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Hematologic Oncology

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WASHINGTON -The Food and Drug Administration, acting with dispatch, has approved the marketing of Gleevec (imatinib mesylate, Novartis) for the treatment of chronic myeloid leukemia (CML). The agency granted the drug priority review and orphan drug status, and approved it under the FDA’s "accelerated approval" regulations less than 3 months after the sponsor submitted its marketing request.

SAN FRANCISCO-Patients with acute myeloid leukemia (AML) in first relapse who achieve remission with the antibody gemtuzumab ozogamicin (Mylotarg) before undergoing stem cell transplantation have prolonged disease-free survival, according to research presented at the 42nd Annual Meeting of the American Society of Hematology (ASH).

NEW YORK-The promise of molecularly targeted therapies has been validated in chronic myelogenous leukemia (CML), Brian J. Druker, MD, of Oregon Health Sciences University, Portland, said at the Chemotherapy Foundation Symposium XVIII. "This disease has provided an ideal opportunity to test the concept that drugs targeted against a tumor-specific abnormality will have therapeutic utility," he said.

SAN FRANCISCO-Patients receiving monoclonal antibody-targeted chemotherapy with gemtuzumab ozo-gamicin (Mylotarg) rather than conventional combination chemotherapy for first relapse of acute myelogenous leukemia (AML) are more likely to be treated as outpatients, resulting in considerable cost savings, according to a study from Fred Hutchinson Cancer Research Center and Wyeth-Ayerst Research.

SAN FRANCISCO-Results of a phase II, open-label, multicenter study show that the investigational agent STI571 holds promise for many patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) whose disease has proved resistant to interferon therapy.

ASCO-STI-571, an investigational drug that has high activity in benign-phase chronic myelogenous leukemia (CML), also produces significant hematologic responses in patients with advanced-stage CML or acute forms of leukemia, Moshe Talpaz, MD, said at the 36th annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans.

ASCO-Mylotarg (gemtuzumab ozogamicin) has received FDA approval for treatment of CD33-positive acute myelogenous leukemia (AML) in patients age 60 and older in first relapse who are poor candidates for cytotoxic therapy. The agent, manufactured by Wyeth-Ayerst, was approved as an orphan drug.

PORTLAND, Oregon-A rationally designed drug now known as STI 571 is both effective and well tolerated in treating certain leukemia patients that have not responded to other therapies. The results of two phase I clinical trials using STI 571 for chronic myelogenous leukemia (CML) and acute lymphoblastic leukemia (ALL) were reported by Brian Druker, MD, of the Oregon Health Sciences University in Portland, at the ASH meeting. The trials were conducted in collaboration with M.D. Anderson Cancer Center in Houston, Novartis Pharmaceuticals in East Hanover, New Jersey, and the University of California at Los Angeles.

NEW YORK-Acute myelogenous leukemia (AML) is an aggressive disease. But improved diagnosis with cytogenetic examinations and other special studies have made it possible to select the most effective induction therapy, Frederick R. Appelbaum, MD, told patients at a teleconference sponsored by Cancer Care Inc. and the Leukemia Society of America.

NEW ORLEANS-STI 571, an investigational drug for the treatment of chronic myelogenous leukemia (CML), produced complete hematologic responses in all patients receiving higher doses, according to preliminary analysis of phase I data presented at the 41st Annual Meeting of the American Society of Hematology (ASH) (see illustration ). All participants had failed interferon-alfa therapy.

High-dose therapy with hematopoietic progenitor-cell transplantation plays a key role in the treatment of Hodgkin’s disease and the non-Hodgkin’s lymphomas. First and foremost, transplantation is used as a salvage treatment for those who relapse or do not achieve a complete remission with first-line chemotherapy. Carefully selected patients with poor prognostic features may benefit from the incorporation of high-dose therapy and transplant into their initial treatment programs. Despite a myriad of trials, many pivotal questions regarding the appropriate application of high-dose therapy with transplantation to the lymphoid malignancies remain unsettled, including the role of allogeneic transplantation and the optimal timing of transplant for patients with poor prognostic indicators. Phase III studies are required to address these issues; these trials will demand the active commitment of concerned transplanters and referring hematologists and oncologists. Although autologous transplantation has been the preferred approach for the majority of patient subgroups, new approaches to allogeneic transplantation that have diminished toxicity may pave the way for a greater role for allogeneic grafting in the lymphoid diseases. [ONCOLOGY 13(12):1635-1645, 1999]

Data published in a recent issue of Blood suggest that valspodar (Amdray), a multidrug resistance modulator being developed by Novartis Pharmaceuticals Corporation, may show promise in treating certain patients with acute myelogenous leukemia

MIAMI BEACH-Long-term follow-up of 23 patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in first complete remission showed a relatively low relapse rate at 3 years when treated with allogeneic bone marrow transplant from HLA-matched siblings, D.S. Snyder, MD, reported at the American Society of Hematology (ASH) annual meeting.

TUCSON-Cyclosporine (Sandimmune) significantly reduces resistance to daunorubicin (Cerubidine), prolongs the duration of remission, and improves overall survival of patients with high-risk acute myelogenous leukemia (AML), Alan F. List, MD, of the University of Arizona, said at the ASH meeting. Dr. List’s observations were based on a randomized trial conducted with the Southwest Oncology Group.

SEATTLE-Preliminary phase II data show that CMA-676, an engineered human anti-CD33 antibody linked to calicheamicin, a potent cytotoxic agent, produced an objective response in 10 of 23 patients (43%) with acute myelogenous leukemia in first relapse after initial chemotherapy. Six responders went on to allogeneic bone marrow transplant.

GOTEBORG, Sweden-A postconsolidation regimen of low-dose interleukin-2 (IL-2) and the investigational agent histamine dihydrochloride (Maxamine) appears to increase leukemia-free survival in acute myelogenous leukemia (AML) patients in remission, Bo I. Nilsson, MD, PhD, reported at an ASH poster session.

GAITHERSBURG, Md-The Oncologic Drugs Advisory Committee (ODAC) has unanimously recommended the approval of Busulfex Injection (busulfan, Orphan Medical) in combination with other chemotherapeutic agents and/or radiation as a conditioning regimen prior to hematopoietic progenitor cell transplantation-but only in chronic myelogenous leukemia (CML).