Skip to main content

Table 2 Major characteristics and clinical outcomes in patients receiving a phase I trial therapy (n = 27)

From: Characteristics and outcomes for patients with advanced vaginal or vulvar cancer referred to a phase I clinical trials program: the MD Anderson cancer center experience

Age Pathology Prior therapy OS BMI MDACC score Phase I trials PFS CMS46 or Foundation Med
Vaginal cancer
45 A 2 41.9 33.2 1 Bevacizumab and Temsirolimus 1.0 ND
81 S 0 5.8 21.9 0 Gemcitabine and Dasatinib 0.9 ND
61 M 4 2.0 23.0 3 PI3K Inhibitor and Paclitaxel 0.9 ND
59 A 3 4.8 37.8 2 Bevacizumab and Temsirolimus plus Carboplatin PFS1 = 1.4 ND
CHK1 Inhibitor PFS2 = 1.5
Erlotinib and Pralatrexate PFS3 = 2.2
53 S 2 12.9 18.6 0 Aurora Kinase Inhibitor 4.9 ND
57 S 1 1.8 22.9 2 Trientine and Carboplatin 0.7 PIK3CA (E545K)
57 S 0 28+ 21.3 1 Everolimus and Pazopanib PFS1 = 18.2 PIK3CA (E545K), PTPRD (S1845fs*2) and STK11 loss
PI3K Inhibitor PFS2 = 1.9
72 M 1 4.3 21.0 1 Ipilimumab and Imatinib 2.3 PTEN loss, C17orf39, KDR, KIT and MYST3 amplification
58 S 1 15+ 19.5 1 Erlotinib and Pralatrexate 14.6+ ERBB2 (S310F), ERBB4 (D609N), FBXW7 (R479Q), RB1 (E539*), ARID2 (Q1194*) and amplification of EPHBI, PIK3CA and SOX2
67 A 2 8.4 31.3 1 Anastrozole and Everolimus 2.6 PTEN (210-1G > A), KRAS (G12V), CTNNB1 (D32N), MPL (P106L), and amplification of MCL1, MYC and NFKB1A
52 S 1 7.1 24.0 0 Erlotinib and Valproic Acid 2.8 ND
Vulvar cancer
37 S 1 3.7 21.2 2 PI3K inhibitor plus Caboplatin and Paclitaxel PFS1 = 1.4 PIK3CA: mutation not detected
Erlotinib and Valporic acid PFS2 = 0.6
58 S 1 13.2 30.5 1 Erlotinib and Valporic acid PFS1 = 3.9 BRAF, KRAS and PIK3CA: no mutation detected
Bevacizumab and Cetuximab plus Erlotinib PFS2 = 7.2
74 S 1 6.4 23.7 1 Microtube Inhibitor 3.1 ND
60 M 6 4.4 22.3 2 PI3K Inhibitor 2.0 Single Gene: c-KIT (L576P)
42 S 1 2.0 23.7 1 Bevacizumab and Trastuzumab plus Lapatinib 0.7 ND
42 S 0 1.5 19.9 2 Src Inhibitor 0.5 ND
78 S 0 20.3 35.5 1 Erlotinib and Valporic Acid 6.1 ND
37 S 1 1.7 18.7 2 Camptothecin 0.8 ND
55 S 3 4.8 15.8 1 Histone Deacetylase Inhibitor 0.5 ND
41 S 0 2.2 18.8 2 Sirolimus and Docetaxel 1.7 ND
54 S 1 2.9 26.6 1 Lapatinib and Sirolimus 1.5 Single Gene: BRAF (V600E)
60 M 2 4.6 22.9 3 Multikinase Inhibitor 2.9 ND
69 S 1 22.6 30.9 2 Carboplatin and Trientine 0.9 A 46-gene panel: no mutation detected
33 S 1 10.0 24.8 2 Lenalidomide and Temsirolimus 1.9 ND
73 S 1 5.6 22.4 2 Crizotinib and Pazopanib 1.6 KRAS (R102T), TET2 (W1198*), TP53 (R248Q), and CDK2NA/B loss
55 M 1 3.4 24.2 2 Translation Initiation Inhibition 1.0 ND
  1. OS overall survival, BMI body mass index, MDACC score the sum of five variables (low serum albumin, high serum lactate dehydrogenase, ECOG performance status of 1 or higher more than two metastatic sites, and gastrointestinal tumor type), PFS progression-free survival (1, 2, or 3 indicates the first, second, or third line of phase I trial), * deletion , A adenocarcinoma, S squamous cell carcinoma, M melanoma, ND not done