Evidence map›Paper›PMID 25667291›Full record

SynthesisJournal of clinical oncology : official journal of the American Society of Clinical Oncology2015

Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses.

Gideon M Blumenthal, Stella W Karuri, Hui Zhang, Lijun Zhang, Sean Khozin, Dickran Kazandjian, Shenghui Tang, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 108 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
108citing papers in PubMed, 10 pooled it
20.1field-weighted citation impact, top 1% 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

108 citing papers in PubMed, 10 syntheses or guidelines pooled it, 221 citations in OpenAlex.

  1. Pooled it
  2. Efficacy and safety of brigatinib inFrontiers in oncology · 2022
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  10. Integrative cancer therapies
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  16. Systematic evaluation of pembrolizumab dosing in patients with advanced non-small-cell lung cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
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48 more citing papers are in PubMed but not listed here.

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

10 authors at 1 institution in 1 country.

Gideon M BlumenthalAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD. Gideon.Blumenthal@fda.hhs.gov.
Stella W KaruriAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Hui ZhangAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Lijun ZhangAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Sean KhozinAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Dickran KazandjianAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Shenghui TangAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Rajeshwari SridharaAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Patricia KeeganAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
Richard PazdurAll authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, White Oak, MD.
United States Food and Drug Administration · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo conduct analyses exploring trial-level and patient-level associations between overall response rate (ORR), progression-free survival (PFS), and overall survival (OS) in advanced non-small-cell lung cancer (NSCLC) trials.

methodsWe identified 14 trials (N = 12,567) submitted to US Food and Drug Administration since 2003 of treatments for advanced NSCLC. Only randomized, active-controlled trials with more than 150 patients were included. Associations between trial-level PFS hazard ratio (HR), OS HR, and ORR odds ratio were analyzed using a weighted linear regression model. Patient-level responder analyses comparing PFS and OS between patients with and without an objective response were performed using pooled data from all studies.

resultsIn the trial-level analysis, the association between PFS and ORR was strong (R(2) = 0.89; 95% CI, 0.80 to 0.98). There was no association between OS and ORR (R(2) = 0.09; 95% CI, 0 to 0.33) and OS and PFS (R(2) = 0.08; 95% CI, 0 to 0.31). In the patient-level responder analyses, patients who achieved a response had better PFS and OS compared with nonresponders (PFS: HR, 0.40; 95% CI, 0.38 to 0.42; OS: HR, 0.40; 95% CI, 0.38 to 0.43).

conclusionOn a trial level, there is a strong association between ORR and PFS. An association between ORR and OS and between PFS and OS was not established, possibly because of cross-over and longer survival after progression in the targeted therapy and first-line trials. The patient-level analysis showed that responders have a better PFS and OS compared with nonresponders. A therapy in advanced NSCLC with a large magnitude of effect on ORR may have a large PFS effect.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungDisease-Free SurvivalFemaleHumansLinear ModelsLung NeoplasmsMaleMiddle AgedOdds RatioProportional Hazards ModelsRandomized Controlled Trials as Topic

Identifiers

PMID25667291
PMCPMC4356710
OpenAlexW2151337547

What OpenQuestion holds

Textmetadata
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.