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The July, 1997 issue of ONCOLOGY(11:947-970, 1997) featured a discussion by Alan Venook, “Update on Hepatic

The authors provide a comprehensive overview of the role of axillary lymphadenectomy in the treatment of early-stage breast cancer. They do not argue against lymphadenectomy for patients with clinical T2 and 3 tumors and clinical N1 and 2 nodes. However, for clinical N0 cancers and for postmenopausal patients with hormone-receptor-positive tumors, the authors propose radiotherapy to the axilla as a modality less expensive than surgery and with fewer complications. They suggest observation only for lesions associated with a less than 10% to 15% chance of axillary metastasis (T1a cancers, tubular carcinomas, ductal carcinoma in situ [DCIS] with microinvasion). However, for patients with lesionsless than 1 cm with “high-risk features (presence of tumor emboli in vessels, poor nuclear grade, etc),” axillary lymphadenectomy “should continue to serve as a refined prognostic indicator for selection of patients for adjuvant therapy.”

Many of the more commonly observed adverse effects of standard doxorubicin (Adriamycin) are lessened by pegylated liposomal delivery (Doxil). The slow release of doxorubicin into normal tissue cells via this form of liposomal delivery ameliorates its potential for severe alopecia, nausea and vomiting, cardiotoxicity, and myelosuppressive toxicity. Infusion-related acute reactions are managed by slowing infusion rates and thorough dilution and mixing of the infused drug. Vesicant properties normally seen with doxorubicin are absent. Palmar-plantar erythrodysesthesia can be reduced by decreasing the dose or increasing the dosing interval. Many of these side effects are developing a predictable profile and are manageable. Because of its overall reduced toxicity profile, pegylated liposomal doxorubicin may be well-suited for use in combination chemotherapeutic regimens. [ONCOLOGY 11(Suppl 11):54-62, 1997]

The treatments employed for Kaposi’s sarcoma in patients with acquired immunodeficiency syndrome (AIDS-KS) have been limited in their usefulness by toxicities and underlying immunodeficiency in this patient population.

Liposome-encapsulated drug delivery is a methodology that has been evolving over the past 30 years. A number of liposome-encapsulated anthracycline products are in development and two, pegylated liposomal doxorubicin

SAN FRANCISCO-Surgery appears to offer better results than radiation as primary therapy for many laryngeal cancers. Results of a five-year study in Germany suggest that tumor excision and subsequent reconstruction offer better clinical outcomes, better preservation of voice function, and lower cost than radiation therapy.

GAITHERSBURG, Md-An FDA advisory committee voted unanimously to recommend Anesta Corporation’s Actiq (oral transmucosal fentanyl citrate) for approval for use in cancer patients with breakthrough pain.

Although the combination of uracil and tegafur (UFT) has been available commercially in Japan since 1984 and is one of the most extensively prescribed antineoplastic agents in that country, few physicians outside Japan have knowledge of and

Both cisplatin (Platinol) and fluorouracil (5-FU) have demonstrated single-agent clinical efficacy in a variety of solid neoplasms. The combination of these agents has revealed synergistic cytotoxicity in models in vitro and in vivo, which may explain the clinical effectiveness of 5-FU-cisplatin regimens. UFT (tegafur and uracil) and bis-aceto-ammine-dichloro-cyclohexyl-amine platinum (IV) (JM-216) are novel oral analogues of 5-FU and cisplatin, respectively. In preclinical models, JM-216 has demonstrated equivalent cytotoxicity to cisplatin, while phase I trials suggest its dose-limiting toxicity is myelosuppression. In contrast to cisplatin, JM-216 has not demonstrated significant neurotoxicity or nephrotoxicity. UFT has been used extensively in Japan, where phase II data suggest disease response rates similar to single-agent 5-FU in colorectal, gastric, and breast carcinomas. Combination studies of prolonged administration UFT and single-dose cisplatin have shown efficacy, but also significant hematologic toxicity. We propose a phase I study of UFT and JM-216 administered daily over 14 consecutive days with leucovorin (90 mg/d). Ease of administration and continuous drug exposure are potential advantages of this regimen. Several disease specific investigations may be warranted given demonstrated feasibility in this phase I study.[ONCOLOGY 11(Suppl 10):26-29, 1997]

This phase III study compares leucovorin plus fluorouracil (5-FU) 425 mg/m2, days 1 through 5, 28-day cycle, with oral leucovorin plus oral UFT (tegafur and uracil) 300 mg/m2, days 1 through 28, 35-day cycle, in terms of

Despite recent progress in surgery and chemotherapy, advanced gastric cancer carries a poor prognosis. Although several antitumor agents have some clinical activity, responses are usually of short duration and fail to

Thirty-nine patients with locally advanced or metastatic gastric carcinoma received oral UFT (tegafur and uracil) plus leucovorin. Treatment consisted of UFT 360 mg/m2/day plus leucovorin 25 mg/m2/day, given orally in divided

The selective antineoplastic effect of tegafur and uracil (UFT) is attributed to its preferential enhancement of fluorouracil concentration in tumor tissues compared with that in normal tissues. The result of this effect is evident in the clinical benefit and lower toxicity associated with UFT compared with other fluorinated pyrimidines. Beginning with preclinical studies in the 1980s, significant therapeutic advantages of UFT have been reported in numerous trials conducted in Japan, including phase I dose-finding studies, phase II multicenter studies, comparative studies, and combination-chemotherapy studies. In phase II studies conducted at 211 institutions, for example, it was shown that the response rate was over 30% in patients with head/neck, bladder, or breast cancer, and the survival rate was superior to that previously reported in Japanese studies. Two comparative studies suggested that UFT was more effective than single-agent tegafur, and a number of combination-chemotherapy studies have shown that it has an advantage in terms of toxicity, response, and/or survival. UFT is also useful for postoperative adjuvant therapy, as well as therapy for advanced disease in a variety of neoplasms. UFT holds considerable promise and future trials should continue the evaluation and refinement of its role in the treatment of cancer.[ONCOLOGY 11(Suppl 10):30-34, 1997]

The phase I development program of tegafur and uracil (UFT) in the United States has included evaluation of the drug as a single agent and subsequent studies of its biochemical modulation by oral leucovorin. Phase I trials of single-agent UFT examined both a 5-day schedule repeated every 21 days and a 28-day schedule repeated every 35 days. In all of the trials the total dose was divided by three and administered three times daily at 8-hour intervals. Like intravenous schedules of fluorouracil (5-FU), UFT has schedule-dependent toxicity, with granulocytopenia being the dose-limiting toxicity for the 5-day regimen and diarrhea being the dose-limiting toxicity for the 28-day regimen. The suggested phase II doses for UFT administered without leucovorin were 800 mg/m2/day for the 5-day schedule and 360 mg/m2/day for the 28-day schedule. Subsequent phase I studies combining UFT with oral leucovorin used a 28-day schedule repeated every 35 days. Diarrhea was the dose-limiting toxicity, and the recommended phase II dose was UFT, 300 mg/m2/day, plus leucovorin, 90 mg/day. Pharmacokinetic evaluation showed that single-dose UFT results in maximum plasma levels and an area under the concentration-time curve that increased with escalating UFT doses. In addition, 5-FU levels were detectable throughout the 28-day dosing period; however, there was no evidence of significant accumulation of uracil, tegafur, or 5-FU. The administration of leucovorin in this trial provided continuous exposure of d,l-leucovorin and 5-methyltetrahydrofolate with little variation between doses or days.[ONCOLOGY 11(Suppl 10):35-39, 1997]

Several trials performed in the United States and Europe have demonstrated the efficacy of UFT (uracil and tegafur in a 4:1 molar combination) with oral leucovorin in the treatment of several tumor types, but particularly

Fujii et al reported that Uracil potentiated the antitumor activity of fluorouracil (5-FU) and 1-(2-tetrahydrofuryl)-5-fluorouracil (tegafur). This effect was due to inhibition of the degradation of 5-FU, yet the phosphorylation of 5-FU was unaffected. The molar ratio of tegafur and uracil was 1:4, a combination that has since been widely prescribed in Japan for the treatment of cancer patients. We present here our experimental and clinical results when investigating the antineoplastic effects of this combination of drugs-known as UFT-and provide evidence that UFT is an effective treatment for patients with cancer. [ONCOLOGY 11(Suppl 10):14-21, 1997]

An open-label, randomized phase III trial has been established to compare the efficacy and safety profile of tegafur and uracil (UFT) plus leucovorin with fluorouracil (5-FU) plus leucovorin as first-line chemotherapy for

The escalating role played by managed care organizations in the health-care system is reflected in the increased demand for cost-effectiveness analyses (CEAs) to assess the balance between economic impact

NEW ORLEANS-After years of hearing about the benefits of mammog-raphy screening, many women still resist the test. A number of posters at the annual meeting of the American Society of Preventive Oncology (ASPO) examined the question of who gets screened, who doesn’t, and why.

WASHINGTON-A funny thing happened to the National Cancer Policy Board (NCPB) on its way to issuing a "white paper" on tobacco control. Between its decision to do so and its public hearing on the issue, the tobacco industry and the attorneys general of 40 states announced their proposed $368.5 billion settlement of the states' lawsuit.

Cancer Care, Inc., a voluntary cancer agency dedicated to providing supportive services for people with cancer and their families, is providing copies of Cancer Care Briefs-single-page information sheets that help cancer patients cope with their

NEW YORK-In a presentation sponsored by the American Cancer Foundation, Ernst Wynder, MD, boiled down what he has learned from five decades of cancer research into three basic principles: Cancer is not an inevitable consequence of aging; cancer is usually due to metabolic overload; and cancer can be prevented by “listening to nature” without a thorough understanding of its molecular biology.

The map shown in Figure 1 provides the annual rates of acquired immunodeficiency syndrome (AIDS) per 100,000 population, by state of residence from January through December 1996. Table 1 lists the metropolitan areas with the 50

CHAPEL HILL, NC-Men infected with HIV who also have another sexually transmitted disease (STD) have approximately an eightfold increase in the amount of HIV in their semen, compared with men who do not have a second sexually transmitted disease, a study conducted in Africa has shown.

WASHINGTON-Children living in the western United States in the 1950s learned to “duck and cover” at school in case of a nuclear attack, unaware that a more tangible nuclear danger lay in their lunchtime milk cartons.

Combined-modality therapy integrating chemotherapy with radiotherapy and/or surgery is playing an increasing role in the day-to-day management of a wide variety of solid tumors. No longer is this approach solely a clinical research tool. In fact, in

MENLO PARK, Calif-Neurex Corporation has announced a pause in enrollment of a trial of intravenous SNX-111 for patients with severe head trauma, to review data from earlier studies for overall risk/benefit. The agent is an N-type neuron-specific calcium blocker derived from the venom of the cone snail.

WASHINGTON-In its review of the proposed tobacco settlement, the American Cancer Society (ACS) recommended a number of changes it considers essential.

NEW YORK-Today’s treatments for lung cancer are much better tolerated than treatments used 20 years ago, Robert Ginsberg, MD, chief of the Thoracic Service, Memorial Sloan-Kettering Cancer Center, said at an NIH video satellite symposium beamed to 20 selected centers nationwide.

MONTREAL-A group of Canadian physicians hope to spark renewed interest in the use of infrared breast imaging as a complement to mammography.