Investigation of non-completion factors for durvalumab maintenance therapy in locally advanced non-small cell lung cancer

Introduction

Concurrent chemoradiotherapy (CCRT) is considered the standard treatment for unresectable stage III non-small cell lung cancer (NSCLC) (1-5). In cases of unresectable locally advanced NSCLC, definitive CCRT aims to achieve a cure. However, disease progression or metastasis occurs in 89% of patients after CCRT, with a reported 5-year survival rate of 15% (6-10). Stage III NSCLC is the final stage at which the goal remains curative through local control and prevention of distant metastasis. Prior to the approval of durvalumab maintenance therapy, the standard of care following CCRT was limited to observation without active treatment, highlighting the strong need for new therapeutic options.

In patients with unresectable stage III NSCLC, the phase III PACIFIC trial compared one year of durvalumab maintenance therapy with observation without active treatment following CCRT (11). The study demonstrated that durvalumab treatment following CCRT significantly prolonged overall survival (OS) compared with the standard of care, regardless of programmed death-ligand 1 (PD-L1) expression, reducing the risk of death by 28% (12). Beyond the PACIFIC trial, several real-world cohorts have reported broadly consistent outcomes for consolidation durvalumab after CCRT in routine practice. These studies suggest that the benefits observed in PACIFIC are reproducible in real-world settings (13-16). Based on this supporting evidence, durvalumab maintenance therapy has shown superior therapeutic efficacy over traditional observation and is increasingly becoming the standard of care for locally advanced NSCLC.

Despite these advances, the 1-year progression-free survival (PFS) rate is 55.9%, with approximately 45% of patients experiencing recurrence within the first year (11). A previous study indicated that completing the full course of durvalumab reduces the risk of cancer recurrence and prolongs survival (17). Conversely, early discontinuation has been reported to increase the risk of cancer recurrence and exacerbate prognosis. Therefore, avoiding early termination and completing the 1-year durvalumab treatment as much as possible is crucial (18). Given the potential adverse effect of early discontinuation of durvalumab therapy on prognosis, investigating the factors associated with treatment completion rates holds significant value. While examining major prognostic indicators, such as OS and PFS, would be ideal, focusing on treatment completion rates may help elucidate the clinical factors associated with the continuation or discontinuation of durvalumab therapy, thereby providing guidance for achieving better treatment outcomes.

This retrospective analysis sought to identify the factors associated with the discontinuation of durvalumab maintenance therapy, with the goal of identifying patient populations who may require alternative therapeutic strategies to complete durvalumab maintenance therapy. We present this article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-739/rc).

Methods

Patients and data collection

From August 1, 2018, to December 31, 2022, patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0–2 who initiated durvalumab maintenance therapy for NSCLC in the outpatient treatment room of Niigata University Medical and Dental Hospital were enrolled. The data cutoff date was March 31, 2024. Of the 69 patients, three who discontinued treatment at their own request and one who prioritized treatment for other diseases were excluded, resulting in 65 patients being included in the analysis (Figure 1). All patients received durvalumab at a dose of 10 mg/kg biweekly after definitive CCRT.

Figure 1 Patient selection flow. Of 69 patients who initiated durvalumab maintenance between August 2018 and December 2022, 4 were excluded, resulting in 65 patients included in the analysis. AEs, adverse events; ECOG PS, Eastern Cooperative Oncology Group performance status; NSCLC, non-small cell lung cancer.

The study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. This study was approved by the Ethics Review Committee of Niigata University (approval No. 2022-0312). Consent to participate was obtained using the opt-out method from the Department of Pharmacy at Niigata University Medical and Dental Hospital, Japan.

Investigation methods

Patients were divided into two groups (durvalumab completion and non-completion groups) based on whether patients completed one year of durvalumab maintenance therapy. A retrospective investigation of patient background and blood test results was conducted using electronic medical records. Patient backgrounds included age, sex, ECOG PS, histological type of NSCLC (squamous cell carcinoma, adenocarcinoma, and others), stage at diagnosis, PD-L1 expression rate, CCRT regimens, interval between the end of radiotherapy and the start of durvalumab maintenance therapy, and reasons for discontinuation of durvalumab maintenance.

Statistical analysis

Univariate analysis was performed using the Mann-Whitney U test for continuous variables and Fisher’s exact test for nominal variables. PFS, OS, and time to treatment failure (TTF) were analyzed using the Kaplan-Meier curves and differences in PFS, OS, and TTF between the two groups were assessed using a log-rank test. The starting date for PFS, OS, and TTF was the date of durvalumab treatment initiation. The TTF was capped at 365 days, the duration for which durvalumab therapy administration was possible. The significance level was set at P<0.05. Statistical analyses were performed using EZR (version 1.68) (19).

Results

Patient factors

Of the 65 patients, 30 (46.2%) completed 1-year durvalumab maintenance therapy. The reasons for discontinuation of durvalumab were disease progression in 20 patients (30.8%) and adverse events (AEs) in 15 patients (23.1%). Among the AEs, 12 cases of durvalumab discontinuation were due to radiation pneumonitis, two were due to immune-related AEs, and one was due to aspiration pneumonia (Figure 1). Three patient-initiated discontinuations for non-medical reasons—anxiety about continuing therapy, financial constraints, and refusal of treatment—were excluded from the primary analysis. In the refusal case, the treating physician judged that continuation was feasible; the decision to discontinue was made by the patient.

Comparing the differences in patient backgrounds, patients with adenocarcinoma had a significantly higher rate of durvalumab treatment completion (P=0.03; Table 1). The composition of the CCRT regimens included the following: weekly carboplatin + paclitaxel [administered weekly: six cycles, carboplatin (area under the curve =2, day 1), paclitaxel (40 mg/m², day 1)], low-dose carboplatin [administered weekly: six cycles, carboplatin (30 mg/m², daily)], cisplatin + docetaxel [every 4 weeks: two cycles, cisplatin (40 mg/m², day 1, 8), docetaxel (40 mg/m², day 1, 8)], cisplatin + vinorelbine [every 4 weeks: two cycles, cisplatin (80 mg/m², day 1)], vinorelbine (20 mg/m², day 1, 8), and carboplatin + nanoparticle albumin-bound (nab)-paclitaxel (details unknown as we followed a regimen from another institution, carboplatin (day 1) nab-paclitaxel (day 1, 8, 15). Three of 15 patients (20%) who received low-dose carboplatin completed durvalumab maintenance therapy, which was a significantly lower completion rate than that of the other regimens (27/50 cases, 54%) (P=0.04, Table 1). If the value for any variable could not be determined, it was recorded as “Unknown”. The choice of CCRT regimen was largely at the treating physician’s discretion, guided by an overall clinical assessment that typically considered age, comorbidities, organ function, prior treatment-related toxicities, and the estimated risk of radiation pneumonitis or other radiation-related lung injury. Background clinical factors not readily captured by the ECOG PS were also taken into account.

Durvalumab maintenance therapy completion and survival

First, we focused on the differences in survival times between the completion and non-completion groups. The median PFS was 44.8 months in the completion group and 7.8 months in the non-completion group (P<0.001, Figure 2A). The median OS was not reached in the completion group, whereas it was 22.3 months in the non-completion group (P<0.001, Figure 2B).

Figure 2 Kaplan-Meier curves of PFS (A) and OS (B) for the durvalumab maintenance therapy completion and non-completion groups. CI, confidence interval; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression-free survival.

To exclude patients who discontinued durvalumab owing to progressive disease, a comparison between the treatment completion (n=30) and treatment discontinuation owing to AEs (n=15) groups was performed. This demonstrated that PFS tended to be longer in the treatment completion group compared to the discontinuation due to AEs group (median: 44.8 vs. 11.3 months, P=0.053, Figure 3A). Furthermore, OS was significantly longer in the treatment completion group (not reached vs. 26.3 months, P<0.001, Figure 3B).

Figure 3 Kaplan-Meier curves of PFS (A) and OS (B) for durvalumab maintenance therapy completion group and discontinuation due to AEs group. AE, adverse event; CI, confidence interval; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression-free survival.

Low-dose carboplatin therapy and survival

As mentioned previously, patients who received low-dose carboplatin as a CCRT regimen had a significantly lower completion rate of durvalumab maintenance therapy. Therefore, we compared the characteristics of patients treated with low-dose carboplatin to those of patients treated with CCRT regimens other than low-dose carboplatin (Table 2). The age of the low-dose carboplatin group (median: 78 years) was significantly higher than that of the non-low-dose carboplatin group (median: 66 years) (P<0.001). In contrast, the distribution of ECOG PS (0/1/2) did not differ between groups (P=0.77/1.00/0.55). Although the median PFS was not significantly different between the low-dose carboplatin and non-low-dose carboplatin groups (19.5 vs. 21.8 months, P=0.44, Figure 4A), the median OS tended to be shorter in the low-dose carboplatin group (47 months vs. not reached, P=0.06, Figure 4B). Furthermore, the median TTF was significantly shorter in the low-dose carboplatin group (3.8 months vs. not reached, P=0.002; Figure 4C) than in the non-low-dose carboplatin group. Subsequently, multivariate analysis was performed, incorporating age (≥75 vs. <75 years), histology (adenocarcinoma vs. non-adenocarcinoma), and CCRT regimen (low-dose carboplatin vs. non-low-dose carboplatin) (Table 3). The results indicated that TTF was significantly shorter and OS tended to be worse in the low-dose carboplatin group.

Figure 4 Kaplan-Meier curves of PFS (A), OS (B), and TTF (C) for the low-dose carboplatin and non-low-dose carboplatin groups. CBDCA, carboplatin; CI, confidence interval; NA, not applicable; NR, not reached; OS, overall survival; PFS, progression-free survival; TTF, time to treatment failure.

Discussion

This study investigated the factors associated with non-completion of one year of durvalumab maintenance therapy in patients with unresectable stage III NSCLC following CCRT. The study analyzed 65 patients and found that 53.8% of them did not complete durvalumab therapy. Patients who failed to complete the durvalumab maintenance therapy had significantly shorter PFS and OS, suggesting that treatment completion may significantly affect patient prognosis. The real-world outcomes observed in our cohort were broadly concordant with previously reported real-world data (13-16). Specifically, the completion rate of durvalumab maintenance therapy was approximately half, and treatment discontinuations were predominantly attributable to disease progression and pneumonitis. On multivariable analysis, use of a low-dose carboplatin regimen was associated with a lower likelihood of completing the planned 12 months of durvalumab maintenance, whereas adenocarcinoma histology was associated with a higher likelihood of completion. Further analyses revealed that patients treated with low-dose carboplatin had a significantly shorter TTF of durvalumab and tended to have shorter OS. In a previous phase III study, OS was significantly improved in patients aged ≥71 years when low-dose carboplatin therapy was compared to radiation therapy alone (20). Based on these results, the low-dose carboplatin CCRT regimen is used in Japan for selected older patients, particularly those considered clinically vulnerable. Compared with platinum-doublet CCRT, low-dose carboplatin has the advantage of fewer AEs. However, fewer AEs do not necessarily indicate higher therapeutic efficacy. Our results suggest that the therapeutic effects of durvalumab maintenance therapy after low-dose carboplatin treatment may be less favorable than those of durvalumab after platinum-doublet CCRT. A post-hoc exploratory analysis of the PACIFIC study evaluated the therapeutic effects of types of CCRT regimens followed by durvalumab therapy (21). However, only four patients (0.8%) received low-dose carboplatin in the PACIFIC study (11). The present study is the first to identify lower completion rates of durvalumab after low-dose carboplatin therapy, highlighting the need for alternative treatment strategies. Although the PS distribution was comparable (PS 0/1/2; P=0.77/1.00/0.55), the low-dose carboplatin group was significantly older (median age 78 vs. 66 years, P<0.001, Table 2), suggesting the potential presence of confounding factors such as age and frailty related to patient background in this comparison. The pronounced age imbalance suggests that the observed differences may reflect not only a direct effect of the regimen itself but also treatment-selection effects related to age and clinical vulnerability.

In the PACIFIC trial, the completion rate of durvalumab maintenance therapy was 42.7%, and 31.3% of the patients discontinued durvalumab maintenance therapy because of disease progression (11). The results of our real-world clinical practice are consistent with those observed in the clinical trial. The completion rate of durvalumab therapy was significantly higher in patients with adenocarcinoma than in those with other histological types. This trend is similar to that in previous reports comparing adenocarcinoma and squamous cell carcinoma in patients who underwent durvalumab maintenance therapy after CCRT (22). Among NSCLC cases, smoking is epidemiologically considered to be the most significant risk factor for squamous cell carcinoma (23,24). Additionally, complications, such as chronic obstructive pulmonary disease and cardiovascular diseases, which may be promoted by atherosclerosis, are highly likely to be induced by smoking (25). Compared to patients with adenocarcinoma, patients with squamous cell carcinoma may inherently have various underlying diseases, which could account for this difference.

This single-center, retrospective analysis of 65 patients with a relatively small sample size, derived from routine clinical practice data, is inherently susceptible to selection and information biases; therefore, residual and unmeasured confounding cannot be excluded, and statistical power, particularly for subgroup analyses, is limited. Although we adjusted for key confounders, residual confounding from unmeasured variables may influence our findings. Because of the small sample size, we were not able to perform formal testing of the comparative superiority of individual regimens; these issues remain to be clarified in future studies. In addition, several chemotherapy regimens used in this cohort reflect Japanese practice patterns and are less commonly used in other countries, which may further limit the generalizability of our findings. This study is a retrospective analysis, and because molecular testing at diagnosis was not routinely performed for locally advanced NSCLC in earlier periods, many patients did not undergo comprehensive testing. Considering the ongoing debate regarding the efficacy of immunotherapy following chemoradiotherapy in NSCLC harboring targetable driver gene mutations, particularly among Asian populations, the possibility of unmeasured confounding cannot be excluded (26-28). Finally, as this study was conducted at a single institution, the results may not be generalizable to other settings or patient populations.

Conclusions

This study revealed that patients receiving low-dose carboplatin had lower completion rates, shorter TTF, worse OS than non-low-dose carboplatin, and were more likely to be older individuals. In summary, these findings highlight that both the choice of CCRT regimen and the feasibility of the CCRT regimen significantly impact durvalumab completion and clinical outcomes. Accordingly, treatment planning should take into careful account the patient’s background and, when durvalumab maintenance is deemed unlikely, re-examine the appropriateness of more intensive platinum-doublet CCRT or alternative strategies, rather than routine use of low-dose carboplatin.

Acknowledgments

The authors thank the patients, their families, and all study investigators for their contributions to the study.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-739/rc

Data Sharing Statement: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-739/dss

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2025-739/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-2025-739/coif). S.W. reports speaking fees from Lilly, Chugai Pharma, Ono Pharmaceutical, Taiho Pharmaceutical, Kyowa Kirin, Takeda Pharmaceutical, AstraZeneca, Novartis Pharma, Bristol-Myers, Daiichi Sankyo, Nippon Kayaku, Merck, and Celltrion, outside of the submitted work. T.K. reports grants to his institution from Nobelpharma, Taiho Pharmaceutical, Shionogi, Asahi Kasei, Nippon Kayaku, Boehringer Ingelheim, KYORIN Pharmaceutical, Chugai Pharma, Daiichi Sankyo, and TEIJIN PHARMA; consulting fees from AN2 Therapeutics; speaking fees from Viatris, Insmed, Terumo, AstraZeneca, KYORIN Pharmaceutical, Bristol-Myers, Eisai, Chugai Pharma, MSD, Shionogi, Astellas Pharma, Boehringer Ingelheim, Daiichi Sankyo, Ono Pharmaceutical, GSK, Kyowa Kirin, TSUMURA, Gilead Sciences, Kracie, Pfizer Japan, Merck, Asahi Kasei Pharma, Japan Blood Products Organization, Sumitomo Pharma, Nippon Kayaku, NIPPON SHINYAKU, and Takeda Pharmaceuticals; participation on an Advisory Board for Janssen Pharmaceutical; and receipt of drugs from Nobelpharma, all outside of the submitted work. 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 Review Committee of Niigata University (approval No. 2022-0312). Consent to participate was obtained using the opt-out method from the Department of Pharmacy at Niigata University Medical and Dental Hospital, Japan. This was a retrospective observational study; therefore, it did not intervene with any clinical practice for participants.

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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