ONCOLOGY Vol 14 No 11 | Oncology

Phase II Trial of Thalidomide for Treatment of Nonresectable Hepatocellular Carcinoma*

November 01, 2000

Therapy of hepatocellular carcinoma in cirrhotic patients is challenging. Liver dysfunction, portal hypertension, third spacing, thrombocytopenia, and neutropenia limit the choice of chemotherapeutic agents. However, the abundant vascularity of hepatocellular carcinoma presents an attractive target for antiangiogenic therapy, potentially tolerable even in cirrhotics.

Implementing Recommendations for the Early Detection of Breast and Cervical Cancer Among Low-Income Women

November 01, 2000

Although the causes and natural histories of breast and cervical cancer are different, the public health responses to these diseases have been similar. Early detection of breast cancer and primary prevention of cervical cancer are possible through community-based screening programs; however, early detection of both breast and cervical cancer is less common among low-income women (defined as up to 250% of poverty level, depending on family size). This report presents morbidity and mortality data regarding breast and cervical cancer, screening recommendations, an update on the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), and recommended priority activities for the NBCCEDP. The NBCCEDP is a major public health effort to increase breast and cervical cancer screening among uninsured, low-income women.

Clinical Oncology, Second Edition

November 01, 2000

A comprehensive textbook on clinical oncology should have broad appeal to readers from various disciplines, including educators, clinicians, and scientists working with cancer patients. Students of the medical disciplines must also have a reference textbook to guide them in their educational exploration, whether they are in the field of medicine itself or in complementary areas. We look to comprehensive textbooks not only to provide us with the latest updates in different disease entities, but also to guide us by choosing the most relevant areas of study and investigation. The editors who compiled this textbook have met these challenges, while maintaining a readability that is suitable for various levels of expertise and comprehension

New Chemotherapy Regimen Far Less Toxic Than Standard Bladder Cancer Treatment

November 01, 2000

Researchers who conducted a large, randomized clinical trial across Europe, Great Britain, and Canada found that in order to improve safety and reduce toxicity, advanced bladder cancer patients can be treated with a combination of gemcitabine (Gemzar) and cisplatin (Platinol). This combination (known as GC) did not extend survival, but it was much less toxic than the currently used combination, MVAC (methotrexate, vinblastine, doxorubicin [Adriamycin], and cisplatin).

Phase II Study of Thalidomide as an Antiangiogenic Agent in the Treatment of Recurrent Glioblastoma Multiforme

November 01, 2000

Thalidomide (Thalomid) has been demonstrated to be an antiangiogenic agent with some activity in glioblastoma multiforme. This ongoing study currently has 37 enrolled patients. Patients were started on a dose of 100 mg/d of thalidomide. This was increased by 100 mg/d, weekly, to a maximum dose of 500 mg/d, if tolerated. The mean age was 52 years (range: 27–69 years). The male/female ratio was 19/18. The mean dose tolerated was 300 mg, with a range of 200 to 500 mg/d.

Early Diet May Play Important Role in Breast Cancer Risk

November 01, 2000

At the 10th annual conference of the American Institute for Cancer Research (AICR), Dr. Leena Hilakivi-Clarke, of the Lombardi Cancer Center at Georgetown University, outlined the increasing evidence that fetal and childhood diets may have a greater impact on lifetime breast cancer risk than diets during adulthood. Dr. Hilakivi-Clarke described her own work and summarized ongoing worldwide research efforts.

Response of Metastatic Angiosarcoma to Thalidomide: Possible Synergism With Radiation Therapy

November 01, 2000

A 67-year-old female developed metastatic angiosarcoma involving the scalp, left neck, and pulmonary nodules. Disease progression occurred while she received two cycles of doxorubicin/ifosfamide (Ifex)/mesna (Mesnex), complicated by sepsis

Novel Treatment Option in Older Patients With Relapsed Lung Cancer: Weekly Docetaxel

November 01, 2000

Weekly dosing of the chemotherapy agent docetaxel (Taxotere) is active and well tolerated in elderly patients with advanced non–small-cell lung cancer (NSCLC), according to the results of a phase II study published in a recent issue of Cancer (89[2]:328-333, 2000).

Pilot and Safety Trial of Carboplatin, Paclitaxel, and Thalidomide in Advanced Non–Small-Cell Lung Cancer

November 01, 2000

The aim of this pilot study was to assess the safety of the angiogenesis inhibitor thalidomide (Thalomid) given in combination with standard chemotherapy to patients with advanced non–small-cell lung cancer. Patients with unresectable stage IIIA, IIIB,

The FDA Experience on the Use of Thalidomide in Advanced Malignancies

November 01, 2000

In 1997 and 1998, the Division of Oncology Drug Products at the U.S. Food and Drug Administration approved 575 single-patient investigational new drug applications for the use of thalidomide (Thalomid) for advanced malignancies. We subsequently surveyed 544 practitioners with a questionnaire, and received responses from 359 (response rate: 66%) with data on 480 patients.

Activity of Thalidomide in Waldenström’s Macroglobulinemia

November 01, 2000

Thalidomide (Thalomid) is a potent teratogen and sedative that inhibits angiogenesis. Based on the activity of this agent in patients with multiple myeloma, we initiated a phase II study in Waldenstrom’s macroglobulinemia.

Thalidomide Treatment of Metastatic Renal-Cell Carcinoma

November 01, 2000

Thalidomide (Thalomid) has antiangiogenic and immunomodulatory properties with activity in myeloma and other tumors. We treated 15 patients with advanced progressive metastatic renal-cell cancer with escalating divided daily doses of thalidomide

Higher Doses of Methotrexate Dramatically Improve Survival in Some Lymphoma Patients

November 01, 2000

High-dose chemotherapy with methotrexate offers up to a fivefold increase in survival to patients with primary central nervous system lymphoma. Researchers at Memorial Sloan-Kettering Cancer Center found that using significantly more methotrexate, while adding drugs that penetrate the blood-brain barrier, improved disease control and survival in patients with newly diagnosed cancer.

Three-Arm Phase II Study of Temozolomide in Metastatic Melanoma: Preliminary Results

November 01, 2000

Temozolomide, an oral alkylating agent, has shown activity against metastatic melanoma. The drug is schedule dependent and is given daily for 5 days. Altering the schedule may enhance its activity by depletion of the protein O6-alkylguanine-DNA

Medicare Coverage of Clinical Trials

November 01, 2000

The Clinton administration memorandum on coverage of Medicare patient costs in clinical trials, which drew concern from ASCO when the White House published its incipient statement last June, has apparently morphed into a “final national coverage decision”-announced in late September-that most groups are quite happy with. Ellen Stovall, president and CEO of the National Coalition for Cancer Survivorship, says her group is very happy with the coverage document published by HCFA. She does note, however, that there is a need to monitor the new rules HCFA will be developing for coverage of a subgroup of trials-so-called IND-exempt trials run by cancer centers and pharmaceutical companies-that are testing existing drugs for new uses. Some of these trials are extremely legitimate. Some are not. No one in the cancer community wants to see Medicare pay for clinical trials involving the use of tea leaves to cure colon cancer. However, in writing rules meant to exclude Medicare coverage of those kinds of questionable trials, Stovall indicates that it will be important to ensure that those rules, based on imprecise wording, don’t exclude Medicare coverage for legitimate trials.” We will be concerned with how the language develops,” she explained. One other area of possible concern is Medicare’s intention to pay only for trials that have a “therapeutic” objective. That would rule out some phase I trials designed to test the toxicity of a new medication.

Antinausea Cancer Treatment Shows Promise for Alcoholics

November 01, 2000

Research suggests that a drug used to relieve nausea in cancer patients can help the most difficult-to-treat alcoholics significantly reduce their drinking. Success with the drug ondansetron (Zofran) comes amid growing search for new medications to help treat a disease that affects some 14 million Americans.

HCFA Backs Off of Reimbursement Cuts for Oncology Drugs

November 01, 2000

The Health Care Financing Administration (HCFA) sent a letter to Medicare insurance carriers in September telling them not to cut reimbursement to oncologists for 14 oncology drugs that are administered in the oncologist’s office. This was a reversal of what HCFA said it planned to do, based on pricing data developed by the US Justice Department. Those data showed that drug manufacturers were reporting “average wholesale prices” (AWPs) to Medicare for those 14 drugs that were much higher than the actual AWPs. Medicare reimburses the oncologist for 95% of the AWP. The Justice Department alleges that the drug companies report a very high AWP and then actually sell the drug to the oncologist for a considerably lower price, allowing the oncologist to make a tidy profit after Medicare reimburses at the higher price. The American Society of Clinical Oncology (ASCO) argued that Medicare woefully under-reimburses oncologists for chemotherapy administration, and, therefore, any additional revenue the doctors can generate via AWP reimbursements is warranted. ASCO took that argument to Capitol Hill, and legislators brought pressure to bear on HCFA administrator Nancy-Ann Min DeParle. “We would like to acknowledge HCFA’s willingness to work with the cancer community on this important issue,” said Lawrence H. Einhorn, MD, president of ASCO. Of equal importance is DeParle’s commitment to increase practice expenses for the CPT codes for chemotherapy administration. That will be done in the summer of 2001, when HCFA publishes a proposed Medicare fee schedule for calendar year 2002.

Stress and Burnout in Oncology

November 01, 2000

This article identifies the professional stressors experienced by nurses, house staff, and medical oncologists and examines the effect of stress and personality attributes on burnout scores. A survey was conducted of 261 house

Screening for Ovarian Cancer: What We Know, What We Need to Know

November 01, 2000

The majority of women with ovarian cancer present with advanced-stage disease. Women with early-stage ovarian cancer have a much better chance of achieving a cure than do women with late-stage disease. This

Screening for Ovarian Cancer: What We Know, What We Need to Know

November 01, 2000

The majority of women with ovarian cancer present with advanced-stage disease. Women with early-stage ovarian cancer have a much better chance of achieving a cure than do women with late-stage disease. This

Screening for Ovarian Cancer: What We Know, What We Need to Know

October 01, 2000

The majority of women with ovarian cancer present with advanced-stage disease. Women with early-stage ovarian cancer have a much better chance of achieving a cure than do women with late-stage disease. This

Current Perspectives on Locally Advanced Pancreatic Cancer

November 01, 2000

This year, approximately 40% of the 28,300 patients diagnosed with pancreatic carcinoma in the United States will present with locally advanced disease. Radiotherapeutic approaches are often employed, as these patients

Current Perspectives on Locally Advanced Pancreatic Cancer

November 01, 2000

This year, approximately 40% of the 28,300 patients diagnosed with pancreatic carcinoma in the United States will present with locally advanced disease. Radiotherapeutic approaches are often employed, as these patients

Research on Thalidomide in Solid Tumors, Hematologic Malignancies, and Supportive Care

November 01, 2000

Interest in thalidomide (Thalomid) has intensified in recent years as research has identified and elucidated its immunomodulatory, anti-inflammatory, and antiangiogenic properties. In this supplement, we present a selection of abstracts

Current Perspectives on Locally Advanced Pancreatic Cancer

November 01, 2000

This year, approximately 40% of the 28,300 patients diagnosed with pancreatic carcinoma in the United States will present with locally advanced disease. Radiotherapeutic approaches are often employed, as these patients

Commentary on Abstracts #613, #1384, and #599

November 01, 2000

In the phase II study of thalidomide (Thalomid) in the treatment of recurrent glioblastoma multiforme, Marx et al (abstract #613) concluded that there was no correlation with vascular endothelial growth factor (VEGF) levels and response or

Commentary on Abstracts #28, #27, #99, and #111

November 01, 2000

These four studies further establish the remarkable antitumor activity of thalidomide (Thalomid) in a variety of hematologic disorders. This drug was initially used as a nonbarbiturate sedative/hypnotic and antiemetic during pregnancy in the 1950s.

Stress and Burnout in Oncology

November 01, 2000

This article identifies the professional stressors experienced by nurses, house staff, and medical oncologists and examines the effect of stress and personality attributes on burnout scores. A survey was conducted of 261 house

Screening for Ovarian Cancer: What We Know, What We Need to Know

November 01, 2000

The majority of women with ovarian cancer present with advanced-stage disease. Women with early-stage ovarian cancer have a much better chance of achieving a cure than do women with late-stage disease. This

Thalidomide-Induced Cessation of Weight Loss and Improved Sleep in Advanced Cancer Patients With Cachexia

November 01, 2000

The cachexia of malignancy is considered mediated through excess production of tumor necrosis factor–alpha and other cytokines. Thalidomide (Thalomid), a sedative/hypnotic, has been shown to inhibit tumor necrosis factor–alpha production.

Encouraging Improvement in Cytopenias of Patients With Myelodysplastic Syndromes With Thalidomide

November 01, 2000

Myelodysplastic syndrome patients present with variable cytopenias even though their bone marrows are generally hypercellular. Excessive cytokine-induced apoptosis of hematopoietic cells in the marrows has been proposed as a possible

Stress and Burnout in Oncology

November 01, 2000

This article identifies the professional stressors experienced by nurses, house staff, and medical oncologists and examines the effect of stress and personality attributes on burnout scores. A survey was conducted of 261 house