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2011 ASCO Genitourinary Cancers Symposium
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2011 ASCO Genitourinary Cancers Symposium
Jacopin/Science Photo Library
RTOG 9601
The 2011 ASCO Genitourinary Cancers Symposium took place in Orlando, FL, USA on Feb 17–19, 2011
William Shipley (Boston, MA, USA) and colleagues presented the initial report of the Radiation Therapy Oncology Group (RTOG) 9601 trial, a phase 3 study assessing the effect of radiotherapy plus antiandrogen therapy for patients with pT2–3,N0 prostate cancer who have been treated by radical prostatectomy and have rising concentrations of prostate specific antigen (PSA). 387 patients were randomly assigned to receive biclutamide for 24 months during and after radiotherapy while 383 were assigned to receive radiotherapy alone. After a median follow-up of 7·1 years, there had been too few events to statistically compare the primary endpoint—overall survival— between groups, although actuarial overall survival at 7 years was 91% for the antiandrogen plus radiotherapy group and 86% for the radiotherapy alone group. At 7 years, 57% of patients in the antiandrogen plus radiotherapy group were free from PSA progression, compared with 40% of those in the radiotherapy alone group (p<0·0001); the 7-year cumulative incidence of metastasis was 7% in the combined group versus 13% in the radiotherapy alone group (p<0·041). Although late grade 3–4 adverse events were similar between groups, gynaecomastia (mostly grade 2–3) was much more frequent in the combined group than for those treated with radiotherapy alone (89% vs 15%).
REDEEM trial The results of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management of Prostate Cancer (REDEEM) trial, presented by Neil Fleshner (Toronto, Canada), suggest that dutasteride, a 5α-reductase inhibitor, reduces the risk of progression for men with low risk, localised prostate cancer on active surveillance, compared with placebo. 330
302 men were randomly assigned to receive dutasteride or placebo for 3 years, and were then followed for progression of disease (defined as either therapeutic progression [ie, to prostatectomy, radiotherapy, or hormonal treatment] or pathological progression). Compared with placebo, dutasteride reduced the time to progression (relative risk reduction 38·9%, 95% CI 12·4–57·4, p=0·007). Patients in the dutasteride group reported significantly less prostatecancer related anxiety than did those on placebo. Although toxicity data were not reported, Fleshner stated that the adverse events noted in the experimental arm were much the same as reported in earlier trials involving dutasteride.
Renal EFFECT
Intermittent vs continuous androgen suppression
Vandetanib for urothelial cancer
Intermittent androgen suppression for patients with localised prostate cancer that had shown signs of PSA recurrence after radical radiotherapy might be as effective as continuous androgen suppression, according to data presented by Laurence Klotz (Toronto, Canada). In a phase 3 trial, 690 patients were randomly assigned to receive intermittent androgen suppression while 696 were assigned to receive continuous suppression. After a median follow-up of 6·9 years, median overall survival was 8·8 years in the intermittent group versus 9·1 years in the continuous group (hazard ratio [HR] 1·02, 95% CI 0·86–1·21, p for non-inferiority 0·009). Time to becoming castrateresistant was significantly longer in the intermittent group than in the continuous group. There were no reported differences in adverse events between the two groups, although Klotz pointed out that adverse events were recorded at any time, and did not account for off treatment periods in the intermittent group. Quality-oflife analyses are pending.
The addition of vandetanib to docetaxel for treatment of platinumpretreated advanced urothelial cancer does not improve outcomes, according to data presented by Toni Choueiri (Boston, MA, USA) and colleagues. 142 patients with metastatic urothelial cancer who had failed on previous platinum-based treatment were enrolled in this phase 3 trial, and were randomly assigned to receive either docetaxel plus vandetanib or docetaxel plus placebo. Median progression-free survival was 11·1 weeks in the vandetanib group versus 6·9 weeks in the docetaxel group (HR 1·04, p=0·92). Further, no significant differences were noted in objective response rates or overall survival. There were more grade 3 or worse adverse events in the vandetanib group than in the docetaxel group, most commonly rash or photosensitivity (11% of patients in the vandetanib group vs none in the docetaxel group) and diarrhoea (7% vs none).
The approved schedule of sunitinib for first-line treatment for renal-cell carcinoma appears to be correct, according to the findings of the randomised phase 2 Renal EFFECT study, presented by Robert Motzer (New York, USA). This trial compared the conventional schedule (50 mg/day, 4 weeks on, 2 weeks off [4/2 schedule]) with continuous dosing of sunitinib at 37·5 mg/day. Median time to progression—the primary endpoint—was 9·9 months in the 4/2 schedule group versus 7·1 months in the continuous group (HR 0·77, 95% CI 0·57–1·04; p=0·09); there were no differences in objective response rates, overall survival, or grade 3–4 adverse events between groups.
Rob Brierley www.thelancet.com/oncology Vol 12 April 2011
2011 ASCO Genitourinary Cancers Symposium
Jacopin/Science Photo Library
RTOG 9601
The 2011 ASCO Genitourinary Cancers Symposium took place in Orlando, FL, USA on Feb 17–19, 2011
William Shipley (Boston, MA, USA) and colleagues presented the initial report of the Radiation Therapy Oncology Group (RTOG) 9601 trial, a phase 3 study assessing the effect of radiotherapy plus antiandrogen therapy for patients with pT2–3,N0 prostate cancer who have been treated by radical prostatectomy and have rising concentrations of prostate specific antigen (PSA). 387 patients were randomly assigned to receive biclutamide for 24 months during and after radiotherapy while 383 were assigned to receive radiotherapy alone. After a median follow-up of 7·1 years, there had been too few events to statistically compare the primary endpoint—overall survival— between groups, although actuarial overall survival at 7 years was 91% for the antiandrogen plus radiotherapy group and 86% for the radiotherapy alone group. At 7 years, 57% of patients in the antiandrogen plus radiotherapy group were free from PSA progression, compared with 40% of those in the radiotherapy alone group (p<0·0001); the 7-year cumulative incidence of metastasis was 7% in the combined group versus 13% in the radiotherapy alone group (p<0·041). Although late grade 3–4 adverse events were similar between groups, gynaecomastia (mostly grade 2–3) was much more frequent in the combined group than for those treated with radiotherapy alone (89% vs 15%).
REDEEM trial The results of the Reduction by Dutasteride of Clinical Progression Events in Expectant Management of Prostate Cancer (REDEEM) trial, presented by Neil Fleshner (Toronto, Canada), suggest that dutasteride, a 5α-reductase inhibitor, reduces the risk of progression for men with low risk, localised prostate cancer on active surveillance, compared with placebo. 330
302 men were randomly assigned to receive dutasteride or placebo for 3 years, and were then followed for progression of disease (defined as either therapeutic progression [ie, to prostatectomy, radiotherapy, or hormonal treatment] or pathological progression). Compared with placebo, dutasteride reduced the time to progression (relative risk reduction 38·9%, 95% CI 12·4–57·4, p=0·007). Patients in the dutasteride group reported significantly less prostatecancer related anxiety than did those on placebo. Although toxicity data were not reported, Fleshner stated that the adverse events noted in the experimental arm were much the same as reported in earlier trials involving dutasteride.
Renal EFFECT
Intermittent vs continuous androgen suppression
Vandetanib for urothelial cancer
Intermittent androgen suppression for patients with localised prostate cancer that had shown signs of PSA recurrence after radical radiotherapy might be as effective as continuous androgen suppression, according to data presented by Laurence Klotz (Toronto, Canada). In a phase 3 trial, 690 patients were randomly assigned to receive intermittent androgen suppression while 696 were assigned to receive continuous suppression. After a median follow-up of 6·9 years, median overall survival was 8·8 years in the intermittent group versus 9·1 years in the continuous group (hazard ratio [HR] 1·02, 95% CI 0·86–1·21, p for non-inferiority 0·009). Time to becoming castrateresistant was significantly longer in the intermittent group than in the continuous group. There were no reported differences in adverse events between the two groups, although Klotz pointed out that adverse events were recorded at any time, and did not account for off treatment periods in the intermittent group. Quality-oflife analyses are pending.
The addition of vandetanib to docetaxel for treatment of platinumpretreated advanced urothelial cancer does not improve outcomes, according to data presented by Toni Choueiri (Boston, MA, USA) and colleagues. 142 patients with metastatic urothelial cancer who had failed on previous platinum-based treatment were enrolled in this phase 3 trial, and were randomly assigned to receive either docetaxel plus vandetanib or docetaxel plus placebo. Median progression-free survival was 11·1 weeks in the vandetanib group versus 6·9 weeks in the docetaxel group (HR 1·04, p=0·92). Further, no significant differences were noted in objective response rates or overall survival. There were more grade 3 or worse adverse events in the vandetanib group than in the docetaxel group, most commonly rash or photosensitivity (11% of patients in the vandetanib group vs none in the docetaxel group) and diarrhoea (7% vs none).
The approved schedule of sunitinib for first-line treatment for renal-cell carcinoma appears to be correct, according to the findings of the randomised phase 2 Renal EFFECT study, presented by Robert Motzer (New York, USA). This trial compared the conventional schedule (50 mg/day, 4 weeks on, 2 weeks off [4/2 schedule]) with continuous dosing of sunitinib at 37·5 mg/day. Median time to progression—the primary endpoint—was 9·9 months in the 4/2 schedule group versus 7·1 months in the continuous group (HR 0·77, 95% CI 0·57–1·04; p=0·09); there were no differences in objective response rates, overall survival, or grade 3–4 adverse events between groups.
Rob Brierley www.thelancet.com/oncology Vol 12 April 2011