	These online tools are a part of the Research Projects of the Laboratory for Quantitative Medicine from the Massachusetts General Hospital found on CancerMath.net (part of LifeMath.net). There are 3 Web-based calculators for melanoma: an outcome calculator, a conditional outcome calculator, and a nodal status calculator. The nodal status calculator uses patient information such as age, tumor thickness, Clark level, ulceration, histology, and tumor location to calculate the probability of positive nodes in a patient. The outcome calculator requires the age and gender of the patient as factors of noncancer lethality, as well as tumor thickness, number of positive nodes, nodal mass, Clark level, ulceration, histology, tumor location, location of distant metastasis (if any), and whether serum lactate dehydrogenase (LDH) levels are normal or elevated. The calculator will then display the patient’s classification and American Joint Committee on Cancer (AJCC) stage, the cancer mortality rate, the average life expectancy of a person without cancer who is the same age and gender as the patient, and how many years this cancer shortens that life expectancy. The calculator will also display a graph showing the patient’s mortality risk over time from the cancer, from noncancer reasons and overall. This graph can also be viewed as survival curves, a bar graph, a pie chart, or a pictogram. The conditional outcome calculator is similar, except that it takes into account the number of years since diagnosis and does not include number of years by which the patient’s life expectancy has been shortened. These calculators are based on observed outcomes from patients with melanoma from 1987 to 2006.

	The Melanoma International Foundation (MIF) is a nonprofit organization dedicated to helping patients with melanoma through education and support. The “Melanoma Info” section of the MIF Website has a number of pages that patients with melanoma may find useful: a melanoma pictoral atlas; melanoma facts; advice for the newly diagnosed; explanations of pathology, biopsy, and sentinel node biopsy; how to find the right doctor; treatment for stages I to III; treatment for stage IV; and a glossary of medical terms associated with melanoma. In the “Resources” section, patients can find information on cancer centers, support sites, educational programs, clinical trials, and more. The MIF Website also features online forums for people affected by melanoma and a memorial section for loved ones lost to the disease.

	Clinical correlates of NRAS and BRAF mutations in primary human melanoma

 Ellerhorst JA, Greene VR, Ekmekcioglu S, et al

NRAS and BRAF mutations are both common in cutaneous melanomas, though they are rarely found together in the same tumor. The purpose of this study was to test whether cutaneous melanomas with NRAS or BRAF mutations had a more aggressive clinical phenotype than tumors that were wild type at both loci. The study included 223 primary melanomas that were microdissected before having their NRAS and BRAF mutational status determined. The authors then correlated the genotypic findings with factors that have a proven influence on tumor behavior, including age, gender, Breslow depth, Clark level, mitotic rate, ulceration, and AJCC staging.

 The study found that Breslow depth and Clark levels varied significantly among the different genotypes, with NRAS mutants demonstrating the deepest levels and 

	wild-type tumors showing the least depth. Ulceration also varied, with BRAF mutants having the highest rate. Tumors with NRAS mutations were more likely to be found on extremities. Patients with either NRAS or BRAF mutation presented with more advanced AJCC stages and were more likely to have stage III disease at diagnosis than patients with wild-type tumors. There was no difference in overall survival. The authors concluded that melanomas with NRAS or BRAF mutations are associated with features that are known to predict aggressive tumor behavior, and that the impact of these mutations is most evident at the earlier stages of disease progression.

Carboplatin, paclitaxel, and temozolomide for patients with metastatic melanoma

	Sponsor: New Mexico Cancer Care Alliance

	ClinicalTrials.gov Identifier: NCT01009515

	Purpose: This clinical trial will be testing the combination of carboplatin, paclitaxel, and temozolomide in the treatment of metastatic or recurrent melanoma. The primary outcome measure of the study will be the objective response rate for this combination of drugs in this setting. Secondary outcome measures include the median overall survival and median time to progression, as well as the safety profile and major adverse events for this combination.

Imatinib in patients with mucosal or acral/lentiginous melanoma (BUS255)

	Purpose: Imatinib (Gleevec) is a tyrosine kinase inhibitor that obstructs protein signals that lead to cancer cell growth. This phase II, interventional, nonrandomized, open-label, single-group assignment study is examining the efficacy of imatinib in treating acral lentiginous and mucosal melanoma that has spread to other parts of the body in patients with c-kit mutations. The primary outcome measures of this clinical trial are response rate and time to progression. Secondary outcome measures for the study are to correlate c-kit mutational status with response to therapy and to evaluate the tolerability of imatinib in the patient population. Study participants will receive a bottle of 100 mg imatinib pills and will be directed to take 4 pills once daily. If a patient’s condition worsens, the dose may be increased to 400 mg twice daily. The treatment will last approximately 1 year. 

Articles

Net Guide

Useful Online Resources and Clinical Trials for Melanoma

Net Guides: Melanoma

	Bonetumor.org is a nonprofit organization that provides information on bone tumors to healthcare professionals and their patients.  The Website features a large number of articles contributed from researchers and physicians around the globe, covering more than 100 different types of bone tumors and bone tumor topics. In the “Tumor Information” section, visitors can find tumor information by type or category, browse a bone tumor image library, read about delay and error in tumor diagnosis, and access a spotlight section on tumors of the foot and ankle. The “Learning Resources” section is largely for healthcare professionals and includes actual clinical cases of bone tumors, an article on the evaluation of pathologic fracture risk due to a tumor, first steps to take in the management of a bone tumor, an overview of limb salvage surgery, and a collection of bone tumor learning modules. Bonetumor.org is also available in Spanish.

	This PDF booklet, which was published by the Bone and Cancer Foundation (BCF), educates patients on various topics regarding pain management related to cancer in the bones. The topics are presented in the form of questions and cover subjects such as how pain is measured, how bone metastases pain feels, and how it is treated. The booklet also covers the types of medication used to treat bone metastases and offers a table with commonly used over-the-counter and prescription medications. Later sections cover alternative treatments, when surgery is required, and which medical specialists help manage pain. The BCF, a program of the Paget Foundation for Paget’s Disease of Bone and Related Disorders, offers a number of other patient education booklets on bone metastases, which can be downloaded from its home Website at 

Questions and Answers About Breast Cancer, Bone Metastases, & Treatment-Related Bone Loss

	This PDF, which is provided by the Bone & Cancer Foundation, provides Q&As on the relationship between breast cancer and bone health, decreasing the chance of breast cancer spreading to the bone, finding out if breast cancer has spread to the bone, problems caused by breast cancer in bone, and treating breast cancer that has spread to the bone. Some of the specific questions include, “What parts of the skeleton are most likely to be affected by breast cancer?” and “What problems are caused by the spread of breast cancer to the bone?” The PDF includes a glossary of terms related to cancer-related bone issues.  

Preventing bone complications in advanced prostate cancer

	Although the diagnosis and treatment of prostate cancer continues to improve, most patients with advanced cancer will still develop disease metastatic to bone, leading to severe pain, fracture, spinal cord compression, marrow failure, or hypercalcemia. Androgen deprivation therapy (ADT), the standard treatment for advanced prostate cancer, increases the risk of bone disease. In this review, the authors discuss the current strategies and advances for preventing skeletal complications associated with advanced prostate cancer and with the use of ADT. The authors conducted a computer-assisted search of the PubMed database using the keywords “prostate cancer,” “bone metastases,” “androgen deprivation therapy,” “skeletal complications,” and “bisphosphonates,” identifying relevant articles. Citations from other papers were also selected for the review.

	The review begins by discussing the pathophysiology of bone metastases, bone complications induced by ADT in patients with advanced prostate cancer, and the clinical manifestations and diagnosis of skeletal metastases. It then focuses on targeting bone metastases, discussing bisphosphonates, denosumab, and bone-seeking radiopharmaceuticals. The following sections of the article discuss the roles of radiation and chemotherapy in this setting, and a look at new drug development. The final section covers the prevention of ADT-related bone complications. The authors concluded the review by stating that although no therapeutic modality has demonstrated significant improvement in overall survival, a number of new treatments have shown palliative improvements and the ability to prevent major bone complications. They emphasize that physicians must evaluate the risk of bone metastases in each patient and follow disease progression carefully in order to detect and treat metastatic disease to the bone early in patients with prostate cancer.

Single-fraction compared with multiple-fraction therapy in treating patients with previously irradiated painful bone metastases

	ClinicalTrials.gov Identifier:  NCT00080912

	Purpose:  This randomized, multicenter phase III trial is testing to determine whether single-fraction radiation therapy is as effective as multiple-fraction radiation therapy in treating patients with previously irradiated painful bone metastases. The primary measure of the study will be the pain relief experienced by patients undergoing single-fraction versus multiple-fraction re-irradiation at 2 months after treatment. Secondary measures include overall pain relief, time to pain progression, the correlation of initial irradiation response with pain relief after re-

	irradiation, changes in functional interference, quality of life, characteristics of nonresponders, the incidence of acute severe radiation-related side effects, and the incidence of in-field pathological fractures and spinal cord compression.

Useful Online Resources and Clinical Trials for Bone Metastases

Net Guides: Bone Metastases

	Mind-body methods are increasingly being used in cancer treatment, as patients are supplementing standard care with integrative therapies. (Be sure to check out the article “Integrative Medicine and Cancer Treatment” on page 46.) Evidence increasingly suggests that holistic treatment programs help improve patients’ overall quality of life in patients with cancer. 

	In this regard, exercise has been acknowledged as an important component of cancer care during and after treatment to promote health and well-being. As an excellent source of exercise and lifestyle management, yoga can be a rich and powerful addition to cancer care. In the past few years, research using yoga and yoga therapy as interventions in patients with cancer has emerged. 

	The practice of yoga can be traced back thousands of years to its origins in ancient India. Yoga is traditionally recognized for its physical practice (asana), breathing practices (pranyama), and meditation (dhyana). These practices are most often researched and undertaken to promote health. 

	Patients may come to you and other healthcare practitioners asking about yoga, its safety and efficacy, and if yoga practice is right for them. However, unless you are a yoga practitioner yourself, you may not be able to discuss the full scope of a yoga lifestyle with your patients.

	To help oncology nurses understand yoga as a lifestyle, apply the current evidence supporting yoga in cancer care, and demonstrate how to practice yoga, I am launching a new blog on OncLive Nursing’s flagship Website, OncLive (

). The blog will be called Yoga for Cancer Care and will replace the Fitness Forum column in 2011. Learning and living yoga will help you become informed about this practice and how it can be used to help your patients. The blog will guide you to obtain the knowledge and skills you need to direct your patients in their yoga journey.

	Yoga for Cancer Care will contain both written text and short 2- to 3-minute videos that discuss and demonstrate aspects of yoga practice. Posts on the blog will facilitate dialogue and discussion among oncology nurses, patients, and researchers. 

	I am honored and blessed to have had the opportunity to author the Fitness Forum column and hope that oncology nurses found it to be beneficial in their practice. 

	Moving forward, dedicating a blog with the singular focus of yoga will help oncology nurses, patients, and families throughout the world. Let us begin 2011 with an open mind and heart as we explore Yoga for Cancer Care. Namaste.

Fitness Forum

Mind-body methods are increasingly being used in cancer treatment, as patients are supplementing standard care with integrative therapies.

Yoga for Cancer Care

Eribulin Gains FDA Approval as Breast Cancer Treatment

	The FDA approved eribulin mesylate (Halaven), a microtubule inhibitor developed synthetically from a compound found in a sea sponge, in patients with metastatic breast cancer (MBC) who have already undergone at least 2 late-stage chemotherapy regimens. The approval was based on a study of 762 women with MBC in which median overall survival for patients receiving eribulin was 13.1 months versus 10.6 months for those receiving single-agent therapy. 

Denosumab Approved for Skeletal-Related Events 

	The FDA approved denosumab (XGEVA) for skeletal-related events in patients with bone metastases from solid tumors. The agency did not authorize denosumab for treatment of patients with multiple myeloma. Denosumab targets a protein known as RANK ligand that contributes to bone destruction in patients with cancer. 

Ipilimumab Decision Date Is Postponed Until March  

	According to manufacturer Bristol-Myers Squibb, the FDA has pushed its decision date on ipilimumab from December 25 to March 26. The agency determined more time is needed to review the biologics license application for the use of ipilimumab in pretreated advanced melanoma. 

FDA Approves Trastuzumab for HER2-Positive Gastric Cancer

	Based on positive data from the ToGA (Trastuzumab for Gastric Cancer) trial, the FDA has announced its approval of trastuzumab (Herceptin) for patients with HER2-positive metastatic gastric cancer or adenocarcinoma of the gastroesophageal junction. Trastuzumab is approved for concomitant use with a chemotherapy regimen combining cisplatin plus capecitabine (Xeloda) or 5-fluorouracil. It is the first targeted therapy cleared for use in patients with stomach cancer.

Updates

Eribulin, Denosumab, Ipilimumab, and trastuzumab

FDA Updates

	In October 2010, the Institute of Medicine (IOM) released its highly anticipated report, The Future of Nursing: Leading Change, Advancing Health (the complete report is accessible at 

). In a nutshell, it calls for new and expanded roles for nurses in a redesigned, patient-centered healthcare system. The report presents 4 key recommendations. 

	The first recommendation is that nurses practice to the full extent of their education and training. This doesn’t mean that nurses arbitrarily expand their scope of practice; what it means is that nurses should be able to fully use their knowledge and skills. State licensing laws determine a nurse’s scope of practice, and nurses must practice within this scope. Unfortunately, many nurses discover a disconnect between the skillset their education has equipped them with and what they’re authorized to do at their healthcare facility.   

	 Nursing education is the focus of the IOM’s second recommendation. The Institute proposes that nurses achieve higher levels of education and training through an improved education system that promotes seamless academic progression. This is music to the ears of nurses who want to advance their education but have encountered barriers. Nurses have told me that admission criteria varies and often there is little to no recognition of coursework already completed, especially for nurses returning to school several years after earning their nursing degree. 

	According to the IOM, the renewed focus on nursing education should promote a more diverse nursing workforce, particularly in the areas of gender and ethnicity. This last point is one that should be emphasized, since 94% of nurses are women. Unlike with flight attendants and teachers, in which both genders are represented, nursing remains a female-dominated profession. 

	The third IOM recommendation is that nurses should be partners with physicians and other healthcare professionals in redesigning healthcare in the United States. Nursing education programs must integrate leadership development, and leadership development opportunities must be available to nurses practicing at all levels. Nurses also need to take personal responsibility for their own professional growth by developing or strengthening leadership competencies and demonstrating those competencies across all care settings.

	The IOM’s final recommendation is that effective nursing workforce planning and health policy require better data collection and an improved information infrastructure. Workforce data must be collected and analyzed, and made publicly available. Reliable data will enable researchers to accurately predict future nursing workforce needs.

	As its suggestions demonstrate, the IOM recognizes that nurses represent the largest segment of the healthcare workforce and work on the frontline of patient care. Nurses can—and should&mdash;play a fundamental role in the transformation of healthcare. Unfortunately, not everybody agrees. The American College of Physicians (ACP) and American Medical Association (AMA) promptly released responses to the IOM report. Both organizations noted that although many of the recommendations are consistent with their positions, the IOM report also contains some elements that concern them. These include the role of nurses (especially advanced practice nurses) in providing primary care. The ACP asserts that internists are well suited to providing comprehensive care and that patients may be best served by internists or other physicians who work with a team of healthcare providers that may include advanced practice nurses. The ACP notes that advanced practice nursing cannot substitute for nor replace primary care medical practice. The AMA asserted that only physicians can lead healthcare teams because they are more educated than nurses. 

	So the turf war in healthcare continues. Unfortunately, this struggle is destined to focus less on what patients need and more on publicizing contentious disagreements. Thus, the IOM report is another step forward for the nursing profession, but the medical community’s response is a half step backward. Regardless, the patients themselves will ultimately decide who they want their healthcare providers to be. For my part, I’m hoping that they’ll choose well-educated nurses who practice to the full extent of their education and training.

Nurse's Notes

In October 2010, the Institute of Medicine (IOM) released its highly anticipated report, The Future of Nursing: Leading Change, Advancing Health

The Future of Nursing

Diagnosis and Treatment of Hepatocellular Carcinoma

	This 12-page PDF consists of an article from the journal Gastroenterology that reviews the diagnosis and treatment of liver cancer. It begins with a brief background of liver cancer before discussing the clinical features of and screening for the disease. It explores the available tests to use and which patient groups should be screened. Several images taken from an MRI accompany the information on diagnosing liver cancer. The focus moves to the importance of staging in making treatment decisions and lists several common staging systems for liver cancer. A proposed treatment algorithm is presented, with treatment modalities for the disease: surgical resection, liver transplantation, radiofrequency ablation, percutaneous ethanol injection, and transarterial chemoembolization. A table lists each modality, which patients each is appropriate for, and their average 1-, 3-, and 5-year survival rates. The article also summarizes additional treatment options and molecular therapies, such as angiogenesis inhibitors, growth-receptor signaling, and telomerase inhibition.

	The Liver Cancer Network is a Website presented by The Liver Program at Allegheny General Hospital, Pittsburgh, Pennsylvania. The Website is designed to educate patients about the liver and liver cancer, and features sections such as “How the Liver Works,” which explains the anatomy as well as the digestive and circulatory functions of the liver. “How Liver Cancer Develops” summarizes liver cancer and describes cancer in general, carcinogenesis, and cancer growth. Under “Diagnosis,” visitors can read about how liver cancer is staged and find descriptions of the various tests used to diagnose it. The “Treatments” section provides descriptions of various liver cancer treatments, such as surgery, transplantation, radiotherapy, chemotherapy, and more. The Liver Cancer Network also features a “Web Resources” section with links to other websites containing useful information on liver disease, general health, and related support groups

Obstructions of portal veins and tumor numbers are associated with humped hepatocellular carcinoma

 A tumor protrusion in HCC is a sign of increased risk of tumor rupture, which can lead to recurrences after curative treatment. The purpose of this study was to determine the characteristics of humped HCC clinically and radiologically associated with liver damage, tumor progression, and treatment. The

	179 patients with liver cancer  included in the study underwent angiographic examination. The areas of the tumors were measured using MRI and helical computed tomography.

	metastasis (TNM) stage was significantly different between the humped and non-humped HCC groups. Humped HCC was more common in the right lobe, and an analysis of recurrent HCC showed that patients with multiple treatments of more than 4 sessions more frequently had humped HCC than those with 1 to 3 sessions. Multivariate regression analysis showed that tumor invasion in the portal vein, rather than large tumor size, was significantly associated with tumor protrusion. The authors concluded that HCC recurrence with humped HCC is more common in patients with multiple treatments, and that tumor factors of the TNM classification—especially tumor invasion in the portal vein&mdash;may be associated with tumor protrusion in liver cancer.

AZD6244 in treating patients with locally advanced or metastatic liver cancer

	ClinicalTrials.gov Identifier: NCT00550719

	Purpose: This phase II study will be testing AZD6244, an inhibitor of the mitogen-activated protein kinase/extracellular signal-regulated kinase (MEK), in the treatment of locally advanced or metastatic liver cancer. Patients will receive a single dose of AZD6244 on day 1 of the study and, beginning 48 hours later, will receive oral AZD6244 twice daily until day 21. Patients will undergo frequent blood testing for pharmacokinetic sampling during the first 48 hours and on day 15; concentrations of AZD6244 in the blood are quantified by high performance liquid chromatography. Tumor biopsy is done at baseline and on day 8. Patients will receive AZD6244 on days 1—21 and the treatment repeats (in the absence of disease progression or unacceptable toxicity) every 21 days. The primary outcome measure of the study is the objective response rate.

Dasatinib in treating patients with advanced liver cancer that cannot be removed by surgery

	Purpose: Dasatinib (Sprycel) is a tyrosine kinase inhibitor that recently received accelerated approval from the FDA for the treatment of newly diagnosed adult patients with Philadelphia chromosome—positive chronic myeloid leukemia in chronic phase. This open-label, single group assignment phase II trial is testing the efficacy of dasatinib in treating patients with advanced liver tumors that cannot be taken out through surgery. The primary outcome measures are progression-free survival (PFS) and complete and partial response rates at 4 months. Secondary outcome measures include median PFS and overall survival, as well as toxicity and tolerability. Patients will be administered dasatinib orally twice daily for 28-day cycles. Follow-up will occur at 4 weeks and then every 3 to 6 months. The trial, which aims to accrue a total of 41 patients, is being conducted at multiple sites throughout the United States.

Useful Online Resources and Clinical Trials for Liver Cancer

Net Guides: Liver Cancer

	The Cancer of Unknown Primary (CUP) Foundation is a UK-based charity organization created to provide information and support to patients with CUP. The Website has 2 informational sections: “About CUP” and “Diagnosis and Treatment.” Patients can find information on basic cancer biology, a definition of CUP, cancer FAQs, what a primary is, a chart showing the typical steps of a patient’s battle with cancer, why the primary cannot be found, metastasis, and symptoms. The “Diagnosis and Treatment” pages explain general practitioner and hospital diagnoses, referrals, how patients can ask constructive questions and help doctors make the correct diagnosis, tests, disease classifications, and prognosis. Various treatments are described, such as chemotherapy, radiation therapy, hormone therapy, immunotherapy, and palliative/supportive care. For patients seeking support, the CUP Foundation offers a forum for people affected by CUP, a telephone service, and a section where patients and family members can post their stories.

Significance of serum tumor markers monitoring in carcinomas of unknown primary site

Pejcic´ I, Vrbic´ S, Filipovic´ S, et al

 The purpose of this study was to evaluate the prognostic and predictive value of 8 different serum tumor markers in patients with CUP. The study included 63 patients whose primary origin could not be determined using noninvasive methods. Histological findings were split into 3 classifications: planocellular carcinoma (8 patients), adenocarcinoma (33 patients), and unclassifiable carcinoma (22 patients). The 8 serum tumor markers evaluated in the study were: alpha-fetoproteins (AFP); chronic gonadotrophin beta submit, human (beta-HCG); neuron-specific enolase (NSE); marker of malignant ovarian tumors (CA 125); prostate-specific antigen (PSA); marker of malignant breast tumor (CA 15-3); marker of malignant pancreas tumor and gastrointestinal tumor (CA 19-9); and carcinoembryonic antigen (CEA). Thirty-two of the patients underwent chemotherapy and had the markers determined after the third and sixth chemocycles. Those who responded to chemotherapy had the markers determined every 3 months until relapse or disease progression. 

 NSE values were the most commonly elevated (82.54%), while AFP values were the least commonly elevated (11.11%). Average tumor marker values for NSE and CA 125 were significantly lower after chemotherapy, with significantly better survival in cases of more than 20% decrease in NSE and CA 125. The authors concluded that increased serum tumor markers are common in CUP, and that the tumors show nonspecific overexpression of tumor markers. They also concluded that NSE and CA 125 values showed a correlation with response to chemotherapy; however, they noted that commonly used serum tumor markers seem to show no prognostic or predictive value.

Treatment based on molecular profiling diagnosis carcinoma of unknown primary site

	Sponsor: Sarah Cannon Research Institute

	ClinicalTrials.gov Identifier: NCT00737243

	Purpose: This nonrandomized phase II study is testing the 92-gene RT-PCR molecular profiling assay in identifying the primary site in patients with CUP. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients who receive specific diagnoses from the assay will receive treatments that have proved effective for their respective diagnoses. Patients who do not receive specific diagnoses will be administered empiric chemotherapy with paclitaxel, carboplatin, bevacizumab, and erlotinib. The primary outcome measure of the study will be the utility of the 92-gene RT-PCR assay. The secondary measure will be the efficacy of treatments selected according to the assay’s diagnosis.

Carboplatin, paclitaxel, and everolimus in treating patients with previously untreated cancer of unknown primary

	Sponsor: North Central Cancer Treatment Group

 This phase II, interventional, open-label study is examining the efficacy of treatment with carboplatin, paclitaxel, and everolimus in patients with previously untreated cancer of unknown primary. The primary outcome measure for this clinical trial is response rate. Secondary outcome measures for the study include time to progression, overall survival, duration of response, time to treatment failure, and adverse events as assessed by NCI CTCAE v 4.0. Patients will be administered carboplatin IV and paclitaxel IV on day 1, and oral everolimus once daily on days 1, 8, and 15 every

	21 days until disease progression or unacceptable toxicity. Patient follow-up will occur every 3 months after treatment until disease progression, and then every 6 months for a maximum of 3 years. The study is taking place at 180 locations throughout the United States, and is being conducting in collaboration with the National Cancer Institute. 

Useful Online Resources and Clinical Trials for Carcinomas of Unknown Primary Origin

Net Guides: Carcinoma of Unknown Primary Orgin

	Monica Knoll is no stranger to cancer. Her sister is a breast cancer survivor and her father died from esophageal cancer. Still, she was not prepared for a breast cancer diagnosis in 2000. 

	“When I was diagnosed, I was at a loss for what to do. Once I heard the words ‘you have cancer,’ I felt like I was kicked in the stomach,” she told attendees at the Second Annual NCONN Conference. “I called my nurse ‘Sarge’ because she pushed me around and really told me what to do, which I needed because I was very much in denial.”

	Now 10 years later, Knoll is a 4-time cancer survivor with a mission. “Before my cancer, I think I was lost. I didn’t really have a passion for a career. I didn’t really have a big motivating factor in my life,” she said. “Once I started talking with other breast cancer patients, I found we were overwhelmed by the process. There are so many resources we didn’t know where to begin.”

	“Navigation was not even a word that was used when I was diagnosed. So many nurses didn’t have the tools they needed to provide for patients. Great resources existed, but there wasn’t a great way to disseminate them,” she said.

	Knoll wanted a way for cancer patients to get these necessary resources. “One of the components with cancer is getting organized. I felt that was missing in the cancer world because when I was diagnosed, there was no way of getting resources organized.”

	Taking her experiences and those of other patients with breast cancer and survivors, Knoll founded the nonprofit organization CANCER101—an information resource for cancer patients&mdash;in 2002. According to CANCER101’s Website, its mission is “to empower cancer patients and their caregivers to take control over their diagnoses from the moment they learn they have cancer, a recurrence, or metastases through 10 years of follow-up care. Having a plan of attack, the means to stay organized, and access to appropriate resources and information is half the battle to getting through a cancer diagnosis.” 

		Empower patients and caregivers to get organized and informed to fight their cancer

		Help healthcare professionals better manage their patients’ needs

		Educate patients about clinical trials and how to find them

		Ensure patients receive CANCER101’s resources when they need them most: when they learn they have cancer

		Provide complementary wellness support to help patients manage their side effects and emotional well-being

		Provide a unique social media and video campaign that offers nonmedical advice for patients, caregivers, medical professionals, and survivors

		Encourage survivors to educate family and friends about early detection and prevention

	Knoll, who serves as the organization’s executive director, explained that the program has a three-fold strategy. 

	The organization provides free CANCER101 Planners to participating National Cancer Institute (NCI) and Association of Community Cancer Centers across the country. Following the first appointment with an oncology specialist, patients receive Planners that include national resources, important questions to ask their healthcare team, a glossary of medical terminology, a section for tracking medical bills, insurance information, and more. The Planners also include information provided by NCI, the American Society of Clinical Oncology, and the Coalition of Cancer Cooperative Groups (CCCG). CANCER101 also partnered with NCI to develop cancer-specific information for patients with each tumor type.

	The Planner is designed as a tool to help nurse navigators manage their patients’ medical needs. “If the nurse navigator organizes the patient, the patient will be more likely to partner and take ownership of their health. If the patient takes ownership, they will allow the nurse navigator to help more patients,” explained Knoll.

	She recommended that nurse navigators put the Planners together in advance and include additional cancer information and an NCI booklet inside the folder. Nurse navigators also should ensure patients know how to use the Planner, encourage patients to use the Planner and take it with them to all appointments, and check periodically that patients are filling out the Planner correctly.

) complements the Planner. It offers a live calendar of national teleconferences, Webinars, annual conferences, and retreats. Many of the same resources found in the CANCER101 Planner are available on the Website. An online version of the Planner and a smartphone application are under development.

	In addition to CANCER101 resources, the Website provides external links to numerous cancer resources. When you click “National Cancer Resources” under “Get Informed” on the home page, you reach a CANCER101-compiled list of available Web resources covering a variety of cancer topics. Some of the specific topics include advocacy, drug information, employment issues, fertility, and financial help.

	Another valuable tool the site provides is the “Learn From Our Partners” section, which hosts cancer resources furnished by CANCER101’s strategic partners. The Profiler Tool provided by Nexcura helps patients make informed treatment decisions by giving them access to the latest clinical research relevant to their diagnosis. The CCCG “What Is a Clinical Trial” section offers a Q&A of pertinent clinical trial topics to help patients who are weighing participation in the research programs. The “Questions to Ask Your Doctor” page by Cancer.net facilitates open communication between patients and doctors, which will empower patients as they make crucial treatment decisions.   

	CANCER101 has launched a social media campaign that offers patients, caregivers, survivors, and healthcare professionals nonmedical advice to help make their lives easier using Facebook and Twitter.

	In concluding her presentation, Knoll stressed that CANCER101 and healthcare professionals are a team. “We look at you [nurses] as our customers. We provide these resources to you as well as the patients and want your feedback.”

Nurse Navigators

Monica Knoll is no stranger to cancer. Her sister is a breast cancer survivor and her father died from esophageal cancer. Still, she was not prepared for a breast cancer diagnosis in 2000

Tools to Help Patients Navigate Their Treatment Path

	The John Theurer Cancer Center (JTCC) at Hackensack University Medical Center in New Jersey, one of the largest cancer centers in the United States, recently opened a new $130-million, 155,000-square-foot comprehensive cancer facility. “This new facility will help us build on our promise to deliver extraordinary care by providing patients with an unparalleled experience through innovative approaches in comfortable surroundings,” said Andrew L. Pecora, MD, FACP, CPE, chief innovations officer and professor and vice president of cancer services, JTCC.

The John Theurer Cancer Center (JTCC) at Hackensack University Medical Center in New Jersey, one of the largest cancer centers in the United States

John Theurer Cancer Center Opens New Comprehensive Facility

	Older patients with cancer taking bisphosphonates for bone metastases are at modestly increased risk for atrial fibrillation and stroke. According to a study published online in the 

, the absolute risk for these patients within 6 years of starting bisphosphonate treatment was approximately 8% for all supraventricular tachycardia events and 4% for stroke. 

Older patients with cancer taking bisphosphonates for bone metastases are at modestly increased risk

Bone Loss Drugs Increase Stroke Risk in Patients With Cancer

	Hospitals, pharmacists, and physicians across the United States are reporting shortages of critical anticancer drugs. The FDA Website confirms that growing demand and manufacturing problems have resulted in an insufficient supply of common chemotherapy agents, including carboplatin, cisplatin, dacarbazine, fludarabine, and cytarabine.

	The American Society of Clinical Oncology (ASCO) recently warned that the “oncology community is experiencing severe and worsening shortages of many critical therapies.” According to ASCO, doxorubicin, leucovorin, etoposide, nitrogen mustard, and vincristine are also in short supply. In a statement, ASCO president-elect Michael P. Link, MD, a pediatric oncologist, said these shortages have caused treatment delays for patients and hampered drug development research. Supplies of drugs used to mitigate treatment-related adverse effects or cancer pain are also insufficient to meet demand. The American Society of Health System Pharmacists (ASHP) added several supportive care agents to its drug shortage list in November, such as epoetin alfa, granisetron hydrochloride

	injection, propofal, and morphine. To address the growing concern about the widespread drug shortages, which extend well beyond oncology, ASCO, ASHP, the American Society of Anesthesiologists, and the Institute for Safe Medication Practice (ISMP) convened a Drug Shortages Summit in early November. They invited representatives of health professional organizations, along with pharmaceutical manufacturers and suppliers, to discuss the issue. Recommendations that emerged from the summit include having the pharmaceutical supply chain notify providers sooner of impending shortages; giving drug manufacturers and the FDA more leeway in finding ways to deal with a drug shortage, such as extending a drug’s expiration date; and updating the definition of a “medically necessary” therapeutic, triggering more rapid

	reporting of an impending shortage to the FDA. Most of the shortages are for drugs that are no longer patent protected.In published statements and interviews, representatives from the FDA have ascribed the lack of profitability for these generic drugs as the underlying cause of the shortages. Valerie Jensen, an associate director with the FDA’s drug shortage program, told MSNBC in October that manufacturing problems account for 40% of the shortages, 20% are due to production delays, and 20% have occurred because a manufacturer has stopped making the drug.

Hospitals, pharmacists, and physicians across the United States are reporting shortages of critical anticancer drugs, including carboplatin, cisplatin, dacarbazine, fludarabine, and cytarabine.

Oncology Community Facing Severe Drug Shortages

Clinical Practice Guidelines for Head and Neck Cancer 

	This 116-page PDF document contains the latest version of the National Comprehensive Cancer Network clinical practice guidelines for all head and neck cancers. Tumor and cancer types covered in these guidelines include: ethmoid sinus, maxillary sinus, and salivary gland tumors; cancers of the lip, oral activity, oropharynx, hypopharynx, glottix larynx, and nasopharynx; occult primary cancer; unresectable head and neck cancer; and recurrent head and neck cancer. The guidelines also discuss a multidisciplinary team approach, support modalities, radiation techniques, and the principles of systemic therapy. Each type of cancer features several pages of branching charts that begin with a description of standard workup, split into different clinical stages, and link to different treatment charts to follow for each specific clinical stage of the disease, with both primary and adjuvant treatments presented. In-depth explanations of the diseases and associated treatments can be found in the “Discussion” section toward the end of the document.

	The Oral Cancer Foundation (OCF) is a nonprofit organization dedicated to fighting oral cancer through prevention, research, advocacy, education, and patient support. The OCF Website provides up-to-date oral cancer news and information, including articles on disease statistics, diagnosis, treatment, restoration and rehabilitation, dental issues, emotional aspects, and how the disease is connected to tobacco and the human papillomavirus. In the “People” section, patients can read about historical and current celebrities, athletes, and politicians who were diagnosed with oral cancer. Under “Products,” patients can find lists of recommended publications and oral care products, as well as links to where they can be purchased. The OCF Website also has a multimedia library of podcasts and videos, a list of other online resources, and a patient/survivor forum.

	According to the National Cancer Institute (NCI), more than 21,000 men and 9000 women are diagnosed with oral cancer each year, most of whom are >60 years of age. Oral cancers develop in the oral cavity or oropharynx (the part of the throat at the back of the mouth). The NCI offers a comprehensive, printable online booklet, What You Need to Know About Oral Cancer. The literature is highly useful for patients and nurses. The vast list of oral cancer topics covered in the booklet includes Risk Factors, Symptoms, Treatment, Second Opinion, Nutrition, Reconstruction, Rehabilitation, Follow-up Care, Sources of Support, and Taking Part in Cancer Research. To help healthcare professionals and patients understand the content, the booklet includes illustrated diagrams of the cancer areas and a glossary of terms. The booklet also includes a list of questions patients can ask their doctors. To order a hardcopy of the booklet directly from the NCI, call (800) 422-6237. 

	Survival and quality of life of patients with oral and oropharyngeal cancer at 1-year follow-up of tumor resection

 This study’s goal was to evaluate changes in the survival and quality of life of patients who underwent surgical excision of oral and oropharyngeal squamous cell carcinoma. The study included 47 patients who were treated between 2006 and 2007 at a Brazilian healthcare unit that specialized in head and neck surgery. The authors of the study reviewed hospital files and administered the University of Washington Quality of Life questionnaire prior to and 1 year following surgery. 

 One year after surgery, 7 patients had dropped out of the cohort, 15 had died, and 25 completed the questionnaire again. The study found that the risk of death was associated with having regional metastasis before undergoing surgery and tumor size of T3 or T4. The survivors presented with significantly lower overall and domain-specific ratings of quality of life, the largest reduction being chewing (74.0 before surgery and 34.0 after 1 year), and the only increase being anxiety (from 36.0 to 70.7). The authors concluded that this study may contribute to the  development of interventions designed to reduce functional limitations in patients treated for oral and oropharyngeal cancer.

	Age/Sex Requirements: 18-85 years (None)

	Sponsor:  Department of Veterans Affairs

	ClinicalTrials.gov Identifier:  NCT00953849

 This phase II study will be testing an immunotherapeutic approach for the treatment of oral cancer. The treatment consists of the COX-2 inhibitor celecoxib and vitamin D given for 3 weeks between diagnosis and surgical treatment. The theory behind the study is that the treatment will lessen the immune inhibitory environment and mature cells that can stimulate T-cell reactivity against oral cancer cells. The study has

	4 arms: vitamin D alone, celecoxib alone,  vitamin D with celecoxib, and no intervention. The primary outcome measure of the study will be increased dendritic cell levels and T-cell activity.

Useful Online Resources and Clinical Trials for Oral Cancer

December 2010