Patients with non-small cell lung cancer, also known as NSCLC, are anxiously awaiting a decision from the FDA’s Oncologic Drugs Advisory Committee regarding Eli Lilly’s introduction of Necitumumab to the already formidable Gemcitabine and Cisplatin combination. Both Gemcitabine and Cisplatin are currently the first line-treatment for patients diagnosed with NSCLC, and the addition of Necitumumab looks to be a promising happening on the horizon. Not only was the addition of Necitumumab to the Gemcitabine and Cisplatin pair tolerable in studies, overall survival rates significantly improved with the new trio of treatments.
Results from the successful phase III clinical trial which combined Gemcitabine, Cisplatin and Necitumumab have been encouraging. Approximately 1,093 patients were enrolled in this landmark study, which demonstrated a median overall survival time of 11.5 months for patients treated with all three drugs. Compared to patients who were dosed with Gemcitabine and Cisplatin only, there was a definite improvement in overall survival rates- 11.5 months versus 9.9 months, respectively. The aforementioned study, coined SQUIRE, included 184 investigative sites in 26 countries. All of the patients in the study had stage IV squamous NSCLC and were admitted to the study, regardless of their EGFR mutation status. A 3-week schedule is most often administered when dosing both Gemcitabine and Cisplatin, and this was the case in the SQUIRE study. Of the 1,093 patients, 545 patients were randomized to receive Gemcitabine and Cisplatin plus Necitumumab and 548 patients were dosed Gemcitabine and Cisplatin only. Exactly 800 milligrams of Necitumumab was administered to patients on day 1 and 8 every 3 weeks. In both groups Gemcitabine was dosed at 1250 mg/m2 on days 1 and 8 and 75 mg/m2 of Cisplatin was given on day 1 only. Patients were balanced in both of the study arms, with statistical data revealing an average participant age of 62, with 84 percent of patients being of the Caucasian ethnicity and 91 percent of people being smokers. More information will be presented in September 2015 at the 16th World Conference on Lung Cancer.
As the most commonly diagnosed form of lung cancer NSCLC accounts for roughly 85 percent of all lung cancer patients. The squamous form of NSCLC is less common, and effects less patients, but is much more difficult to treat effectively. Unfortunately the majority of patients are diagnosed with squamous NSCLC when the disease has progressed extensively, leaving an average five year survival rate of less than five percent. Further R&D is needed using the effectual Gemcitabine and Cisplatin products.
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