February 1 Clinical Cancer Research Highlights

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Selected Articles from the February 1, 2007 Issue

The articles referenced in this Highlights section will be available online in HTML and PDF formats to all interested users at no charge until the next issue of Clinical Cancer Research is published. Click on the article title to view the complete article.

View the Table of Contents for the February 1 issue of Clinical Cancer Research.

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System Validated for Measurement of Circulating Tumor Cells

Riethdorf et al.
Page 920

The major goals of detecting circulating tumor cells (CTCs) in peripheral blood are to monitor the efficacy of anti-cancer therapies and to gain information about the effects of such therapies on metastatic tumor cell spread. Riethdorf et al. validated the analytical performance of the CellSearch system. The authors have presented independent validation data from three laboratories in Europe and the United States that supported the reliability of this system for measuring CTCs in blood of metastatic breast cancer patients. Their data show that samples can be shipped at room temperature within 72 hours, which facilitates testing at central laboratories or remote sites requiring transportation.

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Celecoxib Yields Synergistic Anti-tumor Effects

Javle et al.
Page 965

Cyclooxygenase-2 (COX-2) inhibitors may ameliorate chemotherapy-induced mucosal toxicity and enhance anti-tumor effect. Javle et al. investigated this hypothesis in the rat Ward colorectal cancer model and in a phase I clinical study. In the phase I clinical study, irinotecan was escalated along with a fixed dose of celecoxib. Pharmacokinetics (PK) of irinotecan, SN-38, and SN-38G were investigated. Celecoxib had limited influence on the PK of irinotecan. Celecoxib ameliorated diarrhea and resulted in synergistic anti-tumor effect in the rat model. In the phase I clinical study, diarrhea was limited, and stable disease resulted in 8 of 12 cases.

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Setting the Bar in Phase II Trials  

Vickers et al.
Page 972

Phase II trials aim to determine whether a cancer treatment is sufficiently promising to justify phase III study. Whether an agent is declared promising in phase II trial depends on pre-specified “null” and “alternative” rates of an outcome of interest such as tumor response. In some cases, the null must be determined with reference to historical data. Vickers et al. determined the proportion of phase II trials that require historical data to establish the null, and they determined how these historical estimates were derived. Many phase II trials require historical data to determine null response rates. Simple guidelines may improve design and reporting of such trials.

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Beta Tubulin III Helps Select Chemotherapy Patients

Séve et al.
Page 994

High class III beta tubulin (bTubIII) expression in advanced non-small-cell lung cancer (NSCLC) is known to correlate with reduced response rates and inferior survival with anti-microtubule agents. In this study, Sève et al. examined the prognostic and predictive value of bTubIII expression in patients enrolled in a large randomized trial of adjuvant chemotherapy for operable NSCLC, using cisplatin in combination with the anti-tubulin agent vinorelbine. Elevated bTubIII was associated with poor prognosis in patients treated with surgery alone but was associated with a greater likelihood of benefit from adjuvant chemotherapy. This study adds to an emerging body of work on the use of molecular markers to select patients for chemotherapy.

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