JTO clinical and research reports · 2026
Comparison of Long-Term Survival Between Nivolumab Plus Ipilimumab and Nivolumab Plus Ipilimumab With Chemotherapy in Advanced NSCLC: A Multicenter Retrospective Cohort Study.
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Komuta Kiyohide, Matsumoto Kinnosuke, Tamiya Motohiro, Shiroyama Takayuki, Kinehara Yuhei, Tamiya Akihiro, Kuge Tomoki, Uchida Junji, Suzuki Hidekazu, Yamamoto Suguru, Tobita Satoshi, Niki Toshie, Tetsumoto Satoshi, Morimura Osamu, Osa Akio, Minami Toshiyuki, Nishino Kazumi, Takeda Yoshito, Kumanogoh Atsushi
Аннотация
INTRODUCTION: Pivotal clinical trials have reported the survival benefits of both nivolumab plus ipilimumab (NI) and nivolumab plus ipilimumab with 2 cycles of platinum-based chemotherapy (NICT) compared with chemotherapy. However, real-world evidence comparing NI and NICT with long-term follow-up remains limited.
METHODS: We retrospectively analyzed 181 patients treated with NICT or NI across 13 institutions in Japan. The primary end points were median overall survival (OS) and the 36-month OS rate. Secondary end points included progression-free survival (PFS), objective response rate, disease control rate, and treatment-related adverse events (TRAEs). To reduce treatment-selection bias, 1:1 propensity score matching was performed using 11 covariates.
RESULTS: In the post-propensity score matching cohort (47 pairs; n = 94; median follow-up, 42.6 and 44.1 months), the median PFS was 8.7 months with NICT versus 4.7 months with NI (hazard ratio [HR] 0.86; p = 0.51). The median OS was 19.5 months with NICT versus 16.3 months with NI (HR 0.79; p = 0.37), with similar 36-month OS rates (34.3% versus 30.9%). The objective response rate was significantly higher with NICT than with NI (68.1% versus 34.0%) (p = 0.002), as was the disease control rate (83.0% versus 53.2%) (p = 0.004). NICT was associated with a higher cumulative incidence of TRAEs of grade 3 or higher (HR 2.25 [95% confidence interval, 1.03-4.91]) (Gray's test p = 0.039). Treatment discontinuation and treatment-related deaths were comparable between the groups.
CONCLUSIONS: With more than 40 months of follow-up, NICT was associated with higher response rates and a higher incidence of TRAEs of grade 3 or higher than NI, without a clear PFS or OS advantage. Adding 2-cycles of chemotherapy may enhance early disease control but at the cost of increased toxicity, and this balance should be considered when selecting treatment for patients for whom tolerability is a major concern.
METHODS: We retrospectively analyzed 181 patients treated with NICT or NI across 13 institutions in Japan. The primary end points were median overall survival (OS) and the 36-month OS rate. Secondary end points included progression-free survival (PFS), objective response rate, disease control rate, and treatment-related adverse events (TRAEs). To reduce treatment-selection bias, 1:1 propensity score matching was performed using 11 covariates.
RESULTS: In the post-propensity score matching cohort (47 pairs; n = 94; median follow-up, 42.6 and 44.1 months), the median PFS was 8.7 months with NICT versus 4.7 months with NI (hazard ratio [HR] 0.86; p = 0.51). The median OS was 19.5 months with NICT versus 16.3 months with NI (HR 0.79; p = 0.37), with similar 36-month OS rates (34.3% versus 30.9%). The objective response rate was significantly higher with NICT than with NI (68.1% versus 34.0%) (p = 0.002), as was the disease control rate (83.0% versus 53.2%) (p = 0.004). NICT was associated with a higher cumulative incidence of TRAEs of grade 3 or higher (HR 2.25 [95% confidence interval, 1.03-4.91]) (Gray's test p = 0.039). Treatment discontinuation and treatment-related deaths were comparable between the groups.
CONCLUSIONS: With more than 40 months of follow-up, NICT was associated with higher response rates and a higher incidence of TRAEs of grade 3 or higher than NI, without a clear PFS or OS advantage. Adding 2-cycles of chemotherapy may enhance early disease control but at the cost of increased toxicity, and this balance should be considered when selecting treatment for patients for whom tolerability is a major concern.