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Early results from NRG-LU001 indicate that although the diabetes agent, metformin, was well tolerated by patients, it did not clearly improve progression-free survival or overall patient survival participating in the test with locally advanced advanced cells. lung cancer (NSCLC). These results are based on results reported by local centers. Participants in the trial will continue to be tracked for status changes. The initial report of these findings was presented at the annual meeting of the ASCO (American Society of Clinical Oncology) and the abstract was awarded the title "Best of ASCO".
"In previous preclinical studies, metformin had improved the response of non-small cell lung cancer (NSCLC) models to radiotherapy and chemotherapy," said Dr. Theodoros Tsakiridis, MD, PhD of McMaster University and lead author of the NRG-Abstract LU001. "The preclinical data suggested a potential benefit for lung cancer patients.For this, we continued the NRG-LU001 trial to determine whether metformin could actually improve outcomes in patients with chronic lung cancer. Stage III NSCLC treated with standard chemotherapy and radiotherapy. "
In NRG-LU001, patients were randomly badigned to either the control group receiving standard chemotherapy and radiotherapy alone, or to the experimental group receiving chemotherapy, radiation and 2000 mg metformin daily during these treatments. The aim of this study was to detect a 15% improvement in 12-month PFS from 50% to 65% or, equivalently, a CF of 0.622. After treatment, the researchers followed the participating patients to detect changes in survival results, toxicity or adverse effects, neuro-regional progression delay (TTLRP) and distance to distant metastasis (TTDM).
NRG-LU001 closed its rights in December 2016 after completing the reporting process and randomizing the pre-planned number of 168 patients. There was no statistically significant difference in the rates or degree of toxicity between the two arms, indicating that metformin was well tolerated by patients. At the time of badysis, local centers reported 102 SSP events. The one- and two-year PHC rates were 60.4% (95% CI: 48.5, 70.4) and 40.1% (95% CI: 29.0, 51.0). the control group and 51.3% (95% CI: 39.8, 61.7). and 34.5% (95% CI: 24.2, 45.1) in the experimental treatment group with metformin. The 2-year OS was 65.4% (95% CI: 53.5, 75.0) in the control group and 64.9% (95% CI: 53.1, 74.5) in the control arm. (HR = 1.03 (95% CI: 0.64, 1.68).) Deaths were due to lung cancer in 90% of the control groups and 71% of the experimental group. -LU001 did not reveal any difference between the treatment groups for TTLRP and TTDM.
"Although we did not find any difference in the primary endpoint between treatment groups, we are encouraged to see higher than normal rates of PFS and OS in both arms of this study." "said Dr. Heath Skinner, MD, PhD of the UPMC Hillman Cancer Center. co-principal investigator of the trial, with Dr. Tsakiridis. "We plan to complete the secondary badyzes with a central clinical and radiological review of all cases, as well as with biomarker studies involving the biological samples collected during this trial."
The results of NRG-LU001 demonstrate the value of continuing research on NSCLC, one of the world's deadliest cancers, in multi-institutional environments such as NRG-Oncology.
This project was funded by grants from the National Cancer Institute (NCI): U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), U24CA180803 (IROC).
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Tsakiridis T *, Hu C, Skinner H *, Santana-Davila R, Lu B, JJ Erasmus, Doemer AJ, GMM video, Coster J, Yang AX, Lee RY, Werner-Wasik M, Schaner PE, McCormack SE, Esparaz BT , RC McGarry, J Bazan, Struve T, J Bradley. Initial declaration of NRG-LU001, randomized phase II trial of chemoradiotherapy (CRT) + / – concomitant metformin HCL in locally advanced non-small cell lung cancer (NSCLC). Abstract presented at the annual meeting of the American Society of Clinical Oncology (ASCO). Chicago, IL.
* The authors also contributed to this work.
About NRG Oncology
NRG Oncology conducts multi-institutional clinical and translational research that changes practices to improve the lives of cancer patients. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit company that integrates research from the National Project on Breast and Surgical Adjuvant Adjuvants (NSABP), the Radiation Oncology Group (RTOG) and the Group. of Gynecologic Oncology (GOG). The research network seeks to conduct clinical trials with a focus on badual malignancies, including gynecological, bad and prostate cancers, as well as all types of localized or locally advanced cancers. NRG Oncology's extensive research organization includes multidisciplinary researchers, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists and statisticians. It has more than 1,300 research sites around the world, with a predominance in the United States and Canada. NRG Oncology is primarily funded by grants from the National Cancer Institute (NCI) and is one of five research groups in NCI's National Clinical Trials Network.
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