Table 2.
Molecular screening studies.
| Author/Study | Type of Metastatic Tumor (n, %) |
Enrolled Patients (n) | Evaluable Patients (n) | Patients with Actionable Alterations (n, %) |
Patients Receiving Targetable Therapies (n, %) |
Results |
|---|---|---|---|---|---|---|
| Massard et al. [27]/ Moscato-01 |
solid tumors (breast: 135, 14%) |
948 | 843 | 411, 49% | 199, 27% | PFS2/PFS1 > 1.3. Sixty-three out of 948 pts (7%) benefited in PFS. |
| Andrè et al. [28]/ Safir01/UNICANCER |
breast (423, 100%) |
423 | 297 | 195, 66% | 55, 19% | Four out of 43 patients (9%) had an objective response. Nine (21%) had stable disease for more than 16 weeks. |
| Pezo et al. [29] | breast (483, 100%) |
483 | 440 | 203, 46% | 15% | No difference in median time on treatment between patients treated with matched therapies and those with unmatched therapies (3.6 vs. 3.8 months, p = 0.89). |
| Pernas et al. [30]/ SOLTI-1301 AGATA |
breast (305, 100%) |
305 | 260 | 123, 47% | 13, 5% | Among 13 patients, 46.2% had PFS ≥ 6 months with combination therapy. |
| Parker et al. [31] | breast (43, 100%) |
43 | 40 | 17, 42% | 17, 42% | PFS was significantly worse for patients receiving a therapy not matched with the identified genomic alteration. |
| Walter et al. [32] | breast (52, 100%) |
52 | 52 | 45, 87% | 22, 42% | - |
| Aftimos et al. [33]/ AURORA |
breast (381, 100%) |
381 | 88% | 51% | 7% | - |
| Le Tourneau et al. [34]/ SHIVA |
solid tumor (breast: 59, 20%) |
741 | 741 | 293, 39.5% | 195, 26% | The use of targeted drugs did not statistically significantly improve PFS (HR = 0.88; p = 0.41). |
| Andrè et al. [35]/ SAFIR02-BREAST and SAFIR-PI3K |
breast (1462, 100%) |
1462 | 238 | 115, 48% | - | Median PFS was 9.1 and 2.8 months in the targeted therapy and chemotherapy arms, respectively (HR = 0.41; p < 0.001). |
| Hlevnjak et al. [36]/ CATCH |
breast (200, 100%) |
200 | 128 | 64, 50% | 53, 41% | Twenty-one out of 53 patients (40%) achieved stable disease (n = 13.25%) or partial response (n = 8.15%). Sixteen (30%) of those patients showed PFS improvement of at least 30% during MTB-recommended treatment compared to PFS of the previous line of treatment. |
| Bruzas et al. [37] | breast (95, 100%) |
95 | 83 | 63, 76% | 30, 36% | The ratio of PFS in NGS-based therapy to PFS in the last line of standard therapy before NGS was >1.3 of 13 (43.3%) patients, indicative of a clinical benefit to NGS-directed therapy. The one-year overall survival rates were 22.7% in the 65 patients assigned to standard therapy compared with 62.9% in the 30 patients who received combination therapy. |
| Fukada et al. [38] | 310 (breast: 37, 100%) |
37 | 35 | 30, 86% | 9, 26% | - |
| Turner et al. [39]/ plasmaMATCH |
breast (1051, 100%) |
1051 | 1034 | - | Cohort A: 74, 7.2% Cohort B: 20, 1.9% Cohort C: 18, 1.7% Cohort D: 19, 1.8% |
Five (25%) of 20 patients in cohort B and four (22%) of 18 patients in cohort C having a response. Six (8%) of 74 in cohort A and two (11%) of 19 patients in cohort D having a response. |
| van Geelen et al. [40] | breast (322, 100%) |
322 | 234 | 171, 73% | 74, 32% | Patients with a higher number of mutations had significantly worse overall survival. |
| Botticelli et al. [24]/ ROME |
solid tumor (breast: 62, 6.3%) |
62 | 62 | 34, 55% | 28, 45% | Germline mutations have been identified in patients with no prior indication for germline testing. |
PFS: progression-free survival; PFS2: progression-free survival on therapy decided by MTB; PFS1: progression-free survival on therapy before that decided by MTB; MTB: molecular tumor board; NGS: next-generation sequencing.