Targeted Therapy Causes Chronic Lymphocytic Leukemia Remission
A new, targeted therapy has produced durable remissions in patients with relapsed or treatment-resistant chronic lymphocytic leukemia (CLL), according to the results of a multicenter phase I/II trial.
“PCI-32765, one of a new class of experimental drugs called B cell receptor inhibitors, has shown impressive potential in this clinical trial for its effectiveness and relatively minimal toxicity,” said lead investigator Susan O’Brien, M.D., a professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center.
PCI-32765 is administered orally and inhibits Bruton tyrosine kinase, which is central to B cell receptor signaling. Disrupting this signaling induces apoptosis (cell death) and hinders cell migration and adhesion in malignant B cells.
In the clinical trial, 61 patients received a daily dose of either 420 mg or 840 mg of PCI-32765. Of the 27 patients receiving 420 mg daily, 67% had experienced a complete or partial remission at a median follow-up of 10.2 months.
Of the 34 patients receiving 840 mg daily, 68% achieved a complete or partial remission at a median follow-up of 6.5 months, which was similar to the response rate of the lower-dose cohort at 6.2 months.
The 6-month progression-free survival rates were 92% and 90% for the 420-mg and 840-mg cohorts, respectively. Serious adverse events considered potentially related to PCI-32765 occurred in only 10% of patients. “The main side effect is mild diarrhea that is usually self-limiting,” said Dr. O’Brien, who added that unlike the standard combination chemotherapies used to treat CLL, PCI-32765 is not myelosuppressive.
The results of the trial were reported at the 53rd Annual Meeting of the American Society of Hematology in December. A phase III clinical trial of PCI-32765 is being planned.
Study Finds Acupuncture Can Prevent Radiation-Induced Chronic Dry Mouth
Acupuncture performed on patients receiving radiation therapy can reduce the severity of xerostomia and other side effects, according to researchers at The University of Texas MD Anderson Cancer Center and Fudan University Shanghai Cancer Center.
The findings from the first randomized controlled trial of acupuncture for the prevention of xerostomia were reported in the journal Cancer.
Xerostomia, or severe dry mouth, is characterized by reduced salivary flow and commonly affects patients receiving radiation therapy for head and neck cancer.
“There have been a number of small studies examining the benefits of acupuncture after xerostomia develops, but no one previously examined if it could prevent xerostomia,” said principal investigator Lorenzo Cohen, Ph.D., a professor in the Department of General Oncology and the Department of Behavioral Science and the director of the Integrative Medicine Program at MD Anderson. “We found that incorporating acupuncture alongside radiation therapy diminished the incidence and severity of this side effect.”
In the study, 86 patients receiving radiation therapy for nasopharyngeal carcinoma at Fudan University Shanghai Cancer Center were randomly assigned to receive acupuncture or the standard of care. The 40 patients in the acupuncture group received acupuncture therapy three times per week during the 7-week course of radiation therapy. Patients were evaluated before beginning radiation therapy, weekly during therapy, and then again 1 and 6 months after the completion of therapy.
During evaluations, investigators measured saliva flow, and patients completed two questionnaires that assessed symptoms consistent with xerostomia as well as other cancer-related symptoms and their interference with quality of life.
One month after the end of radiation therapy, 54% of the acupuncture group and 86% of the control group reported clinically significant xerostomia symptoms. Six months after the completion of radiation therapy, 24% of the acupuncture group and 63% of the control group still reported xerostomia symptoms. Saliva flow rates were higher for patients in the acupuncture group than for those in the control group starting at 3 weeks into radiation therapy and persisting through the 6-month follow-up visit.
Acupuncture also reduced the severity of cancer-related symptoms other than xerostomia; the differences between the acupuncture and control groups emerged at 3 weeks and continued through the 6-month follow-up visit.
“The medical implications are quite profound in terms of quality of life because while chronic dry mouth may sound benign, it has a significant impact on sleeping, eating, and speaking,” Dr. Cohen said. “Without saliva, there also can be an increase in microbial growth, possible bone infection, and irreversible nutritional deficits.”
Further research is ongoing, including a large trial being conducted at MD Anderson and Fudan University Shanghai Cancer Center in which patients undergoing radiation therapy for head and neck cancer receive one of two forms of acupuncture or the standard of care. Researchers will examine saliva flow along with other measures to better determine the mechanisms of acupuncture’s effect.
For more information, talk to your physician, visit www.mdanderson.org, or call askMDAnderson at 877-632-6789.
Other articles in OncoLog, February 2012 issue: