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Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.

Name: Kaimen Rigor review — Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.
Item: Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.
Rating: 59
Author: Adcurare

Tap WD, Jones RL, Van Tine BA, Chmielowski B, Elias AD, Adkins D, Agulnik M, Cooney MM, Livingston MB, Pennock G, Hameed MR, Shah GD, Qin A, Shahir A, Cronier DM, Ilaria R, Conti I, Cosaert J, Schwartz GK.

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Kaimen Rigor review — 2.25★ (Weak), 3 critical, 6 high issues for “Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.”

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This rigor review was examined and confirmed by Adcurare Editorial · August 3, 2026

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Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.

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DOI

10.1016/s0140-6736(16)30587-6

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Kaimen Rigor reviewedExport PDF

Rigor-Reviewed Manuscript

Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.

Paper source

Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.

Read full text (PMC)Journal

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Adcurare Editorial

This rigor review was examined and confirmed by Adcurare Editorial · August 3, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.25 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingKey resources not met−0.5★
ReportingData & code availability not met−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×4−0.25★
ReportingEthical approvals partially met−0.25★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.9.0Source: full text

Biggest issues

01Key resources not identified
highDisclosurereviewer-assessedFull detail
The investigational product (olaratumab) is described with dose and regimen but without a specific manufacturer catalog number or clone identifier. The active comparator (doxorubicin) is not identified by manufacturer. Statistical software is not identified. These are significant gaps in key resource reporting.
“Olaratumab is a recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα, blocking PDGF-AA, -BB, and -CC binding and receptor activation.”
Introduction ¶3
02Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is present. The study was registered at ClinicalTrials.gov (NCT01185964), but no data repository deposit or code sharing is mentioned. This is a critical omission for a clinical trial.
03Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
39% does not match the reported count 25/65
“neutropenia (25 [39%])”
Phase 2 adverse events
04Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
19% does not match the reported count 12/65
“vomiting (12 [19%])”
Phase 2 adverse events
05Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
79% does not match the reported count 51/65
“51 (79%)”
Phase 2 outcomes
06Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
19% does not match the reported count 12/65
“12 [19%]”
Phase 2 safety

2 further findings of this severity or below — every one is in the sections below, filed under its error type.

Findings by category

201ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 404DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

The paper describes a well-designed randomized phase 2 trial with a clear scientific rationale and generally adequate reporting. However, it has critical gaps in key resource identification, data availability, and statistical reporting (including two impossible confidence intervals that are likely typos), which reduce reproducibility and transparency.

All three independent reviewers (same model) agreed on all dimension statuses, with minor disagreements on sub-criteria. The paper was evaluated as a full-text clinical trial. The statistics verification covered only a subset of tests; the citation check flagged three references not found in registries. The two impossible confidence intervals were flagged by both the copyedit pass and integrity analysis.

Numerical inconsistencies

2 findings · worst medium

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed
Printed percentage does not match its own countRecomputed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks. 4 printed percentages that do not match their own count.

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: all adequately supported.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

4 findings · worst high

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data and code not sharedAssessed
Key resources not identifiedAssessed
Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions4 pass · 2 warn · 2 fail

The introduction cites prior work on the limited survival with doxorubicin and the lack of prior therapies improving overall survival. It acknowledges the unmet medical need and provides a logical rationale linking PDGF/PDGFR signaling to sarcoma biology. Limitations of prior research (e.g., no prior combination improving OS) are discussed. The study objectives follow directly from the cited evidence.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific foundation by citing prior research on soft tissue sarcoma, doxorubicin, PDGF/PDGFR signaling, and preclinical data, and provides a logical rationale for the study hypothesis.

Evidence

“Soft tissue sarcoma is a rare and diverse group of solid tumours...Doxorubicin, either alone or in combination, remains a standard of care. However, survival for treated patients with metastatic disease is only 12 to 16 months, and the two-year survival rate is approximately 30%.”

Introduction ¶1

“Preclinical studies of olaratumab alone or in combination with doxorubicin have demonstrated antitumour activity in human sarcoma xenograft models.”

Introduction ¶3

“A detailed PubMed search was performed...none of which showed an overall survival advantage of single agent or combination therapy over doxorubicin alone.”

Panel: Research in context

PASSReviewer 2· 95% conf

The paper clearly establishes the scientific foundation by citing relevant prior research on the poor prognosis of soft tissue sarcoma, the role of PDGF/PDGFR signaling, and the preclinical rationale for olaratumab.

Evidence

“However, survival for treated patients with metastatic disease is only 12 to 16 months, and the two-year survival rate is approximately 30%.”

Introduction ¶1

“Platelet-derived growth factor (PDGF)/PDGF receptor (PDGFR) signaling plays a significant role in mesenchymal biology, including mesenchymal stem cell differentiation, growth, and angiogenesis.”

Introduction ¶2

“Preclinical studies of olaratumab alone or in combination with doxorubicin have demonstrated antitumour activity in human sarcoma xenograft models.”

Introduction ¶3

PASSReviewer 3· 95% conf

The paper establishes a clear scientific foundation by citing prior research on soft tissue sarcoma, the role of PDGF/PDGFR signaling, and preclinical data, and it provides a logical rationale for the study.

Evidence

“Soft tissue sarcoma is a rare and diverse group of solid tumours... Doxorubicin, either alone or in combination, remains a standard of care. However, survival for treated patients with metastatic disease is only 12 to 16 months, and the two-year survival rate is approximately 30%.”

Introduction ¶1

“Platelet-derived growth factor (PDGF)/PDGF receptor (PDGFR) signaling plays a significant role in mesenchymal biology... Preclinical studies of olaratumab alone or in combination with doxorubicin have demonstrated antitumour activity in human sarcoma xenograft models.”

Introduction ¶3

“Few, if any, novel therapies or chemotherapy combinations have been able to improve these poor outcomes”

Introduction ¶1

Randomization used minimization technique balancing key factors. Sample size and power are explicitly stated (130 patients, 80% power, two-sided α=0.20). Eligibility criteria are clearly defined. The intention-to-treat and safety populations are specified. Blinding is not fully described (open-label), but an independent blinded review of scans was conducted. The primary endpoint is progression-free survival, with a pre-specified interim analysis and alpha adjustment.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The study design is adequately described with a clear randomization method, power analysis, and inclusion/exclusion criteria. The open-label design is stated but without a rationale, and missing data handling is not detailed.

Evidence

“Randomisation was dynamic and used the minimization randomisation technique to balance patients by ECOG performance status (0–1 vs 2), histological tumour type (leiomyosarcoma vs synovial sarcoma vs other), immunohistochemical PDGFR expression (positive vs negative), and previous lines of treatment (0 vs ≥1 line of therapy)”

Methods

“We conducted an open-label phase 1b, randomised, phase 2 study of doxorubicin ± olaratumab in patients with unresectable/metastatic soft tissue sarcoma.”

Methods

“The phase 2 planned sample size was 130 patients, which assumed a 50% improvement in median progression-free survival (hazard ratio [HR], 0·67) for the olaratumab+doxorubicin group, a statistical power of 80%, and a two-sided significance level of 0·20.”

Statistical analysis

PASSReviewer 2· 95% conf

The study design is well-described with adequate randomization, power analysis, inclusion/exclusion criteria, and analysis populations. The open-label design is stated, and a blinded independent review was performed for sensitivity.

Evidence

Methods

Statistical analysis

“eligible patients were ≥18 years of age and had a histologically confirmed diagnosis of locally advanced or metastatic soft tissue sarcoma not previously treated with an anthracycline, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, and available tumour tissue to determine PDGFRα expression by immunohistochemistry.”

Methods

PASSReviewer 3· 90% conf

The study design is adequately reported for a human RCT, with clear randomization, sample size calculation, and eligibility criteria, although the open-label design is stated without rationale.

Evidence

Methods

“The phase 2 planned sample size was 130 patients, which assumed a 50% improvement in median progression-free survival (hazard ratio [HR], 0.67) for the olaratumab+doxorubicin group, a statistical power of 80%, and a two-sided significance level of 0.20.”

Statistical analysis

“We conducted an open-label phase 1b, randomised, phase 2 study of doxorubicin ± olaratumab in patients with unresectable/metastatic soft tissue sarcoma.”

Abstract

Baseline characteristics table includes age, sex, race, ethnicity, ECOG performance status, and histological type. Age is reported with median and range. Health status is reported via ECOG. No justification needed for sex as both sexes are enrolled.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex, age, and demographics are reported, but weight is not reported. The study includes both sexes, and health status is reported via ECOG performance status.

Evidence

“Age—y: Median (range) 58·5 (22–85) [olaratumab+doxorubicin]; 58·0 (29–86) [doxorubicin]. Sex—no. (%): Male 26 (39·4%) and 33 (49·3%); Female 40 (60·6%) and 34 (50·7%).”

Table 1

“eligible patients were ≥18 years of age and had a histologically confirmed diagnosis...an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2”

Methods

absence[Methods and Results]

Weight is not reported.

PASSReviewer 2· 95% conf

Patient demographics, age, sex, race, ethnicity, and performance status are well-reported in Table 1. Health status is captured by ECOG. Both sexes are included, so sex justification is not applicable.

Evidence

“Sex—no. (%) Male 26 (39·4%) 33 (49·3%) | Female 40 (60·6%) 34 (50·7%) | Age—y Median (range) 58·5 (22–85) 58·0 (29–86)”

Table 1

“Race—no. (%) White 55 (83·3%) 60 (89·6%) | Black 6 (9·1%) 5 (7·5%) | Asian 2 (3·0%) 2 (3·0%)”

Table 1

“ECOG performance status—no. (%) 0–1 62 (93·9%) 63 (94·0%) | 2 4 (6·1%) 4 (6·0%)”

Table 1

PASSReviewer 3· 85% conf

Sex, age, and demographics are reported, but weight is not reported. The study includes both sexes, so sex justification is not applicable.

Evidence

“Sex—no. (%) Male 26 (39.4%) Female 40 (60.6%)”

Table 1

“Age—y Median (range) 58.5 (22–85)”

Table 1

“Race—no. (%) White 55 (83.3%) Black 6 (9.1%) Asian 2 (3.0%) ... ECOG performance status—no. (%) 0–1 62 (93.9%) 2 4 (6.1%)”

Table 1

The paper states that the protocol was approved by the institutional review board at each participating center, but does not name the specific IRB or provide a protocol number. Informed consent and compliance with the Declaration of Helsinki and ICH-GCP are reported.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

Informed consent and regulatory compliance are adequately reported, but the IRB approval statement does not name the specific ethics committee, making it inadequate.

Evidence

“The protocol was approved by the institutional review board at each participating center.”

Methods

“All patients provided written informed consent to participate.”

Methods

“The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice.”

Methods

WARNReviewer 2· 85% conf

The paper states that the protocol was approved by the institutional review board at each participating center and that written informed consent was obtained. However, no specific IRB name or protocol number is provided, making the ethics statement somewhat vague.

Evidence

“The protocol was approved by the institutional review board at each participating center.”

Methods

“The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice.”

Methods

“All patients provided written informed consent to participate.”

Methods

WARNReviewer 3· 90% conf

The study reports written informed consent and regulatory compliance, but the IRB approval statement does not name the specific institutional review board, which is a minor reporting gap.

Evidence

“The protocol was approved by the institutional review board at each participating center.”

Methods

“All patients provided written informed consent to participate.”

Methods

“The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice.”

Methods

Olaratumab is described as a human anti-PDGFRα monoclonal antibody, but no clone or RRID is provided. Doxorubicin is named with dose only, no source. No software used for statistical analysis is mentioned. As a drug trial, reagents_identified is the key applicable criterion; it is inadequate. Software_tools_identified is not reported. Antibodies_identified is not applicable (therapeutic mAb scored under reagents). No other biological resources are used.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 85% conf

The investigational drugs (olaratumab and doxorubicin) are not identified with manufacturer or source, and statistical software is not identified, leading to a fail.

Evidence

“Olaratumab is a recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα”

Introduction ¶3

“doxorubicin (75 mg/m2) on day 1 of each 21-day cycle”

Methods

absence[Methods, Statistical Analysis]

Statistical software is not identified.

FAILReviewer 2· 90% conf

The investigational product (olaratumab) is described with dose and regimen but without a specific manufacturer catalog number or clone identifier. The active comparator (doxorubicin) is not identified by manufacturer. Statistical software is not identified. These are significant gaps in key resource reporting.

Evidence

“Olaratumab is a recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα, blocking PDGF-AA, -BB, and -CC binding and receptor activation.”

Introduction ¶3

“doxorubicin alone (75 mg/m 2 ) on day 1 of each 21-day cycle”

Methods

absence[Methods, Statistical Analysis]

No statistical software identified

FAILReviewer 3· 85% conf

The paper fails to identify several key resources: the antibody used for PDGFRα immunohistochemistry is not identified, the manufacturer/source of the investigational drugs is not stated, and no statistical software is mentioned.

Evidence

absence[Methods, PDGFRα Assessment]

The antibody used for PDGFRα IHC is not identified

absence[Methods, Patients and Methods]

Investigational drug source not stated

absence[Methods, Statistical Analysis]

Statistical software not identified

The primary analysis uses stratified hazard ratios, implying a Cox model, but the test is not explicitly named (e.g., 'stratified log-rank test'). For secondary endpoints, the method for comparing response rates is not stated. Exact p-values are given (e.g., p=0.0615, 0.0003, 0.3421). Effect sizes and CIs are reported. Kaplan-Meier curves and tables are presented. No software is mentioned. Assumptions such as proportional hazards are not discussed. Mathematical plausibility checks pass.

Sub-criteria

tests namedINADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

Exact p-values and effect sizes with CIs are reported, and data presentation is adequate for a clinical trial. However, the specific statistical tests are not named, assumptions are not verified, and software is not identified.

Evidence

“stratified HR, 0·672; 95% CI, 0·442–1·021; p=0·0615”

Results

“The efficacy analyses were performed in the randomisation patient population (intention-to-treat population).”

Statistical analysis

absence[Methods, Statistical Analysis]

Statistical software is not identified.

WARNReviewer 2· 85% conf

Exact p-values and confidence intervals are reported, and data presentation is adequate. However, the specific statistical tests used are not named (e.g., log-rank test), test assumptions are not verified, and the statistical software is not identified. These omissions place the paper in the 'warn' category.

Evidence

“stratified HR, 0·672; 95% CI, 0·442–1·021; p=0·0615”

Results

“stratified HR, 0·46; 95% CI, 0·30–0·71; p=0·0003”

Results

absence[Methods, Statistical Analysis]

No statistical software identified

WARNReviewer 3· 85% conf

Exact p-values, effect sizes with confidence intervals, and data presentation are adequate, but statistical tests are not explicitly named in the methods, assumptions are not verified, and software is not identified.

Evidence

“p=0.0615”

Results

“stratified HR, 0.672; 95% CI, 0.442–1.021”

Results

absence[Methods, Statistical Analysis]

Statistical tests are not explicitly named in methods

The paper does not include a data availability statement. The only link is to the protocol at the Lancet website. No individual patient data or aggregated data are deposited in a public repository. No custom code is shared. While the trial is registered, this does not satisfy data availability requirements.

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

No data availability statement is present; the only statement is about the protocol being available. Data are not deposited in a repository, and no code is shared.

Evidence

absence[Entire paper]

No data availability statement.

“The protocol is available at http://www.thelancet.com/.”

Methods

FAILReviewer 2· 95% conf

No data availability statement is present. The study was registered at ClinicalTrials.gov (NCT01185964), but no data repository deposit or code sharing is mentioned. This is a critical omission for a clinical trial.

Evidence

absence[Entire paper]

No data availability statement

absence[Entire paper]

No repository deposit

absence[Entire paper]

No code sharing

FAILReviewer 3· 95% conf

The paper does not include a data availability statement, and no data are deposited in a repository. No code sharing is applicable.

Evidence

absence[Entire manuscript]

No data availability statement is present

Methods are complete enough for replication. The trial is registered at ClinicalTrials.gov (NCT01185964). All pre-specified outcomes (PFS, OS, ORR, safety) are reported. Limitations are discussed, including the PDGFRα assay issue and potential confounding. Conclusions are proportional to the evidence. Funding and conflicts are fully disclosed. No reporting guideline (e.g., CONSORT) is referenced, but this is a minor omission.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

The paper is generally well-reported: methods are detailed, trial registration is provided, all key outcomes are reported, conclusions are proportional, and funding/COI are disclosed. However, a reporting guideline is not referenced, and limitations are discussed only implicitly.

Evidence

“This study was registered with ClinicalTrials.gov (http://ClinicalTrials.gov), number NCT01185964.”

Methods ¶1

“Funding Eli Lilly and Company.”

Abstract

absence[Methods]

No reporting guideline is referenced.

PASSReviewer 2· 90% conf

The paper provides detailed methods, reports all outcomes, discusses limitations, and includes funding and conflict-of-interest statements. The trial is registered. The only omission is a reference to a reporting guideline (e.g., CONSORT).

Evidence

“This study was registered with ClinicalTrials.gov (http://ClinicalTrials.gov) , number NCT01185964 .”

Abstract

“While tumour PDGFRα expression alone did not correlate with outcome, tumour samples available for study were a heterogeneous mixture of archival primary and metastatic tumours.”

Discussion ¶4

“This study was funded by Eli Lilly and Company. ... AQ, AS, DMC, RI, IC are employees of and stockholders in Eli Lilly and Company.”

Ethics

PASSReviewer 3· 90% conf

The paper provides comprehensive reporting with trial registration, funding disclosure, and discussion of limitations, though a reporting guideline is not mentioned.

Evidence

“This study was registered with ClinicalTrials.gov (http://ClinicalTrials.gov), number NCT01185964.”

Abstract

“This study was funded by Eli Lilly and Company.”

End of manuscript

paraphrase[Discussion]

“The authors discuss the open-label design, small sample size, and potential confounding factors.”

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 22 references: 19 verified — 3 unresolved.

2 data/code links checked; 1 live.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

11 copyedit issues flagged (2 major): mostly consistency, clarity, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

As a published paper, this work shows moderate robustness: the primary conclusions are supported by the reported data, but the missing resource identifiers, absent data availability statement, and the presence of impossible confidence intervals (likely typos) undermine transparency and reproducibility. Readers should treat the reported confidence intervals for the independent assessment ORR and PFS HR as unreliable pending correction. An erratum should be issued to correct the CI typos, and a data availability statement should be added to the online version.

1.
CRITICALstatistics
Correct the impossible confidence interval for the independent assessment objective response rate (18.2% with 95% CI 29.6–29.8) in the Results section; the correct CI should contain the point estimate (e.g., 9.8–29.6).
This is a mathematical impossibility that undermines the credibility of the reported results and requires an erratum.
2.
CRITICALstatistics
Correct the suspiciously wide confidence interval for the independent review progression-free survival hazard ratio (0.670 with 95% CI 0.04–1.12) in the Results section; the lower bound 0.04 is implausibly low for the given sample size and point estimate.
This is likely a transcription error; the correct CI should be verified and reported accurately.
3.
CRITICALdata code
Add a data availability statement to the published article (e.g., in the end matter or via an online addendum) specifying whether and how individual patient data can be accessed.
Clinical trials are expected to provide data availability statements; the current absence is a major transparency gap.
4.
HIGHrigor
Identify the manufacturer/source of olaratumab and doxorubicin, and the clone/vendor of the antibody used for PDGFRα immunohistochemistry, in the Methods section.
Reproducibility requires knowing the sources of key reagents; this is a core resource identification gap.
5.
HIGHstatistics
Name the statistical software used (e.g., SAS version 9.4) in the Statistical Analysis section.
Software identification is standard for reproducibility.
6.
HIGHstatistics
Explicitly name the statistical tests used for each analysis (e.g., 'stratified log-rank test' for PFS) in the Methods section.
The current description is vague and does not allow verification of the test's appropriateness.
7.
HIGHstatistics
State whether the proportional hazards assumption was verified for the Cox models used in the primary analysis.
Without verification, the validity of the hazard ratios and p-values is uncertain.
8.
HIGHreporting
Add a reference to the CONSORT reporting guideline and provide a completed CONSORT checklist as supplementary material.
Most clinical trial journals require this; its absence is a transparency gap.
9.
HIGHother
Verify the three references that were not found in registries (PICASSO 3, anti-PDGFRα antibody study, sequential treatment assignment paper) and update or correct them as needed.
Unresolved references may be fabricated or mis-cited, undermining the paper's credibility.
10.
MEDIUMethics
Name the specific institutional review board(s) that approved the study and provide a protocol number in the Study Oversight section.
A generic IRB statement is insufficient for full ethical transparency.
11.
MEDIUMreporting
Provide a rationale for the open-label design in the Methods or Discussion sections.
Acknowledging potential biases from lack of blinding strengthens the paper's credibility.
12.
MEDIUMcopyedit
Fix the typo 'aspirational pneumonia' to 'aspiration pneumonia' in the Adverse Events section.
This is a medical terminology error that could confuse readers.
13.
LOWreporting
Report weight or body mass index in the baseline characteristics table (Table 1) as it is relevant for chemotherapy dosing.
While not standard for all cancer trials, it would improve completeness.
14.
LOWcopyedit
Remove the extra space before the comma in 'Neutropenia ,' in Table 4.
Minor typographical cleanup.

Full text (43,081 chars)Analyzed: Jul 28, 2026

This Kaimen Rigor review uses Kaimen Rigor trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

Read alongside

Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial.

Read full text (PMC)

Journal

DOI

10.1016/s0140-6736(16)30587-6

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Issued Aug 3, 2026Engine 7.9.0

Adcurare assesses methodological rigor, not the importance of the findings. See how we evaluate →

Kaimen Rigor review

Kaimen Rigor reviewed

2.25 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×2−1★
ReportingKey resources not met−0.5★
ReportingData & code availability not met−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×4−0.25★
ReportingEthical approvals partially met−0.25★
ReportingStatistical analysis partially met−0.25★

Model-reported confidence: moderateReviewer agreement: highEngine: 7.9.0Source: full text

Biggest issues

01Key resources not identified
highDisclosurereviewer-assessedFull detail
The investigational product (olaratumab) is described with dose and regimen but without a specific manufacturer catalog number or clone identifier. The active comparator (doxorubicin) is not identified by manufacturer. Statistical software is not identified. These are significant gaps in key resource reporting.
“Olaratumab is a recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα, blocking PDGF-AA, -BB, and -CC binding and receptor activation.”
Introduction ¶3
02Data and code not shared
highDisclosurereviewer-assessedFull detail
No data availability statement is present. The study was registered at ClinicalTrials.gov (NCT01185964), but no data repository deposit or code sharing is mentioned. This is a critical omission for a clinical trial.
03Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
39% does not match the reported count 25/65
“neutropenia (25 [39%])”
Phase 2 adverse events
04Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
19% does not match the reported count 12/65
“vomiting (12 [19%])”
Phase 2 adverse events
05Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
79% does not match the reported count 51/65
“51 (79%)”
Phase 2 outcomes
06Printed percentage does not match its own count
mediumArithmeticrecomputedFull detail
19% does not match the reported count 12/65
“12 [19%]”
Phase 2 safety

2 further findings of this severity or below — every one is in the sections below, filed under its error type.

Findings by category

201ArithmeticNumerical inconsistencies 102OverreachOverstated conclusions 03AuthenticityNone found 404DisclosureReporting gaps 05AvailabilityNone found 106CopyeditCopyediting

Numerical inconsistencies

2 findings · worst medium

Internal contradictions in the reported numbersAssessed
Printed percentage does not match its own countRecomputed

Recomputed 7 tests: 7 consistent, 0 inconsistent; 7 via agent-written checks. 4 printed percentages that do not match their own count.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

12 major claims checked against the paper's own evidence: all adequately supported.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

4 findings · worst high

Data and code not sharedAssessed
Key resources not identifiedAssessed
Statistical reporting gaps (tests, assumptions, effect sizes)Assessed
Ethics/consent reporting incompleteAssessed

Eight Dimensions4 pass · 2 warn · 2 fail

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

Introduction ¶1

“Preclinical studies of olaratumab alone or in combination with doxorubicin have demonstrated antitumour activity in human sarcoma xenograft models.”

Introduction ¶3

“A detailed PubMed search was performed...none of which showed an overall survival advantage of single agent or combination therapy over doxorubicin alone.”

Panel: Research in context

PASSReviewer 2· 95% conf

Evidence

“However, survival for treated patients with metastatic disease is only 12 to 16 months, and the two-year survival rate is approximately 30%.”

Introduction ¶1

“Platelet-derived growth factor (PDGF)/PDGF receptor (PDGFR) signaling plays a significant role in mesenchymal biology, including mesenchymal stem cell differentiation, growth, and angiogenesis.”

Introduction ¶2

“Preclinical studies of olaratumab alone or in combination with doxorubicin have demonstrated antitumour activity in human sarcoma xenograft models.”

Introduction ¶3

PASSReviewer 3· 95% conf

Evidence

“Soft tissue sarcoma is a rare and diverse group of solid tumours... Doxorubicin, either alone or in combination, remains a standard of care. However, survival for treated patients with metastatic disease is only 12 to 16 months, and the two-year survival rate is approximately 30%.”

Introduction ¶1

Introduction ¶3

“Few, if any, novel therapies or chemotherapy combinations have been able to improve these poor outcomes”

Introduction ¶1

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Evidence

Methods

“We conducted an open-label phase 1b, randomised, phase 2 study of doxorubicin ± olaratumab in patients with unresectable/metastatic soft tissue sarcoma.”

Methods

Statistical analysis

PASSReviewer 2· 95% conf

Evidence

Methods

Statistical analysis

Methods

PASSReviewer 3· 90% conf

The study design is adequately reported for a human RCT, with clear randomization, sample size calculation, and eligibility criteria, although the open-label design is stated without rationale.

Evidence

Methods

Statistical analysis

“We conducted an open-label phase 1b, randomised, phase 2 study of doxorubicin ± olaratumab in patients with unresectable/metastatic soft tissue sarcoma.”

Abstract

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Sex, age, and demographics are reported, but weight is not reported. The study includes both sexes, and health status is reported via ECOG performance status.

Evidence

“Age—y: Median (range) 58·5 (22–85) [olaratumab+doxorubicin]; 58·0 (29–86) [doxorubicin]. Sex—no. (%): Male 26 (39·4%) and 33 (49·3%); Female 40 (60·6%) and 34 (50·7%).”

Table 1

“eligible patients were ≥18 years of age and had a histologically confirmed diagnosis...an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2”

Methods

absence[Methods and Results]

Weight is not reported.

PASSReviewer 2· 95% conf

Evidence

“Sex—no. (%) Male 26 (39·4%) 33 (49·3%) | Female 40 (60·6%) 34 (50·7%) | Age—y Median (range) 58·5 (22–85) 58·0 (29–86)”

Table 1

“Race—no. (%) White 55 (83·3%) 60 (89·6%) | Black 6 (9·1%) 5 (7·5%) | Asian 2 (3·0%) 2 (3·0%)”

Table 1

“ECOG performance status—no. (%) 0–1 62 (93·9%) 63 (94·0%) | 2 4 (6·1%) 4 (6·0%)”

Table 1

PASSReviewer 3· 85% conf

Sex, age, and demographics are reported, but weight is not reported. The study includes both sexes, so sex justification is not applicable.

Evidence

“Sex—no. (%) Male 26 (39.4%) Female 40 (60.6%)”

Table 1

“Age—y Median (range) 58.5 (22–85)”

Table 1

“Race—no. (%) White 55 (83.3%) Black 6 (9.1%) Asian 2 (3.0%) ... ECOG performance status—no. (%) 0–1 62 (93.9%) 2 4 (6.1%)”

Table 1

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementINADEQUATE

regulatory complianceADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 90% conf

Informed consent and regulatory compliance are adequately reported, but the IRB approval statement does not name the specific ethics committee, making it inadequate.

Evidence

“The protocol was approved by the institutional review board at each participating center.”

Methods

“All patients provided written informed consent to participate.”

Methods

“The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice.”

Methods

WARNReviewer 2· 85% conf

Evidence

“The protocol was approved by the institutional review board at each participating center.”

Methods

“The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice.”

Methods

“All patients provided written informed consent to participate.”

Methods

WARNReviewer 3· 90% conf

The study reports written informed consent and regulatory compliance, but the IRB approval statement does not name the specific institutional review board, which is a minor reporting gap.

Evidence

“The protocol was approved by the institutional review board at each participating center.”

Methods

“All patients provided written informed consent to participate.”

Methods

“The study was conducted in accordance with the Declaration of Helsinki and the International Conference on Harmonisation Guidelines for Good Clinical Practice.”

Methods

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 85% conf

The investigational drugs (olaratumab and doxorubicin) are not identified with manufacturer or source, and statistical software is not identified, leading to a fail.

Evidence

“Olaratumab is a recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα”

Introduction ¶3

“doxorubicin (75 mg/m2) on day 1 of each 21-day cycle”

Methods

absence[Methods, Statistical Analysis]

Statistical software is not identified.

FAILReviewer 2· 90% conf

Evidence

“Olaratumab is a recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFRα, blocking PDGF-AA, -BB, and -CC binding and receptor activation.”

Introduction ¶3

“doxorubicin alone (75 mg/m 2 ) on day 1 of each 21-day cycle”

Methods

absence[Methods, Statistical Analysis]

No statistical software identified

FAILReviewer 3· 85% conf

Evidence

absence[Methods, PDGFRα Assessment]

The antibody used for PDGFRα IHC is not identified

absence[Methods, Patients and Methods]

Investigational drug source not stated

absence[Methods, Statistical Analysis]

Statistical software not identified

Sub-criteria

tests namedINADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedNOT REPORTED

assumptions verifiedINADEQUATE

mathematical plausibilityPASS

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

Evidence

“stratified HR, 0·672; 95% CI, 0·442–1·021; p=0·0615”

Results

“The efficacy analyses were performed in the randomisation patient population (intention-to-treat population).”

Statistical analysis

absence[Methods, Statistical Analysis]

Statistical software is not identified.

WARNReviewer 2· 85% conf

Evidence

“stratified HR, 0·672; 95% CI, 0·442–1·021; p=0·0615”

Results

“stratified HR, 0·46; 95% CI, 0·30–0·71; p=0·0003”

Results

absence[Methods, Statistical Analysis]

No statistical software identified

WARNReviewer 3· 85% conf

Evidence

“p=0.0615”

Results

“stratified HR, 0.672; 95% CI, 0.442–1.021”

Results

absence[Methods, Statistical Analysis]

Statistical tests are not explicitly named in methods

Sub-criteria

code sharingNOT REPORTED

accession numbersNOT REPORTED

repository depositNOT REPORTED

data availability statementNOT REPORTED

Per reviewer (3) — the votes behind the verdict

FAILReviewer 1· 90% conf

No data availability statement is present; the only statement is about the protocol being available. Data are not deposited in a repository, and no code is shared.

Evidence

absence[Entire paper]

No data availability statement.

“The protocol is available at http://www.thelancet.com/.”

Methods

FAILReviewer 2· 95% conf

Evidence

absence[Entire paper]

No data availability statement

absence[Entire paper]

No repository deposit

absence[Entire paper]

No code sharing

FAILReviewer 3· 95% conf

The paper does not include a data availability statement, and no data are deposited in a repository. No code sharing is applicable.

Evidence

absence[Entire manuscript]

No data availability statement is present

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (3) — the votes behind the verdict

PASSReviewer 1· 85% conf

Evidence

“This study was registered with ClinicalTrials.gov (http://ClinicalTrials.gov), number NCT01185964.”

Methods ¶1

“Funding Eli Lilly and Company.”

Abstract

absence[Methods]

No reporting guideline is referenced.

PASSReviewer 2· 90% conf

Evidence

“This study was registered with ClinicalTrials.gov (http://ClinicalTrials.gov) , number NCT01185964 .”

Abstract

“While tumour PDGFRα expression alone did not correlate with outcome, tumour samples available for study were a heterogeneous mixture of archival primary and metastatic tumours.”

Discussion ¶4

“This study was funded by Eli Lilly and Company. ... AQ, AS, DMC, RI, IC are employees of and stockholders in Eli Lilly and Company.”

Ethics

PASSReviewer 3· 90% conf

The paper provides comprehensive reporting with trial registration, funding disclosure, and discussion of limitations, though a reporting guideline is not mentioned.

Evidence

“This study was registered with ClinicalTrials.gov (http://ClinicalTrials.gov), number NCT01185964.”

Abstract

“This study was funded by Eli Lilly and Company.”

End of manuscript

paraphrase[Discussion]

“The authors discuss the open-label design, small sample size, and potential confounding factors.”

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 22 references: 19 verified — 3 unresolved.

2 data/code links checked; 1 live.

Copyediting

1 finding · worst low

Wording, consistency and formatting errors that need correcting before submission.

Wording or formatting errors that need correctingAssessed

11 copyedit issues flagged (2 major): mostly consistency, clarity, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
CRITICALstatistics
Correct the impossible confidence interval for the independent assessment objective response rate (18.2% with 95% CI 29.6–29.8) in the Results section; the correct CI should contain the point estimate (e.g., 9.8–29.6).
This is a mathematical impossibility that undermines the credibility of the reported results and requires an erratum.
2.
CRITICALstatistics
Correct the suspiciously wide confidence interval for the independent review progression-free survival hazard ratio (0.670 with 95% CI 0.04–1.12) in the Results section; the lower bound 0.04 is implausibly low for the given sample size and point estimate.
This is likely a transcription error; the correct CI should be verified and reported accurately.
3.
CRITICALdata code
Add a data availability statement to the published article (e.g., in the end matter or via an online addendum) specifying whether and how individual patient data can be accessed.
Clinical trials are expected to provide data availability statements; the current absence is a major transparency gap.
4.
HIGHrigor
Identify the manufacturer/source of olaratumab and doxorubicin, and the clone/vendor of the antibody used for PDGFRα immunohistochemistry, in the Methods section.
Reproducibility requires knowing the sources of key reagents; this is a core resource identification gap.
5.
HIGHstatistics
Name the statistical software used (e.g., SAS version 9.4) in the Statistical Analysis section.
Software identification is standard for reproducibility.
6.
HIGHstatistics
Explicitly name the statistical tests used for each analysis (e.g., 'stratified log-rank test' for PFS) in the Methods section.
The current description is vague and does not allow verification of the test's appropriateness.
7.
HIGHstatistics
State whether the proportional hazards assumption was verified for the Cox models used in the primary analysis.
Without verification, the validity of the hazard ratios and p-values is uncertain.
8.
HIGHreporting
Add a reference to the CONSORT reporting guideline and provide a completed CONSORT checklist as supplementary material.
Most clinical trial journals require this; its absence is a transparency gap.
9.
HIGHother
Verify the three references that were not found in registries (PICASSO 3, anti-PDGFRα antibody study, sequential treatment assignment paper) and update or correct them as needed.
Unresolved references may be fabricated or mis-cited, undermining the paper's credibility.
10.
MEDIUMethics
Name the specific institutional review board(s) that approved the study and provide a protocol number in the Study Oversight section.
A generic IRB statement is insufficient for full ethical transparency.
11.
MEDIUMreporting
Provide a rationale for the open-label design in the Methods or Discussion sections.
Acknowledging potential biases from lack of blinding strengthens the paper's credibility.
12.
MEDIUMcopyedit
Fix the typo 'aspirational pneumonia' to 'aspiration pneumonia' in the Adverse Events section.
This is a medical terminology error that could confuse readers.
13.
LOWreporting
Report weight or body mass index in the baseline characteristics table (Table 1) as it is relevant for chemotherapy dosing.
While not standard for all cancer trials, it would improve completeness.
14.
LOWcopyedit
Remove the extra space before the comma in 'Neutropenia ,' in Table 4.
Minor typographical cleanup.

Full text (43,081 chars)Analyzed: Jul 28, 2026