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SOUTH SAN FRANCISCO, California—Hana Biosciences has received FDA clearance for its Investigational New Drug Application for Zensana (ondansetron oral spray) to prevent chemotherapy-induced nausea and vomiting. In a press release, Hana said it is initiating a series of pivotal pharmacokinetic trials, including comparison of Zensana with ondansetron tablets (Zofran). Zensana is the first multidose oral spray 5-HT3 antagonist. Patients experiencing nausea and vomiting have difficulty swallowing and holding down pills. Zensana delivers full doses of ondansetron. In addition, drug delivery via a spray to the oral mucosa avoids degradation in the gastrointestinal tract and metabolism by liver enzymes.

The myriad changes that oncology physicians have experienced in the last 20 years are certainly applicable to oncology nurses, in particular, the technology explosion and its effects on diagnosis, treatment, and survivorship; the emergence of cancer as a disease of the elderly; challenges posed by shortages of health care workers; and the fact that almost all cancer patients today are treated as outpatients. Recent therapeutic innovations and management approaches have been keenly felt by oncology nurses, who typically play a major role in patient education.

A 1999 Institute of Medicine (IOM) report, "Ensuring Quality Cancer Care," suggested that many cancer patients in the United States are not receiving the care known to be effective for their disease. The IOM committee recommended a number of remedial steps including the development of a national quality care monitoring system. CC&E spoke with Eric C. Schneider, MD, assistant professor of health policy and management, Harvard School of Public Health, and assistant professor of medicine, Harvard Medical School, about, among other things, the ongoing initiatives to link quality care performance measures to the delivery and reimbursement of oncology services.

On the weekend before Hurricane Katrina struck, Gabriela Ballester, MD, was the hematology/oncology fellow on call for LSU patients at University Hospital (part of the Medical Center of Louisiana at New Orleans, along with Charity Hospital). She shared her story in a telephone interview with ONI.

DENVER-Dose escalation of high dose rate (HDR) brachytherapy may improve long-term survival in men with intermediate- or high-risk prostate cancer, according to findings of a study presented at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology (abstract 63).

Several developments in the past few years have incrementally progressedthe field and provided additional insights into the managementof advanced colorectal cancer. This review discusses the componentsof current cytotoxic chemotherapy regimens for advanced colorectalcancer: fluorouracil (5-FU), capecitabine (Xeloda), irinotecan(Camptosar), and oxaliplatin (Eloxatin). The equivalence of severalfront-line regimens has provided opportunities for increased tailoringof therapies for individual patients. Preliminary data onpharmacogenomics provides hope that we will be able to better matchpatients with regimens and doses on the basis of individualized predictionsof toxicity and response. The importance of second-line therapyin overall survival has again been highlighted; the best outcomes haveoccurred in patients treated with 5-FU, oxaliplatin, and irinotecan incombination with targeted therapies during the course of their disease.Elderly patients are no exception to this finding. Combination regimensand second-line therapy should be offered to elderly patients whohave adequate performance status and no contraindicated comorbidconditions, without regard for their chronological age.

Colorectal cancer is a worldwide public health problem, with nearly 800,000new cases diagnosed each year resulting in approximately 500,000deaths. In the United States, it is the second leading cause of cancer mortality,and nearly 60,000 deaths will be attributed to this disease in 2005. Whendiagnosed as advanced, metastatic disease, colorectal cancer is traditionally associatedwith a poor prognosis, with 5-year survival rates in the range of 5% to 8%. Thissurvival rate has remained unchanged over the past 35 to 40 years. However, duringthe past 5 years, significant advances have been made in treatment options so thatimprovements in 2-year survival are now being reported, with median survival ratesin the 21- to 24-month range in patients with metastatic disease.

WASHINGTON-Older cancer patients who received the colony-stimulating factor (CSF) pegfilgrastim (Neulasta) during each cycle of chemotherapy, including the first, had significantly less febrile neutropenia than patients who received it only after the first cycle, according to the results of a large, community-based clinical trial. Those receiving the drug in the first cycle also had fewer hospitalizations and other neutropenia-related complications, said Lodovico Balducci, MD, head of the senior adult oncology program at H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Dr. Balducci reported the findings at the Geriatric Oncology Consortium annual meeting (abstract 3).

Kauh and colleagues nicely outlinethe major problems facingclinicians who treat humanimmunodeficiency virus (HIV)-positivepatients with squamous cell carcinomaof the anus. This is a highly curabledisease with combined-modality therapy,though the HIV-positive populationpresents unique challenges. Weagree with the approaches outlined bythe authors and would also like to emphasizeseveral principles in the managementof anal cancer.

Squamous cell anal cancer remains an uncommon entity; however,the incidence appears to be increasing in at-risk populations, especiallythose infected with human papillomavirus (HPV) and human immunodeficiencyvirus (HIV). Given the ability to cure this cancer using synchronouschemoradiotherapy, management practices of this disease arecritical. This article considers treatment strategies for HIV-positive patientswith anal cancer, including the impact on chemoradiation-inducedtoxicities and the role of highly active antiretroviral therapy in the treatmentof this patient population. The standard treatment has beenfluorouracil (5-FU) and mitomycin (or cisplatin) as chemotherapy agentsplus radiation. Consideration to modifying the standard treatment regimeis based on the fact that patients with HIV tend to experience greatertoxicity, especially when CD4 counts are below 200; these patients alsorequire longer treatment breaks. Additional changes to the chemotherapydosing, such as giving 5-FU continuously and decreasing mitomycin dose,are evaluated and considered in relation to radiation field sizes in an effortto reduce toxicity, maintain local tumor control, and limit need forcolostomy. The opportunity for decreasing the radiation field size andusing intensity-modulated radiation therapy (IMRT) is also considered,particularly in light of the fact that IMRT provides dose-sparing whilemaximizing target volume dose to involved areas. The impact of the immunesystem in patients with HIV and squamous cell carcinoma of theanus and the associated response to therapy remains unknown. Continuedstudies and phase III trials will be needed to test new treatment strategiesin HIV-infected patients with squamous cell cancer of the anus todetermine which treatment protocols provide the greatest benefits.

The article by Kauh and colleaguesprovides a timely reviewof the therapeutic approachto invasive carcinoma of theanus in human immunodeficiency virus(HIV)-infected patients, which isan emerging clinical problem. Importantlimitations of the published experience,however, need to be pointedout; given the present pursuit of moretargeted anticancer therapy, new avenuesare being explored, even in themanagement of HIV-associated analcancer.

Tremendous gains have been made regarding the treatment of breastcancer. The combination of chemotherapy, radiation therapy, and surgeryhave vastly improved patient course. Hepatic manifestations ofmetastatic breast cancer are extremely difficult to treat. Traditionally,chemotherapy and hormonal treatment of hepatic metastases of breastcarcinoma have not significantly improved survival. For patients withbreast cancer metastases isolated to the liver, operative treatment isincreasingly being used to prolong life and disease-free intervals. Thisarticle reviews the use of surgery for treatment of isolated breast cancermetastases to the liver.

The patient is a 74-year-old gentleman who presented with a visual disturbance and right shoulder pain. On routine chest x-ray, he was found to have a right apical lung mass.

Drs. Winell and Roth provide agood overview of the commonpsychiatric disorders andcancer-related symptoms in elderly individualswith cancer. Because of thelarge and growing percentage of cancerpatients who are over age 65, theauthors duly highlight the importanceof this topic. The article is highly relevantto the clinical practice of oncologyand detailed information is includedto help guide treatment options formajor depression, anxiety, delirium,and other cancer-related symptoms.

Even now, cancer is a disease ofaging; the average age of a newlydiagnosed cancer patient inthe United States is greater than 65years. Safe and effective medical carefor the elderly will become an increasinglyimportant issue as our populationages over the next severaldecades. By 2025, 20% of the USpopulation will be over the age of 65.It will be essential for physicians tobe well versed in assessing and treatingpatients in this age group in a mannerappropriate to their unique medicalneeds. As the population ages, and bettertreatment for other diseases contributesto longer life expectancy, theassessment and treatment of cancer inthe elderly will be an increasingly commonproblem for oncologists.

The review by Beth Peshkin andClaudine Isaacs in this issue ofONCOLOGY is an excellentoverview of the recognition, evaluation,and clinical management ofwomen with BRCA1 and BRCA2mutations. It is comprehensive andpractical, and emphasizes the approachthat a risk assessment and clinicalgenetics program might take tothe evaluation of an individual concernedabout the possibility thathereditary breast/ovarian cancer predispositionmight be present in herkindred. The authors clearly and conciselypresent the risks of breast, ovarian,and other cancers associated withBRCA1 and BRCA2 mutation carrierstatus, as well as some of the issues thathave arisen in the estimation of thoserisks. They provide a review of factorsthat may modify gene penetrance(cancer risks), and devote the finalsegment of their article to a clear andrational discussion of the surveillanceand preventive options available forthe management of the associatedbreast and ovarian cancer risks.

Assessing outcome after ablation is difficult because few studies with good long-term followup have evaluated local recurrence, disease-free survival, and overall survival after ablation. This and other limitations make it difficult to draw meaningful conclusions.

The number of older adults in the general population continues togrow. As their numbers rise, the elderly and the management of theirmedical problems must be of increasing concern for health-care professionals.Within this older population, cancer is a leading cause ofmorbidity and mortality. Although many studies have looked at the psychiatricimplications of cancer in the general population, few studiestackle the issues that may face the older adult with cancer. This articlefocuses on the detection and treatment of depression, anxiety, fatigue,pain, delirium, and dementia in the elderly cancer patient.

In this issue of ONCOLOGY,Winell and Roth review the veryimportant topic of assessment andtreatment of psychiatric symptoms inelderly cancer patients. Their reviewis comprehensive and practical. Thiscommentary further develops a numberof themes raised in their article.

In their article, Drs. Michener andBelinson make the case for treatingrecurrent ovarian cancer as achronic disease, with limiting morbidityand providing palliation of symptomstheir major goals. A review ofrecent literature would support their contention and management strategy.The cure rate for patients with recurrentovarian cancer is < 5%, and theaverage patient in the United Statesreceives more than five separate regimensof chemotherapy for recurrentdisease. Previous attempts at aggressivetreatment for recurrent disease haveshown, at best, very modest benefitwith significant expense and morbidity.What we are left with is a strategy oftrying to determine which patients maybenefit from aggressive salvage therapyand which are better managed witha chronic palliative attempt.

Despite major advances in cancerbiology and therapeutics,cancer and its treatment continueto cause devastating suffering,not only for the more than half a millionpatients who will die this yearfrom cancer, but also for many ofthose who will be successfully treated.[1] Symptom burden has a profoundimpact on the quality of life ofcancer patients across all stages of disease.Routine screening of ambulatorycancer patients identifies an average of7 to 10 distressing physical and psychologicalsymptoms per patient.[2]Even patients with a good performancestatus have a median of nine or moresymptoms.[3,4] Not surprisingly, theseverity and burden of symptoms nearthe end of life is even greater.[4]

Twenty years of research in controlling symptoms such as pain andnausea have shown persistent suboptimal performance by the US oncologysystem. The data suggest that some of the tools of palliative careprograms can improve physical symptoms of seriously ill patients at acost society can afford. To fix these problems will require recognitionof the symptoms or concerns, a system such as an algorithm or careplan for addressing each, measurement of the change, and accountabilityfor the change. Symptom assessment scales such as the EdmontonSymptom Assessment Scale or Rotterdam Symptom Check List work tomake symptoms manifest. Listing symptoms on a problem list is a necessarystep in addressing them. Physical symptoms such as pain can beimproved by use of computer prompts, algorithms, dedicated staff time,team management, or combinations of these strategies. Less concreteproblems such as medically appropriate goal-setting, integrating palliativecare into anticancer care sooner, and informing patients aboutthe benefits and risks of chemotherapy near the end of life require morecomplex solutions. We review what is known about symptom control inoncology, how and why some programs do better, and make suggestionsfor practice. Finally, we suggest a practical plan for using symptomassessment scales, listing the problems, and managing them accordingto algorithms or other predetermined plans.

This supplement to Oncology News International includes more than 15 reportson presentations made at the 41st annual meeting of the American Society of Clinical Oncology.Reviews focus on the use of targeted agents in non–small-cell lung cancer and other solid tumors,evaluating the novel therapies bevacizumab, cetuximab, bortezomib, erlotinib, and gefitinib, aloneand/or in combination with other chemotherapy agents. Continuing medical education credit isavailable by completing a post-test and evaluation online at www.cancernetwork.com/cme.

HOUSTON, TEXAS-Preliminarydata from a phase II study ofoxaliplatin (Eloxatin) and capecitabine(Xeloda) in patients with unresectablegallbladder and biliary tract cancersshow a response rate of 18% in

ORLANDO-XELOX (capecitabine[Xeloda] and oxaliplatin [Eloxatin])is effective and well tolerated asfirst-line treatment for elderly patients

ORLANDO - Combined immunochemotherapy results in superior remission rates and overall survival in recurrent follicular and mantle cell lymphoma, and providing rituximab (Rituxan) maintenance therapy prolongs duration of response, according to new findings presented by Martin Dreyling, MD, PhD, at the American Society of Clinical Oncology 41st Annual Meeting (abstract 6527 and abstract 6528). "Combined immunotherapy resulted in superior remission rates and survival rates," said Dr. Dreyling, of the University of Munich, Germany. "To the best of my knowledge, this is the first study that proves that on a solid base of data."

The two-part article, "ThromboembolicComplications ofMalignancy," by Drs. Linenbergerand Wittkowsky, provides a contemporaryand clear review of thepathogenesis, prevention, and treatmentof cancer-associated hypercoagulabilityand venous thrombosis. Questionsabout the cancer and coagulation connectioncontinue to abound and greatlyoutnumber evidence-based answers. Asthe relationship between cancer and coagulationgains attention from the medicaland surgical oncology communities(ie, not only from the coagulation community),the gap between questions andanswers will likely close.

The dosing of chemotherapy is,at best, an imperfect science.Long-standing convention hasus calculating body surface area totwo decimal places-a largely discreditedand unnecessary exercise-yet wehave so far failed to learn how to incorporatepotentially important variablesrelated to race, sex, and pharmacogenetics.This review, “ChemotherapyDosing in the Setting of Liver Dysfunction,”by Eklund et al highlightsanother limitation in our understandingof how to use chemotherapy: There islittle known about how to dose drugs inpatients with anything other than normalorgan function.

Advances in cancer treatmentover the past 50 years havecured or prolonged the life expectancyof many patients with cancer.These advances have accelerated overthe past 2 decades. Increasingly, physicianswho manage patients with cancerare turning their attention to the managementof the complications of malignancy,since these complications areoften avoidable, can shorten life spans,and can reduce quality of life.

Thromboembolism affects many patients with solid tumors and clonalhematologic malignancies. Thromboprophylaxis with low-molecularweightheparin (LMWH) is indicated for surgery and other high-risksituations, but not routinely for central venous catheters or nonsurgical,ambulatory management. Thrombotic events require full anticoagulationfor the duration of active disease and/or the prothromboticstimulus. LMWHs are safe and more effective than both unfractionatedheparin for initial therapy and warfarin for secondary prevention. Antiinflammatoryand antiangiogenic properties might account for thisadvantage and for a survival benefit of chronic LMWH in subgroupsof cancer patients. Ongoing studies are characterizing the cost-effectivenessand antitumor mechanisms of LMWHs, the potential utility ofnewer anticoagulants, and the ability of predictive models to identifyhigh-risk candidates for thromboprophylaxis.