Neoadjuvant Treatment Approach: The Rosetta Stone for Breast Cancer?
Breast cancer represents a heterogeneous group of diseases with varied biological features, behavior, and response to therapy; thus, management of breast cancer relies on the availability of robust predictive and prognostic factors to support therapy decision-making. Traditionally, neoadjuvant treatment for breast cancer was preserved for locally advanced, converting an inoperable to a surgical resectable cancer. Neoadjuvant trials, additionally, offer: 1) the opportunity to evaluate new treatment options in a faster way and with fewer patients than large adjuvant trials; 2) to identify and validate the prognostic and pred...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Generali, D., Ardine, M., Strina, C., Milani, M., Cappelletti, M. R., Zanotti, L., Forti, M., Bedussi, F., Martinotti, M., Amoroso, V., Sigala, S., Simoncini, E., Berruti, A., Bottini, A. Tags: Article Source Type: research
Comprehensive Review on the Surrogate Endpoints of Efficacy Proposed or Hypothesized in the Scientific Community Today
An intermediate endpoint is a surrogate marker of treatment efficacy assessed earlier than the true outcome of interest. A suitable intermediate endpoint in neoadjuvant trials of specific breast cancer subtypes is pathological complete response (pCR) rate, defined as no invasive (+/–noninvasive) residual cancer in breast and nodes at surgery. On the basis of available evidence, Food and Drug Administration the US allowed to use of pCR as a surrogate endpoint for accelerated approval process. However, surrogacy to long-term outcome remains an unresolved issue. Literature data provide indications that triple-negative, ...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: von Minckwitz, G., Fontanella, C. Tags: Article Source Type: research
Early Surrogate Markers of Treatment Activity: Where Are We Now?
The assessment of new therapies in the adjuvant setting in early breast cancer requires large numbers of patients and many years of follow-up for results to be presented. Therefore, the neoadjuvant study setting, which allows for early prediction of treatment response in smaller patient sets, has become increasingly popular. Ki67 is the most commonly used and extensively studied intermediate biomarker of treatment activity and residual risk in neoadjuvant trials on endocrine therapy, new biological therapies, and chemotherapy. It is increasingly being used as a primary endpoint for new therapies particularly those added to...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Klintman, M., Dowsett, M. Tags: Article Source Type: research
RECIST for Response (Clinical and Imaging) in Neoadjuvant Clinical Trials in Operable Breast Cancer
Although approximately 70% of breast cancer patients demonstrate a clinical response on neoadjuvant systemic therapy on physical examination or on anatomic radiographic imaging, only 3%–40% achieve a pathologic complete response (pCR). Magnetic resonance imaging (MRI) is superior to physical examination, ultrasound, and mammography in response evaluation during neoadjuvant systemic therapy. The accuracy of breast MRI to predict pCR has a moderate sensitivity, but high specificity. The accuracy of anatomic imaging to assess residual disease and predict pCR depended on anatomic radiographic imaging cancer subtypes. Res...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Semiglazov, V. Tags: Article Source Type: research
Magnetic Resonance Imaging, Digital Mammography, and Sonography: Tumor Characteristics and Tumor Biology in Primary Setting
The use of imaging in the arena of primary treatment for breast cancer is gaining importance as a technique for assessing response to chemotherapy as well as assessing the underlying tumor biology. Both mammography and ultrasound have traditionally been used, in addition to clinical evaluation, to evaluate response to treatment although they have shed little light on the underlying biological processes. Functional magnetic resonance imaging techniques have the ability to assess response to treatments in addition to providing valuable information on changes in tumor perfusion, vascular permeability, oxygenation, cellularity...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Woolf, D. K., Padhani, A. R., Makris, A. Tags: Article Source Type: research
Surgical Considerations After Neoadjuvant Chemotherapy: Breast Conservation Therapy
The increasing use of chemotherapy before surgery has affected a number of local-regional treatment decisions including surgical and radiation management of the breast, management of axillary lymph nodes, and the indications for postmastectomy radiation. In this monograph, we will focus on surgical and radiation management as components of breast conservation therapy. The early randomized trials that compared neoadjuvant to adjuvant chemotherapy in breast cancer demonstrated that rates of breast conservation can be increased when chemotherapy is sequenced first. This was a direct consequence of high response rates seen wit...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Buchholz, T. A., Mittendorf, E. A., Hunt, K. K. Tags: Article Source Type: research
Optimizing Radiation Treatment Decisions for Patients Who Receive Neoadjuvant Chemotherapy
The indications for postoperative radiotherapy after surgery following neoadjuvant systemic therapy for breast cancer are reviewed and the controversial issues summarized. Current standards and areas of future development are delineated. The need of collecting data on radiotherapy characteristics and results, according to different clinical and biological parameters, in the framework of perspective clinical studies, is underlined. (Source: JNCI Monographs)
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Magrini, S. M., Buglione, M., Costa, L. Tags: Article Source Type: research
Primary Systemic Treatment in the Management of Operable Breast Cancer: Best Surgical Approach for Diagnosis, Biological Evaluation, and Research
Despite the ever-changing breast surgeon’s technical role, the surgeon forms an indispensible link between imaging, diagnostics, pathology, and the medical oncologist. Biomarkers of prognosis, prediction of response, and resistance to treatments, including imaging, tissue and circulating markers apply to the primary diagnostic and treatment settings as well as scenarios which include disease recurrence, both in the early and advanced settings. Whether it is via the diagnostic clinic referred by the primary care physician or via a breast screening service, primary early breast cancer is referred for initial treatment ...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Barry, P. A., Schiavon, G. Tags: Article Source Type: research
Neoadjuvant Model in Cancer Treatment: From Clinical Opportunity to Health-Care Utility
In the last few decades, research has demonstrated that cancer can be treated and cured if diagnosed at very early stage and a proper therapeutic strategy is adopted. Recent omics-based approaches have unveiled the molecular mechanisms of cancer tumorigenesis and have aided in identifying next-generation molecular markers for early diagnosis, prognosis, and targeted therapy. New tests based on genomic profiling, circulating tumor cells, or mutation profiling are appraised for purpose by Health Technology Assessment. The potential clinical utility of these tests lies on their ability to discriminate between patients who wil...
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Authors: Generali, D., Fox, S. B., Cristofanilli, M., Bianchini, G., Zambelli, A., Hatzis, C., Barberis, M., Tarricone, R., Bottini, A., Rossi, C., Tringali, M. Tags: Article Source Type: research
Table of Contents
(Source: JNCI Monographs)
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Tags: Cover / Standing Material Source Type: research
Editorial Board
(Source: JNCI Monographs)
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Tags: Cover / Standing Material Source Type: research
Cover
(Source: JNCI Monographs)
Source: JNCI Monographs - June 10, 2015 Category: Cancer & Oncology Tags: Cover / Standing Material Source Type: research
Erratum
(Source: JNCI Monographs)
Source: JNCI Monographs - November 21, 2014 Category: Cancer & Oncology Tags: Erratum Source Type: research
Health-Care Utilization by Prognosis Profile in a Managed Care Setting: Using the Surveillance, Epidemiology and End Results Cancer Survival Calculator SEER*CSC
Conclusions
We found that although a new diagnosis of cancer increased utilization of cancer-related services for an extended time period, the timing of cancer diagnosis did not appear to affect other types of utilization. Future research should assess the reason for the lack of impact of cancer and unrelated comorbid conditions on utilization and whether desired outcomes of care were achieved. (Source: JNCI Monographs)
Source: JNCI Monographs - November 21, 2014 Category: Cancer & Oncology Authors: Rabin, B. A., Ellis, J. L., Steiner, J. F., Nekhlyudov, L., Feuer, E. J., Hankey, B. F., Cynkin, L., Bayliss, E. Tags: Article Source Type: research
The Surveillance, Epidemiology, and End Results Cancer Survival Calculator SEER*CSC: Validation in a Managed Care Setting
Conclusions
The results of the external validation indicated that the colorectal and prostate cancer nomograms are reliable tools for physicians and patients to use to obtain information on prognosis and assist in establishing priorities for both treatment of the cancer and other conditions, particularly when a patient is elderly and/or has significant comorbidities. The slightly better than predicted risk of death from other causes in a health maintenance organization (HMO) setting may be due to an overall healthier population and the integrated management of disease relative to the overall population (as represented by S...
Source: JNCI Monographs - November 21, 2014 Category: Cancer & Oncology Authors: Feuer, E. J., Rabin, B. A., Zou, Z., Wang, Z., Xiong, X., Ellis, J. L., Steiner, J. F., Cynkin, L., Nekhlyudov, L., Bayliss, E., Hankey, B. F. Tags: Article Source Type: research
