Abstract 678P
Background
Results from a phase II trial showed efficacy of CT plus weekly PX in patients (pts) with SCCHN who are medically unfit for platinum-based (PT) chemotherapy. This study aimed to validate the efficacy of the proposed combination as first-line treatment for recurrent/metastatic SCCHN pts in the real world.
Methods
This was a retrospective, non-interventional study in 16 centers in Spain. Inclusion criteria were: histologically confirmed SCCHN including oral cavity, oropharynx, hypopharynx and larynx; age ≥18 y; PT chemotherapy-ineligibility due to performance status (PS), comorbidities, high accumulated dose of PT or early disease progression after PT. Pts had received between 2012-2018 according to standard clinical practice at least one starting dose of both weekly PX 80 mg/m2 and CX (400mg/m2 loading dose, and then 250 mg/m2).
Results
The study enrolled 531 pts. The median age was 66 y (range: 35-92), 82.7% were male, 3% p16 positive, and 83.5% current/former smokers. The median duration of treatment was 3.5 m (95% CI: 3-4.1) for CX and 2.8 m (95% CI: 2.7-3.2) for PX. Response rate was 37.7%, with a median duration of response of 5.6 m (95% CI: 4.4-6.6). With a median follow-up of 8.7 m (95% CI: 7.7-10.2), the median PFS and OS were 4.5 m (95% CI: 3.9-5) and 8.9 m (95% CI: 7.8-10.3) respectively. Survival by subgroups is shown in the table. Most common any-grade toxicities leading to discontinuation or dosage reduction of treatment were acne-like rash (15.4%) and mucositis (6.6%). Table: 678P
| Pts group | N | Median PFS (95% CI) | Median OS (95%CI) | p-value PFS/OS | |
| Overall | 531 | 4.5 (3.9-5) | 8.9 (7.8-10.3) | - | |
| PT ineligibility | ECOG 2 | 267 | 3.9 (3.4-4.7) | 7.3 (6.5-8.5) | 0.004 / <0.001 |
| Comorbidities | 170 | 5.6 (4.3-6.8) | 11.1 (9.7-12.8) | ||
| PT ≥225 mg/m2 | 56 | 6.3 (3.9-8.4) | 15 (10.4-20.7) | ||
| PD ≤ 6 m | 38 | 2.8 (2.3-7.8) | 7.1 (4.2-12.7) | ||
| Baseline ECOG | 0 | 18 | 10.1 (5.1-NR) | 18.6 (13.8-42.6) | 0.002 / <0.001 |
| 1 | 246 | 5.2 (4-6.3) | 10.7 (9.4-12) | ||
| 2 | 267 | 3.9 (3.4-4.7) | 7.3 (6.5-8.5) | ||
| Subsequent treatments | Immunotherapy | 43 | 8.8 (5.6-11.3) | 29.8 (18.9-42.6) | 0.002 / < 0.001 |
| Other | 142 | 6 (5.3- 7.2) | 13.8 (12.7-16.3) | ||
| No | 341 | 3.4 (2.8-4) | 6 (5.1-6.6) |
NR, not reached.
Conclusions
This study confirms the efficacy and tolerability of CX-PX as first-line treatment in non-selected pts with recurrent/metastatic SCCHN in the real world. Pts with ECOG 2 pts do worse. Pts who received immunotherapy after treatment with CX-PX showed remarkable promising survival.
Clinical trial identification
NCT04672772.
Editorial acknowledgement
We acknowledge Mfar Clinical Research staff for their assistance in the development of this abstract.
Legal entity responsible for the study
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC).
Funding
This research was financially supported by the healthcare business of Merck KGaA, Darmstadt, Germany.
Disclosure
B. Cirauqui Cirauqui: Financial Interests, Personal, Invited Speaker: BMS; Financial Interests, Personal, Other, Training grant: BMS, MSD; Non-Financial Interests, Personal, Member: GEICAM, SEOM, SOLTI; Non-Financial Interests, Personal, Member, Board of directors: TTCC group. J. Martinez Trufero: Financial Interests, Personal, Advisory Board, Advisory Board meeting: Eisai, PharmaMar; Financial Interests, Personal, Invited Speaker: Eisai, Medicamenta, Merck, Roche; Non-Financial Interests, Institutional, Principal Investigator, Clinical trial: Blueprint, Kariopharm Therapeutics, Lilly, RAIN Therapeutics, Syneos Health; Non-Financial Interests, Member of the Board of Directors, Spanish group of Sarcoma Research: GEIS Group; Non-Financial Interests, Member of the Board of Directors, Spanish Group of Head and Neck cancer Research: TTCC Group. M. Plana Serrahima: Financial Interests, Institutional, Other: Nanobiotix; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Other: BMS. A. García Castaño: Non-Financial Interests, Advisory Role: Bristol, MSD, Novartis. J. Rubió-Casadevall: Financial Interests, Personal, Advisory Board, Advisory board meeting in 2021: Sanofi. A. Carral Maseda: Non-Financial Interests, Institutional, Principal Investigator: G1 Therapeutics, Pierre Fabre, BMS; Non-Financial Interests, Personal, Member of the Board of Directors: TTCC; Financial Interests, Personal, Advisory Board: Servier, Merck KGaA, BMS, Bayer, Amgen; Financial Interests, Personal, Invited Speaker: Sanofi, Pierre Fabre, Novartis, MSD, Lilly, Kyowa Kirin, Grunenthal. P. Pérez Segura: Financial Interests, Other, Speaker, consultancy or advisory role or similar activity: MSD, BMS, Merck, Roche, Kyowa Kirin. I. Ceballos Lenza: Financial Interests, Personal, Invited Speaker: Pfizer, Novartis, Merck, MSD, BMS, Roche; Financial Interests, Personal, Advisory Board: Seagen; Non-Financial Interests, Principal Investigator: BMS, GSK. C. Pena Álvarez: Financial Interests, Personal, Invited Speaker, Speaker: MSD, Merck. V. Arrazubi Arrula: Financial Interests, Personal, Advisory Board: BMS, Bristol; Financial Interests, Personal, Invited Speaker: BMS, Lilly. M. Chaves Conde: Financial Interests, Personal, Invited Speaker: Merck, MSD; Financial Interests, Personal, Principal Investigator: MSD, Roche, Adlai Nortye; Financial Interests, Institutional, Other, Hospital educational program immunotherapy: Bristol; Financial Interests, Other, Finance for congress or course attendance: Pfizer, Merck, MSD. V. Quiroga: Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Institutional, Other, Steering committee member: Roche; Non-Financial Interests, Member: GEICAM, SEOM, SOLTI. E. Ortega: Financial Interests, Personal, Expert Testimony: GSK; Financial Interests, Personal, Invited Speaker: Clovis, AstraZeneca, PharmaMar. R. Mesia Nin: Financial Interests, Personal, Advisory Board: Merck, MSD, BMS, Bayer, Seattle Genetics, Nanobiotix, Boehringer; Financial Interests, Personal, Invited Speaker: Merck, MSD, BMS; Non-Financial Interests, Principal Investigator, Clinical Trial PI: BMS; Non-Financial Interests, Principal Investigator, Observational trial PI: Merck. All other authors have declared no conflicts of interest.