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With three available tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia (CML), attention has turned from the ability to achieve a sustained response to the possibility of “curing” patients. Updates of pivotal trials presented at ASCO may help define the role of the tyrosine...
The third-generation tyrosine kinase inhibitor ponatinib showed robust efficacy in the 10-month follow-up of the phase II PACE trial (Ponatinib Ph+ALL and CML Evaluation), which is evaluating ponatinib in treatment-refractory chronic myeloid leukemia (CML)1 At the 2012 ASCO Annual Meeting, Jorge E. ...
Agents with novel mechanisms of action may strongly impact outcomes in chronic lymphocytic leukemia (CLL) and acute lymphocytic leukemia (ALL), if data from early-phase studies presented at this year’s ASCO Annual Meeting are any indication. There is a clear unmet need for more effective therapies...
The FDA has approved vincristine sulfate liposome injection (Marqibo) to treat adults with Philadelphia chromosome–negative acute lymphoblastic leukemia (ALL). Administered once a week, liposomal vincristine is approved for patients whose leukemia has relapsed two or more times, or whose leukemia...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Computed tomography scans with...
The FDA has approved bosutinib (Bosulif) to treat chronic myelogenous leukemia (CML). The drug is intended for patients with chronic, accelerated, or blast phase Philadelphia chromosome–positive CML who are resistant to or who cannot tolerate other therapies, including imatinib (Gleevec). The...
As tyrosinse kinase inhibitors become increasingly effective in treating chronic myeloid leukemia (CML), major molecular responses (≥ 3-log reduction in BCR-ABL transcripts) are being achieved for a growing percentage of patients. “In the new era of tyrosinse kinase inhibitors, we are learning how...
Key studies on cancer epidemiology and prevention delivered both reassuring and not-so-reassuring findings on exposure to agents believed to be cancer-promoting. Kala Visvanathan, MD, MHS, of The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine and School of Public Health, Baltimore,...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In September 4, 2012, bosutinib (Bosulif) was approved...
Bosutinib (Bosulif) is an oral dual Src/Abl kinase inhibitor that is active against many Bcr-Abl mutations associated with imatinib (Gleevec) resistance and that has reduced activity against nonspecific molecular targets associated with toxicities reported for other second-generation kinase...
Contradicting what some previous investigations have found, a study from The US Oncology Network found that adjuvant chemotherapy for breast cancer does not increase the risk of acute myeloid leukemia and myelodysplastic syndromes (AML/MDS), at least within the first 3 years of treatment.1 The...
Speakers at the National Comprehensive Cancer Network (NCCN) 7th Annual Congress on Hematologic Malignancies reviewed the current standard of care for various hematologic cancers and explored new concepts in treatment. Below are highlights from presentations on chronic myelogenous leukemia (CML),...
Chronic lymphocytic leukemia (CLL) is mainly a disease of the elderly, and the lack of a standard regimen for elderly patients has been a major challenge. The myelosuppressive regimens used to treat younger patients are not well tolerated by the elderly. However, some newer approaches currently...
Health-care professionals should report all serious adverse events suspected to be associated with the use of any medicine or device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178), by mailing the postage-paid...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In August 2012, vinCRIStine sulfate LIPOSOME injection...
Among patients aged 70 years and older with chronic lymphocytic leukemia (CLL), “front-line therapy with fludarabine does not improve outcomes” compared to chlorambucil (Leukeran), according to an analysis of patients enrolled in successive front-line Cancer and Leukemia Group B (CALGB) studies...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On October 26, 2012, the FDA granted accelerated...
Although still in preliminary testing with no phase III data, ibrutinib is poised to become an important new agent for patients with chronic lymphocytic leukemia (CLL). Two phase II trials reported at the 54th Annual Meeting of the American Society of Hematology (ASH) found that ibrutinib achieved...
In December, the FDA granted accelerated approval to ponatinib (Iclusig) for the treatment of adult patients with chronic-, accelerated-, or blast-phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome–positive...
The pivotal phase II Ponatinib Ph+ ALL and CML Evaluation (PACE trial) found that 1 year of treatment with the novel investigational drug ponatinib achieved robust activity in heavily pretreated patients with chronic myeloid leukemia (CML) and Philadelphia chromosome–positive acute lymphoblastic...
James F. Holland, MD, began his journey into oncology when it was still a nascent discipline, working alongside groundbreaking pioneers in the field such as Drs. Emil “Tom” Frei and C. Gordon Zubrod. Dr. Holland recently shared a glimpse of his role in oncology’s formative years with The ASCO Post. ...
Omitting cranial irradiation from the treatment regimen for acute lymphoblastic leukemia (ALL) may help preserve global cognitive abilities. “Treatment with chemotherapy alone is not without risks,” however, noted researchers from St. Jude Children’s Research Hospital in Memphis. “The St. Jude...
Single-agent inotuzumab ozogamicin achieved an encouraging overall response rate of 57% in the treatment of relapsed/refractory acute lymphoblastic leukemia (ALL) in a phase II trial reported at the 54th Annual Meeting of the American Society of Hematology (ASH). Response was independent of monthly ...
Research led by scientists at St. Jude Children’s Research Hospital, Memphis, Tennessee, has identified a possible lead in treatment of two childhood leukemia subtypes known for their dramatic loss of chromosomes and poor treatment outcomes. The findings also provide the first evidence of the...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication On December 14, 2012, ponatinib (Iclusig) was granted...
The work of an American Society of Hematology (ASH) international clinical network collaborative focused on modernizing treatment protocols for patients in the developing world with acute promyeloctyic leukemia (APL) has drastically improved cure rates in patients in Central and South America. In...
The 54th Annual Meeting of the American Society of Hematology (ASH) featured about 5,000 abstracts, including oral sessions and posters, as well as named lectures and symposia. In addition to our regular news coverage from the meeting, below are capsule summaries of a few news highlights that we...
The risk for developing a secondary malignancy after chemotherapy for breast cancer is very small, but it is statistically significantly higher than for the general population, a review of the National Comprehensive Cancer Network (NCCN) database revealed in a study presented at the 2012 San...
Omitting daunorubicin from induction therapy for children with standard-risk acute B-cell lymphoblastic leukemia (ALL) does not compromise survival and at the same time reduces the risk of associated toxicities, including myelosuppression and cardiac damage, according to results of the large phase...
Over the past 2 decades, we have witnessed remarkable progress in the treatment of patients with acute promyelocytic leukemia (APL). The introduction of all-trans retinoic acid (ATRA) in the front-line therapy setting and arsenic trioxide in the relapse setting had already led to a significant...
For the first time, a chemotherapy-free regimen was superior to conventional cytotoxic chemotherapy for the treatment of acute promyelocytic leukemia (APL). The combination of all-trans retinoic acid (ATRA) plus arsenic trioxide (Trisenox) achieved significantly superior overall survival compared...
The word “revival” signifies a renewed use or acceptance after a period of inactivity; similarly, the word “resurrection” refers to the concept of an entity coming back to life after death. In the past year, these terms have been used frequently by us (and others) in articles calling for the return ...
The FDA approved a new use of imatinib (Gleevec) to treat children newly diagnosed with Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL). ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated....
At the 54th Annual Meeting of the American Society of Hematology (ASH), held in Atlanta, nearly 5,000 abstracts were presented in oral sessions and posters. As part of our ongoing comprehensive coverage from the meeting, here are several more studies of note. New Targets in Acute Myeloid Leukemia...
Waiting a short period of time for laboratory results to better characterize acute myeloid leukemia (AML) and design therapeutic approaches is a reasonable strategy, researchers in Toulouse, France, found after a retrospective review of 599 newly diagnosed AML patients treated by induction...
Patients ≥ 50 years old with leukemia/lymphoma are increasingly undergoing allogeneic hematopoietic cell transplants, raising questions about whether they might have better outcomes with transplants from younger allele-level 8/8 human leukocyte antigen (HLA)-matched unrelated donors than from...
The investigational oral FLT3 inhibitor quizartinib appears to be a safe and effective treatment for patients with relapsed or refractory acute myeloid leukemia (AML), according to results of a phase II trial presented at the 54th Annual Meeting of the American Society of Hematology (ASH) in...
Apogenix GmbH, a biopharmaceutical company developing novel protein therapeutics for the treatment of cancer and inflammatory diseases, announced that its lead compound, APG101 (Apocept), has been granted orphan drug designation from the FDA for the treatment of myelodysplastic syndromes (MDS)....
The authors are to be congratulated for successfully conducting a randomized study of FLAG (fludarabine, cytarabine, and granulocyte colony-stimulating factor [Neupogen]) vs FLAG plus liposomal daunorubicin (DaunoXome) in relapsed pediatric acute myeloid leukemia (AML). The difficulty in conducting ...
Optimal reinduction therapy for patients with relapsed pediatric acute myeloid leukemia (AML) remains undefined. Liposomal daunorubicin (DaunoXome), which offers the potential for reduced cardiotoxicity compared with traditional daunorubicin, is effective in this setting. Gertjan J.L. Kaspers, MD,...
In August 2011, researchers from the University of Pennsylvania published their breakthrough findings of a pilot study showing sustained remissions of up to 1 year in a small number of patients with advanced chronic lymphocytic leukemia (CLL) who had been treated with genetically engineered...
First, a clarification: Homoharringtonine is a natural plant alkaloid derived from Cephalotaxus fortunei; from the 1970s until the present, it was the subject of intensive research efforts by Chinese investigators to clarify its role as an antileukemic agent.1-3 Omacetaxine mepesuccinate (Synribo)...
Among 3,919 patients with acute myeloid leukemia (AML) who did not undergo transplantation in first complete remission, 1,271 relapsed and 19% were successfully treated with salvage therapy, according to an analysis of three AML trials in the United Kingdom. This percentage can be improved with a...
Adding bortezomib (Velcade) to standard daunorubicin and cytarabine induction chemotherapy for acute myeloid leukemia (AML) “resulted in an encouraging remission rate” in previously untreated older adults, according to results of Cancer and Leukemia Group B (CALGB/Alliance) study 10502. The...
Early trial results in single-agent therapy with the oral Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib have produced excellent responses in patients with chronic lymphocytic leukemia (CLL). Moreover, ibrutinib is extremely well tolerated, allowing patients to remain on trial and receive the...
The RESONATE trial is randomly assigning patients with refractory or relapsed CLL to either ofatumumab (Arzerra) or the investigational oral agent ibrutinib. Ofatumumab is an anti-CD20 monoclonal antibody like rituximab (Rituxan), but is more potent as a single agent. It was approved for refractory ...
High-dose monotherapy with vincristine sulfate liposome injection (Marqibo) resulted in meaningful clinical outcomes, including durable responses and bridging to hematopoietic cell transplantation, in adult patients with advanced, relapsed, and refractory Philadelphia chromosome (Ph)-negative acute ...
Forty years ago, President Richard Nixon announced a “war on cancer.” Some of that war’s first battles were won in the field of acute myeloid leukemia (AML) with two agents, cytarabine and daunorubicin, receiving U.S. Food and Drug Administration (FDA) approval based on their ability to produce...
Two small phase I studies at separate centers demonstrated encouraging results in the treatment of children with acute lymphoblastic leukemia (ALL) using reinfused autologous genetically engineered T cells. Results of both studies were presented at the Annual Meeting of the American Association for ...
Results from an ongoing phase II study reported at the recent Annual Meeting of the American Association for Cancer Research (AACR) demonstrate impressive activity with the use of ibrutinib in patients with chronic lymphocytic leukemia (CLL) and 17p deletions, which are associated with a poor...