Clinical Trial Reports: November 2007

By Stanton R. Mehr
Published: Tuesday, Jun 29, 2010
%u25BA PHASE III

Trastuzumab and Anastrozole Extend Breast Cancer Survival in Patients Who Received Anastrozole Alone Earlier


Treatment with trastuzumab plus anastrozole significantly improved progression-free survival in postmenopausal women with HER2/ hormone receptor–positive metastatic breast cancer who had earlier received the hormonal therapy alone, according to post hoc results from the TAnDEM study, which include 77 centers from 22 countries around the world.

One hundred four patients were randomized to receive the aromidase inhibitor alone (oral anastrozole 1 mg/day), and 103 received combination therapy (oral anastrozole 1 mg/day plus intravenous trastuzumab 4 mg/kg on day 1, followed by 2 mg/kg every wk) until progression of disease. Patients in the monotherapy arm could cross over to the combined arm if so desired after progression. Seventy-three of the patients in the monotherapy arm did cross over to the combined chemotherapy arm.

The investigators noted slightly longer overall survival in the combined therapy group compared with the anastrozole monotherapy group (28.5 vs. 23.9 mo; P = .325) in the original study.

In the post hoc analysis, the researchers reported that cross over to combined therapy had a significant effect on overall survival. Patients who later received this combined treatment experienced median overall survival extended by 7.9 months to 25.1 months for subjects who received combined therapy after progressive disease, each compared with 17.2 months for patients who received only anastrozole (P = .04).

The researchers concluded that adding trastuzumab to previous aromidase inhibitor therapy in women with HER2/hormone receptor–positive metastatic breast cancer may prolong overall survival, the researchers indicated, compared with anastrozole alone.


   Clemens M: Trastuzumab plus anastrozole may prolong overall survival in women with HER2- positive, hormone-dependent metastatic breast cancer: Results of a post-hoc analysis from the TAnDEM study. Presented at the annual ASCO Breast Cancer symposium. San Francisco, September 7–8, 2007.






%u25BA PHASE II

Motexafin for Non–Small Cell Lung Cancer


According to the American Cancer Society, more than 213,000 new cases of lung cancer in the United States will have occurred in 2007, and the most common form, non– small cell lung cancer (NSCLC), is incurable in its advanced stages. Motexafin gadolinium disrupts redox-dependent pathways by targeting oxidative stress-related proteins, such as thioredoxin reductase. Recent results involving the use of motexafin gadolinium injection indicate that this agent may play a promising role in patients with advanced disease.

American and Canadian researchers presented data from an open-label, multicenter phase II clinical trial evaluating motexafin as a single agent and in combination with chemotherapy as a second-line treatment at a recent lung cancer conference. Patients with non-small cell lung cancer (NSCLC) who had not responded to one platinum-based chemotherapy regimen were enrolled in the investigation.

The trial evaluated safety, tumor response, and survival in patients with recurrent NSCLC. Patients were randomized to receive either a 10-mg/kg dose of motexafin every week or a 15-mg/kg dose every three weeks. A confirmed response rate of 5%, or three partial responses, was reported in 60 of the patients who were evaluated. Stable disease was noted in 17 (30%) of the subjects. The one-year survival was 34%, with a median survival of 9.2 months. Side effects (grade 3 or higher) included hypophosphatemia (23%), fatigue (12%), dyspnea (8.3%), and pneumonia (6.7%).

The investigators concluded that motexafin appears active as second-line monotherapy for patients with advanced or metastatic NSCLC who have failed prior platinum-based chemotherapy, with a response rate similar to other approved agents and a favorable side-effect profile.


   Natale RB: Motexafin gadolinium (MGd) is active as a single agent in advanced non–small–cell lung cancer (NSCLC) patients who failed platinum- based chemotherapy: Preliminary results of a phase II trial. Presented at the 2007 World Conference on Lung Cancer of the International Association for the Study of Lung Cancer, Seoul, Korea, September 5–8, 2007.





Oral Satraplatin Monotherapy for the Treatment of Metastatic Breast Cancer Shows Little Response

Intravenous cisplatin and carboplatin are both active agents for treating metastatic breast cancer. Satraplatin, a well-tolerated platinum analog, may be a convenient oral alternative to intravenous chemotherapy. A recent study sought to determine the overall response rate in patients with metastatic breast cancer who had received at most one prior chemotherapy regimen for metastatic breast cancer.


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Online CME Activities
TitleExpiration DateCME Credits
Community Practice Connections™: 18th Annual International Lung Cancer Congress®Oct 31, 20181.5
Clinical Interchange™: Translating Research to Inform Changing Paradigms: Assessment of Emerging Immuno-Oncology Strategies and Combinations across Lung, Head and Neck, and Bladder CancersOct 31, 20182.0
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