July 12th 2024
“In LITESPARK-005, PFS and response rates favored belzutifan vs everolimus across [several patient subgroups, including] IMDC risk, number of prior lines [of therapy], and number of prior VEGF TKIs, specifically,” said Laurence Albiges, MD, PhD.
Advances In™: Targeting PSMA to Advance Diagnosis And Management Of Patients With Prostate Cancer
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Clinical Case Vignette Series: Integrating Recent Data into Practice to Improve Outcomes in Advanced Prostate Cancer
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Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board
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Medical Crossfire®: How Does Recent Evidence on PARP Inhibitors and Combinations Inform Treatment Planning for Prostate Cancer Now and In the Future?
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Medical Crossfire®: Where Are We in the World of ADCs? From HER2 to CEACAM5, TROP2, HER3, CDH6, B7H3, c-MET and Beyond!
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Community Oncology Connections™: Overcoming Barriers to Testing, Trial Access, and Equitable Care in Cancer
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Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care
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When a Support System Falls Apart
September 1st 2006This case study illustrates some of the off-treatment issues your patients may face when their coping support system is inadequate. Some of the psychological effects cancer patients deal with do not manifest until years after treatment is completed.
New Agents Top Standard Rx in First-Line Advanced RCC
July 1st 2006Two phase III international randomized trials of sunitinib (Sutent) and of the investigational mTOR kinase inhibitor temsirolimus indicate targeted therapy may provide both clinical and survival benefits to patients with advanced renal cell carcinoma (RCC). Sunitinib is an oral multi-targeted receptor tyrosine kinase inhibitor of the VEGF and PDGF receptors.
Sunitinib Proves Beneficial in Advanced Kidney Cancer, Promising in Lung Cancer
July 1st 2006According to a new multicenter study, the drug sunitinib malate (Sutent) is more effective than the current standard cytokine treatment given as initial therapy for patients with metastatic renal cell carcinoma. The study was presented at the annual American Society of Clinical Oncology meeting in Atlanta.
Temsirolimus Prolongs Survival of Patients With Advanced Renal Cell Carcinoma
July 1st 2006Preliminary data from an interim analysis of an ongoing phase III clinical trial of investigational temsirolimus (CCI-779) for the treatment of advanced renal cell carcinoma showed that single-agent therapy with temsirolimus significantly increased overall survival as a first-line treatment of patients with advanced disease and poor-risk features compared to interferon-alpha, a treatment for advanced renal cell carcinoma. In the trial, patients who were treated with temsirolimus alone experienced a 3.6-month, or 49%, increase in median overall survival time compared with patients treated with interferon-alpha alone (10.9 vs 7.3 months, P = .0069).
Updated Overall Survival Analysis Presented on Sorafenib Trial
July 1st 2006Dr. Tim Eisen provided an update on the sorafenib (Nexavar) phase III trial in patients with advanced renal cell carcinoma (RCC), or kidney cancer, during the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta. Dr. Eisen is the consultant medical oncologist at The Royal Marsden Hospital in London. The updated analysis confirmed that overall survival was longer for sorafenib than for placebo patients.
General and Statistical Hierarchy of Appropriate Biologic Endpoints
May 1st 2006The introduction of newer classes of chemotherapeutic agents, with varying mechanisms of action by which they affect tumor growth and viability, has challenged the traditional norms of clinical trial design and drug approval in oncology. Most notably, the emergence of cytostatic biologic agents with antitumor efficacy has necessitated reassessment of appropriate primary endpoints for phase II and III trials in advanced disease from both a clinical and regulatory standpoint. Recent data in the field establishes an endpoint hierarchy, which places progression-free survival (PFS) between overall survival (OS) and response rate (RR) as appropriate primary endpoints for assessing the clinical efficacy of cytostatic and cytotoxic agents.
Historic Evidence and Future Directions in Clinical Trial Therapy of Solid Tumors
May 1st 2006Although improved survival is the "gold standard" for proving clinical benefit of oncologic therapy, the US Food and Drug Administration (FDA) has accepted significant results in clinical trials using surrogate endpoints as the basis for drug approval. One surrogate is the amount of tumor reduction, or tumor response. Although tumor shrinkage would seem to be a necessary precondition for improved survival, clinical studies of a variety of oncologic agents have not consistently demonstrated a correlation between the two in patients with renal cell carcinoma. Moreover, tumor response may not be an appropriate endpoint for evaluating the effects of the new targeted therapies, whose putative mechanisms are generally cytostatic rather than cytotoxic. Clinical trials suggest that some patients with other solid tumors, such as lung cancer, may derive clinical benefit from treatment that helps stabilize their disease. There is also controversy as to whether the Response Evaluation Criteria in Solid Tumors (RECIST) provides the most appropriate instrument for assessing tumor burden. Ultimately, use of a variety of endpoints as well as different trial designs may provide an adequate basis for investigating the benefits/risks of newer therapies.
Defining Clinical Endpoints in Renal Cell Carcinoma
May 1st 2006The manuscripts that comprise this supplement "Defining Clinical Endpoints in Renal Cell Carcinoma" are presented by six leading international clinical and basic investigators, and are derived from their presentations at the roundtable discussion, "Defining Clinical Endpoints in Renal Cell Carcinoma," which took place in Chicago on October 21, 2005, sponsored by Bayer HealthCare.
Emerging Efficacy Endpoints for Targeted Therapies in Advanced Renal Cell Carcinoma
May 1st 2006Several novel targeted agents are being tested for the treatment of advanced renal cell carcinoma (RCC), and results of phase I and II trials have been encouraging. A recently completed phase III, placebo-controlled study showed that median progression-free survival doubled from 12 weeks to 24 weeks in patients treated with the multi-kinase inhibitor sorafenib (Nexavar) (hazard ratio [HR], 0.44; P < .00001), and approximately three-quarters of patients had some degree of tumor regression. Furthermore, interim analysis showed an estimated 39% improvement in overall survival in sorafenib-treated patients (HR, 0.72; P = .018) and an investigator-assessed response rate of 10%, indicating that many more patients had clinical benefit than had tumor regression qualifying as response by traditional criteria. These data and others have added to the evidence of lack of correlation between response rate and clinical benefit in RCC patients (as well as in other tumor types) treated with targeted therapies. Issues surrounding study endpoints and biologic efficacy markers for molecular targeted agents in RCC are discussed in this article, with a focus on results of the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGETs).
Radiation Therapy in the Management of Brain Metastases From Renal Cell Carcinoma
May 1st 2006Brain metastases from renal cell carcinoma (RCC) cause significant morbidity and mortality. More effective treatment approaches are needed. Traditionally, whole-brain radiotherapy has been used for palliation. With advances in radiation oncology, stereotactic radiosurgery and hypofractionated stereotactic radiotherapy have been utilized for RCC brain metastases, producing excellent outcomes. This review details the role of radiotherapy in various subgroups of patients with RCC brain metastases as well as the associated toxicities and outcomes. Newer radiosensitizers (eg, motexafin gadolinium [Xcytrin]) and chemotherapeutic agents (eg, temozolomide [Temodar]) used in combination with radiotherapy will also be discussed.
New Oral Agent Approved for Kidney Cancer and GIST
March 1st 2006The US Food and Drug Administration (FDA) recently approved sunitinib malate (Sutent) capsules for two types of cancer: advanced renal cell carcinoma and malignant gastrointestinal stromal tumor (GIST), after disease progression on or intolerance to the frontline drug imatinib mesylate (Gleevec).
FDA Approves Sutent for Resistant GIST and Kidney Cancer
February 1st 2006For the first time, the US Food and Drug Administration (FDA) has granted a new oncologic drug product approval for indications for two different cancers simultaneously. The agency approved Sutent (suniti-nib, Pfizer) for the treatment of patients with gastrointestinal stromal tumors (GIST) whose disease has progressed on imatinib (Gleevec) or who are unable to tolerate imatinib. It also granted Sutent accelerated approval for treating advanced renal cell carcinoma (RCC).
FDA Approves Nexavar for Use in Advanced Kidney Cancer
January 1st 2006The Food and Drug Administration (FDA) has approved Nexavar (sorafenib tosylate) tablets for the treatment of patients with advanced renal cell carcinoma. Nexavar, a multikinase inhibitor that has been shown to double progression-free survival in these patients, is the first FDA-approved treatment for this type of cancer in more than a decade, Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals, Inc.
Percutaneous Ablation of Kidney Tumors in Nonsurgical Candidates
October 1st 2005Although resection currently remains the standard of care for renalcarcinoma, the search for less invasive treatments has led to alternativesurgical approaches. Even less invasive, and appropriate for manygroups of patients, is percutaneous radiofrequency ablation, which inducestumor necrosis via lethal hyperthermia. Multiple series of renaltumors treated with percutaneous ablation in vivo and left in situ havebeen published; these series reveal that for small renal tumors,radiofrequency ablation results in complete necrosis at imaging in 79%to 100% of cases. Because current results come from tumors left in situwith short postablation follow-up, long-term results are necessary tocompare outcomes to surgical standards. Complication rates are lowerthan those following partial nephrectomy. Future reports will shed lighton the long-term outcomes of percutaneous ablation and the relativeadvantages and disadvantages of various technologies for thermal ablation.
Bevacizumab/Erlotinib CombinedBoost Responses in Renal Cell Ca
September 1st 2005This supplement to Oncology News International includes more than 15 reportson presentations made at the 41st annual meeting of the American Society of Clinical Oncology.Reviews focus on the use of targeted agents in non–small-cell lung cancer and other solid tumors,evaluating the novel therapies bevacizumab, cetuximab, bortezomib, erlotinib, and gefitinib, aloneand/or in combination with other chemotherapy agents. Continuing medical education credit isavailable by completing a post-test and evaluation online at www.cancernetwork.com/cme.
Novel TKIs Produce Major Responses in Renal Cell Ca
September 1st 2005This supplement to Oncology News International includes more than 15 reportson presentations made at the 41st annual meeting of the American Society of Clinical Oncology.Reviews focus on the use of targeted agents in non–small-cell lung cancer and other solid tumors,evaluating the novel therapies bevacizumab, cetuximab, bortezomib, erlotinib, and gefitinib, aloneand/or in combination with other chemotherapy agents. Continuing medical education credit isavailable by completing a post-test and evaluation online at www.cancernetwork.com/cme.
Sorafenib Doubles PFS in Advanced Renal Cell Ca
July 1st 2005ASCO - In a large randomized double-blind phase III international trial in patients with previously treated metastatic renal cell cancer (RCC), the oral multikinase inhibitor sorafenib (BAY 43-9006) was well tolerated and doubled progression-free survival (PFS) vs placebo with best supportive care. Lead investigator Bernard Escudier, MD, presented interim results in 769 patients at the 41st Annual Meeting of the American Society of Clinical Oncology (LBA4510) on behalf of the BAY 43-9006 TARGETs Clinical Trial Group. The primary endpoint of the study, overall survival, has not yet been reached, he said, and will be reported at a later date.
Early Study Shows 35% Response to SU011248 in Patients With Metastatic Renal Cell Carcinoma
January 1st 2005This supplement to Oncology News International includes 17 reportson clinical trials of targeted therapies used alone, in combination with chemotherapy,or in combination with each other in the treatment of non–small-cell lung cancer (NSCLC),bronchoalveolar carcinoma, glioblastoma multiforme, and renal cell carcinoma.Included is a report on a novel targeted agent recently approved for treatment of NSCLC.
The Evolving Role of Cytoreductive Surgery for Metastatic Renal Cell Carcinoma
May 1st 2003Drs. Uzair Chaudhary and GeraldHull provide a comprehensivereview of the role ofcytoreductive surgery in metastaticrenal cell carcinoma. This controversialtopic has been debated for manyyears. Metastatic renal cell carcinomacontinues to be a chemotherapyresistanttumor with a poor prognosis.About 30% of newly diagnosedpatients present with metastatic disease.In the metastatic setting, themost recognized treatment modalitiesinvolve the biologic agents interferon-alpha and interleukin-2 (IL-2,Proleukin). They produce an objectiveresponse rate of about 10% to15%, with approximately 5% of patientsachieving a durable completeresponse.
The Evolving Role of Cytoreductive Surgery for Metastatic Renal Cell Carcinoma
May 1st 2003In this issue of ONCOLOGY,Chaudhary and Hull succinctlysummarize historical trends andcurrent thinking regarding the role ofcytoreductive nephrectomy in patientswith metastatic kidney cancer.Before the era of immunotherapy,there was little evidence that the naturalhistory of metastatic renal cellcarcinoma was improved by cytoreductivenephrectomy.[1] Patientswith metastatic cancer generally diefrom complications related to theirsites of tumor spread and not fromthe primary tumor; thus, on face value,it seems illogical to surgicallyremove the primary tumor in thesepatients.
The Evolving Role of Cytoreductive Surgery for Metastatic Renal Cell Carcinoma
May 1st 2003Metastatic renal cell carcinoma is a devastating disease associatedwith poor survival. Immunotherapy is the mainstay of treatment, butresponse rates are low. The role of cytoreductive surgery in thepresence of metastatic disease is evolving. From both retrospective andrecently published randomized clinical trials, it is now apparent thatamong patients with metastatic renal cell carcinoma and good performancestatus, cytoreductive surgery followed by immunotherapy improvessurvival. However, this approach is likely to be detrimental inpatients with poor performance status. Clinical trials of novel agentsremain a priority in this disease.