Is the Efficacy of Adding Ramucirumab to Docetaxel Related to a History of Immune Checkpoint Inhibitors in the Real-World Clinical Practice?
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patients and Study Design
2.2. Ethical Statement
2.3. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Tumor Overall Response Rate and the Disease Control Rate
3.3. Survival Analysis
3.4. Univariate Analyses
3.5. Multivariate Analysis
3.6. Propensity Score Analysis
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Variables | DTX | DTX/RAM | p-Values | ICI-Untreated | ICI-Pretreated | p-Value | |
---|---|---|---|---|---|---|---|
(n = 50) | (n = 43) | (n = 48) | (n = 45) | ||||
Age (years) (%) | <75 | 32 (64.0) | 30 (69.8) | 0.66 | 32 (66.7) | 30 (66.7) | 1 |
≥75 | 18 (36.0) | 13 (30.2) | 16 (33.3) | 15 (33.3) | |||
Gender (%) | Female | 8 (16.0) | 20 (46.5) | 0.002 | 20 (41.7) | 8 (17.8) | 0.014 |
Male | 42 (84.0) | 23 (53.5) | 28 (58.3) | 37 (82.2) | |||
ECOG PS (%) | 0 | 19 (38.0) | 26 (60.5) | 0.014 | 22 (45.8) | 23 (51.1) | 0.686 |
1 | 25 (50.0) | 12 (27.9) | 21 (43.8) | 16 (35.6) | |||
2 | 0 (0.0) | 3 (7.0) | 2 (4.2) | 1 (2.2) | |||
3 | 6 (12.0) | 2 (4.7) | 3 (6.2) | 5 (11.1) | |||
Smoking status (%) | Non-smoker | 5 (10.0) | 13 (30.2) | 0.018 | 15 (31.2) | 3 (6.7) | 0.003 |
Smoker | 45 (90.0) | 30 (69.8) | 33 (68.8) | 42 (93.3) | |||
Lung honeycombing (%) | Negative | 47 (94.0) | 43 (100.0) | 0.246 | 45 (93.8) | 45 (100) | 0.243 |
Positive | 3 (6.0) | 0 (0.0) | 3 (6.2) | 0 (0.0) | |||
Disease stage (%) | II | 2 (4.0) | 0 (0.0) | 0.385 | 1 (2.1) | 1 (2.2) | 0.23 |
III | 16 (32.0) | 10 (23.3) | 10 (20.8) | 16 (35.6) | |||
IV | 27 (54.0) | 24 (55.8) | 31 (64.6) | 20 (44.4) | |||
Recurrence | 5 (10.0) | 9 (20.9) | 6 (12.5) | 8 (17.8) | |||
Histology (%) | Adenocarcinoma | 23 (46.0) | 36 (83.7) | <0.001 | 36 (75.0) | 23 (51.1) | 0.045 |
Squamous cell carcinoma | 24 (48.0) | 5 (11.6) | 10 (20.8) | 19 (42.2) | |||
Large cell carcinoma | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (2.2) | |||
NOS | 3 (6.0) | 1 (2.3) | 2 (4.2) | 2 (4.4) | |||
ALK transfusion (%) | Wild type | 34 (68.0) | 41 (95.3) | <0.001 | 40 (83.3) | 35 (77.8) | 0.424 |
Positive | 0 (0.0) | 1 (2.3) | 1 (2.1) | 0 (0.0) | |||
Not evaluated | 16 (32.0) | 1 (2.3) | 7 (14.6) | 10 (22.2) | |||
EGFR Mutation (%) | Wild type | 41 (82.0) | 29 (67.4) | 0.004 | 28 (58.3) | 42 (93.3) | <0.001 |
Exon 19 deletion | 5 (10.0) | 7 (16.3) | 11 (22.9) | 1 (2.2) | |||
Exon 21 L858R | 0 (0.0) | 6 (14.0) | 6 (12.5) | 0 (0.0) | |||
Exon 20 insertion | 0 (0.0) | 1 (2.3) | 1 (2.1) | 0 (0.0) | |||
Not evaluated | 4 (8.0) | 0 (0.0) | 2 (4.2) | 2 (4.4) | |||
EGFR and ALK (%) | Wild type or not evaluated | 46 (92.0) | 28 (65.1) | 0.002 | 29 (61.7) | 45 (97.8) | <0.001 |
Mutation positive | 4 (8.0) | 15 (34.9) | 18 (38.3) | 1 (2.2) | |||
PD-L1 status (%) | <1% | 16 (32.0) | 7 (16.3) | 0.162 | 13 (27.1) | 10 (22.2) | 0.017 |
1–49% | 11 (22.0) | 7 (16.3) | 6 (12.5) | 12 (26.7) | |||
>50% | 8 (16.0) | 7 (16.3) | 4 (8.3) | 11 (24.4) | |||
Unknown | 15 (30.0) | 22 (51.2) | 25 (52.1) | 12 (26.7) | |||
Previous ICI treatment (%) | None | 22 (44.0) | 26 (60.5) | 0.128 | 48 (100.0) | 0 (0.0) | <0.001 |
Atezolizumab | 3 (6.0) | 1 (2.3) | 0 (0.0) | 4 (8.9) | |||
Nivolumab | 7 (14.0) | 4 (9.3) | 0 (0.0) | 11 (24.4) | |||
Pembrolizumab | 9 (18.0) | 4 (9.3) | 0 (0.0) | 13 (28.9) | |||
CBDCA + nab-PTX + Atezolzumab | 0 (0.0) | 1 (2.3) | 0 (0.0) | 1 (2.2) | |||
CBDCA + PEM + Pembrolizumab | 2 (4.0) | 6 (14.0) | 0 (0.0) | 8 (17.8) | |||
CBDCA + nab-PTX + Pembrolizumab | 6 (12.0) | 1 (2.3) | 0 (0.0) | 7 (15.6) | |||
CBDCA + PTX + Durvalumab | 1 (2.0) | 0 (0.0) | 0 (0.0) | 1 (2.2) | |||
Findings of interstitial pneumonia (%) | Negative | 44 (88.0) | 40 (93.0) | 0.498 | 41 (85.4) | 43 (95.6) | 0.16 |
Positive | 6 (12.0) | 3 (7.0) | 7 (14.6) | 2 (4.4) |
All Patients | |||
---|---|---|---|
Docetaxel | Docetaxel/Ramucirumab | p-Value | |
n | 50 | 43 | 0.017 |
Complete response (%) | 0 (0.0) | 1 (2.3) | |
Partial response (%) | 5 (10.0) | 11 (25.6) | |
Stable disease (%) | 19 (38.0) | 13 (30.2) | |
Progressive disease (%) | 22 (44.0) | 9 (20.9) | |
Not evaluated (%) | 4 (8.0) | 9 (20.9) | |
Overall response rate (%) | 5 (10.9, 95% CI 3.6–23.6) | 12 (35.3, 95% CI 19.7–53.5) | |
Disease control rate (%) | 14 (30.4 95% CI 17.7–45.8) | 25 (73.5, 95% CI 55.6–87.1) | |
Docetaxel/ramucirumab-treated group | |||
ICI-untreated group | ICI-pretreated group | p-Value | |
n | 26 | 17 | 0.047 |
Complete response (%) | 1 (3.8) | 0 (0.0) | |
Partial response (%) | 3 (11.5) | 8 (47.1) | |
Stable disease (%) | 11 (42.3) | 2 (11.8) | |
Progressive disease (%) | 5 (19.2) | 4 (23.5) | |
Not evaluated (%) | 6 (23.1) | 3 (17.6) | |
Overall response rate (%) | 4 (20.0, 95% CI 5.7–43.7) | 8 (57.1, 95% CI 28.9–82.3) | |
Disease control rate (%) | 15 (75.0, 95% CI 50.9–91.3) | 10 (71.4 95% CI 41.9–91.6) | |
Docetaxel-treated group | |||
ICI-untreated group | ICI-pretreated group | p-Value | |
n | 22 | 28 | 0.639 |
Complete response (%) | 0 (0.0) | 0 (0.0) | |
Partial response (%) | 1 (4.5) | 4 (14.3) | |
Stable disease (%) | 10 (45.5) | 9 (32.1) | |
Progressive disease (%) | 9 (40.9) | 13 (46.4) | |
Not evaluated (%) | 2 (9.1) | 2 (7.1) | |
Overall response rate (%) | 1 (5.0, 95% CI 0.10–24.9) | 4 (15.4, 95% CI 4.4–34.9) | |
Disease control rate (%) | 11 (55, 95% CI 31.5–76.9) | 13 (50, 95% CI 29.9–70.1) |
Time-to-Treatment Failure | ||||||
---|---|---|---|---|---|---|
Independent Variables | Univariate Analysis | Multivariate Analysis | ||||
n | Hazard ratio (95% CI) | p-Value | Hazard ratio (95% CI) | p-Value | ||
Treatment | DTX | 50 | Ref | 0.055 | Ref | 0.12 |
DTX/RAM | 43 | 0.65 (0.42–1.01) | 0.66 (0.40–1.11) | |||
Previous ICI treatment | ICI-untreated | 48 | Ref | 0.32 | Ref | 0.25 |
ICI-pretreated | 45 | 1.23 (0.81–1.88) | 1.35 (0.81–2.23) | |||
Age (years) | <75 | 62 | Ref | 0.26 | Ref | 0.049 |
≥75 | 31 | 1.29 (0.82–2.03) | 1.66 (1.00–2.77) | |||
ECOG PS | 0 or 1 | 82 | Ref | 0.0064 | Ref | 0.052 |
≥2 | 11 | 2.47 (1.28–4.74) | 2.04 (1.00–4.17) | |||
EGFR and ALK Status | Wild type | 74 | Ref | 0.64 | Ref | 0.62 |
Positive | 19 | 0.88 (0.52–1.48) | 1.17 (0.63–2.17) | |||
Histology | Non-squamous cell | 64 | Ref | 0.2 | Ref | 0.99 |
Squamous cell | 29 | 1.34 (0.85–2.12) | 1.00 (0.57–1.75) | |||
CT honeycombing | negative | 90 | Ref | 0.0045 | Ref | 0.018 |
positive | 3 | 5.77 (1.72–19.39) | 5.45 (1.34–22.19) | |||
Overall survival | ||||||
Univariate analysis | Multivariate analysis | |||||
n | Hazard ratio (95% CI) | p-Value | Hazard ratio (95% CI) | p-Value | ||
Treatment | DTX | 50 | Ref | 0.00041 | Ref | 0.006 |
DTX/RAM | 43 | 0.39 (0.23–0.66) | 0.38 (0.19–0.76) | |||
Previous ICI treatment | ICI-untreated | 48 | Ref | 0.055 | Ref | 0.12 |
ICI-pretreated | 45 | 1.61 (0.98–2.64) | 1.58 (0.89–2.81) | |||
Age (years) | <75 | 62 | Ref | 0.12 | Ref | 0.013 |
≥75 | 31 | 1.49 (0.89–2.49) | 2.01 (1.16–3.48) | |||
ECOG PS | 0 or 1 | 82 | Ref | 0.0022 | Ref | 0.033 |
≥2 | 11 | 3.06 (1.49–6.28) | 2.39 (1.08–5.30) | |||
EGFR and ALK Status | Wild type | 74 | Ref | 0.44 | Ref | 0.27 |
Positive | 19 | 0.79 (0.43–1.43) | 1.56 (0.71–3.42) | |||
Histology | Non-squamous cell | 64 | Ref | 0.018 | Ref | 0.56 |
Squamous cell | 29 | 1.86 (1.11–3.11) | 1.20 (0.65–2.24) | |||
CT honeycombing | Negative | 90 | Ref | 0.0079 | Ref | 0.045 |
Positive | 3 | 5.01 (1.52–16.53) | 4.18 (1.03–16.92) |
n | Time-to-Treatment Failure | Overall Survival | ||||
---|---|---|---|---|---|---|
Treatment | Hazard Ratio (95% CI) | p-Value | Hazard Ratio (95% CI) | p-Value | ||
Unadjusted | DTX | 50 | Ref | 0.055 | Ref | 0.00041 |
DTX/RAM | 43 | 0.65 (0.42–1.01) | 0.39 (0.23–0.66) | |||
IPTW-weighted | DTX | 49 | Ref | 0.16 | Ref | 0.00018 |
DTX/RAM | 41 | 0.69 (0.41–1.16) | 0.37 (0.22–0.62) | |||
1:1 Matching | DTX | 22 | Ref | 0.22 | Ref | 0.0034 |
DTX/RAM | 26 | 0.69 (0.38–1.25) | 0.32 (0.15–0.68) | |||
Unadjusted | ICI-untreated | 48 | Ref | 0.32 | Ref | 0.055 |
ICI-pretreated | 45 | 1.23 (0.81–1.88) | 1.61 (0.98–2.64) | |||
IPTW-weighted | ICI-untreated | 48 | Ref | 0.35 | Ref | 0.52 |
ICI-pretreated | 45 | 0.68 (0.30–1.53) | 1.28 (0.59–2.79) | |||
1:1 Matching | ICI-untreated | 23 | Ref | 0.5 | Ref | 0.25 |
ICI-pretreated | 23 | 1.23 (0.66–2.27) | 1.54 (0.73–3.22) |
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Nishimura, T.; Fujimoto, H.; Okano, T.; Naito, M.; Tsuji, C.; Iwanaka, S.; Sakakura, Y.; Yasuma, T.; D’Alessandro-Gabazza, C.N.; Oomoto, Y.; et al. Is the Efficacy of Adding Ramucirumab to Docetaxel Related to a History of Immune Checkpoint Inhibitors in the Real-World Clinical Practice? Cancers 2022, 14, 2970. https://doi.org/10.3390/cancers14122970
Nishimura T, Fujimoto H, Okano T, Naito M, Tsuji C, Iwanaka S, Sakakura Y, Yasuma T, D’Alessandro-Gabazza CN, Oomoto Y, et al. Is the Efficacy of Adding Ramucirumab to Docetaxel Related to a History of Immune Checkpoint Inhibitors in the Real-World Clinical Practice? Cancers. 2022; 14(12):2970. https://doi.org/10.3390/cancers14122970
Chicago/Turabian StyleNishimura, Tadashi, Hajime Fujimoto, Tomohito Okano, Masahiro Naito, Chikashi Tsuji, Soichi Iwanaka, Yasumasa Sakakura, Taro Yasuma, Corina N. D’Alessandro-Gabazza, Yasuhiro Oomoto, and et al. 2022. "Is the Efficacy of Adding Ramucirumab to Docetaxel Related to a History of Immune Checkpoint Inhibitors in the Real-World Clinical Practice?" Cancers 14, no. 12: 2970. https://doi.org/10.3390/cancers14122970