Evidence map›Paper›PMID 30334002›Full record

ReviewKidney cancer (Clifton, Va.)2017

Transforming the Perioperative Treatment Paradigm in Non-Metastatic RCC-A Possible Path Forward.

L C Harshman, C G Drake, N B Haas, J Manola, M Puligandla, S Signoretti, D Cella, R T Gupta, R Bhatt, E Van Allen and 11 more

Open access · diamondAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Kidney cancer (Clifton, Va.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 33% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. "PROBE"ing the Role of Cytoreductive Nephrectomy in Advanced Renal Cancer.Kidney cancer journal : official journal of the Kidney Cancer Association · 2022
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

21 authors at 14 institutions in 2 countries.

L C HarshmanLank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
C G DrakeDivision of Hematology/Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, NY, USA.
N B HaasDivision of Hematology/Oncology, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
J ManolaDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
M PuligandlaDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Boston, MA, USA.
S SignorettiDepartment of Pathology, Brigham and Women's Hospital, Boston, MA, USA.
D CellaNorthwestern University Feinberg School of Medicine, Chicago, IL, USA.
R T GuptaDepartments of Radiology and Surgery and The Duke Cancer Institute, Duke University Medical Center, Durham, NC, USA.
R BhattDivision of Hematology-Oncology and Cancer Biology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
E Van AllenLank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
P LaraUniversity of California Davis School of Medicine, Sacramento, CA, USA.
T K ChoueiriLank Center for Genitourinary Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA, USA.
A KapoorDivision of Urology, McMaster University, Hamilton, ON, Canada.
D Y C HengTom Baker Cancer Center, Calgary, AB, Canada.
B ShuchDivision of Urology, Yale Cancer Institute, New Haven, CT, USA.
M JewettDepartments of Surgery(Urology) and Surgical Oncology, Princess Margaret Cancer Centre, University Health Network and the University of Toronto, Toronto, ON, Canada.
D GeorgeDuke University Departments of Medicine, Surgery, and Pharmacology and Cancer Biology, Division of Medical Oncology, The Duke Cancer Institute, Durham, NC, USA.
D MichaelsonGenitourinary Cancer Center, Massachusetts General Hospital, Boston, MA, USA.
M A CarducciSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
D McDermottDivision of Hematology-Oncology and Cancer Biology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
M AllafSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.
Harvard University · USBeth Israel Deaconess Medical Center · USDana-Farber Cancer Institute · USDuke Medical Center · USSidney Kimmel Comprehensive Cancer Center · USBrigham and Women's Hospital · USColumbia University Irving Medical Center · USMassachusetts General Hospital · USMcMaster University · CANorthwestern University · USUniversity Health Network · CAUniversity of California, Davis · USUniversity of Pennsylvania · USYale Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In 2017, there is no adjuvant systemic therapy proven to increase overall survival in non-metastatic renal cell carcinoma (RCC). The anti-PD-1 antibody nivolumab improves overall survival in metastatic treatment refractory RCC and is generally tolerable. Mouse solid tumor models have revealed a benefit with a short course of neoadjuvant PD-1 blockade compared to adjuvant therapy. Two ongoing phase 2 studies of perioperative nivolumab in RCC patients have shown preliminary feasibility and safety with no surgical delays or complications. The recently opened PROSPER RCC trial (A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy; EA8143) will examine if the addition of perioperative nivolumab to radical or partial nephrectomy can improve clinical outcomes in patients with high risk localized and locally advanced RCC. With the goal of increasing cure and recurrence-free survival (RFS) rates in non-metastatic RCC, we are executing a three-pronged, multidisciplinary approach of presurgical priming with nivolumab followed by resection and adjuvant PD-1 blockade. We plan to enroll 766 patients with clinical stage ≥T2 or node positive M0 RCC of any histology in this global, randomized, unblinded, phase 3 National Clinical Trials Network study. The investigational arm will receive two doses of nivolumab 240 mg IV prior to surgery followed by adjuvant nivolumab for 9 months. The control arm will undergo the current standard of care: surgical resection followed by observation. Patients are stratified by clinical T stage, node positivity, and histology. The trial is powered to detect a 14.4% absolute benefit in the primary endpoint of RFS from the ASSURE historical control of 55.8% to 70.2% at 5 years (HR = 0.70). The study is also powered to detect a significant overall survival benefit (HR 0.67). Key safety, feasibility, and quality of life endpoints are incorporated. PROSPER RCC exemplifies team science with a host of planned correlative work to investigate the impact of the baseline immune milieu and changes after neoadjuvant priming on clinical outcomes.

Indexed as

adjuvantEA8143neoadjuvantnephrectomynivolumabPD-1 blockadeprimingPROSPER RCCrecurrence-free survivalRenal cell carcinoma

Identifiers

PMID30334002
PMCPMC6179104
OpenAlexW2741346996

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.