Safety and Treatment Outcomes of Nivolumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Retrospective Multicenter Cohort Study
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Patient and Tumor Characteristics
2.2. Treatment Characteristics and Survival Data
2.3. Statistical Analysis
3. Results
3.1. Patient and Tumor Characteristics
3.2. Treatment Characteristics
- (1)
- CDF: Nivolumab following recurrence or progression after neo-adjuvant chemotherapy (n = 1); within 6 months of completing primary/adjuvant concurrent chemoradiotherapy with platinum-based chemotherapy (n = 32); within 6 months of receiving palliative chemotherapy with platinum-based chemotherapy (n = 86).
- (2)
- Four patients did not fit the criteria above (n = 2, co-payment: one before CDF approval and the other had nasopharynx cancer; 1 compassionate access; 1 received nivolumab having progressed more than 6 months after platinum chemotherapy).
3.3. Efficacy
3.4. PD-L1 Express PD-L1 Expression Status and Response to Treatment
3.5. Progression-Free Survival (PFS)
3.6. Overall Survival (OS)
3.7. Reasons for Stopping Treatment
3.8. Safety and Immune-Related Toxicity (IRT)
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A
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Characteristics | Nivolumab Patients (n = 123) |
---|---|
Age (years) | |
Median (range) | 64 (22–94) |
Male sex (%) | 99 (80.5%) |
Smoking status (%) | |
Never | 23 (18.7%) |
Ex-smoker | 48 (39.0%) |
Current smoker | 38 (30.9%) |
Not recorded | 14 (11.4%) |
Site of primary tumor (%) | |
Oral cavity | 33 (26.8%) |
Nasopharynx | 1 (0.8%) |
Oropharynx | 43 (35.0%) |
Hypopharynx | 8 (6.5%) |
Larynx | 25 (20.3%) |
Paranasal sinuses | 5 (4.1%) |
Unknown primary | 8 (6.5%) |
Staging TNM7 at time of diagnosis | |
1 | 2 (1.6%) |
2 | 5 (4.1%) |
3 | 17 (13.8%) |
4 | |
4a | 75 (61.0%) |
4b | 7 (5.7%) |
4c | 15 (12.2%) |
Not available | 2 (1.6%) |
PD-L1 status (%) | |
Negative | 17 (13.8%) |
≥1% | 12 (9.8%) |
Not tested | 94 (76.4%) |
Characteristics | Nivolumab Patients (n = 123) |
---|---|
Intent of treatment at diagnosis (%) | |
Curative | 95 (77.2%) |
Palliative | 28 (22.8%) |
Primary treatment (%) | |
Surgery +/− adjuvant (C)RT (including IC) | 38 (30.9%) |
(C)RT +/− IC | 59 (48.0%) |
Palliative chemotherapy | 21 (17.1%) |
Palliative radiotherapy | 5 (4.0%) |
Characteristics | Nivolumab Patients (n = 119) |
---|---|
Best response to treatment (%) | |
PD | 75 (63.0%) |
CR/PR | 23 (19.3%) |
SD | 19 (16.0%) |
Ν/A | 2 (1.7%) |
Reason for stopping treatment (%) | |
PD | 74 (62.2%) |
Death | 10 (8.4%) |
Toxicity | 8 (6.7%) |
Ongoing treatment | 6 (5.0%) |
Not fit for treatment | 11 (9.3%) |
Completion of treatment (24 months) | 3 (2.5%) |
Patient choice | 1 (0.9%) |
n/a | 6 (5.0%) |
IO-Related Toxicities | Total = 18 |
---|---|
Pneumonitis | n = 3; Grade 3 (1), suspected pneumonitis (2) |
Hepatitis | n = 3; Grade 4 (1), grade 3 (1), grade 2 (1) |
Colitis | n = 3; Grade 3 (2), unknown grading (1) |
Endocrine toxicities | n = 6 (hypothyroidism, hypophysitis) |
Other | n = 3; lichen planus (1; grade 2), hyponatremia (1; grade 4), thrombocytopenia (1; grade 1) |
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Vasiliadou, I.; Breik, O.; Baker, H.; Leslie, I.; Sim, V.R.; Hegarty, G.; Michaelidou, A.; Nathan, K.; Hartley, A.; Good, J.; et al. Safety and Treatment Outcomes of Nivolumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Retrospective Multicenter Cohort Study. Cancers 2021, 13, 1413. https://doi.org/10.3390/cancers13061413
Vasiliadou I, Breik O, Baker H, Leslie I, Sim VR, Hegarty G, Michaelidou A, Nathan K, Hartley A, Good J, et al. Safety and Treatment Outcomes of Nivolumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Retrospective Multicenter Cohort Study. Cancers. 2021; 13(6):1413. https://doi.org/10.3390/cancers13061413
Chicago/Turabian StyleVasiliadou, Ifigenia, Omar Breik, Holly Baker, Isla Leslie, Van Ren Sim, Gemma Hegarty, Andriana Michaelidou, Kannon Nathan, Andrew Hartley, James Good, and et al. 2021. "Safety and Treatment Outcomes of Nivolumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Retrospective Multicenter Cohort Study" Cancers 13, no. 6: 1413. https://doi.org/10.3390/cancers13061413