JPM, Vol. 12, Pages 1998: A Historical Misconception in Clinical Trials of Drugs for Cancer—Age Grouping

Figure 1. Distribution of incidence rates and hormone levels. (A). The disease incident rate of Lymphocytic leukemia at different ages. (B). The disease incident rate of Breast cancer at different ages. (C). The disease incident rate of Colorectal cancer at different ages. (D). The levels of hormone at different life stages.

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Figure 2. Possible route to promote the use of life stages in clinical trials and therapeutic applications.

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Table 1. Age grouping in clinical trials of drugs for lung cancer.

Table 1. Age grouping in clinical trials of drugs for lung cancer.

First Author/ReferenceDiseaseAge Groups in Treament PopulationAge Groups in Ontrol/Other Treatment PopulationMedian≥75<7565–75<65≥65Median≥75<7565–75<65≥65Cheng [8]Extensive-Stage Small Cell Lung Cancer63 (28–76) 235 (60.4) 62 (31–83) 119 (60.7) O’Brien [9]completely resected stage IB-IIIA non-small-cell lung cancer65 (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 cancer76 (73–78)61 (64%)34 (36%) 77 (73–80)65 (67%)32 (33%) Peters [11]metastatic NSCLC66 (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 cancer63.0 (56.7–70.5) Lu [13]EGFR-mutated non-squamous non-small-cell lung cancer59 (32–75) 1044457 (33–78) 11536Wang [14]extensive-stage small-cell lung cancer62 (55–66) 155 (67%)75 (33%)62 (56–67) 147 (63%)85 (37%)Saji [15]small-sized peripheral non-small-cell lung cancer67 (35–85)211341 67 (32–83)211343 Forde [16]Resectable Lung Cancer64 (41–82) 93 (52.0)86 (48.0)65 (34–84) 83 (46.4)96 (53.6)Zhou [17]metastatic non-small-cell lung cancer62.0 (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 Cancer64 (26–87)58 (9.9) 219 (37.6)306 (52.5) 64 (29–87)55 (9.4) 223 (38.3)305 (52.3)

Table 2. Age grouping in clinical trials of drugs for breast cancer.

Table 2. Age grouping in clinical trials of drugs for breast cancer.

First Author/ReferenceDiseaseAge Groups in Treament PopulationAge Groups in Ontrol/Other Treatment PopulationAge groups Median≥7060–6950–59<50Median≥7060–6950–59<50Chua [19]Non-low-risk ductal carcinoma in situ in the breast58 (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 cancer50 (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 Metastases53 (27–79) 52 (24–77) Age groups Median<65≥65 Median<65≥65 Xu [22]Hormone receptor-positive and HER2-negative advanced breast cancer 21130 10812 Age groups Median≥7665–7555–64<55Median≥7665–7555–64<55Del Mastro [23]Early-stage breast cancer60 (54–67)5830439327561 (54–68)56343386271Age groups median (IQR)≥50<50 median (IQR)≥50<50 van der Voort [24]ERBB2-Positive Breast Cancer49 (43–55)1101118 48(43-56)100119 Age groups median (IQR)>50≤50 median (IQR)>50≤50 Mayer [25]Early breast cancer52 (45–61)15731309 52 (45–60)13701304 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)

Table 3. Age grouping in clinical trials of drugs for lymphoblastic leukemia.

Table 3. Age grouping in clinical trials of drugs for lymphoblastic leukemia.

First Author/ReferenceDiseaseAge Groups in Treatment PopulationAge Groups in Control/Other Treatment PopulationMedian ≥101–10<1 Median≥101–10<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 16–3010–151–9 Analysis ≥16 Years <16 Years Burke [28]High-risk B-lymphoblastic leukemia 3040 20% 47% 33% 597 2443 Age groups Median 10–181–9 Median10–181–9 Locatelli [29]High-risk First-Relapse B-Cell Acute Lymphoblastic Leukemia6 (1–17) 15 (27.8)39 (72.2) 5 (1-17) 16 (29.6) 38 (70.4) Age groups Median (IQR)21–2718–2013–1710–121–9 Median (IQR) 21–2718–2013–1710–121–9Brown [30]First Relapse of B-Cell Acute Lymphoblastic Leukemia9 (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>6–104–6Median >14>10–14>6–104–6Peters [31]Childhood acute lymphoblastic leukemia212 48 (23%)64 (30%)66 (31%)34(16%)201 62 (31%)42 (21%)75 (37%)22 (11%)Age groups ≥101–9 ≥101–9 Shen [32]Pediatric Philadelphia Chromosome–Positive Acute Lymphoblastic Leukemia 60123 XX 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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