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The first and largest national clinical study to evaluate the safety and efficacy of an IGF-1R antibody (cixutumumab) and an mTOR inhibitor (temsirolimus) in combination therapy for a range of sarcomas has achieved its primary endpoint of improvement in progression-free survival at 12 weeks in patients with bone and soft-tissue sarcomas.
Gastrointestinal perforations occurred in 3% and fistula formation in 1% of COMETRIQ®-treated patients.
Results of the international, multicenter, randomized, double-blind EXAM study in patients with progressive, metastatic MTC (N=330).
Hemorrhage: Severe, sometimes fatal, hemorrhage including hemoptysis and gastrointestinal hemorrhage occurred in 3% of COMETRIQ-treated patients.
Perforations and Fistulas: Serious gastrointestinal (GI) perforations and fistulas were reported, of which one GI fistula was fatal. Thrombotic Events: COMETRIQ treatment results in an increased incidence vs placebo of venous thromboembolism (6% vs 3%) and arterial thromboembolism (2% vs 0%). Hypertension: COMETRIQ treatment results in an increased incidence of treatment-emergent hypertension vs placebo (61% vs 30%).
Palmar-Plantar Erythrodysesthesia Syndrome (PPES): PPES occurred in 50% of patients treated with COMETRIQ and was severe in 13% of patients. Proteinuria: Proteinuria was observed in 2% of patients receiving COMETRIQ (vs 0% receiving placebo), including 1 with nephrotic syndrome. Drug Interactions: Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors. Hepatic Impairment: COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment. Embryo-fetal Toxicity: COMETRIQ can cause fetal harm when administered to a pregnant woman. Adverse Reactions: The most commonly reported adverse drug reactions (?25% and ?5% difference from placebo) were diarrhea (63% vs 33%), stomatitis (51% vs 6%), PPES (50% vs 2%), decreased weight (48% vs 10%), decreased appetite (46% vs 16%), nausea (43% vs 21%), fatigue (41% vs 28%), oral pain (36% vs 6%), hair color changes (34% vs 1%), dysgeusia (34% vs 6%), hypertension (33% vs 4%), abdominal pain (27% vs 13%), and constipation (27% vs 6%). Increased levels of thyroid stimulating hormone (TSH) were observed in 57% of patients receiving COMETRIQ (vs 19% receiving placebo). In clinical trials, the dose was reduced in 79% of patients receiving COMETRIQ compared to 9% of patients receiving placebo. Please click here to see the full Prescribing Information for COMETRIQ®, including Boxed Warnings. PFS was defined as the time from randomization to the first documentation of disease progression as determined by Independent Response Adjudication Committee (IRAC), based on International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurred first during the study until the end of the PFS follow-up phase. Click to view study design. REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant.
REVLIMID is an analogue of thalidomide, a known human teratogen that causes life-threatening human birth defects or embryo-fetal death. Females of Reproductive Potential: Must avoid pregnancy for at least 4 weeks before beginning REVLIMID therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Because of embryo-fetal risk, REVLIMID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) the REVLIMID REMS® program (formerly known as the “RevAssist®” program).
Venous and Arterial Thromboembolism: Venous thromboembolic events (DVT and PE) and arterial thromboses are increased in patients treated with REVLIMID. Increased Mortality in Patients With CLL: In a clinical trial in the first line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil.
Second Primary Malignancies: In clinical trials in patients with MM receiving REVLIMID, an increase of invasive second primary malignancies (SPM) notably AML and MDS have been observed. Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID in combination with dex. Allergic Reactions: Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. Tumor Lysis Syndrome: Fatal instances of tumor lysis syndrome (TLS) have been reported during treatment with lenalidomide.
Periodic monitoring of digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of REVLIMID. REVLIMID®, REVLIMID REMS®, and Celgene Patient Support® are registered trademarks of Celgene Corporation.
My Moments, My Support is a new program for people who are taking REVLIMID for multiple myeloma or for people who want more information about REVLIMID.
If you or a loved one are currently on REVLIMID and would like a Patient Starter Kit, please check the box to request a Kit when you enroll. In Trial 2, PFS was based on the assessment by the Independent Review Adjudication Committee (IRAC) review at the final PFS analysis. Indicated for patients who have received at least two prior therapies, including an immunomodulatory agent and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Multiple Myeloma, Version 2.2016.
POMALYST® (pomalidomide) is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Please see Important Safety Information and full Prescribing Information, including Boxed WARNINGS. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping POMALYST treatment.
POMALYST is only available through a restricted distribution program called POMALYST REMS®.
Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with POMALYST.
Females of Reproductive Potential: Must avoid pregnancy while taking POMALYST and for at least 4 weeks after completing therapy.
Venous and Arterial Thromboembolism: Venous thromboembolic events (DVT and PE) and arterial thromboembolic events (ATE) (myocardial infarction and stroke) have been observed in patients treated with POMALYST. Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with POMALYST.
Hypersensitivity Reactions: Angioedema and severe dermatologic reactions have been reported. Neuropathy: In Trials 1 and 2, patients who received POMALYST + Low-dose Dex experienced neuropathy (18%) and peripheral neuropathy (~12%).


Risk of Second Primary Malignancies: Cases of acute myelogenous leukemia have been reported in patients receiving POMALYST as an investigational therapy outside of multiple myeloma.
Tumor Lysis Syndrome: Tumor lysis syndrome (TLS) may occur in patients treated with POMALYST. Nearly all patients treated with POMALYST + Low-dose Dex experienced at least one adverse reaction (99%). Pediatric Use: Safety and effectiveness of POMALYST in patients under the age of 18 have not been established. POMALYST®, POMALYST REMS®, and Celgene Patient Support® are registered trademarks of Celgene Corporation. Cora Sternberg, from the San Camillo and Fortanini Hospitals, Rome, Italy, made an oral presentation of the results of a randomized, double-blind, Phase III study of pazopanib in treatment-naive and cytokine (either Interferon-alpha or Interleukin-2) refractory (pre-treated) patients with advanced renal cell carcinoma. The primary endpoint of the study was progression-free survival with secondary endpoints being overall survival, ORR (overall response rate), safety, and quality of life.
The investigators performed an interim overall survival (OS) analysis with the results provided in the next table. The investigators also compared pazopanib with placebo using three quality of life standards. To judge the effectiveness of pazopanib, we have to compare it to Sutent (sunitinib), the standard tyrosine kinase inhibitor generally used to treat metastatic kidney cancer. He noted that pazopanib had less hand-foot syndrome than sunitinib, and although it did report liver toxicity, he thought that perhaps it would be better tolerated than Sutent.
GlaxoSmithKline, the producer of pazopanib, is obviously looking to place pazopanib as an alternative to Sutent since it is now running a large scale (876-patient) Phase III trial going head-to-head with Pfizer’s Sutent.
Finally, we cannot close this report without mentioning the fact that GlaxoSmithKline (GSK) designed and ran this trial testing pazopanib against a control group that received a placebo.
ACKC in ActionMeet some of the team and see us in action as we advocate for kidney cancer research funding during ACKC Capitol Hill 2015 and 2016. The drug combination demonstrated clinical activity that merits the need for future trials.The evidence of stable disease for more than 1 year in patients with solitary fibrous tumor and of partial response in patients diagnosed with Ewing sarcoma, osteosarcoma, or chondrosarcoma indicates that these drugs offer significant clinical benefit to subsets of patients. Patients with IGF-1R-negative Ewing sarcoma also had a numerical improvement in median overall survival when compared with those who were IGF-1R-positive.
Discontinue COMETRIQ in patients who develop an acute myocardial infarction or any other clinically significant arterial thromboembolic complication.
ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain or slow healing of the mouth or jaw after dental surgery. Withhold COMETRIQ in patients who develop intolerable Grade 2 PPES or Grade 3-4 PPES until improvement to Grade 1; resume COMETRIQ at a reduced dose.
Perform an evaluation for RPLS in any patient presenting with seizures, headache, visual disturbances, confusion, or altered mental function.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. The most common laboratory abnormalities (?25%) were increased AST (86% vs 35%), increased ALT (86% vs 41%), lymphopenia (53% vs 51%), increased ALP (52% vs 35%), hypocalcemia (52% vs 27%), neutropenia (35% vs 15%), thrombocytopenia (35% vs 4%), hypophosphatemia (28% vs 10%), and hyperbilirubinemia (25% vs 14%).
The median number of dosing delays was one in patients receiving COMETRIQ compared to none in patients receiving placebo.
Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control beginning 4 weeks prior to initiating treatment with REVLIMID, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of REVLIMID.
Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 28 days after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Prescribers and pharmacies must be certified with the program and patients must sign an agreement form and comply with the requirements. In patients who are autologous stem cell transplant (ASCT) candidates, referral to a transplant center should occur early in treatment to optimize timing of the stem cell collection. Please make sure you have completed all fields and that you have used valid e-mail addresses. Must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks prior to initiating treatment with POMALYST, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of POMALYST therapy.
Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking POMALYST and for up to 28 days after discontinuing POMALYST, even if they have undergone a successful vasectomy. Elevated levels of alanine aminotransferase and bilirubin have also been observed in patients treated with POMALYST. Discontinue POMALYST for angioedema, skin exfoliation, bullae, or any other severe dermatologic reactions, and do not resume therapy.
Instruct patients to avoid situations where dizziness or confusional state may be a problem and not to take other medications that may cause dizziness or confusional state without adequate medical advice.
Report any suspected fetal exposure to POMALYST to the FDA via the MedWatch program at 1-800-332-1088 and also to Celgene Corporation at 1-888-423-5436. Patients >65 years of age were more likely than patients ?65 years of age to experience pneumonia. The trial was conducted from April 2006 to April 2007 at 80 sites in 22 countries outside of North America. Of the 435 patients, 233 were treatment-naive and 202 experienced one prior cytokine treatment. Based on the hazard ratio, patients receiving pazopanib have a 27% lower risk in dying than those on a placebo. Sternberg’s side-effect data, which give the reader an appreciation of the type and severity of adverse events caused by pazopanib versus those experienced by patients taking a placebo.
Sternberg presented the data on selected adverse events for pazopanib that other tyrosine kinase inhibitors are known to cause. As can be seen, the progression-free survival for treatment-naive patients was comparable while Sutent’s PFS figures for cytokine refractory patients was somewhat better than pazopanib’s.
Given that none of the targeted therapies provide a durable response to metastatic kidney cancer, if pazopanib only comes in a close second to Sutent, it will give it a good argument to jump ahead of all the other therapies as an alternative option, at least until tivozanib and axitinib are approved.
Many people believe that it is unethical to give a placebo to patients suffering from metastatic disease and Jay Bitkower, the President of ACKC brought up that issue during the Q & A following Dr. We need your help to advocate for Congress to pass a $10 million line item for kidney cancer research in the Defense Appropriations Bill for 2017.


Toxicities were consistent with what has been reported previously for this drug combination.Approximately 13,000 cases of soft-tissue and bone sarcoma are diagnosed annually in the United States. Resume COMETRIQ therapy after surgery based on clinical judgment of adequate wound healing. Withhold COMETRIQ for hypertension that is not adequately controlled with medical management; when controlled, resume COMETRIQ at a reduced dose. Perform an oral examination prior to initiation of COMETRIQ and periodically during COMETRIQ therapy.
Adverse reactions led to study treatment discontinuation in 16% of patients receiving COMETRIQ and in 8% of patients receiving placebo. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects.
Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding.
Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID treatment arm.
Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death.
Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient’s underlying risk factors. Because many drugs are excreted in human milk and because of the potential for adverse reactions in nursing infants from POMALYST, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
The influence of renal and hepatic impairment on the safety, efficacy, and pharmacokinetics of pomalidomide has not been evaluated. Pazopanib is an oral angiogenic inhibitor that especially targets VEGEFR-1, VEGFR-2, and VEGFR-3.
Sternberg provided no specific data results but stated that ”there was no difference between treatment with pazopanib and placebo at any of the on-therapy assessment time points”. The median survival time from diagnosis for patients with metastatic disease is about 10 to 18 months.Researchers at Memorial Sloan-Kettering Cancer Center undertook the multicenter, open-label, phase II study in 19 cancer centers nationwide.
Withhold COMETRIQ in patients with dehiscence or wound healing complications requiring medical intervention.
Discontinue COMETRIQ for severe hypertension that cannot be controlled with anti-hypertensive therapy. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient's underlying risks.
Cases of B-cell malignancies (including Hodgkin’s Lymphomas) were observed in clinical trials where patients received REVLIMID in the post-ASCT setting. In females of reproductive potential, obtain 2 negative pregnancy tests before starting POMALYST treatment.
Arterial thromboembolic events include terms for arterial thromboembolic events, ischemic cerebrovascular conditions, and ischemic heart disease. If medically necessary to co-administer strong inhibitors of CYP1A2 in the presence of strong inhibitors of CYP3A4 and P-gp, reduce POMALYST dose by 50%. The material on this site is for informational purposes only and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. For invasive dental procedures, withhold COMETRIQ treatment for at least 28 days prior to scheduled surgery, if possible. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients who received REVLIMID-containing therapy until disease progression did not show a higher incidence of invasive SPM than patients treated in the fixed duration REVLIMID-containing arms. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions.
Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.
Vogelzang echoed ACKC’s concerns, pointing out that many of the trial’s participants were from ‘resource poor countries’ (many were from Asia) and decried the fact that there was only a 48% crossover to pazopanib for patients on the placebo arm whose disease progressed. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program (formerly known as the “RevAssist®” program). Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g. This figure is low as compared to the crossover on other trials – he compared it to crossovers of 55% and 63% on two other trials where Interferon-alpha was the control arm.
In this trial, we have placebo patients off therapy for three to four months, as well as insufficient control of the trial by GSK to ensure that the placebo patients were crossed over to therapy once they progressed. In NDMM study, which nearly all patients received antithrombotic prophylaxis, overall frequency of thrombotic events was 17.4% in combined Rd Continuous and Rd18 arms.
ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision.



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