Table 2.

Overview of the screening cohort with different ALK tests and clinical outcome in 29 patients with stage IV NSCLC treated with crizotinib

PatientALK-IHCFISH, %CopiesRT-PCRResponsePFS, moOS, moVariants in EML4/ALK-RT-PCR
1+45N/A+PR12.018.3var 1
2N/A15N/APD1.413.9
3+15ER+aPR6.813.8E20; A20-var 2
4+21+PR15.947.5E6; A20-var 3
5+61–4N/APR5.05.8
6+781–2; ER+PR9.524.5E6; A20-var 3
7+691–3N/APR39.039.0
8N/A52ERPD1.62.4
925b1–2PD0.20.9
10+551–2N/ASD9.614.2
11+59N/AN/APR22.031.0
1222N/AN/APD3.510.1
13352–4N/APD1.916.1
14+471–2+PR8.431.5E6; A20-var 3
1515N/AN/APD1.02.1
16+64ER+PR4.118.9E6; A20-var 3
17N/A201N/APD1.53.1
1835ERN/APD0.50.5
1964ERN/APD2.611.2
20+471N/APD1.61.9
21+c121N/APD1.12.5
22211N/APD2.05.0
23191N/APD1.35.3
24+401N/APD0.90.9
25171N/APD1.54.6
26181N/APD0.74.4
27661N/APD0.74.8
28411N/APD1.85.2
29161N/APD1.16.0
  • NOTE: Dichotomous ALK-IHC is called either positive or negative and N/A means no neoplastic cells in the available pretreatment biopsy; ALK-FISH is positive if >15% of 100 counted neoplastic nuclei show the defined break-apart patterns.

  • Abbreviations: ER, extra red (5′ allele); PD, progressive disease; PR, partial response; SD, stable disease.

  • aALK translocation confirmed by RNA seq (Saber and colleagues; ref. 30).

  • bALK-FISH–positive (ALK-IHC not tested in 2012) in a very small area of tumor tissue (<2%), the largest part of tumor is ALK-FISH, ALK-IHC, and EML4/ALK-RT-PCR–negative.

  • cDichotomous ALK-IHC shows heterogeneous immunostaining of positive and negative neoplastic cells (see Fig. 2B).