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The prognosis of patients with biliary cancers is poor. Although surgery is potentially curative in selected patients, local recurrence is a common pattern of failure. Adjuvant or neoadjuvant radiation therapy improves local control and possibly survival. In locally advanced patients, radiation therapy provides palliation and may prolong survival. Concurrently administered chemotherapy may further enhance these results. Newer radiation therapy techniques, including intraluminal transcatheter brachytherapy, intraoperative radiation therapy, intensity-modulated radiation therapy, and three- and four-dimensional treatment planning, permit radiation dose escalation without significant increases in normal tissue toxicity, thereby increasing the effective radiation dose. Preliminary results of studies employing hepatic transplantation with radiation therapy are encouraging. Although these new approaches hold promise, the prognosis in patients with biliary cancers remains poor, and the integration of novel therapeutic strategies is indicated.

The prognosis of patients with biliary cancers is poor. Although surgery is potentially curative in selected patients, local recurrence is a common pattern of failure. Adjuvant or neoadjuvant radiation therapy improves local control and possibly survival. In locally advanced patients, radiation therapy provides palliation and may prolong survival. Concurrently administered chemotherapy may further enhance these results. Newer radiation therapy techniques, including intraluminal transcatheter brachytherapy, intraoperative radiation therapy, intensity-modulated radiation therapy, and three- and four-dimensional treatment planning, permit radiation dose escalation without significant increases in normal tissue toxicity, thereby increasing the effective radiation dose. Preliminary results of studies employing hepatic transplantation with radiation therapy are encouraging. Although these new approaches hold promise, the prognosis in patients with biliary cancers remains poor, and the integration of novel therapeutic strategies is indicated.

Investigators affiliated with the Children's Oncology Group (COG) have launched a multicenter trial aimed at determining why the relapse and survival rates of children with acute lymphoblastic leukemia (ALL) differ among the major racial and ethnic groups living in the United States.

Thalidomide (Thalomid) has "changed the paradigm" for treating multiple myeloma, and advances in understanding the relationship between myeloma cells and the bone marrow microenvironment promise to change it even more, Kenneth C. Anderson, MD, of the Dana-Farber Cancer Institute, said at the National Comprehensive Cancer Network (NCCN) 11th Annual Conference.

After 2 years of steady failure with a potential cancer drug, Cliff, an oncology postdoc, suddenly achieves dramatic cures in mice, to the point that his findings are questioned as "too good to be true." Is it fraud or sloppy recordkeeping, or maybe a true breakthrough? The pleasure in reading Allegra Goodman's novel Intuition (The Dial Press, 2006) comes not so much from the plotline (the initial giddy celebration of the findings, and then the near destruction of the lab when fraud is alleged) as from the richness of the depiction of an oncology research lab and its motley inhabitants.

"Cancer increases the risk of venous thromboembolism (VTE) by four- to sevenfold, and is a precipitating factor in almost 20% of VTEs," Michael B. Streiff, MD, said at the 11th Annual Conference of the National Comprehensive Cancer Network (NCCN).

Cancer remains the second leading cause of death in the United States, but the disease's mortality rate declined by 2.9% in 2004, according to the Centers for Disease Control and Prevention (CDC). Total US cancer deaths in 2004 numbered 550,270. Preliminary mortality data put the age-adjusted death rate for malignant neoplasms at 184.6 per 100,000 population, down from 190.1 in 2003. The nation's overall death rate fell to a record low of 801 per 100,000 persons, down from 833 the previous year. The preliminary data are based on approximately 90% of the 2004 death records reported by the 50 states.

GPC Biotech AC is accruing patients with advanced solid tumors onto a phase I trial of satraplatin, its investigational oral platinum agent, in combination with capecitabine (Xeloda). The open label study of the oral/oral combination, led by William Gradishar, MD, of Northwestern University, is expected to enroll approximately 24 patients, the company indicated in a news release.

Nereus Pharmaceuticals, Inc. has initiated a phase I trial of its novel, small molecule proteasome inhibitor, NPI-0052, in patients with solid tumors and lymphomas. The trial will enroll approximately 50 patients at two sites, M.D. Anderson Cancer Center and Memorial Sloan-Kettering Cancer Center. NPI-0052 was discovered during the fermentation of Salinispora sp, a new class of Gram-positive marine bacteria, Nereus said in a press release.

Better, cheaper digital video equipment has brought sophisticated movie-making within the reach of the ordinary person. At the Oncology Nursing Society 31st Annual Congress (abstract 3), a team of oncology nurses led by Ellen Carroll, BSN, RN, demonstrated that this gear can be put to use in cancer patient education.

The use of clinical practice guidelines such as those developed by the National Comprehensive Cancer Network (NCCN) is emerging as a key strategy for assuring cancer patients access to quality care; for empowering physicians professionally, politically, and financially; and for reducing health care costs. Panelists discussing "Oncology Practice Today" at the NCCN 11th Annual Conference repeatedly pointed to the usefulness of guidelines in quality evaluation, designing insurance coverage, and obtaining adequate reimbursement.

The FDA has awarded a $1.09 million contract for an evaluation of the agency's process of establishing postmarketing, or phase IV, studies. The consulting firm of Booz Allen Hamilton will conduct the 1-year evaluation and make recommendations to the agency for improving and standardizing the process.

The National Cancer Institute (NCI) has begun publishing a free biannual newsletter that focuses on the agency's activities in the area of complementary and alternative medicine (CAM). NCI CAM News, produced by NCI's Office of Cancer Complementary and Alternative Medicine, is available online.

The Lung Cancer Alliance applauded a recent court decision on the rights of terminally ill cancer patients to take experimental drugs. In 2003, The Abigail Alliance and the Washington Legal Foundation filed suit against the Food and Drug Administration (FDA) in order to give terminally ill cancer patients access to drugs that have passed initial safety tests but not the full regalia of clinical trials normally required for approval.

Valeant Pharmaceuticals International announced that the US Food and Drug Administration (FDA) has given marketing approval for nabilone (Cesamet, CII) oral capsules. Nabilone is used to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

As a 20-plus-year cancer survivor, I have been heartened to see the number of cancer survivors increase (currently estimated at well over 10 million Americans), and new attention paid to the unique, wide-ranging, and long-term issues that follow the diagnosis and treatment of cancer. This volume reflects that trend. It reports the work of an Institute of Medicine (IOM) and National Research Council (NRC) of the National Academies "Committee on Cancer Survivorship: Improving Care and Quality of Life."

An article in the New England Journal of Medicine (Emanuel EJ, Fuchs VR: 352:1255-1260, 2005) proposes a dramatic alternative to our current health care financing system—universal health care vouchers offering basic medical coverage for all Americans. Cancer Care & Economics (CC&E) spoke with one of the authors, Ezekiel J. Emanuel, MD, PhD, about the financial and political realities of this proposed new system. Dr. Emanuel is chair of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center, National Institutes of Health. He is also a breast oncologist.

An increasing body of evidence suggests that geriatric patients can benefit from and tolerate standard chemotherapy similarly to younger patients in the settings of both early- and advanced-stage colorectal cancer. Assessment of this unique population requires more comprehensive evaluation in addition to routine history, physical examination, and laboratory tests. Specific considerations of their physiologic functional changes will help physicians better manage these patients. Ongoing studies are now designed to better understand the decision-making process, safety profile, and efficacy of various treatment regimens in geriatric patients.

The minimally invasive procedure of radiofrequency ablation (RFA) appears to be as effective as surgical resection for the treatment of patients with a small hepatocellular carcinoma (HCC) and offers similar survival, according to a study presented at the 31st Annual Meeting of the Society of Interventional Radiology (abstract 1021). "Radiofrequency ablation can offer the same life expectancy as surgical resection to patients with solitary, small HCC, most of whom cannot tolerate a resection," said Riccardo Lencioni, MD, University of Pisa, Italy.

FDA Grants Orphan Drug Status for Cephalon's Lestaurtinib

In early 2003, NCI director Andrew C. von Eschenbach, MD, set the Institute's goal as eliminating the suffering and death caused by cancer by 2015, and he challenged his staff to produce the strategies needed to do just that. Now, the Institute has published the NCI Strategic Plan, which outlines the paths it plans to follow to reach its 2015 objective.

High-dose external beam radiation therapy (EBRT) and brachytherapy are equally effective in treating localized prostate cancer, according to a study presented at the 2006 Prostate Cancer Symposium (abstract 38). "Our findings show that either therapy is an excellent choice for treating early-stage prostate cancer," said John J. Coen, MD, assistant professor of radiation oncology at Harvard Medical School.

After a rocky start with a 2005 Demonstration Project designed to assess symptoms of nausea and vomiting, pain, and fatigue in Medicare patients receiving chemotherapy, the Centers for Medicare & Medicaid Services (CMS) has shifted toward improving quality through more effective payments and evidence-based care. This will include assessing whether patients are treated according to evidence-based standards of care (typically the NCCN or ASCO guidelines) and focusing payments on patient-centered care rather than administration of chemotherapy, Christopher E. Desch, MD, national medical director of the National Comprehensive Cancer Network, said at the 11th Annual NCCN Conference.

Novartis Seeks Approval for Gleevec in Four Rare Cancers

Orphan Drug Status Granted to Sorafenib for Liver Cancer

New Report on Survivorship Finds Minorities and Poor Least Likely to Remain Cancer-Free

Although the Medicare Modernization Act (MMA) is into its third year, the full effects of this legislation on the oncology community are still a matter of speculation. To bring our readers up to speed on current MMA issues, Cancer Care & Economics (CC&E) spoke with CC&E editor, Joseph S. Bailes, MD. Dr. Bailes is interim executive vice president and chief executive officer of the American Society of Clinical Oncology (ASCO). He also serves as co-chair of ASCO's Government Relations Council.

Twenty years ago, antiestrogen therapy with tamoxifen played only a secondary role in breast cancer care. All hopes to cure metastatic breast cancer were still pinned on either the discovery of new cytotoxic drugs or a dose-dense combination of available cytotoxic drugs with bone marrow transplantation. A similar strategy with combination chemotherapy was employed as an adjuvant for primary breast cancer. Simply stated, the goal was to kill the cancer with nonspecific cytotoxic drugs while keeping the patient alive with supportive care. However, medical research does not travel in straight lines, and an alternative approach emerged to solve the problem of controlling tumor growth with minimal side effects: targeted therapy. The approach of using long-term antihormone therapy to control early-stage breast cancer growth would revolutionize cancer care by targeting the tumor estrogen receptor (ER). The success of the strategy would contribute to a decrease in the national mortality figures for breast cancer. More importantly, translational research that targeted the tumor ER with a range of new antiestrogenic drugs would presage the current fashion of blocking survival pathways for the tumor by developing novel targeted treatments. But a surprise was in store when the pharmacology of "antiestrogens" was studied in detail: The nonsteroidal "antiestrogens" are selective ER modulators—ie, they are antiestrogens in the breast, estrogens in the bone—and they lower circulating cholesterol levels. This knowledge would establish a practical approach to breast cancer chemoprevention for women at high risk (tamoxifen) and low risk (raloxifene).

Twenty years ago, antiestrogen therapy with tamoxifen played only a secondary role in breast cancer care. All hopes to cure metastatic breast cancer were still pinned on either the discovery of new cytotoxic drugs or a dose-dense combination of available cytotoxic drugs with bone marrow transplantation. A similar strategy with combination chemotherapy was employed as an adjuvant for primary breast cancer. Simply stated, the goal was to kill the cancer with nonspecific cytotoxic drugs while keeping the patient alive with supportive care. However, medical research does not travel in straight lines, and an alternative approach emerged to solve the problem of controlling tumor growth with minimal side effects: targeted therapy. The approach of using long-term antihormone therapy to control early-stage breast cancer growth would revolutionize cancer care by targeting the tumor estrogen receptor (ER). The success of the strategy would contribute to a decrease in the national mortality figures for breast cancer. More importantly, translational research that targeted the tumor ER with a range of new antiestrogenic drugs would presage the current fashion of blocking survival pathways for the tumor by developing novel targeted treatments. But a surprise was in store when the pharmacology of "antiestrogens" was studied in detail: The nonsteroidal "antiestrogens" are selective ER modulators—ie, they are antiestrogens in the breast, estrogens in the bone—and they lower circulating cholesterol levels. This knowledge would establish a practical approach to breast cancer chemoprevention for women at high risk (tamoxifen) and low risk (raloxifene).

Twenty years ago, antiestrogen therapy with tamoxifen played only a secondary role in breast cancer care. All hopes to cure metastatic breast cancer were still pinned on either the discovery of new cytotoxic drugs or a dose-dense combination of available cytotoxic drugs with bone marrow transplantation. A similar strategy with combination chemotherapy was employed as an adjuvant for primary breast cancer. Simply stated, the goal was to kill the cancer with nonspecific cytotoxic drugs while keeping the patient alive with supportive care. However, medical research does not travel in straight lines, and an alternative approach emerged to solve the problem of controlling tumor growth with minimal side effects: targeted therapy. The approach of using long-term antihormone therapy to control early-stage breast cancer growth would revolutionize cancer care by targeting the tumor estrogen receptor (ER). The success of the strategy would contribute to a decrease in the national mortality figures for breast cancer. More importantly, translational research that targeted the tumor ER with a range of new antiestrogenic drugs would presage the current fashion of blocking survival pathways for the tumor by developing novel targeted treatments. But a surprise was in store when the pharmacology of "antiestrogens" was studied in detail: The nonsteroidal "antiestrogens" are selective ER modulators—ie, they are antiestrogens in the breast, estrogens in the bone—and they lower circulating cholesterol levels. This knowledge would establish a practical approach to breast cancer chemoprevention for women at high risk (tamoxifen) and low risk (raloxifene).