Abstract 520P
Background
While immune checkpoint inhibitors (ICIs) have been shown to be effective for non-small cell lung cancer (NSCLC), their monotherapeutic response rate (RR) is roughly 20%. It has been noted that local radiation therapy (RT) might potentially activate off-target antitumor effect, which is so called “abscopal effect” induced by immune-mediated mechanism. We evaluated whether palliative-RT induced abscopal effect, resulting in improvement of Nivolumab (Nivo) effectiveness.
Methods
Pretreated advanced NSCLC patients (pts) who were indicated for Nivo and scheduled for palliative-RT were started on RT within 10 days of administration of Nivo 3 mg/kg q2 weeks until attached document was revised to 240 mg/body q2 weeks. The primary endpoint was RR of non-irradiated tumor lesions.
Results
Twenty-eight pts were enrolled from May 2016 to January 2019. The study was terminated before completion of targeted initial sample size (n = 35), because of poor accrual. The median age was 67 years (range: 53-89). 15 pts were male. 21 pts had adenocarcinoma histology, 2 pts squamous histology, and 6 pts driver oncogene alterations. 25 pts were PS0/1, and 3 pts PS2. 14 pts were treated as 2nd-line, 2 pts as 3rd-line, and 12 pts as 4th-line or later. The median number of treatment cycles was 4 (range: 1-6). Median radiation dose was 30 Gy (range: 25-40), and 16 pts were irradiated on the bone, 5 pts on the adrenal grand, and 2 pts on the primary lesion. The objective RR of non-irradiated tumor lesions was 14.3% (95% CI: 1.3–27.2). Partial response (PR) was observed in 3 pts treated as 2nd-line (3/14, 21.4%), and 1 pt as 3rd-line (1/2, 50%). No PR was observed in pts treated as 4th-line or later (0/12, 0%). The median PFS was 2.7 months (95% CI: 1.0–3.5). No severe and specific adverse events (AEs) of Nivo in combination with RT were observed compared to historical data of Nivo monotherapy.
Conclusions
Although the sample size was small, cleared abscopal effect by palliative-RT was not observed in Nivo treatment. However, some pts well responded to Nivo with palliative-RT during early-lines of treatment (2nd/3rd-line). Further investigations in the early-lines are warranted to evaluate a substantial synergistic effect of RT with ICIs.
Clinical trial identification
UMIN000023646.
Editorial acknowledgement
Legal entity responsible for the study
HANSHIN Oncology Group.
Funding
ONO Pharmaceutical Company.
Disclosure
A. Hata: Speaker Bureau / Expert testimony, Research grant / Funding (institution): Boehringer Ingelheim; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli Lilly; Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Speaker Bureau / Expert testimony: Chugai; Research grant / Funding (institution): MSD. M. Satouchi: Speaker Bureau / Expert testimony, Research grant / Funding (institution): AstraZeneca; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Boehringer Ingelheim; Speaker Bureau / Expert testimony, Research grant / Funding (institution): BMS; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Chugai; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Eli Lilly; Speaker Bureau / Expert testimony, Research grant / Funding (institution): MSD; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Novartis; Speaker Bureau / Expert testimony, Research grant / Funding (institution): ONO; Speaker Bureau / Expert testimony, Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Takeda; Speaker Bureau / Expert testimony: Taiho. D. Harada: Honoraria (self): ONO; Honoraria (self): BMS. All other authors have declared no conflicts of interest.
Resources from the same session
87P - Negative to positive lymph node ratio-prognostic marker of survival in node positive rectal cancer
Presenter: Pavan Jonnada
Session: Poster display session
Resources:
Abstract
88P - The Sidra LUMC advanced colon cancer NGS cohort
Presenter: Wouter Hendrickx
Session: Poster display session
Resources:
Abstract
89P - A phase II trial of adjuvant chemoradiotherapy for patients with high-risk rectal submucosal invasive cancer after local resection
Presenter: Masaaki Noguchi
Session: Poster display session
Resources:
Abstract
90P - High MICB expression confers prognostic benefit in colorectal cancer
Presenter: Shanchao Yu
Session: Poster display session
Resources:
Abstract
91P - Adjuvant therapy for high-risk stage II or stage III colon adenocarcinoma: A propensity score-matched, nationwide, population-based cohort study
Presenter: Chien-Hsin Chen
Session: Poster display session
Resources:
Abstract
92P - Prospective randomized controlled study comparing primary surgery versus neoadjuvant chemotherapy followed by surgery in gastric carcinoma
Presenter: Vipin Goel
Session: Poster display session
Resources:
Abstract
93P - Biomarker selection of liver metastatic colorectal patients for anti-EGFR monoclonal antibodies: A machine learning analysis
Presenter: Yijiao Chen
Session: Poster display session
Resources:
Abstract
94P - NORTH/HGCSG1003: North Japan multicenter phase II study of oxaliplatin-containing regimen as adjuvant chemotherapy for stage III colon cancer: Final analysis
Presenter: Michio Nakamura
Session: Poster display session
Resources:
Abstract
95P - Anatomical resections improve relapse-free survival in patients with KRAS/NRAS/BRAF- mutated colorectal liver metastases
Presenter: Ye Wei
Session: Poster display session
Resources:
Abstract
96P - Incidence, characteristics and prognosis in colorectal cancer with CNS metastases
Presenter: Nicola Taylor
Session: Poster display session
Resources:
Abstract