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In today's cost-conscious health care environment, the pricing of cancer drugs has come under scrutiny from payers, providers, policy makers, and the public. Large pharmaceutical companies are often cast as the villain in this debate. In order to shed light on this issue, Cancer Care & Economics (CC&E) recently spoke with Joshua J. Ofman, MD, MSHS, vice president of reimbursement and payment policy at Amgen, one of the world's leading biotechnology companies.

Back in September, the FDA's Oncologic Drugs Advisory Committee (ODAC) failed to recommend that the agency grant accelerated approval to Genta's oblimersen (Genasense) plus chemotherapy (fludarabine/cyclophosphamide) for treatment of relapsed/refractory chronic lymphocytic leukemia (CLL).

This comprehensive guidebook is an invaluable reference for patients and health professionals as they navigate the murky waters of cancer treatment and survivorship. While several other books address only specific aspects of living with cancer and its aftermath, Silver's reference covers all aspects of life during and after cancer, touching on issues that range from pain management to responding to children's questions about cancer such as, "Are you going to die?"

Myelosuppression and particularly neutropenia and associated complications, including febrile neutropenia, continue to represent the major dose-limiting toxicity of cancer chemotherapy.

The chemotherapy of most cancers may be beneficial to older individuals as long as patients are selected on the basis of their life expectancy and functional reserve, conditions that may interfere with the tolerance of chemotherapy are corrected, and adequate doses of chemotherapy are administered. Prevention of neutropenia-related infection may both improve the outcome of cancer and reduce the risk of toxic deaths in older patients. The prophylactic use of myelopoietic growth factors is recommended in individuals aged 65 and older when the risk of chemotherapy-induced neutropenic infection is at least 10% or higher. In this article we explore the management of neutropenia and neutropenic infections in older cancer patients, as well as review the causes and the risk of this complication.

It has been more than 15 years since the initial approval of myeloid growth factors to reduce febrile neutropenia in cancer patients receiving myelosuppressive chemotherapy.[1] As with other novel therapeutics, the approval of filgrastim (Neupogen) did not mark the end of research in this area, but rather the beginning.

Acute myeloid leukemia (AML) is a disease of the elderly, with the majority of patients diagnosed in their 6th and 7th decade of life. Older patients with AML are less likely to achieve complete remission after induction chemotherapy, and they suffer from higher rates of leukemia relapse compared to younger cohorts. Suboptimal outcomes are the result of adverse biologic characteristics of leukemia in the elderly, as well as the presence of medical comorbidities and patient or physician preferences as to initiating treatment. In addition, there is a distinct lack of randomized, prospective data to guide management decisions for the treatment of AML in the elderly. Patients who are over age 75, with poor performance status, multiple comorbidities, or poor prognostic features, should be considered for a clinical trial or palliative therapy. Elderly patients who are candidates for standard induction chemotherapy and achieve complete remission are unlikely to benefit from intensive postremission therapy and should be referred to a clinical trial when possible. Further prospective trials are needed to identify a tolerable, effective treatment regimen for older patients with AML.

Acute myeloid leukemia (AML) is a disease of the elderly, with the majority of patients diagnosed in their 6th and 7th decade of life. Older patients with AML are less likely to achieve complete remission after induction chemotherapy, and they suffer from higher rates of leukemia relapse compared to younger cohorts. Suboptimal outcomes are the result of adverse biologic characteristics of leukemia in the elderly, as well as the presence of medical comorbidities and patient or physician preferences as to initiating treatment. In addition, there is a distinct lack of randomized, prospective data to guide management decisions for the treatment of AML in the elderly. Patients who are over age 75, with poor performance status, multiple comorbidities, or poor prognostic features, should be considered for a clinical trial or palliative therapy. Elderly patients who are candidates for standard induction chemotherapy and achieve complete remission are unlikely to benefit from intensive postremission therapy and should be referred to a clinical trial when possible. Further prospective trials are needed to identify a tolerable, effective treatment regimen for older patients with AML.

Rituxan (rituximab, Genentech/Biogen Idec) has been approved for two new indications in patients with CD20-positive, B-cell non-Hodgkin's lymphoma.

Our nation's health care systemis facings an economicmeltdown of unprecedentedproportions. Overthe past 20 years, medicalinflation has averaged double the generalinflation rate.

As the Centers for Medicare & Medicaid Services(CMS) moves toward a payment system linked toquality performance, it is important that the oncologycommunity participates in the ongoing debateover how to define best quality care and how todeliver it.

The new Doctor of Nursing Practice (DNP) degree is meant to be to nursing clinical practice what the PhD is to nursing research, Sharon Krumm, RN, PhD, said at the Oncology Nursing Society 31st Annual Congress (abstract 34).

The frequency and duration of chemotherapy-induced oral mucositis may be significantly improved by either prophylactic chlorhexidine or by cryotherapy, according to the results of a randomized, double-blind, placebo-controlled study presented at the 31st Congress of the European Society for Medical Oncology (ESMO) (abstract 988 O).

BioLucent, Inc. has received 510(k)clearance from the FDA for its SAVIapplicator. The SAVI device offersa multicatheter, single-entry approachto breast brachytherapy.

The FDA has approved Schering-Plough's novel triazole antifungal agent Noxafil (posaconazole) Oral Suspension for the treatment of oropharyngeal candidiasis, including infections refractory to itraconazole and/or fluconazole.

Enrollment in clinical trials is crucialto continued scientific discovery andimproved patient care.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

Primary neuroendocrine neoplasms of the lung represent a clinical spectrum of tumors ranging from the relatively benign and slow-growing typical carcinoid to the highly aggressive small-cell lung carcinoma. The rarity of carcinoids has made the role of radiation therapy in their management controversial. This review considers the results of published studies to generate treatment recommendations and identify areas for future research. Surgery remains the standard of care for medically operable disease. Histology plays the most important role in determining the role of adjuvant radiation. Resected typical carcinoids likely do not require adjuvant therapy irrespective of nodal status. Resected atypical carcinoids and large-cell neuroendocrine carcinomas have a significant risk of local failure, for which adjuvant radiation likely improves local control. Definitive radiation is warranted in unresectable disease. Palliative radiation for symptomatic lesions has demonstrated efficacy for all histologies. Collaborative group trials are warranted.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

Primary neuroendocrine neoplasms of the lung represent a clinical spectrum of tumors ranging from the relatively benign and slow-growing typical carcinoid to the highly aggressive small-cell lung carcinoma. The rarity of carcinoids has made the role of radiation therapy in their management controversial. This review considers the results of published studies to generate treatment recommendations and identify areas for future research. Surgery remains the standard of care for medically operable disease. Histology plays the most important role in determining the role of adjuvant radiation. Resected typical carcinoids likely do not require adjuvant therapy irrespective of nodal status. Resected atypical carcinoids and large-cell neuroendocrine carcinomas have a significant risk of local failure, for which adjuvant radiation likely improves local control. Definitive radiation is warranted in unresectable disease. Palliative radiation for symptomatic lesions has demonstrated efficacy for all histologies. Collaborative group trials are warranted.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

This article summarizes the current management of patients with newly diagnosed cervical cancer. The topics range from the management of early-stage disease to the phase III randomized studies that have established the current standard of care for patients with locally advanced cancer of the cervix. New approaches to combined-modality therapy with the goal of improving outcomes and decreasing complications are also described.

Primary neuroendocrine neoplasms of the lung represent a clinical spectrum of tumors ranging from the relatively benign and slow-growing typical carcinoid to the highly aggressive small-cell lung carcinoma. The rarity of carcinoids has made the role of radiation therapy in their management controversial. This review considers the results of published studies to generate treatment recommendations and identify areas for future research. Surgery remains the standard of care for medically operable disease. Histology plays the most important role in determining the role of adjuvant radiation. Resected typical carcinoids likely do not require adjuvant therapy irrespective of nodal status. Resected atypical carcinoids and large-cell neuroendocrine carcinomas have a significant risk of local failure, for which adjuvant radiation likely improves local control. Definitive radiation is warranted in unresectable disease. Palliative radiation for symptomatic lesions has demonstrated efficacy for all histologies. Collaborative group trials are warranted.

The Starr Foundation, one of the largest private foundations in the United States, has launched the multi-institutional Starr Cancer Consortium with a $100 million grant to coordinate the research efforts of five internationally recognized cancer research centers.

Medicare's 2005 chemotherapy demonstration project cost the Centers for Medicare & Medicaid Services (CMS) about $220 million, with beneficiary liability totaling approximately $55 million.

The Oncologic Drugs Advisory Committee voted 7-to-3 against recommending accelerated approval for Genasense (oblimersen sodium, Genta) to treat relapsed/refractory chronic lymphocytic leukemia (CLL) in combination with fludarabine (Fludara) and cyclophosphamide.

"Declining reimbursement rates are forcing oncologists to manage their practices more efficiently,"

As half of all breast cancers occur in patients beyond the age of 65 and a quarter beyond the age of 75, a significant number of patients with metastatic breast cancer are elderly. New hormonal therapies, such as aromatase inhibitors, appear to have favorably improved the survival of these patients. Side effects such as osteoporosis or cognitive issues appear manageable. Information specific to elderly patients has recently emerged in the field of chemotherapy for metastatic breast cancer. This article reviews data on anthracyclines, taxanes, capecitabine (Xeloda), gemcitabine (Gemzar), trastuzumab (Herceptin), and bevacizumab (Avastin). For most patients in this setting, sequential single-agent chemotherapy appears at this time to be the preferred course of treatment.

As half of all breast cancers occur in patients beyond the age of 65 and a quarter beyond the age of 75, a significant number of patients with metastatic breast cancer are elderly. New hormonal therapies, such as aromatase inhibitors, appear to have favorably improved the survival of these patients. Side effects such as osteoporosis or cognitive issues appear manageable. Information specific to elderly patients has recently emerged in the field of chemotherapy for metastatic breast cancer. This article reviews data on anthracyclines, taxanes, capecitabine (Xeloda), gemcitabine (Gemzar), trastuzumab (Herceptin), and bevacizumab (Avastin). For most patients in this setting, sequential single-agent chemotherapy appears at this time to be the preferred course of treatment.

It is an unusual oncologist in the United States who has not had a patient receive a second opinion at the M. D. Anderson Cancer Center (MDA). Long a respected and well-known force in cancer research and patient care, MDA has exerted significant national and international influence not only with scientific publications but also through its training programs and large clinical operation. This book will add to that influence with concise disease-oriented chapters covering the patient population a medical oncologist will see in practice. The MD Anderson Manual of Medical Oncology is not a small handbook. Rather, it is a hardbound text of more than 1,000 pages authored by nearly 100 MDA clinicians.