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Drug-clinical research updates

12/27/2009

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Carfilzomib may benefit patients with relapsed, refractory multiple myeloma.
According to findings reported at the American Society of Hematology meeting, "An investigational proteasome inhibitor led to major responses in about half of patients with relapsed and refractory multiple myeloma," In an ongoing trial of 59 patients, researchers found that "treatment with carfilzomib led to objective response in 25 of 54 (46 percent) evaluable patients, including one complete response and five very good partial responses." The study showed "a disease control rate of 83 percent," with "median response duration" at "8.8 months in patients who had a minor response or better result," and "8.4 months in those who achieved at least a partial response."

Ofatumumab not viable option for patients with follicular lymphoma who failed rituximab.
According to research reported at the American Society of Hematology meeting, "Ofatumumab (Arzerra) monotherapy is not a viable treatment option in patients with follicular lymphoma that doesn't respond to rituximab (Rituxan)". Researchers found that "in 116 patients who failed to achieve at least a partial response to rituximab -- either alone or with chemotherapy -- objective responses occurred in only 11 percent of those taking ofatumumab." Notably, "the response was higher -- 22 percent -- in a subgroup of patients who had failed rituximab monotherapy," which "opens the possibility that ofatumumab might still be helpful in a combination regimen," the researchers noted. Meanwhile, "patients who had failed rituximab in combination with chemotherapy -- either as maintenance or as part of an induction regimen -- had much worse responses."

Drug combo elicits responses in patients with relapsed, refractory mantle-cell lymphoma.
A researcher from Mayo Clinicreported, "Half of patients with relapsed or refractory mantle-cell lymphoma achieved major responses when treated with the investigational agent temsirolimus and rituximab (Rituxan), data from an ongoing clinical study showed".Responses persisted for almost 10 months and demonstrated durability in rituximab-refractory patients," according to MedPage. Ansell added, "We observed complete responses in about 20% of patients, and complete responses are uncommon after transplant failure or in patients who have received multiple regimens."

Once-daily dose of enoxaparin may be feasible for children at high risk of VTE. The study presented at the American Society of Hematology reported, "Researchers said it is feasible to provide once daily dosing of the low molecular weight heparin enoxaparin (Lovenox) to children at high risk of venous thromboembolism”.Pharmacokinetic modeling and data from 126 children -- including neonates, infants and children -- who were administered enoxaparin off-label" to perform "pharmacokinetic analyses." The lead researcher said, "According to these results...a once-daily enoxaparin dosing regimen seems to be feasible for at least 50% of this population."

Bisphosphonates may cut breast cancer risk in postmenopausal women.
A new study that shows a drug a lot of older women already take to protect against bone loss, might also help protect against breast cancer." NBC (Bazell) added, "At a major meeting of breast cancer researchers in San Antonio, the scientists today released the study of the records of 154,000 women" taking "the class of drugs called bisphosphonates, including Actonel [risedronate], Boniva [ibandronate sodium], and Fosamax [alendronate]." Retrospective analysis of data from the Women's Health Initiative" revealed that "there were 3.29 cancers per 1,000 women taking the drugs over the course of a year, compared with 4.38 cancers per 1,000 women not taking the drugs." Researchers calculated that "there were 32 percent fewer new breast cancers among users of oral bisphosphonates."  

Meanwhile, a second study of 4,500 postmenopausal women who took bisphosphonates, presented at the San Antonio Breast Cancer Symposium, showed a 30 percent reduction in breast cancer risk. But, because neither trial randomized women to bisphosphonates, it remains unclear whether the drugs were actually responsible for the drop in cancer risk. Neither study collected information on side effects," even though the drugs "can cause bone, joint, or muscle pain, and in rare cases, jawbone decay." In addition, the analysis of the Women's Health Initiative data showed that "women taking bisphosphonates were more likely to develop a noninvasive tumor of the milk duct called DCIS."  

The researchers "said they would urge that new studies be undertaken comparing the bone drugs with placebos to see if the drugs really do cut the risk of cancer and urged caution in judging the implications for breast cancer prevention." They said, "The findings could mean that bisphosphonates prevent invasive but not in situ breast cancer, prevent the progression of in situ cancer to invasive cancer, or something entirely different."  

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