This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
150 mg orally once a day for 12 months
IRCCS Istituto Nazionale Tumori Fondazione Pascale; Oncologia Medica A
Naples, Campania, Italy
Ospedale Bellaria; U.O. Oncologia Medica
Bologna, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, Italy
Percentage of Participants With Disease Progression or Death at 12 Months After Baseline
According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), progressive disease (PD) was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: 12 months
Progression-Free Survival (PFS)
PFS was defined as the time from baseline to the date of first occurrence of disease progression or death. According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. PFS was assessed using Kaplan-Meier method.
Time frame: Up to 1 year after enrollment of the last participant (maximum up to 27 months)
Probability of Being Progression Free 12 Months After Baseline
According to RECIST v1.1, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: 12 months
Percentage of Participants Who Died
Time frame: Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)
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Istituto Regina Elena; Oncologia Medica A
Rome, Lazio, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardy, Italy
Az Ospedaliera Nuovo Garibaldi Quartiere Nesima; Oncologia Medica
Catania, Sicily, Italy
Policlinico P. Giaccone; Istituto Di Oncologia, Clinica Medica 1
Palermo, Sicily, Italy
A.O. Universitaria Pisana-Ospedale Cisanello; Dipartimento Cardio Toracico-Pneumologia Ii
Pisa, Tuscany, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica
Perugia, Umbria, Italy
Overall Survival (OS)
OS was defined as the time from randomization to the date of death due to any cause. OS was assessed using Kaplan-Meier method.
Time frame: Every 8 weeks during treatment, after discontinuation participants were followed for up to 1 year after enrollment of the last participant (maximum up to 27 months)
Percentage of Participants With a Response by Best Overall Response
Tumor response was assessed according to RECIST v1.1. Complete response (CR): complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. Partial response (PR): greater than or equal to (\>=) 30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Stable disease (SD): not qualifying for CR, PR, or PD.
Time frame: Baseline up to disease progression or end of study (up to 12 Months)
Percentage of Participants With Objective Response
Objective response was defined as the percentage of participants with CR or PR as best overall response by RECIST v1.1. To be assigned the status of PR or CR, changes in tumor measurements were to be confirmed by repeated assessments no less than 4 weeks after the criteria for response were first met. CR was defined as complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as \>=30% decrease under baseline of sum of diameters of all target lesions. The short axis was used in sum for target nodes, while longest diameter was used in sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. Participants with no tumor assessment after start of study treatment were considered as non-responders. The percentage of participants with response is presented.
Time frame: Baseline up to disease progression or end of study (up to 12 Months)
Percentage of Participants Achieving CR, PR, or SD as Best Overall Response
The Disease Control Rate was defined as the percentage of participants who had CR or PR or SD as Best Overall Response achieved within the time between the first drug administration and documented disease progression or end of study. According to RECIST v1.1, CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than 10 mm), with no new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. SD was defined as not qualifying for CR, PR, or PD.
Time frame: Baseline up to disease progression or end of study (up to 12 Months)
Percentage of Participants With Primary and Secondary Resistance
Primary resistance: participants did not reach SD or PR or CR before going to PD. Secondary resistance: participants experienced PD after having reached SD or PR or CR at least once. CR: complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes must decrease to normal (short axis less than 10 mm), with no new lesions. PR: \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease, and no new lesions. PD: \>=20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.
Time frame: Baseline up to disease progression (up to 12 Months)
Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Mutation by Mutation Type
EGFR is a gene in the tumor tissues and mutations in this gene have been linked to a variety of tumors. Presence or absence of EGFR mutation was determined in liquid biopsies by reverse transcriptase-polymerase chain reaction (RT-PCR /Cobas).
Time frame: Baseline, At progression of disease (up to 12 Months)