Abstract
Lung cancer continues to be a major global health problem; the disease is diagnosed in more than 1.6 million new patients each year. However, significant progress is underway in both the prevention and treatment of lung cancer. Lung cancer therapy has now emerged as a "role model" for precision cancer medicine, with several important therapeutic breakthroughs occurring during 2015. These advances have occurred primarily in the immunotherapy field and in treatments directed against tumors harboring specific oncogenic drivers. Our knowledge about molecular mechanisms for oncogene-driven tumors and about resistance to targeted therapies has increased quickly over the past year. As a result, several regulatory approvals of new agents that significantly improve survival and quality of life for patients with lung cancer who have advanced disease have occurred. The International Association for the Study of Lung Cancer has gathered experts in different areas of lung cancer research and management to summarize the most significant scientific advancements related to prevention and therapy of lung cancer during the past year.
| Original language | English |
|---|---|
| Pages (from-to) | 613-638 |
| Number of pages | 26 |
| Journal | Journal of Thoracic Oncology |
| Volume | 11 |
| Issue number | 5 |
| DOIs | |
| State | Published - 2016 |
Bibliographical note
Publisher Copyright:© 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
Funding
Section Authors: Yang Zhou, PhD, MPH, Roy S. Herbst, MD, PhD, Vassiliki A. Papadimitrakopoulou, MD, Mary W. Redman, PhD, David R. Gandara, MD, Fred R. Hirsch, MD, PhD The development of a new cancer therapy from the initial stages of discovery to regulatory approval is a complex and expensive process that can take more than a decade. Clinical trials face many challenges, including lengthy start-up time, high upfront expense, and inability to recruit an adequate number of participants in a timely manner. This process is particularly difficult when attempting to develop targeted therapies for rare genotype subtypes of lung cancer. With this in mind, modernizing the clinical trials process to keep up with the molecular age by using innovative approaches and new trial designs is of high importance. The research community, along with government and patient advocates, have risen to the challenge to create “master protocols” that can screen large numbers of patients and then simultaneously test multiple new drugs or combinations, with resultant efficiencies in patient recruitment and regulatory approval. 248 In the advanced metastatic stage, one of the first master protocols to have been developed is the Lung-MAP (S1400) study for previously treated squamous cell lung cancer. Lung-MAP is a registration-intent umbrella trial that simultaneously evaluates multiple treatments through a series of genotypically driven phase II/III substudies, with “rolling” opening and closing so that each functions in an independent manner. The current schema for Lung-MAP is shown in . The project is a unique public-private partnership led by SWOG (formerly the Southwest Oncology Group) together with the National Cancer Institute and its National Cancer Trials Network, the Friends of Cancer Research, and the Foundation of the National Institutes of Health. Figure 7 249,250 This master protocol provides a mechanism to genomically test a large population of patients with squamous lung cancer for genetic alterations. Although most of the substudies evaluate therapies specifically targeted at the particular alteration found in a specimen of a patient’s tumor, patients who do not have one of the genetic alterations currently being studied are assigned to a “nonmatch” substudy. Lung-MAP was first launched on June 16, 2014, and has undergone several protocol amendments to address the evolving therapeutic landscape and the emergence of immunotherapy as one of the prime treatment modalities for NSCLC. An example of a master protocol in the early-stage setting, the ALCHEMIST (see Fig. 5 ) trial, which was described previously in the “Role of Adjuvant Therapy” section, randomizes patients with resected stage IB–IIIA NSCLC with EGFR mutations or ALK translocations to receive either placebo or adjuvant erlotinib or crizotinib, respectively. The duration of administration of the adjuvant targeted therapy treatment or placebo is 2 years.
| Funders | Funder number |
|---|---|
| The Yeasts Foundation | |
| Friends of Cancer Research | |
| National Cancer Trials Network | |
| SWOG Statistical Center | |
| Southwest Oncology Group | |
| National Institutes of Health (NIH) | |
| National Childhood Cancer Registry – National Cancer Institute | P30CA016672 |
UN SDGs
This output contributes to the following UN Sustainable Development Goals (SDGs)
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SDG 3 Good Health and Well-being
Keywords
- Adjuvant chemotherapy
- Biomarkers
- Cancer prevention
- Gene mutations
- Immunotherapy
- Lung cancer
- Master protocols
- Pathology
- Radiotherapy
- Screening
- Smoking cessation
- Staging
- Surgery
- Targeted therapy
- Value of therapy
ASJC Scopus subject areas
- Oncology
- Pulmonary and Respiratory Medicine
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