Abstract 4036
Background
Patients (pts) not candidates to platinum-based therapies have limited therapeutic options. The addition of P to PTX followed by RT + P may be an alternative to platinum-based therapy. This study aimed to evaluate the activity of P + PTX as induction treatment (Tx) in pts with LAHNC.
Methods
Phase II, single arm, multicenter study, in pts≥18 years with CT/RT-naive stage III-IVb LAHNC not candidates to aggressive Tx. All pts received PTX (80 mg/m2/week [w]) + P (6 mg/kg every 2w) during 9w as induction Tx followed by P and RT (70 Gy/35 fractions/7w).The primary endpoint was RR after induction Tx. With a Simon’s two stage design, p1 at the end of the study was defined as > 36 of 61 patients achieving complete (CR) or partial response (PR) to induction Tx.
Results
The study included 51 pts: median 70 years (range 45-84), 98% men. Reasons for cisplatin ineligibility: > 70 years old in 3 pts, mild or moderate adult comorbidity [ACE-27 comorbidity index] in 46 pts, severe adult comorbidity in 1 pt and ECOG: 2 in 1 pt. RR after induction was 66.7% (95% confidence interval [CI]: 53.7-79.6): 8 (15.7%) CR and 26 (51.0%) PR. Median progression-free survival was 12.2 months (m) (95% CI: 7.6 - 35.0] and median overall survival was 31.5 m (95%: 14.3 - not reached) with a median duration of follow-up of 31.9 m (range, 1-61). Incidence of grade 3/4 P and/or PTX-related Adverse Events (AEs) was 72.5%. Most frequent grade 3/4 P and/or PTX- related AEs (>5% of pts) were: 5.9% dermatitis, 5.9% neutropenia, 5.9% dry mouth, 5.9% stomatitis, 7.8% asthenia, 15.7% eruption, 15.7% skin toxicity and 27.5% mucosal inflammation. Five (9.8%) pts had fatal AEs, 2 (3.9%) of them related to P and/or PTX.
Conclusions
Despite the study ended prematurely, the RR observed is higher than the pre-specified boundary to consider the treatment active to justify further studies. PTX combined with P as induction Tx provide a clinically significant benefit with an acceptable safety profile.
Clinical trial identification
2012-003038-17.
Editorial acknowledgement
Marta Muñoz-Tudurí (TFS, S.L.).
Legal entity responsible for the study
Study carried out by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC).
Funding
Amgen S.A.
Disclosure
J. Martinez Trufero: Advisory / Consultancy: PharmaMar, Merck, Lilly, Eisai, Bristol-Myers; Honoraria (self), Medical meetings sponsor: PharmaMar, Merck, Lilly, Eisai. R. Mesia Nin: Advisory / Consultancy: Merck, BMS, MSD, AZ, Roche, Nanobiotix; Speaker Bureau / Expert testimony: Merck, BMS, MSD. M. Taberna Sanz: Non-remunerated activity/ies: Merck; Non-remunerated activity/ies: AstraZeneca; Honoraria (self): Merck; Honoraria (self): Nanobiotics; Honoraria (self): MSD; Honoraria (self): Bristol Myers. J. Lambea Sorrosal: Honoraria (self), Advisory / Consultancy, Speaker Bureau / Expert testimony: Merck-Serono, MSD, Bristol. All other authors have declared no conflicts of interest. L. Iglesias: Honoraria (self), Advisory / Consultancy: Merck Serono, MSD, BMS, Bayer, Sanofi; Honoraria (self), medical education with honoraria: Merck Serono, MSD, AstraZeneca y BMS; Research grant / Funding (institution): Merck Serono, MSD, AstraZeneca, BMS, Novartis, Kura Oncology, Sanofi y Kura Oncology. P. Perez Segura: Speaker Bureau / Expert testimony: BMS, Merck. J.J. Cruz-Hernández: Honoraria (self): Amgen, AstraZeneca, Bristol-Myers Squibb, Novartis, Pfizer, Roche; Advisory / Consultancy, Advisory Board: Bristol-Myers Squibb, Merck, MSD, Roche, Pfizer, Janssen Cilag; Advisory / Consultancy, Consulting: Roche.
Resources from the same session
3630 - Results of phase 1 clinical trial of high doses of Seleno-L-methionine (SLM) in sequential combination with Axitinib in previously treated and relapsed clear cell renal carcinoma (ccRCC) patients
Presenter: Yousef Zakharia
Session: Poster Display session 3
Resources:
Abstract
2356 - Safety and Efficacy of CDX-014 , an Antibody-Drug Conjugate against T Cell immunoglobulin mucin-1 (TIM-1), in advanced Renal Cell Carcinoma
Presenter: Bradley McGregor
Session: Poster Display session 3
Resources:
Abstract
1028 - SPAZO2 (SOGUG): Outcomes and prognostic significance of IMDC intermediate prognosis subclassification in metastatic renal cell carcinoma (mRCC) in patients treated with 1st-line pazopanib (1stPz).
Presenter: Begona P. Valderrama
Session: Poster Display session 3
Resources:
Abstract
2293 - Effect of Antacid Intake on the Therapeutic Efficacy of Sunitinib (SUN) in Metastatic Renal Cell Carcinoma (mRCC) Patients (pts): a Sub-Analysis of the STAR-TOR Registry
Presenter: Katrin Schlack
Session: Poster Display session 3
Resources:
Abstract
1451 - Randomized phase 3 trial of avelumab + axitinib vs sunitinib as first-line treatment for advanced renal cell carcinoma: JAVELIN Renal 101 Japanese subgroup analysis
Presenter: Motohide Uemura
Session: Poster Display session 3
Resources:
Abstract
4399 - Overall and progression-free survival according to MSKCC scores in 1st line sunitinib treatment of metastatic renal cell carcinoma (mRCC)
Presenter: Jindrich Finek
Session: Poster Display session 3
Resources:
Abstract
1344 - Combination therapy with checkpoint inhibitors for first-line treatment of advanced renal cell carcinoma: A systematic review and meta-analysis of randomized controlled trials
Presenter: Kyaw Thein
Session: Poster Display session 3
Resources:
Abstract
3462 - A phase II trial of TKI induction followed by a randomized comparison between nivolumab or TKI continuation in renal cell carcinoma (NIVOSWITCH)
Presenter: Viktor Grünwald
Session: Poster Display session 3
Resources:
Abstract
5268 - Nivolumab (N) treatment beyond progression in a real-world cohort of patients (pts) with metastatic renal cell carcinoma (mRCC)
Presenter: Sophie Hans
Session: Poster Display session 3
Resources:
Abstract
4235 - First results of safety profile of nivolumab (NIVO) in combination with stereotactic body radiotherapy (SBRT) in II and III line of patients (pts) with metastatic renal cell carcinoma (mRCC) in NIVES Study
Presenter: Cristina Masini
Session: Poster Display session 3
Resources:
Abstract