Comment on ASCO-ESMO Consensus Statement on Quality Cancer Care

Correspondence

US Intergroup trial of adjuvant therapy with concurrent chemoradiotherapy and the multiple positive adjuvant chemotherapy trials (in which either a minority of patients or no patients received PORT), chemotherapy (without concurrent radiation) does represent standard adjuvant therapy.” We feel it is important to interpret these trials paying careful attention to critical details; only two of the trials included patients whom we would consider candidates (N2) for PORT. The International Adjuvant Lung trial allowed PORT but did not report the results of PORT outcomes.4 The Adjuvant Navelbine International Trialist Association trial reported PORT outcomes and most interestingly, patients with N2 involvement who received PORT (predetermined by treatment centers), and chemotherapy had a 5-year overall survival of 47% compared with 34% for those who received chemotherapy alone.5 However, after reviewing our report with the insight gained from both the accompanying Editorial6 and the respondents’ letter, we have identified one particular flaw. All failed to mandate a prospective adjuvant phase III chemoadjuvant radiation therapy trial. This trial needs to be properly designed with appropriate end points (survival and morbidity) and adequate power. Radiotherapy dose and treatment planning techniques must be the current standard with proper centralized quality assurance of the radiation technique utilized. Failure to do so will not only result in more controversy but also fail to improve the standard of care for lung cancer patients following surgery.

Brian Edward Lally Wake Forest University, School of Medicine, Winston-Salem, NC

Daniel Zelterman Yale Cancer Center, New Haven, CT

Joseph Colasanto Yale University, New Haven, CT

Bruce G. Haffty Robert Wood Johnson Medical School, Piscataway, NJ

Frank C. Detterbeck Yale University, New Haven, CT

Lynn D. Wilson Yale University School of Medicine, New Haven, CT

REFERENCES 1. Lally BE, Zelterman D, Colasanto JM, et al: Postoperative radiotherapy for stage II or III non-small-cell lung cancer using the Surveillance, Epidemiology, and End Results database. J Clin Oncol 24:2998-3006, 2006 2. Bekelman JE, Rosenzweig KE, Bach PB, et al: Trends in the use of postoperative radiotherapy for resected non-small-cell lung cancer. Int J Radiat Oncol Biol Phys 66:492-499, 2006 3. Wakelee HA, Stephenson P, Keller SM, et al: Post-operative radiotherapy (PORT) or chemoradiotherapy (CPORT) following resection of stages II and IIIA non-small cell lung cancer (NSCLC) does not increase the expected risk of death from intercurrent disease (DID) in Eastern Cooperative Oncology Group (ECOG) trial E3590. Lung Cancer 48:389-397, 2005 4. Arriagada R, Bergman B, Dunant A, et al: Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. N Engl J Med 350:351-360, 2004 5. Douillard JY, Rosell R, De LM, et al: Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-smallcell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): A randomised controlled trial. Lancet Oncol 7:719-727, 2006

6. Bonner JA: The role of postoperative radiotherapy for patients with completely resected nonsmall cell lung carcinoma: Seeking to optimize local control and survival while minimizing toxicity. Cancer 86:195-196, 1999

DOI: 10.1200/JCO.2006.09.1819 ■ ■ ■

Authors’ Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.

Comment on ASCO-ESMO Consensus Statement on Quality Cancer Care TO THE EDITOR: We feel that the ASCO-ESMO (American Society of Clinical Oncology–European Society for Medical Oncology) consensus statement on quality cancer care omits mentioning an important member, the pharmacist, from the section on Multidisciplinary Cancer Care.1 Drug therapy is an integral part of primary cancer management and is essential to managing the adverse consequences of chemotherapy. Pharmaceutical use in the oncology patient continues to expand in complexity, variety, toxicity, distribution requirements, and cost. As a pharmacotherapy expert, the involvement of pharmacists in the cancer patient’s team has a firm foundation in many countries. Pharmacists are licensed health care professionals who make a significant contribution to improving health outcomes and quality of life in the cancer patient. Pharmacists provide patient-specific advice to the health care team about complex chemotherapy regimens, supportive care medications, and other medications used in the cancer patient; as well as educate the patients themselves. Pharmacists establish policies for safe medication use, chemotherapy preparation, and safe-handling of toxic chemotherapy agents. Given the expanding role and availability of oral anticancer agents, the pharmacist’s specific training in medication counseling is of vital importance to the patient and health care team, making them a critical link in providing seamless care as the patient transitions between community and hospitalbased treatment. As a result of the specialized knowledge and unique contributions that oncology pharmacists make to patient care, oncology pharmacy was recognized by the Board of Pharmaceutical Specialties in the United States as a pharmacy practice specialty in 1996. In the application to approve this specialty, the oncology pharmacist is noted to promote optimal care of the patient with malignant disease and its complications. It was stated that they are closely involved with other members of the patient’s health care team in providing recognition, management, and prevention of unique morbidities associated with cancer and cancer treatment; recognize the balance between improved survival and quality of life as primary outcome indicators; and provide the safeguards against drug misadventures in a treatment area where novel and experimental drug therapies are frequently employed. Currently, more than 550 board-certified oncology pharmacists (BCOP) practice all over the world. In addition to the United States, there are 5613

www.jco.org

Downloaded from jco.ascopubs.org on May 21, 2011. For personal use only. No other uses without permission. Copyright © 2006 American Society of Clinical Oncology. All rights reserved.

Correspondence

BCOPs in Australia, Canada, Hong Kong, Jordan, Korea, Saudi Arabia, Scotland, Singapore, Spain, and the United Kingdom. In addition, thousands of oncology pharmacists are members of national, continental, and international oncology pharmacy associations whose mission statements mirror those made in the BCOP application. To meet the goals of the statement, that is, to provide equality in cancer patient care across the globe, we feel strongly that cancer patients should have access to a pharmacist for their pharmaceutical care needs. We hope that this omission will be addressed when the consensus statement is due to be reviewed.

Paula Trahan Rieger International Affairs Department, American Society of Clinical Oncology, Alexandria, VA

REFERENCE 1. ASCO-ESMO consensus statement on quality cancer care. J Clin Oncol 24:3498-3499, 2006

DOI: 10.1200/JCO.2006.08.9425 ■ ■ ■

Authors’ Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.

Barry Goldspiel National Institutes of Health Clinical Center, Bethesda, MD

John Wiernikowski McMaster Children’s Hospital, Hamilton, Ontario, Canada

REFERENCE 1. ASCO-ESMO consensus statement on quality cancer care. J Clin Oncol 24:3498-3499, 2006

DOI: 10.1200/JCO.2006.08.6181 ■ ■ ■

Authors’ Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.

IN REPLY: We appreciate Dr Goldspiel’s comment on the role of oncology pharmacists in cancer care and would like to explain why their specialty has not explicitly been stated in the ASCO-ESMO (American Society of Clinical Oncology–European Society for Medical Oncology) Consensus Statement on Quality Cancer Care, published in the July 20, 2006, issue of the Journal of Clinical Oncology.1 It is without doubt that many other specialists than those few mentioned in the Consensus Statement often play an important role in the treatment and care of patients with cancer. Among those are oncology pharmacists, radiologists, physical therapists, occupational therapists, clinical psychologists, speech therapists, social workers, and several others. The role, availability, and participation in patient care of these professionals do, however, vary markedly from region to region. In many parts of the world, including China and other large countries and regions, oncology pharmacists are not available. It is often the nurse who prepares the cytotoxic drugs and other medications. The presence of the oncology pharmacist is primarily seen in countries with very specialized cancer care, such as the United States, Canada, and increasingly in Europe. In appraisal of these variations, the work group decided to give only selected examples of the most commonly seen participants in cancer care and avoided portraying an inclusive scenario for the various models in place in global cancer care. We appreciate however, that depending on the conditions of the individual health care system, oncology pharmacists as well as other specialists can play an important role in care of patients diagnosed with cancer. Heinz Ludwig Wilhelminenspital, Vienna, Austria

Tony S.K. Mok The Chinese University of Hong Kong, Hong Kong, China 5614

Outpatient Oral Antibiotics for Febrile Neutropenic Cancer Patients TO THE EDITOR: The report of Klastersky et al1 in the September 1, 2006, issue of the Journal of Clinical Oncology provides interesting data about oral antibiotics with early discharge from hospital in cancer patients with low-risk febrile neutropenia. Nevertheless, the authors reported a statistically different response rate between early discharged patients and those who remained hospitalized. It is questionable whether this result can be relevant, as patients discharged after 24 hours were clinically stable or improving, meaning that patients remaining hospitalized were not. Also, with regards to the low number of documented infections in cancer patients with low-risk febrile neutropenia, it is debatable whether the end point of studies testing oral and/or hospital discharge should not be the failure rate of treatment rather than the success.2,3 This would probably result in the need for studies with a larger number of patients. Therefore, conclusions would be more relevant, as the risk of oral/outpatients antibiotics for chemotherapy-induced febrile neutropenia is the failure of treatment.

Matthieu-John Ouvrier, Jean-Christophe Thery, and Emmanuel Blot Medical Oncology Department, Henri Becquerel Centre, Rouen, France

REFERENCES 1. Klastersky J, Paesmans M, Georgala A, et al: Outpatient oral antibiotics for febrile neutropenic cancer patients using a score predictive for complications. J Clin Oncol 24:4129-4134, 2006 2. Finberg RW, Talcott JA: Fever and neutropenia: How to use a new treatment strategy. N Engl J Med 341:362-363, 1999 3. Vidal L, Paul M, Ben-Dor I, et al: Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients: A systematic review and meta-analysis of randomized trials. J Antimicrob Chemother 54:29-37, 2004

DOI: 10.1200/JCO.2006.09.0571 ■ ■ ■

Authors’ Disclosures of Potential Conflicts of Interest The authors indicated no potential conflicts of interest.

IN REPLY: We thank Dr Ouvrier and colleagues for their interest and their comments about our article dealing with outpatient oral antibiotics for febrile neutropenia in predicted low-risk patients. 1 First of all, primary objective of our work was to assess whether it was safe to discharge febrile neutropenic patients predicted at low-risk of serious medical complication on the basis of a standardized tool from the hospital early. When we designed our research protocol, two JOURNAL OF CLINICAL ONCOLOGY

Downloaded from jco.ascopubs.org on May 21, 2011. For personal use only. No other uses without permission. Copyright © 2006 American Society of Clinical Oncology. All rights reserved.