Evidence map›Paper›PMID 24420556›Full record

Trial reportInvestigational new drugs2014

Phase II trial of sorafenib in conjunction with chemotherapy and as maintenance therapy in extensive-stage small cell lung cancer.

Neelesh Sharma, Nathan Pennell, Myles Nickolich, Balazs Halmos, Patrick Ma, Tarek Mekhail, Pingfu Fu, Afshin Dowlati

Abstract readClinical Trial, Phase IIControlled Clinical TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 10% 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

27 citing papers in PubMed, 2 syntheses or guidelines pooled it, 40 citations in OpenAlex.

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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

8 authors at 6 institutions in 1 country.

Neelesh SharmaUniversity Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, USA, neelesh.sharma@uhhospitals.org.
Nathan Pennell
Myles Nickolich
Balazs Halmos
Patrick Ma
Tarek Mekhail
Pingfu Fu
Afshin Dowlati
Case Comprehensive Cancer CenterUniversity Hospitals Seidman Cancer Center · USCase Western Reserve University · USCleveland Clinic · USNewYork–Presbyterian Hospital · USUniversity School · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesSorafenib is a multi-tyrosine kinase inhibitor of Raf kinase, VEGFR, and PDGFR. Angiogenesis is important for growth and progression of SCLC. This trial was conducted to evaluate whether the combination of cisplatin and etoposide plus concurrent and sequential sorafenib could prolong survival in patients with previously untreated SCLC.

methodsPreviously untreated patients with extensive stage SCLC were treated with cisplatin and etoposide days 1, 2, 3 for four cycles, concurrent with sorafenib 200 mg orally bid starting day 1 cycle 1. Patients with no disease progression after four cycles continued sorafenib 400 mg orally bid as maintenance for maximum of 12 months. The primary endpoint was 1 year survival with response rate and safety as secondary endpoints.

resultsA total of 18 patients were enrolled with 17 evaluable patients. One patient had a complete response, seven patients had a partial response (overall response rate of 47 %) and one patient had stable disease. Overall median survival was 7.4 months and 1 year survival was 25 %. The most common treatment-related adverse events included fatigue, anorexia, rash, diarrhea, neutropenia and weight loss. Grade 5 GI bleeding, pulmonary hemorrhage and neutropenia occurred in one pt (6 %) each. Accrual was halted on the basis of safety profile as well as preliminary efficacy data.

conclusionsThe combination of platinum based chemotherapy and sorafenib has significant toxicity at current dose levels and is associated with disappointing efficacy data.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCisplatinDisease-Free SurvivalEtoposideFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsSmall Cell Lung CarcinomaCisplatinEtoposideNiacinamidePhenylurea CompoundsProtein Kinase InhibitorsSorafenib

Identifiers

PMID24420556
OpenAlexW1968299736

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.