Table 1b Association of platelet response rates and transfusion needs with various platelet response criteria

From: Relationship of different platelet response criteria and patient outcomes in a romiplostim myelodysplastic syndromes trial

Platelet response criteria

Response rate

Platelet transfuse RR a (95% CI)

Bleeding b

OS c

 

Placebo N=83, n (%)

Romiplostim N=167, n (%)

P-value

OR (95% CI) b

 

All RR (95% CI)

CSBE RR (95% CI)

HR (95% CI)

IWG 2006 HI-P

3 (3.6)

61 (36.5)

<0.001

15.6* (4.7–51.8)

9.8* (7.8–12.3)

2.3* (2.1–2.6)

1.4* (1.0–2.0)

2.6* (1.4–4.7)

IWG 2000 Major or Minor

2 (2.4)

56 (33.5)

<0.001

21.2* (5.0–90.3)

13.0* (9.8–17.2)

2.5* (2.2–2.8)

1.2 (0.8–1.6)

2.2* (1.2–4.1)

Italian MDS group

 Complete (IWG AML 2003)

4 (4.8)

63 (37.7)

<0.001

15.4* (5.0–47.2)

5.8* (4.7–7.2)

2.6* (2.3–2.9)

1.8* (1.2–2.7)

1.9* (1.0–3.4)

 Any

26 (31.3)

115 (68.9)

<0.001

5.1* (2.8–9.1)

2.6* (2.3–2.9)

2.1* (1.9–2.3)

1.2 (0.9–1.7)

1.5 (0.9–2.6)

 Durable

4 (4.8)

82 (49.1)

<0.001

19.7* (6.9–56.5)

9.5* (7.8–11.4)

2.5* (2.3–2.7)

1.8* (1.3–2.4)

2.2* (1.2–3.8)

CALGB

6 (7.2)

75 (44.9)

<0.001

12.5* (4.9–31.5)

1.8* (1.6–2.0)

2.8* (2.5–3.1)

0.8 (0.6–1.1)

1.6 (0.9–2.9)

ITP

17 (20.5)

95 (56.9)

<0.001

6.3* (3.2–12.4)

2.8* (2.4–3.2)

2.1* (1.9–2.3)

0.9 (0.7–1.2)

1.6 (0.9–2.9)

  1. Abbreviations: AML, acute myeloid leukemia; CALGB, Cancer and Leukemia Group B; CI, confidence interval; CSBE, clinically significant bleeding event; HI-P, hematologic improvement—platelet; HR, hazard ratio; IPSS, International Prognostic Scoring System; ITP, immune thrombocytopenia; IWG, International Working Group; MDS, myelodysplastic syndrome; OR, odds ratio; OS, overall survival; RR, rate ratio.
  2. aRomiplostim-treated patients only, responders vs nonresponders; adjusted for baseline platelet count and IPSS status.
  3. bRomiplostim vs placebo; adjusted for baseline platelet count and IPSS status.
  4. cRomiplostim-treated patients, nonresponders vs responders; adjusted for baseline age (65 years or older) and IPSS status. Statistically significant OR and RR are bolded with asterisks.