Poster Display Poster Display session

73P - A randomized phase II study of neoadjuvant immunotherapy or immunochemotherapy in locally advanced oral squamous cell carcinoma (ID 165)

Presentation Number
73P
Lecture Time
12:30 - 12:30
Speakers
  • Gang Chen (Wuhan, China)
Session Name
Poster Display
Room
Foyer mezzanine
Date
Thu, Dec 8, 2022
Time
12:30 - 13:15

Abstract

Background

To evaluate the therapeutic efficacy and safety of neoadjuvant PD-1 inhibitor camrelizumab combined with TPF induction chemotherapy versus camrelizumab alone in patients with locally advanced resectable oral squamous cell carcinoma (OSCC). This study also aims to build predictive models for treatment decision based on a multivariable logistic regression analysis of multi-dimensional data.

Methods

A phase II study (NCT04649476) was conducted. Untreated stage III or IVA (UICC 8th edition) OSCC patients received neoadjuvant therapy with three 2-week cycles of camrelizumab (200 mg, d1, q2w) (arm A, n=34) or three 2-week cycles of camrelizumab (200 mg, d1, q2w) combined with two 3-week cycles of TPF induction chemotherapy [docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2 and 750 mg/m2 5-fluorouracil (F)] (arm B, n=34), followed by surgery and adjuvant radiotherapy. The primary end point was pathological response rate.

Results

Of the 68 patients enrolled into this trial, 60 completed the full treatment protocol. The pathological response rate in arm B was 83.4%, which was much higher than arm A (16.7%). The pathological complete response (pCR) rate was 30.0% in arm B, while no patient with pCR was observed in arm A. The median follow-up duration was 9.7 months, and the 1-year event-free survival (EFS) of arm A and arm B were 66.7% and 96.7%, respectively. Grade 3-5 neoadjuvant therapy-related adverse events were occurred in 7 patients from arm B and one patient from arm A. A decision tree, mainly based on lymph node metastasis, tumor site, and infiltrated immunocytes in biopsy tissue, was developed to screen patients with high responsivity and low adverse effects.

Pathological response rate

Pathological response Arm A Camrelizumab (n = 30) Arm B Camrelizumab + TPF (n = 30)
No. % No. %
pCR (0% viable tumor) 0 0 9 30.0
pMPR (≤10% viable tumor) 5 16.7 16 53.4
pPR (11-50% viable tumor) 4 13.3 3 10.0
pNR (51%-100% viable tumor) 21 70.0 2 6.6
Pathological response rate (pCR+pMPR) [95% CI interval] 5 (16.7) [3.3 – 30.0] 25 (83.4) [70.0 – 96.7]

Conclusions

Neoadjuvant camrelizumab plus TPF induction chemotherapy for locally advanced resectable OSCC showed high pathological response rate, with acceptable adverse effects. Newly developed predictive models may benefit precise treatment decision for OSCC patients in clinical practice.

Clinical trial identification

NCT04649476.

Legal entity responsible for the study

Gang Chen.

Funding

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.

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