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Table 1 Quality assessment of included studies

From: Dose fractionation of CAR-T cells. A systematic review of clinical outcomes

 

Risk of bias

Indirectness

Imprecision

 

Selection bias

Attrition bias

Reporting/Detection bias

First Author

IRC involved in patient selection (Yes; No)

Loss to follow-up

(< 5%; 5–20%; >20%)

Objective outcomes assessed (Yes; No)

IRC involved in assessment of response (Yes; No)

Safety outcomes reported (Yes; No)

Heterogeneity

(Single sub-type; 2 sub-types; >2 sub-types in the study)

Sample size

(< 30; 30–50; >50 patients treated)

Duration of follow-up

(< 6 months; 6–12 months; >12 months)

Studies with single dose and fractionated-dose patients

Frey NV(37)

No*

> 20%

Yes

No

Yes

Single sub-type

30–50

> 12 months

Frey NV(35)

No*

5–20%

Yes

No

Yes

Single sub-type

30–50

> 12 months

Xu J(36)

No*

Consort Diagram Not Reported

Yes

No

Yes

Single sub-type

< 30

> 12 months

Anti-CD19 CAR-T cells

Li M(48)

No*

> 20%

Yes

No

Yes

Single sub-type

> 50

NR

Jiang H(22)

No*

Consort Diagram Not Reported

Yes

No

Yes

Single sub-type

> 50

NR

Ying Z(28)

No*

Consort Diagram Not Reported

Yes

No

Yes

> 2 sub-types

< 30

NR

Roddie C(40)

No*

Consort Diagram Not Reported

Yes

No

Yes

Single sub-type

< 30

> 12 months

Wang CM(45)

No

Consort Diagram Not Reported

Yes

No

Yes

> 2 sub-types

< 30

NR

Geyer MB(38)

No

> 20%

Yes

No

Yes

> 2 sub-type

< 30

> 12 months

Davila ML(41)

No

< 5%

Yes

No

Yes

Single sub-type

< 30

> 12 months

Sauter CS(39)

No

Consort Diagram Not Reported

Yes

No

Yes

> 2 sub-types

< 30

> 12 months

Hu Y(46)

No

5–20%

Yes

No

Yes

Single sub-type

< 30

< 6 months

Porter DL(47)

No*

> 20%

Yes

No

Yes

Single sub-type

< 30

> 12 months

Geyer MB(27)

No

Consort Diagram Not Reported

Yes

No

Yes

Single sub-type

< 30

> 12 months

Zhang Q(29)

No*

Consort Diagram Not Reported

Yes

No

No

Single sub-type

< 30

NR

Kalos M(44)

No*

Consort Diagram Not Reported

Yes

No

Yes

Single sub-type

< 30

NR

Anti-BCMA CAR-T cells

Zhao WH(43)

No*

Consort Diagram Not Reported

Yes

No

Yes

Single sub-type

> 50

6–12 months

Cohen AD(42)

No

5–20%

Yes

Yes

Yes

Single sub-type

< 30

> 12 months

  1. * Independent review committee/board approved the study’s protocol and had patients sign consent forms
  2. IRC, independent review committee
  3. All observational and single arm unblinded studies are given low grade and the grade is moved upwards based on quality assessment [48,49,50]
  4. Risk of Bias mainly involves selection bias and reporting or detection bias. Selection bias is low, and quality is high for studies that included an IRC for patient selection and that had < 5% loss of patients to follow-up. Studies with 5–20% loss to follow-up are considered to have medium selection bias and studies with over 20% loss to follow-up are considered to have high selection bias
  5. Reporting or detection bias is considered low for studies that evaluated objective outcomes, included an IRC for response assessment, and reported treatment-related adverse events (safety). Studies that reported subjective outcomes (e.g. patient reported outcomes) or studies that did not include IRC for response assessment or studies that did not report safety outcomes are rated as high for reporting or detection bias
  6. Indirectness (comparability) of the cohort between studies is considered low and quality is also high for studies that have a homogenous cohort (single type of cancer). Studies with up to 2 cancer-subtypes are rated as medium for indirectness and with > 2 cancer-subtypes are rated as low for comparability
  7. Imprecision of the cohort is considered high and quality is low for studies that have low sample size (< 30 patients) and small follow-up (< 6 months). Studies that have a sample size of 30–50 patients or with 6–12 months follow-up are rated medium for imprecision. Studies with sample size of > 50 patients and with follow-up over 12 months are rated low for imprecision and high for quality
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Journal of Experimental & Clinical Cancer Research

ISSN: 1756-9966

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