930P - Weekly paclitaxel, carboplatin and cetuximab (PCC) as first-line treatment of recurrent and/or metastatic head & neck squamous cell carcinoma (R/M-HNSCC) for patients ineligible to cisplatin based chemotherapy

Background

For R/M-HNSCC patients (pts), the first line standard of care has been for over a decade the EXTREME regimen. Nevertheless, a significant number of pts remains unfit for the EXTREME regimen because of poor performance status (PS), age or severe comorbidities. Consequently, we have evaluated the efficacy and the the safety of PCC as an alternative regimen for cisplatin unfit pts.

Methods

We reviewed retrospectively the medical charts of all pts treated with PCC at our institution. Eligibility criterias were: First line R/M-HNSCC of the oral cavity, oropharynx, hypopharynx or larynx not suitable for local therapy, Cisplatin and/or 5-Fu inegibility, ECOG-PS: 0-2. PCC consisted of Paclitaxel 80 mg/m², Carboplatin AUC 2 and Cetuximab at an initial dose of 400 mg/m² then 250 mg/m^2, for 16 weekly administrations followed by Cetuximab maintenance for pts for whom a disease control was obtained. The primary endpoint was overall survival (OS), secondary endpoints were overall response rate (ORR), progression free survival (PFS) and safety.

Results

We identified 60 consecutive pts treated between 2010 and 2016, 83% male, median age was 61 (23-79), PS 2 for 52% of pts, and there were at least 3 frailty criteria in 62% of pts. 48 pts (80%) were smokers. Primary tumor site was the oral cavity/oropharynx/hypopharynx/larynx in 17/24/12/7 cases and 33 (55%) pts had a loco-regional relapse only. With a median follow-up of 37 months (mo), median OS was 11.7 mo for all pts, 14.8 mo (95%CI: 12.2-21.7) for PS 0-1 pts, and 7,5 mo (95%CI: 5.5-12.7) for PS 2 pts (p<0.04). PFS was 5.8 mo, ORR 43% and Disease control rate 65%. Grade III-IV toxicities occured in 30 (50%) pts: Neutropenia (25%) with 10% febrile neutropenia, Anemia (12%) and skin reaction (12%).

Conclusions

The weekly PCC regimen seems to be an interesting option for cisplatin unfit pts. This study shows favourable OS and PFS compared to the standard of care, a high disease control rate with predictable and manageable toxicities even in the more fragile population.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

CRLCC - Paul Strauss.

Funding

Has not received any funding.

Disclosure

H. Carinato, P. Coliat: Travel/Accommodation/Expenses: Merck. M. Burgy: Honoraria (self), Travel/Accommodation/Expenses: BMS; Travel/Accommodation/Expenses: Sanofi; Honoraria (self): MSD; Travel/Accommodation/Expenses: Merck; Honoraria (self): Ipsen; Travel/Accommodation/Expenses: Mundipharma. C. Fischbach: Travel/Accommodation/Expenses: Mundipharma; Travel/Accommodation/Expenses: Chugai. M. Kalish-Weindling: Travel/Accommodation/Expenses: Mundipharma. V. Frasie: Travel/Accommodation/Expenses: Amgen. T. Petit: Advisory/Consultancy: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Travel/Accommodation/Expenses: Mylan. C. Borel: Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Merck; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): MSD. All other authors have declared no conflicts of interest.