Trials involving exogenous TPO administration in chemotherapy-induced thrombocytopenia.
| Trial . | Form of exogenous thrombopoietin . | No. pts. . | Clinical setting . | Was administration of exogenous TPO deemed useful overall? . | Were platelet transfusions avoided? . | Were platelet nadirs less low? . | Were delays in chemotherapy administration or reduction in dose avoided? . |
|---|---|---|---|---|---|---|---|
| *Phase 1/2 study. | |||||||
| †Phase 3 study. | |||||||
| Abbreviations: PEG-rHuMGDF, pegylated recombinant human megakaryocyte growth and development factor; rhTPO, recombinant human thrombopoietin; AML, acute myeloid leukemia; ICE, ifosphomide, carboplatin, etoposide; ASCT, autologous stem cell transplantation; NR, not reported | |||||||
| Studies in nonmyeloablative chemotherapy regimens for solid tumors | |||||||
| Basser et al18 | PEG-rHuMGDF | 41 | Advanced cancer | Yes | NR | No | No |
| Fanucci et al19 | PEG-rHuMGDF | 53 | Lung cancer | Yes | NR | Yes | NR |
| Crawford et al20 | PEG-rHuMGDF | 40 | Lung cancer | Yes | Yes | Yes | NR |
| Basser et al21 | PEG-rHuMGDF | 68 | Advanced cancer | Yes | No | Yes | NR |
| Vadhan-Raj et al22 | rhTPO | 29 | Gynecological tumors | Yes | Yes | Yes | Yes |
| Vadhan-Raj et al32 | rhTPO | 66 | Sarcoma | Yes | Yes | Yes | NR |
| Angiolillo et al24 | rhTPO | 12 | Pediatric solid tumor | Yes | Yes | Yes | NR |
| Moskowitz et al62 | PEG-rHuMGDF | 41 | Relapsed and refractory aggressive non-Hodgkin lymphoma receiving ICE prior to ASCT | Yes | Yes | Yes | Yes |
| Studies in chemotherapy regimens for leukemia | |||||||
| Cripe et al25 | rhTPO | 28 | AML induction | No | NR | NR | NR |
| Archimbaud et al26 | PEG-rHuMGDF | 108 | AML induction, consolidation | No | No | No | NR |
| Schiffer et al28 | PEG-rHuMGDF | 57 | AML induction, consolidation | No | No | No | NR |
| Geissler et al27 | PEG-rHuMGDF | 88 | AML consolidation | No | No | No | NR |
| Studies in ablative chemotherapy prior to hematopoietic stem cell transplantation (HSCT) | |||||||
| Nash et al63 | rhTPO | 38 | Patients with delayed platelet recovery after HSCT | Kinetics of platelet recovery not dose related and therefore efficacy inconclusive. | NR | NR | NR |
| Wolff et al64 | rhTPO | 33 | after HSCT | Kinetics of platelet recovery not dose related and therefore efficacy inconclusive. | NR | NR | NR |
| Schuster et al31 | PEG-rHuMGDF | 75*/64† | Autologous HSCT in patients with breast cancer | Inconclusive | Yes in phase 1/2 No in phase 3 | NR | NR |
| Trial . | Form of exogenous thrombopoietin . | No. pts. . | Clinical setting . | Was administration of exogenous TPO deemed useful overall? . | Were platelet transfusions avoided? . | Were platelet nadirs less low? . | Were delays in chemotherapy administration or reduction in dose avoided? . |
|---|---|---|---|---|---|---|---|
| *Phase 1/2 study. | |||||||
| †Phase 3 study. | |||||||
| Abbreviations: PEG-rHuMGDF, pegylated recombinant human megakaryocyte growth and development factor; rhTPO, recombinant human thrombopoietin; AML, acute myeloid leukemia; ICE, ifosphomide, carboplatin, etoposide; ASCT, autologous stem cell transplantation; NR, not reported | |||||||
| Studies in nonmyeloablative chemotherapy regimens for solid tumors | |||||||
| Basser et al18 | PEG-rHuMGDF | 41 | Advanced cancer | Yes | NR | No | No |
| Fanucci et al19 | PEG-rHuMGDF | 53 | Lung cancer | Yes | NR | Yes | NR |
| Crawford et al20 | PEG-rHuMGDF | 40 | Lung cancer | Yes | Yes | Yes | NR |
| Basser et al21 | PEG-rHuMGDF | 68 | Advanced cancer | Yes | No | Yes | NR |
| Vadhan-Raj et al22 | rhTPO | 29 | Gynecological tumors | Yes | Yes | Yes | Yes |
| Vadhan-Raj et al32 | rhTPO | 66 | Sarcoma | Yes | Yes | Yes | NR |
| Angiolillo et al24 | rhTPO | 12 | Pediatric solid tumor | Yes | Yes | Yes | NR |
| Moskowitz et al62 | PEG-rHuMGDF | 41 | Relapsed and refractory aggressive non-Hodgkin lymphoma receiving ICE prior to ASCT | Yes | Yes | Yes | Yes |
| Studies in chemotherapy regimens for leukemia | |||||||
| Cripe et al25 | rhTPO | 28 | AML induction | No | NR | NR | NR |
| Archimbaud et al26 | PEG-rHuMGDF | 108 | AML induction, consolidation | No | No | No | NR |
| Schiffer et al28 | PEG-rHuMGDF | 57 | AML induction, consolidation | No | No | No | NR |
| Geissler et al27 | PEG-rHuMGDF | 88 | AML consolidation | No | No | No | NR |
| Studies in ablative chemotherapy prior to hematopoietic stem cell transplantation (HSCT) | |||||||
| Nash et al63 | rhTPO | 38 | Patients with delayed platelet recovery after HSCT | Kinetics of platelet recovery not dose related and therefore efficacy inconclusive. | NR | NR | NR |
| Wolff et al64 | rhTPO | 33 | after HSCT | Kinetics of platelet recovery not dose related and therefore efficacy inconclusive. | NR | NR | NR |
| Schuster et al31 | PEG-rHuMGDF | 75*/64† | Autologous HSCT in patients with breast cancer | Inconclusive | Yes in phase 1/2 No in phase 3 | NR | NR |