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!
Spanish scientists create a 3-D bioprinter to print human skin
24.01.2017 | Carlos III University of Madrid
Tracking movement of immune cells identifies key first steps in inflammatory arthritis
23.01.2017 | Massachusetts General Hospital
A Swedish-German team of researchers has cleared up a key process for the artificial production of silk. With the help of the intense X-rays from DESY's...
For the first time ever, a cloud of ultra-cold atoms has been successfully created in space on board of a sounding rocket. The MAIUS mission demonstrates that quantum optical sensors can be operated even in harsh environments like space – a prerequi-site for finding answers to the most challenging questions of fundamental physics and an important innovation driver for everyday applications.
According to Albert Einstein's Equivalence Principle, all bodies are accelerated at the same rate by the Earth's gravity, regardless of their properties. This...
An important step towards a completely new experimental access to quantum physics has been made at University of Konstanz. The team of scientists headed by...
Yersiniae cause severe intestinal infections. Studies using Yersinia pseudotuberculosis as a model organism aim to elucidate the infection mechanisms of these...
Researchers from the University of Hamburg in Germany, in collaboration with colleagues from the University of Aarhus in Denmark, have synthesized a new superconducting material by growing a few layers of an antiferromagnetic transition-metal chalcogenide on a bismuth-based topological insulator, both being non-superconducting materials.
While superconductivity and magnetism are generally believed to be mutually exclusive, surprisingly, in this new material, superconducting correlations...
19.01.2017 | Event News
10.01.2017 | Event News
09.01.2017 | Event News
24.01.2017 | Physics and Astronomy
24.01.2017 | Life Sciences
24.01.2017 | Health and Medicine