A Historical Misconception in Clinical Trials of Drugs for Cancer—Age Grouping
Abstract
:1. Introduction
2. Life Stage, Age, and Cancers
2.1. Age-Specific Cancers
2.2. Age Grouping in Clinical Trials
2.3. The Disagreement between Age and Life Stage
2.4. The Difference in Response to Cancer Drug Treatment between Different Life Stages Is More than the Difference between Arbitrarily Divided Age Groups
2.5. Lack of Study on Drugs of Age Specificity
2.6. Current Considerations for Cancer Treatment of Different Ages
2.7. Hormone Levels and Life Stages
2.8. Immune System and Life Stages
3. Cancer Therapy Design and Life Stages
3.1. Body Growth and the Early Drugs of Chemotherapy
3.2. Life Stages and Targeted Therapy
3.3. Life Stages and Immune Checkpoint Inhibitors
3.4. Life Stages and Molecular Radiotherapy
4. Grouping According to Life Stage and Detailed Analyses
5. Conclusions
5.1. Basic Research to Understand Similarities and Differences in Cancer Development and Differences among Life Stages
5.2. Preclinical Test of the Similarities and Differences Using Animal Models
5.3. Standardization of Life Stage Grouping in Drug Test Protocols
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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First Author/Reference | Disease | Age Groups in Treament Population | Age Groups in Ontrol/Other Treatment Population | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Median | ≥75 | <75 | 65–75 | <65 | ≥65 | Median | ≥75 | <75 | 65–75 | <65 | ≥65 | ||
Cheng [8] | Extensive-Stage Small Cell Lung Cancer | 63 (28–76) | 235 (60.4) | 62 (31–83) | 119 (60.7) | ||||||||
O’Brien [9] | completely resected stage IB-IIIA non-small-cell lung cancer | 65 (59.0–70.0) | 285 (48%) | 305 (52%) | 65 (59.0–70.0) | 273 (47%) | 314 (53%) | ||||||
64.5 (60.0–69.5) | 84 (50%) | 84 (50%) | 65.0 (58.0–71.0) | 82 (50%) | 82 (50%) | ||||||||
Kogure [10] | squamous non-small-cell lung cancer | 76 (73–78) | 61 (64%) | 34 (36%) | 77 (73–80) | 65 (67%) | 32 (33%) | ||||||
Peters [11] | metastatic NSCLC | 66 (39–89) | 108 (46) | 66 (33–86) | 102 (43) | ||||||||
65 (39–89) | 72 (50) | 66 (40–86) | 65 (45) | ||||||||||
Westeel [12] | completely resected non-small-cell lung cancer | 63.0 (56.7–70.5) | |||||||||||
Lu [13] | EGFR-mutated non-squamous non-small-cell lung cancer | 59 (32–75) | 104 | 44 | 57 (33–78) | 115 | 36 | ||||||
Wang [14] | extensive-stage small-cell lung cancer | 62 (55–66) | 155 (67%) | 75 (33%) | 62 (56–67) | 147 (63%) | 85 (37%) | ||||||
Saji [15] | small-sized peripheral non-small-cell lung cancer | 67 (35–85) | 211 | 341 | 67 (32–83) | 211 | 343 | ||||||
Forde [16] | Resectable Lung Cancer | 64 (41–82) | 93 (52.0) | 86 (48.0) | 65 (34–84) | 83 (46.4) | 96 (53.6) | ||||||
Zhou [17] | metastatic non-small-cell lung cancer | 62.0 (56.0–67.0) | 202 (63%) | 118 (37%) | 64.0 (56.0–68.0) | 91 (57%) | 68 (43%) | ||||||
Hellmann [18] | Advanced Non-Small-Cell Lung Cancer | 64 (26–87) | 58 (9.9) | 219 (37.6) | 306 (52.5) | 64 (29–87) | 55 (9.4) | 223 (38.3) | 305 (52.3) |
First Author/Reference | Disease | Age Groups in Treament Population | Age Groups in Ontrol/Other Treatment Population | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Age groups | Median | ≥70 | 60–69 | 50–59 | <50 | Median | ≥70 | 60–69 | 50–59 | <50 | |
Chua [19] | Non-low-risk ductal carcinoma in situ in the breast | 58 (52–64) | 74 (9%) | 292 (36%) | 306 (38%) | 133 (17%) | 57 (51–65) | 71 (9%) | 267 (33%) | 334 (42%) | 131 (16%) |
Age groups | Median | ≥40 | <40 | Median | ≥40 | <40 | |||||
Wang [20] | Metastatic triple-negative breast cancer | 50 (22–69) | 101 (79.5) | 26 (20.5) | 52 (30–75) | 107 (85.0) | 19 (15.0) | ||||
Age groups | Median | Median | |||||||||
Tripathy [21] | Metastatic Breast Cancer and Brain Metastases | 53 (27–79) | 52 (24–77) | ||||||||
Age groups | Median | <65 | ≥65 | Median | <65 | ≥65 | |||||
Xu [22] | Hormone receptor-positive and HER2-negative advanced breast cancer | 211 | 30 | 108 | 12 | ||||||
Age groups | Median | ≥76 | 65–75 | 55–64 | <55 | Median | ≥76 | 65–75 | 55–64 | <55 | |
Del Mastro [23] | Early-stage breast cancer | 60 (54–67) | 58 | 304 | 393 | 275 | 61 (54–68) | 56 | 343 | 386 | 271 |
Age groups | median (IQR) | ≥50 | <50 | median (IQR) | ≥50 | <50 | |||||
van der Voort [24] | ERBB2-Positive Breast Cancer | 49 (43–55) | 1101 | 118 | 48(43-56) | 100 | 119 | ||||
Age groups | median (IQR) | >50 | ≤50 | median (IQR) | >50 | ≤50 | |||||
Mayer [25] | Early breast cancer | 52 (45–61) | 1573 | 1309 | 52 (45–60) | 1370 | 1304 | ||||
Age groups | Median age(IQR) | ≤35 | >35 | Median age (IQR) | ≤35 | >35 | |||||
Yu [26] | Young Women With Breast Cancer | 35 (32–38) | 145 (55.6) | 116 (44.4) | 35 (31-37) | 139 (53.5) | 121 (46.5) |
First Author/Reference | Disease | Age Groups in Treatment Population | Age Groups in Control/Other Treatment Population | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Median | ≥10 | 1–10 | <1 | Median | ≥10 | 1–10 | <1 | ||||||
Yang [27] | Acute lymphoblastic leukemia | 21 (1.46) | 1421 (98.54) | 0 | 23 (1.55) | 1458 (98.45) | 0 | ||||||
263 (24.56) | 777 (72.55) | 31 (2.90) | 265 (25.00) | 758 (71.51) | 37 (3.49) | ||||||||
Age groups | Total | 16–30 | 10–15 | 1–9 | Analysis | ≥16 Years | <16 Years | ||||||
Burke [28] | High-risk B-lymphoblastic leukemia | 3040 | 20% | 47% | 33% | 597 | 2443 | ||||||
Age groups | Median | 10–18 | 1–9 | Median | 10–18 | 1–9 | |||||||
Locatelli [29] | High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia | 6 (1–17) | 15 (27.8) | 39 (72.2) | 5 (1-17) | 16 (29.6) | 38 (70.4) | ||||||
Age groups | Median (IQR) | 21–27 | 18–20 | 13–17 | 10–12 | 1–9 | Median (IQR) | 21–27 | 18–20 | 13–17 | 10–12 | 1–9 | |
Brown [30] | First Relapse of B-Cell Acute Lymphoblastic Leukemia | 9 (6–16) | 7 (6.7) | 8 (7.6) | 25 (23.8) | 10 (9.5) | 55 (52.4) | 9 (5–16) | 8 (7.8) | 10 (9.7) | 19 (18.4) | 11 (10.7) | 55 (53.4) |
Age groups | Total | >14 | >10–14 | >6–10 | 4–6 | Median | >14 | >10–14 | >6–10 | 4–6 | |||
Peters [31] | Childhood acute lymphoblastic leukemia | 212 | 48 (23%) | 64 (30%) | 66 (31%) | 34(16%) | 201 | 62 (31%) | 42 (21%) | 75 (37%) | 22 (11%) | ||
Age groups | ≥10 | 1–9 | ≥10 | 1–9 | |||||||||
Shen [32] | Pediatric Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia | 60 | 123 | X | X | ||||||||
Age groups | Overall | ≥10 | <10 | ≥10 | <10 | ||||||||
Place [33] | Newly diagnosed childhood acute lymphoblastic leukaemia | 551 | 55 (24%) | 176 (76%) | 67 (29%) | 165 (71%) |
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Chen, J.; Yao, L.; Alamoudi, A.J.; Aleya, L.; Gu, W. A Historical Misconception in Clinical Trials of Drugs for Cancer—Age Grouping. J. Pers. Med. 2022, 12, 1998. https://doi.org/10.3390/jpm12121998
Chen J, Yao L, Alamoudi AJ, Aleya L, Gu W. A Historical Misconception in Clinical Trials of Drugs for Cancer—Age Grouping. Journal of Personalized Medicine. 2022; 12(12):1998. https://doi.org/10.3390/jpm12121998
Chicago/Turabian StyleChen, Jingyu, Lan Yao, Abdulmohsin J. Alamoudi, Lotfi Aleya, and Weikuan Gu. 2022. "A Historical Misconception in Clinical Trials of Drugs for Cancer—Age Grouping" Journal of Personalized Medicine 12, no. 12: 1998. https://doi.org/10.3390/jpm12121998