Abstract 5753
Background
A phase II trial of trastuzumab plus docetaxel in patients with advanced HER2–positive salivary duct carcinoma (SDC) showed 70% of the overall response rate. However, biomarkers which predict survival in this population remain unknown.
Methods
A total of 91 patients with HER2–positive SDC treated with trastuzumab plus docetaxel were included. Age, sex, ECOG performance status (PS), status of visceral metastases, previous treatment, previous docetaxel exposure, previous combined androgen blockade, the best overall response to the treatment, pretreatment serum C-reactive protein (CRP) level, modified Glasgow Prognosis Score (mGPS), HER2 status (immunohistochemistry [IHC] score, HER2/CEP17 ratio, HER2 copy number, overall positivity according to ASCO/CAP Guidelines), mutational status of PIK3CA, HRAS, and TP53, IHC score of AR, Ki-67, CK5/6, p53, HER3, Akt, PI3K, FOXA1, adipophilin, mTOR and PTEN were assessed and correlated with progression-free survival (PFS) and overall survival (OS).
Results
Treatment response (PR or CR vs. SD or PD) and PTEN IHC score (1+ – 3+ vs. 0) were related with favorable PFS (hazard ratio [HR], 0.25 and 0.39, respectively) and OS (HR, 0.29 and 0.36, respectively). CRP (≥ 0.50 mg/dL) was related with shorter PFS (HR, 2.28) and OS (HR 4.46). Presence of previous treatment and mTOR IHC (1+ – 3+ vs. 0) had significant predictive value of better PFS (HR 0.47 and 0.22, respectively) but not significantly related with OS. ECOG PS of 1-2 (vs. 0), presence of visceral metastasis, and mGPS of 1-2 (vs. 0) had significant relationship with shorter OS but not with PFS. Neither previous docetaxel exposure nor previous combined androgen blockade did not affect the survival outcome. HER2, PIK3CA, HRAS and TP53 status did not related with survival.
Conclusions
Although HER2 status did not correlated with survival, its downstream factors PTEN and mTOR can serve as predictive biomarkers in patients with advanced SDC treated with trastuzumab plus docetaxel. Serum CRP level may predict survival of this population.
Clinical trial identification
UMIN000009437, Released on 03/12/2012.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
MEXT/JSPS.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4370 - Continental differences in pathologic response with neoadjuvant ipilimumab (IPI) plus nivolumab (NIVO) in patients with macroscopic stage III melanoma in the phase 2 OpACIN-neo trial.
Presenter: Irene Reijers
Session: Poster Display session 3
Resources:
Abstract
3230 - Comparable responses of melanoma at primary site and synchronous lymph node metastases upon neoadjuvant ipilimumab (IPI) and nivolumab (NIVO)
Presenter: Judith Versluis
Session: Poster Display session 3
Resources:
Abstract
3171 - Adjuvant Therapies for Stage III Melanoma: Benchmarks for Bringing Clinical Trials to Clinical Practice
Presenter: Tina HIEKEN
Session: Poster Display session 3
Resources:
Abstract
3493 - Mixture-cure modeling for resected stage III/IV melanoma in the phase 3 CheckMate 238 trial
Presenter: Jeffrey Weber
Session: Poster Display session 3
Resources:
Abstract
3036 - An open-label, non-randomized, phase IIIb study of trametinib in combination with dabrafenib for patients with unresectable advanced BRAFV600-mutant melanoma: a subgroup analysis of patients with brain metastasis
Presenter: Caroline Dutriaux
Session: Poster Display session 3
Resources:
Abstract
2233 - Adverse event (AE) kinetics in patients (pts) treated with dabrafenib + trametinib (D + T) in the metastatic and adjuvant setting
Presenter: Jean Jacques Grob
Session: Poster Display session 3
Resources:
Abstract
2435 - A Single Arm, Open Label, Phase II, Multicenter Study to Assess the Detection of the BRAF V600 Mutation on cfDNA from Plasma in Patients with Advanced Melanoma
Presenter: Piotr Rutkowski
Session: Poster Display session 3
Resources:
Abstract
1766 - Efficacy and Safety of Dabrafenib and Trametinib in Patients with Metastatic BRAFV600 Mutation-positive Melanoma in the Real-World Setting – Interim results of the non-interventional COMBI-r study
Presenter: Carola Berking
Session: Poster Display session 3
Resources:
Abstract
2131 - Trial update: A randomized Phase Ib/II study of the selective small molecule Axl inhibitor Bemcentinib (BGB324) in combination with either dabrafenib/trametinib (D/T) or pembrolizumab in patients with metastatic melanoma
Presenter: Oddbjørn Straume
Session: Poster Display session 3
Resources:
Abstract
4074 - Analysis of pyrexia in patients (pts) treated with dabrafenib (D) and/or trametinib (T) across clinical trials
Presenter: Caroline Robert
Session: Poster Display session 3
Resources:
Abstract