Evidence map›Paper›PMID 30917871›Full record

Trial reportJournal for immunotherapy of cancer2019

Overall survival by clinical risk category for high dose interleukin-2 (HD IL-2) treated patients with metastatic renal cell cancer (mRCC): data from the PROCLAIM

M Fishman, J P Dutcher, J I Clark, A Alva, G P Miletello, B Curti, Neeraj Agarwal, R Hauke, K M Mahoney, H Moon and 8 more

Registry-linked trialAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01415167 (Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
–field-weighted citation impact
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.

NCT01415167 completednot on this map

Proleukin Observational Registry to Evaluate the Treatment Patterns and Clinical Response in Malignancy

TypeobservationalSponsorPrometheus LaboratoriesRan2011 to 2018Enrolled1,690ConditionsMetastatic Renal Cell Carcinoma, Metastatic Melanoma
3 · Its place in the literature

Who cites it

29 citing papers in PubMed.

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  11. Cancer chemoprevention: signaling pathways and strategic approaches.Signal transduction and targeted therapy · 2025
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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

18 authors.

M FishmanMoffitt Cancer Center, Tampa, FL, USA.
J P DutcherCancer Research Foundation of NY, Chappaqua, NY, USA. jpd4401@aol.com.ORCID 0000-0002-2267-9187
J I ClarkLoyola University Medical Center, Maywood, IL, USA.
A AlvaUniversity of Michigan, Ann Arbor, MI, USA.
G P MiletelloHematology/Oncology Clinic, Baton Rouge, LA, USA.
B CurtiEarle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR, USA.
Neeraj AgarwalHuntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.
R HaukeNebraska Cancer Specialist, Omaha, NE, USA.
K M MahoneyBeth Israel Deaconess Medical Center, Boston, MA, USA.
H MoonSouthern California Permanente Medical Group, Pasadena, CA, USA.
J TreismanMedical College of Wisconsin, Milwaukee, WI, USA.
S S TykodiUniversity of Washington and Fred Hutchinson Cancer Center, Seattle, WA, USA.
G DanielsUniversity of California San Diego, San Diego, CA, USA.
M A MorseDuke University, Durham, NC, USA.
M K K WongMD Anderson Cancer Center, Houston, TX, USA.
H KaufmanMassachusetts General Hospital, Boston, MA, USA.
N GregoryPrometheus Laboratories, San Diego, CA, USA.
D F McDermottBeth Israel Deaconess Medical Center, Boston, MA, USA.

Funding

Women's Cancer Research ProgramP30CA014236 · NCI · DUKE UNIVERSITY · PI DONNA NIEDZWIECKI · 1985 to 2026
$174.8M
NCI NIH HHS P30 CA014236
6 · The paper itself

Abstract

backgroundPrognostic scoring systems are used to estimate the risk of mortality from metastatic renal cell carcinoma (mRCC). Outcomes from different therapies may vary within each risk group. These survival algorithms have been applied to assess outcomes in patients receiving T-cell checkpoint inhibitory immunotherapy and tyrosine kinase inhibitor therapy, but have not been applied extensively to patients receiving high dose interleukin-2 (HD IL-2) immunotherapy.

methodsSurvival of 810 mRCC patients treated from 2006 to 2017 with high dose IL-2 (aldesleukin) and enrolled in the PROCLAIM

resultsAmong the 810 patients, 721 were treatment-naïve (89%) and 59% were intermediate risk. Overall, of the 249 patients with favorable risk, the median overall survival (OS) is 63.3 mo. and the 2-year OS is 77.6%. Of 480 patients with intermediate risk, median OS is 42.4 mo., 2-year OS 68.2%, and of 81 patients with poor risk, median OS 14 mo., 2-year OS 40.4%. Among those who received IL-2 alone (356 patients), median OS is 64.5, 57.6, and 14 months for favorable, intermediate and poor risk categories respectively. Two year survival among those treated only with HD IL-2 is 73.4, 63.7 and 39.8%, for favorable, intermediate and poor risk categories respectively.

conclusionsAmong mRCC patients treated with HD IL-2, all risk groups have median and 2-year survival consistent with recent reports of checkpoint or targeted therapies for mRCC. Favorable and intermediate risk (by IMDC) patients treated with HD IL-2 have longer OS compared with poor risk patients, with most durable OS observed in favorable risk patients. Favorable risk patients treated with HD IL-2 alone have a 2-year OS of 74%. These data continue to support a recommendation for HD IL-2 for patients with mRCC who meet eligibility criteria.

trial registrationPROCLAIM, NCT01415167 was registered with ClinicalTrials.gov on August 11, 2011, and initiated for retrospective data collection until 2006, and prospective data collection ongoing since 2011.

Indexed as

AgedAntineoplastic AgentsCarcinoma, Renal CellDose-Response Relationship, DrugFemaleHumansInterleukin-2Kidney NeoplasmsMaleMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisProspective StudiesRetrospective StudiesSurvival AnalysisTreatment OutcomeAntineoplastic AgentsInterleukin-2Interleukin-2Patient registryPROCLAIMSMRenal cell cancerRisk factorsSurvival

Identifiers

PMID30917871
PMCPMC6437874

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Registered trials

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.