“Ramucirumab added to first-line docetaxel failed to improve progression-free survival in patients with metastatic breast cancer in the large, randomized, placebo-controlled ROSE/TRIO-12 trial. An interim analysis of overall survival showed no advantage for the addition of ramucirumab. This study, presented at the 2013 San Antonio Breast Cancer Symposium, joins a number of other failed antiangiogenesis trials in breast cancer, most of them evaluating bevacizumab (Avastin).”
” ‘Thus far, no antiangiogenesis strategy has improved survival in breast cancer. Ramucirumab did not significantly prolong progression-free survival in this trial, and there is no signal that it will prolong overall survival. This was a failed trial,’ said lead author John R. Mackey, MD, Professor of Medical Oncology at the University of Alberta and Cross Cancer Institute, Edmonton, Alberta, Canada.”
Editor’s note: Antiangiogenesis drugs like ramucirumab are meant to prevent the formation of blood vessels that supply tumors with nutrients needed for them to grow. This clinical trial found disappointing results for ramucirumab for patients with metastatic breast cancer. Ramucirumab is also being tested as a potential treatment for colorectal cancer, liver cancer, and lung cancer.
“Among patients with advanced non-small cell lung cancer without a mutation of a certain gene, conventional chemotherapy, compared with treatment using epidermal growth factor receptor tyrosine kinase inhibitors, was associated with improvement in survival without progression of the cancer, but not with overall survival, according to a study.”
Editor’s note: The drugs discussed in this story, “epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors,” are targeted therapies that are used to treat lung cancer patients whose tumors have mutations in the EGFR gene, as detected by molecular testing. Scientists wanted to find out whether the drugs could also help patients without EGFR mutations. However, it was found that the drugs were no more effective than chemotherapy in improving patients’ overall survival. This supports the idea that EGFR inhibitor drugs should only be given to patients whose tumors have EGFR mutations.
Clinical trials help determine whether new cancer treatments are safe and effective, and they provide access to cutting-edge drugs that patients wouldn’t otherwise be able to have. But the clinical trial system is notoriously inefficient, slow, expensive, and laborious. Now, a new and ambitious clinical trial design called the Lung Cancer Master Protocol seeks to overhaul the system, promising to benefit patients and drug companies alike. Continue reading…
“Tasquinimod prolonged survival in men with minimally symptomatic, metastatic castration-resistant prostate cancer compared with placebo, according to results of a randomized, phase 2 study. Results suggest the survival advantage was particularly apparent among men with skeletal metastases. The study included 201 men. Researchers assigned 134 of them to tasquinimod (Active Biotech), an oral immunomodulatory, anti-angiogenic and anti-metastatic novel agent. The other 67 men were assigned placebo; however, 41 of them crossed over to treatment with tasquinimod during the study.”
“Exelixis, Inc. today announced that it has initiated a phase II clinical trial comparing cabozantinib plus abiraterone and prednisone (abiraterone/prednisone) versus abiraterone/prednisone in patients with castration-resistant prostate cancer (CRPC) who have bone metastases and have not been previously treated with chemotherapy. The primary endpoint for the randomized, open-label trial is radiographic progression-free survival (PFS).”
Takeda Pharmaceutical Company announced the unblinding of its randomized. phase III trial, meaning that the patients involved will now be made aware of which treatment they were receiving (often, trials are ‘blind’ to minimize bias that could skew results). The company made the decision after a report indicated that the study was unlikely to meet its primary endpoint (or main objective) of improving overall survival in patients with metastatic castration-resistant prostate cancer (mCRPC). The study was evaluating the effects of orteronel (an androgen synthesis inhibitor) plus prednisone (an antiinflammatory drug used to treat many conditions) compared to the effects of a placebo pill plus prednisone. The company said that while orteronel did not appear to significantly extend overall survival compared to the control group, it did appear to extend progression-free survival of the disease. Patients participating in the study had all experienced disease progression during or following treatment with chemotherapy, and those who had been assigned to receive orteronel will be allowed to continue taking the drug following consultation with their doctors and study investigators.
Campos-Parra AD, Zuloaga C, Manríquez ME, Avilés A, et al. Am J Clin Oncol. Mar 28, 2013.
“In patients with non-small cell lung cancer (NSCLC), knowledge of the epidermal growth factor receptor (EGFR) mutation status is fundamental for selecting the treatment involving EGFR-tyrosine kinase inhibitors (EGFR-TKIs). Little information is available regarding the response and progression-free survival (PFS) in platinum-based chemotherapy (CT) versus EGFR-TKIs in the presence or absence of KRAS mutation, particularly in patients without EGFR mutation…”