Assessing Osteolytic Lesion Size on Sequential CT Scans Is a Reliable Study Endpoint for Bone Remineralization in Newly Diagnosed Multiple Myeloma
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Population
2.2. Imaging Parameters
2.3. Radiological Assessment of Treatment Response
2.4. Statistics
3. Results
3.1. Patient Characteristics
3.2. Quantitative Lesion Characterization before and after Induction Therapy
3.3. Qualitative Criteria of Therapy Response
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
E-KRd | elotuzumab, carfilzomib, lenalidomide, and dexamethasone |
IMWG | International Myeloma Working Group |
MM | multiple myeloma |
(s)CR | (stringent) complete response |
SLAMF-7 | signaling lymphocytic activation molecule family member 7 |
VGPR | very good partial response |
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Patient | Age | Sex | Diagnosis | R-ISS | E-KRd Cycles | Bone Therapy (q4w) | Interval between CT Scans (days) | Bone Marrow Infiltration at Baseline (%) | Bone Marrow Infiltration after Treatment (%) | Hematologic Response at End of E-KRd |
---|---|---|---|---|---|---|---|---|---|---|
1 | 52 | m | IgG lambda | II | 6 | Denosumab | 209 | 90 | <10 | VGPR |
2 | 61 | m | IgG kappa | I | 6 | Zoledronic acid | 204 | 90 | 3 | VGPR |
3 | 54 | m | IgG lambda | II | 6 | Zoledronic acid | 245 | 20 | 0 | VGPR |
4 | 69 | f | IgG kappa | I | 6 | Zoledronic acid | 207 | 50 | 0 | VGPR |
5 | 58 | m | IgG kappa | II | 6 | Zoledronic acid | 218 | 70 | <10 | VGPR |
6 | 59 | f | IgG kappa | I | 6 | Zoledronic acid | 214 | 30 | 0 | VGPR |
7 | 48 | m | IgG lambda | I | 6 | Zoledronic acid | 294 | 0 | 0 | VGPR |
8 | 58 | f | IgG kappa | I | 6 | Zoledronic acid | 202 | 70 | 0 | VGPR |
9 | 57 | m | IgG kappa | I | 6 | Zoledronic acid | 198 | 8 | 0 | CR |
10 | 58 | m | IgG kappa | II | 6 | Zoledronic acid | 230 | 70 | 0 | VGPR |
11 | 62 | f | IgG kappa | I | 6 | Denosumab * | 204 | 15 | 0 | VGPR |
12 | 56 | m | IgA kappa | II | 6 | Zoledronic acid | 205 | 90 | 0 | VGPR |
13 | 57 | m | IgG kappa | II | 6 | Zoledronic acid | 280 | 90 | 0 | VGPR |
14 | 63 | m | IgG lambda | I | 6 | Zoledronic acid | 209 | 20 | <10 | VGPR |
15 | 40 | m | IgA kappa | I | 6 | Zoledronic acid | 229 | 30 | 0 | CR |
16 | 58 | f | IgA kappa | I | 6 | Zoledronic acid | 211 | 80 | 10 | VGPR |
17 | 69 | m | IgA lambda | I | 6 | Pamidronic ** | 207 | 15 | 0 | CR |
18 | 41 | f | IgG kappa | II | 6 | Zoledronic acid | 242 | 45 | 0 | sCR |
19 | 68 | m | IgG kappa | III | 6 | Zoledronic acid | 217 | 60 | <10 | VGPR |
20 | 66 | f | IgG lambda | II | 6 | Zoledronic acid | 196 | 50 | 5 | VGPR |
Patient | Number of Lesions | Sum of Lesion Sizes at Baseline (mm2) | Sum of Lesion Sizes after Treatment (mm2) | Sum of Response Ratios | Mean Response (%) |
---|---|---|---|---|---|
1 | 6 | 1108 | 818 | 0.74 | −25 |
2 | 4 | 912 | 811 | 0.89 | −3 |
3 | 9 | 1877 | 1506 | 0.80 | −20 |
4 | 5 | 933 | 526 | 0.56 | −37 |
5 | 8 | 2238 | 1706 | 0.76 | −25 |
6 | 5 | 542 | 530 | 0.98 | +2 |
7 | 10 | 1136 | 498 | 0.44 | −58 |
8 | 5 | 510 | 496 | 0.97 | −4 |
9 | 4 | 621 | 249 | 0.4 | −82 |
10 | 4 | 492 | 402 | 0.82 | −38 |
11 | 9 | 1320 | 910 | 0.69 | −51 |
12 | 3 | 808 | 692 | 0.86 | −15 |
13 | 6 | 2040 | 1726 | 0.85 | −15 |
14 | 2 | 104 | 56 | 0.54 | −35 |
15 | 6 | 640 | 632 | 0.99 | −1 |
16 | 4 | 477 | 433 | 0.91 | −24 |
17 | 5 | 745 | 710 | 0.95 | −7 |
18 | 2 | 212 | 198 | 0.93 | −8 |
19 | 5 | 2291 | 1659 | 0.72 | −35 |
20 | 6 | 766 | 554 | 0.72 | −36 |
Reader Analysis | Lesions Described by Reader 1 (n = 103) | Lesions Described by Reader 2 (n = 99) | Lesions Described by Reader 1 and 2 (n = 94) | Inter-Reader Reliability | |||
---|---|---|---|---|---|---|---|
CT Scan | Before Treatment | After Treatment | Before Treatment | After Treatment | Before Treatment | After Treatment | Krippendorff’s α |
Cortical destruction | 35% (36/103) | 17% (17/103) | 37% (37/99) | 12% (12/99) | 35% (33/94) | 13% (12/94) | 0.85 (0.76–0.93) |
Pathologic fracture | 6% (6/103) | 9% (9/103) | 5% (5/99) | 8% (8/99) | 5% (5/94) | 9% (8/94) | 0.92 (0.81–1) |
Rim sclerosis | 14% (14/103) | 72% (74/103) | 9% (9/99) | 56% (55/99) | 10% (9/94) | 54% (51/94) | 0.74 (0.64–0.83) |
Trabecular sclerosis | 0% (0/103) | 33% (34/103) | 1% (1/99) | 39% (39/99) | 0% (0/94) | 31% (29/94) | 0.81 (0.68–0.91) |
Lesion Level Response | No Trabecular Sclerosis | Trabecular Sclerosis | Sum | p Value |
---|---|---|---|---|
Therapy response ≤20% | 58 (54%) | 5 (5%) | 63 (58%) | |
Therapy response >20% | 21 (19%) | 24 (22%) | 45 (42%) | |
Sum | 79 (73%) | 29 (27%) | 108 (100%) | <0.001 * |
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Grunz, J.-P.; Kunz, A.S.; Baumann, F.T.; Hasenclever, D.; Sieren, M.M.; Heldmann, S.; Bley, T.A.; Einsele, H.; Knop, S.; Jundt, F. Assessing Osteolytic Lesion Size on Sequential CT Scans Is a Reliable Study Endpoint for Bone Remineralization in Newly Diagnosed Multiple Myeloma. Cancers 2023, 15, 4008. https://doi.org/10.3390/cancers15154008
Grunz J-P, Kunz AS, Baumann FT, Hasenclever D, Sieren MM, Heldmann S, Bley TA, Einsele H, Knop S, Jundt F. Assessing Osteolytic Lesion Size on Sequential CT Scans Is a Reliable Study Endpoint for Bone Remineralization in Newly Diagnosed Multiple Myeloma. Cancers. 2023; 15(15):4008. https://doi.org/10.3390/cancers15154008
Chicago/Turabian StyleGrunz, Jan-Peter, Andreas Steven Kunz, Freerk T. Baumann, Dirk Hasenclever, Malte Maria Sieren, Stefan Heldmann, Thorsten Alexander Bley, Hermann Einsele, Stefan Knop, and Franziska Jundt. 2023. "Assessing Osteolytic Lesion Size on Sequential CT Scans Is a Reliable Study Endpoint for Bone Remineralization in Newly Diagnosed Multiple Myeloma" Cancers 15, no. 15: 4008. https://doi.org/10.3390/cancers15154008