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Last update: 07/01/2009

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News Items:

ASCO 2009 Lymphoma abstracts: Browse / Search / PAL's

Non-Hodgkin Lymphoma Trial Results  Cancer.gov
R-CHOP versus R-CVP in the treatment of follicular lymphoma: a meta-analysis and critical appraisal of current literature  pubmedcentral.nih.gov 
ASCO 2009: Expert Video Perspective on Lymphoma James O. Armitage, MD  medscape.com/ 
Study Suggests New First-line Treatment Option for Follicular Lymphoma cancer.gov 
Updated Phase II Results With Radiolabeled Epratuzumab in Non-Hodgkin's Lymphoma drugs.com 

n = 62 

The overall objective response rate (partial and complete responses) in 62 evaluable patients was 64%, with 49% of patients having a complete response. Both the objective and complete response rates appear to correlate with cumulative doses. In 16 patients unresponsive to last therapy, 75% responded to Y-90 epratuzumab tetraxetan with 56% complete responses. More importantly, responses were seen across all different types of NHL.

Understanding Clinical Trial Design: PDF A Tutorial for Research Advocates

Authored by Jane Perlmutter, PhD
for Research Advocacy Network’s Advocate Institute
Allogeneic stem cell transplantation in children and adolescents with recurrent and refractory Hodgkin's lymphoma Claviez A, Canals C, Dierickx D, Stein J, Badell I, Pession A, Mackinnon S, Slavin S, Dalle JH, Jurado Chacon M, Sarhan M, Wynn RF, Suttorp M, Dini G, Sureda A, Schmitz N. 
Blood. 2009 Jun PMID: 19498021
Background for professionals: Optimal Use of Prognostic Factors in NHL  
asheducation book.hematologyl ibrary.org
Reports and background on novel gene-based immunotherapy, ISF35

Intra-nodal injection of adenovirus encoding recombinant CD40-ligand (Ad-ISF35) in patients with CLL (ASCO 2009). http://www.abstract.asco.org/AbstView_65_33602.html 

Abstract on chemo-sensitizing properties (ASCO 2009):
http://www.abstract.asco.org/AbstView_65_35718.html 

Technical details on ISF35 technology - Patent information: 
http://www.faqs.org/patents/app/20080318886 

ABT-263 activity and safety in patients with relapsed or refractory lymphoid malignancies in particular chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). 
http://www.abstract .asco.org/ AbstView_ 65_30712. html

ABT-263 showed favorable PK and safety profiles with anti-tumor activity in relapsed/refractory CLL/SLL and follicular lymphoma. Identification of optimal dose and schedule for phase II trials continues.

ABT-263 studies recruiting: ClinicalTrials.gov
Comparing R-CHOP 14 and R-CHOP 21 for the treatment of patients with newly diagnosed DLBCL. 

n = 1,080 randomized to CHOP-R x14 (dose dense schedule) vs. CHOP-R 21 day schedule

Comment: Very encouraging overall results: 2-year failure-free survival rate for the entire cohort of 74% .  Important study because of the size (n >1,000) and that it was randomized.  Curious that the protocols compared were not given with an equal number of  rounds? x6 vs. x8.   Small increased trend  in cardiac toxicity with dose dense CHOP-R x 6 - 2% vs 0.4%
The "autophagy pathway" could be a very important nut to crack, so it bears watching. http://www.ncbi.nlm.nih.gov/pubmed/19216910  

This pathway appears to shut down treatment-stressed cells so that they survive in a dormant-like state, or in hypoxic (low oxygen) conditions.  This cell survival pathway might explain resistance to Rituxan http://www.abstract.asco.org/AbstView_65_33619.html  

For technical background on autophagy, Autophagy in Cancer: Good, Bad, or Both?: http://cancerres.aacrjournals.org/cgi/content/full/66/19/9349 
Idiotype vaccine therapy (BiovaxID) in follicular lymphoma in first complete
remission: Phase III clinical trial results.  abstract .asco.org 

n = 234 pts  enrolled; 177 (76%) achieved CR/CRu and were randomized. 
Of 177 randomized pts, 117 maintained CR/CRu ≥ 6 mo per protocol requirement and then received at least one dose of vaccine, 55 relapsed before vaccination, 4 were vaccine manufacturing failures, and 1 violated protocol.


Comment: This report from a controlled study appears to support that idiotype vaccines are active and have the potential to provide meaningful clinical benefit.  However,  this analysis is for a "modified intent-to-treat population" ... representing roughly half of the patients who started in the study, and these outcomes with PACE and vaccine  may not compare well with Rituxan-based chemotherapy, the new standard of care.  So the key going forward will be if the improvement in outcomes can be reproduced following Rituxan-based chemo.  
Progressive multifocal leukoencephalopathy [PML] after Rituxan therapy in HIV-negative patients: a report of 57 cases from the Research on Adverse Drug Events and Reports project  bloodjournal.hematologylibrary.org

In conclusion, rituximab administration may increase risks of developing PML, although the absolute risk of developing PML is probably low. As use of rituximab expands to diverse clinical settings, clinicians and patients should be aware of the potential for PML after rituximab therapy. Awareness and reporting of rituximab-associated PML cases to the FDA are essential to improve our understanding of risk factors, natural course, and alternative therapeutic approaches. Despite widespread public health advisories describing 2 patients with SLE and 1 patient with rheumatoid arthritis who were diagnosed with rituximab-associated PML, we identified 22 previously unreported cases associated with lymphoid malignancies and immunologically mediated cytopenias. Early diagnosis of PML will prompt efforts at immune reconstitution, which may be beneficial in improving survival rates. Finally, early diagnosis before irreversible neurologic damage has occurred will be crucial for evaluation of the efficacy of new antiviral treatments.
Efficacy and tolerability of currently available therapies for the mycosis fungoides and Sezary syndrome variants of cutaneous T-cell lymphoma. Whittaker SJ, Foss FM. Cancer Treat Rev. 2007 Apr;33(2):146-60. Epub 2007 Feb 1. Review. PMID: 17275192
Efficacy of lenalidomide (Revlimid) oral monotherapy in relapsed or refractory indolent NHL: 
Final results of NHL-001. abstract.asco.org 

Oral lenalidomide monotherapy can produce durable responses with manageable side effects in relapsed or refractory indolent NHL
Complete remissions with weekly dosing of SGN-35, a novel antibody-drug conjugate (ADC) targeting CD30, in a phase I dose-escalation study in patients with relapsed or refractory Hodgkin lymphoma (HL) or systemic anaplastic large cell lymphoma (sALCL).  abstract.asco.org

SGN-35 was generally well tolerated and induced CRs in 7 of 8 evaluable pts at the two highest doses in heavily pretreated patients. Pivotal trials of this antibody-drug conjugate will initiate in early 2009.
YM155 shows activity in relapsed and refractory DLBCL. abstract.asco.org 

Targets Survivin - inhibitor of apoptosis proteins (IAPs)
Additional Evidence That Antibiotics Are Effective Against Gastric MALT Lymphomas http://patient.cancerconsultants.com 
Rituximab Maintenance for the Treatment of Patients With Follicular Lymphoma: Systematic Review and Meta-analysis of Randomized Trials medscape.com (free login req.)
Phase I Trial of Daily Oral Polyphenon E in Patients With Asymptomatic Rai Stage 0 to II Chronic Lymphocytic Leukemia

http://jco.ascopubs.org/cgi/content/short/JCO.2008.21.1284v1?rss=1

Epigallocatechin-3-gallate (EGCG) was administered using the standard phase I design with three to six patients per dose level (range, 400 to 2,000 mg by mouth twice a day).
The Sponsor and FDA are negotiating an indication statement for ARZERRA (ofatumumab) in the treatment of chronic lymphocytic leukemia (CLL) under the provisions of accelerated approval based on studies that have investigated response rate, a surrogate endpoint for clinical benefit. 

Briefing documents:

Advisory board:
http://www.fda. gov/ohrms/ dockets/ac/ 09/briefing/ 2009-4444b1- 01-FDA.pdf

GSK:
http://www.fda. gov/ohrms/ dockets/ac/ 09/briefing/ 2009-4444b1- 02-GSK.pdf
Wrong Way in the War on Cancer alternet.org  

"The result is that many of the nation’s 30,000 oncologists are engaged in what could be described as an unobserved and uncontrolled science experiment, especially when it comes to treating the 560,000 Americans who die each year from the more than 100 forms of the disease. As these patients’ cancers advance, their physicians try regimens they read about in journals or hear about from colleagues. The outcomes are never gathered. The data is never analyzed. And the findings are never disseminated."
Beyond Monoclonal Antibodies: 
New Therapeutic Agents in Non-Hodgkin's Lymphomas

http://theoncologist.alphamedpress.org/cgi/content/full/14/5/511 
[Rituxan] Linked To Often Fatal Brain Virus [PML] sciencedaily.com

"But concerns about the drug's association with PML first surfaced in 2006 when two patients with lupus developed the illness after taking rituximab and other immunosuppressive treatments."
Study Shows Disruption Of Immune-System Pathway Key Step In Cancer Progression  medicalnewstoday.com  

"Silencing an inter-cell signaling mechanism called the interferon pathway may be one way newly developing cancers gain the upper hand. It may also explain the immune dysfunctions seen in many cancer patients and why cancer immunotherapies are often ineffective."
Two Targeted Therapies (Rituxan and Epratuzumab) Yields Very Good Results in Patients with Aggressive Lymphoma bio-medicine.org/ 

researchers say that adding the targeted therapy epratuzumab to a regimen known as R-CHOP resulted in an overall 12-month survival of 88 percent in 78 patients. While they call that a very good outcome, the researchers were especially encouraged because the survival rate was 85 percent in patients with high-risk disease.
Technical and preclinical: Ribavirin (anti-viral drug) suppresses eIF4E-mediated oncogenic transformation
2004 Dec 15. PMID: 15601771

Ribavirin and its derivatives offer a pharmacologic means to interrupt networks of tumor suppressors and oncogenes that maintain and enhance neoplasia and malignancy.
Vaccine Concept: Recognition of live labeled tumor cells by dendritic cells: a novel approach to immunotherapy of skin cancer. Shurin MR, Potapovich AI, Tyurina YY, Tourkova IL, Shurin GV, Kagan VE.  Cancer Res. 2009 Mar 15;69(6):2487-96. Epub 2009 Mar 10. PMID: 19276376 

Dendritic cells (DC) loaded with tumor antigens from apoptotic/necrotic tumor cells are commonly used as vaccines for cancer therapy. However, the use of dead tumor cells may cause both tolerance and immunity, making the effect of vaccination unpredictable. To deliver live tumor "cargoes" into DC, we developed a new approach based on the "labeling" of tumors with a phospholipid "eat-me" signal, phosphatidylserine.
Highly increased familial risks for specific lymphoma subtypes. 
Goldin LR, Björkholm M, Kristinsson SY, Turesson I, Landgren O. Br J Haematol. 2009 May 4. PMID: 19438470

Relatives were at the highest risk for developing the same lymphoma subtype as the case. DLBCL was increased 10-fold among relatives of DLBCL patients, FL was increased fourfold among relatives of FL patients and HL was increased fourfold among relatives of HL patients. These results imply that germline susceptibility genes are specific to lymphoma subtype.
Home Diet and Exercise May Benefit Long-Term Cancer Survivors oncologystat.com 

A home-based diet and exercise program reduced the rate of functional decline in a study of more than 600 overweight and older cancer survivors, according to a report in the May 13 issue of JAMA. 
Ginger Eases Nausea From Chemo healthday.com  

Participants were randomized to receive either a placebo or one of three doses of ginger supplement: 0.5 grams, 1 gram or 1.5 grams for three days before the start of chemo and three days after for the next two cycles. All also received traditional antiemetic drugs on the first day of treatment.
Placebo-Controlled Phase III Trial of Patient-Specific Immunotherapy With Mitumprotimut-T  (Fav-Id) and Granulocyte-Macrophage Colony-Stimulating Factor After Rituximab in Patients With Follicular Lymphoma.
J Clin Oncol
. 2009 May 4 PMID: 19414675
TTP was shorter with mitumprotimut-T/GM-CSF compared with placebo/GM-CSF. This difference was possibly due to the imbalance in FLIPI scores.
Genetic variation in caspase genes and risk of NHL: a pooled analysis of three population-based case-control studies.  Blood. 2009 May 4.  PMID: 19414860

"It is noteworthy that genetic variants in CASP8 were associated with risk of all major NHL subtypes. Our findings suggest that genetic variation in caspases may play an important role in lymphomagenesis."
Late-onset neutropenia (LON) following RCHOP chemotherapy in diffuse large B-cell lymphoma 
Am J Hematol. 2009 Mar 31. PMID: 19415727

"it is reassuring that LON is self-limiting and unassociated with life-threatening infection. A watchful waiting approach is appropriate in majority of patients who develop LON following RCHOP.
Extranodal marginal zone lymphoma of the ocular adnexa bloodjournal.hematologylibrary.org 

"Besides radiotherapy and chemotherapy, a variety of new treatment options have emerged in the management of patients with ocular adnexal MALT lymphoma, especially monoclonal antibody therapy and antibiotic therapy against Chlamydia psittaci, which has been associated with the pathogenesis of ocular adnexal lymphomas in some parts of the world. In this review, we are presenting a state of the art summary on ocular adnexal MALT lymphomas."
Diffuse large B-cell lymphoma: reduced CD20 expression is associated with an inferior survival bloodjournal.hematologylibrary.org 

"In conclusion, we have demonstrated that discordant CD20 expression by FCM (flow cytometry) using diagnostic DLBCL biopsies may be a novel biomarker that could identify a subgroup of high-risk patients treated with R-CHOP. Moreover, this biomarker could be identified using flow cytometry, a technique that is already used in most clinical laboratories.
A Phase I Study of a Bispecific Chain Immunotoxin for the Treatment of CD19(+), CD22 (+) B-Lineage Leukemia or Lymphoma ClinicalTrials.gov 

"Immunotoxins, such as DT2219ARL, can find certain cancer cells and kill them without harming normal cells.

PURPOSE: This phase I trial is studying the side effects and best dose of DT2219ARL immunotoxin in treating patients with B-cell leukemia or lymphoma that has relapsed or not responded to treatment."
PERSPECTIVE: A re-examination of radioimmunotherapy in the treatment of NHL: prospects for dual-targeted antibody/radioantibody therapy Robert M. Sharkey1, Oliver W. Press2, and David M. Goldenberg1  bloodjournal.hematologylibrary.org

Discusses potential of clearing normal b-cells with non-competing antibody to optimize the effect of the radiolabeled antibody - so that all the cd20 receptors are available to the "hot" antibody. Also discusses fractionated dosing to improve safety without compromising efficacy.

More ... Archive 2006 / 7

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