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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).

Permanent prostate brachytherapy with or without supplemental therapies is a highly effective treatment for clinically localized prostate cancer, with biochemical outcomes and morbidity profiles comparing favorably with competing local modalities. However, the absence of prospective randomized brachytherapy trials evaluating the role of supplemental external-beam radiation therapy (XRT) has precluded the development of evidence-based treatment algorithms for the appropriate inclusion of such treatment. Some groups advocate supplemental XRT for all patients, but the usefulness of this technology remains largely unproven and has been questioned by recent reports of favorable biochemical outcomes following brachytherapy used alone in patients at higher risk. Given that brachytherapy can be used at high intraprostatic doses and can obtain generous periprostatic treatment margins, the use of supplemental XRT may be relegated to patients with a high risk of seminal vesicle and/or pelvic lymph node involvement. Although morbidity following brachytherapy has been acceptable, supplemental XRT has shown an adverse impact on long-term quality of life. The completion of ongoing prospective randomized trials will help define the role of XRT as a supplement to permanent prostate brachytherapy.

Chemotherapy-induced neutropenia (CIN) and its complications exact a substantial toll on patients with cancer. Febrile neutropenia (FN), a sign of life-threatening infections, is associated with lengthy hospitalizations, early mortality, and high medical costs. In addition, neutropenia is the primary cause of dose reductions and dose delays, limiting the delivery of the chemotherapy at full dose and on schedule and thus compromising long-term survival in patients with potentially curable malignancies. Many recent studies in several major tumor types have documented that the greatest risk of neutropenia and its complications is in the first cycle of chemotherapy, with more than 50% of the first episodes of neutropenia and FN occurring in the first cycle. In addition to their other negative effects, these first-cycle events are also associated with early termination of the chemotherapy. The disproportionately high risk of neutropenia in the first cycle has important implications for managing CIN, as well as for the development and use of guidelines for supportive care. It highlights the importance of determining which patients are at high risk for neutropenia and its complications before the chemotherapy is initiated and implementing interventions, such as prophylactic growth factor support in the first and subsequent cycles, to reduce that risk.

Neutropenia is the primary dose-limiting toxicity in patients with cancer treated with systemic chemotherapy. The risk of febrile neutropenia (FN) has been estimated on the basis of the chemotherapy regimen, but studies are now finding a number of patient-related and disease-related risk factors for FN and other complications, such as hospitalization, chemotherapy dose reductions and delays, and mortality. These patient-related risk factors have been incorporated into clinical guidelines for managing neutropenia. The newly released guidelines on the use of myeloid growth factors with cancer chemotherapy of the National Comprehensive Cancer Network use disease- and patient-related factors along with the chemotherapy regimen risk. These guidelines also differ from previous guidelines in that they recommend the routine use of colony-stimulating factors (CSFs) in patients in whom the risk of neutropenia is > 20% (the previous threshold was ≥ 40%); this recommendation is based on recent data that show the clinical benefits of filgrastim (Neupogen) and pegfilgrastim (Neulasta) in studies in which the overall populations had FN risks of between 20% and 40%. The use of guidelines such as these in clinical practice will make it possible to target CSFs to appropriate patients in the first cycle of chemotherapy, when the risk of neutropenia is highest.

Permanent prostate brachytherapy with or without supplemental therapies is a highly effective treatment for clinically localized prostate cancer, with biochemical outcomes and morbidity profiles comparing favorably with competing local modalities. However, the absence of prospective randomized brachytherapy trials evaluating the role of supplemental external-beam radiation therapy (XRT) has precluded the development of evidence-based treatment algorithms for the appropriate inclusion of such treatment. Some groups advocate supplemental XRT for all patients, but the usefulness of this technology remains largely unproven and has been questioned by recent reports of favorable biochemical outcomes following brachytherapy used alone in patients at higher risk. Given that brachytherapy can be used at high intraprostatic doses and can obtain generous periprostatic treatment margins, the use of supplemental XRT may be relegated to patients with a high risk of seminal vesicle and/or pelvic lymph node involvement. Although morbidity following brachytherapy has been acceptable, supplemental XRT has shown an adverse impact on long-term quality of life. The completion of ongoing prospective randomized trials will help define the role of XRT as a supplement to permanent prostate brachytherapy.

Childbearing is one of the most important life goals for many women, and fertility preservation is a very important factor in the overall quality of life of cancer survivors. Cervical cancer frequently affects young women; because some women tend to delay childbearing, fertility preservation must be considered when treatment options are discussed. Over the past decade, the radical trachelectomy procedure has become a well established fertility-preserving option for young women with early-stage cancer; this procedure is associated with low morbidity, good oncologic outcome, and a high proportion of pregnancies that reach the third trimester and babies that are delivered at term. This article will review available literature on the vaginal radical trachelectomy procedure and data from other surgical approaches, such as the abdominal radical trachelectomy. In addition, the potential future application of neoadjuvant chemotherapy followed by fertility-preserving surgery in patients with locally advanced cervical cancer will be examined. Finally, ultraconservative surgical approaches (eg, conization alone with or without laparoscopic lymphadenectomy) in very early-stage disease will be discussed.

Permanent prostate brachytherapy with or without supplemental therapies is a highly effective treatment for clinically localized prostate cancer, with biochemical outcomes and morbidity profiles comparing favorably with competing local modalities. However, the absence of prospective randomized brachytherapy trials evaluating the role of supplemental external-beam radiation therapy (XRT) has precluded the development of evidence-based treatment algorithms for the appropriate inclusion of such treatment. Some groups advocate supplemental XRT for all patients, but the usefulness of this technology remains largely unproven and has been questioned by recent reports of favorable biochemical outcomes following brachytherapy used alone in patients at higher risk. Given that brachytherapy can be used at high intraprostatic doses and can obtain generous periprostatic treatment margins, the use of supplemental XRT may be relegated to patients with a high risk of seminal vesicle and/or pelvic lymph node involvement. Although morbidity following brachytherapy has been acceptable, supplemental XRT has shown an adverse impact on long-term quality of life. The completion of ongoing prospective randomized trials will help define the role of XRT as a supplement to permanent prostate brachytherapy.

The Oncology Nursing Society (ONS) Board of Directors has announced the 12th Annual Oncology Nursing Day and Month celebration to recognize oncology nurses and to increase awareness of the specialty.

The decline in total cancer mortality in the United States that began in 2003 looks set to continue and even accelerate as more research moves "from bench to bedside"—unless the basic and translational science feeding that change is strangled by budget cuts and red tape, according to experts at the 11th Annual Conference of the National Comprehensive Cancer Network (NCCN).

Medicare Part D, the outpatient prescription drug plan that went into effect on January 1, is having a major impact on community oncology practices as they struggle to deal with widespread confusion as well as the extra requirements imposed by the private plans.

President Bush has nominated NCI director Andrew C. von Eschenbach, MD, as commissioner of the Food and Drug Administration (FDA).