Feasibility of Molecular Testing in Patients with Chemorefractory Non-Small Cell Carcinoma
Neda Kalhor, Ximing Tang, Edward S Kim, Vali Papadimitrakopoulou, Jack J Lee, Roy S Herbst, Christine M Alden, Heidi S Erickson, Cesar A Moran, Alda L Tam, Sanjay Gupta, Scott M Lipmann, Waun K Hong, Ignacio I Wistuba. MD Anderson Cancer Center, Houston, TX; Yale School of Medicine, New Haven, CT
Background: The majority of patients with advanced Non-Small Cell Carcinoma (NSCLC) experience relapse or disease progression on chemotherapy. Targeted therapies based on tumor biomarker profile may be beneficial in these patients. Obtaining adequate tissue for molecular profiling in patients who are heavily treated may be challenging. This study was conducted to evaluate the feasibility of biopsy for molecular testing in patients with chemorefractory NSCLC.
Design: We analyzed the database for BATTLE trials (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination), including first BATTLE trial and the data from the ongoing BATTLE II trial. Biopsies were collected in 324 patients from BATTLE I and 46 patients from BATTLE II. The biopsy material included core needle biopsies (CNB) for BATTLE I and CNB together with Fine Needle Aspiration (FNA) for BATTLE II. Immediate assessment for tissue adequacy was performed by an onsite cytopathologist for all the BATTLE II cases. Tissue source included lung and metastatic sites including lymph node, liver, adrenal gland, skin, bone and mediastinum. Mutation analysis for EGFR and KRAS was performed in all the cases with adequate material within 2 weeks after the biopsy.
Results: Of 324 patients enrolled in BATTLE-1 trial, CNBs with adequate (≥200 cells/slide) content for molecular testing were obtained in 271 (84%) cases. Tissue fibrosis and necrosis were the major histological findings in the cases with non-adequate tissues. The specimen adequacy did not correlate with tissue source. KRAS and EGFR mutation analyses were successfully performed in 270 cases and were detected in 18% (n=48) and 17% (n=46), respectively. Of the 46 patients enrolled in the ongoing BATTLE-2 trial, adequate tissue was obtained in all cases except one. Similar rates of EGFR (11%) and KRAS (16%) mutations have so far been detected in this ongoing trial.
Conclusions: We have studies the diagnostic yield of CNB for molecular testing in patients with advanced, chemorefractory NSCLC. Successful molecular testing, utilizing CNB is feasible in patients in this clinical setting. Combined CNB and FNA may have a role in reducing the failure rate.
Tuesday, March 20, 2012 9:30 AM
Poster Session III # 310, Tuesday Morning