ONCOLOGY Vol 21 No 8 | Oncology

The Myriad Challenges of Informed Consent

July 01, 2007

Virginia Sun outlines the elements that must be included in an informed consent document for clinical research. The purpose in stipulating such categories is to ensure that an individual receives, both in writing and during the discussion, sufficient information to make a decision about participation in the research study.

Hodkin's Lymphoma in the Elderly: Who is 'Older' and Is the Disease Really Worse in Older Patients?

July 01, 2007

With improved prognosis for patients with Hodgkin's lymphoma (HL), interest has increasingly focused on high-risk groups such as elderly patients. Advanced age at presentation is still one of the strongest negative risk factors. Many different factors influence the prognosis in elderly patients. These include biologic differences such as more aggressive histology, different distribution of disease, more frequent diagnosis of advanced stage, and shorter history of disease. In addition, however, aging itself and associated factors such as comorbidity, reduced tolerability of conventional therapy, more severe toxicity and treatment-related deaths, failure to maintain dose intensity, shorter survival after relapse, and death due to other causes contribute to the poorer outcome in elderly patients. Besides the evaluation of specific causes and risk factors, this review highlights recent and ongoing studies for elderly patients with HL as well as international approaches and recommendations for this age group.

he Oncology Nurse's Role in the Informed Consent Process

July 01, 2007

Cancer clinical trials are a necessary component of the effort to improve cancer prevention, diagnosis, and treatment. Essential to this process is the informed consent of the individuals who participate in these research studies. The purpose of this article is to describe patient, provider, and informed consent process issues with presentations of data reported in the current literature. The role of nursing in the facilitation of informed consent is discussed.

Radiation Dermatitis

July 01, 2007

42-year-old Caucasian female who was in her usual state of health when her first mammogram showed suspicious calcifications and a spiculated mass in the upper outer quadrant of the right breast. An ultrasound-guided biopsy showed an invasive ductal carcinoma. She underwent a lumpectomy, with the excised tumor measuring 1.2 cm. The tumor was estrogen and progesterone positive and HER2/neu negative.

A Clear Need for Randomized Trials

July 01, 2007

The recommended primary treatment approach for women with metastatic breast cancer and an intact primary tumor is the use of systemic therapy. Local therapy of the primary tumor is recommended only for palliation of symptoms. However, a series of retrospective studies examining practice patterns for this problem show that about half the women presenting with de novo metastatic disease undergo resection of the primary tumor, and suggest that women so treated survive longer than those who do not undergo resection of the intact primary. In analyses that adjust for tumor burden (number of metastatic sites), types of metastases (visceral, nonvisceral), and the use of systemic therapy, the hazard ratio for death is reduced by 40% to 50% in women receiving surgical treatment of the primary tumor. The benefit of surgical treatment appears to be confined to women whose tumors were resected with free margins. However, these results may simply reflect a selection bias (ie, younger, healthier women with a smaller tumor burden are more likely to receive surgical treatment). In addition, the role of other locoregional therapy such as axillary dissection and radiotherapy is not addressed in these studies. In view of these data, the role of local therapy in women with stage IV breast cancer needs to be reevaluated, and local therapy plus systemic therapy should be compared to systemic therapy alone in a randomized trial.

Monoclonal Antibodies to EGFR: What Does the Future Hold?

July 01, 2007

Monoclonal antibodies to the epidermal growth factor receptor (EGFR) are among the promising novel targeted therapies being explored in colorectal cancer. Two such agents that inhibit EGFR signaling by interfering with ligand-binding are cetuximab (Erbitux) and panitumumab (Vectibix). This review will address the use of cetuximab and panitumumab in chemotherapy-refractory colorectal cancer as well as in front-line therapy for the disease, consider predictors of response and resistance, and outline comparisons between these agents.

Hodgkin's in the Elderly: More Questions Than Answers

July 01, 2007

With improved prognosis for patients with Hodgkin's lymphoma (HL), interest has increasingly focused on high-risk groups such as elderly patients. Advanced age at presentation is still one of the strongest negative risk factors. Many different factors influence the prognosis in elderly patients. These include biologic differences such as more aggressive histology, different distribution of disease, more frequent diagnosis of advanced stage, and shorter history of disease. In addition, however, aging itself and associated factors such as comorbidity, reduced tolerability of conventional therapy, more severe toxicity and treatment-related deaths, failure to maintain dose intensity, shorter survival after relapse, and death due to other causes contribute to the poorer outcome in elderly patients. Besides the evaluation of specific causes and risk factors, this review highlights recent and ongoing studies for elderly patients with HL as well as international approaches and recommendations for this age group.

One Moment in Research

July 01, 2007

Recently, I was approached by one of my Texas colleagues and asked if I could help out with some legislation before the Texas state Senate. The bill (HJR90), which would authorize $3 billion for cancer prevention and research over the next 10 years, had passed the Texas House of Representatives, and was currently "in process" in the state Senate.

Premenopausal Estrogen Levels Linked to Higher Death Rate Among Women Receiving Chemotherapy for Advanced NSCLC

July 01, 2007

Cell Therapeutics, Inc (CTI) announced that data presented at the 2007 Annual Meeting of the American Society for Clinical Oncology (ASCO), held in Chicago on June 1-5, provides independent supportive data validating the potential survival benefit of paclitaxel poliglumex (Xyotax) over standard chemotherapy in the treatment of advanced non-small-cell lung cancer (NSCLC) in women whose estrogen levels are in the normal range for premenopausal women.

Phase III Ixabepilone Study Shows Improvement in Progression-Free Survival in Patients With Advanced Metastatic Breast Cancer

July 01, 2007

Bristol-Myers Squibb reported results from a large randomized phase III study of the investigational compound ixabepilone in patients with breast cancer whose disease had rapidly progressed through, or did not respond to, prior treatment with chemotherapies (anthracycline and taxane). Results showed that patients treated with ixabepilone in combination with capecitabine (Xeloda), experienced a statistically significant improvement in progression-free survival, the primary endpoint, compared to patients treated with capecitabine alone.

Management of Comorbid Diabetes and Cancer

July 01, 2007

Diabetes mellitus is a frequent comorbidity of cancer patients. The growing epidemic of diabetes is anticipated to have tremendous impact on health care. Diabetes may negatively impact both cancer risk and outcomes of treatment. Oncology nurses are ideally positioned to identify patients at risk for complications that arise from cancer treatment in the setting of pre-existing diabetes. Additionally, oncology nurses may be the first to identify underlying hyperglycemia/hidden diabetes in a patient undergoing cancer treatment. Strategies for assessment and treatment will be discussed, along with specific strategies for managing hyperglycemia, potential renal toxicity, and peripheral neuropathy. Guidelines for aggressive treatment of hyperglycemia to minimize risks of complications will be reviewed. The role of interdisciplinary care, utilizing current evidence, is crucial to supporting patients and their families as they manage the challenges of facing two life-limiting diseases. Whole-person assessment and individualized treatment plans are key to maximizing quality of life for patients with cancer and diabetes.

S-1 Plus Cisplatin Demonstrates Significant Improvement in Overall Survival of Advanced Gastric Cancer Patients Over S-1 Alone

July 01, 2007

Taiho and sanofi-aventis announced the results of a phase III trial in advanced gastric cancer, which shows that the combination of the investigational oral fluoropyrimidine S-1 with cisplatin significantly reduces the risk of death by 22.6% (hazard ratio = 0.774; 95% confidence interval = 0.608-0.985) over S-1 alone.

The Explanation Behind the Observation?

July 01, 2007

The recommended primary treatment approach for women with metastatic breast cancer and an intact primary tumor is the use of systemic therapy. Local therapy of the primary tumor is recommended only for palliation of symptoms. However, a series of retrospective studies examining practice patterns for this problem show that about half the women presenting with de novo metastatic disease undergo resection of the primary tumor, and suggest that women so treated survive longer than those who do not undergo resection of the intact primary. In analyses that adjust for tumor burden (number of metastatic sites), types of metastases (visceral, nonvisceral), and the use of systemic therapy, the hazard ratio for death is reduced by 40% to 50% in women receiving surgical treatment of the primary tumor. The benefit of surgical treatment appears to be confined to women whose tumors were resected with free margins. However, these results may simply reflect a selection bias (ie, younger, healthier women with a smaller tumor burden are more likely to receive surgical treatment). In addition, the role of other locoregional therapy such as axillary dissection and radiotherapy is not addressed in these studies. In view of these data, the role of local therapy in women with stage IV breast cancer needs to be reevaluated, and local therapy plus systemic therapy should be compared to systemic therapy alone in a randomized trial.

Monoclonal Antibodies in Colorectal Cancer: What We Know

July 01, 2007

Monoclonal antibodies to the epidermal growth factor receptor (EGFR) are among the promising novel targeted therapies being explored in colorectal cancer. Two such agents that inhibit EGFR signaling by interfering with ligand-binding are cetuximab (Erbitux) and panitumumab (Vectibix). This review will address the use of cetuximab and panitumumab in chemotherapy-refractory colorectal cancer as well as in front-line therapy for the disease, consider predictors of response and resistance, and outline comparisons between these agents.

Clinical Use of Monoclonal Antibodies to the Epidermal Growth Factor Receptor in Colorectal Cancer

July 01, 2007

Monoclonal antibodies to the epidermal growth factor receptor (EGFR) are among the promising novel targeted therapies being explored in colorectal cancer. Two such agents that inhibit EGFR signaling by interfering with ligand-binding are cetuximab (Erbitux) and panitumumab (Vectibix). This review will address the use of cetuximab and panitumumab in chemotherapy-refractory colorectal cancer as well as in front-line therapy for the disease, consider predictors of response and resistance, and outline comparisons between these agents.

Hodgkin's Lymphoma in the Elderly: A Different Disease in Patients Over 60

July 01, 2007

With improved prognosis for patients with Hodgkin's lymphoma (HL), interest has increasingly focused on high-risk groups such as elderly patients. Advanced age at presentation is still one of the strongest negative risk factors. Many different factors influence the prognosis in elderly patients. These include biologic differences such as more aggressive histology, different distribution of disease, more frequent diagnosis of advanced stage, and shorter history of disease. In addition, however, aging itself and associated factors such as comorbidity, reduced tolerability of conventional therapy, more severe toxicity and treatment-related deaths, failure to maintain dose intensity, shorter survival after relapse, and death due to other causes contribute to the poorer outcome in elderly patients. Besides the evaluation of specific causes and risk factors, this review highlights recent and ongoing studies for elderly patients with HL as well as international approaches and recommendations for this age group.

Does Resection of an Intact Breast Primary Improve Survival in Metastatic Breast Cancer?

July 01, 2007

The recommended primary treatment approach for women with metastatic breast cancer and an intact primary tumor is the use of systemic therapy. Local therapy of the primary tumor is recommended only for palliation of symptoms. However, a series of retrospective studies examining practice patterns for this problem show that about half the women presenting with de novo metastatic disease undergo resection of the primary tumor, and suggest that women so treated survive longer than those who do not undergo resection of the intact primary. In analyses that adjust for tumor burden (number of metastatic sites), types of metastases (visceral, nonvisceral), and the use of systemic therapy, the hazard ratio for death is reduced by 40% to 50% in women receiving surgical treatment of the primary tumor. The benefit of surgical treatment appears to be confined to women whose tumors were resected with free margins. However, these results may simply reflect a selection bias (ie, younger, healthier women with a smaller tumor burden are more likely to receive surgical treatment). In addition, the role of other locoregional therapy such as axillary dissection and radiotherapy is not addressed in these studies. In view of these data, the role of local therapy in women with stage IV breast cancer needs to be reevaluated, and local therapy plus systemic therapy should be compared to systemic therapy alone in a randomized trial.

Chemotherapy-Induced Nausea and Vomiting: Which Antiemetic for Which Therapy?

July 01, 2007

Chemotherapy-induced nausea and vomiting (CINV) remains an important and common toxicity of cancer treatment. Recent guideline revisions have classified chemotherapeutic agents into four categories of emesis risk without the use of preventive agents: high (> 90%), moderate (30%-90%), low (10%-30%), and minimal (< 10%). Currently available antiemetic agents, including corticosteroids, 5-hydroxytryptamine (HT)3 receptor antagonists, and neurokinin (NK)-1 antagonists are used alone or in combination depending on the level of emetogenic potential as prophylaxis against the development of CINV during the acute period (up to 24 hours after chemotherapy) and the delayed period (up to 5 days after treatment). Newer agents, including the second-generation 5-HT3 receptor antagonist palonosetron (Aloxi) and the NK-1 antagonist aprepitant (Emend), offer additional clinical benefit in highly and moderately emetogenic therapy. However, delayed nausea and vomiting continue to occur frequently in many patients and have an impact on quality of life. Other classes of agents including the benzodiazepines and cannabinoids offer the potential for additional protective benefit. Continued research with new drugs and combinations is necessary to meet this significant unmet need of cancer patients.

Reviving the Acid Phosphatase Test for Prostate Cancer

July 01, 2007

Prostatic acid phosphatase (PAP) emerged as the world's first clinically useful tumor marker in the 1940s and 1950s. With the introduction of the prostate-specific antigen (PSA) test in the 1980s, which performed significantly better than PAP in terms of screening and monitoring response to treatment, PAP fell into disfavor. An increasing number of recent studies have identified PAP as a significant prognostic factor for patients with intermediate- and high-risk prostate cancer. PAP appears to be particularly valuable in predicting distant failure in higher-risk patients for whom high levels of local control are achieved with aggressive initial local treatment. As prostate cancer care becomes increasingly focused on identifying the minority of patients who would benefit from aggressive systemic therapy, a reevaluation of the potential contribution of the prostatic acid phosphatase test seems timely.