Table 2. Stratified analyses for FACT-F in (i) all included RCTs, (ii) RCTs in patients receiving chemotherapy and (iii) placebo-controlled RCTs in patients receiving chemotherapy.
| |
All RCTs |
Chemotherapy RCTs |
Placebo-controlled chemotherapy RCTs |
||||||
|---|---|---|---|---|---|---|---|---|---|
| FACT-F | Studies/ESA/control | MD (95% CI) | P-valuea | Studies/ESA/control | MD (95% CI) | P-valuea | Studies/ESA/control | MD (95% CI) | P-valuea |
| Overall |
23/3389/2719 |
2.41 (1.39 to 3.43) |
|
19/2566/2131 |
2.81 (1.73 to 3.90) |
|
10/1543/1171 |
1.78 (0.82 to 2.73) |
|
| Anticancer treatment |
|
|
0.218 |
|
|
NA |
|
|
NA |
| Chemotherapy | 19/2566/2131 | 2.81 (1.73 to 3.90) | 19/2566/2131 | 2.81 (1.73 to 3.90) | 10/1543/1171 | 1.78 (0.82 to 2.73) | |||
| Radiotherapy | 1/127/134 | 0.00 (−2.82 to 2.82) | — | — | — | — | |||
| None |
3/696/454 |
0.62 (−1.83 to 3.07) |
|
— |
— |
|
— |
— |
|
| Anticancer treatment (condensed) |
|
|
0.079 |
|
|
NA |
|
|
NA |
| Chemotherapy | 19/2566/2131 | 2.81 (1.73 to 3.90) | 19/2566/2131 | 2.81 (1.73 to 3.90) | 10/1543/1171 | 1.78 (0.82 to 2.73) | |||
| Radiotherapy, none |
4/823/588 |
0.28 (−1.34 to 1.90) |
|
— |
— |
|
— |
— |
|
| Baseline Hb |
|
|
0.424 |
|
|
0.362 |
|
|
0.153 |
| >12 g dl–1 | 3/474/478 | 0.43 (−0.94 to 1.80) | 2/347/344 | 0.56 (−1.01 to 2.13) | — | — | |||
| 10–12 g dl–1 | 12/1535/1172 | 3.07 (1.47 to 4.67) | 10/1182/1080 | 3.31 (1.52 to 5.09) | 4/596/573 | 0.97 (−0.34 to 2.28) | |||
| ⩽10 g dl–1 |
8/1380/1069 |
2.32 (0.74 to 3.90) |
|
7/1037/707 |
2.82 (1.57 to 4.08) |
|
6/947/598 |
2.41 (1.19 to 3.62) |
|
| Baseline Hb (condensed) |
|
|
0.098 |
|
|
0.11 |
|
|
NA |
| >12 g dl–1 | 3/474/478 | 0.43 (−0.94 to 1.80) | 2/347/344 | 0.56 (−1.01 to 2.13) | |||||
| ⩽12 g dl–1 |
20/2915/2241 |
2.78 (1.64 to 3.92) |
|
17/2219/1787 |
3.15 (2.00 to 4.29) |
|
10/1543/1171 |
1.78 (0.82 to 2.73) |
|
| Disease stage |
|
|
0.025b |
|
|
0.005b |
|
|
0.225b |
| >70% not metastatic/advanced | 1/168/170 | 5.40 (3.09 to 7.71) | 1/168/170 | 5.40 (3.09 to 7.71) | — | — | |||
| >70% metastatic/advanced | 11/1977/1650 | 1.15 (0.21 to 2.08) | 10/1634/1288 | 1.41 (0.49 to 2.32) | 7/1131/879 | 1.40 (0.37 to 2.42) | |||
| Other | 6/699/476 | 3.12 (0.31 to 5.93) | 3/219/250 | 5.59 (2.93 to 8.25) | — | — | |||
| Unknownc |
5/545/423 |
3.21 (1.64 to 4.77) |
|
5/545/423 |
3.21 (1.64 to 4.77) |
|
3/412/292 |
2.95 (0.68 to 5.23) |
|
| Frequency |
|
|
0.032b |
|
|
0.044b |
|
|
0.134b |
| ⩽Q2W | 6/1170/685 | 0.85 (−0.79 to 2.49) | 3/474/231 | 1.37 (−1.49 to 4.23) | 3/474/231 | 1.37 (−1.49 to 4.23) | |||
| QW | 7/849/848 | 2.20 (0.81 to 3.59) | 7/849/848 | 2.20 (0.81 to 3.59) | 4/491/481 | 1.85 (0.56 to 3.14) | |||
| TIW | 9/1125/947 | 3.72 (1.91 to 5.54) | 8/998/813 | 4.22 (2.47 to 5.97) | 2/333/220 | 3.54 (0.62 to 6.46) | |||
| Otherc |
1/245/239 |
0.80 (−1.56 to 3.16) |
|
1/245/239 |
0.80 (−1.56 to 3.16) |
|
1/245/239 |
0.80 (−1.56 to 3.16) |
|
| Target Hb |
|
|
0.008 |
|
|
0.053 |
|
|
0.105 |
| >13–15 g dl–1 | 17/2486/1903 | 3.00 (1.91 to 4.09) | 15/2156/1727 | 3.17 (2.02 to 4.31) | 9/1380/1019 | 2.06 (1.11 to 3.01) | |||
| ⩽13 g dl–1 | 5/846/761 | −0.13 (−1.20 to 0.93) | 3 /353/349 | 0.22 (−1.29 to 1.74) | 1/163/152 | −0.45 (−2.97 to 2.07) | |||
| Not reportedc |
1/57/55 |
5.60 (0.91 to 10.29) |
|
1/57/55 |
5.60 (0.91 to 10.29) |
|
— |
— |
|
| Placebo control |
|
|
0.054 |
|
|
0.083 |
|
|
NA |
| Yes | 12/2036/1583 | 1.36 (0.39 to 2.34) | 10/1543/1171 | 1.78 (0.82 to 2.73) | 10/1543/1171 | 1.78 (0.82 to 2.73) | |||
| No |
11/1353/1136 |
3.46 (1.77 to 5.16) |
|
9/1023/960 |
3.85 (1.96 to 5.74) |
|
— |
— |
|
| QoL primary end point |
|
|
0.027 |
|
|
0.091 |
|
|
0.724 |
| Yes | 8/850/878 | 3.87 (1.98 to 5.76) | 8/850/878 | 3.87 (1.98 to 5.76) | 1/151/148 | 1.25 (−1.42 to 3.92) | |||
| No |
15/2539/1841 |
1.53 (0.58 to 2.48) |
|
11/1716/1253 |
1.93 (0.88 to 2.98) |
|
9/1392/1023 |
1.87 (0.80 to 2.95) |
|
| Source of data |
|
|
0.907 |
|
|
0.537 |
|
|
0.446 |
| Full publication | 17/2628/2053 | 2.41 (1.35 to 3.47) | 13/1805/1465 | 2.98 (1.97 to 4.00) | 8/1258/990 | 1.92 (0.94 to 2.90) | |||
| Clinical study report |
6/761/666 |
2.36 (−0.37 to 5.10) |
|
6/761/666 |
2.36 (−0.37 to 5.10) |
|
2/285/181 |
1.78 (−3.14 to 6.69) |
|
| Study industry funded |
|
|
0.362 |
|
|
0.476 |
|
|
NA |
| Yes | 21/3256/2588 | 2.29 (1.22 to 3.35) | 17/2433/2000 | 2.70 (1.54 to 3.85) | 10/1543/1171 | 1.78 (0.82 to 2.73) | |||
| No | 2/133/131 | 3.99 (1.26 to 6.71) | 2/133/131 | 3.99 (1.26 to 6.71) | — | — | |||
Abbreviations: CI=confidence interval; ESA=erythropoiesis-stimulating agents; FACT-F=Functional Assessment of Cancer Therapy-Fatigue subscale; Hb=haemoglobin; MD=mean difference; NA=not applicable; QoL=quality of life; RCT=randomised controlled trial.
Frequency: ⩽Q2W=every second week or less frequent, QW=once per week, TIW=three times per week, other=frequency changing during the study.
Planned weekly ESA dose: high=>40 000 U epoetin α/δ or 30 000 U epoetin β or 100 μg darbepoetin, middle=40 000 U epoetin α/δ or 30 000 U epoetin β or 100 μg darbepoetin, low=<40 000 U epoetin α/δ or 30 000 U epoetin β or 100 μg darbepoetin, other=weight based or Hb based.
a
P-value: refers to test for interaction unless otherwise specified.
b
Test for trend.
c
Not used for interaction/trend test.