Editor’s note: Researchers organized a clinical trial with volunteer patients to compare two treatments for people with metastatic colorectal cancer. All patients in the trial took a chemotherapy treatment called FOLFIRI. (FOLFIRI combines the drugs fluorouracil, leucovorin, and irinotecan.) Some of the patients were also given the drug cetuximab, and the rest took the drug bevacizumab along with FOLFIRI. The patients who took FOLFIRI plus cetuximab survived significantly longer than the patients who took FOLFIRI plus bevacizumab.
“In a European phase III FIRE-3 trial reported in The Lancet Oncology, Heinemann et al found no difference in response rate, the primary endpoint, between FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus the anti-EGFR antibody cetuximab (Erbitux) vs FOLFIRI plus the anti-VEGF-A antibody bevacizumab (Avastin) in first-line treatment of patients with metastatic colorectal cancer. The cetuximab-containing regimen was associated with a significant overall survival advantage…
“In this open-label trial, 592 patients with KRAS exon 2 codon 12/13 wild-type metastatic colorectal cancer aged 18 to 75 years from centers in Germany and Austria were randomly assigned between January 2007 and September 2012 to receive FOLFIRI plus either cetuximab (n = 297) or bevacizumab (n = 295). The primary endpoint was objective response in the intention-to-treat population. The study has completed recruitment, but patient follow-up is ongoing.”
The gist: Researchers conducted a clinical trial with volunteer patients to test two drugs, alone and in combination, for recurrent glioblastoma. The two drugs tested were bevacizumab (aka Avastin) and lomustine (aka CeeNU). The researchers found promising results for patients who took both bevacizumab and lomustine, and recommend that further clinical trials be conducted to continue to study the new combination treatment. The patients who participated in the study all had glioblastoma that was treated with temozolomide chemoradiotherapy, but recurred.
“Bevacizumab (Avastin) is frequently used in patients with recurrent glioblastoma, although it is unclear whether responses observed with such treatment result in improved overall survival. In the phase II Dutch BELOB study reported in The Lancet Oncology, Taal et al found that overall survival results supported phase III evaluation of the combination of bevacizumab and lomustine (CeeNU) but not bevacizumab monotherapy…
“In this open-label trial, 153 adult patients from 14 Dutch hospitals with a first recurrence of glioblastoma after temozolomide chemoradiotherapy were randomly assigned between December 2009 and November 2011 to receive oral lomustine at 110 mg/m2 once every 6 weeks, intravenous bevacizumab at 10 mg/kg once every 2 weeks, or combination treatment at the same doses. The primary endpoint outcome was overall survival at 9 months in the intent-to-treat population.
“A preplanned safety analysis after eight patients had received the combination regimen showed that three had grade 3 and two had grade 4 thrombocytopenia, with these toxicities requiring a reduction in bevacizumab dose intensity. The lomustine dose in the combination group was subsequently reduced to 90 mg/m2. In addition to the eight combination recipients getting the higher lomustine dose, 51 received bevacizumab alone, 47 received lomustine alone, and 47 received bevacizumab plus lomustine at 90 mg/m2.
“The investigators concluded, ‘The combination of bevacizumab and lomustine met prespecified criteria for assessment of this treatment in further phase 3 studies. However, the results in the bevacizumab alone group do not justify further studies of this treatment.’ ”
The gist: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process.The drug Avastin (bevacizumab), already FDA-approved for several subtypes of several different cancers, was recently granted Priority Review status for the treatment of women with recurrent platinum-resistant ovarian cancer. The decision was based on promising results for the treatment in a clinical trial with volunteer patients.
“The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
“ ‘The majority of women with ovarian cancer will become resistant to platinum therapy, and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.
“The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.’ The supplemental Biologics License Application for bevacizumab plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the phase III AURELIA trial.”
“Genentech, a member of the Roche Group (six:RO)(six:ROG)(otcqx:RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin® (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastaticcervical [sic] cancer.
“ ‘This regulatory application for Avastin is important because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer,’ said Sandra Horning, M.D., chief medical officer and head of Global Product Development. ‘Treatment with Avastin plus chemotherapy may help women with these conditions live longer than chemotherapy alone, and we look forward to working with the FDA on potentially making this medicine available to patients.’ ”
“The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.’ The sBLA for Avastin plus chemotherapy in persistent, recurrent or metastaticcervical cancer is based on data from the Phase III GOG-0240 trial with an FDA action date of October 24, 2014.”
The gist: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The drug Avastin (bevacizumab), already FDA-approved for several subtypes of several different cancers, was recently granted Priority Review status for the treatment of women with persistent, recurrent or metastatic cervical cancer. These patients currently only have the option of being treated with chemotherapy, but clinical trial evidence indicates that adding Avastin to the standard chemotherapy regimen might help these women live longer.
“For patients with KRAS wild-type untreated colorectal cancer, adding cetuximab or bevacizumab to combination chemotherapy offers equivalent survival, researchers said at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.” ‘The CALGB/SWOG 80405 trial was designed and formulated in 2005, and the rationale was simple: we had new drugs —bevacizumab and cetuximab— and the study was designed to determine if one was better than the other in first-line for patients with colon cancer,’ said lead study author Alan P. Venook, distinguished Professor of Medical Oncology and Translational Research at the University of California, San Francisco, USA.
“The CALGB/SWOG 80405 trial studied patients whose tumours were KRAS wild-type at codons 12 and 13. Patients received mFOLFOX6 or FOLFIRI at the discretion of their doctor and were randomised to cetuximab (578 patients) or bevacizumab (559 patients).
” ‘There was no meaningful difference in outcome between treatment arms,’ said Venook. ‘In both arms patients lived close to 30 months. About 10% of patients lived more than 5 years. Overall patients did much better than anticipated and it was indifferent to the type of treatment.’ ”
Editor’s note: This story discusses the results of a clinical trial that tested a treatment for colorectal cancer in volunteer patients without mutations in the KRAS gene in their tumors (as detected by molecular testing). The goal of the trial was to compare two chemotherapy drugs—bevacizumab and cetuximab—to see whether one is better than the other as a first-line colorectal cancer for so-called “KRAS wild-type” colorectal cancer. The results showed that there was no significant difference between the two.
“The presence of a six-gene profile in the microRNA of patients with advanced non-squamous non-small-cell lung cancer (NSCLC) predicts reduced survival likelihood after first-line treatment with targeted therapy followed by chemotherapy for disease progression, indicate research results.
“While the findings ‘should be further validated’, the researchers believe their analysis ‘supports the hypothesis that circulating [microRNA’s] may further be developed as predictive markers for EGFR-targeted treatment’ in an NSCLC population whose response to epidermal growth-factor receptor (EGFR) tyrosine kinase inhibitors is unknown.”
Editor’s note: This story describes a new, blood test-based method by which oncologists may be able to predict the effects of targeted therapy treatment on the survival of patients with non-squamous non-small cell lung cancer (NSCLC). Specifically, it may be able to predict the effects of first-line treatment with drugs known as EGFR inhibitors, which are prescribed to people whose tumors have mutations in the EGFR gene, as detected by molecular testing. In a study with volunteer patients, scientists took blood samples just before and just after the patients began taking the drugs bevacizumab or erlotinib. The scientists identified six different kinds of a molecule called microRNA that, if present, were associated with a lower chance of survival (29 months versus more than 45 months). More testing will be needed to determine if this six-gene signature can be used widely; it would be a non-invasive alternative to making predictions and monitoring treatment effectiveness using repeat tumor biopsies.
“Adding bevacizumab (Avastin) to first-line targeted therapy delayed progression in a subgroup of non-small cell lung cancer (NSCLC), an open-label trial showed.
“Progression-free survival was 46% better with bevacizumab plus erlotinib (Tarceva), at 16.0 months compared with 9.7 on erlotinib alone in an EGFR mutation-positive population (P=0.0015), Terufumi Kato, MD, of Kanagawa Cardiovascular and Respiratory Center in Yokohama, Japan, and colleagues found.”
Editor’s note: A combination of two targeted therapy drugs has shown promise for treating some patients with non-small cell lung cancer (NSCLC). The two drugs are called bevacizumab (brand name Avastin) and erlotinib (brand name Tarceva). The research described in this story found that the combination works better for patients whose tumors have mutations in the EGFR gene (as detected by molecular testing) than erlotinib alone.
“Accounting for approximately half of all cancers in the United States, skin cancer is widely recognized as the most common cause of cancer nationwide. More than 3.5 million cases of skin cancer are diagnosed each year, and according to the Skin Cancer Foundation, incidences of skin cancer outnumber all combined cases of breast, colon, lung and prostate cancers.
“With the month of May designated as National Skin Cancer Awareness Month, HemOnc Today highlights 10 issues for oncologists and dermatologists to consider for their patients, as well as the new guideline revisions and research regarding the identification, treatment and management of patients with melanoma and skin cancer.”
“Clinical records of elderly patients with non-small-cell lung cancer (NSCLC) show that treatment with bevacizumab seems to be safe and effective in patients with controlled pre-existing cardiovascular disease and good performance status. Furthermore, another targeted agent, erlotinib, represents a valuable treatment option in elderly NSCLC patients with co-morbidities, especially if they harbour EGFR mutations. The data were presented by Prof. Kostas Syrigos on behalf of colleagues from the Oncology Unit, Sotiria General Hospital, Athens School of Medicine, Athens, Greece in a general poster session at the 4th European Lung Cancer Conference (26-29 March 2014, Geneva, Switzerland).”