Symptoms and General Pathology

All Conditions

Nervous System Diseases

Pain

Breakthrough Pain

Neurologic Manifestations

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Fentanyl

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

This was an observational study. Therefore, the physician decided about dosage according to individual needs.

Instanyl (Intranasal Fentanyl)

Dr. Thomas D. Bethke, PhD; MD

The aim of the study was to evaluate the safety and efficacy of intranasal fentanyl spray in cancer patients over four weeks, especially during cancer-related breakthrough pain (BTP) attacks. The fentanyl spray was applied into the nose by a metered-spray device. The study was to provide further data on pharmacoeconomic efficiency of intranasal fentanyl spray.

Efficacy and Tolerability of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients Older Than 18 Years

A Prospective Non-interventional/Observational Patient Cohort Study on the Efficacy of Intranasal Fentanyl Spray for the Treatment of Breakthrough Pain in Cancer Patients.

Initially prescribed dose/ most efficient single dose of Instanyl at study end

Scale: 0=no, 1=mild, 2=moderate, 3=strong, 4=very strong, 5=extreme

Scale: 1=very good, 2=good, 3=satisfactory, 4=poor, 5=very poor, 6=insufficient

5=completely, 4=for the most part, 3=partially, 2= more or less, 1=rather not, 0=not at all

Scale: -3= very much improved, -2= much improved, -1= improved, 0= comparable, 1= worsened, 2= much worsened ,3= very much worsened

0=no reduction, 1=slight, 2=medium, 3=strong, 4=very strong, 5=complete

0=no pain, 10= most intense pain imaginable

Scale: 1=very bad, 2=bad, 3=mediocre, 4=good, 5=very good

Scale: 0=no impairment, 70=complete impairment

Scale: 0=complete impairment, 43=no impairment

0= conspicuous ≤20

1= inconspicuous \>20

conspicuous score \<1.5 inconspicuous score ≥1.5

5=completely, 4=for the most part, 3=partially, 2=more or less, 1=rather not, 0=not at all

Scale: -3= very much improved, -2= much improved, -1= improved , 0= comparable, 1= worsened, 2= much worsened, 3= very much worsened

Scale: -3= very much less, -2= much less, -1= less, 0=comparable, 1= more, 2= much more, 3= very much more

Takeda

Patients included and treated with at least one application of Instanyl

All Patients Treated

GENISIS

Number of valid cases = 130. Number of valid cases = patients with data available.

Age Continuous

Female

Male

Missing

Sex/Gender, Customized

Number of valid cases = 126. Number of valid cases = patients with data available.

Body Mass Index (BMI)

Pain not caused by tumor

C00-C14 lip, oral cavity and pharynx

C15-C26 digestive organs

C30-C39 respiratory and intrathoracic organs

C40-C41 bone and articular cartilage

C43-C44 Melanoma and other skin

C50-C50 Mamma

C51-C58 female genital organs

C60-C63 male genital organs

C64-C68 urinary tract

C73-C75 thyroid and other endocrine glands

C76-C80 ill-defined, secondary + unspecified sites

C81-C96 lymphoid, hematopoietic and related tissue

Tumor diagnosis (malignant neop-lasms ICD10)

score 0= worst (death) , 100= best (no limitation in health)

Number of valid cases = 125. Number of valid cases = patients with data available.

Karnofsky-index

ASA 2

ASA 3

ASA 4

ASA 5

ASA = physical status.

* state 2: patient with slight generalized disease
* state 3: patient with severe generalized disease
* state 4: life threatening generalized disease
* state 5: moribund patient, unlikly to survive without operation

American Society of Anesthesiologists (ASA)-physical state (2-5)

ECOG 0

ECOG 1

ECOG 2

ECOG 3

ECOG 4

ECOG 0 (fully active) ECOG 1 (restricted in strenuous activity, ambulatory) ECOG 2 (ambulatory, up and about more than 50% of waking hours ECOG 3 (limited selfcare, confined to bed \> 50% of waking hours ECOG 4 (completely disabled, no selfcare)

ECOG (Eastern Cooperative Oncology Group) performance status (0-4)

No previous BTP medication

Previous BTP medic./Insufficient efficacy

Previous BTP medic./Insufficient speed of action

Previous BTP medic./Insufficient handling

Previous BTP medic./Insufficient tolerability

Previous BTP medic./Other reasons

Reason for the use of Instanyl

Medical Responsible

50 µg

100 µg

200 µg

400 µg

Study Start

Study End

Patients included and treated (without imputation of missing values), intention to treat.

All patients included

Dose of Instanyl

Persistent pain (IV: N= 126, LV: N= 116)

Breakthrough pain (IV: N= 126, LV: N= 115)

Initial Visit

Last Visit

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

Physician: Degree of Maximum Pain Intensity During the Last Days/ Since the Last Examination

Patients included and treated with valid data (without imputation of missing values), intention to treat.

All patients with valid values at last visit. N= number of valid cases (=114). From the 116 participants analyzed, only 114 participants had valid values at the last visit.

Physician: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End

speed of action (FV: N= 45, LV: N= 114)

strength of action (FV: N= 45, LV: N= 115)

tolerability (FV: N= 44, LV: N= 113)

safety (FV: N= 45, LV: N= 114)

handling (FV: N= 45, LV: N= 115)

patient satisfaction (FV: N= 45, LV: N= 116)

First Visit (FV): Patients With Previous BTP- Medication Only

Last Visit (LV)

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed')= N.

Physician: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)

Physician Last Visit (LV)

Patients included and treated with valid data (without imputation of missing values), intention to treat.

All patients with valid values at last visit. N= number of valid cases (=110). From the 116 participants analyzed, only 110 participants had valid values at the last visit.

Physician: To What Extent Did Your Expectations in Instanyl Have Met? (Last Visit)

Nursing and support efforts (N= 113)

Autonomy of the patient (N= 113)

Pain-related impairment in everyday life (N= 113)

Quality of patient's life (N= 112)

Extent of use of other medical services (N= 112)

All patients included and treated, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N=number of valid cases.

Physician: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ... (at Last Visit)

persistent pain (IV: N=131, LV: N=112)

breakthrough pain (IV: N=130, LV: N=111)

nausea (IV: N=130, LV: N=112)

vomiting (IV: N=130, LV: N=112)

dyspnoea (IV: N=130, LV: N=111)

constipation (IV: N=129, LV: N=112)

weakness (IV: N=129, LV: N=112)

poor appetite (IV: N=131, LV: N=112)

tiredness (IV: N=130, LV: N=112)

efforts due to wounds/decubitus (N=130, N=112)

need for assistance (IV: N=130, LV: N=111)

depressiveness (IV: N=129, LV: N=111)

anxiety (IV: N=130, LV: N=112)

tension (IV: N=130, LV: N=112)

disorientation, confusion (IV: N=130, LV: N=111)

Problems with organization of care (N=129, N=112)

Overburdening family/environment N=129, N=112

Initial Visit (IV)

Physician: What is the Current Treatment Needs of Your Patient Regarding ...

First Visit

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases (= 91). From the 95 participants analyzed, only 91 participants had valid values at the last visit.

Patient: How Many Episodes of Pain You Experience on Average?

Persistent pain in the last 24 hrs on average N=94

Pain during the last pain attacks maximally N=93

Pain intensity bearable N= 94

Patients at First Visit

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed') =N.

Patient: Description of Pain at Initial Visit

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

* Initial Visit N=94
* Last Visit N=83

Patient: How do You Feel Today?

Patient: To What Extent Your Present Condition is Affected by Your Pain Attacks?

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

* Initial Visit N=92
* Last Visit N= 80

Patient: Modified Pain Disability Index (mPDI) - Sum - Score (Complete Questionnaires Only)

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

* Initial Visit N=93
* Last Visit N=82

Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only)

QLIP - score (classified):QLIP conspicuous (≤20)

QLIP - score (classified):QLIP inconspicuous (>20)

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

Patient: Quality-of-Life-Impairment by Pain =QLIP - Sum - Score (Complete Questionnaires Only) Conspicuous ≤20

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases.

* Initial Visit N=93
* Last Visit N=81

Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only)

MQHH - score (classified):conspicuous:score <1.5

MQHH - score (classified):inconspicuous:score ≥1.5

Patient: Marburg Questionnaire on Habitual Health (MQHH): Sum - Score (Complete Questionnaires Only) Conspicuous <1.5

Patients at Final Visit

Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.

All patients with valid values at last visit. N= number of valid cases (80). From the 83 participants analyzed, only 80 participants had valid values at the last visit.

Patient: Degree of Relief of Breakthrough Pain Achieved by Instanyl at Study End

speed of action (FV: N=33, LV: N=82)

strength of action (FV: N=33, LV: N=82)

tolerability (FV: N=33, LV: N=82)

handling (FV: N=33, LV: N=80)

total satisfaction (FV: N=NA, LV: N=82)

First Visit (FV)(Patients With Previous BTP-medication Only)

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed').

Patient: Assessment of Breakthrough Pain Therapy (Initial Visit: Previous/Last Visit: Instanyl)

speed of action (N=79)

strength of action (N=80)

tolerability (N=78)

handling (N=79)

total satisfaction (N=80)

Patients included and treated who filled in the patient's documentation with valid data (without imputation of missing values), intention to treat.

All patients with valid values at last visit. N= number of valid cases.

Patient: To What Extent Did Your Expectations in Instanyl Have Met With Respect to ... (Last Visit)

Nursing and support efforts (N= 81)

Autonomy of the patient (N= 81)

Pain-related impairment in everyday life (N= 81)

Quality of patient's life (N= 81)

All patients included and treated who filled in the patient's documentation, intention to treat, missing values not imputed.

All patients with valid values ('as observed'). N= number of valid cases (=81). From the 83 participants analyzed, only 81 participants had valid values at the last visit.

Patient: To What Extent Changes Have Occurred Induced by the Treatment of Breakthrough Pain With Instanyl With Respect to ...(at Last Visit)

Caregiver at Final Visit

Patients included and treated with caregiver documentation (without imputation of missing values), ITT.

All patients with valid values at last visit. N= number of valid cases (=67). From the 70 participants analyzed, only 67 participants had valid values at the last visit.

Caregiver: Degree of Relief of Breakthrough Pain Achieved by Instany at Study End

speed of action (N=69)

strength of action (N=69)

tolerability (N=69)

safety (N=68)

handling (N=69)

patient satisfaction (N=68)

Patients included and treated with caregiver documentation (without imputation of missing values), intention to treat.

All patients with valid values ('as observed'). N= number of valid cases.

Spots Global Cancer Trial Database for instanyl (intranasal fentanyl)