What is needed for colorectal cancer screening in Japan

There have been accumulated evidence with colorectal cancer(CRC)screening programs using the fecal occult blood test (FOBT). However, the purpose of CRC mortality reduction has not been attained as are the same with the other cancer screening programs in Japan. Thus the present issue with the CRC screening program is how we could reach the goal. Organized screening(OS), which is the strategy for reducing cancer mortality through screening, should be constructed in Japan for the purpose. Scientific evidence to reduce mortality is the prerequisite of OS. In addition, the second step required is to establish a quality assurance system or the management of the screening program, which can maximize the benefit and minimize the harms from screening. Finally, establishing a call-recall system enabling high participation rate is important. The above change may need an implementation of institutional reform on cancer screening in Japan.     

End points in cancer clinical trials and the drug approval process.

The sequencing of the human genome and the elucidation of many molecular pathways important in cancer cell proliferation, apoptosis, and metastasis have provided unprecedented opportunities for development of new agents to prevent and treat cancer. The types of molecules in development are increasingly varied and include small molecules, monoclonal antibodies, antisense oligonucleotides, and ribozymes. Thus, the variety of anticancer agents in clinical development is now greater than ever before, and the number of agents currently in clinical trial for various cancer indications is estimated to exceed 400. Many of these drugs would be expected to work in only narrowly defined patient populations that must be prospectively identified. Thus, the development of the therapeutic agent must often be linked to the development of a molecular diagnostic product. Drugs that produce primarily cytostatic effects might not be expected to produce regression of tumor masses; thus, evaluation of such agents would best be done in populations of patients with low tumor burdens but high risk of disease progression. As traditional clinical end points prove more difficult to apply in evaluation of molecularly targeted therapies, a great need exists to define and validate surrogate markers of effect and of benefit. New clinical trial designs and end points are necessary to permit more efficient evaluation of putative cancer treatments. This editorial will review commonly used clinical trial end points and describe their potential advantages and disadvantages to expedite the drug approval process required in the United States.     

Rectal cancer: situation where a referral center is needed

One of the objectives of the French strategic plan for cancer 2009-2013 is to structure the need for referral surgery, particularly for low rectal carcinoma. However, low rectal cancer is not the only situation in the field of rectal surgery where expert unit are needed for the referral of appropriate patients. We developed the multidisciplinary strategies for low rectal cancer, advanced rectal cancer, recurrent rectal cancer and peritoneal carcinomatosis. Optimal management of these difficult situations can give a chance of long term survival while a non-optimal management could jeopardise the future of patients by changing a potentially curable disease into an incurable one.     

Defining cancer survivorship: a more transparent approach is needed

Introduction  

There is a lack of a consistent, operational definition of what it means to be a cancer survivor despite widespread use of the term. The term carries positive connotations of ‘beating’ cancer, but some people living past cancer do not identify with this portrayal.     

National comprehensive cancer network recommendations for drugs without US food and drug administration approval in metastatic breast cancer: A cross-sectional study

BackgroundNational Comprehensive Cancer Network (NCCN) guidelines can include recommendations for off-label use of anti-cancer drugs. Here, we evaluate NCCN recommendations not supported by US Food and Drug Administration (FDA) approval and explore associations with such recommendations.MethodsAll NCCN recommendations for MBC and their supporting data were identified. Drug labels were reviewed to determine whether recommendations are FDA approved. Logistic regression was used to compare FDA approved and off-label recommendations for pre-specified categories, including drug type, tumor subtype, level of recommendation and line of therapy.ResultsOf 124 recommendations identified, 68 (55%) were off-label. Chemotherapy and human epidermal growth factor receptor 2 (HER2) targeted drugs were associated with lower odds of FDA approval (OR = 0.28, p = 0.001 and OR = 0.29, 95% p = 0.005, respectively). Recommendations for endocrine therapy (OR = 3.44, p = 0.009) and non-HER2 targeted treatment (OR = 10.0, p < 0.001) were more commonly FDA approved indications. Compared to combination therapies, monotherapies were more likely to be FDA approved (OR = 3.45, p = 0.001) as were category 1 (OR = 7.63, p = 0.001) and preferred NCCN recommendations (OR = 4.07, p < 0.001). Compared to off-label recommendations, NCCN recommendations of approved drugs were based on significantly higher sample size (mean 477 vs. 342 patients, p = 0.02) and were non-significantly associated with availability of randomized data (OR = 2.0, 95% CI 0.89–4.49, p = 0.09).ConclusionMore than half of all NCCN recommendations for MBC are off-label, mostly involving chemotherapy containing regimes for HER2 negative disease and combinations which include HER2-targeted drugs. Improved transparency of NCCN guidelines may result from reporting of the strength of the evidence supporting recommendations for MBC.     

FDA pulls approval for avastin in breast cancer

One agent reduces tamoxifen resistance in preclinical studies, while lysine acetylation measurements may monitor clinical benefit of a second drug.     

Enhancing early breast cancer screening: an expanded role for mammography facilities is needed

Registered mammography facilities in Connecticut were surveyed in 1988 to determine the capacity and scope of services provided to women. A total of 112 responses were analyzed. Early cancer screening service other than mammography are not routinely provided. Less than 50% of facilities offer instruction on breast self-exams or provide physical breast examinations in conjunction with mammograms. Only one in three facilities have mechanisms in place to notify women of their need for periodic screening. We conclude that efforts to expand the scope of screening services offered by mammography facilities may enhance our capacity to detect early breast cancer in women.