Formal discussant Giorgio V. Scagliotti, MD, PhD, Professor and Chair of Medical Oncology at the University of Turin and San Luigi Hospital, Orbassano, Italy, tackled each of the studies presented at the European Society for Medical Oncology (ESMO) session on metastatic non–small cell lung cancer (NSCLC).
Three Studies
Beginning with the TARGET trial, he said that the use of functional imaging to select patients who are folate receptor–positive was an interesting aspect of the study.
“Patients selected for [folate receptor] expression did best in ovarian cancer trials of vintafolide, but questions remain about use of this biomarker in NSCLC, including the number of patients who were folate receptor–positive, the threshold values for folate receptor positivity, no assessment of genomic alteration in adenocarcinoma, and lack of poststudy information,” he commented.
Turning to the study by Kim et al, Dr. Scagliotti could draw no meaningful conclusion because the study was stopped after only 156 patients enrolled, despite a planned enrollment of 562 patients. “Noninferiority cancer clinical trials need to be realistic and correct.” This study failed to meet that bar, in his opinion.
He noted that the design of the study did not reflect current practice, which includes maintenance therapy and more than four cycles of chemotherapy.
In the study reported by Ahn et al, Dr. Scagliotti commented that thymidylate synthase is potentially the most reliable biomarker identified for pemetrexed (Alimta), but the predictive/prognostic role of this biomarker is unresolved.
“Thus far, there are no data to support the use of this biomarker in clinical practice. Standardization of measurement techniques is still an issue,” he said.
Overview Remarks
Looking at all three studies, Dr. Scagliotti said that pemetrexed-based chemotherapy remains the preferred doublet for first-line treatment of non–oncogene-addicted nonsquamous NSCLC.
“Biomarker-driven chemotherapy is still a matter of clinical research, and, remember, the jury is not yet in. There is still huge room for improvement in terms of selecting candidate patients and treatments,” he stated. ■
Disclosure: Dr. Scagliotti has received honoraria from Eli Lilly, AstraZeneca, Roche, Pfizer, and Clovis Oncology.