Roche Says Avastin Prolongs Life in Breast Cancer Study

“Swiss drugmaker Roche said its cancer drug Avastin helped women with a common form of breast cancer live longer without their disease worsening, when used in combination with chemotherapy drug Xeloda.

“Results of a Phase III study involving 185 patients with HER2-negative metastatic breast cancer found those treated with both drugs saw an almost threefold improvement in how long they lived without their disease getting worse compared with those taking Avastin alone.

“A second late-stage trial with 494 patients who continued treatment with Avastin and standard chemotherapy after their disease had progressed showed patients lived significantly longer without the disease getting worse compared with those treated only with chemotherapy.”

Learn more about clinical trials—research studies with volunteer patients.


Eribulin Plus Trastuzumab Safe, Effective in HER-2–Positive Metastatic Breast Cancer

The gist: Researchers recently tested a breast cancer treatment in a clinical trial—a research study with volunteer patients. The treatment combines the drug trastuzumab (aka Herceptin) with a new drug called eribulin mesylate. The goal of the trial was to find out how well the combination might work for patients who had already been treated with trastuzumab. All patients who participated had HER-positive metastatic breast cancer. It was found that the treatment was safe and effective, regardless of whether patients had already taken trastuzumab.

“Eribulin mesylate plus trastuzumab demonstrated activity in patients with HER-2–positive metastatic breast cancer regardless of prior treatment with trastuzumab, according to phase 2 study results presented at the Breast Cancer Symposium.

“Joyce O’Shaughnessy, MD, of the Texas Oncology Baylor Charles A. Sammons Cancer Center, and colleagues sought to evaluate whether prior trastuzumab (Herceptin, Genentech) affected the efficacy of eribulin mesylate (Halaven, Eisai) plus trastuzumab. Previous data indicated the combination conferred a 71% objective response rate as a first-line treatment.

“The analysis included 52 patients (median age, 59.5 years) who had not undergone prior chemotherapy for metastatic breast cancer. Twenty-one patients had previously received trastuzumab and 31 had not. A median of 23 months had passed since previous treatment.

“Patients received 1.4 mg/m2 IV eribulin mesylate on days 1 and 8 of a 21-day cycle. They also received an initial trastuzumab dose of 8 mg/kg, followed by 6-mg/kg doses on day 1 of each cycle. Median treatment duration was approximately 30 weeks.

“Researchers reported similar rates of objective clinical response (62% vs. 77%) and clinical benefit (81% vs. 87%) between patients who had received prior trastuzumab and those who had not.”


Team Successfully Completes Fisrt [sic] Clinical Trial on HER-2-Negative Breast Cancer with Nintedanib

The gist: People with early-stage HER-2-negative breast cancer might benefit from a new drug called nintedanib combined with standard chemotherapy. That insight came from a recently completed clinical trial—a research study with volunteer patients. 50% of the patients who took the new treatment in the trial had total remission of their tumors.

“The experimental drug nintedanib, combined with standard chemotherapy with paclitaxel, causes a total remission of tumours in 50% of patients suffering from early HER-2- negative breast cancer, the most common type of breast cancer. These are the conclusions of the Phase I Clinical Trial, sponsored by the Spanish National Cancer Research Centre (CNIO) and carried out by CNIO ́s Breast Cancer Clinical Research Unit. The study has been published today in British Journal of Cancer.

“According to Miguel Ángel Quintela, head of the Unit: ‘The drug combination of paclitaxel and nintedanib has turned out to be a complete success, given that it is proved to be safe and that the pathologic complete response [rate of complete recovery] was 50%, which doubles the response compared to patients treated with standard therapy with paclitaxel.’ The trial has also included 10 HER-2-negative breast cancer patients, all of them in early stages of the disease.

“In light of the results, the CNIO Breast Cancer Clinical Research Unit has already launched a large-scale Phase II Clinical Trial to validate the results in a large group of patients. These results, including biomarker studies that will facilitate advances in personalised medicine, will be released by early 2015.”


Phase II Trial Shows Overall Survival Benefit With VT-122 Plus Sorafenib in Advanced Hepatocellular Carcinoma

The gist: People with advanced hepatocellular carcinoma may benefit from treatment with a combination of the drugs VT-122 and sorafenib (Nexavar). That was the conclusion of a recent clinical trial—a research study with volunteer patients. The goal of the trial was to test the combination treatment. In the trial, people who took the combination had an 11-month increase in overall survival compared to people who took only sorafenib.

“The investigational agent VT-122 appeared to benefit survival when combined with sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma, according to data presented at the 8th Annual International Liver Cancer Association Conference in Kyoto, Japan. Researchers reported an 11-month increase in median overall survival in patients treated with VT-122 plus sorafenib, compared to those receiving sorafenib alone.

“VT-122 is a novel, oral, chronodosed combination of the nonsteroidal anti-inflammatory drug (NSAID) etodolac and the beta-blocker propranolol. The investigational compound inhibits prostaglandin and beta-adrenergic signaling to reduce tumor-promoting inflammation and restore a tumor-suppressing immune state…

“In this phase II randomized, open-label, controlled clinical trial, 24 patients with advanced hepatocellular carcinoma were randomly assigned to receive VT-122 plus sorafenib or sorafenib alone.”


Erlotinib Alone or with Bevacizumab as First-Line Therapy in Patients with Advanced Non-Squamous Non-Small-Cell Lung Cancer Harbouring EGFR Mutations (JO25567): An Open-Label, Randomised, Multicentre, Phase 2 Study

Editor’s note: This article describes the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to compare two different treatment approaches for non-squamous non-small cell lung cancer (NSCLC) with mutations in the EGFR gene. One treatment combined the drugs erlotinib and bevacizumab, and the other treatment was simply erlotinib alone. Based on the results, the researchers say that erlotinib plus bevacizumab could be a new standard treatment for people with NSCLC with EGFR mutations.

“The authors aimed to compare the efficacy and safety of the combination of erlotinib and bevacizumab compared with erlotinib alone in patients with non–squamous NSCLC with activating EGFR mutation–positive disease. Erlotinib plus bevacizumab combination could be a new first–line regimen in EGFR mutation–positive NSCLC. Further investigation of the regimen is warranted.”


Trial Shows Improved Overall Survival for Patients with Liver Cancer not Amenable to Surgery

The gist: This article describes the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to test a new treatment for people with inoperable advanced hepatocellular carcinoma (HCC). The new treatment combines two existing treatments: a chemotherapy drug called sorafenib and Selective Internal Radiation Therapy (SIRT). The results of the trial showed improved survival for the patients who participated. The new treatment will continue to be tested in the hopes that it may prove good enough to be widely used to treat advanced HCC.

“The mature results from a trial conducted by the Asia-Pacific Hepatocellular Carcinoma Trials Group led by the National Cancer Centre Singapore (NCCS) and Singapore General Hospital (SGH) have shown that patients who suffer from inoperable advanced hepatocellular carcinoma (HCC) may have a chance to live significantly longer by using a combined therapy.

“The multi-centre phase II clinical trial was conducted at four Asia Pacific tertiary medical centres to evaluate the efficacy of combining two existing treatment modalities, Sorafenib and Selective Internal Radiation Therapy (SIRT). The combination therapy involves starting patients on SIRT using SIR-Spheres microspheres, a medical device that contains radioactive microspheres labeled with yttrium-90 for short range high energy radiation therapy, followed by systemic therapy with an oral chemotherapy drug, Sorafenib, 14 days later.

“The mature results of the trial published recently in a peer-reviewed journal, PLOS ONE, show that median overall survival was 20.3 months for patients with intermediate stage HCC and 8.6 months for patients with advanced liver cancer. These final results were better than the preliminary data released in 2010.”


Erbitux Edges Avastin for First-Line Colorectal Cancer Therapy

Editor’s note: This article discusses the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to compare two drugs—bevacizumab and cetuximab—when they were added to the standard chemotherapy combo FOLFIRI. All patients who participated in the trial had metastatic colorectal cancer. The researchers found that patients treated with FOLFIRI plus cetuximab had longer overall survival times that patients treated with FOLFIRI plus bevacizumab. The results differ from those from another recent study, which found no significant difference between the two treatments.

“Adding cetuximab (Erbitux) to the standard first-line FOLFIRI chemotherapy regimen resulted in longer overall survival compared with FOLFIRI plus bevacizumab (Avastin) in patients with metastatic colorectal cancer, according to results of the phase III FIRE-3 trial published this month in the Lancet.

“This result was seen in patients with a wild-type exon 2 KRAS gene. The longer overall survival was observed despite there being no significant difference in objective response between the two study groups.

“The study analyzed data from 592 patients with KRAS exon 2 wild-type colorectal cancer treated with FOLFORI and either cetuximab (an epidermal growth factor receptor inhibitor) or bevacizumab (an angiogenesis inhibitor). Patients were recruited at 116 Austrian and German cancer centers.”


Pfizer to Test Xalkori Lung Cancer Drug with Merck Immunotherapy

Editor’s note: This article is about two big drug companies that are teaming up to see if their non-small cell lung cancer drugs work even better when combined. The two drugs are called pembrolizumab and crizotinib (aka Xalkori). Pembrolizumab is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. Crizotinib is a targeted therapy that is meant to treat people whose tumors have mutations in the ALK gene. To test the combo, the companies are organizing a clinical trial—a research study with volunteer patients. The clinical trial will not begin until 2015.

“Pfizer Inc said Tuesday it will test its Xalkori lung cancer drug with Merck & Co’s experimental immunotherapy pembrolizumab, in hopes the combination will improve the outcomes for patients taking the approved Pfizer therapy.

“The largest U.S. drugmakers said the combination study will begin in 2015 and be conducted by Pfizer. Financial terms of the deal were not disclosed.

“Xalkori, which has annual sales of $400 million and is also known by its chemical name, crizotinib, was approved in 2011 for lung cancer patients who have a specific mutation in the so-called ALK gene, as determined by an approved diagnostic test.

“The mutation occurs in a small percentage of patients with non small cell lung cancer, the most common form of lung cancer. It makes them good candidates for treatment with Xalkori, a targeted drug that can help shrink or slow tumor growth for these patients.

“Pembrolizumab works by removing the brakes from the immune system, allowing it to detect and destroy cancer cells.”

 


Pemetrexed Plus Cisplatin Active in Advanced, Recurrent Cervical Carcinoma

Editor’s note: This article describes the results of a clinical trial—a research study with volunteer patients. The goal of the trial was to test a new treatment for women with advanced, recurrent cervical cancer. The treatment combines the drugs pemetrexed and cisplatin. The results were promising: the new treatment appeared to be safe and effective. More research needs to be done to determine just how effective it is. Also, scientists are interested in testing whether it is even more effective when combined with the targeted drug bevacizumab (Avastin).

“The combination of pemetrexed and cisplatin appeared safe and effective in women with advanced, persistent or recurrent carcinoma of the cervix, according to results of a phase 2 trial.

“ ‘This combination should be further developed in the treatment of cervical cancer,’ David Scott Miller, MD, professor of obstetrics and gynecology at UT Southwestern Medical Center, and colleagues wrote. ‘Given that it may be less toxic than and as active as cisplatin plus paclitaxel, and that it can be combined with bevacizumab (Avastin, Genentech), comparison of cisplatin–pemetrexed plus bevacizumab with cisplatin–paclitaxel plus bevacizumab would be appropriate.’ ”