James Epstein, MD, Senior Medical Adviser for Imedex, is the editor for this month’s issue of OncoFacts. In this issue, Dr Epstein reports on the latest findings from the American Society of Hematology (ASH) conference held on December 6-9, 2008 in San Francisco, California.

In this issue:

• 2008 ASH Highlights
• Multiple Myeloma
• Chronic Lymphocytic Leukemia
• Chronic Myeloid Leukemia and Myelodysplasia
• Lymphoma
• Quick Poll

2008 ASH Highlights

Multiple Myeloma
Abstract #161: One question that has come up frequently in the management of younger patients with myeloma is that of the importance of achieving a complete remission. Is a very good partial response (VGPR) or an immunofixation (IF)–positive complete response (CR) as good as an IF-negative CR? Dr Juan Jose Lahuerta for the PETHEMA/GEM group presented the results of their GEM200 trial where 632 transplant eligible patients were given induction therapy with vincristine, bleomycin, chlorambucil, melphalan, prednisone (VBCMP)/vincristine, bleomycin, doxorubicin, dexamethasone (VBAD) followed by high-dose therapy, autologous stem cell transplant (ASCT) and maintenance with interferon and prednisone. This Spanish cooperative group evaluated the impact of post-induction response as well as post-transplant response on event-free survival (EFS) and overall survival (OS). Here are the main points the authors made:

• The probability of achieving a post-transplant CR was significantly higher among patients in whom a near complete response (nCR) is achieved versus partial response (PR) versus stable disease (SD) or progressive disease (PD) post-induction.
• Patients in whom a nCR and PR is achieved post-induction had similar outcomes, but were inferior to those achieving CR.
• Post-transplant, the EFS of those achieving CR was significantly greater than those patients in whom a nCR or PR was achieved post-transplant.
• Overall survival was also significantly longer for patients in whom a CR was achieved post-transplant.
• Patients who were post-transplant patients and in whom a nCR was achieved had similar outcomes to those patients in whom only a PR was achieved.
• For patients in whom a nCR was achieved post-induction, but in whom a response was not improved post-transplant, these patients worse than those patients who improved from a PR to nCR after ASCT.

In discussing this abstract with Dr Ken Anderson from Dana-Farber Cancer Institute, he reminded me that “no one is cured without achieving a CR”.

Abstract #650: Dr Jesus San Miguel updated the VISTA Trial that was originally presented at ASH 2007. In this trial, newly diagnosed transplant ineligible patients with myeloma were randomized to induction therapy with melphalan-prednisone (MP) with or without bortezomib (VMP). At 26 months of follow-up, the OS for the VMP group is 72% versus 59% for MP and the time to next treatment for the VMP group was 28 months versus 19.2 months for the MP group. In an analysis of prognostic factors for the VMP group, age did not affect OS except for patients older than 75 years. Response rates were NOT dependent on age, renal function, or high-risk cytogenetics. Those patients with the t(4;14) translocation, the t(14;16) translocation and the 17p deletion responded just as well to VMP as did those with standard-risk myeloma.

Abstract #092: Dr Paul Richardson reported an update of his phase I/II trial of lenalidomide, bortezomib, and dexamethasone (RVD) in newly diagnosed patients with myeloma. Median follow-up is at 8 months, and at that point, median time-to-progression (TTP), progression-free survival (PFS) and OS had not yet been reached. However, in the phase II portion of the trial, 100% of patients had achieved at least a PR with 33% CR, 15% nCR and 32% VGPR with this combination.

Abstract #095: Dr Prashant Kapoor from the Mayo Clinic presented data on the impact of high-risk cytogenetics on survival of 100 newly diagnosed patients with myeloma undergoing therapy with lenalidomide-dexamethasone (Len-Dex). They defined high-risk cytogenetics as the presence of at least 1 of the following: hypodiploidy, del13q, del17p, t(4;14), t(14;16) or plasma cell labeling index >3%. The PFS for high-risk patients treated with Len-Dex was 18.5 months compared to 37 months for those with standard-risk cytogenetics. Values for TTP were similar. The follow-up is too short at this time to detect any differences in OS.

Multiple Myeloma – Emerging Novel Agents
Abstracts #864 and 865: Carfilzomib is a second generation proteasome inhibitor that binds irreversibly to the proteasome. Two phase II trials were presented using the day 1 and 2 weekly regimen in patients with relapsed disease and in patients with highly refractory disease. Both studies demonstrated encouraging activity in patients previously treated with bortezomib. In addition, the ORR in the bortezomib treatment naïve patients with relapsed disease was 50%.

Abstract #866: Pomalidomide is a novel immunomodulatory compound that appears to have a better adverse event profile than both thalidomide and lenalidomide. This phase II trial combined pomalidomide with dexamethasone in patients with myeloma with 1 – 3 prior treatment regimens. Two-thirds of the patients had received prior IMiD therapy. The ORR was 58% with 2% stringent CRs, 23% VGPR, and 33% PR. Twenty-nine percent of patients whose disease was refractory to lenalidomide responded to pomalidomide.

Abstract #870: Perifosine is an oral Akt inhibitor. Treatment of myeloma with bortezomib causes up-regulation of Akt. So the combination treatment of perifosine with bortezomib in patients with bortezomib refractory disease was examined by Dr Paul Richardson and colleagues. Of 72 evaluable patients, 4 had CR/nCR and 17 had PRs for an overall response rate (ORR) of 38%. A phase III trial is beginning that will randomize patients with 1 – 3 prior regimens between bortezomib-dexamethasone-perifosine versus bortezomib-dexamethasone-placebo.

Abstract #867: There was a very interesting presentation by Dr Jean-Francois Rossi concerning an anti-interleukin-6 chimeric monoclonal antibody in myeloma. This trial included 21 patients who were bortezomib treatment naïve with 1 – 3 prior treatment regimens. Patients received CNTO 328 every other week in combination with standard dose bortezomib. There were 3 CRs, 3 VGPRs and 6 PRs for an ORR of 57%. Median TTP was 280 days.

Chronic Lymphocytic Leukemia
Abstract #003: B-Cell lymphoproliferative disorders were highlighted during one of this year’s Plenary Session presentations. Dr Jonathan Friedberg from the University of Rochester discussed the role of the splenic tyrosine kinase (Syk) in tonic B-Cell receptor (BCR) signaling, and its role in downstream signaling and amplification of the original B-Cell receptor signaling that leads to inhibition of apoptosis. Many B-cell lymphomas appear to be addicted to BCR signaling. Fostamatinib disodium (FosD) is an oral small molecule inhibitor of Syk that has been under development for rheumatoid arthritis. Dr Friedberg reported the results of a phase I/II study of FosD in B-cell lymphomas and chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) that were relapsed from or refractory to several lines of therapy including ASCT and radioimmunotherapy (RIT). Sixty-eight patients were treated in the phase II portion of this study. The ORR in this heavily pre-treated population included 21% for diffuse large B-cell lymphoma (DLBCL), 10% for follicular lymphoma (FL), 11% for mantle cell lymphoma (MCL) and 55% for CLL/SLL. Progression-free survival was approximately 5 months. Several of the patients with CLL/SLL experienced a flare reaction with shrinkage of their lymph nodes and a concomitant, though transient rise, in their peripheral lymphocyte count. Further studies are anticipated.

Abstract #044: Two phase II studies were presented during the Oral CLL Therapy session on the utility of lenalidomide in previously untreated symptomatic patients with CLL. Dr Christine Chen from the Princess Margaret Hospital reported on a trial of 25 patients. The original starting dose of 10 mg daily had to be reduced because of 2 serious episodes of tumor lysis syndrome requiring dialysis. Twenty-three patients were treated on a starting dose of 2.5mg with plans to escalate the dose weekly if possible. Forty-three percent of patients suffered grade 3-4 neutropenia with 4 episodes of febrile neutropenia. Eighty percent of patients developed tumor flare, and 40% of them required steroids for the flare symptoms. Fifty-six percent of patients achieved a PR, and 40% had stable disease. There were no complete responses.

Abstract #045: Dr Alessandra Ferrajoli from M. D. Anderson then reported on their trial of continuous daily oral lenalidomide in elderly patients with symptomatic CLL. Patients received 5 mg daily for the first 2 (28 day) cycles. Then daily doses were escalated by 5 mg increments every 28 days. Forty-five patients had a minimum of 3 (28 day) continuous cycles. Patients were treated until disease progression. After 3 cycles the nodular PR rate was 2% and rose to 6% after 9 cycles. After 3 cycles, the PR rate was 42% and rose to 45% after 9 cycles. Among 17 patients with SD after 3 cycles, 7 went on to develop a PR after 9 cycles and 5 remained stable, while 5 others progressed. Forty-four percent of patients had tumor flares that were grade 1-2 in intensity. No tumor lysis syndrome (TLS) was seen.

Abstract #046: During this same session on CLL Therapy, Dr Tom Lin from Ohio State University reported on his institution’s experience with flavopiridol in relapsed CLL using their new pharmacokinetically developed schedule of a 30 minute intravenous (IV) bolus followed by a 4 hour continuous infusion weekly for 3 weeks out of 4. Flavopiridol is a CDK inhibitor whose activity is independent of p53 signaling. Dr Lin reminded everyone that flavorpiridol should not be given to patients with CLL with white blood cell (WBC) counts >200,000 because of the risk of TLS. At the time of presentation, 116 patients with CLL had been treated. Eighty percent were stage III-IV, and 73% had bulky adenopathy. Seventy percent were refractory to purine nucleoside analogs. The ORR was 43% including 60% of those with del11q and 48% of those with del17p. Median PFS was 12.7 months in this heavily pre-treated population. Seven of the responders went on to receive reduced intensity ASCT.

Abstract #047: Dr Danelle James reported a phase II study of newly diagnosed patients with CLL treated with weekly rituximab for 12 straight weeks plus methyl prednisolone 1 gm/m2 daily for 3 days every 4 weeks. With this prolonged course of rituximab plus high-dose corticosteroids, they treated 28 patients. Ninety-six percent responded to treatment with 32% CR, 4% nPR and 61% PR. Eight percent of the treated patients were minimal residual disease (MRD)–negative following the 12-week treatment cycle. Median PFS was 54% at 30 months follow-up. Prognostic factors suggestive of poor response included splenomegaly >5cm below the costal margin and an elevated β2M.

Abstract #325: For a number of years the leukemia group at M. D. Anderson has pioneered the chemoimmunotherapy regimen for CLL of fludarabine, cyclophosphamide, and rituximab (FCR). Originally used for patients with relapsed disease, the combination has become the standard of care at M. D. Anderson for front-line therapy of symptomatic CLL. However, most of the very impressive data for FCR has come from non-randomized studies. At ASH this year, Dr Michael Hallek reported the results of a phase III randomized trial sponsored by the German CLL Study Group comparing the M. D. Anderson version of FCR to fludarabine and cyclophosphamide without rituximab (FC). Fludarabine and cyclophosphamide had previously been shown in several trials to be superior to fludarabine alone and was generally considered to be the standard of care in Europe, where rituximab is not approved for CLL. In this study, 817 patients were randomized and treated. The 2 arms were well balanced with regards to age, stage, genomic aberrations and immunoglobulin variable heavy-chain (VH) mutation status. Results of FCR were significantly better than FC with regards to ORR, CR rate and PFS. The CR rate for FCR was nearly double the CR rate for FC. There was a trend for OS favoring the FCR arm. Although neutropenia was more common with FCR, there was no increase in the infection rate. Dr Hallek stated that for front-line therapy of symptomatic CLL, FCR might become the new standard of care.

Abstract #328: Dr Anders Osterborg reported the first interim analysis of an international trial of the anti-CD20 monoclonal antibody, ofatumumab, in patients who were double refractory (DR) to both fludarabine and alemtuzumab or who had bulky adenopathy and refractoriness (BFR) to fludarabine. Ofatumumab targets a different epitope on the CD20 molecule than rituximab and is capable of inducing complement mediated cytotoxicity even in malignant B-cells with low CD20 expression. Ofatumumab was generally well tolerated. Infusion reactions were mild and progressively diminished with subsequent cycles. Patients were heavily pre-treated with an average of 4 – 5 prior regimens. Over 50% had previously received rituximab. The ORR was 58% for the DR group and 47% for the BFR group. Median duration of response was over 6 months and overall survival was approximately 14 months. Response rates were similar in patients with del11q and del17p and in those with prior rituximab exposure.

Abstract #330: Finally, Dr Kirsten Fischer from the German CLL Study Groups reported the results of a phase II trial of bendamustine and rituximab in patients with relapsed CLL. Eighty-one patients with 1 – 3 prior regimens received bendamustine on days 1 and 2 plus rituximab on day 1 of each 28 day cycle. Patients received a median of 4.5 cycles. Among the 62 evaluable patients, 48 experience a response including 9 CRs and 1 nodular PR. Twelve out of 13 patients with del11q, and 4 out of 9 with del17p responded. No data was available regarding response duration or survival as yet.

Chronic Myeloid Leukemia and Myelodysplasia
Abstract #334: Dr Tim Hughes from Adelaide, Australia presented an analysis of quantitative polymerase chain reaction (QPCR) measurements of BCR-ABL transcripts from the IRIS trial of interferon versus imatinib in chronic phase chronic myelogenous leukemia (CP-CML). Among the patients receiving front-line imatinib on the IRIS trial, major molecular responses (MMR) were obtained by 13% at 3 months, 33% at 6 months, 50% at 12 months, 65% at 18 months, 85% at 60 months and 86% at 72 months. This indicates that the percentage of patients whose responses progressively improved to the level of an MMR increased with their duration of imatinib therapy. Event-free survival at 72 months was highest in those patients who achieved a complete molecular response.

Abstract #445: Dr Hagop Kantarjian then reported on the significance of rising BCR-ABL transcript levels in patients with Philadelphia chromosome-positive (Ph+) CP-CML in complete cytogenetic response (CCyR). In the study, 116 patients out of a total of 258 patients who had achieved and remained in a CCyR for at least 18 months on imatinib experienced a significant rise in QPCR measurement. However, only 13 of them experienced a progression of CML. In 11 of those 13 patients, there was either a loss of MMR or MMR had never been achieved. Patients should be monitored closely and possibly evaluated for mutations of the kinase domain of BCR-ABLE if MMR is lost or MMR was never achieved, and if the patients experience a >1 log increase in BCR-ABL transcripts by QPCR. A rise in QPCR without loss of MMR should not trigger a change in therapy unless CCyR is lost.

Abstract #187: A question that frequently rises is whether patients who have maintained a complete molecular response (CMR) to imatinib after years of therapy can stop treatment. Dr Francois Mahon reported the results of the retrospective STIM study. Sixty-nine patients, who had maintained a CMR for at least 2 years while taking imatinib for at least 3 years, discontinued therapy. Approximately half of these patients had previously received interferon before starting imatinib. Twenty-seven of the 69 patients experience a CML relapse within 6 months after stopping imatinib. Thirteen of these relapses were in patients previously treated with interferon. The other 14 had received only imatinib. Only 1 patient relapsed after 6 months off imatinib. At 9 months off imatinib, 53% of those who had previously received interferon were still in CMR, but only 39% of those who had not received interferon were still in CMR. All patients who relapsed proved sensitive to further imatinib therapy. Of the 7 patients who remained in CMR at 14 months off imatinib, 5 had previously received interferon.

Abstract #183: Dr Francois Guilhot reported the first results of the SPIRIT trial in patients with newly diagnosed CP-CML. Patients were randomized between 4 arms for initial therapy for CML. These included the standard arm of imatinib 400 mg daily versus imatinib 600 mg daily versus imatinib 400 mg plus Ara-C versus imatinib 400 mg plus pegylated interferon. Although approximately 45% of patients stopped treatment with pegylated interferon within the first 12 months of therapy, CCyR rates and MMR rates were significantly higher at 6 and 12 months for the pegylated interferon–imatinib groups compared to the imatinib 400 mg alone group. Overall survival, the primary study endpoint, is not available as yet.

Abstract #184: The German CML Study Group reported their results from another imatinib combination trial. This ongoing trial has randomized1242 patients. For low- to intermediate-risk, patients were randomized to imatinib 400 mg versus imatinib plus Ara-C versus imatinib plus interferon versus interferon followed by imatinib 400 mg at treatment failure. Patients with high-risk disease were randomized to imatinib 400 mg versus imatinib 800 mg. The first of 3 interim analyses reported the results for 715 patients of whom 694 were evaluable. In this report, 687 achieved complete hematologic remission (CHR), 639 CCyR and 633 MMR. The arms are un-blinded thus far, so reported results are for the entire group as a whole. Times to best response appear to be about the same in each of the initial imatinib containing arms, but slower for the imatinib following interferon failure arm. Overall survival is 92%, and PFS is approximately 90%. Further data will be presented after the second and third interim analyses.

Abstract #446: Dr Jorge Cortes gave an update of the front-line nilotinib trial in CP-CML. Median follow-up for the 49 patients is now 13 months. Complete hematologic response at 12 months is 100%. Complete cytogenetic response at 12 months is 98%, and MMR at 12 months is 47%, while CMR is 7%. Responses were rapid with 95% of patients achieving CCyR at 6 months and 40% achieving MMR at 6 months. Therapy was well tolerated. Grade 3-4 adverse events were generally <10%, and the actual median dose received was the planned 800 mg/day.

Abstract #449: Dr Martin Muller reported an analysis of patients who had baseline mutations in BCR-ABL from 3 phase II-III trials with dasatinib. Responses and response durability were evaluated based on the dasatinib cellular IC50 for each mutation. Those patients with mutations with dasatinib cellular IC50 <3 nM had responses and response durations comparable to those without baseline mutations. Those patients with mutations that had dasatinib IC50 >3 nM had MCyR of 34%, CCyR of 25% and MMR of 18%. These included Q252H, E255K/V, V299L and F317L. Those with T315I were not included in this analysis. The authors concluded that dasatinib had broad efficacy against all BCR-ABL mutations except T315I.

Abstract #635: Dr Hagop Kantarjian presented this abstract on a new prognostic scoring system for myelodysplastic syndrome (MDS). The International Prognostic Scoring System (IPSS) is currently the prognostic scoring system most commonly employed by physicians planning therapy for newly diagnosed patients with MDS, but it has come under criticism because it does not include transfusion history, previous therapies, and preceding hematologic disorders, and it does not give proper weight to cytogenetic abnormalities. Consequently the M. D. Anderson group led by Dr Kantarjian analyzed 1915 patients with MDS randomly assigning them to a test group and a validation group. A multivariate analysis was performed for prognostic factors and a new MDS prognostic model was developed that divided patients into 4 groups with significantly different outcomes. The prognostic factors included in this model include performance status, age, platelet count, hemoglobin, marrow blast percentage, WBC count, karyotype and prior transfusions. Each factor is weighted, and a score is then calculated. Patients with low-risk disease had scores of 0 – 4 and a median survival of 45 months. Patients with intermediate-1disease had scores of 5 – 6 with median survivals of 23 months. Patients with intermediate-2 MDS had scores of 7 – 8 and median survivals of 13 months. Patients with high-risk MDS had scores of >9 with median survivals of only 6 months. Additional information helped determine median survival in each prognostic group among patients with chronic myelomonocytic leukemia (CMML), patients with prior MDS therapy, secondary MDS or patients receiving therapy with decitabine.

Lymphoma
Abstract #261: There were a number of interesting presentations at this year’s ASH meeting regarding T-cell Lymphomas. Dr Owen O’Connor presented the results of the PROPEL trial. This was the largest prospective study in peripheral T-cell lymphoma. Patients with peripheral T-cell lymphoma were treated with pralatrexate, a novel targeted antifolate that selectively enters cells via an oncofetal protein, RFC-1. Cancer cells and embryonic cells over express RFC-1. Pralatrexate is rapidly polyglutamated leading to high intracellular drug levels. This agent is administered intravenously weekly for 6 out of 7 weeks. Supplementation with vitamin B12 and folic acid is necessary to minimize adverse events. In this trial, 107 patients with peripheral T-cell lymphoma were evaluable. They had a median of 3 prior treatment regimens, and 15% had undergone ASCT. The patients were heavily pretreated, and 29% responded to pralatexate. Thirty-seven percent of those responders had CRs. Grade 3-4 toxicities included thrombocytopenia (31%), mucositis (19%), and anemia (12%).

Abstract #1569: Dr Steven Horwitz presented additional data on pralatexate in cutaneous T-cell lymphoma. This small dose finding study produced clinical responses in 9 out of 17 patients treated including 2 CRs.

Abstract #1570: Pralatrexate is also being combined with gemcitabine in both B-cell and T-cell lymphomas. Doses of pralatrexate 10 mg/m2 and gemcitabine 300 mg/m2 given every 2 weeks have produced responses in patients with Hodgkin Lymphoma and diffuse large B-cell (DLBC) lymphoma who were very heavily pretreated.

Abstract #262: The NHL-002 trial evaluated the efficacy & safety of single agent lenalidomide in aggressive non-Hodgkin lymphomas. Analysis showed significant benefit in both mantle cell lymphoma (MCL) and DLBCL. A larger international trial, the NHL-003 trial, was then initiated expanding the experience with oral lenalidomide in aggressive lymphomas. Dr Pier Luigi Zinzani presented the data for the 39 patients with MCL in the NHL-003 trial. These patients had at least 1 prior treatment regimen and a median of 3 prior regimens, and 9 of the 39 patients with MCL had received bortezomib. Patients received 25 mg of lenalidomide daily for 21 out of 28 days. The response rate was 41% including 5 CRs and 11 PRs. Median duration of response was over 7 months.

Abstract #268: Dr Myron Czuczman then presented the results of the NHL-003 trial in 73 patients with DLBC lymphoma. Once again these patients had received a median of 3 prior regimens. Twenty-nine percent of patients responded including 3 CRs and 18 PRs. Myelosuppression was the primary adverse event with 32% grade 3-4 neutropenia and 15% grade 3-4 thrombocytopenia. Lenalidomide as a single agent demonstrated in the NHL-003 trial significant clinical benefit in patients with relapsed/refractory aggressive lymphoma who were heavily pre-treated.

Abstract #584: Dr Michael Pfreundschuh presented an interesting study comparing patients from the RICOVER-60 trial of older patients with DLBCL who received rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP)–14 for 6 cycles plus radiotherapy for bulky disease with another set of older patients with DLBCL who were treated with R-CHOP-14 for 6 cycles without radiation therapy. Overall responses, CR rates, EFS, PFS and OS were all similar between the 2studies. The authors pointed out that in the era of rituximab-chemotherapy regimens the addition of radiation therapy to sites of bulky disease was NOT necessary for patients who achieved a CR from R-CHOP-14, but it was beneficial to those patients with bulky disease whose best response to R-CHOP-14 was a PR.

Abstract #3615: Another interesting presentation from a group in Barcelona looked at the benefit of adding rituximab to chemotherapy in patients with primary extra-nodal lymphoma. They examined 230 patients with CD20+ lymphoma, excluding central nervous system (CNS) lymphoma. In this analysis, 119 patients received chemotherapy alone and 111 received R-chemotherapy. Eighty-two of the patients had extra-nodal lymphoma. The response rates and 5-year OS were significantly better for the patients with nodal lymphoma who received rituximab, but the differences in ORR and 5-year OS were not significantly different among the patients with extra nodal lymphoma who received chemotherapy alone or chemotherapy plus rituximab. This was a retrospective analysis and not a prospective randomized study.

Abstract #370: Finally, Dr Peter Johnson from the United Kingdom presented the results of a randomized comparison of the Stanford V regimen (doxorubicin, vinblastine, mechlorethamine, vincristine, bleomycin, etoposide, and prednisone)versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) in advanced Hodgkin lymphoma. In this trial, 520 patients were randomized. Patients had stage I-II bulky disease or stage III-IV disease. Grade 3-4 pulmonary toxicity was greater in the ABVD group. Other toxicities were slightly more common with Stanford V. A higher percentage of patients treated with Stanford V received radiation therapy (72% versus 53% for ABVD). The ORR rate, including CR, (unconfirmed complete response [Cru] and PR) were almost identical. In addition, there were no significant differences in 5-year PFS rates and OS rates.

OncoFacts™ Editor:

James Epstein, MD

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