Safety of Combined Targeted and Helixor® Viscum album L. Therapy in Breast and Gynecological Cancer Patients, a Real-World Data Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Description of Study Participants
2.3. Data Source and Assessment
2.4. Statistical Methods
3. Results
3.1. Baseline Characteristics
3.2. Oncological Treatment
3.3. Characterization of Targeted Therapy
3.4. AEs Related to Targeted and Combinational Treatment
3.5. Factors Associated with Occurrence of AE, Treatment Discontinuation or Dose Disruption in Targeted Therapy
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Patient Characteristics | Total Cohort n = 242 | CTRL n = 160 | COMB n = 82 | Significance p-Value |
---|---|---|---|---|
Age at first diagnosis, years, mean (SD) | 54.5 (14.2) | 54.7 (14.4) | 54.3 (13.7) | 0.84 |
Cancer entity, n (%) | 1.13 | |||
Breast, n (%) | 212 (87.6) | 136 (85) | 75 (91.5) | |
Ovarian, n (%) | 25 (10.3) | 19 (11.9) | 6 (7.3) | |
Other 1), n (%) | 5 (2.1) | 5 (3.1) | 0 (0) | |
UICC stage | 0.08 | |||
0 | 1 (0.4) | 1 (0.6) | 0 | |
I | 49 (20.2) | 26 (16.3) | 23 (28.0) | |
II | 86 (35.5) | 55 (34.4) | 31 (37.8) | |
III | 49 (20.2) | 39 (24.4) | 10 (12.2) | |
IV | 44 (18.2) | 29 (18.1) | 15 (18.3) | |
NA | 13 (5.4) | 10 (6.3) | 82 (3.7) |
Total Cohort, n = 242 | CTRL n = 160 | COMB n = 82 | Significance p-Value | |
---|---|---|---|---|
Surgery | 0.91 | |||
yes | 208 (86.0) | 140 (87.5) | 68 (82.9) | |
no | 27 (11.2) | 19 (11.9) | 8 (9.8) | |
NA | 7 (2.9) | 1 (0.6) | 6 (7.3) | |
Radiation | 0.08 | |||
yes | 140 (57.9) | 88 (55.0) | 52 (63.4) | |
no | 95 (39.3) | 71 (44.4) | 24 (29.3) | |
NA | 7 (2.9) | 1 (0.6) | 6 (7.3) | |
CTx | 0.51 | |||
yes | 229 (94.6) | 153 (95.6) | 76 (92.7) | |
no | 13 (5.4) | 7 (4.4) | 6 (7.3) |
Patient Characteristics | Total Cohort n = 242 | CTRL n = 160 | COMB n = 82 | Significance p-Value |
---|---|---|---|---|
CDKi, n (%) | 26 (10.7) | 17 (10.6) | 9 (11.0) | 1.0 |
abemaciclib, n (%) | 4 (1.7) | 1 (0.6) | 3 (3.7) | |
palbociclib, n (%) | 18 (7.4) | 14 (8.8) | 4 (4.9) | |
ribociclib, n (%) | 5 (2.1) | 3 (1.9) | 2 (2.4) | |
mAB, n (%) | 206 (84.1) | 136 (85.0) | 70 (85.4) | 1.0 |
bevacizumab, n (%) | 47 (19.4) | 35 (2.19) | 12 (14.6) | |
denusomab, n (%) | 8 (3.3) | 4 (2.5) | 4 (4.9) | |
glembatumumab, n (%) | 1 (0.4) | 1 (0.6) | 0 | |
pertuzumab, n (%) | 2 (0.8) | 1 (0.6) | 1 (1.2) | |
pertuzumab/trastuzumab, n (%) | 62 (25.6) | 30 (18.8) | 32 (39.0) | |
rituximab, n (%) | 2 (0.8) | 1 (0.6) | 1 (1.2) | |
trastuzumab, n (%) | 74 (30.6) | 55 (34.4) | 19 (23.2) | |
trastuzumab-emtasin, n (%) | 3 (1.2) | 3 (1.9) | 0 | |
ICI, n (%) | 13 (5.4) | 8 (5) | 5 (6.1) | 1.0 |
atezolizumab, n (%) | 11 (4.5) | 7 (4.4) | 4 (4.9) | |
pembrolizumab, n (%) | 2 (0.8) | 1 (0.6) | 1 (1.2) | |
PARPi, n (%) | 4 (1.7) | 3 (1.9) | 1 (1.2) | 1.0 |
niraparib, n (%) | 1 (0.4) | 1 (0.6) | 0 | |
olaparib, n (%) | 3 (1.2) | 2 (1.3) | 1 (1.2) | |
TKI, n (%) | 6 (2.5) | 4 (2.5) | 2 (2.4) | 1.0 |
erlotinib, n (%) | 1 (0.4) | 1 (0.6) | 0 | |
lapatinib, n (%) | 4 (1.7) | 2 (1.3) | 2 (2.4) | |
nintedanib, n (%) | 1 (0.4) | 1 (0.6) | 0 | |
pazopanib, n (%) | 1 (0.4) | 1 (0.6) | 0 |
System Organ Class | Adverse Event (AE) | Total n = 242 | CTRL n = 160 | COMB n = 82 |
---|---|---|---|---|
gastrointestinal disorders | nausea | 2 | a 1), d 4) | - |
appetite loss | 1 | d 4) | - | |
vomiting | 1 | d 4) | - | |
general disorders and administration site conditions | pain | 1 | c 3)* | - |
temperature elevated | 1 | b 2)* | - | |
fatigue | 1 | e 5) | - | |
neck stiffness | 1 | e 5) | - | |
impaired vision | 1 | e 5) | - | |
skin and subcutaneous tissue disorder | erythema | 1 | e 5) | - |
Total number of AEs | 10 | 10 | - | |
Total number of patients experiencing AE | 5 | 5 | 0 | |
AE per patient frequency (AE events divided by number of all patients, n (%) §) | 4.13% §) | 6.25% | 0 | |
Patient with AE frequency (patient experiencing an AE divided by number of all patients) §§) | 2.07% §§) | 3.13% | 0 |
Total Cohort n = 242 | CTRL n = 160 | COMB n = 82 | Significance p-Value | |
---|---|---|---|---|
AE due to targeted treatment, n (%) | 5 (2.1) | 5 (3.1) | 0 | 0.254 |
Disruption of targeted treatment, n (%) | 6 (2.9) | 5 (3.1) | 1 (1.2) | 0.642 |
Dose reduction of targeted treatment, n (%) | 8 (3.3) | 5 (3.1) | 3 (3.7) | 1.0 |
Any event (AE or therapy adjustment §), n (%) | 14 (5.8) | 10 (6.3) | 3 (4.9) | 0.586 |
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Schad, F.; Thronicke, A. Safety of Combined Targeted and Helixor® Viscum album L. Therapy in Breast and Gynecological Cancer Patients, a Real-World Data Study. Int. J. Environ. Res. Public Health 2023, 20, 2565. https://doi.org/10.3390/ijerph20032565
Schad F, Thronicke A. Safety of Combined Targeted and Helixor® Viscum album L. Therapy in Breast and Gynecological Cancer Patients, a Real-World Data Study. International Journal of Environmental Research and Public Health. 2023; 20(3):2565. https://doi.org/10.3390/ijerph20032565
Chicago/Turabian StyleSchad, Friedemann, and Anja Thronicke. 2023. "Safety of Combined Targeted and Helixor® Viscum album L. Therapy in Breast and Gynecological Cancer Patients, a Real-World Data Study" International Journal of Environmental Research and Public Health 20, no. 3: 2565. https://doi.org/10.3390/ijerph20032565
APA StyleSchad, F., & Thronicke, A. (2023). Safety of Combined Targeted and Helixor® Viscum album L. Therapy in Breast and Gynecological Cancer Patients, a Real-World Data Study. International Journal of Environmental Research and Public Health, 20(3), 2565. https://doi.org/10.3390/ijerph20032565