Evidence map›Paper›PMID 29486797›Full record

Trial reportJournal for immunotherapy of cancer2018

A randomized, controlled trial evaluating the efficacy and safety of BTH1677 in combination with bevacizumab, carboplatin, and paclitaxel in first-line treatment of advanced non-small cell lung cancer.

Walburga Engel-Riedel, Jamie Lowe, Paulette Mattson, J Richard Trout, Richard D Huhn, Michele Gargano, Myra L Patchen, Richard Walsh, My My Trinh, Mariève Dupuis and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00874107 (A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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.

NCT00874107 phase2completednot on this map

A Phase 2, Randomized, Efficacy and Safety Study of Imprime PGG® Injection in Combination With Bevacizumab and Concomitant Paclitaxel and Carboplatin Therapy in Patients With Previously Untreated Advanced (Stage IIIB or IV) Non-Small Cell Lung Cancer

TypeinterventionalSponsorHiberCell, Inc.Ran2009 to 2016Enrolled90ConditionsNon-Small Cell Lung CancerArmsImprime PGG® Injection, Bevacizumab, Paclitaxel, Carboplatin
3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

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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

11 authors.

Walburga Engel-RiedelKliniken der Stadt Köln gGmbH, Krankenhaus Merheim, Thoraxchirurgische u. Pneumologische Klinik, Ostmerheimer Str. 200, 51109, Köln, Germany.
Jamie LoweBiothera Pharmaceuticals, Inc., 3388 Mike Collins Drive, Suite A, Eagan, MN, 55121, USA.
Paulette MattsonBiothera Pharmaceuticals, Inc., 3388 Mike Collins Drive, Suite A, Eagan, MN, 55121, USA.
J Richard TroutRutgers University, 82 Rittenhouse Circle, Newtown, PA, 18940, USA.
Richard D HuhnBiothera Pharmaceuticals, Inc., 3388 Mike Collins Drive, Suite A, Eagan, MN, 55121, USA.
Michele GarganoBiothera Pharmaceuticals, Inc., 3388 Mike Collins Drive, Suite A, Eagan, MN, 55121, USA.
Myra L PatchenBiothera Pharmaceuticals, Inc., 3388 Mike Collins Drive, Suite A, Eagan, MN, 55121, USA. mpatchen@immunoresearch.com.
Richard WalshBiothera Pharmaceuticals, Inc., 3388 Mike Collins Drive, Suite A, Eagan, MN, 55121, USA.
My My TrinhCertara Strategic Consulting, 2000 Peel Street, Suite 570, Montréal, Québec, H3A2WS, Canada.
Mariève DupuisCertara Strategic Consulting, 2000 Peel Street, Suite 570, Montréal, Québec, H3A2WS, Canada.
Folker SchnellerMedical Clinic and Polyclinic of Klinikum rechts der Isar of Technical University Munich, Ismaninger Str. 22, 81675, Munich, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBTH1677, a beta-glucan pathogen-associated molecular pattern molecule, drives an anti-cancer immune response in combination with oncology antibody therapies. This phase II study explored the efficacy, pharmacokinetics (PK), and safety of BTH1677 combined with bevacizumab/carboplatin/paclitaxel in patients with untreated advanced non-small cell lung cancer (NSCLC).

methodsPatients were randomized to the BTH1677 arm (N = 61; intravenous [IV] BTH1677, 4 mg/kg, weekly; IV bevacizumab, 15 mg/kg, once each 3-week cycle [Q3W]; IV carboplatin, 6 mg/mL/min Calvert formula area-under-the-curve, Q3W; and IV paclitaxel, 200 mg/m

resultsORR was higher in the BTH1677 vs Control arm but the difference between groups was not statistically significant (60.4% vs 43.5%; P = .2096). All other clinical endpoints also favored the BTH1677 arm but none statistically differed between arms. PK was consistent with previous studies. Although a higher incidence of Grade 3/4 AEs occurred in the BTH1677 vs Control arm (93.2% vs 66.7%), no unexpected AEs were observed. Serious AEs and discontinuations due to AEs were lower in the BTH1677 vs Control arm.

conclusionsImprovements in tumor assessments and survival were observed with BTH1677/bevacizumab/carboplatin/paclitaxel compared with control treatment in patients with advanced NSCLC.

trial registrationClinicalTrials.gov registration ID: NCT00874107 . Registered 2 April 2009. First participant was enrolled on 29 September 2009.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCarboplatinCarcinoma, Non-Small-Cell LungFemaleGlucansHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedPaclitaxelTreatment OutcomeBevacizumabBTH1677CarboplatinGlucansPaclitaxelBeta-glucanBevacizumabImmunotherapyNSCLC

Identifiers

PMID29486797
PMCPMC5830087

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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.