A Prospective Real-World Multi-Center Study to Evaluate Progression-Free and Overall Survival of Radiotherapy with Cetuximab and Platinum-Based Chemotherapy with Cetuximab in Locally Recurrent Head and Neck Cancer
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patients
2.2. Study Design and Treatments
2.3. Endpoints and Assessments
2.4. Study Oversight
2.5. Statistical Analysis
3. Results
3.1. Patients
3.2. Treatment
3.3. Efficacy
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Patients’ Characteristics | RT + Cet (n = 63) | CT + Cet (n = 129) | p-Value |
---|---|---|---|
Age at Study Inclusion [years], mean ± SD | 66.6 ± 9.3 | 62.2 ± 9.5 | 0.003 |
Weight [kg], mean ± SD | 66.2 ± 12.6 | 66.3 ± 13.0 | 0.959 |
Sex, n (%) | 0.938 | ||
Female | 13 (21) | 26 (20) | |
Male | 50 (79) | 103 (80) | |
Location of Primary Tumor *, n (%) | |||
Oropharynx | 20 (32) | 34 (26) | 0.436 |
Hypopharynx | 14 (22) | 27 (21) | 0.838 |
Larynx | 5 (8) | 23 (18) | 0.068 |
Oral cavity | 21 (33) | 43 (33) | 1.000 |
Other location | 6 (10) | 12 (9) | 1.000 |
Stage of Disease at Initial Diagnosis | 0.396 | ||
I | 4 (6) | 12 (9) | |
II | 9 (14) | 12 (9) | |
III | 11 (17) | 15 (12) | |
IV | 37 (59) | 87 (67) | |
unknown | 2 (3) | 3 (2) | |
Prior Therapy, n (%) | |||
Radiotherapy (with or without concomitant chemotherapy) | 44 (70) | 119 (92) | <0.001 |
Chemotherapy concomitant to radiotherapy | 28 (44) | 81 (63) | 0.0134 |
Surgery | 42 (67) | 87 (67) | 0.915 |
Time Interval since Initial Diagnosis, median (years) | 2.2 | 1.2 | <0.001 |
Charlson Comorbidity Index at study inclusion, n (%) | 0.089 | ||
0 | 25 (40) | 70 (54) | |
1 | 12 (19) | 25 (19) | |
>1 | 26 (41) | 34 (26) | |
ECOG Performance Status at treatment initiation, n (%) | 0.909 | ||
0 | 11 (18) | 20 (17) | |
1 | 38 (62) | 74 (62) | |
≥2 | 12 (20) | 23 (19) | |
Alcohol Consumption, n (%) | 0.061 | ||
Never | 18 (29) | 26 (20) | |
Several times per month | 18 (29) | 26 (20) | |
Several times per week or daily | 16 (25) | 31 (24) | |
Missing | 11 (17) | 46 (36) | |
Smoking Habits, n (%) | 0.247 | ||
Never smoked | 20 (32) | 35 (27) | |
Former smoker | 27 (43) | 45 (35) | |
Current smoker | 16 (25) | 48 (38) | |
Pack Years of former/current smoker, mean ± SD | 35.8 ± 24.7 | 37.5 ± 31.7 | 0.775 |
Treatment | RT + Cet (n = 63) | CT + Cet (n = 129) | p-Value |
---|---|---|---|
Radiotherapy | |||
Conventional fractionation, n (%) | 58 (92) | ||
Dose per fraction [Gy], mean ± SD | 1.9 ± 0.1 | ||
Total dose | |||
<60 Gy, n (%) | 42 (67) | ||
≥60 Gy, n (%) | 21 (33) | ||
Mean ± SD [Gy] | 51.8 ± 15.4 | ||
Location | |||
Local relapse | 44 (70) | ||
Lymph node | 21 (33) | ||
Duration of radiotherapy [weeks], mean ± SD | 6.6 ± 2.2 | ||
Radiotherapy completed as planned, n (%) | 54 (86) | ||
Chemotherapy | |||
Cisplatin + 5-Flurouracil, n (%) | 52 (40) | ||
Carboplatin + 5-Flurouracil, n (%) | 37 (29) | ||
Carboplatin, n (%) | 18 (14) | ||
Cisplatin, n (%) | 12 (9) | ||
Carboplatin + Paclitaxel, n (%) | 7 (5) | ||
Other, n (%) | 3 (2) | ||
Duration of chemotherapy [weeks], mean ± SD | 12.8 ± 10.6 | ||
Cetuximab | |||
Total duration of Cetuximab treatment [weeks], mean ± SD | 8.6 ± 7.7 | 18.9 ± 19.6 | <0.001 |
Cetuximab maintenance performed, n (%) | 8 (13) | 47 (36) | 0.001 |
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Hecht, M.; Hahn, D.; Wolber, P.; Hautmann, M.G.; Reichert, D.; Weniger, S.; Belka, C.; Bergmann, T.; Göhler, T.; Welslau, M.; et al. A Prospective Real-World Multi-Center Study to Evaluate Progression-Free and Overall Survival of Radiotherapy with Cetuximab and Platinum-Based Chemotherapy with Cetuximab in Locally Recurrent Head and Neck Cancer. Cancers 2021, 13, 3413. https://doi.org/10.3390/cancers13143413
Hecht M, Hahn D, Wolber P, Hautmann MG, Reichert D, Weniger S, Belka C, Bergmann T, Göhler T, Welslau M, et al. A Prospective Real-World Multi-Center Study to Evaluate Progression-Free and Overall Survival of Radiotherapy with Cetuximab and Platinum-Based Chemotherapy with Cetuximab in Locally Recurrent Head and Neck Cancer. Cancers. 2021; 13(14):3413. https://doi.org/10.3390/cancers13143413
Chicago/Turabian StyleHecht, Markus, Dennis Hahn, Philipp Wolber, Matthias G. Hautmann, Dietmar Reichert, Steffi Weniger, Claus Belka, Tobias Bergmann, Thomas Göhler, Manfred Welslau, and et al. 2021. "A Prospective Real-World Multi-Center Study to Evaluate Progression-Free and Overall Survival of Radiotherapy with Cetuximab and Platinum-Based Chemotherapy with Cetuximab in Locally Recurrent Head and Neck Cancer" Cancers 13, no. 14: 3413. https://doi.org/10.3390/cancers13143413