Lung Cancer Workshop Accomplishments
Seven publications from topics that relate to activities arising from activities of investigators participating in the Workshops:
- James L. Mulshine, et al. “Developing CT image-processing tools to accelerate progress in lung cancer drug development.” Oncology, 20:1608-10, 2006
- Thomas M. Baer, Mulshine J.L., Jacobs J.J., “Biomedical imaging archive network,” Skeletal Radiology, 36:799-801, 2007
- James L. Mulshine, and Baer T. (Editors)Quantitative Imaging Tools for Lung Cancer Drug Assessment. Wiley Press, NY, 2008
- James L. Mulshine, et al. “Use of high-resolution CT imaging data in lung cancer drug development: measuring progress.” Oncology (Williston Park). 2009 Apr 30;23(5):434-8
- Nasser N. Altorki et al. “Phase II Proof-of-Concept Study of Pazopanib Monotherapy in Treatment-Naive Patients With Stage I/II Resectable Non–Small-Cell Lung Cancer” J Clin Oncol. 2010 Jul 1;28(19):3131-7. Epub 2010 Jun 1.
- Petros G. Nikolinakos et al. “Plasma cytokine and angiogenic factor profiling identifies markers associated with tumor shrinkage in early-stage non-small cell lung cancer patients treated with pazopanib,” Cancer Research. 2010 Mar 15;70(6):2171-9. Epub 201
- James L. Mulshine, Thomas M. Baer, and Ricardo S. Avila, Workshop VI:
Optics Express Special Interactive Scientific Publishing Supplement “Introduction: Imaging in diagnosis and treatment of lung cancer,” Optics Express (suppl) 18, 15242-15243 (2010)
Lung cancer remains the most lethal cancer, but a number of positive trends are emerging:
- Lung cancer rates continue to fall slowly in men and are also beginning to stabilize in women.
- A number of new molecularly-targeted therapies for advanced cancer are being introduced.
- From a quantitative imaging perspective, a recentNew England Journal report from a European randomized lung cancer screening trial reported that a disciplined work-up strategy using a quantitative imaging tool was associated with a high diagnostic efficiency and a stage I detection rate of 74%.
This finding underscores the growing feasibility of routine detection of early stage lung cancer and highlights the pivotal role that quantitative imaging can play in anchoring the clinical management of early lung cancer. Early clinical management strategies are driving important progress in the breast cancer research world, as they are validating targeted therapeutic drugs with more limited side-effect profiles than traditional cancer drugs. Given the recent progress with molecularly-targeted therapeutics, it is timely to come together to explore avenues for accelerating progress in early lung cancer drug development using quantitative imaging approaches.
Workshop VII built on the considerable progress achieved in earlier Workshops in applying quantitative CT imaging to facilitate drug development. The Workshop series has maintained a focus on driving innovation and broad cross-disciplinary inclusion. It has facilitated the development of several image databases, such as the
- National Cancer Institute RIDER Database
- Prevent Cancer Foundation-Cornell Database
- Lung Cancer Alliance Patient-donated Database (Give-A-Scan)
These databases include collections of different types of image files and these diverse resources are critical in allowing the development of software measurement tools.
The forum has also catalyzed the completion of the first neoadjuvant window-of-opportunity trial by Dr. Nasser Altorki and colleagues, using the GlaxoSmithKline (GSK) drug, pazopanib. In this trial, which was published on July 1, 2010 (JCO) a group of patients scheduled to undergo curative lung cancer surgery agreed to a 2-3 week course of the oral, dual kinase, vascular endothelial growth factor (VEGF) inhibitor, pazopanib, to determine its effect on tumor growth and molecular markers. Over 80 percent of the cases showed a favorable volume-reduction response to pazopanib along with a favorable modulation of molecular endpoints. This successful proof-of-concept led the leadership of GSK to move directly to a randomized Phase II adjuvant trial for early stage lung cancer patients at high risk of relapse.
This strategy is a new model for drug development in non small cell lung cancer. It establishes an efficient path to potential regulatory approval for an adjuvant drug indication for early lung cancer. Based on the tamoxifen precedent, this approach may also ultimately allow an eventual chemoprevention claim as well. The neoadjuvant, window-of-opportunity clinical trial strategy with pazopanib provides a model pathway for accelerating the drug approval process.
A critical enabler of progress in previous Workshops evolved from the productive partnership between the Foundation and the Optical Society of America. This interaction has led to the development of dedicated open source lung cancer lesion-sizing tools for the research community, the publication of a monograph summarizing the activities of the field and a special issue of Optics Express, which featured these tools with a range of curated DICOM image files.
The seventh workshop focused on several key areas with in-depth reviews of current progress in image processing research and the steps to integrate these tools in a regulatory setting – including the use of imaging phantoms to improve image quality and minimize variance across different vendor platforms. Representatives of the Radiological Society of North America (RSNA) Quantitative Imaging Biomarker Alliance (QIBA) reviewed their important progress in working toward acceptance of quantitative imaging. Strategies to advance open publication efforts and the contribution of the reference quantitative imaging tools were also reviewed.
A major opportunity was the advancement of dialogue on the use of quantitative imaging tools to cross- fertilize and accelerate image processing research across lung cancer and chronic obstructive pulmonary disease (COPD). The use of high resolution CT imaging is providing a window into a much earlier stage of COPD, another tobacco-induced disease. Progress in this area will be reviewed and opportunities for enhanced collaborative progress will be defined. Key sessions will explore emerging developments with imaging technology and the infrastructure to support the storage and distribution of these high-content modalities. Cooperation among diverse collaborators will be essential to enable the rapid organic evolution of this field, so that improved outcomes with lung cancer and COPD can occur.
Summary of accomplishments related to activities of the Workshop:
- Publication of the neoadjuvant window of opportunity trial performed in resectable NSCLC patients
- Drug given daily for~3 wks
- High Resolution CT done before & after drug exposure prior to lung CA resection
- Endpoint frequency of tumor shrinkage by volumetric CT
- Image results compared to molecular/pathological outcomes
- Development of the Prevent Cancer Foundation-Cornell Database
- Facilitation of the quantitative imaging process optimization performed within the Roche Pharmaceuticals-sponsored Abigail Lung Cancer Clinical Trial
- Support of the efforts of the Optical Society of America to develop a hosted image repository to allow full DICOM images of published imaging cases, to allow re-analysis as well as re-purposing of peer-reviewed published images to stimulate quantitative imaging research
- Support of the publication of the first lung cancer special supplement of Optics Express, authored by Workshop participants to describe foundational efforts to improve quantitative imaging processing research in drug response evaluation for lung cancer
- Facilitation of a dialogue with Workshop participants including the Quantitative Imaging Biomarker Alliance, Critical Path and the Prevent Cancer Foundation to collaborate with a broad consortium of stake holders to apply to the Food and Drug Administration for a preliminary regulatory qualification for the use of volume CT as a biomarker of lung cancer drug response assessment.
- Helping the Lung Cancer Alliance develop and launch its “Give a Scan” project, in which patients donate their images pre- and post-treatment.
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