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Poster display session

1081 - Predicted benefits of adjuvant sorafenib after nephrectomy for renal cell carcinoma (RCC) in SORCE: an international, placebo-controlled, randomised phase 3 trial

Date

10 Sep 2017

Session

Poster display session

Presenters

Nicola Lawrence

Citation

Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371

Authors

N.J. Lawrence1, A. Martin2, I.D. Davis3, S. Troon4, S. Sengupta5, E.J. Hovey6, X. Coskinas2, R. Kaplan7, A.W..S. Ritchie7, A. Meade7, T. Eisen8, P. Blinman9, M.R. Stockler2

Author affiliations

  • 1 Renal Subcommittee, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, 2050 - Sydney/AU
  • 2 Medical Oncology, NHMRC Clinical Trials Centre, 1450 - Camperdown/AU
  • 3 Medical Oncology, Monash University Eastern Health Clinical School, 3128 - Box Hill/AU
  • 4 Medical Oncology, Royal Perth Hospital, 6000 - Perth/AU
  • 5 Urology, Olivia Newton-John Cancer and Wellness Centre, Austin Hospital, Melbourne/AU
  • 6 Medical Oncology, Prince of Wales Hospital, Sydney/AU
  • 7 Mrc Clinical Trials Unit, University College London, London/GB
  • 8 Cambridge Biomedical Campus, Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital, CB2 0QQ - Cambridge/GB
  • 9 Concord Cancer Centre, Concord Repatriation General Hospital, Sydney/AU
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Resources

Abstract 1081

Background

The effects on survival of adjuvant therapy with a VEGF-TKI after nephrectomy for RCC are uncertain. Survival rates, times and benefits were predicted by medical oncologists at baseline for each patient they recruited to SORCE.

Methods

Medical oncologists at 20 sites in ANZ and 12 in the UK answered the following questions at baseline for each patient they recruited: the predicted overall survival rate at 5 years (SR) and predicted overall survival time (ST) without adjuvant sorafenib; and, the predicted absolute improvements in SR and ST with 1 year of adjuvant sorafenib. We used Spearman’s rank correlation (rs) to assess associations, and Wilcoxon signed rank tests to assess differences between the paired SR–ST values. We assumed exponential survival distributions to calculate: (i) % alive at 5-yrs corresponding to ST estimates, and (ii) hazard ratios (HRs) corresponding to predicted benefits on overall survival. We hypothesized that these HRs should be less extreme (numerically larger) than the target HR of 0.75 for disease free survival used to design the trial.

Results

The table shows paired estimates of ST and SR from 61 medical oncologists for 176 of the 1711 SORCE patients. Predictions of survival without sorafenib were similar whether based on ST or SR. The predicted benefits of sorafenib based on SR were moderately correlated with those based on ST, but significantly larger. The proportion of HRs > 0.75 was 51% based on SRs vs 66% based on STs.Table:

881P

ST1ST1SR1Difference1rs
In YearsCalculated % alive at 5-yrs [a]Estimated % alive at 5-yrs [b][a]-[b][a] vs [b]
Survival without sorafenib761600 (-7 to 9)0.62
(5 to 12)(50 to 75)(50 to 70)p = 0.6p < .001
Improvement with sorafenib167−2 (-6 to 1)0.53
(1 to 5)(3 to 10)(5 to 15)p < .0001p < .001
Hazard Ratio0.830.830.760.09 (-0.01 to 0.21)0.41
(0.67 to 0.91)(0.67 to 0.91)(0.62 to 0.82)p < .0001p < .0001
1

Medians (IQRs)

Conclusions

The predicted benefits of adjuvant sorafenib based on SRs were often larger than hypothesized, and larger than predictions based on ST, which were more consistent with the target HR. These data suggest that predictions of benefit in this setting may be more conservative and plausible when based on ST rather than SR.

Clinical trial identification

NCT00492258

Legal entity responsible for the study

NHMRC Clinical Trials Centre, University of Sydney

Funding

Cancer Australia, NHMRC, Bayer, CRUK

Disclosure

I.D. Davis: International Patent Application No: PCT/US2004/032147 (NY-ESO-1) through Ludwig Institute for Cancer Research. Research Funding for institution: Astellas Pharma, Exelixis. M.R. Stockler: Research Funding for institution: Astellas Pharma, Celgene, Bayer, Bionomics, Medivation, Sanofi, Pfizer, AstraZeneca, Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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