Lymphoma. Hodgkinlymfomen and non-Hodgkin's disease
Information on current developments in both regular and alternative or complementary treatments and resources for lymphoma - non-Hodgkin's lymphoma and Hodgkin's disease at all stages.
Recent articles in left column more or less in alphabetical order classified
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FDA has serious doubts presented Phase III study results for Pixantrone lymfklierkankerpatienten - non-Hodgkin's where previously failed chemotherapy. Article updated February 9, 2010
February 9, 2010: Source Reuters
The review of the FDA has put big question marks on the presented research data from a Phase III trial for Pixantrone lymphoma - non-Hodgkin. (See this article study results from 2003 with Pixantrone)
In a further analysis of the results of a phase III study showed that only 140 enrolled patients there was progression of the cancer after at least two cycles of chemotherapy. That was less than half the 320 patients initially planned for this study . Cell Therapeutics said the FDA that they were having trouble attracting patients because doctors preferred other follow chemotherapy or palliative care only advised.
In summary, the company said that pixantrone worked better than other drugs with "manageable toxicity." Twenty percent of patients treated with pixantrone met the main goal of the study - halting or even a remission of their lymphoma - non -Hodgkin's lymphoma compared with about 6 percent with another drug.
FDA reviewers also cite the statistics show that pixantrone may have more heart problems and can cause heart damage compared to other chemotherapy or anthracenediones called anthracyclines, known that heart disease and heart damage can cause.
Deaths and complications of severe heart damage and bone marrow appeared to be more common in the group of patients who received pixantrone compared to controls. says an FDA official.
Switzerland's Novartis (NOVN.VX) has an option for a worldwide license to develop and sell pixantrone.
Here is a first message of the good results can Pixantrone from a phase II study was voraf the phase III study:
dated August 25, 2003:
Pixantrone provides remarkable effects of recurrent aggressive non-Hodgkin's where chemo failed.
Pixantrone seems excellent cure for metastatic non-Hodgkin's, which previously failed to chemotherapy, according to a phase II study. 30% of the participating patients responded to treatment with Pixantrone which 17% within two years a full elimination of the disease might experience. This study is published in the August issue of Haematologica, Journal of Haematology (Borch Mann et al, Volume 88, No. 8.). An unusual feature of these results it is also that most study participants already had chemo and other treatments followed but to no avail. Then a 17% complete remission, very special. We must be careful to note that this press release by the company that pixantrone produce was given out, and the study is no longer followed over two years, but it is still a remarkable result compared to statistics from the results of a treatment Non-Hodgkin.
Phase II Results Demonstrate Long Lasting Tumor Responses for
Pixantrone in Relapsed Aggressive NHL
Mercedes Bresso, Italy, August 26 / PRNewswire-FirstCall / - Novuspharma SpA (Nuovo
Mercato: NOV.MI), a biopharmaceutical company focused on Developing Novel
treatments for cancer, today announces the publication of the results of a phase
II study for Pixantrone (BBR 2778) in relapsed aggressive non-Hodgkin's lymphoma
(NHL). These results demonstrated an overall response rate of 30%, with 17% or
Patients experiencing a complete disappearance of Their tumor following
Pixantrone therapy. Response to treatment was long lasting, averaging 11
months, with some patiënten still in remission 24 months following treatment.
Grade 4 neutropenia was the must frequently Reported side effects, observed in 13
Patients and Requiring dose reduction in only 5 patients. Were the results
published in the August issue of Haematologica, Journal of Haematology
(Mann et al Borch, Volume 88, No. 8), in a paper Entitled: Phase II study of the
New aza-anthracenediones BBR 2778 in Patients with relapsed aggressive
non-Hodgkin's lymphomas.
"We are encouraged by the Extremely high rate of durable tumor responses
thesis revealed by results, Especially When One recitals That the Majority of
thesis patiënten Were elderly, had chemotherapy-resistant disease and "almost all
had failed prior anthracycline-containing regimens, "noted Silvano Spinelli,
Chief Executive Officer or Novuspharma.
"This impressive efficacy, coupled with the low incidence of cardiac-related
events despite re-exposure to therapeutic doses or Pixantrone, supports the
Suggested That Pixantrone preclinical profile Which May Be Less toxic and cardio
more effective Than Existing anthracenediones and anthracyclines. Tasks
Phase I together with our experience in a similar population of Patients with
aggressive NHL, this study increases our experience with single agent Pixantrone
to 42 patiënten Where we have observed 7 complete remission and 5 partial
remission. We believe this data to compromise serve as the basis for planning a pivotal
trial in the third-line treatment setting for aggressive NHL, Which We Would Iho
to Initiate early next year. "
Trial Design and Patient Characteristics
This study was an open label, non-randomized, non-comparative, multicentre
Phase II trial, Which patiënten enrolled with relapsed aggressive NHL, as defined
by the REAL classification. Single agent Pixantrone was Administered at 85
mg / m (2) on day 1, 8 and 15 or a 4-week cycle. Pixantrone Belongs to the DNA
intercalator family of chemotherapy agents, Which include the widely Used
anthracenediones and anthracyclines. These agents are associated with a high
rate of tumor responses in blood borne tumoren Such As lymphoma and are
Potentially Curative in front-line therapy. However, the Currently marketed
agents from this class duffer from cumulative cardiotoxicity, Which Prevents
Them being Used in patiënten Those who relapse. Pixantrone was designed by
scientists at Novuspharma by modifying the structure of the Currently marketed
DNA intercalators to remove portions of the molecules Those Responsible for
cardiotoxicity, while retaining Those Responsible for anti-tumor activity.
Of the 33 patients enrolled in the trial, 78% had chemotherapy-resistant
disease, enforcement Received 2 or more prior chemotherapy regimens, with Their
cancer progression within-tion 123 days following treatment Their burden on average.
Patients had Previously Received 300mg/m2 or anthracycline on average (range
100-600mg/m2) Which Would Make Them Typically ineligible for Further Treatment
Currently marketed with anthracycline agents. Pixantrone was Considered as
therapy for relapsed patiënten thesis due to the Potentiallysuperior cardiac
safety profile in preclinical studies, an indication it compared to doxorubicin and
mitoxantrone. Of the 33 patients enrolled, 22 (67%) Were over the age of 65,
25 had advanced stage disease (stage III or IV) and 15 had extra-nodal disease
(Ie Their cancer had spread from the lymphatic system). Of the 33 patients
enrolled, seven had mantle cell lymphoma, a Which represents entry Particularly resistant
and hard-to-treat form of lymphoma.
Efficacy and safety results
The primary Objective of the trial was to Evaluate the efficacy of Pixantrone
In terms of the overall patient response rate (CR + PR) According To the WHO
criteria. Were 30 patients evaluable for a response, or Which Achieved a 5
complete response (CR) and 4 Achieved a partial response (PR), represents an
overall response rate of 30% (27% on an intent to treat basis). 5 Additional
Patients Achieved an UNCONFIRMED partial response (PRU, ie a response
Determined by a single measurement but not confirmed 12 weeks later) and 3
Patients Achieved stable disease. Were durable tumor responses, tax on
24 months (range 2.3 to 24 + months). Notably, of the 7 patients with mantle
cell lymphoma, 6 Experienced a response, Achieving a patient with a CR and 5
Pru a patiënten enforcement.
Additional Objectives of the trial included an assessment of progression-free
survival, overall survival and safety. Among the Patients who responded to
therapy, the average time to tumor progression was 11 months from the time of
first response (2.3 to 24 + months). Follow-up is still ongoing. 19 patients
had died of disease progression 12 months after study termination. The musts
Reported toxicity frequently associated with Pixantrone treatment was
neutropenia (depressed levels of white blood cells), with grade 4 neutropenia
being seen in 13 or 33 patients (39%). Generally this was short Lived, tax
a median of 7.5 days and Could Be Easily Controlled Using immune cell growth
factors. Five patiënten required dose reduction for neutropenia. One patient
Experienced grade 4 anemia, with no patiënten experiencing grade 4
thrombocytopenia (reduction in clot forming flat pallets).
Pixantrone's cardiac safety was assessed by Using a MUGA scan to monitor the
left ventricular ejection fraction (LVEF) of the heart. Decrease in an absolute
Greater Than 10% LVEF and may possibly treatment related was seen in 3 patients and
this was accompanied by cardiac symptoms in 2 patients. All 3 of These Patients
Previously Received Currently marketed had the DNA intercalators and 1 had a
pre-existing cardiac condition. Such a low level of cardiac events is
Encouraging Considering That the Majority of Patients have Previously Received
Their lifetime maximum dose Permitted or DNA intercalators / anthracyclines and
Would have normally precluded from receiving leg Further treatment with prosthesis
agents.
