Table 5.
Phases I/II trials evaluated the triplets and sequential regimens
| Authors | Treatments | Trial phase | No | Efficacy | Toxicity |
|---|---|---|---|---|---|
| Bellmunt et al [47] | CPG | I/II | 58 | ORR = 77.6%; CR = 27.6%; PR = 50%; OS = 24 months. | Hematological+++ (Grade 3/4 neutropenia and thrombocytopenia in 55% and 22%, respectively) |
| Bajorin et al [49] | ITP | II | 44 | CR = 23%.; PR = 45%.; OS = 20 months. | Well tolerated |
| Hussain et al [50] | CaPG | II | 49 | CR = 32%; PR = 36%; OS = 14.7 months; 1 years survival = 59% | Hematological+++ |
| Hainsworth et al [51] | CaPG | II | 60 (7% in 2nd line) | ORR = 43%; CR = 12%; OS = 11 months; | Hematological+++ (10% of febril neutropenia) One toxic death |
| Edelman et al [52] | M-CaP (GCSF) | I/II | 33 | ORR = 56%; OS = 15.5 months. | Hematological and neuropathy |
| Tu et al [53] | M-CP | II | 25 (2nd line) | PR = 40%; CR = 0% | Acceptable |
| Law et al [54] | M-GP | II | 20 | ORR = 45% (CR = 6; PR = 3); OS = 18 months; PFS = 6.3 months | Neutropenia+++ (1 toxic death) |
| Pectasides et al [55] | EDC | II | 30 | ORR = 66.7% (CR = 30%; PR = 36.7%); OS = 14.5 months. | Hematological (4 episodes of febril neutropenia) |
| Milowsky MI et al [56] | AG → ITP with GCSF | II | 60 | ORR = 73% (CR = 35% and PR = 38%); PFS = 12.1 months; OS = 16.4 months | Myelosupression (grade 3-4): 68% Febril neutropenia (25%) |
| Galsky MD et al [57] | AG → ITCa with GCSF | I/II | 21 | ORR = 56% (CR = 5; RP = 9) | Myelosupression (grade 3-4): 28% Febril neutropenia: 8% |
Abbreviations. ITP: ifosfamide-paclitaxel-cisplatin; CPG: cisplatin-paclitaxel-gemcitabine; CaPG: carboplatin-paclitaxel-gemcitabine; M-CaP: methotrexate-carboplatin-paclitaxel; M-CP: methotexate-cisplatin-paclitaxel; M-GP: methotrexate-gemcitabine-paclitaxel; EDC: epirubicin-docetaxel-cisplatin; AG: doxorubicin-cisplatin; ITCa: ifosfamide-paclitaxel-carboplatin; CR: complete response; PR: partial response; ORR: objective response rate; OS: overall survival; PFS: progression free survival.