Pancreatic Cancer
Conditions
Brief summary
This observational study will evaluate the impact of rash on survival of patients with metastatic pancreatic cancer treated with erlotinib plus gemcitabine. Further, clinical effectiveness, efficacy and safety will be assessed. Data will be collected for 12 months.
Interventions
DRUGerlotinib
Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC)
DRUGgemcitabine
Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC)
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults, age \>= 18 years * Patients with metastatic pancreatic cancer where investigators have decided to give combination therapy of erlotinib and gemcitabine according to Summary of Product Characteristics (SmPC)
Exclusion criteria
* Contraindications for erlotinib according to Summary of Products Characteristics (SmPC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival Stratified by Rash | Up to 12 months | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 12 months | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
| Number of Dose Modifications and Dose Withdrawals of Erlotinib | Up to 12 months | Reported is the total number of dose modifications/withdrawals for erlotinib. |
| Number of Dose Modifications and Dose Withdrawals of Gemcitabine | Up to 12 months | Reported is the number of dose modifications/withdrawals for gemcitabine. |
| Time of Onset of Rash After Start Erlotinib Treatment | Up to 12 months | Reported is the number of days from first erlotinib treatment to first rash onset. |
| Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Up to 12 months | Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. |
| Number of Participants With Rash by Severity | Up to 12 months | Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. |
| Time to Disease Progression | Up to 12 months | Disease progression was defined in accordance with daily routine practice. |
| Score in Patient Questionnaire: Possible Side Effects | At Weeks 4, 8, 9 and 16 | Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. |
| Score in Participant Questionnaire: What to Do in Case of Side Effect | At Weeks 4, 8, 9 and 16 | Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study. |
| Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | At Weeks 4, 8, 9 and 16 | Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study. |
| Score in Participant Questionnaire: Quality of Life | At Weeks 4, 8, 9 and 16 | Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study. |
| Percentage of Participants With Best Overall Response | Up to 12 months | Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Plus Gemcitabine Participants with metastatic pancreatic cancer, who were planned to receive combination therapy of erlotinib and gemcitabine based on the investigator's assessment. | 338 |
| Total | 338 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Absent rash | 9 |
| Overall Study | Death | 133 |
| Overall Study | Lost to Follow-up | 31 |
| Overall Study | Not reported | 7 |
| Overall Study | Patient's wish | 21 |
| Overall Study | Physician Decision | 13 |
| Overall Study | Study completion unknown | 7 |
| Overall Study | Toxicity of erlotinib | 1 |
| Overall Study | Toxicity of gemcitabine | 1 |
| Overall Study | Tumor progression | 74 |
| Overall Study | Withdrawal of informed consent | 2 |
Baseline characteristics
| Characteristic | Erlotinib Plus Gemcitabine |
|---|---|
| Age, Continuous | 66.9 years STANDARD_DEVIATION 9.1 |
| Sex: Female, Male Female | 135 Participants |
| Sex: Female, Male Male | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 261 / 338 |
| serious Total, serious adverse events | 171 / 338 |
Outcome results
Primary
Overall Survival Stratified by Rash
Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by rash status. Participants with rash: rash = yes. Participants without rash: rash = no.
Time frame: Up to 12 months
Population: Full Analysis Set (FAS) included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Erlotinib Plus Gemcitabine | Overall Survival Stratified by Rash | Rash = Yes | 9.9288 months | 95% Confidence Interval 0.5066 |
| Erlotinib Plus Gemcitabine | Overall Survival Stratified by Rash | Rash = No | 8.6795 months | 95% Confidence Interval 0.3151 |
Comparison: Comparison of Rash=Yes versus Rash=No within Erlotinib plus Gemcitabine armp-value: 0.2361Log Rank
Secondary
Number of Dose Modifications and Dose Withdrawals of Erlotinib
Reported is the total number of dose modifications/withdrawals for erlotinib.
Time frame: Up to 12 months
Population: Safety population included all participants who received at least one treatment with study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib Plus Gemcitabine | Number of Dose Modifications and Dose Withdrawals of Erlotinib | 152 dose modifications/withdrawals |
Secondary
Number of Dose Modifications and Dose Withdrawals of Gemcitabine
Reported is the number of dose modifications/withdrawals for gemcitabine.
Time frame: Up to 12 months
Population: Safety population included all participants who received at least one treatment with study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib Plus Gemcitabine | Number of Dose Modifications and Dose Withdrawals of Gemcitabine | 738 dose modifications/withdrawals |
Secondary
Number of Participants With Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Up to 12 months
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib Plus Gemcitabine | Number of Participants With Adverse Events (AEs) | 310 participants |
Secondary
Number of Participants With Rash by Severity
Reported is the total number of participants with rash as well as the number of participants with specific forms of rash, including paronychia, dry skin and papulopustulous eczema. Severity was reported according to Common Terminology Criteria for Adverse Events version 4.0 (CTC AE 4.0): Grade 1 = mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2 = moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily living (ADL); Grade 3 = severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Time frame: Up to 12 months
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Dry skin Grade 1 | 62 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Dry skin Grade 2 | 26 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Total number with rash | 174 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Paronychia Grade 1 | 10 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Paronychia Grade 2 | 7 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Paronychia Grade 3 | 2 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Papulopustulous eczema Grade 1 | 89 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Papulopustulous eczema Grade 2 | 69 participants |
| Erlotinib Plus Gemcitabine | Number of Participants With Rash by Severity | Papulopustulous eczema Grade 3 | 6 participants |
Secondary
Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
Overall survival was defined as the time from the date of randomization to the date of death from any cause and was stratified by ECOG-PS at baseline (0-1 versus 2). ECOG-PS 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours.
Time frame: Up to 12 months
Population: FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Erlotinib Plus Gemcitabine | Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | ECOG-PS grade 0-1 | 9.8301 months | 95% Confidence Interval 0.3726 |
| Erlotinib Plus Gemcitabine | Overall Survival Time Stratified by Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | ECOG-PS grade 2 | 6.3452 months | 95% Confidence Interval 0.7396 |
Secondary
Percentage of Participants With Best Overall Response
Best overall response was defined as complete response (CR) plus partial response (PR). Tumor evaluations were performed in accordance with daily routine practice.
Time frame: Up to 12 months
Population: FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib Plus Gemcitabine | Percentage of Participants With Best Overall Response | 24.74 percentage of participants |
Secondary
Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation
Participant questionnaire regarding the actual side effects of therapy compared to what one expected before therapy. Assessment ranged from 1 (less than expected) to 6 (more than expected). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Week 4 | 2.6 scores on a scale | Standard Deviation 1.1 |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Week 8 | 2.6 scores on a scale | Standard Deviation 1.1 |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Week 9 | 6.0 scores on a scale | — |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Actual Side Effects of Therapy Compared to Expectation | Week 16 | 2.7 scores on a scale | Standard Deviation 1.1 |
Secondary
Score in Participant Questionnaire: Quality of Life
Participant assessment of life quality under therapy. Assessment ranged from 1 (very good) to 6 (very bad). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Quality of Life | Week 4 | 2.9 scores on a scale | Standard Deviation 1.1 |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Quality of Life | Week 8 | 2.9 scores on a scale | Standard Deviation 1.2 |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Quality of Life | Week 9 | 1.0 scores on a scale | — |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: Quality of Life | Week 16 | 2.9 scores on a scale | Standard Deviation 1.1 |
Secondary
Score in Participant Questionnaire: What to Do in Case of Side Effect
Participant questionnaire regarding satisfaction with the information about what one should do in case of side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: What to Do in Case of Side Effect | Week 4 | 1.9 scores on a scale | Standard Deviation 0.8 |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: What to Do in Case of Side Effect | Week 8 | 2.0 scores on a scale | Standard Deviation 1 |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: What to Do in Case of Side Effect | Week 9 | 1.0 scores on a scale | — |
| Erlotinib Plus Gemcitabine | Score in Participant Questionnaire: What to Do in Case of Side Effect | Week 16 | 1.9 scores on a scale | Standard Deviation 0.7 |
Secondary
Score in Patient Questionnaire: Possible Side Effects
Participant questionnaire regarding satisfaction with the information about possible side effects. Assessment ranged from 1 (very satisfied) to 6 (not satisfied). Questionnaire scores were assessed at several time points during the study.
Time frame: At Weeks 4, 8, 9 and 16
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Erlotinib Plus Gemcitabine | Score in Patient Questionnaire: Possible Side Effects | Week 4 | 1.9 scores on a scale | Standard Deviation 0.9 |
| Erlotinib Plus Gemcitabine | Score in Patient Questionnaire: Possible Side Effects | Week 8 | 1.9 scores on a scale | Standard Deviation 0.9 |
| Erlotinib Plus Gemcitabine | Score in Patient Questionnaire: Possible Side Effects | Week 9 | 1.0 scores on a scale | — |
| Erlotinib Plus Gemcitabine | Score in Patient Questionnaire: Possible Side Effects | Week 16 | 1.9 scores on a scale | Standard Deviation 0.9 |
Secondary
Time of Onset of Rash After Start Erlotinib Treatment
Reported is the number of days from first erlotinib treatment to first rash onset.
Time frame: Up to 12 months
Population: Safety population included all participants who received at least one treatment with study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Erlotinib Plus Gemcitabine | Time of Onset of Rash After Start Erlotinib Treatment | 18.4 days | Standard Deviation 21.6 |
Secondary
Time to Disease Progression
Disease progression was defined in accordance with daily routine practice.
Time frame: Up to 12 months
Population: FAS included those enrolled participants who started treatment with erlotinib in combination with gemcitabine.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Erlotinib Plus Gemcitabine | Time to Disease Progression | 4.3726 months | 95% Confidence Interval 0.2945 |