Table 6.
Phase II trials evaluating the role of targeted therapies
| Organisations | Treatments | Trial phase | Line | No | Results | Most common grades 3-4 toxicities |
|---|---|---|---|---|---|---|
| Hoosier Oncology Group [66] | GC + Bevacizumab | II | 1st | 43 | ORR = 72% (21% de; CR et 51% de RP); PFS = 8.2 months; OS = 20.4 months | Hematological, thromboembolism |
| USA (Texas) [70] | GC + sunutinib | II | 1st | 15 | Interrupted for toxicity | Hematological++ |
| Espagne [71] | Sunitinib | II | 1st | 37 | DC = 8%; PFS = 5.9 months | Fatigue, Hypertention, Hand-Foot syndrom |
| Allemagne [73] | GC + sorafenib | IIR | 1st | 85 | ORR = 82% vs. 78%; PFS = 6.3 mois vs. 7.2 months | Hematological |
| NCI Trial [79] | Trastuzumab + CaPG | II | 1st | 44 (HER2+++) | ORR = 70% (11% de CR et 59% de RP); OS = 14 months | Hematological, sensory neuropaty, cardiac |
| CALGB [81] | Gefitinib + GC | II | 1st | 58 | ORR = 48%,; PFS = 7 months,; OS = 15 months; Equivalents results to GC et MVAC | Hematological, skin rash, diarrhea, |
| Allemagne [82] | Lapatinib | II | 2nd and more | 59 | PR = 3%; S = 12%; PFS = 8.6 weeks | Diarrhea, vomiting, dehydration |
| Italy and USA [84] | Everolimus | II | 2nd | 45 | PR = 8%; PFS = 3.3 months; OS = 10.5 months | Hematological, fatigue, metabolic, mucositis |
Abbreviations. GC: gemcitabine-cisplatin; ORR: objective response rate; RC: complate response; PR: partial response; S: stabilisation; DC: disease control; PFS: progression free survival; OS: overall survival; CaPG: paclitaxel-gemcitabine-carboplatin.