MD Conference Express - ELCC 2015 - (Page 7)

Table 1. OS and PFS With Gemcitabine vs BSC Gemcitabine BSC HR P Value OS, mo (95% CI) 10 (9.2 to 10.7) 8 (6.7 to 9.2) 0.64 (0.51 to 0.77) .002 PFS, mo (95% CI) 9 (8.1 to 9.9) 7 (6.3 to 7.7) 0.67 (0.50 to 0.84) .009 BSC, best supportive care; OS, overall survival; PFS, progression-free survival. Source: Jakhar SL et al. Ann Oncol. 2015 (abstr 100PD). and not switch therapy; the findings of this trial support results from a larger trial of gemcitabine maintenance therapy [Brodowicz T et al. Lung Cancer. 2006] yet stand in contrast to a trial [Belani CP et al. J Clin Oncol. 2010] that found no advantage for gemcitabine maintenance plus BSC vs BSC alone. Patients in the gemcitabine group experienced a higher incidence of grade 3 and 4 adverse events: anemia (12% G; 8.1% BSC), neutropenia (18% G; 4.1% BSC), thrombocytopenia (14% G; 2% BSC), and fatigue (8% G; 2% BSC). Otherwise, the researchers reported that maintenance therapy was well tolerated. This study has a number of limitations that affect its interpretation. These include the open-label design, which could have influenced the results because the patients and the investigators knew who was receiving active treatment. The histologic subgroups (ie, squamous, nonsquamous) were not reported. Importantly, there is no information about the frequency of followup visits or restaging of cancer by imaging for each group and the percentage of patients who eventually had second-line therapy, particularly in the BSC group. The results of this small study may provide a signal that switch maintenance therapy with gemcitabine may extend OS and PFS for patients with advanced NSCLC, a finding that must be interpreted carefully and balanced against the increase in high-grade toxicity. ASSESS: EGFR Mutations Can Be Analyzed With ctDNA Written by Kathy Boltz, PhD Circulating tumor DNA (ctDNA) was found to have utility for EGFR mutation testing in advanced non-small cell lung cancer (NSCLC) in a real-world setting in the diagnostic ASSESS study [NCT01785888], according to Martin Reck, MD, PhD, Lung Clinic Grosshansdorf, Grosshansdorf, Germany. The study enrolled 1288 eligible patients, with 997 from Europe and 291 from Japan. Overall, 75.8% of the patients were white and 23.0% were Asian; 19.6% were never-smokers; smokers had 40.0 median pack-years; and the majority of patients (84.6%) had stage IV disease. The majority of the tissue/cytology samples were obtained during the current diagnosis, derived from the primary tumor, and collected via bronchoscopy. Most samples were prepared as paraffin-embedded tissue blocks and fixed with 4% neutral-buffered formalin. The median turnaround time for EGFR mutation testing was 11 days in Europe (95% CI, 14.0 to 17.3) and 8 days in Japan (95% CI, 8.2 to 14.1). The average test success rate was 98.3% in Europe and 99.6% in Japan. In Japan, the tests used to evaluate tissue/cytology samples and plasma samples for EGFR mutations were Cycleave PCR and PNA LNA clamp PCR. In Europe, for tissue/cytology testing, PNA LNA clamp PCR and the older methods of DNA sequencing and pyrosequencing were used, along with newer, more sensitive methods, including the Roche cobas EGFR Mutation Test and Sequenom; for plasma testing, the QIAGEN Therascreen RGQ PCR kit and Roche cobas EGFR Mutation Test were used. The overall concordance was 89.1% (1035 of 1162 patients; 95% CI, 87.1 to 90.8) and overall positive predictive value (PPV) was 77.7% (87 of 112; 95% CI, 68.8 to 85.0). In patients in whom the same testing method was used for tissue/cytology and plasma evaluations, the PPV was 92.6% (95% CI, 75.7 to 99.1) compared with 72.9% (95% CI, 62.2 to 82.0) when different testing methods were used for the evaluations. The sensitivity was 46.0% (95% CI, 38.8 to 53.4), specificity was 97.4% (95% CI, 96.2 to 98.3), and the negative predictive value was 90.3% (95% CI, 88.3 to 92.0) in the overall cohort. The QIAGEN Therascreen RGQ PCR kit had a sensitivity of 72.7%, specificity of 99.1%, and PPV of 94.1% in this trial. A previous trial of white patients, IFUM [Douillard JY et al. Br J Cancer. 2014], used the same kit and reported a sensitivity of 65.7%, specificity of 99.8%, and PPV of 98.6%. False-positive results, meaning an EGFR mutationpositive plasma sample and an EGFR mutation-negative tissue/cytology sample, were believed to have come from 25 patients. These patients were from multiple sites and countries, indicating no specific laboratory-based Peer-Reviewed Highlights From the European Society for Medical Oncology 2015 European Lung Cancer Conference 7

Table of Contents for the Digital Edition of MD Conference Express - ELCC 2015

Contents

MD Conference Express - ELCC 2015