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BETHESDA, Md-National Cancer Institute director Richard D. Klausner, MD, has taken strong exception to two criticisms leveled at NCI in a recent Institute of Medicine (IOM) report on NIH research programs for minorities and the medically underserved . Dr. Klausner told the National Cancer Advisory Board (NCAB), “there are clearly either misunderstandings or profound philosophical differences.”

Protease inhibitors, routinely used to treat the human immunodeficiency virus (HIV) in the United States, are highly effective against the subtype C viral strain thought to be most prevalent worldwide, report Stanford researchers.

Waldenström’s macroglobulinemia is a rare, low-grade lymphoproliferative disorder for which few therapies are effective. Although patients with Waldenström’s macroglobulinemia often are reported with cases of small lymphocytic lymphoma, this disease has characteristic lymphoplasmacytic histology, bright CD20 expression, and IgM paraproteinemia. Rituximab (Rituxan) is a chimeric anti-CD20 monoclonal antibody that produces a 50% response rate in previously treated low-grade lymphoma, but has no previously described efficacy in the Waldenström’s macroglobulinemia subtype. We report 7 patients with Waldenström’s macroglobulinemia treated on clinical trials performed by IDEC Pharmaceuticals (N = 6) or at our institution (N = 1). Characteristics of these patients included a median age of 60 years (range, 50-75 years) with 5 being female. All patients were symptomatic, with a median performance status of 1 (range, 1-3), with all having measurable disease independent of paraproteinemia.

Our studies have shown that unconjugated antibody therapy targeted to the B-cell marker CD20 by the anti-CD20 antibody, C2B8, inhibits the growth of B-cell lymphomas in vitro. We have also demonstrated that B-lymphoma tumor cells can be sensitized to subtoxic doses of therapeutic drugs by the same antibody.

Several published reports have suggested that although there is a lesser relapse rate for allogeneic bone marrow transplantation (BMT) compared to autologous BMT in patients with low-grade lymphoma, no survival advantage was evident because of higher toxicity associated with allogeneic BMT. To address this issue, we compared outcome in 38 patients with low-grade lymphoma who received allogeneic BMT to 72 patients who underwent autologous BMT at our institution.

Splenomegaly has been considered by some to be a contraindication to monoclonal antibody immunotherapy or

Dr. Nag and colleagues present an excellent review of several of the techniques of brachytherapy used in both the pediatric and adult populations. The authors are to be commended for their comprehensive summary of the results of the major trials of pediatric brachytherapy in the management of soft-tissue sarcomas.

COLLEGEVILLE, Penn-Lovenox (enoxaparin sodium) Injection, from Rhône-Poulenc Rorer Inc., has received FDA approval for the inpatient treatment of acute deep-vein thrombosis (DVT) with or without pulmonary embolism and the outpatient treatment of acute DVT without pulmonary embolism. Both indications require that Lovenox be administered in conjunction with warfarin sodium.

Combination chemotherapy, such as CHOP (cyclophosphamide, doxorubicin HCl, Oncovin, and prednisone), or purine analogs, such as fludarabine (Fludara), are commonly used in the treatment of alkylating agent–resistant, relapsed, low-grade B-cell non-Hodgkin’s lymphoma (NHL). Response rates of around 50% are seen, with median remission duration of 6 to 9 months.

Apanel that included top oncologists at some of the nation’s premier cancer centers criticized the National Cancer Institute(NCI) for not looking behind statistics showing that poor people and ethnic minorities have higher cancer rates in some instances. The Institute of Medicine (IOM), which is part of the National Academy of Sciences, chartered the Committee on Cancer Research Among Minorities and the Medically Underserved. Representatives from the Robert Lurie Cancer Center, Fox Chase Cancer Center, Memorial Sloan-Kettering Cancer Center, and the Stanley S. Scott Cancer Center sat on the committee, which was chaired by M. Alfred Haynes, the former president and dean of the Drew Postgraduate Medical School.

COLUMBUS, Ohio-A trial sponsored by NOAT (Society for Nutritional Oncology Adjuvant Therapy) is examining the effect of eating high-fiber cereal on patients with colon polyps, Daniel Nixon, MD, president of NOAT, said at the group’s 4th Annual Congress.

Actress Jane Seymour, a strong advocate of alternative cancer therapies, was the headlining witness at hearings of the Government Reform Committee held on February 24. Rep. Dan Burton (R-Ind.), chairman of the committee, held the hearings to find out whether federal agencies-be they health care providers, such as Medicare, or research-based, such as the NCI-are aggressive enough in promoting alternative therapies. Those like Burton, who feel that federal agencies have to be more aggressive, support the “Access to Medical Treatment Act,” a bill promoted in the last two Congresses, and again in this one, by Rep. Peter DeFazio (D-OR). DeFazio’s bill had a hearing in 1998 in Burton’s committee, which has no legislative jurisdiction.

We and others have recently confirmed that arsenic trioxide (As2O3) induces a complete remission (CR) in a high proportion of patients

WASHINGTON-In an agreement negotiated by the National Institutes of Health and the American Association of Health Plans, the association says it will encourage its members to “reimburse the routine patient-care costs associated with NIH-sponsored clinical trials, provided those costs are not substantially higher than the costs a plan would incur in the course of standard treatment.”

Rituximab (Rituxan) was recently approved for use in relapsed and previously treated low-grade non-Hodgkin’s lymphoma (NHL); however, little data exist regarding the safety of this agent in patients with hematologic malignancies who have a high number of tumor cells in the blood. We describe our preliminary experience with two such patients in whom we noted a rapid reduction of blood tumor cells, which was associated with severe pulmonary infusion-related toxicity and thrombocytopenia. Two additional patients were collected from physician-submitted reports of adverse events related to rituximab treatment.

With the aim to overcome the limitations of ex vivo bone marrow purging, we have assessed the ability of the anti-CD20 monoclonal antibody rituximab (Rituxan), given in combination with chemotherapy, to eradicate polymerase chain reaction (PCR)–detectable disease, and to enable the harvesting of large amounts of uncontaminated peripheral blood progenitor cells in patients with low-grade lymphoma (in vivo purging). From April 1997 to July 1998, 20 consecutive patients entered the study. Eligibility included age £ 60 years, a diagnosis of untreated mantle cell lymphoma or of refractory/early relapsed follicular lymphoma, CD20 expression by tumor cells, histologic bone marrow infiltration, and availability of a molecular marker for minimal residual disease detection.

Rituximab (Rituxan) is active in low-grade non-Hodgkin’s lymphoma (NHL), but its efficacy in poor-prognosis intermediate-grade NHL is unknown. To address this issue, we administered rituximab to seven patients with CD20-positive diffuse large cell NHL who had progressive disease despite high-dose therapy and peripheral stem-cell transplantation (PSCT). The median age was 59 years (range, 45-62 years) with ECOG performance status 0-1. Prior to rituximab therapy, all patients had undergone PSCT, with responses of two complete responses (CRs), two partial responses (PRs), one patient with stable disease (SD), and two patients with progressive disease (PD). The CRs lasted 9 and 11 months. Upon relapse or progression of disease, the patients received 4 weekly infusions of rituximab (375 mg/m²).

COLUMBUS, Ohio-Recent experiments with rats showed that a restricted-calorie diet led to reductions in prostate tumor size and progression, Steven K. Clinton, MD, PhD, said at the Society for Nutritional Oncology Adjuvant Therapy (NOAT) meeting. Dr. Clinton is director of Cancer Prevention, James Cancer Hospital and Solove Research Institute, Ohio State University

WASHINGTON-The FDA has approved Orphan Medical’s Busulfex (busulfan) Injection for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia (CML). (See Oncology News International, February 1999, for a report on the Oncology Drugs Advisory Committee’s discussion of the agent and its recommendation to the FDA.)

SAN FRANCISCO-Preliminary results of a prospective Centers for Disease Control and Prevention study of nearly 45,000 US patients show a dose-response relationship between anti-HIV regimens incorporating protease inhibitors (highly active antiretroviral therapy or HAART) and decreased HIV-related mortality.

COLUMBUS, Ohio-A large research study has validated a short questionnaire for cancer patients designed to assess nutritional risk and to establish a triage system for intervention, Faith Ottery, MD, PhD, president of Ottery & Associates, Oncology Care Consultants, said at the Fourth Annual Congress of the Society for Nutritional Oncology Adjuvant Therapy (NOAT). Dr. Ottery founded NOAT in 1993.

BETHESDA, Md-The presidentially appointed National Cancer Advisory Board (NCAB) has expressed its concern that President Clinton’s proposed budget increase of 2.4% for the National Cancer Institute is inadequate and will seriously damage the National Cancer Program “over the short and long term.”

The success of purine nucleoside analogs in the treatment and management of indolent leukemias has generated interest in

NEW YORK-Although a cure for non-Hodgkin’s lymphoma remains elusive, several potential new approaches could bolster remissions, Richard I. Fisher, MD, told patients during a Cancer Care, Inc. teleconference.

Clinical trials with yttrium-90 and iodine-131 radioimmunotherapy have demonstrated efficacy in the treatment of non-

WASHINGTON-About one-third of patients who undergo cancer chemotherapy and/or radiation treatments suffer serious oral complications, many of which could be mitigated. Four federal health agencies have joined together in a national campaign to make oncologists and other health care providers more aware of the problem and how to deal with it.

Unlabeled monoclonal antibodies (MoAbs) are attractive for the treatment of non-Hodgkin’s lymphoma (NHL) as they may: (1) mediate cytotoxicity with complement (complement-dependent cytotoxicity [CDC]) or effector cells (antibody-dependent cellular cytotoxicity [ADCC]); (2) effect apoptosis; (3) be less toxic, less immunogenic, and more effective than toxin- or drug-conjugated MoAbs; (4) not require the complex procedures needed for radiolabeled MoAb therapy (RIT); and (5) not produce the myelosuppression typical of high-dose RIT.

Rituximab (Rituxan) is the first monoclonal antibody (MoAb) approved for the treatment of non-Hodgkin’s lymphoma (NHL). This anti-CD20 MoAb is effective in inducing apoptosis, complement-dependent cytotoxicity (CDC), and antibody-dependent cellular cytotoxicity (ADCC). In single-agent studies in relapsed or refractory low-grade or follicular NHL (International Working Formula [IWF] types A-D), an overall response rate (ORR) of 48% has been reported.

Age is a risk factor and a prognostic parameter in elderly high-grade non-Hodgkin’s lymphoma (NHL) patients. Several

Drs. Peeters and Haller provide a thorough review of the recent historical development, current state of knowledge, and future of adjuvant therapy for early-stage colon and rectal cancers. They provide reasonable recommendations for the