Abstract 505P
Background
The RATIONALE-312 study reports PD-1 inhibitor (tislelizumab) plus platinum–etoposide could improve survival of patients with extensive-stage small-cell lung cancer (SCLC). Based on this, we initiated a pilot study to explore the safety and feasibility of neoadjuvant Tislelizumab plus platinum–etoposide in limited-stage SCLC.
Methods
Treatment-naïve limited-stage SCLC patients with ECOG PS 0-1 status were enrolled. Patients received 4 cycles of Tislelizumab (200mg, q3w) plus platinum (Cisplatin 75 mg/m2 or Carboplatin AUC5) – etoposide (100 mg/m2). The feasibility of surgery was then reassessed by radiology. Candidates for complete resection underwent surgery; otherwise, they received radiotherapy. Patients who received surgery also received adjuvant Tislelizumab plus platinum–etoposide therapy for 4 cycles. Primary endpoints were safety and feasibility. Secondary endpoints were objective response rate (ORR), pathologic response, and survival.
Results
A total of 8 eligible patients were enrolled up to April 2023. The median age was 65 (range: 57-70) with 6 male patients and 7 smokers. Among them, 1, 4, and 3 patients had stage ⅡB, ⅢA and ⅢB disease, respectively. No previously unreported toxic effects were observed. Treatment-related adverse events (TRAEs) of any grade occurred in 7 of 8 (87.5%) patients. Grade 3-4 events occurred in 6 of 8 (75%) patients. There were no severe adverse events. The majority of TRAEs was chemotherapy-related, and 2 patients suffered mild immune-related thyroid dysfunction. Seven patients completed 4 cycles of neoadjuvant therapy, and the best ORR was 85.7% (5 partial response and 1 stable disease). Of the 7 patients, 5 were assessed to be resectable. There were no treatment-related surgical delays. R0 resection and pathological downstaging were achieved for all 5 patients (100%) without any serious surgical complications. At a median of 18 months (range: 10 - 20) of follow-up, all patients were alive, and all the patients who received surgery were recurrence-free.
Conclusions
Neoadjuvant Tislelizumab plus platinum–etoposide was associated with tolerable side effects and was effective for patients with limited-stage SCLC.
Clinical trial identification
NCT04542369.
Editorial acknowledgement
Legal entity responsible for the study
Shanghai Pulmonary Hospital.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
280P - Radium-223 for patients with metastatic castration-resistant prostate cancer with symptomatic bone metastases progressing after first-line abiraterone or enzalutamide: One institutional experience
Presenter: Keng Man Chiang
Session: Poster Display
Resources:
Abstract
281P - 10-year treatment outcome of prostate cancer patients with 3D conformal radiation: Experience of a single cancer institution in Iran
Presenter: Reyhane Bayani
Session: Poster Display
Resources:
Abstract
282P - Predictors of outcomes in patients with clinically lymph node-positive prostate cancer after definitive radiotherapy
Presenter: Jae-Sung Kim
Session: Poster Display
Resources:
Abstract
283P - Radiotherapy utilization rate and treatment patern of protate cancer at Cipto Mangunkusumo Central General Hospital (RSCM): What we learn from pre-pandemic era
Presenter: Riyan Apriantoni
Session: Poster Display
Resources:
Abstract
284TiP - CYCLONE 3: A phase III, randomized, double-blind, placebo-controlled study of abemaciclib in combination with abiraterone plus prednisone in men with high-risk metastatic hormone-sensitive prostate cancer
Presenter: Nobuaki Matsubara
Session: Poster Display
Resources:
Abstract
292P - Comparative characteristics of early cervical cancer diagnosis methods for Tashkent women
Presenter: Gulnoza Goyibova
Session: Poster Display
Resources:
Abstract
293P - Carboplatin in locally advanced cervical cancer treated with chemoradiation: An alternative to cisplatin
Presenter: Natalia Isabel Valdiviezo Lama
Session: Poster Display
Resources:
Abstract
294P - Concurrent chemoradiation with cisplatin every 3 weeks in locally advanced cervical cancer: A single arm phase II clinical trial
Presenter: Long Nguyen
Session: Poster Display
Resources:
Abstract
295P - A prospective study of dose escalated simultaneous integrated boost in node-positive cervical cancer
Presenter: Ritusha Mishra
Session: Poster Display
Resources:
Abstract
296P - Safety, efficacy, and immunogenicity of therapeutic vaccines for patients with high-grade cervical intraepithelial neoplasia (CIN 2/3) associated with human papillomavirus: A systematic review
Presenter: Caroline Amélia Gonçalves
Session: Poster Display
Resources:
Abstract