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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).

Age alone should not be a contraindication to FOLFOX4 chemotherapy in older adults with colorectal cancer.

Neuropsychologists play a key role in helping identify cognitive issues in childhood cancer survivors and in developing rehabilitation programs to increase their functioning, Lisa A. Jackson, PhD, said at the Cancer in the Classroom meeting hosted by Roswell Park Cancer Institute.

Psychosocial factors influence life-or-death eligibility decisions in bone marrow transplant (BMT) procedures, and yet there is a serious lack of consensus as to what these factors are and how they should be weighted.

Liver transplantation is lifesaving in patients with localized hepatocellular carcinoma, with some 75% of transplant recipients still alive 5 years later, compared with only 12% of other patients, finds the first large population-based study of this treatment for this disease.

The American Journal of Nursing (AJN) recently released a consensus report based on the outcome of the invitational symposium, "The State of the Science on Nursing Approaches to Managing Late and Long-Term Sequelae of Cancer and Cancer Treatment," which took place in Philadelphia in July 2005. The report, which accompanied the March issue of AJN, offers action strategies and recommendations, from a nursing perspective, for addressing the health needs of the more than 10 million long-term cancer survivors alive today.

Elderly patients with stage I-III non-small-cell lung cancer (NSCLC) constitute a peculiar patient population and need specific therapeutic approaches. Limited resections are an attractive alternative for elderly patients with resectable NSCLC because of the potential reduction in postoperative complications. Curative radiation therapy is an acceptable alternative for elderly patients who are unfit for or refuse surgery. Hypofractionated stereotactic body radiation therapy is of particular interest for this population because of its favorable tolerance.

Elderly patients with stage I-III non-small-cell lung cancer (NSCLC) constitute a peculiar patient population and need specific therapeutic approaches. Limited resections are an attractive alternative for elderly patients with resectable NSCLC because of the potential reduction in postoperative complications. Curative radiation therapy is an acceptable alternative for elderly patients who are unfit for or refuse surgery. Hypofractionated stereotactic body radiation therapy is of particular interest for this population because of its favorable tolerance.

Elderly patients with stage I-III non-small-cell lung cancer (NSCLC) constitute a peculiar patient population and need specific therapeutic approaches. Limited resections are an attractive alternative for elderly patients with resectable NSCLC because of the potential reduction in postoperative complications. Curative radiation therapy is an acceptable alternative for elderly patients who are unfit for or refuse surgery. Hypofractionated stereotactic body radiation therapy is of particular interest for this population because of its favorable tolerance.

President Bush's budget request for fiscal year (FY) 2007 contained some unpleasant news for the cancer community, including a small but symbolically significant cut in funding for the National Cancer Institute (NCI).

Eli Lilly and Company and the National Coalition for Cancer Survivorship have issued a call for entries for the 2006 Lilly Oncology on Canvas: Expressions of a Cancer Journey International Art Competition and Exhibition.

Officials at the National Cancer Institute have welcomed two new guidance documents issued by the FDA. The two aim at making it easier for clinical researchers to conduct small-scale human studies of exploratory drugs prior to phase I trials. The documents are designed to increase the number of promising drugs that researchers can evaluate by administering them at microdose levels to small numbers of patients before deciding whether the agents warrant further human study.

When an adjacent hospital closed its research unit with cancer trials pending, the Arthur G. James Cancer Hospital, Ohio State Univesity, Columbus, successfully added a clinical study component to an existing hematology-oncology unit, to ensure that patients could enroll in phase I trials and receive the care they need during their enrollment.

The North Shore-Long Island Jewish (LIJ) Health System has opened its Monter Cancer Center, a $17 million, 37,000-square-foot facility that offers a spectrum of cancer services in a stunning outpatient setting, providing patients with a calming atmosphere complete with indoor gardens and skylights.

Unrelated cord blood transplantation (UCBT) appears at least as effective as haploidentical T-cell-depleted peripheral blood stem cell transplantation (PBSCT) in adults with acute leukemia, with outcomes varying according to leukemia subtype, according to a retrospective analysis of European transplant patients.