Linda D. Bosserman

Final 5-year results of Z-FAST trial: adjuvant zoledronic acid maintains bone mass in postmenopausal breast cancer patients receiving letrozole.

Postmenopausal breast cancer (BC) patients receiving adjuvant aromatase inhibitor therapy are at risk of progressive bone loss and fractures. Zoledronic acid inhibits osteoclastic bone resorption, is effective in maintaining bone health, and may therefore be beneficial in this setting.

Treatment of Low-Grade and Intermediate- Grade Lymphoma With Intensive Combination Chemotherapy Results in Long- Term, Disease-Free Survival

To define the role of intensive combination chemotherapy in the treatment of low‐grade or intermediate‐grade lymphomas, the authors report results in 49 patients treated with intermediate‐dose or high‐dose methotrexate, bleomycin, Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH), cytoxan (cyclophosphamide), vincristine, and dexamethasone (m/M‐BACOD) with long‐term follow‐up. The complete response rate was 59% (29 of 49), including 67% (eight of 12) with low‐grade and 57% (21 of 37) with intermediate‐grade disease. The median survival for the entire group was 81 months. The 29 complete responders had a long median survival of 131 months. Forty‐five percent (13 of 29) of the complete responders, 27% of the entire group, continue in remission with a median disease‐free survival of 76 months. This includes five of 19 patients with diffuse poorly differentiated lymphoma, a disease generally characterized by early relapse. Twelve patients achieved a partial response and had a shorter median survival of 53 months, whereas nonresponders survived a median of less than 5 months. Late relapse was noted in patients with low‐grade and intermediate‐grade disease. Age (younger than or older than 60 years) was the only predictor of long‐term survival. These data indicate very long disease‐free survival can be achieved in low‐grade and intermediate‐grade lymphomas after attaining a complete remission. Intensive doxorubicin containing chemotherapy can be considered as an option for patients with advanced low‐grade lymphoma but can only be proven to be superior to single‐agent chemotherapy or no initial therapy by controlled randomized trials.

Correlation of Drug-induced Apoptosis Assay Results With Oncologist Treatment Decisions and Patient Response and Survival

An observational prospective nonblinded clinical trial was performed to determine the effect of a drug‐induced apoptosis assay results on treatments planned by oncologists.

Application of a Drug-Induced Apoptosis Assay to Identify Treatment Strategies in Recurrent or Metastatic Breast Cancer

Background A drug-induced apoptosis assay has been developed to determine which chemotherapy drugs or regimens can produce higher cell killing in vitro. This study was done to determine if this assay could be performed in patients with recurrent or metastatic breast cancer patients, to characterize the patterns of drug-induced apoptosis, and to evaluate the clinical utility of the assay. A secondary goal was to correlate assay use with clinical outcomes. Methods In a prospective, non-blinded, multi institutional controlled trial, 30 evaluable patients with recurrent or metastatic breast cancer who were treated with chemotherapy had tumor samples submitted for the MiCK drug-induced apoptosis assay. After receiving results within 72 hours after biopsy, physicians could use the test to determine therapy (users), or elect to not use the test (non-users). Results The assay was able to characterize drug-induced apoptosis in tumor specimens from breast cancer patients and identified which drugs or combinations gave highest levels of apoptosis. Patterns of drug activity were also analyzed in triple negative breast cancer. Different drugs from a single class of agents often produced significantly different amounts of apoptosis. Physician frequently (73%) used the assay to help select chemotherapy treatments in patients, Patients whose physicians were users had a higher response (CR+PR) rate compared to non-users (38.1% vs 0%, p = 0.04) and a higher disease control (CR+PR+Stable) rate (81% vs 25%, p<0.01). Time to relapse was longer in users 7.4 mo compared to non-users 2.2 mo (p<0.01). Conclusions The MiCK assay can be performed in breast cancer specimens, and results are often used by physicians in breast cancer patients with recurrent or metastatic disease. These results from a good laboratory phase II study can be the basis for a future larger prospective multicenter study to more definitively establish the value of the assay. Trial Registration Clinicaltrials.gov NCT00901264

Is Your Practice Getting the Most from its EHR ? The Wilshire Oncology Medical Group Experience

562. A multicenter, double-blind randomized phase II trial of neoadjuvant treatment with single-agent bevacizumab or placebo, followed by docetaxel, doxorubicin, and cyclophosphamide, with or without bevacizumab, in patients with stage II or stage III breast cancer. ASCO 2008. Available online at: www.asco.org. Last accessed May 20, 2009. 14Chang HR, Slamon D, Prati R, Glaspy J, et al. Abstract 10515. A phase II study of neoadjuvant docetaxel/carboplatin with or without trastuzumab in locally advanced breast cancer: response and cardiotoxicity. ASCO 2006. Available online at: www.asco.org. Last accessed May 20, 2009.

Medical/Legal issues in genetic testing†

Patrick Lynch, J.D., M.D. (Co-Chair) T Matthew Severin, J.D., Ph.D. (Co-Chair) he workgroup considered a number of medical-legal issues in genetic testing, including regulatory issues, legislative issues, Alan Mills (Rapporteur) and emerging standards of patient care that perhaps have, or will, Linda Bosserman, M.D.* represent a ‘‘duty’’ on the part of the physician. These issues Doreine Carson* share a degree of uncertainty as well as a lack of clear and shared Donald C. Chambers, M.D.* standards, and in some instances are driven by competing interMyles Cunningham, M.D.* ests. The workgroup participants agreed that there was a pressing May Sung, M.P.H.* Nicholas J. Vogelzang, M.D.* need to further define and explore these issues, especially among competing interests, and that there should be strong collaborative initiatives among appropriate organizations to establish guidelines to assist the public and providers on issues related to risk assessment and clinical decision making.