Biweekly carboplatin plus nab-paclitaxel with concurrent radiotherapy followed by durvalumab consolidation for unresectable locally advanced non-small cell lung cancer: a real-world retrospective cohort study

Introduction

Non-small cell lung cancer (NSCLC) accounts for approximately 80% of all lung cancers, with 25–35% of cases diagnosed as locally advanced NSCLC (LA-NSCLC) (1). At present, the standard treatment for unresectable LA-NSCLC is concurrent chemoradiotherapy (CRT) (2,3). As reported by the PACIFIC trial, durvalumab consolidation therapy after CRT significantly prolongs progression-free survival (PFS) and overall survival (OS) relative to placebo (4,5). In the updated analysis of this trial, the durvalumab group achieved a median OS of 47.5 months and a 5-year OS rate of 42.9% (6). The recent phase III PACIFIC-5 trial further supports the clinical relevance of consolidation durvalumab after either concurrent or sequential CRT in unresectable stage III NSCLC (7). Taken together, these findings support durvalumab consolidation following CRT as a standard treatment strategy for unresectable LA-NSCLC. However, the optimal CRT regimen in combination with subsequent durvalumab has not yet been clearly established.

In Western countries, commonly used regimens for CRT include cisplatin plus etoposide or weekly low-dose carboplatin plus paclitaxel (8,9). In Japan, several platinum-based regimens incorporating third-generation cytotoxic agents, such as paclitaxel, S-1, or docetaxel, are widely used in clinical practice. The WJTOG0105 trial provides supporting evidence for this treatment landscape. Although carboplatin plus paclitaxel with concurrent radiotherapy (RT) did not demonstrate superiority in terms of OS in the WJTOG0105 trial, the regimen is considered feasible due to its safety and tolerability profile (10). Consequently, in current Japanese clinical practice, platinum doublets combined with third-generation agents constitute major CRT options.

Treatment selection for older patients with LA-NSCLC remains a major clinical challenge and less toxic CRT regimens are generally preferred. The phase III JCOG0301 trial reported that low-dose daily carboplatin plus concurrent RT was more effective than RT alone for patients aged ≥70 years (11), and this regimen is now recommended by the current Japanese Lung Cancer Guidelines (2025 edition) for older patients (12). Notably, a post hoc analysis of data from the PACIFIC trial demonstrated that the survival benefit of durvalumab was maintained even in patients aged ≥70 years (13). More recently, the phase II NEJ039A trial reported the efficacy and tolerability of durvalumab consolidation therapy in older patients or patients with poor performance status (PS) who had received daily carboplatin with concurrent RT (14). However, the PACIFIC trial did not include the daily carboplatin regimen among the CRT regimens it evaluated.

We previously conducted a phase I/II trial supporting the efficacy and tolerability of biweekly carboplatin [area under the curve (AUC) 4] plus nab-paclitaxel (100 mg/m²) with concurrent RT in patients with unresectable LA-NSCLC (15). However, as no data are available on the efficacy or safety of durvalumab consolidation after this CRT regimen, it remains unclear whether this treatment strategy is feasible, particularly for older patients.

To address this research gap, we performed a retrospective analysis of LA-NSCLC patients who received biweekly carboplatin plus nab-paclitaxel with RT followed by durvalumab consolidation therapy to evaluate the efficacy and safety of this treatment sequence. To specifically assess the feasibility of this regimen for older patients, we compared outcomes between younger (<75 years) and older (≥75 years) subgroups. We present this article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0162/rc).

Methods

Study design

This retrospective cohort study was conducted at two institutions in Japan (Hirosaki University Graduate School of Medicine and Aomori Prefectural Central Hospital). The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of Hirosaki University Graduate School of Medicine (approval No. 2023056). Aomori Prefectural Central Hospital was also informed and agreed to this study. Due to the retrospective nature of this study, the requirement for informed consent was waived.

Patients and data collection

We reviewed the medical records of consecutive patients with LA-NSCLC who received biweekly carboplatin plus nab-paclitaxel with concurrent RT between April 1, 2018 and March 31, 2022. The data cutoff date was April 30, 2024. The following data were extracted: age, sex, Eastern Cooperative Oncology Group (ECOG) PS, clinical stage, smoking history, histological type, programmed death-ligand 1 (PD-L1) status, driver mutations, tumor response, and adverse events (AEs). PD-L1 expression and driver mutation status were recorded as not assessed when testing was not performed.

Treatment regimen

All patients received biweekly carboplatin (AUC 4) plus nab-paclitaxel (100 mg/m²) with concurrent RT. As the fixed-dose 1,500 mg regimen had not been approved in Japan at the time of this study, durvalumab was administered at a dose of 10 mg/kg every 2 weeks for up to 12 months.

Efficacy evaluation

PFS from CRT initiation (PFS-CRT) was defined as the time from the start of CRT until disease progression, death, or last contact. PFS from durvalumab initiation (PFS-durvalumab) was defined as the time from the first dose of durvalumab until disease progression, death, or last contact. OS from CRT (OS-CRT) and OS from durvalumab initiation (OS-durvalumab) were defined as the time from the start of each treatment until death from any cause. Patients without an event were censored at the date of last follow-up.

AEs were graded according to the Common Terminology Criteria for Adverse Events (version 5.0) (16). Tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (17). The overall response rate (ORR) was defined as a complete response (CR) or partial response (PR). All assessments were performed by treating physicians at the two institutions.

Statistical analysis

All analyses were performed using JMP 15 software (SAS Institute, Inc., NC, USA). PFS and OS were analyzed using the Kaplan-Meier method and compared between age groups using the two-sided log-rank test. Results with a P value <0.05 were considered statistically significant.

Although earlier CRT studies define older patients as those aged ≥70 years, more recent lung cancer studies commonly use a cutoff of ≥75 years. Accordingly, patients in the present study were divided into two groups: a younger group (aged <75 years) and an older group (aged ≥75 years). Patient characteristics between these two groups were compared using the Wilcoxon rank-sum test or Fisher’s exact test, as appropriate.

Additional exploratory subgroup analyses for PFS-durvalumab and OS-durvalumab were performed according to PS, clinical stage, histology, PD-L1 expression and driver mutation status. Analyses according to PD-L1 expression and driver mutation status were restricted to patients with available data.

Results

Patient characteristics

A CONSORT-style flow diagram of patient inclusion and transitions between treatment phases is shown in Figure S1. A total of 75 patients with unresectable LA-NSCLC received biweekly carboplatin plus nab-paclitaxel with concurrent RT, including 52 in the younger group (age <75 years) and 23 in the older group (age ≥75 years). The median age was 67 years (range, 50–74 years) in the younger group and 78 years (range, 75–85 years) in the older group. As shown in Table 1, there were no significant differences in baseline characteristics between these two groups. Most patients were male (80.0%) and had a history of smoking (94.7%), and squamous cell carcinoma was the most common histological type (62.7%). Patients with PS ≥2 were more frequently observed in the older group (17.4%). Stage II accounted for 13.3% of all patients and 21.7% of the older group. PD-L1 expression was not assessed in approximately 30% of cases. At the data cutoff (April 30, 2024), the median follow-up time from CRT initiation was 44.6 months (interquartile range, 32.3–55.1 months).

Efficacy

Overall results

In all patients, the median PFS-durvalumab was 16.0 months [95% confidence interval (CI): 11.0–20.9] and the median OS-durvalumab was 37.5 months (95% CI: 28.2–46.0) (Figure 1). The median PFS-CRT was 16.1 months (95% CI: 12.4–21.4) and the median OS-CRT was 37.8 months (95% CI: 28.7–47.8) (Figure S2). Table S1 provides a summary of the ORR, which was 84.0% during the CRT phase and 33.3% during the durvalumab consolidation phase.

Figure 1 PFS (A) and OS (B) from durvalumab initiation in all patients. CI, confidence interval; OS, overall survival; PFS, progression-free survival.

Comparison between age groups

PFS-durvalumab and OS-durvalumab did not differ significantly between the younger and older groups (PFS-durvalumab: 16.2 vs. 12.3 months, log-rank test, P=0.44; OS-durvalumab: 39.5 vs. 29.7 months, log-rank test, P=0.23) (Figure 2A,2B). The 1-year PFS-durvalumab rate was 62.5% in the younger group and 50.0% in the older group, while the 1-year OS-durvalumab rate was 85.4% in the younger group and 82.6% in the older group. The median PFS-CRT was 17.3 months in the younger group and 12.2 months in the older group (P=0.45). The median OS-CRT was 39.4 months in the younger group and 30.4 months in the older group (P=0.36) (Figure S3A,S3B). The 1-year PFS-CRT rate was 70.1% in the younger group and 56.3% in the older group. The 1-year OS-CRT rate was 86.3% in the younger group and 85.7% in the older group.

Figure 2 PFS (A) and OS (B) from durvalumab initiation in the younger and older groups. OS, overall survival; PFS, progression-free survival.

Exploratory subgroup analysis

Additional exploratory subgroup analyses were performed according to PS, stage, histology, PD-L1 expression and driver mutation status (Table S2). Analyses according to PD-L1 and driver mutation were limited to patients with available data. Patients with PS ≥2 had shorter PFS and OS than those with PS 0–1. Although no statistically significant differences were observed between patients with stage II and stage III, those with stage II patients tended to have shorter PFS and OS.

Treatment delivery

Table 2 summarizes the treatment delivery profiles during the CRT and durvalumab phases. In all patients, 24% of patients required skipping chemotherapy and 10.7% required dose reduction. There were no statistically significant differences between the younger and older groups in terms of treatment discontinuation or dose skipping.

The transition rate to durvalumab consolidation therapy was 88.0% in all patients, 92.3% in the younger group, and 78.3% in the older group (P=0.08). The reasons for failure to progress from CRT to durvalumab consolidation therapy were as follows: in the younger group, there were three cases of progressive disease (PD) and one case of death due to pneumonia. In the older group, there was one case of PD, three cases that were unable to receive durvalumab due to poor PS, and one case that developed colon cancer during the CRT phase. The completion rate of durvalumab consolidation therapy was 40.9% in all patients, 43.8% in the younger group, and 33.3% in the older group (P=0.44). The reasons for discontinuation of durvalumab were as follows: in the younger group, there were 15 cases of AEs, 10 cases of PD, and two cases involving other reasons. In the older group, there were three cases of AEs, five cases of PD, and four cases involving other reasons.

Safety

Table 3 presents the overall incidence of AEs during the CRT phase and immune-related AEs during the durvalumab consolidation phase, including all-grade and grade ≥3 events. A more detailed breakdown by grade is provided in Tables S3,S4. Neutropenia (86.7%), anemia (85.3%), thrombocytopenia (53.3%), and esophagitis (62.7%) were frequently observed in all patients. Although cases of grade ≥3 neutropenia (28.0%) and anorexia (9.3%) were observed, other grade ≥3 AEs were infrequent.

Compared to the younger group, the older group showed higher rates of all-grade neutropenia (91.3%), anemia (91.3%), thrombocytopenia (78.3%), constipation (60.9%), and pneumonitis (13.0%). The grade ≥3 AEs that occurred more frequently in the older group were neutropenia (30.4%), anemia (4.4%), and anorexia (21.7%). There was one case of death due to pneumonitis in the younger group.

During the durvalumab consolidation phase, all-grade pneumonitis (including radiation pneumonitis) occurred in 69.7% of all patients. The rate of grade ≥3 pneumonitis was 14.6% in the younger group and 5.5% in the older group. Other grade ≥3 irAEs were observed in a small number of patients.

Discussion

This study evaluated treatment outcomes in a real-world clinical setting for 75 unresectable LA-NSCLC patients who received durvalumab consolidation therapy following biweekly carboplatin plus nab-paclitaxel with concurrent RT. In a previous phase I/II trial of this CRT regimen, we found that biweekly carboplatin (AUC 4) and nab-paclitaxel (100 mg/m²) with concurrent RT achieved a median PFS of 18.2 months (95% CI: 13.1–not reached) and an ORR of 96.4% with a median follow-up period of 33.2 months (15). At the time of this phase I/II trial, durvalumab had not yet been approved in Japan and the data were limited to CRT induction therapy alone. Thus, the present study is the first to report the efficacy and safety of durvalumab consolidation following the biweekly carboplatin plus nab-paclitaxel regimen in a real-world setting.

This regimen was used in routine clinical practice among patients eligible for concurrent CRT, rather than being restricted to a specific patient subgroup. The study population therefore reflects a heterogeneous real-world cohort. Despite the inclusion of approximately 10% of patients with PS ≥2 in the present sample, a high response rate comparable to that of our previous phase I/II study was achieved. The median PFS-durvalumab was 16.0 months, which is comparable to the median PFS of 16.8 months reported in the PACIFIC trial (4,5). A recent Japanese study of CDDP + S-1 followed by durvalumab for LA-NSCLC reported a transition rate to durvalumab of 86.4%, which is comparable to our study’s transition rate of 88% (18). These findings suggest that this biweekly carboplatin plus nab-paclitaxel regimen enables a favorable transition to durvalumab consolidation.

Treatment selection for older patients with LA-NSCLC remains an important clinical issue. The PACIFIC trial demonstrated consistent survival benefits of durvalumab even in patients aged ≥70 years with manageable toxicity (13). Similar to our findings, another real-world study found no significant differences in PFS or OS between younger (<70 years) and older (≥70 years) groups (PFS: 17.7 vs. 19.4 months, P=0.43; OS: 35.7 months vs. not reached, P=0.13, respectively) (19). These findings support the feasibility of durvalumab consolidation in older patients and underscore the importance of CRT regimens that provide high response rates and a consistent transition to durvalumab consolidation.

In Japan, daily carboplatin with concurrent RT is recommended for older patients based on the results of the phase III JCOG0301 trial (11). More recently, the phase II NEJ039A trial evaluated durvalumab consolidation after CRT with daily carboplatin in patients aged ≥75 years or those with poor PS and reported a median PFS of 12.3 months, a 1-year PFS rate of 51.0%, and a median OS of 28.1 months after durvalumab initiation (14). In the present study, the older group showed a median PFS-durvalumab of 12.3 months, a 1-year PFS-durvalumab rate of 50.0%, and a median OS-durvalumab of 29.7 months. Thus, the outcomes of older patients treated with biweekly carboplatin plus nab-paclitaxel followed by durvalumab did not markedly differ from those reported in NEJ039A. However, such cross-study comparisons should be interpreted with caution. This is because the present study was not designed to directly comparisons regimens, and patient characteristics and stage distributions differed between the studies. Therefore, although the ORR in our older subgroup was numerically higher than that reported in NEJ039A (91.3% vs. 47.0%) (14), this difference should not be overinterpreted. Taken together, these findings support the feasibility of this regimen in older patients in routine clinical practice.

In terms of AEs during the CRT phase, grade ≥3 hematologic toxicities and anorexia were frequent in the older group than in the younger group. However, these toxicities were generally manageable and there were no statistically significant group differences regarding the incidence of chemotherapy dose reductions or treatment interruptions.

The transition rate to durvalumab consolidation therapy was 78.3% in the older group, which was lower than that in the younger group but comparable to previously reported rates of 60–70% (14,18). Poor PS was the most common reason for failure to transition. Age-related decline in activities of daily living (ADL) and treatment tolerance may have contributed to this difficulty. Although AEs associated with biweekly carboplatin plus nab-paclitaxel combined with RT were generally acceptable in the older group, clinical caution is warranted because older patients often present with diminished organ function and multiple comorbidities that may increase risks of treatment-related toxicities.

Pneumonitis remains a major concern during durvalumab consolidation therapy. In the present study, the incidence rates of all-grade and grade ≥3 pneumonitis were 69.7% and 12.1%, respectively, both of which were higher than those reported in the PACIFIC trial (33.9% and 3.4%, respectively) (5). This difference may be partially attributable to differences in patient characteristics, such as ethnicity, as well as treatment-related factors. In previous studies, Asian ethnicity, stage IIIA disease, PS 1, and the absence of induction chemotherapy have been associated with a higher risk of grade ≥2 pneumonitis and radiation pneumonitis (20). Similarly, high incidence rates of pneumonitis have been reported in Japanese studies, including the NEJ039A trial (all-grade, 80.3%; grade ≥3, 8.2%) (14) and the phase II DATE trial, which evaluated durvalumab consolidation initiated immediately after concurrent CRT (all-grade, 78.7%; grade ≥3, 4.3%) (21). Thus, compared with global cohorts, pneumonitis may occur more frequently in Asian populations, particularly in Japanese patients. In addition to patient background, dosimetric factors may also influence the risk of pneumonitis. For example, lung V20 has been identified as an important predictor of grade ≥2 radiation pneumonitis after CRT followed by durvalumab consolidation (22). Although lung V20 was not evaluated in the present study, it should be considered when assessing the risk of pneumonitis in clinical practice. Although the overall incidence of pneumonitis in our cohort was higher than that reported in global studies, most cases were manageable, with severe pneumonitis occurring at a frequency comparable to that reported in previous Japanese studies (14,21,23). Therefore, this regimen does not appear to confer an excessive risk of pneumonitis beyond what has already been observed in Japanese clinical practice. However, because pneumonitis may occur more frequently in Asian populations than in global cohorts, careful monitoring and early intervention remain important during durvalumab consolidation in routine clinical practice.

This study has several limitations. First, this was a retrospective analysis of a relatively small real-world cohort of 75 patients from two institutions, and treatment selection was left to the discretion of the treating physicians. Therefore, although this regimen was not restricted to a specific patient group, selection bias cannot be completely excluded. Data were collected from electronic medical records, and both treatment response and AE assessments were performed by individual physicians at each institution. Interobserver variability may have existed in AE grading and tumor response evaluation. In addition, the timing and frequency of radiologic evaluations were not standardized. These factors may have affected disease progression assessment, the reported incidence and severity of AEs, and decisions regarding treatment continuation. The efficacy and safety outcomes of this study should therefore be interpreted in light of these potential sources of selection and information bias.

Second, this study included a small number of patients with stage II disease who underwent CRT because of their clinical condition or patient preference. Stage II NSCLC is typically managed with surgical resection and is not generally included in CRT-based clinical trials, potentially introducing heterogeneity into the study population. Although patients with stage II disease generally have a more favorable prognosis than those with stage III disease, the present exploratory subgroup analyses revealed a non-significant trend toward shorter PFS-durvalumab and OS among stage II patients. However, these findings were derived from a small exploratory subgroup analysis and should not be overinterpreted. Some of these patients may have had comorbidities or poor PS that precluded standard surgical resection despite their relatively earlier stage. Therefore, it is unlikely that the inclusion of stage II patients resulted in an overestimation of treatment efficacy, although caution is warranted when making direct comparisons with more typical population of unresectable LA-NSCLC.

Finally, comprehensive data on PD-L1 expression and driver mutations were missing in approximately 20–30% of patients. The PACIFIC-R study reported that patients with PD-L1 ≥1% had longer survival outcomes than those with PD-L1 <1% (PFS: 22.4 vs. 15.6 months; 3-year OS rate: 67% vs. 55.4%, respectively) (24,25). In addition, Naidoo et al. conducted a post hoc exploratory analysis of patients with EGFR-mutant NSCLC from the PACIFIC trial and found that, in this subgroup, PFS and OS with durvalumab were similar to those with placebo (26). In the subgroup analysis of patients with available PD-L1 data, PD-L1 positive patients showed only a non-significant trend toward improved survival. Thus, the missing biomarker data likely did not substantially affect the main conclusions of the present study, although the possible influence of unmeasured data cannot be completely excluded. It should also be noted that the age-based analyses and other subgroup analyses in this study were exploratory and based on limited sample sizes. These analyses may have had limited power to detect clinically meaningful differences, and their results should be interpreted with caution. The present findings provide clinically meaningful real-world information; however, caution is warranted when interpreting the results, comparing them directly with typical clinical trial populations, and generalizing them more broadly.

Future prospective studies are needed to further define the clinical role of this regimen, particularly through comparisons with other commonly used concurrent CRT regimens (e.g., cisplatin plus vinorelbine and weekly carboplatin plus paclitaxel). Moreover, the acceptable tolerability observed even in older patients suggests the value of clarifying its clinical utility through further comparative studies in older populations, including those using daily carboplatin-based regimens.

Conclusions

This study suggests that biweekly carboplatin plus nab-paclitaxel with concurrent RT followed by durvalumab consolidation may provide favorable efficacy and acceptable tolerability in patients with unresectable LA-NSCLC. This regimen appeared to be well tolerated in older patients (age ≥75 years) and may therefore represent a feasible treatment option for this population.

Acknowledgments

We thank the patients and investigators who contributed to this study. Part of this study was previously presented as a poster at the ESMO Asia Congress 2024, Singapore, 6–8 December 2024. The authors also thank Enago (www.enago.jp) for the English language review.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0162/rc

Data Sharing Statement: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0162/dss

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0162/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0162/coif). H.T. reports receiving honoraria from Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, AstraZeneca K.K., Chugai Pharmaceutical Co., Ltd., Boehringer Ingelheim Japan Inc., Pfizer Japan Inc., Takeda Pharmaceutical Co., Ltd., Daiichi Sankyo, MSD K.K., and Amgen. Hisashi Tanaka reports receiving honoraria from Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb, Eli Lilly, Chugai Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., Teijin Pharma Ltd., Novartis Pharma K.K., and Care Net Inc. The other authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Committee of Hirosaki University Graduate School of Medicine (approval No. 2023056). Aomori Prefectural Central Hospital was also informed and agreed to this study. Due to the retrospective nature of this study, the requirement for informed consent was waived.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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