Trial reportInvestigational new drugs2013
Sunitinib malate in previously untreated, nonsquamous, non-small cell lung cancer patients over the age of 70 years: results of a Phase II trial.
Trial report in Investigational new drugs, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 12 citations in OpenAlex.
- Benefit, Risk, and Outcomes in Drug Development: A Systematic Review of Sunitinib.Journal of the National Cancer Institute · 2016Pooled it
- Congestive heart failure risk in cancer patients treated with vascular endothelial growth factor tyrosine kinase inhibitors: a systematic review and meta-analysis of 36 clinical trials.British journal of clinical pharmacology · 2014Pooled it
- Observational
- Effects of local irradiation combined with sunitinib on early remodeling, mitochondria, and oxidative stress in the rat heart.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2016Article
- Identification of kinase inhibitor targets in the lung cancer microenvironment by chemical and phosphoproteomics.Molecular cancer therapeutics · 2014Article
- Clinical response to sunitinib as a multitargeted tyrosine-kinase inhibitor (TKI) in solid cancers: a review of clinical trials.OncoTargets and therapy · 2014Review
Corrections and comments
- Erratum issuedMueller, Suzanne E [corrected to Bradie-Muller, Suzanne J]
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSome elderly patients may have reduced tolerance the standard therapy (chemotherapy doublets) for stage III/IV non-small cell lung cancer (NSCLC). Sunitinib malate (S), an oral, multitargeted kinase inhibitor, shows promise as 2nd-line NSCLC treatment. This study explored the safety/efficacy of S in elderly patients with previously untreated NSCLC.
methodsPRIMARY
objectivedisease control rate (DCR) at six-weeks. SECONDARY
objectivesoverall response (OR, CR+PR), progression-free survival (PFS), time to progression (TTP), one-yr survival, quality of life (QOL), and safety. TREATMENT: S 37.5 mg daily/42-day cycle until PD or intolerable toxicity. Key inclusion: chemo-naïve stage IIIB/IV NSCLC (nonsquamous histology); ECOG PS=0-1; ≥ 70 years; normal organ function. Exclusion: hemoptysis, anticoagulation, or clotting diathesis. Other standard S-specific criteria applied.
results63 patients enrolled/60 treated. DEMOGRAPHICS: 51 % male, 95 % white, median age 78 years (range, 70-88), 73 % ECOG=1, 97 % Stage IV, 83 % adenocarcinoma, 44 % prior surgery, 19 % prior radiation. With a median of 2 cycles (range, 1-16), DCR=63 %, OR=7 % (0 CR, 4 PR). Median follow-up=5.8 months (all; 15.9 months survivors), median PFS =3.0 months (range, <1-25.1), median TTP=4.5 months (range, <1-25.1), and 1-year survival=26.4 % [95 % CI: 15.9, 38.2]. QOL declined initially, but improved over time. TREATMENT-related adverse events included: fatigue (48.3 %); diarrhea (38.3 %); thrombocytopenia (33.3 %), anorexia (26.7 %), mucositis (25.0 %); nausea (25.0 %), dysgeusia (20.0 %), and neutropenia (20.0 %). Conclusions The study met its primary endpoint. S produced acceptable DCR and QOL improved; however, OR was disappointing (7 %) and toxicity was greater than expected. A biomarker to identify patients more likely to benefit from S is needed.
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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.