Trial Outcomes & Findings for First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation (NCT NCT00344773)

Last Updated: 2010-06-29

Results Overview

Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. RECIST criteria: CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

46 participants

Primary outcome timeframe

baseline to 12 months

Results posted on

2010-06-29

Participant Flow

147 patients were screened for epidermal growth factor receptor (EGFR) mutation and 46 patients were enrolled in this study. Subjects were recruited by 7 investigational centers throughout South Korea from Mar 2006 to May 2007

Participant milestones

Participant milestones
Measure	Gefitinib Gefitinib 250mg tablet
Overall Study STARTED	46
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Gefitinib Gefitinib 250mg tablet
Overall Study Adverse Event	2
Overall Study Objective Disease Progression	16
Overall Study Withdrawal by Subject	1
Overall Study Not Eligible for the study	2

Baseline Characteristics

First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gefitinib n=46 Participants Gefitinib 250mg tablet
Age Continuous	60 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 12 months

Outcome measures

Outcome measures
Measure	Gefitinib n=46 Participants Gefitinib 250mg tablet
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.	0 Percent of Participants

SECONDARY outcome

Timeframe: baseline to 4 months

Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.

Outcome measures

Outcome measures
Measure	Gefitinib n=46 Participants Gefitinib 250mg tablet
Progression Free Survival (PFS)	86.25 Percent of Participants Interval 0.7191 to 0.9358

SECONDARY outcome

Timeframe: baseline to 12 months

Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.

Outcome measures

Outcome measures
Measure	Gefitinib n=46 Participants Gefitinib 250mg tablet
Overall Survival (OS)	82.26 Percent of Participants 0

SECONDARY outcome

Timeframe: baseline to end of study

Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.

Outcome measures

Outcome data not reported

Adverse Events

Gefitinib

Serious events: 4 serious events

Other events: 44 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Gefitinib Gefitinib 250mg tablet
Infections and infestations Pneumonia	4.3% 2/46
Injury, poisoning and procedural complications Multiple contusion with Lt.9.10.11th rib fracture	2.2% 1/46
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Intramuscular myxoma in the left intraspinatos muscle	2.2% 1/46
Gastrointestinal disorders Diarrhea	2.2% 1/46
Nervous system disorders Myoclonus	2.2% 1/46

Other adverse events

Other adverse events
Measure	Gefitinib Gefitinib 250mg tablet
Skin and subcutaneous tissue disorders Alopecia	10.9% 5/46
Metabolism and nutrition disorders Anorexia	37.0% 17/46
Musculoskeletal and connective tissue disorders Back-pain	8.7% 4/46
Infections and infestations Common cold	6.5% 3/46
Gastrointestinal disorders Constipation	15.2% 7/46
Respiratory, thoracic and mediastinal disorders Cough	28.3% 13/46
Skin and subcutaneous tissue disorders Desquamation	19.6% 9/46
Gastrointestinal disorders Diarrhea	34.8% 16/46
Nervous system disorders Dizziness	10.9% 5/46
Skin and subcutaneous tissue disorders Dry-skin	6.5% 3/46
Gastrointestinal disorders Dyspepsia	8.7% 4/46
Respiratory, thoracic and mediastinal disorders Dyspnea	13.0% 6/46
Gastrointestinal disorders Epigastric pain	6.5% 3/46
Gastrointestinal disorders Epigastric soreness	6.5% 3/46
Gastrointestinal disorders General-weakness	6.5% 3/46
Skin and subcutaneous tissue disorders Hand foot syndrome	6.5% 3/46
Skin and subcutaneous tissue disorders Hand-foot syndrome	6.5% 3/46
Nervous system disorders Headache	13.0% 6/46
Gastrointestinal disorders Indigestion	6.5% 3/46
Skin and subcutaneous tissue disorders Itching	34.8% 16/46
Skin and subcutaneous tissue disorders Mucositis	6.5% 3/46
Gastrointestinal disorders Nausea	26.1% 12/46
Nervous system disorders Neuropathy	8.7% 4/46
Skin and subcutaneous tissue disorders Rash	6.5% 3/46
Respiratory, thoracic and mediastinal disorders Rhinorrhea	6.5% 3/46
Skin and subcutaneous tissue disorders Skin-rash	30.4% 14/46
Respiratory, thoracic and mediastinal disorders Sorethroat	6.5% 3/46
Respiratory, thoracic and mediastinal disorders Sputum	21.7% 10/46
Gastrointestinal disorders Stomatitis	19.6% 9/46

Additional Information

Gerard Lynch

Astrazeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60