Table 7.
Studies that explored HER2-blockade in SGCs and median age of study populations.
| First Author | Year | N. pts | HER2-blockade | Median age (range) | ORR (%) | Survival outcomes |
|---|---|---|---|---|---|---|
|
Agulnik (162) Phase II trial |
2007 |
20 ACC 19 non-ACC |
Lapatinib 1500 mg daily | 52 (38 – 72) 64 (45 – 80) |
0 (36% SD) | NA |
|
Limaye (163) Retrospective study |
2013 |
5
SDC HER2 3+ |
TCH scheme: • Trastuzumab* • Carboplatin AUC 5-6 q21 • Paclitaxel 175 mg/sqm q21 ChT given up to 6 cycles and trastuzumab until PD |
63 (51 – 82) |
100%
n.4 PR n.1 CR (at 15 months) |
DoR=8–18 months Patient with CR withdrawed trastuzumab after 2 years (NED) and started active surveillance |
|
Takahashi (164) Phase II trial |
2019 |
57
Prior systemic therapy allowed |
• Trastuzumab*
• Docetaxel 70 mg/sqm q21 |
57 (38 – 82) |
70%
14% CR 32% PR |
mPFS=9 months |
|
Kurzrock (165) Phase IIa basket trial MYPATHWAY (NCT02091141) |
2020 |
15
SGCs Prior systemic therapy allowed |
• Trastuzumab*
• Pertuzumab** |
59 (37 – 80) |
60%
n.8 PR n.1 CR |
mDoR=9.2 months mPFS=8.6 mos |
|
Swed (166) Retrospective study Single institution |
2019 |
7
(6/7 = 86% pretreated with trastuzumab) |
T-DM1*** | 58 (45 – 67) |
[86%] n.3 CR (43%) n.3 PR (43%) n.1 mixed |
4/6 (67%) had a duration of treatment > 10 months |
|
Li (167) Phase II basket trial (NCT02675829) |
2019 |
10
Pretreated with HER2-blockade (Trastuzumab, Pertuzumab) |
T-DM1*** | 65 (36 – 90) |
90%
n.5 CR after prior HER2-blockade |
mDoR and mPFS not reached at a median FUP of 12 months (range 4 – 20) |
| HER2 amplification was identified by NGS and tumors were subsequently tested by FISH and IHC. HER2 amplification by NGS (fold change 2.8 to 22.8) correlated with HER2/CEP17 ≥ 2 by FISH (8/8 tested) or IHC 3+ (10/10 tested). | ||||||
|
Jhaveri (168) Phase II trial NCI-MATCH subprotocol Q |
2019 |
3
Prior systemic therapy allowed (no prior HER2 blockade) |
T-DM1*** | NR 64 (39 – 80) referred to the trial cohort |
[67%] n.2 PR |
6-months PFS = 23.6% DoR=24 months for a SCC of the parotid and 9 months for a MEC of the parotid |
| Eligible patients had HER2 amplification at a copy number (CN) >7 based on targeted NGS with a custom Oncomine AmpliSeq™ (ThermoFisher Scientific) panel. | ||||||
|
Tsurutani (169) Phase I study |
2020 |
8
Pretreated with HER2-blockade |
T-DXd
Tested in 3 groups: non-small cell lung cancers, colorectal cancers and other cancers (including n.8 SGCs) |
NR 58 (44 – 76) referred to the group of other cancers |
SGCs among the histologies with promising tumor shrinkage | mDoR not reached (95% CI, 3.0–not reached). mPFS = 11.0 months (95% CI, 2.8–NE) referred to the group of other cancers |
*Trastuzumab standard dose: loading dose of 8 mg/kg i.v. followed by 6 mg/kg i.v. every 3 weeks; **Pertuzumab 840 mg i.v. loading dose, followed by 420 mg i.v. every 3 weeks (q3w); ***T-DM1 = Ado-trastuzumab emtansine, 3.6 mg/kg i.v. every 3 weeks; T-DXd, Trastuzumab-deruxtecan; MEC, mucoepidermoid carcinoma; SCC, squamous cell carcinoma; NR, not reported. NA, Not Available.