Adding necitumumab to gemcitabine-cisplatin was well-tolerated and did not negatively affect health-related quality of life or toxicity in patients with stage 4 squamous non-small cell lung cancer (NSCLC), according to a study published in the Journal of Thoracic Oncology.
Researchers led by Martin Reck, MD, PhD, of the LungenClinic Grosshansdorf in Germany looked at 1093 patients with stage 4 squamous NSCLC who were randomized to necitumumab plus gemcitabine-cisplatin or gemcitabine-cisplatin alone. Those on necitumumab plus gemcitabine-cisplatin who did not experience disease progression would continue necitumumab until progression.
Health-related quality of life was measured by ECOG performance status, the Lung Cancer Symptom Scale (LCSS) and EG-5D. Efficacy and LCSS were analyzed using baseline maximum severity score of the LCSS, while tolerability was measured by study treatment exposure and adverse events.
The researchers found that most patients in both study arms maintained similar ECOG performance status and comparable LCSS and EQ-5D assessments. Those with higher baseline LCSS severity were found to have greater survival benefit with necitumumab.
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Hospitalizations were slightly higher with necitumumab plus gemcitabine-cisplatin at 36.4%, compared to 34% with gemcitabine-cisplatin. The most frequent grade 4 adverse events were found to be neutropenia and thrombocytopenia.
- Reck M, Socinski MA, Luft A, et al. The effect of necitumumab in combination with gemcitabine plus cisplatin on tolerability and on quality of life: results from the phase III SQUIRE trial. [published online ahead of print March 12, 2016]. J Thorac Oncol. doi: http://dx.doi.org/10.1016/j.jtho.2016.03.002.