Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Patient Selection
2.3. Assessment
2.4. Endpoints
2.5. Statistical Analysis
3. Results
3.1. Patient Characteristics
3.2. Baseline Characteristics and Treatment Exposure
3.3. Primary Endpoint
EORTC QLQ-C30 Other Analyses
3.4. Secondary Endpoints
3.4.1. Tumor Response
3.4.2. Progression-Free Survival
3.4.3. Overall Survival
3.5. Subsequent Therapies following Aflibercept Plus FOLFIRI
3.6. Safety
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Baseline Characteristic | ITT/Safety Set (n = 1277) | QoL Set (n = 872) |
---|---|---|
Sex, n (%) | ||
Male | 827 (64.8) | 561 (64.3) |
Female | 450 (35.2) | 311 (35.7) |
Age, years | ||
Median (range) | 66 (28–90) | 66 (28–88) |
<70, n (%) | 785 (61.5) | 564 (64.7) |
70 < 75, n (%) | 259 (20.3) | 165 (18.9) |
≥75, n (%) | 233 (18.3) | 143 (16.4) |
Comorbidities, n (%) | ||
Cardiovascular | 625 (48.9) | 411 (47.1) |
Diabetes | 210 (16.4) | 134 (15.4) |
Dyslipidemia | 67 (5.2) | 39 (4.5) |
Kidney or liver | 79 (6.2) | 48 (5.5) |
disorders | ||
Lung disorders | 77 (6.0) | 51 (5.8) |
ECOG, n (%) | ||
0–1 | 1082 (84.7) | 761 (87.3) |
2–3 | 85 (6.7) | 37 (4.2) |
Missing | 110 (8.6) | 74 (8.5) |
Histology, n (%) | ||
Adenocarcinoma | 1228 (96.2) | 841 (96.4) |
Other | 9 (0.7) | 6 (0.7) |
N/A | 40 (3.1) | 25 (2.9) |
Tumor location, n (%) | ||
Right colon | 352 (27.6) | 245 (28.1) |
Left colon | 885 (69.3) | 607 (69.6) |
Metastatic sites, n (%) | ||
Liver | 679 (53.2) | 475 (54.5) |
Lung | 220 (17.2) | 161 (18.5) |
Peritoneum | 156 (12.2) | 108 (12.4) |
Lymph nodes | 143 (11.2) | 93 (10.7) |
Other | 60 (4.7) | 37 (4.2) |
RAS status, n (%) | ||
RAS wild-type | 497 (38.9) | 339 (38.9) |
RAS mutant | 648 (50.7) | 450 (51.6) |
N/A | 132 (10.3) | 83 (9.5) |
Prior targeted therapy, n (%) | ||
VEGF-I | 688 (53.9) | 469 (53.8) |
EGFR-I | 168 (13.2) | 122 (14.0) |
VEGF-I + EGFR-I | 193 (15.1) | 124 (14.2) |
None | 228 (17.9) | 157 (18.0) |
OS, Months | PFS, Months | Tumor Response, n (%) | ||||||
---|---|---|---|---|---|---|---|---|
N | Median | 95% CI | Median | 95% CI | N | CR + PR | DCR | |
Overall | 1265 | 14.4 | 13.1–18.1 | 7.8 | 7.3–8.3 | 674 | 140 (20.8) | 466 (70.0) |
RAS status | ||||||||
RAS wt | 492 | 15.4 | 12.2–23.6 | 7.7 | 6.9–9.4 | 250 | 52 (20.8) | 175 (69.1) |
RAS mutant | 645 | 14.1 | 11.7–19.4 | 7.7 | 6.8–8.1 | 362 | 77 (21.3) | 21 (66.6) |
Sex | ||||||||
Male | 820 | 14.2 | 12.5–16.8 | 7.9 | 7.3–8.9 | 432 | 93 (21.5) | 304 (70.4) |
Female | 445 | 19.4 | 11.8–23.6 | 7.5 | 6.4–8.3 | 242 | 47 (19.4) | 162 (66.9) |
Therapy line | ||||||||
1L | 82 | NR | 14.4–NR | 13.1 | 9.2–26.5 | 48 | 16 (33.3) | 42 (87.5) |
2L | 636 | 15.2 | 12.8–19.5 | 8.1 | 7.6–9.0 | 350 | 84 (24.0) | 255 (72.9) |
3L | 293 | 13.2 | 10.2–27.0 | 7.4 | 6.3–8.5 | 143 | 22 (15.4) | 89 (62.2) |
>3L | 247 | 11.1 | 9.4–16.4 | 5.9 | 5.5–6.9 | 130 | 17 (13.1) | 77 (59.2) |
Prior targeted therapy | ||||||||
None | 225 | 19.6 | 14.4-NR | 11.6 | 8.7–12.6 | 114 | 33 (28.9) | 93 (81.6) |
EGFR-I | 168 | 17.4 | 10.5–33.7 | 9.5 | 6.5–12.9 | 93 | 22 (23.7) | 73 (78.5) |
VEGF-I | 681 | 14.0 | 11.1–19.4 | 7.3 | 6.3–7.9 | 376 | 73 (19.4) | 245 (65.2) |
Both | 191 | 10.1 | 8.3–16.4 | 6.2 | 5.2–8.1 | 91 | 12 (13.2) | 55 (60.4) |
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Hofheinz, R.-D.; Anchisi, S.; Grünberger, B.; Derigs, H.G.; Zahn, M.-O.; Geffriaud-Ricouard, C.; Gueldner, M.; Windemuth-Kieselbach, C.; Pederiva, S.; Bohanes, P.; et al. Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study. Cancers 2022, 14, 3522. https://doi.org/10.3390/cancers14143522
Hofheinz R-D, Anchisi S, Grünberger B, Derigs HG, Zahn M-O, Geffriaud-Ricouard C, Gueldner M, Windemuth-Kieselbach C, Pederiva S, Bohanes P, et al. Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study. Cancers. 2022; 14(14):3522. https://doi.org/10.3390/cancers14143522
Chicago/Turabian StyleHofheinz, Ralf-Dieter, Sandro Anchisi, Birgit Grünberger, Hans G. Derigs, Mark-Oliver Zahn, Christine Geffriaud-Ricouard, Max Gueldner, Christine Windemuth-Kieselbach, Stefanie Pederiva, Pierre Bohanes, and et al. 2022. "Real-World Evaluation of Quality of Life, Effectiveness, and Safety of Aflibercept Plus FOLFIRI in Patients with Metastatic Colorectal Cancer: The Prospective QoLiTrap Study" Cancers 14, no. 14: 3522. https://doi.org/10.3390/cancers14143522