Corey J. Langer, MD, Professor of Medicine, Director, Thoracic Oncology, Abramson Cancer Center, University of Pennsylvania, explains that as a clinician he does not use cost as a decision factor. The care of the patient and their quality-of-life takes priority over the cost efficacy of a drug. The cost analysis should not be a determining factor for which therapeutic agent to give.

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Dr. Corey Langer from Abramson Cancer Center on Cost Analysis in the Treatment Decision

Dr. Langer on Cost Analysis in the Treatment Decision

Corey J. Langer, MD, Professor of Medicine, Director, Thoracic Oncology, Abramson Cancer Center, University of Pennsylvania, discusses the design and major criticisms of the JMEN phase III trial.

JMEN was a randomized trial looking at maintenance pemetrexed in advanced or metastatic (stage IIIB and IV) non-small-cell lung cancer. The trial examined patients that had been treated with platinum-based first-line chemotherapy and were stable or had not progressed. JMEN demonstrated a significant survival benefit and was heralded as a paradigm changing trial.

The largest criticism of the trial was the absence of a mandatory crossover from the control arm to intravenous pemetrexed. 67% of patients on the placebo arm received a second-line therapy, of this amount only 19% received pemetrexed, the remaining 81% received an EGFR TKI or docetaxel.

Langer believes that receiving second-line pemetrexed alone should have been built into the trial. If this had happened the trial could have prevented major criticism.

Dr. Corey J. Langer from Abramson Cancer Center Discusses the JMEN Maintenance Pemetrexed Trial

Dr. Langer Discusses the JMEN Maintenance Pemetrexed Trial

Corey J. Langer, MD, Professor of Medicine, Director, Thoracic Oncology, Abramson Cancer Center, University of Pennsylvania, explains the importance of assessing the patient populations in clinical trials. If the population is not representative of the patients you see in your practice it may not be relevant to you.

The demographics of the patients entered into a trial may have a direct bearing on the outcome. As an example Langer uses a study by Chandra Belani, MD, which examined continuation maintenance therapy using gemcitabine and carboplatin.

The population of this trial contained somewhat older patients with a marginal performance status (PS) of 2. This trial did not show an improvement in progression-free survival or overall survival and closed earlier than planned, unlike other similar trials. It is suggested that the higher PS of the patients enrolled had a negative effect on the outcome of the trial.

Dr. Corey J. Langer from Abramson Cancer Center on Assessing Patient Populations in Clinical Trials

Corey J. Langer, MD

Articles

Dr. Langer on Cost Analysis in the Treatment Decision

Dr. Langer Discusses the JMEN Maintenance Pemetrexed Trial

Dr. Langer on Assessing Patient Populations in Trials