteristic was analyzed only in female participants.

Number of Participants Who Were Not Pregnant

Safety Analysis Set; The safety analysis set was defined as all participants who had the safety data defined on the protocol.

Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)

HL Participants with PET Data

HL Participants without PET Data

ALCL Participants with PET Data

ALCL Participants without PET Data

Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis. The number analyzed is the number of participants with data available for analysis in the given timeframe.

Percentage of Participants Who Achieve or Maintain Any Best Response

HL Participants

ALCL Participants

Efficacy assessment population; The efficacy assessment population was defined as participants who met the requirement of this study and had efficacy data available for analysis.

Overall Survival (OS)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice.

Leuprorelin acetate SR 11.25 mg injection kit

The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.

This survey was designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate 3 months depot injection kit (Leuplin SR 11.25 mg Injection Kit) in prostate cancer participants in daily medical practice.

For adults, 11.25 mg of leuprorelin acetate is usually administered subcutaneously once every 12 weeks. Prior to injection, the plunger rod of the syringe is pushed upward with the needle pointed upward, allowing the entire suspension fluid contained to be transferred to the powder. The powder is then fully suspended in the fluid while ensuring that bubbles are not generated.

Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

Leuprorelin Acetate SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"

Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

Serious adverse drug reactions are defined as serious adverse events (SAE) which are in the investigator's opinion of causal relationship to the study treatment. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

PFS was defined as the time from the first day of study treatment to documented disease progression or death on study. For participants who experienced no disease progression and did not die while on study, data were censored at the date of the last tumor assessment. Kaplan-Meier methodology was used to estimate PFS. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

OS was defined as the duration from randomization to death (due to any cause). Probability of OS was reported using Kaplan-Meier method. TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Disease-specific survival is defined as time interval between the date of randomization and the earliest date of local, regional or distant relapse, or death due to cancer.

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Only adverse drug reactions were collected in this study.

Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.

Male

Body Mass Index

No lesions

Stage II

Stage III

Cannot be assessed

TNM classification based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant metastasis. Stages included: stage 0(no evidence of cancer cells),stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0),stage IIIb( T4 anyNM0, any TN3M0),stage IIIC(any TN3M0), stage IV(any T any NM1), where T0=early form of tumor, T1=\<2 centimeter (cm), T2=2-5 cm, T3=\>2 cm, T4=large sized, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread \>10 axillary LN, M0=no metastasis, M1= Metastasis.

Tumor Node Metastasis(TNM) Classification (at start of treatment with leuplin SR 11.25 mg injection)

Performance Status (at start of treatment with leuplin SR 11.25 mg injection)

Had predisposition to Hypersensitivity

Had no redisposition to Hypersensitivity

Had Complications

Had no Complications

Participants may be represented in more than 1 category.

Medical Complications

Hypertension

Heart disease

Diabetes mellitus

This baseline characteristic was analyzed in participants who had hypertension, heart disease, diabetes mellitus, hyperlipidemia, malignant tumor, cerebrovascular disease, and any other medical complications.

Breakdown of Complications

The safety analysis set was defined as all participants who were enrolled and completed the study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"	NCT02154139	Breast Cancer	Leuprorelin ace...	-	Takeda
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"	NCT02139592	Relapsed or Ref...	Brentuximab ved...	-	Takeda
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"	NCT02167893	Prostate Cancer	Leuprorelin ace...	-	Takeda
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"	NCT02134977	Breast Cancer	Leuprorelin Ace...	-	Takeda
Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"	NCT02139592	Relapsed or Ref...	Brentuximab ved...	-	Takeda
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"	NCT02154139	Breast Cancer	Leuprorelin ace...	-	Takeda
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"	NCT02167893	Prostate Cancer	Leuprorelin ace...	-	Takeda
Leuprorelin Acetate SR 11.25 mg for Injection Specified Drug-use Survey "Long-term Use Survey on Premenopausal Breast Cancer Patients (96 Weeks)"	NCT02154139	Breast Cancer	Leuprorelin ace...	-	Takeda

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