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Table 1 Characteristics of 11 included studies

From: Efficacy and safety of osimertinib for leptomeningeal metastases from EGFR-mutant non-small cell lung cancer: a pooled analysis

Study (year)

Region

No. of patients (female %)

Study design

Age

Therapy line

Dosage of Osimertinib (mg)

T790M status

LM response assessment criteria

Follow-up (mo.)

Yang 2019

Asian

41 (71%)

Phase I

59 (44–75)

 ≥ 2

160 mg

Positive:22; negative:13; unknown:6

RANO-LM (BICR)

9.9

Lee 2020

Asian

110 (62%)

Retrospective

58 (39–75)

 ≥ 2

80 mg (n = 67);

160 mg (n = 43)

Positive:60; negative:37; unknown:13

NA

NA

Ahn 2020

Global

22 (59%)

Retrospective pooled analysis of 4 prospective studies

58 (36–80)

 ≥ 2

80 mg

100% positive

RANO-LM (BICR)

11.7

Park 2020

Asian

40 (60%)

Phase II

59 (38–77)

 ≥ 2

160 mg

100% positive

RECIST 1.1

9.6

Nanjo 2017

Asian

13 (62%)

Prospective pilot study

67 (54–79)

 ≥ 5

80 mg

100% positive

CNS radiographic change

NA

Zheng 2020

Asian

45 (60%)

Retrospective

54 (22–82)

1(16%); ≥ 2(84%)

80 mg

Positive:9; negative:36

RANO-LM

NA

Saboundji 2018

Europe

20 (70%)

Retrospective

61.2 (11.2)

 ≥ 2

80 mg (17);

160 mg (2);

40 mg (1)

65% positive

NA

11.1

Reungwetwattana 2018

Global

5 (NA)

Preplanned, exploratory analysis of FLAURA

NA

1

80 mg

0%

RECIST 1.1

NA

Akazawa 2019

Asian

6 (50%)

Phase II

61.5 (50–75)

 ≥ 2

80 mg

100%

Radiological response

NA

Ahn 2019

Asian

40 (NA)

Phase II

NA

 ≥ 2

80 mg: 16;

160 mg: 24

100%

NA

8.3

Andrew 2020

American

11

Retrospective

NA

 ≥ 2

160 mg

NA

NA

NA

  1. BICR: blinded central in dependent review; CNS: central nervous system; LM: leptomeningeal metastases; mo.: months; NA: not available; RANO: Response Assessment in Neuro-Oncology; RECIST: Response Evaluation Criteria in Solid Tumors