Showing papers in "Journal of Oncology Practice in 2008"

Chemotherapy dosing strategies in the obese, elderly, and thin patient: results of a nationwide survey.

Abstract: Purpose Determining the optimal starting dose of chemotherapy (CHT) presents a considerable challenge when using body-surface area (BSA)–based dosing, particularly in obese, elderly, or thin patients. We sought to document the range of approaches employed when administering CHT to these patients. Methods A questionnaire was developed by a panel of oncologists and mailed to all members of the Medical Oncology Group of Australia. Results From 315 oncologists, 188 responded (response rate 59.7%). BSA-based dosing is standard practice for 176 (97.2%) of the responding oncologists. In the adjuvant disease setting, 23 (12.7%) use ideal rather than actual body weight (BW) to calculate BSA, or choose whichever is less. When treating obese patients, only 6.1% of respondents routinely use actual BW. Of the remainder, 69.5% either cap the dose at 2 m2 or use ideal BW. In underweight patients, 95% (n = 171) routinely calculate BSA using actual BW. Forty one respondents (22.7%) routinely reduce dose in the fit elderly...

Barriers to enrollment of elderly adults in early-phase cancer clinical trials.

Abstract: Potential strategies to overcome barriers to enrollment of seniors into early-phase trials.

Principles of Safe Practice Using an Oncology EHR System for Chemotherapy Ordering, Preparation, and Administration, Part 1 of 2.

Abstract: An outline of broad principles that should be considered when integrating an electronic health record, and in particular, a chemotherapy ordering module, into practice.

Communication at the End of Life

Abstract: Experienced oncologists know that good communication is therapeutic for patients and families and is a fundamental ingredient of what we have come to appreciate as ‘quality care.’ Seriously ill patients and their loved ones have repeatedly identified the importance of various elements of good care such as trust in physicians, avoidance of unwanted life support, and respect for individual choices. Unfortunately, there are many examples of how physicians fall short of meeting the needs of patients and families. We are typically absent at the bedside at the time of death and may sadly be out of touch with the family if end-of-life care is delivered in the home, at a chronic care hospital, or at an inpatient hospice. In some cases, we may be unaware that a patient died and wonder why he or she did not show up for a routine appointment. The causes are not mysterious: a simple miscommunication between the nurses working in the community, the primary care physician, and multiple specialists, or an incomplete sign-out after a planned absence from the office.

6-STEPPPs: A Modular Tool to Facilitate Clinician Participation in Fair Decisions for Funding New Cancer Drugs

Abstract: Purpose: To design a tool to assist clinician participation with cancer drug funding decisions. Public policy-makers and insurers are struggling with funding decisions regarding increasingly expensive new cancer drugs. Increasingly, oncologists are contributing to the process of review that leads to such decisions. We were asked to design a system for ranking new cancer drugs for priority-based funding decisions. Methods: The “Accountability for Reasonableness” framework informed the design of a six-module multistakeholder decision process blending evidence-based traditional technology assessment methods with individual and cultural values elicitation. The tool was piloted in three settings: (1) videotaped simulated multistakeholder deliberation sessions; (2) clinical oncology leaders; and (3) a regional (Canadian provincial) pharmacy and therapeutics committee making formulary decisions. The modules involve: decision clarification, drug eligibility screening (filtering), clinical performance scoring index, cost modeling, data integration and values clarification, and process evaluation. Results: The tool was feasible to use, acceptable to participants, and able to rank candidate drugs. The pharmacy and therapeutics committee with whom it was tested used the tool as a part of their deliberations, and the tumor group leaders requested its incorporation into organization-based decision making. Conclusion: The decision tool can facilitate priority-based cancer drug funding decisions that meet the conditions of fairness as perceived by participants, including oncologists.

When Doctors and Patients Disagree About Medical Futility

Abstract: Factors that may help physicians determine when additional treatment is medically futile, and what physicians can do to encourage patients to explore more appropriate care options.

Ethical and Legal Implications of Cancer Genetic Testing: Do Physicians Have a Duty to Warn Patients' Relatives About Possible Genetic Risks?

Abstract: This vignette raises questions about the extent of physicians' obligations to warn relatives of a patient about a hereditary cancer risk.

Effect of Pretreatment Distress on Daily Fatigue After Chemotherapy for Breast Cancer

Abstract: Purpose Fatigue is one of the most frequently reported and adverse effects of cancer chemotherapy. The present study tested the hypothesis that women's levels of emotional distress at the time of their initial outpatient chemotherapy treatment would predict the severity of their postinfusion fatigue. Methods Sixty stage I (32.6%) and II (67.4%) patients with breast cancer (mean age, 44.5 years) who were receiving standard outpatient chemotherapy participated. The independent variable, emotional distress, was assessed for “last night,” “this morning,” and “right now” with a visual analog scale (0 to 100). The dependent variable, post-treatment fatigue (PTF), was assessed (0 to 100) over each of the subsequent 6 days using end-of-day diaries, which also included assessments of distress and nausea (0 to 100). For the statistical analyses, post-treatment fatigue was divided into three phases with means calculated for days 1 through 2 (phase 1), 3 to 4 (phase 2), and 5 to 6 (phase 3). Results Consistent with t...

Evaluation of Patient Navigation in a Community Radiation Oncology Center Involved in Disparities Studies: A Time-to-Completion-of-Treatment Study.

Abstract: PURPOSE: To evaluate whether data on length of time from patient referral to treatment completion, collected routinely as part of a quality improvement program, can be used to measure the effectiveness of a patient navigator program. PATIENTS AND METHODS: During a calendar year, 72 disparities patients, 38 of whom received navigator services, and a group of 157 nondisparate, un-navigated patients received external beam radiation therapy at a community center. Data from referral time through completion of treatment, which had been collected routinely under an existing continuous quality improvement program, were compared retrospectively, as well as missed treatments and the percentage of planned treatments completed, for three patient groups. RESULTS: The average number of days from referral to consult and from consult to start of treatment were lower for the navigated disparate group (6.66 and 14.56 days, respectively) than un-navigated groups (disparate: 7.37 and 15.97 days; non-disparate: 8.97 and 16.24 days, respectively). The percentage of patients completing treatment was lower for the navigated group (85%) than the un-navigated groups (95% and 97%), despite equivalent treatment percentage completion rates for all groups (97.0% to 98.8%). The navigated group missed more treatment days (1.86 days/patient) than the un-navigated disparate group (0.47 days/patient) or the non-disparate group (0.83 days/patient.) CONCLUSION: Some statistically insignificant differences were noted in favor of patient navigation (PN) but the significance is unclear because of the large data spread and the small numbers of patients. Given that the study was retrospective, it is also unclear whether these differences were influenced by the patient navigator. Repeat studies using the same data elements will provide a better platform for assessing whether such data can provide a measure of the effectiveness of PN in the radiation oncology setting. Given that the patients were not observed routinely by the navigator after the start of treatment unless a particular barrier was identified, there is an opportunity to assess whether interventions by the navigator could improve treatment completion rates and reduce the number of missed treatments.

Geriatric Oncology: Past, Present, Future

Abstract: Efforts to integrate geriatric oncology principles in the training of all medical oncologists are underway.

Chemotherapy treatments for metastatic colorectal cancer: is evidence-based medicine in practice?

Abstract: Treatment options for colorectal cancer have expanded to include multiple oxaliplatin- and irinotecan-based regimens and more biological/targeted therapies.

Office-based intraperitoneal chemotherapy for ovarian cancer.

Abstract: The challenges and opportunities when implementing an office-based intraperitoneal chemotherapy program.

Continued Regulatory Actions Affecting the Use of Erythropoiesis-Stimulating Agents

Abstract: The FDA sent a “Complete Response and Safety Labeling Change Order” to the sponsors of ESAs on July 30, ordering changes to ESA labels in three important ways. For the first time, the FDA used its statutory authority to order a sponsor to make revisions to a product label.

Informed Consent for Chemotherapy: ASCO Member Resources

Abstract: Consent to treatment is an important part of the delivery of quality cancer care. Physician practices that participate in ASCO’s Quality Oncology Practice Initiative (QOPI) and others expressed interest in having ASCO provide informed consent resources, and indicated that they would be more likely to use a consent form for chemotherapy if ASCO provided a template. Recent Journal of Oncology Practice articles outlining unique factors in consent for chemotherapy, documentation issues, and malpractice concerns also raised member interest. In response, members of ASCO’s Ethics and Quality of Care Committees formed a joint working group to design a consent form template and other resources that provide a framework for consent conversations between oncologists and patients receiving chemotherapy.

Reproductive Health Issues in Women With Cancer

Abstract: According to the American Cancer Society, approximately 679,000 women are newly diagnosed with cancer in the United States annually, and approximately 10% of these cancers occur in women of reproductive age, with 1 per 1,000 in pregnant women.1–3 To achieve the primary objective of cancer treatment—survival—reproductive health issues including fertility conservation, contraception, and pregnancy are often overlooked. However, these challenging issues are critical to providing a complete continuum of care for women with cancer. Although a growing body of literature addresses the issue of fertility preservation for reproductive-aged women with cancer, very little pertains to the other facets of reproductive health. In this article, we describe six cases that illustrate some of the challenges of caring for reproductive-aged cancer patients who become pregnant, desire child bearing, or desire effective contraception.

The 2007 National Practice Benchmark: Results of a National Survey of Oncology Practices

Abstract: Long-term trends in the cost of pharmaceutical goods purchased by community oncology practices seem to have dramatically changed in 2007, potentially ending an era of practice growth built on the economic engine of in-office chemotherapy provision.

Q and A: Magnetic Resonance Imaging in the Detection and Evaluation of Breast Cancer

Abstract: The experts invited to answer questions raised by the recent ACS guideline and studies offer a range of perspectives. Dr Kramer comments that the ACS guideline does not satisfy some of the most fundamental features of high-quality evidence-based guidelines. In particular, the ACS guideline does not explicitly explain how the evidence considered was assigned to categories of evidence. [Editor's note: Representatives from the ACS were invited to contribute to this article, but we had not received their responses by the time the article went to press]. Dr Kramer notes that none of the recommendations was based on data from a randomized clinical trial which, as many have argued, is the gold standard for demonstrating that a screening test reduces mortality.9 Current study designs also do not permit an estimate of the degree of overdiagnosis associated with breast MRI, because all women received both MRI and mammography. Relatively short randomized clinical trials using interval clinical cancers as the end point could address this issue.9 Both Drs Hortobagyi and Kramer underscore that overdiagnosis is a real possibility with MRI screening in the population addressed by the ACS guideline. Dr Hortobagyi ultimately supports use of MRI in high-risk women with the proviso that these women be made aware of the risk of false- positive findings and the consequences of those findings. In a recent systematic review of the literature, Lord et al10 stressed the need for the development of comprehensive risk prediction models to aid in the identification of women at high risk of breast cancer who would benefit the most from MRI screening. Dr Burstein echoes this call for careful attention to the benefits and risks of MRI screening, including the increased risk of biopsy for benign breast disease. He further encourages patients and clinicians to ensure that the MRI facility has sufficient experience with the technique before permitting a facility to perform this test. In evaluating patients with newly diagnosed breast cancer both Drs Morrow and Newman believe that routine MRI use is inappropriate and leads to unnecessary mastectomies. Although MRI detects cancer that is not evident clinically or by mammogram in 10% to 20% of patients, much of the disease found on MRI is controlled by standard postlumpectomy breast radiation. Even in patients with invasive lobular cancer, a subset often proposed to benefit from MRI, no different local recurrence rate is shown compared to patients with ductal cancer. Although contralateral disease is detected in 2% to 3% of patients undergoing bilateral mastectomy for a unilateral breast cancer, both Drs Morrow and Newman agree that MRI should not be used to determine whether contralateral mastectomy should be performed. It is not clear that newly diagnosed breast cancer patients will derive any survival benefit from treating a contralateral tumor detected by MRI but not evident clinically or mammographically. Dr Newman notes, however, that MRI may assist in management decision-making in selected cases, such as when mastectomy and TRAM flap reconstruction is planned (the TRAM flap can only be harvested once but can be used for bilateral reconstruction if done synchronously), or in a patient at increased hereditary risk for cancer. With respect to the number of adequately trained specialists required to accommodate changes in MRI screening practices that may result from the ACS recommendations, Dr Schall and Ms Hartman admit that there are currently not enough radiologists with expertise in breast MRI to handle the potential increase in MRI procedures. They believe, however, that there is sufficient capacity in the system to accommodate the expected increase in breast MRI procedures and they note that there has been progress in training practitioners.

Making the Case for Electronic Health Records: A Report From ASCO's EHR Symposium

Abstract: It started off as a nice enough day, but things were about to get pretty bleak The mail was delivered to the oncology clinic at 11 am, and within the stack of advertisements, payments, and letters of appreciation was an unusual-looking envelope from a major insurance payer The letter did not have a lot to say, but the message was drastic It stated that review of claims demonstrated that the use of an antianemia drug exceeded other practices, and therefore, the reimbursement of this drug was going to be further reduced Throughout the previous 3 years, the practice administrator was certain that the usage had increased, but he was also certain that there must have been a positive outcome from this utilization If the practice had the type of paper medical record that the majority of oncology practices have, I am not sure how he might have mounted an argument Fortunately, this was not the case This practice uses a state-of-the-art electronic health record (EHR) The result was that after investing an hour or two in research, the administrator was able to ascertain that the drug use had increased by almost 50% He was also able to prove that the hospitalizations due to neutropenia had decreased by a similar rate Recognizing that this could have been the result of other therapies, the numbers seemed too close to be a factor of consequence The hour invested was miniscule in comparison to the days that would have been spent searching paper records trying to identify all of the patients who received the drug; and doing the comparison regarding hospitalizations prevented would have been nearly impossible Epoetin alfa is a very expensive drug, but a neutropenic hospitalization is far more expensive for the insurance company Our administrator friend was not only able to stop the arbitrary reduction in reimbursement that was being threatened, but he was able to mount an offense of his own toward increasing reimbursements for use of that drug There are a lot of reasons for moving forward with an EHR purchase, but clearly, the most compelling is the availability of information DuBeshter et al1 reported that “by using computer order entry with error-checking algorithms, it may be possible to eliminate a number of types of errors associated with chemotherapy administration without sacrificing efficiency” Additionally, pay for performance is a reality that is well on its way, and to gain from the process financially, practices will have to be able to prove that various activities have been accomplished For a physician in a large, multispecialty practice, it is difficult using today's paper chart technology to keep up to speed on the details of clinical trials With an EHR the computer receives clinical trial updates and during the examination can remind the physician of trials for which the patient might qualify In the case of commercially-sponsored trials this can mean an increase in practice income, and more importantly, this can mean an increase in survivability for our patients

Hospice referral: an important responsibility of the oncologist.

Abstract: When curative and life-extending therapy is felt to be futile, hospice has a great deal to offer patients, as well as their families and caregivers, with palliative therapy and end-of-life care. More than 1.3 million patients in the US had received services from hospice in 2006, a 162% increase from 1996, with a median length of stay of 20.6 days.1 Nearly three fourths of hospice patients will die in a private residence, nursing home, or other residential facility, compared with the general population, where close to 50% die in acute care hospitals.2 Forty-four percent of the hospice population is made up of patients with cancer.1 Reports have shown that median lengths of stay in hospice are shorter in the population of patients with cancer than for those with other diagnoses. This may be in part due to some barriers to hospice referral by clinical oncologists until the end of a disease trajectory is clearly obvious. This article is written to review the eligibility criteria for entry to hospice, to describe the process of hospice referral, and to suggest the characteristics to evaluate when choosing a hospice. Figure 1 David D. Howell, MD

Collaboration Between Cooperative Groups and Industry

Abstract: By Linda R. Bressler, PharmD, and Richard L. Schilsky, MD The proper relationship between academic investigators and the pharmaceutical industry when conducting large, multicenter, prospective, randomized clinical trials is controversial and can be tense. The potentially conflicting goals of government-funded cooperative groups and pharmaceutical industry sponsors was the subject of a recent commentary in Nature1 by Martine Piccart, current President of the European Organisation for Research and Treatment of Cancer and her colleagues. They expressed particular concern that important features of clinical trials—the design, the duration of patient follow-up, the conduct of any subset analysis, and the adverse event analysis and reporting—may be excessively influenced or controlled by an industry collaborator. They proposed a model for collaboration wherein the clinical trial database is maintained by the academic investigators until the trial end points are met. The data would not be disclosed to the industry collaborator without the approval of an independent data monitoring committee. Once the primary end points of the trial are met (eg, patient survival), the data can be provided to the industry sponsor for an application to regulatory authorities for the new indication. Dr. Piccart suggests that such collaboration is a “. . . win-win situation resulting in commercial registration of products, academic publications, and last but not least, hopefully better outcomes for patient treatments.”

Misdiagnosis: Disclosing a Colleague's Error.

Abstract: In the United States, medical errors cause approximately 44,000 to 98,000 unnecessary deaths each year and as many as 1,000,000 excess injuries.1 Disclosure of these errors is a highly charged ethical and legal issue. While physicians correctly perceive an ethical duty to disclose an error to a patient,2,3 deterrent factors like lawsuits and other punitive actions cause a “disclosure gap.” Although most patients want their physicians to disclose harmful medical errors, this happens less than half of the time.4 The bounds of appropriate behavior are even less clear for physicians who discover medical errors made by their colleagues.5 The following vignette and discussion will address the ethical and legal issues faced by physicians who identify a medical error made by a professional colleague, and discuss the factors they must consider in determining when to disclose the error and to whom.

Caring for the Elderly Cancer Patient: Training the Next Generation of Oncologists

Abstract: Cancer is primarily a disease of aging representing the leading cause of death for both men and women between 60 and 80 years of age.1 In fact, increasing age, undoubtedly, represents the strongest risk factor for developing cancer.2 In addition to the millions of cancer survivors living into their later years, it is estimated that nearly one in three septuagenarians will develop a new cancer diagnosis during the remainder of their lives.1 In addition to the impact of the disease on affected patients and their families, there is a considerable societal cost associated with cancer in elderly individuals. Investigators at the National Cancer Institute have recently estimated the aggregate 5-year net direct costs of cancer care to Medicare at more than $21 billion.3 Such figures, however, do not reflect the enormous nonmedical, indirect and out-of-pocket expenses for cancer care which have been estimated to equal or exceed these numbers.4 Figure 1 Gary H. Lyman, MD, MPH, FRCP(Edin) While there has been an encouraging decrease in cancer-related mortality among younger patients, the same trend has not been observed in the very elderly. Until recently, most clinical trials systematically excluded elderly cancer patients. While considerable progress has been made in addressing such selection bias, particularly by the major cancer cooperative groups, a study in this issue of the Journal of Oncology Practice (JOP) by Basche et al, and elegantly discussed in the accompanying commentary by Cohen highlights the numerous remaining barriers to participation of the elderly in early phase cancer clinical trials.5,6 These concerns, as well as the rapid increase in the proportion of the population older than the age of 65, has spawned professional societies, textbooks, guidelines, and an enormous volume of research and resulting publications addressing a broad range of issues related to cancer in older patients with cancer.7–9 A search of the National Library of Medicine Medline database reveals nearly half a million citations on cancer in the elderly. JOP recently devoted an entire issue to the topic of geriatric oncology.2 At the same time, there has also been considerable discussion about the appropriate preparation of medical specialists, including oncologists, in the specialized needs of the rapidly growing elderly population with cancer. The past decade has witnessed the emergence of subspecialty tracks in geriatric oncology with concentrated training of a limited number of individuals in both medical oncology and geriatrics. Formal training programs were developed at a number of major centers fostered largely by efforts of the American Society of Clinical Oncology (ASCO) and funded by the Hartford Foundation. While these programs focus considerable attention on the specialized needs of the older patient with cancer, it has always been clear that the majority of elderly patients with cancer will continue to be cared for by medical oncologists in practice. As pointed out in the accompanying article by Rao et al in this issue of JOP, both the Accreditation Council for Graduate Medical Education (ACGME) in their guidelines for adult hematology-oncology fellowships and the American Board of Internal Medicine in recent board certification examinations have devoted increasing attention to the education and evaluation of oncologists in the specialized challenges and appropriate management of the older patient with cancer.10 It is noted, however, that trainees in hematology-oncology at most institutions still complete their fellowship without formal training in the care of older patients with cancer. The article by Rao et al presents the conclusions and recommendations of a 2-day consensus conference funded by the Donald W. Reynolds Foundation held at Duke University, and aimed at developing a strategy for developing a core curriculum in geriatric oncology for medical oncology training programs. In addition to surveying current fellowship program directors and previous fellows completing formal geriatric oncology training, funding is being sought for a large conference including the above individuals and other thought leaders in the field to develop a core geriatric oncology curriculum for integration into conventional hematology-oncology training. Key curriculum areas that should be incorporated into fellowship training include the appropriate management of both solid and hematologic malignancies in older patients, the biology of cancer and aging, the pharmacology of cancer therapies in the elderly, and training in comprehensive geriatric assessment and methods of providing optimal supportive care to such patients. As discussed in the last issue of JOP, the elderly patient presents recognized challenges to and opportunities for the delivery of optimal cancer treatment.11,12 With the support and guidance of professional organizations, such as ASCO and ACGME, as well as concerned philanthropy from such organizations as the Hartford and Reynolds Foundations, the goals and objectives put forward in the consensus statement can become reality. The appropriate and comprehensive training of the next generation of oncologists must represent a high priority for the entire profession culminating in greater awareness and appreciation among future cancer specialists of the pervasive yet very special needs of the expanding population of elderly patients with cancer.