Cynthia Rittenberg

Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference

Despite the relevant progress achieved in the last 20 years,vomiting and, especially, nausea, continue to be two of themost distressing side-effects of cancer chemotherapy. In the late1990s several professional organizations publishedrecommendations on the optimal antiemetic prophylaxis inpatients submitted to chemotherapy and radiotherapy.Subsequently, due to the emergence of new findings and newantiemetic agents since the first recommendations from 1997,representatives from several oncology societies met in Perugia,Italy, in 2004 and updated the antiemetic guidelines. On 20–21June 2009 the European Society of Medical Oncology (ESMO)and the Multinational Association of Supportive Care inCancer (MASCC) organized the third Consensus Conferenceon antiemetics in Perugia. The results of this Conference arereported in this paper.The methodology for the guideline process was based ona literature review through 1 June 2009 using MEDLINE(National Library of Medicine, Bethesda, MD, USA) and otherdatabases, with evaluation of the evidence by an expert panelcomposed of 23 oncology professionals in clinical medicine,medical oncology, radiation oncology, surgical oncology,oncology nursing, statistics, pharmacy, pharmacology, medicalpolicy and decision making. With the participating expertscoming from 10 different countries, on five continents, webelieve that this is the most representative and evidence-basedguideline process that has yet been performed.The panel comprised 10 committees dealing with majortopics in this field (e.g. acute or delayed nausea and vomitinginduced by highly emetogenic chemotherapy). Althoughprevention of acute and delayed nausea and vomiting inducedby highly and moderately emetogenic chemotherapy (HEC andMEC) had specific committees, these worked finally together, as

Consensus proposals for the prevention of acute and delayed vomiting and nausea following high-emetic-risk chemotherapy

This paper uses an evidence-based approach whenever possible to formulate recommendations, emphasizing the results of controlled trials concerning the best use of antiemetic agents. We address issues of dose, schedule, and route of administration of five selective 5-HT3 antagonists. We conclude that for each of these five drugs, there is a plateau in therapeutic efficacy above which further dose escalation does not improve outcome. Furthermore, for all classes of antiemetic agents, a single dose is as effective as multiple doses or a continuous infusion. The oral route is as efficacious as the intravenous route of administration, even with chemotherapy of high emetic risk. Selective antagonists of the type 3 serotonin receptor (5-HT3) in combination with dexamethasone and aprepitant are the standard of care for the prevention of emesis following chemotherapy of high emetic risk.

Psychosocial care for patients and their families is integral to supportive care in cancer: MASCC position statement

This position paper, written on behalf of the MASCC Psychosocial Study Group, reviews the most common psychosocial concerns and needs of cancer patients during all phases of the cancer continuum, from diagnosis to death or survivorship. Developments in psychosocial care at both individual and systems levels are surveyed and summarized, along with gaps in knowledge and research and needed improvements in the dissemination and application of acquired knowledge and expertise. The roles of culture, spirituality, and religion as part of psychosocial care are reviewed, along with families’ and caregivers’ specific psychosocial concerns and needs, and areas of needed psychosocial interventions in supportive cancer care. Deficits in recognizing and meeting patients’ psychosocial needs at the system level are examined, and international guidelines and models of psychosocial care are reviewed, including their potential applications to local contexts. The paper calls for a shift to a new paradigm of care through adoption of an integrated approach to identify and meet the psychosocial needs of cancer patients and survivors as part of supportive care worldwide.

A prospective observational study of chemotherapy-related nausea and vomiting in routine practice in a UK cancer centre

ObjectiveThe aim of the study was to assess levels of chemotherapy-induced nausea and vomiting (CINV) in routine practice.Materials and methodsThe study was an observational prospective evaluation using patient self-reports. One hundred and two patients with cancer in a single cancer centre in UK receiving their first chemotherapy treatment participated in the study and were followed up over four cycles, providing a total of 272 assessments of nausea and vomiting. Data was collected with the use of the MASCC Antiemesis Tool (MAT), which is an eight-item short clinical scale assessing acute and delayed nausea and vomiting after chemotherapy.ResultsResults indicated that acute vomiting was experienced by 15.7% of the patients in cycle 1 and delayed vomiting by 14.7%, while acute nausea was present in 37.3% of the patients and delayed nausea in 47.1%, increasing over the subsequent cycles. Moderately emetogenic and highly emetogenic chemotherapy had the highest incidence of CINV, whereas patients receiving highly emetogenic chemotherapy showed significant levels of delayed nausea. Acute symptoms were more easily controlled than delayed symptoms.DiscussionThe data suggest that, while vomiting is well controlled, nausea remains a significant problem in practice, and optimal management of CINV is yet to be achieved. Understanding more clearly the biological basis of nausea will assist in managing this complex symptom more effectively in practice.

Acute emesis: moderately emetogenic chemotherapy

This paper is a review of the recommendations for the prophylaxis of acute emesis induced by moderately emetogenic chemotherapy as concluded at the Perugia Consensus Conference, which took place at the end of March 2004. The review focuses on new studies appearing since the last consensus conference in 1997. The following issues are addressed: dose and schedule of antiemetics, different groups of antiemetics such as corticosteroids, serotonin (5-HT3)-receptor antagonists, dopamine D2 receptor antagonists, and neurokinin (NK1) receptor antagonists. Antiemetic prophylaxis in patients receiving multiple cycles of moderately emetogenic chemotherapy is also reviewed. Consensus statements are given, including optimal dose and schedule of 5-HT3-receptor antagonists and of dexamethasone. The new 5-HT3-receptor antagonist, palonosetron, is a reasonable alternative to the well-established agents of this class—ondansetron, granisetron, tropisetron and dolasetron. It is concluded that the best prophylaxis in patients receiving moderately emetogenic chemotherapy is still the combination of one of the 5-HT3-receptor antagonists and dexamethasone. The results of studies adding a NK1-receptor antagonist to this combination are awaited and might change future recommendations.

Antiemetic therapy for multiple-day chemotherapy and high-dose chemotherapy with stem cell transplant: review and consensus statement

The objective of this paper is to evaluate the efficacy of modern antiemetic therapy for chemotherapy-induced nausea and vomiting for patients receiving multiple-day or high-dose chemotherapy. Published phase II and phase III studies as well as their personal experiences were evaluated by the authors to develop this consensus statement. The largest published experience with multiple-day chemotherapy is with 5-day cisplatin combination chemotherapy. The introduction of 5-HT3 antagonists greatly improved emetic control. However, day 4–5 nausea as well as delayed nausea and vomiting remains a clinical problem despite the inclusion of dexamethasone. A 5-HT3 antagonist plus dexamethasone is the preferred current option for patients receiving high-dose chemotherapy with stem cell transplant. However, the results do not appear as successful as for highly emetic standard-dose chemotherapy.

Antiemetic therapy for multiple-day chemotherapy and additional topics consisting of rescue antiemetics and high-dose chemotherapy with stem cell transplant: review and consensus statement

This paper will evaluate various topics related to chemotherapy-induced nausea and vomiting. The results published reflect a consensus conference convened in Perugia, Italy. The topics discussed include antiemetic therapy of multiple-day chemotherapy, high-dose chemotherapy, and rescue antiemetics.

Role of the nurse in patient education and follow-up of people receiving oral chemotherapy treatment: an International survey

PurposeThe aim of this study was to explore the nursing role in education and follow-up of patients who were taking oral chemotherapy (CT) and to identify the worldwide gap in patient education about oral CT.Materials and methodsMultinational Association of Supportive Care in Cancer members were invited to participate in a survey on oral CT. Nurse coordinators collected data via a 16-item questionnaire. Respondents totaled 1115 oncology nurses from 15 countries.ResultsFindings showed that about half of subjects work in outpatient/ambulatory clinics and had given at least two or more oral CT drugs. Although 52% had some type of guidelines/protocols, 47% reported not having received any education about oral CT drugs. While 64% report being involved in patient education, 58% of subjects indicated lack of patient education materials that are specific for oral CT agents. Only 27% stated that they gave all necessary information such as when and how to take the drugs, drug safety and storage, side effects, and symptom management. Reasons for not being involved in oral CT education and follow-up included beliefs that the physician plans the oral CT and gives patients necessary instructions (34%), that nurses only see patients who receive intravenous chemotherapy (16%), that nurses have lack of knowledge about oral agents (15%), and belief that physicians are responsible for patient follow-up. The nurses suggested better education and follow-up of patients to include the written patient education materials (33%) and professional education for nurses (30%).ConclusionsFindings revealed the need for professional education for nurses to ensure comprehensive, consistent patient education and development of written materials for patients receiving oral CT treatment.

Development of the MASCC teaching tool for patients receiving oral agents for cancer

BackgroundOral agents for cancer treatment commonly are prescribed throughout the world. Since oral agents usually are self-administered or administered by lay caregivers, patient education is vital to help ensure that the oral agents are being stored, handled, and taken correctly. When oral agents are taken as prescribed and patients are well informed about signs and symptoms to report, patient outcomes are optimized. Patient education varies globally; consequently, there is a need for a consistent and comprehensive approach to educate patients about oral cancer treatment.Goal of workTo create a teaching tool to be used with patients receiving oral cancer agents for worldwide use.Materials and methodsSix oncology nurse experts conducted a literature review and convened as an expert panel to draft a teaching tool for patients receiving oral cancer agents. The tool includes key assessment questions, generic education discussion points, drug-specific education, and evaluation questions to help ensure that patients/caregivers understand the information provided. Eighteen healthcare providers from 15 countries reviewed the tool for clarity and usefulness in practice by scoring each item in the teaching tool on a 0–10 scale (“0 = not at all to “10” = most clear/useful”). Items that scored 5 or below required comments. At the Multinational Association for Supportive Care in Cancer (MASCC) Symposium in 2008, the healthcare providers who reviewed the teaching tool met with the oncology nurse experts who had developed the tool to review the item scores and revise the tool as necessary.ResultsAll items on the teaching tool received high scores, with the exception of items on refilling prescriptions and insurance issues, which vary from country to country. There was consensus that the MASCC Teaching Tool for Patients Receiving Oral Agents for Cancer was ready to be used and further evaluated in clinical practice.ConclusionsThe MASCC Teaching Tool for Patients Receiving Oral Agents for Cancer is an available resource to assist healthcare providers assess and teach patients about oral cancer treatment.

Quality of life as a clinical trial endpoint: determining the appropriate interval for repeated assessments in patients with advanced lung cancer

One of the unresolved design issues for clinical trials with quality of life (QOL) as an endpoint is the frequency of measurement in patients with stage III and IV lung cancer. In a retrospective review of clinical trials, the QOL interval varied widely from 1 to 12 weeks during treatment. During follow-up, the interval was generally 2 to 3 months or not at all. The purpose of this methodological study was to determine an appropriate interval for QOL serial measurement based on prospectively collected data. The 20 patients for this study were part of a phase I/II study using combination chemotherapy in patients with advanced non-small cell lung cancer (NSCLC). They were typical of patients in lung cancer clinical trials, with a median age of 67 (interquartile range: 58, 72) years, the majority were male (13, 65%), and a baseline median Karnofsky performance status was 80 (interquartile range: 70%, 90%). The primary instrument, developed in 1985, was the Lung Cancer Symptom Scale (LCSS) patient form, a 9-item self-report and site-specific QOL measure. The method, outcome, and implication of these findings to research are presented for establishing a method for obtaining an appropriate serial measurement interval for QOL during therapy in clinical trials. Based on the findings of this study, an every 3-week QOL assessment for patients with advanced NSCLC provides data similar to more frequent evaluation (94% of data preserved compared to twice-weekly assessment, 95% confidence interval, 86–98%, p=0.05). Less frequent assessment (every 4 or every 6 weeks) retained less than 85% of the data, which is the recommended minimum adequacy rate. Retaining a high percentage of QOL information may lessen the effect of measurement bias due to patient attrition and may give more validity to QOL studies.