In Brief

From OncoLog, September 2005, Vol. 50, No. 9

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Phase I Cancer Findings Under-Reported

Phase I cancer studies are underreported in peer-reviewed journals—a trend that could ultimately delay scientific progress and negatively affect patient care, say researchers at M. D. Anderson in a new study published online in Cancer on August 22, 2005.

Over the last decade, greater understanding of cancer at the molecular and cellular levels has resulted in the development of numerous potential anticancer agents. An excellent indication of this progress, said Luis Camacho, M.D., assistant professor in M. D. Anderson’s Phase I Clinical Trials Program, is the 10-fold increase in the number of Investigational New Drug applications for oncology agents filed with the Food and Drug Administration—from 100 compounds in 1980 to over 1,000 in 1998.

“With all this new knowledge, the need to share information is paramount, now more than ever before,” said Dr. Camacho, the study’s first author. “We, as clinicians and researchers, have a tremendous responsibility to not only investigate and discover new agents but also to disseminate our discoveries—good and bad—to the medical community at large, to ensure the safety and well-being of our patients.

“Obviously, if a phase I agent proves too toxic, we need to ensure that information is shared within the cancer medical community, so as to not put patients in harm’s way,” Dr. Camacho said. “Of course, if phase I studies are promising, publishing can encourage further investigation of these potential therapeutic agents.”

In unique cases, Dr. Camacho said, positive phase I results can have an immediate effect on clinical care. “Phase I studies are not necessarily first-in-human trials—they also can investigate combinations of already approved drugs,” he added. “If those combinations prove relatively nontoxic and show some effect, that combination can potentially be moved forward to phase II trials and, in selected cases, used to treat patients almost immediately.”

“Developmental Reprogramming” Could Explain Cancer Risk

Researchers at M. D. Anderson Cancer Center may have uncovered the reason why some people who are genetically predisposed to hormone-dependent cancers develop the disease as an adult, while others who are similarly susceptible do not.

In a study published in the June 14, 2005, issue of the Proceedings of the National Academy of Sciences USA, the researchers showed, for the first time, that exposure to a pharmaceutical estrogen during fetal development can permanently “reprogram” tissue in a way that determines whether tumors will develop in adulthood.

While the study was conducted with rats that are susceptible to benign uterine tumors, the researchers say their conclusions likely have relevance for humans who inherit defective tumor suppressor genes that make them susceptible to a number of different cancers. The study could explain, for example, why some women who inherited BRCA1 or BRCA2 gene defects develop breast cancer as adults while other women with the same genes remain disease free.

“The kind of developmental reprogramming we see from this work could represent an important determinant of risk in people genetically susceptible to hormone-dependent tumors, such as uterine, breast, and prostate cancer,” said the study’s principal investigator, Cheryl Walker, Ph.D., a professor in the Department of Carcinogenesis.

While more work is needed to make the case that some human cancers occur in the same way, “we need to open our eyes to the notion that cancer that develops in an adult may have been put in motion before the person was born,” said the first author, Jennifer Cook, a graduate student who works with Dr. Walker.

An Alternative to Bone Marrow Biopsies?

New tests may soon be available that will allow physicians to diagnose and monitor disease activity in leukemia and lymphoma patients using blood samples. These tests could reduce the need for the uncomfortable bone marrow biopsies traditionally used.

“Our research has shown that testing for tumor constituents in the blood provides a more clinically useful assessment of disease status because it shows what is happening in the entire body, compared with a biopsy, which only provides information about a specific area,” said Michael J. Keating, M.D., a professor in the Department of Leukemia at M. D. Anderson Cancer Center.

The new tests are designed to detect certain proteins that are expressed on the surface of tumor cells. The assays will look for the proteins CD3, CD4, CD8, CD19, CD20, CD33, and CD52, as well as tumor-specific DNA and RNA in blood plasma. Quest Diagnostics is developing the new tests based on technology developed at M. D. Anderson.

“The new blood tests may give us a less painful and more cost-effective way to monitor patients,” said Dr. Keating. “As a result, oncologists may be able to assess patients more frequently and thus provide more clinically relevant monitoring of their progress.”

For more information on this topic or for questions about M. D. Anderson’s treatments, programs, or services, call askMDAnderson at (877) MDA-6789.

Other articles in OncoLog, September 2005 issue:

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