Abstract Types

CRA
Clinical Review Abstract

LBA
Late-Breaking Abstract

TPS
Trials in Progress Abstract

e
Abstracts selected for publication but not presentation at the Annual Meeting

^
Abstracts granted an exception in accordance with ASCO's Conflict of Interest Policy



An analysis of the prevalence of HER2 and KRAS mutations, and ALK rearrangements and clinical outcomes in Cancer and Leukemia Group B [CALGB (Alliance)] trial 30406 in advanced non-small cell lung cancer (NSCLC).

Sub-category:
Metastatic Non-small Cell Lung Cancer

Category:
Lung Cancer - Non-small Cell Metastatic

Meeting:
2013 ASCO Annual Meeting

Abstract No:
8039

Citation:
J Clin Oncol 31, 2013 (suppl; abstr 8039)

Publication-only abstracts (abstract number preceded by an "e"), published in conjunction with the 2013 Annual Meeting but not presented at the Meeting, can be found online only.

Author(s): Tom Stinchcombe, Lynette M. Sholl, Xiaofei F. Wang, Lin Gu, Mark A. Socinski, Scott J. Rodig, Marzia Capelletti, Jeffrey Crawford, Martin J. Edelman, Miguel Angel Villalona-Calero, Robert Arthur Kratzke, Everett E. Vokes, Vincent A. Miller, Pasi Antero Janne, Alliance; The University of North Carolina at Chapel Hill, Chapel Hill, NC; Dana-Farber Cancer Institute/Brigham and Women’s Hospital, Boston, MA; Cancer and Leukemia Group B Statistical Center, Durham, NC; University of Pittsburgh Medical Center, UPMC Cancer Pavilion, Pittsburgh, PA; Department of Pathology, Division of Hematopathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Dana-Farber Cancer Institute, Boston, MA; Duke University Medical Center, Durham, NC; University of Maryland, Marlene and Stewart Greenebaum Cancer Center, Baltimore, MD; The Ohio State University Wexner Medical Center, Columbus, OH; University of Minnesota, Minneapolis, MN; The University of Chicago Medicine and Biological Sciences, Chicago, IL; Foundation Medicine, Inc., Cambridge, MA

Abstract Disclosures


Abstract:

Background: CALGB (Alliance) 30406 was a randomized phase II trial that investigated erlotinib alone or in combination with carboplatin and paclitaxel in patients (pts) with a never or light smoking history with advanced NSCLC. Tissue collection was mandatory. Methods: Between August 2005 and April 2009 188 pts were enrolled. Tumor specimens were assessed using ALK immunohistiochemistry (IHC; clone D5F3; Cell Signaling); KRAS and HER2 mutations were tested. Results: The rate of mutations was: KRAS 10% (17/164), HER2 2% (3/164), and ALK + 7% (8/114). Given the small numbers of KRAS, HER2 and ALK positives, the analysis combines data from both arms. Pts with ALK + compared to ALK- NSCLC had an inferior ORR and PFS (Table). No statistically significant differences in ORR, PFS, OS between pts with KRAS or HER2 mutant and wild-type NSCLC were observed. In multivariate analysis pts with ALK+ compared to ALK- tumors experienced a statistically significant worse PFS (HR=2.67, p=0.0114) but not OS (HR=1.48, p=0.3217). One pt was identified as having an EGFR exon 21 mutation and ALK +; the pt experienced a best response of progressive disease, a PFS of 2.9 months, and OS of 17.4 months. Conclusions: (1) Pts with ALK+ compared to ALK- NSCLC have a lower ORR, worse PFS, but not OS with erlotinib alone or with carboplatin and paclitaxel. (2) The prevalence ALK+, KRAS and HER2 mutations observed was 7%, 10% and 2%, respectively. Clinical trial information: 00126581.

ORR (%)
(95% CI)
PFS (months)
(95% CI)
OS (months)
(95% CI)
ALK (n=114)
Positive (n=8) 0
(0 – 36.9)
2.2
(0.6 – 6.6)
12.9
(0.9 – 26.1)
Negative (n=106) 38.7
(29.4 – 48.7)
6.3
(5.0 – 8.0)
20.7
(15.0 – 27.8)
2-sided p value* 0.0491 0.0039 0.1948
KRAS (n=164)
MUT (n=17) 29.4
(10.3 – 56.0)
4.0
(2.8 – 12.4)
18.0
(7.7 – 39.9)
WT (n=147) 42.2
(34.1 – 50.6)
6.7
(5.3 – 8.0)
23.8
(18.7 – 27.9)
2-sided p value* 0.4359 0.1318 0.4615
HER2 (n=164)
MUT (n=3) 0
(0 – 70.8)
4.2
(1.2 – 9.7)
17.5
(2.9 – 27.8)
WT (n=161) 41.6
(33.9 – 49.6)
6.6
(5.0 – 7.4)
23.7
(18.4 – 27.8)
2-sided p value* 0.2706 0.2732 0.1911

* P values of testing ORR difference between positive vs. negative/MUT vs. WT are from Fisher’s exact tests, while those for PFS and OS are from log-rank tests.

 

  Other Abstracts in this Sub-Category:

 

1. Biomarkers (BM) France: Results of routine EGFR, HER2, KRAS, BRAF, PI3KCA mutations detection and EML4-ALK gene fusion assessment on the first 10,000 non-small cell lung cancer (NSCLC) patients (pts).

Meeting: 2013 ASCO Annual Meeting Abstract No: 8000 First Author: F. Barlesi
Category: Lung Cancer - Non-small Cell Metastatic - Metastatic Non-small Cell Lung Cancer

 

2. Molecular analysis-directed, international, phase III trial in patients with advanced non-small-cell lung cancer.

Meeting: 2013 ASCO Annual Meeting Abstract No: 8001 First Author: G. Bepler
Category: Lung Cancer - Non-small Cell Metastatic - Metastatic Non-small Cell Lung Cancer

 

3. Interim analysis of the Spanish Lung Cancer Group (SLCG) BRCA1-RAP80 Expression Customization (BREC) randomized phase III trial of customized therapy in advanced non-small cell lung cancer (NSCLC) patients (p) (NCT00617656/GECP-BREC).

Meeting: 2013 ASCO Annual Meeting Abstract No: LBA8002 First Author: T. Moran
Category: Lung Cancer - Non-small Cell Metastatic - Metastatic Non-small Cell Lung Cancer

 

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