Non Small-cell Lung Cancer
Conditions
Keywords
Non-small cell lung cancer., Diagnosis,, Adenocarcinoma,, ALK,, FISH,, IHC, RT-qPCR
Brief summary
Because ALK-positive lung cancer constitutes less than 5% of all lung cancers, it is critically important to select those patients who are more likely to have the ALK mutation. Clinical characteristics of patients with mutations in the target gene should also be known, so that the incidence of a given target mutation is established in a specific population. There is not incidence known in Mexican population, but it is believed it is greater.
Detailed description
Lung adenocarcinoma studies. The only inclusion criterion was the availability of tissue for biomarker studies. To identify ALK rearrangements, fluorescence in situ hybridization (FISH) studies were performed on 3 to 4 mm thick paraffin sections from NSCLCs. The commercially labeled Vysis LSI ALK Dual Color (split-apart), break-apart rearrangement probe (Abbott Molecular, Abbott Park, IL) was used to detect any rearrangement involving the ALK gene. The probe hybridizes to band 2p23, on either side of the ALK gene breakpoint. Criteria for probe signal interpretation in at least 200 interphase nuclei were as follow: 1) separated green and orange signals or single red signals identified cells with rearranged ALK; 2) overlapping of red and green signals (yellowish) indicated cells in which ALK was not rearranged. FISH-positive samples for ALK rearrangement were defined as having cells with a clearly separated pair of probe signals, or with \>15% of cells having loss of the 5´(centromeric) probe. The higher threshold for loss is necessary because parts of probes can be lost during sectioning. The aim of our study is to evaluate the utility of IHC with 5A4 and RT-qPCR in the detection of ALK rearrangements in NSCLC compared with the current method of choice, FISH. Further, we report on the demographics, and clinicopathologic features of ALK-rearranged NSCLC in a Latin-American population. Clinical details of these patients were included in a database. Further results will be analyzed with the program SPSS17
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* The only inclusion criterion was the availability of tissue for biomarker studies.
Exclusion criteria
* Disease Progression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FISH, IHC, RT-qPCR Comparison | TWO YEARS | 200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR. |
Countries
Mexico
Participant flow
Recruitment details
The recruitment began on February 01, 2011 and finished on September 01, 2014. All samples were obtained at the Instituto Nacional de Cancerología, in Mexico.
Pre-assignment details
Samples were sent to the unit of Anatomic Pathology, where a pathologist confirmed the histologic diagnosis. The only inclusion criterion was the availability of tissue for biomarker studies.
Participants by arm
| Arm | Count |
|---|---|
| Demographics and Clinical Features of Overall Population The baseline characteristics of our population were on basis of the presence or absence of ALK gene. | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | scarce samples for evaluation | 30 |
Baseline characteristics
| Characteristic | Demographics and Clinical Features of Overall Population |
|---|---|
| Age, Customized 55 to 87 years old | 109 participants |
| Age, Customized < 55 years old | 91 participants |
| ECOG Performance status ECOG 0-1; ALK - | 148 participants |
| ECOG Performance status ECOG 0-1; ALK + | 15 participants |
| ECOG Performance status ECOG 2-3; ALK - | 33 participants |
| ECOG Performance status ECOG 2-3; ALK + | 4 participants |
| Histology Non-squamus; ALK - | 5 participants |
| Histology Non-squamus; ALK + | 2 participants |
| Histology Squamus; ALK - | 176 participants |
| Histology Squamus; ALK+ | 17 participants |
| Histology Subtype Acinar; ALK - | 39 participants |
| Histology Subtype Acinar; ALK + | 5 participants |
| Histology Subtype Adenousquamous; ALK - | 16 participants |
| Histology Subtype Adenousquamous; ALK + | 0 participants |
| Histology Subtype Lepidic; ALK - | 14 participants |
| Histology Subtype Lepidic; ALK + | 3 participants |
| Histology Subtype Micropapilar; ALK - | 10 participants |
| Histology Subtype Micropapilar; ALK + | 1 participants |
| Histology Subtype No otherwise specified; ALK - | 42 participants |
| Histology Subtype No otherwise specified; ALK + | 5 participants |
| Histology Subtype Papilar; ALK - | 13 participants |
| Histology Subtype Papilar; ALK + | 2 participants |
| Histology Subtype Solid; ALK - | 47 participants |
| Histology Subtype Solid; ALK + | 3 participants |
| Sex: Female, Male Female | 113 Participants |
| Sex: Female, Male Male | 87 Participants |
| Smoking history Non smokers ALK + | 12 participants |
| Smoking history Non smokers ALK- | 95 participants |
| Smoking history smokers ALK- | 86 participants |
| Smoking history Smokers ALK+ | 7 participants |
| Wood smoke expossure Absent; ALK - | 117 participants |
| Wood smoke expossure Absent; ALK + | 9 participants |
| Wood smoke expossure Present; ALK - | 64 participants |
| Wood smoke expossure Present; ALK + | 10 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
FISH, IHC, RT-qPCR Comparison
200 samples underwent FISH, from them 63 underwent IHC and 48 RT-qPCR.
Time frame: TWO YEARS
Population: The only selection criteria of our subjets was the availability of tumor tissue to perform tests.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FISH Test | FISH, IHC, RT-qPCR Comparison | ALK+ | 18 participants |
| FISH Test | FISH, IHC, RT-qPCR Comparison | ALK- | 182 participants |
| IHC Test | FISH, IHC, RT-qPCR Comparison | ALK+ | 15 participants |
| IHC Test | FISH, IHC, RT-qPCR Comparison | ALK- | 48 participants |
| RT-qPCR Test | FISH, IHC, RT-qPCR Comparison | ALK+ | 5 participants |
| RT-qPCR Test | FISH, IHC, RT-qPCR Comparison | ALK- | 43 participants |