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. 2024 Sep 11;16(18):3127.
doi: 10.3390/cancers16183127.

Feasibility Study of Nivolumab in Combination with Carboplatin Plus Paclitaxel and Concurrent Thoracic Radiation in Patients with Untreated Unresectable Locally Advanced Non-Small Cell Lung Cancer

Yuta Yamanaka  1 , Takayo Ota  2 , Yutaka Masuoka  3 , Yuki Takeyasu  1 , Satoaki Nakamura  4 , Masaaki Terashima  2 , Hiroshige Yoshioka  1 , Masahiro Fukuoka  2 , Takayasu Kurata  1
Affiliations

Feasibility Study of Nivolumab in Combination with Carboplatin Plus Paclitaxel and Concurrent Thoracic Radiation in Patients with Untreated Unresectable Locally Advanced Non-Small Cell Lung Cancer

Yuta Yamanaka et al. Cancers (Basel). .

Abstract

Despite advancements in diagnosing and treating non-small cell lung cancer (NSCLC), the prognosis remains poor. Immune checkpoint inhibitors have shown promise in enhancing survival rates. Therefore, this study aimed to investigate the safety of nivolumab administration with concurrent chemoradiation therapy (CCRT) in patients with unresectable locally advanced NSCLC. Twelve patients with unresectable locally advanced NSCLC at Kansai Medical University Hospital and Izumi City General Medical Center were enrolled from May 2018 to September 2020. They received nivolumab (360 mg) tri-weekly twice, weekly carboplatin (AUC 2 min × mg/mL) and paclitaxel (40 mg/m2) for 6 weeks, and thoracic radiotherapy (60 Gy/30 fractions), followed by maintenance nivolumab therapy (360 mg, tri-weekly) for 6 months. The primary endpoint was incidence of dose-limiting toxicities (DLTs), and the secondary endpoints included safety, response rate, progression-free survival (PFS), overall survival (OS), 2-year survival rate, and treatment completion rate. Three patients completed the protocol. Nine discontinued due directly to interstitial pneumonia (three) and pneumonia (one). Ten patients (83.3%) experienced a grade 3 or higher event, of which three (25%) experienced a grade 4 or higher event, and of these, one (8.3%) experienced a grade 5 event. Three patients experienced DLTs. Concurrent nivolumab with CCRT was tolerated in unresectable locally advanced NSCLC, which offers potential treatment benefits.

Keywords: chemoradiotherapy; feasibility study; nivolumab; unresectable locally advanced non-small cell lung cancer.

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Conflict of interest statement

Takayasu Kurata received grants from MSD, Astra Zeneca, Amgen, Boehringer Ingelheim, Daiichi Sankyo Pharmaceutical, Takeda Pharmaceutical, and Bristol Myers Squibb, and honoraria for a lecture from Astra Zeneca, Ono Pharmaceutical, MSD, Nippon Kayaku, Takeda Pharmaceutical, Eli Lilly, Bristol Myers Squibb, Chugai Pharmaceutical, and Pfizer. Hiroshige Yoshioka received honoraria for lecture fees from Boehringer Ingelheim, Chugai Pharmaceutical, Nippon Kayaku, Taiho Pharmaceutical, Eli Lilly, Takeda Pharmaceutical, and Bristol Myers Squibb. The other authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT diagram of this study. * One patient required >10 mg/day of systemic corticosteroids for a non-protocol-related pulmonary infection, while the other patient withdrew from the study.
Figure 2
Figure 2
Kaplan–Meier estimates of (a) PFS and (b) OS in 12 patients who received nivolumab and CCRT. Abbreviations: PFS, progression-free survival; OS, overall survival; CCRT, concurrent chemoradiation therapy.
Figure 2
Figure 2
Kaplan–Meier estimates of (a) PFS and (b) OS in 12 patients who received nivolumab and CCRT. Abbreviations: PFS, progression-free survival; OS, overall survival; CCRT, concurrent chemoradiation therapy.
See this image and copyright information in PMC

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