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Velcade Subcutaneous Injections Show Similar Activity But Fewer Side Effects Compared To IV Injections In Myeloma Patients (ASH 2010)

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Published: Dec 13, 2010 3:23 pm

The use of subcutaneous injections to deliver Velcade treatment is comparable in activity, but associated with fewer side effects, than the standard delivery of IV injections in multiple myeloma patients.

“We have similar efficacy with subcutaneous [injections] and a more convenient route of administration for patients, especially those with poor venous access. We don’t require IV central lines, and we do have, most importantly, a reduction in toxicities, which, in my opinion, is really important for our patients,” said Dr. Philippe Moreau, the lead investigator of the University Hospital in Nantes, France, when he presented the study results at the American Society of Hematology (ASH) annual Meeting in Orlando last week.

In Europe and the United States, Velcade (bortezomib) is currently approved as an IV injection.

However, IV injections are inconvenient for patients with poor vein access because patients require repeated IV access and, in some cases, long-term central venous access devices.

A new formulation of Velcade is under development, that can be given as a subcutaneous injection (a shot of medicine directed to the layer of fat found underneath the outermost layers of skin). This may be more convenient for many patients, since subcutaneous injections typically can be administered at home by caregivers or patients themselves.

Research from a previous randomized Phase 1 trial suggested that both subcutaneous and IV injections produced similar response rates and side effect profiles.

In order to confirm these preliminary findings, Dr. Moreau and his colleagues organized a large, international, randomized, Phase 3 trial with 222 previously treated myeloma patients. Patients who had prior Velcade therapy, more than three previous therapies, or severe peripheral neuropathy (pain and tingling in the arms and legs) were not included in the study.

Of the 222 patients in the study, 148 patients received subcutaneous injections, and 74 patients received IV injections.

Patients in both treatment groups received 1.3 mg/m2 of Velcade on days 1, 4, 8, and 11 of a 21-day treatment cycle.

All patients received Velcade as a single agent for the first four cycles; however, if patients did not show a response or improvement in response, they could receive an additional 20 mg of dexamethasone (Decadron) on the day of and day after Velcade injections. After eight cycles of treatment, patients could receive an additional two cycles if they did not achieve a confirmed partial response.

Patients in both treatment groups received a median of eight treatment cycles. The median time to response in both treatment groups was 1.4 months. Approximately half of the patients in both treatment groups received dexamethasone after four cycles (53 percent IV vs. 56 percent subcutaneous).

Data collected after both four and eight cycles of treatment indicated that the response rates for both treatment arms were identical “There is really no difference regarding efficacy comparing IV and subcutaneous data,” said Dr. Moreau.

The median time-to-progression was 9.4 months for IV and 10.4 months for subcutaneous. According to Dr. Moreau, these findings are superior to the results from the previous study. He explained that this is most likely related to the fact that patients could receive dexamethasone after four cycles of treatment.

There was no difference in the overall survival data for the two treatment groups. The one-year survival rate was 76 percent for patients who received IV Velcade and 73 percent for patients who received Velcade subcutaneously.

Although there was no difference in pre-existing conditions between the treatment groups, the frequency of side effects in the subcutaneous group was significantly lower than that of the IV group.

The rate of severe and life-threatening side effects was reduced in the subcutaneous arm (57 percent) compared to the IV arm (70 percent).

In particular, the rate of severe peripheral neuropathy was dramatically reduced in patients receiving subcutaneous injections (6 percent, versus 16 percent in patients receiving IV).  Dr. Moreau said that pre-existing neuropathy was slightly higher in the IV group, but not significantly.

“In my opinion, that is the most important finding of the study,” said Dr. Moreau.

For more information, please refer to abstract 312 on the American Society of Hematology annual meeting website.

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