scholarly journals Individualised Predictions of the Survival Benefit Due to Adjuvant Therapy in a Randomised Trial of Sorafenib after Nephrectomy for Localised Renal Cell Carcinoma

Kidney Cancer ◽  
2020 ◽  
Vol 4 (4) ◽  
pp. 185-195
Author(s):  
Nicola J. Lawrence ◽  
Andrew Martin ◽  
Ian D. Davis ◽  
Simon Troon ◽  
Shomik Sengupta ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adjuvant Therapy ◽  
Sample Size ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Randomised Trial ◽  
Survival Rates ◽  
Survival Times ◽  
Medical Oncologists ◽  
Sample Size Justification

BACKGROUND: Little has been published regarding how doctors think and talk about prognosis and the potential benefits of adjuvant therapy. OBJECTIVE: We sought predictions of survival rates and survival times, for patients with and without adjuvant therapy, from the clinicians of patients participating in a randomised trial of adjuvant sorafenib after nephrectomy for renal cell carcinoma. METHODS: A subset of medical oncologists and urologists in the SORCE trial completed questionnaires eliciting their predictions of survival rates and survival times, with and without adjuvant sorafenib, for each of their participating patients. To compare predictions elicited as survival times versus survival rates, we transformed survival times to survival rates. To compare predicted benefits elicited as absolute improvements in rates and times, we transformed them into hazard ratios (HR), a measure of relative benefit.We postulated that a plausible benefit in overall survival (OS) should be smaller than that hypothesized for disease–free survival (DFS) in the trials original sample size justification (i.e. HR for OS should be ≥ 0.75). RESULTS: Sixty–one medical oncologists and 17 urologists completed questionnaires on 216 patients between 2007 and 2013. Predictions of survival without adjuvant sorafenib were similar whether elicited as survival rates or survival times (median 5–year survival rate of 61% vs 60%, p = 0.6). Predicted benefits of sorafenib were larger when elicited as improvements in survival rates than survival times (median HR 0.76 vs 0.83, p < 0.0001). The proportion of HR for predicted OS with sorafenib that reflected a plausible benefit (smaller effect of sorafenib on OS than hypothesized on DFS, i.e. HR ≥ 0.75) was 51% for survival rates, and 65% for survival times. CONCLUSIONS: The predicted benefits of adjuvant sorafenib were larger when elicited as improvements in survival rates than as survival times, and were often larger than the sample size justification for the trial. These potential biases should be considered when thinking and talking about individual patients in clinical practice, and when designing clinical trials.

Patients' preferences for adjuvant sorafenib after resection of intermediate or high-risk renal cell carcinoma in the SORCE trial: What makes it worthwhile?

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 415-415 ◽  
Author(s):  
Prunella Louise Blinman ◽  
Ian D. Davis ◽  
Andrew Martin ◽  
Simon Troon ◽  
Shomik Sengupta ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
High Risk ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Survival Rates ◽  
Survival Times ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Treatment Allocation ◽  
Self Administered Questionnaire

415 Background: SORCE is an international, double-blind, placebo-controlled, phase 3 trial comparing adjuvant sorafenib for 1 year, for 3 years, or observation after resection of intermediate or high risk (as per the Leibovich score), localised renal cell carcinoma (RCC). We determined the survival benefits that SORCE participants judged necessary to make adjuvant sorafenib worthwhile 3 months after starting study treatment. Methods: Participants recruited to SORCE from Australia and selected UK sites completed a validated, self-administered questionnaire 3 months after starting study treatment to determine the minimum survival benefits they judged necessary to make adjuvant sorafenib worthwhile. Scenarios used baseline survival times (without adjuvant sorafenib) of 5 and 15 years; and baseline survival rates (without adjuvant sorafenib) of 65% and 85% at 5 years. Preferences were determined for 1 year of adjuvant sorafenib (versus none) and for 3 years of adjuvant sorafenib (versus 1 year). All tests were 2-sided and non-parametric. This substudy of SORCE was conducted by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Results: The 179 participants were mostly male (72%) with a median age of 57 years (range 29 to 78). Participants allocated sorafenib judged larger benefits necessary to make 1 year of adjuvant sorafenib worthwhile than those allocated placebo: median benefit of an extra 1 year versus an extra 1 month for baselines of 5 years (p=0.004) and 15 years (p=0.02); median benefit of an extra 5% versus an extra 1% for baseline of 65% (p=0.03), and an extra 3% versus an extra 1% for a baseline of 85% (p=0.07). Larger survival benefits were judged necessary to make 3 years of adjuvant sorafenib worthwhile (versus 1 year) regardless of treatment allocation: median benefit of an extra 2 months to 1 year for baselines of 5 years (p=0.02) and 15 years (0.02). Conclusions: Experienced toxicity and duration of treatment are important determinants of patients’ preferences for adjuvant sorafenib in RCC.

Adjuvant Therapy in Renal Cell Carcinoma: Current Stance and Future Directions

Kidney Cancer ◽  
2021 ◽  
pp. 1-12
Author(s):  
Austin G. Kazarian ◽  
Neal S. Chawla ◽  
Ramya Muddasani ◽  
Sumanta K. Pal
Keyword(s):  
Renal Cell Carcinoma ◽  
Adjuvant Therapy ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Kinase Inhibitors ◽  
Checkpoint Inhibitors ◽  
Unmet Need ◽  
Disease Free Survival ◽  
Adjuvant Setting ◽  
Metastatic Setting

In recent years, incredible progress has been made in the treatment of metastatic renal cell carcinoma, with a paradigm shift from the use of cytokines to tyrosine kinase inhibitors, and more recently, immune checkpoint inhibitors (ICIs). Despite advances in the metastatic setting, effective therapies in the adjuvant setting are a largely unmet need. Currently, sunitinib (Sutent, Pfizer) is the only therapy for the adjuvant treatment of RCC included in the National Comprehensive Cancer Network guidelines, which was approved by the FDA based on the improvement in disease-free survival (DFS) seen in the S-TRAC trial. However, improvement in DFS has not translated into an overall survival (OS) benefit for patients at high-risk of relapse post-nephrectomy, illustrating the need for more effective therapies. This manuscript will highlight attributes of both historical and current drug trials and their implications on the landscape of adjuvant therapy. Additionally, we will outline strategies for selecting patients in whom treatment would be most beneficial, as optimal patient selection is a crucial step towards improving outcomes in the adjuvant setting. This is especially critical, given the financial cost and pharmacological toxicity of therapeutic agents. Furthermore, we will review the design of clinical trials including the value of utilizing OS as an endpoint over DFS. Finally, we will discuss how the incorporation of genomic data into predictive models, the use of more sensitive imaging modalities for more accurate staging, and more extensive surgical intervention involving lymph node dissection, may impact outcomes.

Adjuvant therapy in renal cell carcinoma: current knowledges and future perspectives

2021 ◽  
pp. 102207
Author(s):  
Mathieu Larroquette ◽  
Florent Peyraud ◽  
Charlotte Domblides ◽  
Félix Lefort ◽  
Jean-Christophe Bernhard ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Adjuvant Therapy ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Future Perspectives

Age-Adjusted Incidence, Mortality, and Survival Rates of Stage-Specific Renal Cell Carcinoma in North America: A Trend Analysis

2011 ◽  
Vol 59 (1) ◽  
pp. 135-141 ◽  
Author(s):  
Maxine Sun ◽  
Rodolphe Thuret ◽  
Firas Abdollah ◽  
Giovanni Lughezzani ◽  
Jan Schmitges ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
North America ◽  
Cell Carcinoma ◽  
Trend Analysis ◽  
Renal Cell ◽  
Survival Rates ◽  
Adjusted Incidence

scholarly journals Safety and oncological outcomes for large (stage ≥T2b) and locally advanced renal cell carcinoma: comparison between laparoscopic and modified hand-assisted laparoscopic radical nephrectomy

2020 ◽  
Vol 48 (10) ◽  
pp. 030006052096123
Author(s):  
Xudong Guo ◽  
Hanbo Wang ◽  
Yuzhu Xiang ◽  
Xunbo Jin ◽  
Shaobo Jiang
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Radical Nephrectomy ◽  
Locally Advanced ◽  
Survival Rates ◽  
Renal Tumors ◽  
Advanced Renal Cell Carcinoma ◽  
Operative Duration ◽  
Laparoscopic Radical Nephrectomy

Objective To compare the operative and oncologic outcomes between hand-assisted laparoscopic radical nephrectomy (HALRN) and laparoscopic radical nephrectomy (LRN) for large (stage ≥T2b) and locally advanced renal cell carcinoma. Methods We retrospectively collected data from patients who underwent HALRN or LRN for stage ≥T2b renal cell carcinoma from January 2011 to January 2018 in our institution. The patients’ demographics, perioperative parameters, and postoperative follow-up data were compared between the two groups. The survival outcome was estimated using the Kaplan–Meier method. Results The HALRN group comprised 78 patients, and the LRN group comprised 63 patients. The median operative duration was significantly shorter in the HALRN than LRN group. The two groups were equivalent in terms of the incision length, blood loss, complication rate, and duration of hospitalization. In the HALRN and LRN groups, the 5-year overall survival rates were 69.4% and 73.1%, the 5-year cancer-specific survival rates were 80.0% and 83.3%, and the 5-year progression-free survival rates were 66.4% and 74.7%, respectively, with no significant differences. Conclusions Compared with LRN, HALRN may offer a shorter operative duration and equivalent surgical outcomes without sacrificing oncological efficacy. In addition, HALRN has specific advantages for extremely large and complicated renal tumors.

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