landmarks

Reports of recent clinical trial data

todd buchanan 2011

annual meeting of the american society of clinical oncology (asco): gastrointestinal (GI) cancers symposium January 20–22, 2011, San Francisco, California

annual meeting of the american society of clinical oncology (asco): genitourinary (GU) cancers symposium

© sabcs / todd buchanan 2010

February 17–19, 2011, Orlando, Florida

american society for radiation oncology meeting (ASTRO) October 31–November 4, 2010, San Diego, California

San antonio breast cancer symposium (SABCS) December 8–12, 2010, San Francisco, Texas

American Psychosocial Oncology Society Annual Conference (APOS) February 17–19, 2011, Anaheim, California Contributors were selected by Jean Maroun, MD, FRCPC, FRCP (London); Joseph Ragaz, MD, FRCPC; Barry D. Bultz, PhD, CPsych

Colon cancer Validation of ColoPrint ® Diagnostic Test Rachel Goodwin, MD, MSc, FRCPC, Investigational New Drug Development Fellow, The Ottawa Hospital Cancer Centre, Ottawa, ON.

TRIAL SUMMARY: Test to predict the development of distant metastasis of Stage II colon cancer patients

An 18-gene profile using gene expression data from whole genome Agilent 44K oligonucleotide arrays was developed from a training set of 188 patient samples from the Netherlands. The profile was translated into a robust diagnostic test (ColoPrint®) using customized 8-pack arrays. The first validation test was conducted on samples from an independent cohort of 206 CC patients and in silico datasets (Salazar et al 2011). In this second ColoPrint validation study by Rosenberg, 233 patients who underwent curative resection (R0) for CC Stage II or III from 1987 to 2003 were selected (median age 64 years; median followup 97 months; median number of resected lymph nodes 21). Fresh frozen tissues, clinical parameters and followup data

for all patients were available. The samples were hybridized and the ColoPrint index was determined for all samples blinded from the clinical data. In the 135 Stage II patients, ColoPrint identified most patients (73%) as low risk. The 5-year distant metastasis-free survival was 95% (95% confidence interval [CI]=90.6–99.2%) for low-risk patients and 80% (95% CI=67.6–93.4%) for high-risk patients. In the univariate analysis, ColoPrint was the only significant parameter to predict the development of distant metastasis (hazard ratio [HR]=4.1, 95% CI=1.31– 13.01; p=0.009). Using clinical parameters from the American Society of Clinical Oncology (ASCO) recommendation (T4, perforation, 50% of any core positive) or need for any definitive intervention for the treatment of prostate cancer. Patients in the dutasteride arm had a significant reduction of progression at year 1.5 (23% vs 35%; p=0.0009) and at the end of the study (38% vs 49%; p=0.0007). Overall, their relative risk reduction was 38.9% (95% CI=12.4–57.4%; p=0.007). Further, patients

Change in Gleason score from baseline to final biopsy No cancer detected

50

No change (Gleason=6)

71

(51)

83

(61)

Progression (Gleason=7, 8)*

19

(14)

22

(16)

* No cases of Gleason 9–10 PCa

©2011 Parkhurst, publisher of Oncology Exchange. All rights reserved.

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VOL. 10, No. 2, may 2011

landmarks in the dutasteride arm had a higher rate of negative end-ofstudy biopsy (36% vs 23%). They also had reduced anxiety (p=0.036), and no significant differences were found in side effects between the two groups. Although progression, as defined by the authors, was reduced, dutasteride did not significantly reduce the rate of Gleason score progression at the end-of-study biopsy (14% in dutasteride arm and 16% in the placebo arm). Any improvement in progression was primarily observed within the first 1.5 years and not the latter 1.5 years (after year 1.5, the risk of progression was 21% with dutasteride and 24% with placebo). These results suggest that dutasteride primarily reduces prostate cancer volume of low-grade tumours, rather than preventing the progression of Gleason score 6 tumours to Gleason score ≥7. In summary, the REDEEM trial shows that dutasteride decreases the rate of future negative biopsies and overall progression as well as anxiety in men on active surveillance. These results now provide evidence for a therapy in men with low-risk prostate cancer who wish to defer their definitive treatment until prostate cancer progression.

IN BRIEF Already known • 5ARIs reduce the risk of prostate cancer compared to placebo, but have been associated with a higher risk of being diagnosed with high-grade disease. What this study showed • In men treated with active surveillance, dutasteride delayed time to prostate cancer progression significantly, increased the number of men with no detectable cancer, and improved disease-related anxiety compared to placebo. There was no indication of greater risk of high-grade cancer. Next steps • More studies are needed to evaluate the effect of 5ARIs on high-grade disease.

Prostate cancer Antiandrogen therapy during and after radiation therapy Richard Choo, MD, FRCPC, Professor of Radiation Oncology, Department of Radiation Oncology, Mayo Clinic, Rochester, MN; Jason Call, MD, Department of Radiation Oncology, Mayo Clinic, Rochester, MN; Cyril Danjoux, MD, DMRT, FRCPC, Associate Professor, Department of Radiation Oncology, University of Toronto; Staff Radiation Oncologist, Sunnybrook Odette Cancer Centre, Toronto.

TRIAL SUMMARY: Benefit of adding androgen ablation therapy to salvage radiotherapy for PSA relapse after RP Shipley WU, Hunt D, Lukka H et al. Initial report of RTOG 9601, a Phase III trial in prostate cancer: Anti-androgen therapy (AAT) with bicalutamide during and after radiation therapy (RT) improves freedom from progression and reduces the incidence of metastatic disease in patients following radical prostatectomy (RP) with pT2–3, N0 disease and elevated PSA levels. ASTRO 2010. Int J Radiat Oncol Biol Phys 2010; 78(3 Supp):S27. Abstract 58.

Table 2. RT + AAT vs RT alone: Results at 7 years RT + AAT

RT alone

Actuarial OS

91%

86%

FFP overall (p