Table 1.
Characteristics of the five eligible trials.
| Study | Regimen of taxanes | Combined Agent | Premedication | GCSF prophylaxis | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Author, year | Phase | Trial Design | PatientPopulation | Arms | dose [mg/m2], frequency | Cycle | Patient NumberCohort (Safety) | ||||||
| Planned | Median | ||||||||||||
| Jones et al., 2005 (5) |
3 | Randomized Open-label Multi-center |
Locally advanced, Metastatic |
2 | D | 100 | Q3W | Until PD | 6 | 225 (222) | Nil | Dexamethasone | Primary: Not specified Secondary: Yes |
| P | 175 | Q3W | 4 | 224 (222) | Dexamethasone + Diphenhydramine + Ranitidine/Cimetidine | ||||||||
| Cassier et al., 2008 (17) |
3 | Randomized Open-label Multi-center |
Metastatic | 2 | D | 75 | Q3W | 8 | 8 | 107 (72) | Doxorubicin (last four cycles) |
Not specified | Primary: (at baseline) D: 9.3%; P 10.7% |
| P | 175 | Q3W | 8 | 8 | 103 (77) | ||||||||
| Kelly et al., 2012 (21) |
3 | Randomized Open-label Single-center |
Adjuvant | 2 | D | 75 | Q3W | 4 | NA | 300 (292) | Capecitabine | Not specified | Not specified |
| P | 80 | QW | 12 | 301 (297) | Nil | ||||||||
| Swain et al., 2013 (22) |
3 | Randomized Multi-center |
Adjuvant | 3 | D | 75 | Q3W | 6 | NA | 1630 (1607) | doxorubicin + cyclophosphamide | Not specified | Primary prophylaxis for all patients |
| P | 175 | Q2W | 4 | 1634 (1623) | |||||||||
| P | 175 | Q2W | 4 | 1630 (1612) | |||||||||
| Watanabe et al., 2017 (23) |
3 | Randomized Open-label Multi-center |
Adjuvant | 4 | D | 75 | Q3W | 4 | NA | 265 (263) | Doxorubicin + Cyclophosphamide | Not specified | Not specified |
| 75 | Q3W | 8 | 265 (261) | Nil | |||||||||
| P | 175 | Q3W | 4 | 263 (262) | Doxorubicin + Cyclophosphamide | ||||||||
| 175 | Q3W | 8 | 267 (263) | Nil | |||||||||
D, docetaxel; P, paclitaxel.
For Jones et al., there was no combined chemotherapy. For Cassier et al., both groups combined taxane with doxorubicin in the last four cycles. For Kelly et al., the docetaxel group was combined with capecitabine. For Swain et al., all the three groups were combined with doxorubicin and cyclophosphamide. For Watanabe et al., Two of the groups took doxorubicin and cyclophosphamide.
In the docetaxel group, 90% of the patients received preplanned number of treatment cycles (Q3W for 4 cycles); In the paclitaxel group, 86% received preplanned number of treatment cycles (QW for 12 cycles).
NA, not available.