Table 3. Stratified analyses for FACT-An 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-An | 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 |
14/1466/1299 |
4.09 (2.37 to 5.80) |
|
11/1310/1126 |
4.50 (2.55 to 6.45) |
|
3/413/308 |
4.55 (1.29 to 7.80) |
|
| Anticancer treatment |
|
|
0.709 |
|
|
NA |
|
|
NA |
| Chemotherapy | 11/1310/1126 | 4.50 (2.55 to 6.45) | 11/1310/1126 | 4.50 (2.55 to 6.45) | 3/413/308 | 4.55 (1.29 to 7.80) | |||
| Radiotherapy | 1/126/133 | 1.60 (−2.24 to 5.44) | — | — | — | — | |||
| None | 1/14/20 | 3.90 (−4.56 to 12.36) | — | — | — | — | |||
| Unclearb |
1/16/20 |
−0.60 (−9.64 to 8.44) |
|
— |
— |
|
— |
— |
|
| Anticancer treatment (condensed) |
|
|
0.458 |
|
|
NA |
|
|
NA |
| Chemotherapy | 11/1310/1126 | 4.50 (2.55 to 6.45) | 11/1310/1126 | 4.50 (2.55 to 6.45) | 3/413/308 | 4.55 (1.29 to 7.80) | |||
| Radiotherapy, none | 2/140/153 | 1.99 (−1.50 to 5.49) | — | — | — | — | |||
| Unclearb |
1/16/20 |
−0.60 (−9.64 to 8.44) |
|
— |
— |
|
— |
— |
|
| Baseline Hb |
|
|
0.389 |
|
|
0.567 |
|
|
0.695 |
| >12 g dl–1 | 4/511/514 | 1.64 (−0.09 to 3.36) | 3/385/381 | 1.91 (−0.58 to 4.39) | 1/40/42 | 6.40 (0.81 to 11.99) | |||
| 10–12 g dl–1 | 7/540/477 | 5.89 (3.31 to 8.48) | 5/510/437 | 6.57 (3.83 to 9.31) | — | — | |||
| <10 g dl–1 |
3/415/308 |
3.76 (0.87 to 6.64) |
|
3/415/308 |
3.76 (0.87 to 6.64) |
|
2/373/266 |
4.14 (0.08 to 8.19) |
|
| Baseline Hb (condensed) |
|
|
0.087 |
|
|
0.137 |
|
|
0.695 |
| >12 g dl–1 | 4/511/514 | 1.64 (−0.09 to 3.36) | 3/385/381 | 1.91 (−0.58 to 4.39) | 1/40/42 | 6.40 (0.81 to 11.99) | |||
| ⩽12 g dl–1 |
10/955/785 |
5.09 (2.89 to 7.29) |
|
8/925/745 |
5.44 (3.04 to 7.83) |
|
2/373/266 |
4.14 (0.08 to 8.19) |
|
| Disease stage |
|
|
0.06c |
|
|
0.064c |
|
|
0.277c |
| >70% not metastatic/advanced | 2/208/212 | 6.55 (4.05 to 9.06) | 2/208/212 | 6.55 (4.05 to 9.06) | 1/40/42 | 6.40 (0.81 to 11.99) | |||
| >70% metastatic/advanced | 7/741/661 | 2.14 (1.01 to 3.28) | 5/711/621 | 2.15 (0.98 to 3.32) | 1/173/176 | 2.40 (0.84 to 3.96) | |||
| Other | 3/254/273 | 5.50 (−1.43 to 12.43) | 2/128/140 | 7.85 (0.03 to 15.67) | — | — | |||
| Unknownb |
2/263/153 |
5.36 (2.39 to 8.34) |
|
2/263/153 |
5.36 (2.39 to 8.34) |
|
1/200/90 |
6.60 (2.83 to 10.37) |
|
| Frequency |
|
|
0.992c |
|
|
0.801c |
|
|
0.64c |
| QW | 5/409/424 | 4.11 (0.96 to 7.25) | 4/395/404 | 4.16 (0.55 to 7.76) | 1/40/42 | 6.40 (0.81 to 11.99) | |||
| TIW |
9/1057/875 |
4.09 (1.84 to 6.34) |
|
7/915/722 |
4.73 (2.10 to 7.36) |
|
2/373/266 |
4.14 (0.08 to 8.19) |
|
| Target Hb |
|
|
0.25 |
|
|
0.201 |
|
|
NA |
| >13–15 g dl–1 | 12/1279/1107 | 4.52 (2.63 to 6.41) | 9/1123/934 | 5.10 (2.92 to 7.29) | 3/413/308 | 4.55 (1.29 to 7.80) | |||
| ⩽13 g dl–1 |
2/187/192 |
1.13 (−1.22 to 3.47) |
|
2/187/192 |
1.13 (−1.22 to 3.47) |
|
— |
— |
|
| Placebo control |
|
|
0.985 |
|
|
0.912 |
|
|
NA |
| Yes | 5/443/348 | 3.91 (1.49 to 6.32) | 3/413/308 | 4.55 (1.29 to 7.80) | 3/413/308 | 4.55 (1.29 to 7.80) | |||
| No |
9/1023/951 |
4.12 (1.67 to 6.56) |
|
8/897/818 |
4.46 (1.74 to 7.17) |
|
— |
— |
|
| QoL primary end point |
|
|
0.471 |
|
|
0.489 |
|
|
NA |
| Yes | 7/568/591 | 4.69 (1.48 to 7.91) | 5/538/551 | 5.29 (1.58 to 9.00) | — | — | |||
| No |
7/898/708 |
3.21 (1.53 to 4.90) |
|
6/772/575 |
3.55 (1.60 to 5.50) |
|
3/413/308 |
4.55 (1.29 to 7.80) |
|
| Source of data |
|
|
0.229 |
|
|
0.24 |
|
|
0.259 |
| Full publication | 7/652/469 | 5.71 (4.02 to 7.39) | 5/622/429 | 6.02 (4.27 to 7.77) | 2/240/132 | 6.54 (3.41 to 9.66) | |||
| Clinical study report |
7/814/830 |
3.18 (0.72 to 5.64) |
|
6/688/697 |
3.48 (0.63 to 6.33) |
|
1/173/176 |
2.40 (0.84 to 3.96) |
|
| Study industry funded |
|
|
0.864 |
|
|
0.777 |
|
|
NA |
| Yes | 13/1403/1236 | 4.13 (2.30 to 5.97) | 10/1247/1063 | 4.61 (2.50 to 6.72) | 3/413/308 | 4.55 (1.29 to 7.80) | |||
| No | 1/63/63 | 3.50 (−1.15 to 8.15) | 1/63/63 | 3.50 (−1.15 to 8.15) | — | — | |||
Abbreviations: CI=confidence interval; ESA=erythropoiesis-stimulating agents; FACT-An=Functional Assessment of Cancer Therapy-Anaemia 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
Not used for interaction/trend test.
c
Test for trend.