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 11.25 mg once every 12 weeks

Leuprorelin Acetate SR 11.25 mg Injection Kit

Leuprorelin Acetate

Postmarketing Group Manager

The purpose of this survey is to examine the effect on quality of life (QOL) improvement and convenience of switching to leuprorelin acetate 3 months depot 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a luteinizing hormone-releasing hormone analog (LH-RHa) 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice. Influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit was also evaluated.

This survey was designed to examine the effect on QOL improvement and convenience of switching to leuprorelin acetate 3 month depot 11.25 mg injection kit (Leuplin SR 11.25 mg injection kit) from a 4-week adjuvant therapy with a LH-RHa 1 month depot over 48 weeks in premenopausal breast cancer participants in daily medical practice, as well as to evaluate the influence of condition of estrogen receptor expression on the efficacy and safety of leuprorelin acetate SR 11.25 mg injection kit .

For adults, leuprorelin acetate SR 11.25 mg injection kit (Leuplin SR 11.25 mg Injection Kit) 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: "QOL Survey in Premenopausal Breast Cancer Patients"

QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale: 5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all \[worst response\] to 5: very much \[best response\]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.

QOL-ACD score is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. It includes 4 subscale domains: Daily Activities, Physical Condition, Social Activities, Mental and Psychological Status. Total and subscale scores are calculated as sum of items within each subscale: Daily Activity (items 1-6), Physical Condition (7-11), Psychological Condition (12-16), Social Attitude (17-21) and total (1-22). Face scale:5-point score for 1 item (22). Participants answer each question on a 5-point scale (1: not at all \[worst response\] to 5: very much \[best response\]). Score range for total score is 22 to 110 and subscale score range for daily activity is 6 to 30, and for physical condition, psychological condition, and social attitude is 5 to 25. Less total/subscale scores reflect greater symptom severity and symptom impact on health-related QOL.

QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all \[worst response\] to 5: very much \[best response\]). Total score was calculated over score range 0-100 for item 1 to 18 as ((a sum of 18 items)/18-1)\*25). Score for physical condition and pain was calculated over score range 0-100 for item 1 to 6 as ((a sum of 6 items)/6-1)\*25)). Score for health-care and illness satisfaction was calculated over score range 0-100 for item 7 to 10 as ((a sum of 4 items)/4-1)\*25)), where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.

QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). QOL-ACD is a score used for cancer participants treated with anti-cancer drug and is a 22-item self-reported instrument assessing differences in symptom severity and health-related QOL. Participants answer each question on a 5-point scale (1: not at all \[worst response\] to 5: very much \[best response\]). Total score for QOL-ACD-B is calculated as a sum of 18 items, score range: 18 to 90 where less scores reflect greater symptom severity and symptom impact on health-related quality of life. Means and standard deviations were calculated for the total score and score of each subscale from questionnaire items 1 to 18.

QOL-ACD-B is a part of QOL-ACD (using questionnaire items 1 to 18). For questionnaire item 19 (Did you feel inferior to your child when you interact with him/her? \[due to the impact of illness and treatment\]), item 20 (Did you worry about child rearing? \[due to the impact of illness and treatment\]), and item 21 (Do you worry about pregnancy or delivery? \[due to the impact of illness and treatment\]), the calculation was based on the score of each item. Each item was scored on a 5-point scale, where 1 was the worst response and 5 was the best.

The question was with regard to the assessment of convenience associated with the changes in agents, "Did the change in agents reduce the frequency of your medical visits?" and the answers were categorized as very much reduced, somewhat reduced, unchanged. Change in medicinal agents means participants with a historical diagnosis of premenopausal breast cancer who switched to leuprorelin acetate sustained-release 11.25 mg injection kit from a 4-week adjuvant therapy with a LH-RHa 1 month depot preparation as part of daily medical practice.

The question was with regard to the assessment of convenience associated with the changes in agents, "The change in agents reduced the frequency of injections by one third; for this reason, did you feel relief from physical and emotional burden?" and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief.

The question was with regard to the assessment of convenience associated with the changes in agents, "Did you feel relief from financial burden (example, 3 months' drug costs and transportation fee) due to the change in agents?" and the answers were categorized as felt extreme relief, felt slight relief, no feeling either way, felt little relief, felt no relief. The sum of all the categories is not 100% because of rounding error.

The question was with regard to the assessment of convenience associated with the changes in agents, "The change in agents reduced the frequency of injections by one third; for this reason, did you worry about the effect?" and the options of the answers were not at all worried, not too worried, no thought either way, somewhat worried, and very worried.

The question was with regard to the assessment of convenience associated with the changes in agents, "Was there a change in adverse drug reactions (e.g., menopausal-like symptoms such as hot flushes, injection-site abnormalities) due to the change in agents?" and the options of the answers were events became much less severe, events became less severe, whether or not the events became severe cannot be determined, events became slightly more severe, and events became very severe.

The question was with regard to the assessment of convenience associated with the changes in agents, "Was there a change in pain at the time of injection due to the change in agents?" and the options of the answers were significantly relieved, slightly relieved, whether or not the pain worsened or was relieved cannot be determined, worsened slightly, and worsened significantly.

The question was with regard to the assessment of convenience associated with the changes in agents, "Was the change in agents good?" and the options of the answers were very good, somewhat good, whether or not the change in agents was good cannot be determined, somewhat bad, very bad.

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 was occurred in breast cancer female.

Takeda

At each visit the investigator had to document any occurrence of adverse drug reactions and abnormal laboratory findings. Only adverse drug reactions were collected in this study.

Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.

Age, Continuous

Female

Sex/Gender, Customized

Grade 0

Grade 1

Following are Eastern Cooperative Oncology Group (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 self-care, unable to carry out any work activities, up and about greater than (\>)50% of waking hours. 3: Capable of limited self-care, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any self-care, totally confined to bed or chair.

Performance status

Outpatient

Inpatient

Participants were categorized as outpatient and inpatient.

Healthcare category

Had no complications

Had complications

Not determined

Presence of Complications

>=30 picogram per milliliter (pg/mL)

Less than (<) 30 pg/mL

Not measured

Number of Participants with Blood Estradiol Level

Only 492 participants had data available for blood estradiol levels.

Blood Estradiol Level

Blood Follicle-Stimulating Hormone (FSH) Level

< 6 months

Greater than or equal to (>=) 6 months to <1 year

>= 1 to <2 years

>= 2 years

Time from surgery to the start of treatment

Safety analysis set was defined as participants who received at least one dose of study medication.

Medical Director

Total score (n=2174)

Daily activity (n=2178)

Physical condition (n=2178)

Psychological condition (n=2178)

Social relationships (n=2177)

Efficacy assessment population where baseline assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

Quality of Life Questionnaire for Cancer Patients Treated With Anticancer Drugs (QOL-ACD) Total and Subscale Score at Baseline

Total score (n=2031)

Daily activity (n=2034)

Physical condition (n=2034)

Psychological condition (n=2035)

Social relationships (n=2034)

Efficacy assessment population where Week 12 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

QOL-ACD Total and Subscale Score at Week 12

Total score (n=1658)

Daily activity (n=1662)

Physical condition (n=1662)

Psychological condition (n=1662)

Social relationships (n=1662)

Efficacy assessment population where Week 48 assessment for total and subscale scores were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

QOL-ACD Total and Subscale Score at Week 48

Total score (n=2172)

Physical condition and pain (n=2175)

Health-care and illness satisfaction (n=2176)

QOL-ACD Breast (QOL-ACD-B) Score at Baseline

Total score: (n=2025)

Physical condition and pain: (n=2031)

Health-care and illness satisfaction: (n=2029)

Score of QOL-ACD-B at Week 12

Total score (n=1651)

Physical condition and pain (n=1659)

Healthcare and illness satisfaction (n=1656)

Score of QOL-ACD-B at Week 48

Item 19: (n=631)

Item 20: (n=624)

Item 21: (n=203)

Efficacy assessment population where baseline assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

Score of QOL-ACD-B Items 19, 20 and 21 at Baseline

Item 19 (n=574)

Item 20 (n=566)

Item 21 (n=180)

Efficacy assessment population where Week 12 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

Score of QOL-ACD-B Items 19, 20 and 21 at Week 12

Item 19 (n=443)

Item 20 (n=441)

Item 21 (n=129)

Efficacy assessment population where Week 48 assessment for each item were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

Score of QOL-ACD-B Items 19, 20 and 21 at Week 48

Very much reduced

Somewhat reduced

Unchanged

Efficacy assessment population where Week 48 assessment for convenience assessment were available. Efficacy assessment population included those participants who received at least one dose of study medication and had efficacy data available.

Spots Global Cancer Trial Database for Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey: "QOL Survey in Premenopausal Breast Cancer Patients"

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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