Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Gefitinib
Brief summary
The purpose of this study is to compare gefitinib with carboplatin / paclitaxel doublet chemotherapy given as first line treatment in terms of progression free survival in selected NSCLC patients with the objective of demonstrating non-inferiority.
Interventions
DRUGGefitinib
oral tablet
DRUGCarboplatin
IV
DRUGPaclitaxel
IV
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Locally advanced Stage IIIB not amenable to local therapy or Stage IV (metastatic) NSCLC with adenocarcinoma histology. * Never smokers or light ex-smokers.(ceased smoking at least 15 years before Day 1 of study treatment and 10 pack-years or fewer)
Exclusion criteria
* Had prior chemotherapy, biological (including targeted therapies such as EGFR and vascular epidermal growth factor (VEGF) inhibitors) or immunological therapy. * Pre-existing idiopathic pulmonary fibrosis evidence by CT scan at baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Progression Free Survival (PFS) in Months | Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). | PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Tumour Response Rate According to RECIST | Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008). | Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response. |
| Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). |
| Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). |
| Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). |
| Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). |
| Neurotoxicity | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) |
| Rashes/Acnes | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) |
| Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010) | Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks. | Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here. |
| Nausea | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) |
| Vomiting | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) |
| Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel). |
| Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. | Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit |
| Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. | Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit |
| Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire | FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation. | Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit |
| Diarrhoea | Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel | Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel) |
Countries
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan, Thailand
Participant flow
Recruitment details
Males or females that had never smoked or were light ex-smokers, who had Stage IIIB or Stage IV adenocarcinoma of the lung and had not received any previous chemotherapy excluding non-platinum based adjuvant chemotherapy were randomised between 30 March 2006 and 9 October 2007. The study was carried out in Asian countries (including Japan & China).
Pre-assignment details
112 patients (out of 1329) failed screening and were not randomized, the majority of patients who failed screening did not comply with inclusion / exclusion criteria. Other reasons were: patient withdrew informed consent; patient lost to follow up. One patient was not randomized for 'other' (non-specified) reason.
Participants by arm
| Arm | Count |
|---|---|
| Gefitinib Gefitinib 250mg daily | 609 |
| Carboplatin/Paclitaxel Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m\^2 doublet chemotherapy every 3 weeks | 608 |
| Total | 1,217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 223 | 227 |
| Overall Study | Eligibility criteria not fulfilled | 0 | 1 |
| Overall Study | Lost to Follow-up | 5 | 2 |
| Overall Study | Withdrawal by Subject | 19 | 46 |
Baseline characteristics
| Characteristic | Total | Carboplatin/Paclitaxel | Gefitinib |
|---|---|---|---|
| Age Continuous | 57 Years | 57 Years | 57 Years |
| Race/Ethnicity, Customized Asian (other than Chinese or Japanese) | 363 Participants | 184 Participants | 179 Participants |
| Race/Ethnicity, Customized Caucasian | 4 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Chinese | 618 Participants | 304 Participants | 314 Participants |
| Race/Ethnicity, Customized Japanese | 233 Participants | 119 Participants | 114 Participants |
| Race/Ethnicity, Customized Oriental | 1209 Participants | 606 Participants | 603 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Female | 965 Participants | 481 Participants | 484 Participants |
| Sex: Female, Male Male | 252 Participants | 127 Participants | 125 Participants |
| Smoking history Ex-smoker (non-light) | 2 Participants | 1 Participants | 1 Participants |
| Smoking history Light ex-smoker | 75 Participants | 38 Participants | 37 Participants |
| Smoking history Never Smoker | 1140 Participants | 569 Participants | 571 Participants |
| WHO performance status 0 (normal activity) | 318 Participants | 161 Participants | 157 Participants |
| WHO performance status 1 (restricted activity) | 773 Participants | 382 Participants | 391 Participants |
| WHO performance status 2 (in bed =< 50% of the time) | 126 Participants | 65 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 574 / — | 573 / — |
| serious Total, serious adverse events | 110 / 607 | 92 / 589 |
Outcome results
Primary
Median Progression Free Survival (PFS) in Months
PFS was defined as the interval from the date of randomization to the date of objective disease progression (as per RECIST) or the date of death (from any cause) in the absence of objective disease progression. The median PFS in months is presented here.
Time frame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).
Population: Analysis was carried out on Intention-to-treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib | Median Progression Free Survival (PFS) in Months | 5.7 Months |
| Carboplatin/Paclitaxel | Median Progression Free Survival (PFS) in Months | 5.8 Months |
Secondary
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia
Number of patients with an anaemia event, identified from the lab data as a worsening in haemoglobin from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia | 11 Participants |
| Carboplatin/Paclitaxel | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Anaemia | 56 Participants |
Secondary
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia
Number of patients with a leukopenia event, identified from the lab data as a worsening in white blood cell count from baseline to a CTC grade 3 or above. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia | 1 Participants |
| Carboplatin/Paclitaxel | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Leukopenia | 202 Participants |
Secondary
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases
Number of patients with an elevated liver transaminase event, identified from the lab data as a worsening in ALT or AST from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases | 57 Participants |
| Carboplatin/Paclitaxel | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Liver Transaminases | 6 Participants |
Secondary
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia
Number of patients with a neutropenia event, identified from the lab data as a worsening in absolute neutrophil count from baseline to a CTC grade 3 or above which Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia | 4 Participants |
| Carboplatin/Paclitaxel | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Neutropenia | 385 Participants |
Secondary
Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia
Number of patients with a thromboctyopenia event, identified from the lab data as a worsening in platelet count from baseline to a CTC grade 3 or above. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia | 5 Participants |
| Carboplatin/Paclitaxel | Common Toxicity Criteria (CTC) Grade 3, 4, or 5 Thrombocytopenia | 29 Participants |
Secondary
Diarrhoea
Number of patients with a diarrhoea event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Diarrhoea | 274 Participants |
| Carboplatin/Paclitaxel | Diarrhoea | 128 Participants |
Secondary
Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010)
Overall Survival was assessed via calculation of the time to death due to any cause. If a participant was known to have died, the time to death was defined as the time from the date of randomization to the date of death. Otherwise, a participant was censored at the last date they were known to be alive. Median Overall Survival in months is presented here.
Time frame: Following the PFS DCO on 14th April 2008 information on survival status was collected every 8 weeks.
Population: Analysis was carried out on Intention-to-treat (ITT) population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gefitinib | Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010) | 18.8 Months |
| Carboplatin/Paclitaxel | Median Overall Survival (OS) in Months at OS Data Cut Off (14th June 2010) | 17.4 Months |
Secondary
Nausea
Number of patients with a nausea event. Based on the evaluable for-safety-population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Nausea | 74 Participants |
| Carboplatin/Paclitaxel | Nausea | 260 Participants |
Secondary
Neurotoxicity
Number of patients with a neurotoxicity event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Neurotoxicity | 30 Participants |
| Carboplatin/Paclitaxel | Neurotoxicity | 411 Participants |
Secondary
Objective Tumour Response Rate According to RECIST
Number of participants with an objective response. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to RECIST, confirmed at least 28 days following the date of the initial response.
Time frame: Tumour assessments as per RECIST were performed at baseline and then every 42 days ± 7 days from randomization until data cut off (14th April 2008).
Population: Analysis was carried out on Intention-to-treat (ITT) population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Objective Tumour Response Rate According to RECIST | 262 Participants |
| Carboplatin/Paclitaxel | Objective Tumour Response Rate According to RECIST | 196 Participants |
Secondary
Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire
Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in FACT-L score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit
Time frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.
Population: Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | 283 Participants |
| Carboplatin/Paclitaxel | Quality of Life (QoL) as Measured by the Total Score of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | 229 Participants |
Secondary
Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire
Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in TOI score (from baseline) of 6 or more, and there were no intervening visits showing a decrease from baseline of 6 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit
Time frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.
Population: Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | 274 Participants |
| Carboplatin/Paclitaxel | Quality of Life (QoL) as Measured by the Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Lung Cancer (FACT-L) Questionnaire | 184 Participants |
Secondary
Rashes/Acnes
Number of patients with a rashes/acnes event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Rashes/Acnes | 398 Participants |
| Carboplatin/Paclitaxel | Rashes/Acnes | 132 Participants |
Secondary
Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire
Number of patients improving: a patient was described as improved if they had 2 visits (at least 21 days apart) where there was an increase in LCS score (from baseline) of 2 or more, and there were no intervening visits showing a decrease from baseline of 2 or more. Includes all patients with QoL data at baseline & at least 1 post-baseline visit
Time frame: FACT-L data were collected at baseline, week 1, every 3 weeks (from baseline) until day 127, then every 42 days until the patient was confirmed as having objectively progressed (via RECIST), and at treatment discontinuation.
Population: Analysis was carried out on the Evaluable-for-QoL (EFQ) population. The EFQ population is a subset of the ITT population containing patients with an evaluable baseline QoL assessment and at least 1 evaluable post-baseline QoL assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire | 304 Participants |
| Carboplatin/Paclitaxel | Symptom Improvement as Measured by the Lung Cancer Subscale (LCS) of the FACT-L Questionnaire | 272 Participants |
Secondary
Vomiting
Number of patients with a vomiting event. Based on the evaluable-for-safety population, which included all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel)
Time frame: Includes events that occurred whilst a patient was receiving first-line randomized treatment: defined as date of first dose to date of last dose +1 day for gefitinib, and date of first infusion to date of last infusion + 21 days for carboplatin/paclitaxel
Population: Analysis was carried out on the Evaluable-for-safety (EFS) population. The EFS population is a subset of the ITT population which includes all patients who received at least 1 dose of study medication (gefitinib, or carboplatin or paclitaxel).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gefitinib | Vomiting | 59 Participants |
| Carboplatin/Paclitaxel | Vomiting | 193 Participants |