This symposium is sponsored by the American Society of Clinical Oncology (ASCO), the American Society for Radiation Oncology (ASTRO), the International Association for the Study of Lung Cancer (IASLC) and The University of Chicago.
ALK gene rearrangements are found in around 5 percent of lung cancer tumors and are more common in people with lung cancer who never smoked. Crizotinib is an oral drug that was found to inhibit the effects of the ALK gene and to stop or reverse tumor growth.
In this phase II trial, researchers followed 901 patients for safety and 261 patients for tumor response; all of the patients had at least one prior chemotherapy treatment for their lung cancer. The overall response rate to crizotinib treatment was 60 percent and the median progression free survival (PFS) was eight months, confirming prior findings that crizotinib shrinks ALK-positive lung cancers and demonstrates a high PFS rate.
¡°This trial demonstrates that we have a good opportunity to shrink cancers and improve symptoms for patients with this subtype of lung cancer,¡± said Gregory Riely, MD, PhD, lead author of the study and a medical oncologist at Memorial Sloan-Kettering Cancer Center in New York who specializes in treating lung cancer. ¡°This confirms the results of prior studies and further shows that crizotinib can reduce the effects of symptoms, thereby improving the quality of life for thousands of patients who are diagnosed with this late-stage lung cancer. This study confirms that crizotinib is the standard of care for patients with ALK positive lung cancer.¡±
The abstract, ¡°Results of a Global Phase II Study with Crizotinib in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC),¡± will be presented during the Plenary Session at 12:30 p.m., Central time on September 7, 2012. To speak with Gregory Riely, MD, PhD, please contact Michelle Kirkwood or Nicole Napoli on September 6-8, 2012, in the press office at the Chicago Marriott Downtown Magnificent Mile at 312-595-3188.Abstract 4
G. J. Riely1, T. L. Evans2, R. Salgia3, S. I. Ou4, S. N. Gettinger5, G. A. Otterson6, S. Lanzalone7, A. Polli8, A. T. Shaw9, 1Memorial Sloan-Kettering Cancer Center, New York, 2University of Pennsylvania, Philadelphia, 3University of Chicago, Chicago, 4University of California at Irvine, Irvine, Calif., 5Yale University School of Medicine, New Haven, Conn., 6The Ohio State University, Columbus, Ohio, 7Pfizer Italy Srl, Milan, Italy, 8Pfizer Inc., Milan, Italy, 9Massachusetts General Hospital Cancer Center, Boston
Purpose/Objective(s): Approximately 3-5% of NSCLC harbors ALK gene rearrangements. Crizotinib is a first-in-class, oral, small-molecule competitive ALK inhibitor with anti-MET activity.
Materials/Methods: PROFILE 1005 is an ongoing global, multicenter, open-label, single-arm, phase II study evaluating the safety and efficacy of crizotinib (250 mg BID in 3-week cycles) in patients with advanced ALK-positive NSCLC who progressed after ¡Ý1 chemotherapy for recurrent/advanced/metastatic disease. Tumor response was evaluated by RECIST 1.1 every 6 weeks.
Results: As of June 2011, 439 patients were evaluable for safety and 255 patients for tumor response. Median age was 53 years. The majority of patients were female (53%), never smokers (65%), and had adenocarcinoma (92%), ECOG PS 0-1 (83%) and ¡Ý2 prior chemotherapy regimens (85%). Among patients evaluable for efficacy, median treatment duration was 25 weeks (77% of patients still ongoing). ORR was 53% (95% CI: 47-60), disease control rate at 12 weeks was 85% (95% CI: 80-89), median duration of response was 43 weeks (96% CI 36-50) and median PFS was 8.5 months (95% CI: 6.2-9.9). The most frequent treatment-related AEs were visual effects (50%), nausea (46%), vomiting (39%), and diarrhea (35%), mostly grade 1-2. 29 patients (6.6%) had treatment-related SAEs, including dyspnea and pneumonitis (4 patients each; 0.9%), and febrile neutropenia and renal cyst (2 patients each; 0.5%).
Conclusions: Crizotinib demonstrated a high response rate and PFS, and a favorable tolerability profile. These results provide strong evidence for crizotinib as a standard of care for advanced ALK-positive NSCLC.
Author Disclosure Block: G.J. Riely: E. Research Grant; BMS, Pfizer, Merck, GSK, Infinity. G. Consultant; Chugai, Tragara, Ariad, Daiichi, Abbott. T.L. Evans: None. R. Salgia: None. S.I. Ou: E. Research Grant; Pfizer. F. Honoraria; Pfizer. G. Consultant; Pfizer. S.N. Gettinger: E. Research Grant; Pfizer. G.A. Otterson: E. Research Grant; Pfizer, Genentech, Tragara, Amgen, Pharmacyclics. G. Consultant; Genentech, Abraxis. S. Lanzalone: A. Employee; Pfizer. K. Stock; Pfizer. A. Polli: A. Employee; Pfizer. K. Stock; Pfizer. A.T. Shaw: E. Research Grant; Novartis, Astra Zeneca, Pfizer, Ariad. F. Honoraria; Novartis, Millenium. G. Consultant; Pfizer, Ariad, Chugai, Daiichi-Sankyo.Media Contacts
Michelle Kirkwood | EurekAlert!
The end of pneumonia? New vaccine offers hope
23.10.2017 | University at Buffalo
Scientists track ovarian cancers to site of origin: Fallopian tubes
23.10.2017 | Johns Hopkins Medicine
Salmonellae are dangerous pathogens that enter the body via contaminated food and can cause severe infections. But these bacteria are also known to target...
University of Maryland researchers contribute to historic detection of gravitational waves and light created by event
On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...
Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.
Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....
Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).
When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...
Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.
How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...
23.10.2017 | Event News
17.10.2017 | Event News
10.10.2017 | Event News
23.10.2017 | Life Sciences
23.10.2017 | Physics and Astronomy
23.10.2017 | Health and Medicine