Table 1.

Patient characteristics

At treatment initiation
PatientSexPrimary tumor originHLA-A2 pos/negBRAF statusPrevious treatmentsTime from diagnosis to ACT (y)aAgePSAJCC stageTarget lesion sum (cm)CNS MetsLDH levelMetastatic sites
Responders, OR (n = 10)
 M15FSkinnegwtIL2/IFNα4.1480M1b5.7NoNormalLN, lung
 M17MSkinnegwtIL2/IFNα, Ipi15.3490M1c3.7NoNormalLN, mesentery
 M20FSkinnegwtIL2/IFNα, Ipi, Tem11.6650M1c21.3NoNormalSC, IM, lung
 M22FSkinnegwtIL2/IFNα, Ipi3.9601M1c9.7NoElevatedSC, lung, IM, pleura, intestines, bone
 M24MSkinposV600EIL2/IFNα, Vem1.8560M1a1.9NoNormalLN
 M26MSkinposBRAF delIpi6.6461M1c34.2NoElevatedSC, muscle, intestines, peritoneal carcinosis
 M31MMucosanegwtIL2/IFNα, Ipi1.6651M1c16NoElevatedSC, LN, lung, kidney, peritoneal carcinosis, bone
 M36FSkinnegV600EIL2/IFNα, Ipi, Vem10.9401M1c7.8NoElevatedLN, IA
 M42FSkinnegV600EIL2/IFNα, Ipi2.8680M1c15.3NoElevatedSC, LN, lung, bone
 M45MUnknownnegV600KIL2/IFNα, Ipi, Vem1.6562M1c34.2YesElevatedIM, adrenal, IA
Median (range)2 (1–4)4 (1.6–15.3)56 (40–68)12.5 (1.9–34.2)2 (1–6)
n (%)5 (50)b8 (80)c2 (20)d5 (50)e8 (80)f1(10)6 (60)g
Nonresponders, NR (n = 14)
 M14FUnknownnegwtIL2/IFNα, Tem, Ipi, DC2.3430M1c21.2NoElevatedLN, IM, lung, pleura, adrenal, mesentery, bone
 M16MSkinposV600EIL2/IFNα, Ipi8.5600M1c20NoNormalSC, LN, pleura
 M18MSkinposwtIL2/IFNα, Ipi7.6511M1c19.3NoElevatedSC, LN, IM, lung, IA, adrenal
 M25MSkinnegV600EIL2/IFNα, Ipi4.5250M1b11.2NoNormalLN, lung
 M27FSkinnegV600EIL2/IFNα, Vem2.7620M1c17.8NoElevatedSC, LN, IM, lung, kidney, mesentery, bone
 M29FSkinposV600EIL2/IFNα, DC, Ipi, Vem6.6523M1c5.7NoNormalSC, LN, lung, bone
 M34FMucosanegwtIL2/IFNα, Ipi, Tem2.8461M1c12.1NoElevatedLN, lung, liver, pancreas
 M35FSkinnegV600EIL2/IFNα, Ipi, Vem19.7460M1c10.3YesNormalSC, IM, bone, brain
 M37FSkinposV600EIL2/IFNα, Ipi3.4360M1c15.6YesElevatedLN, IA
 M40MSkinnegV600EIL2/IFNα, Ipi4.0530M1c9.5YesNormalLN, lung, peritoneal carcinosis, brain
 M43FUnknownposwtIL2/IFNα, Tem0.8480M1c13.7NoElevatedLN, lung, bone
 M46FSkinnegV600EIL2/IFNα, Ipi5.6501M1c9.1NoElevatedLN
 M47FUnknownposwtIL2/IFNα, Ipi5.8630M1c16.8NoElevatedLN, lung, pleura, liver
 M51MSkinposwtIL2/IFNα, Ipi, Dac12.4550M1b5.5NoNormalLN, lung
Median (range)2 (2–4)5.1 (0.8–19.7)51 (25–63)12.9 (5.5–21.2)4 (1–7)
n (%)5 (36)b10 (71)c7 (50)d6 (43)e12 (86)f3 (21)8 (67)g
P (OR vs. NR)0.681.000.211.000.630.780.201.000.880.621.000.30
Not evaluable (n = 1)
 M50FSkinposV600EIL2/IFNα, BRAF inh.4,8491M1c8.8YesElevatedSC, LN, liver, brain
  • Abbreviations: BRAF del, BRAF deletion; BRAF inh., BRAF inhibitor (experimental treatment, RO5212054/PLX3603); Dac, Dacarbazine; DC, dendritic cell vaccination (experimental treatment); F, female; HLA, human leukocyte antigen; IA, intra-abdominal; IM, intramuscular; LDH; lactate dehydrogenase; LN, lymph node; M, male; PS, performance status; SC, subcutaneous; Tem, Temozolomide; Vem, Vemurafenib; wt, wild type.

  • aTime from diagnosis to TIL treatment in years.

  • b% Male.

  • c% Skin.

  • d% HLA-A2 positive.

  • e% BRAF wild-type.

  • f% Stage M1c disease.

  • g% with elevated LDH level.