Retreatment of wild type EGFR non-small cell lung cancer, Kaboti Ni is better than that of erlotinib

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Erlotinib, cabozantinib, or erlotinib plus cabozantinib as second-line or third-line treatment of patients with EGFR wild-type advanced non-

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Erlotinib, cabozantinib, or erlotinib plus cabozantinib as second-line or third-line treatment of patients with EGFR wild-type advanced non-small-cell lung cancer (ECOG-ACRIN 1512): a randomised, controlled, open-label, multicentre, phase 2 trial., Kaboti Ni or erlotinib erlotinib combined with Kaboti Ni as the wild type EGFR patients with advanced non-small cell lung cancer in the second or three line treatment (ECOG-ACRIN 1512): a randomized, controlled, open label, multicenter, phase 2 trial.

Abstract Abstract

BACKGROUND: background:

Erlotinib is approved for the treatment of all patients with advanced non-small-cell lung cancer (NSCLC), but is most active in the treatment of EGFR mutant NSCLC. Cabozantinib, a small molecule tyrosine kinase inhibitor, targets MET, VEGFR, RET, ROS1, and AXL, which are implicated in lung cancer tumorigenesis. We compared the efficacy of cabozantinib alone or in combination with erlotinib versus erlotinib alone in patients with EGFR wild-type NSCLC. of erlotinib was approved for all late stage non-small cell lung cancer (NSCLC) treatment, but the most effective in the treatment of EGFR mutation in non small cell lung cancer. Kaboti Ni, a small molecule tyrosine kinase inhibitor, targets MET, VEGFR, RET, ROS1 and AXL associated with lung cancer. We compared the efficacy of Kaboti Ni alone or with erlotinib combined with erlotinib alone compared with wild-type EGFR in non-small cell lung cancer.

METHODS: method:

This three group, randomised, controlled, open-label, multicentre, phase 2 trial was done in and community oncology practices 37 academic in the USA. Patients were eligible if they had received one or two previous treatments for advanced non-squamous, EGFR wild-type, NSCLC. Patients were stratified by performance status and line of therapy, and randomly assigned using permuted blocks within strata to receive open-label oral daily dosing of erlotinib (150 mg), cabozantinib (60 mg), or erlotinib (150 mg) and cabozantinib (40 mg). Imaging was done every At the time of 8 weeks. radiographic progression, there was optional crossover for patients in either single-drug group to receive combination treatment. The primary endpoint was to compare pr Ogression-free survival in patients given erlotinib alone versus cabozantinib alone, and in patients given erlotinib alone versus the combination of erlotinib plus cabozantinib. We assessed the primary endpoint in the per-protocol population, which was defined as all patients who were eligible, randomly assigned, and received at least one dose of treatment. The safety analysis population included all patients who received study treatment irrespective of eligibility. This trial is registered with ClinicalTrials.gov number NCT01708954., the three group, randomized, controlled, open label, multicenter, phase 2 trial in the United States 37 academic oncology and in the community. Eligible patients with advanced non-small cell lung cancer who had previously received one or two epidermal growth factor receptor wild-type. According to a second tier general and treatment of the patients were stratified, with daily oral erlotinib in section were randomly assigned to receive open label imatinib (150mg), cabozantinib (60mg) or erlotinib (150 mg) combined with cabozantinib (40mg). Imaging was performed every 8 weeks. At the time of radiographic progression, patients in any single drug group may be selected for crossover to combination therapy. The main end point is compared with erlotinib survival with erlotinib alone and Kaboti Ni alone erlotinib with erlotinib combined with cabozantinib patients without. The primary endpoint was evaluated in each protocol group - defined as eligible, randomly assigned and received at least one dose of treatment. The safety analysis population included all patients who received treatment, whether or not qualified. This trial has been registered in ClinicalTrials.gov, number NCT01708954.

FINDINGS: findings:

Between Feb 7, and 2013, July 1, we 2014, enrolled and randomly assigned 42 patients to erlotinib treatment patients to cabozantinib, 40 treatment, 43 patients to erlotinib plus and cabozantinib treatment, of whom 111 (89%) in total were included in the primary analysis (erlotinib [n=38], cabozantinib [n=38], erlotinib plus cabozantinib [n=35]) Compared. With erlotinib alone (median 1.8 months [95% CI 1.7-2.2] progression-free survival was), significantly improved in the cabozantinib group (months [3.6-7.4] hazard ratio 4.3; [HR] 0.39, 80% CI 0.27-0.55; one-sided p=0.0003 and in the erlotinib plus) cabozantinib group (4.7 months [2.4-7.4]; HR 0.25-0.53; 0.37, one-sided p=0.0003 Among participants included). In the safety analysis of the ER Lotinib (n=40), cabozantinib (n=40), and erlotinib plus cabozantinib (n=39) groups, the most common grade adverse events were 3 or 4 diarrhoea (three [8%] cases in the erlotinib group vs three [8%] in the cabozantinib group vs [28%] in the erlotinib plus 11 cabozantinib group), hypertension (none vs ten [25%] vs one [3%] fatigue (five), [13%] vs six [15%] vs six [15%]), oral mucositis (none vs four [10%] vs one [3%]), and thromboembolic event (none vs three [8%] vs two [5%] One death due). To respiratory failure occurred in the cabozantinib group, deemed possibly related to either drug, and one death due to pneumonitis occurred in the erlotinib plus cabozantinib group, deemed related to either drug or the in February 7, 2013 to combination. In July 2014 1 during the day, the group and 42 patients were randomly assigned to erlotinib treatment, 40 cases to cabozantinib treatment, 43 cases to erlotinib combined with Kaboti Ni therapy, including a total of 111 cases (89%) preliminary analysis into erlotinib ([n= 38], cabozantinib [n=38], erlotinib for Horace cabozantinib [n=35]). Progression free survival with erlotinib alone (1.8 months average [95% CI 1.7-2.2]) than the Kaboti Ni group (4.3 months [3.6-7.4]; hazard ratio [HR] 0.39, 80% CI 0.27-0.55; unilateral P = 0.0003) and erlotinib plus cabozantinib group (4.7 months [2.4-7.4]; HR 0.37 0.25-0.53, P = 0.0003); unilateral significantly improved. The participants included the erlotinib group (n = 40), Carbo Tinigo (n = 40) and erlotinib combined with Kaboti Ni (n = 39) safety analysis group, the most common of the 3 or 4 adverse events were diarrhea (3 in erlotinib Group [8%], cabozantinib Group [3 cases 8%], erlotinib plus cabozantinib group 11 cases [28%]), hypertension (0, 10 cases, 1 cases of [25%] [3%]), fatigue (5 cases, 6 cases of [13%] [15%] and [15%] 6 cases), oral mucositis (4[0, 10%] and 1 cases of [3%]) and thromboembolic events (0, 3 cases and 2 cases of [8%] [5%]). Cabozantinib group and 1 cases died of respiratory failure, that may be related to the drug erlotinib combined with cabozantinib group and 1 cases died of pneumonia, associated with a drug or a combination of them.

INTERPRETATION: interpretation:

Despite its small sample size this trial, showed that, in patients with EGFR wild-type NSCLC, cabozantinib alone or combined with erlotinib has clinically meaningful, superior efficacy to that of erlotinib alone, with additional toxicity that was generally manageable. Cabozantinib-based regimens are promising for further investigation in this patient population. although the sample size is small, but the test showed that in the wild type EGFR non-small cell lung cancer patients, Kaboti Ni alone or combined with erlotinib has clinical significance, better curative effect of erlotinib, increase the toxicity is usually controlled. In this patient group, a Kaboti Ni based approach warrants further investigation.

FUNDING: financial support:

ECOG-ACRIN Cancer Group Cancer, National Institute of National of Health. ECOG-ACRIN cancer research group, National Cancer Institute,, the.

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