scholarly journals The importance of the prevention of treatment induced neutropenia in patients with malignant neoplasms of the head and neck

2021 ◽  
Vol 23 (2) ◽  
pp. 356-360
Keyword(s):  
Squamous Cell Carcinoma ◽  
Head And Neck ◽  
Primary Prophylaxis ◽  
Infectious Complications ◽  
Hematological Toxicity ◽  
Malignant Neoplasms ◽  
Common Complication ◽  
Cost Of Treatment ◽  
Risk Of Death ◽  
The Cost

Hematological toxicity is the most common complication of chemotherapy. The most dangerous manifestation of hematological toxicity is febrile neutropenia (FN). FN reduces survival, increases the risk of death, the frequency of infectious complications, hospitalizations, the cost of treatment. The risk of FN should be assessed before the beginning of the therapy, using the general algorithm from the protocol to prevent FN applying the granulocyte colony-stimulating factors (G-CSF). G-CSF for the prevention is required throughout all cycles of myelosuppressive therapy. For the prevention of FN, the most effective is the use of PEGylated G-CSF. Patients with head and neck squamous cell carcinoma, receiving the TPF or DCF regimen, combined with docetaxel and cisplatin, are included in the group of routine primary prophylaxis for neutropenia. In case of developing 34 grade FN in these patients, the use of PEGylated G-CSF (empegfilgrastim) is preferable.

Comparison of treatment costs of pembrolizumab versus nivolumab in head and neck squamous cell carcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19368-e19368
Author(s):  
Justin Yeh ◽  
Achuta Kumar Guddati
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Average Cost ◽  
Standard Of Care ◽  
Neck Squamous Cell Carcinoma ◽  
Published Data ◽  
Cost Of Treatment ◽  
The Cost

e19368 Background: Pembrolizumab and Nivolumab are PD-1 inhibiting immunotherapy agents approved for the treatment of metastatic or recurrent head and neck squamous cell carcinoma in patients previously treated with platinum-based chemotherapy. Both therapies have demonstrated similar survival benefits and adverse event profiles, but there is no published comparison of treatment cost and survival between the two agents. This study aims to analyze the cost-effectiveness of pembrolizumab compared to nivolumab through network meta-analysis techniques. Methods: Data published from the KEYNOTE-040 (pembrolizumab) and CheckMate 141 (nivolumab) studies were used to generate a model incorporating the cost of each drug in both the arms. The cost of treatment of side effects was extracted from previously published data and used for cost estimation in the model. Data from the standard of care arms (cetuximab, methotrexate, or docetaxel) in each study were adjusted to provide a common reference between the two studies. The number of years added in terms of overall survival was calculated for the entire experimental arm and the cost of each such year was calculated. All costs were adjusted for inflation. Results: Using published data from the KENOTE-040 trial, the average cost per patient adjusted for inflation over time, over 24 months in the pembrolizumab arm was $159,302, and similarly using data from the Checkmate 141 trial, the average cost per patient over 18 months in the nivolumab arm was $118,790. The cost of management of adverse effects was $18,728 vs $16,685 (pembrolizumab vs. nivolumab) during these time periods. Our model suggests that the adjusted total cost per month for patients on these drugs is very similar: $7417.91 vs. $7526.38. Assuming that the quality of life was similar in both groups and using an average OS for the standard of care arms, our model predicts that ICER for pembrolizumab is higher than nivolumab ($203,085 vs. 132,644). Conclusions: Both pembrolizumab and nivolumab improve survival benefit compared to their respective standard of care arms. However, the ICER for both medications is higher than the threshold set by many payers and health provider organizations. The model makes several assumptions which may render it less accurate to compare between trials but the cost of treatment for both drugs is not in the cost-effective range. To utilize these drugs in a cost-conscious practice, further research is needed to investigate lower doses at a slower frequency along with reduction of the price for each medication.

scholarly journals Cost-effectiveness of pembrolizumab for treatment of platinum-resistant recurrent or metastatic head and neck squamous cell carcinoma in China: an economic analysis based on a randomised, open-label, phase III trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038867 ◽  
Author(s):  
Wenxiu Xin ◽  
Haiying Ding ◽  
Qilu Fang ◽  
Xiaowei Zheng ◽  
Yinghui Tong ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Squamous Cell Carcinoma ◽  
Cost Effectiveness ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Probabilistic Sensitivity Analysis ◽  
Cost Effective ◽  
Platinum Resistant ◽  
The Cost

BackgroundPembrolizumab was recently demonstrated to have survival benefit in patients with recurrent or metastatic head and neck squamous cell carcinoma (r/mHNSCC). However, the cost-effectiveness of pembrolizumab versus chemotherapy in China remains uncertain.ObjectiveThis analysis aimed to describe the cost-effectiveness of pembrolizumab versus standard-of-care (SOC) therapy in r/mHNSCC in China.DesignA Markov model consisting of three health states (stable, progressive and dead) was developed to compare the cost and effectiveness of pembrolizumab with SOC in platinum-resistant r/mHNSCC. Model inputs for transition probabilities and toxicity were collected from the KEYNOTE-040 trial, while health utilities were estimated from a literature review. Cost data were acquired for the payer’s perspective in China. Costs and outcomes were discounted at an annual rate of 3.0%. Sensitivity analyses were conducted to test the uncertainties surrounding model parameters.Outcome measuresThe primary outcome was incremental cost-effectiveness ratios (ICERs), which were calculated as the cost per quality-adjusted life years (QALYs).ResultsThe total mean cost of pembrolizumab and SOC was US$45 861 and US$41 950, respectively. As for effectiveness, pembrolizumab yielded 0.31 QALYs compared with 0.25 QALYs for SOC therapy. The ICER for pembrolizumab versus SOC was US$65 186/QALY, which was higher than the willingness-to-pay threshold (WTP) of US$28 130/QALY in China. The univariate sensitivity analysis indicated that utility values for progressive state, probability from stable to progressive in the SOC group, as well as cost of pembrolizumab were the three most influential variables on ICER. The probabilistic sensitivity analysis demonstrated that standard therapy was more likely to be cost-effective compared with pembrolizumab at a WTP value of US$28 130/QALY. Results were robust across both univariate analysis and probabilistic sensitivity analysis.ConclusionsPembrolizumab is not likely to be a cost-effective strategy compared with SOC therapy in patients with platinum-resistant r/mHNSCC in China.Trial registration numberNCT02252042; Post-results.

scholarly journals Cetuximab for the treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck

2009 ◽  
Vol 13 (Suppl 3) ◽  
pp. 49-54
Author(s):  
J Greenhalgh ◽  
A Bagust ◽  
A Boland ◽  
N Fleeman ◽  
C McLeod ◽  
...  
Keyword(s):  
Sensitivity Analysis ◽  
Squamous Cell Carcinoma ◽  
Cost Effectiveness ◽  
Incremental Cost ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Response To Therapy ◽  
Metastatic Squamous Cell Carcinoma ◽  
The Cost

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of cetuximab for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s evidence came from a single reasonably high-quality randomised controlled trial (RCT) [EXTREME (Erbitux in First-Line Treatment of Recurrent or Metastatic Head and Neck Cancer); n = 442] comparing cetuximab plus chemotherapy (CTX) with CTX alone. Cetuximab plus CTX had significant effects compared with CTX alone on the primary outcome of overall survival (10.1 versus 7.4 months respectively) and the secondary outcomes of progression-free survival (PFS) (5.6 versus 3.3 months), best overall response to therapy (35.6% versus 19.5%), disease control rate (81.1% versus 60%) and time-totreatment failure (4.8 versus 3.0 months), but not on duration of response (5.6 months versus 4.7 months). No safety issues with cetuximab arose beyond those already previously documented. The manufacturer developed a two-arm state-transition Markov model to evaluate the cost-effectiveness of cetuximab plus CTX versus CTX alone, using clinical data from the EXTREME trial. The ERG recalculated the base-case cost-effectiveness results taking changes in parameters and assumptions into account. Subgroup and threshold analyses were also explored. The manufacturer reported an incremental cost-effectiveness ratio (ICER) of £121,367 per quality-adjusted life-year (QALY) gained and an incremental cost per life-year gained of £92,226. Univariate sensitivity analysis showed that varying the cost of day-case infusion and the utility values in the stable/response health state of the cetuximab plus CTX arm had the greatest impact on the ICER. Probabilistic sensitivity analysis illustrated that cetuximab plus CTX is unlikely to be cost-effective for patients with recurrent and/or metastatic SCCHN, even at what would usually be considered very high levels of willingness to pay for an additional QALY. With regard to the economic model the appropriateness and reliability of parametric survival projection beyond the duration of trial data could not be fully explored because of lack of information. The ERG also questioned the appropriateness of economic modelling in this STA as evidence is available only from a single RCT. In conclusion, the ERG considers that patients with metastatic SCCHN were not shown to receive a significant survival benefit from cetuximab plus CTX compared with CTX alone and that even setting a lower price for cetuximab would not strengthen the manufacturer’s case for cost-effectiveness.

scholarly journals Clinical and epidemiological features of HPV-associated head and neck cancer in Russia: results of a sample study

2021 ◽  
Vol 13 (3) ◽  
pp. 62-69
Author(s):  
E. N. Belyakova
Keyword(s):  
Risk Factors ◽  
Squamous Cell Carcinoma ◽  
Head And Neck Cancer ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Oral Mucosa ◽  
Neck Cancer ◽  
Malignant Neoplasms ◽  
Epidemiological Features ◽  
The World

Recently, an increase in the incidence of all malignant neoplasms of the head and neck has been noted throughout the world. The most common type of head and neck cancer is squamous cell carcinoma, which originates from the epithelium of the oral mucosa, pharynx, and larynx. In Russia, cancer of the oral mucosa and cancer of the oropharynx are in 4th place in the structure of malignant neoplasms: more than 80 thousand new cases are registered every year. Human papillomavirus is the leading cause of increased incidence of squamous cell carcinoma of the head and neck in many regions of the world.Objective: to determine the main clinical and epidemiological features of HPV-associated head and neck cancer.Methods: a study based on a retrospective analysis of the patient's anamnestic data was carried out. Results: Demonstrated the role of smoking OR=2.07 (CI: 1.07—4.02), hookah smoking OR=3.06 (CI: 1.06—8.80), drinking strongly hot drinks OR=3.65 (CI: 1.44—9.25), the presence of a dental prosthesis OR=7.32 (CI: 2.77—19.31), heredity OR=7.38 (CI: 3.07—17.76), “Poor” dental status OR=33.54 (CI: 15.01—74.95), positive HPV status in history OR=7.31 (CI: 2.77—19.31), 5 or more sexual partners lifetime OR=4.95 (CI: 2.47—9.93) as risk factors for HPV-associated. head, and neck cancer. Conclusion: HPV prophylaxis plays an important role in reducing the incidence of associated head and neck malignancies. The results of the study convinced of the need for preventive measures in relation to the identified risk factors for the development of HPV-associated head and neck cancer.

Cost-effectiveness of nivolumab for treatment of platinum-resistant recurrent or metastatic squamous cell carcinoma of the head and neck.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6026-6026 ◽  
Author(s):  
Kate Carroll ◽  
Kathryn Ries Tringale ◽  
Kaveh Zakeri ◽  
Assuntina Gesualda Sacco ◽  
Linda Barnachea ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Cost Effectiveness ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Single Agent ◽  
Cost Effective ◽  
Sensitivity Analyses ◽  
Single Agent Therapy ◽  
The Cost

6026 Background: The Checkmate 141 randomized trial found that patients with platinum-refractory, recurrent or metastatic (R/M) squamous-cell carcinoma of the head and neck (SCCHN) treated with nivolumab had significantly longer overall survival than those treated with standard, single-agent therapy. However, nivolumab is more expensive than standard treatment. We conducted a cost-effectiveness analysis of nivolumab for the treatment of R/M SCCHN. Methods: We constructed a Markov model to simulate treatment with nivolumab or other single-agent therapy (docetaxel, cetuximab, or methotrexate) for patients with R/M SCCHN. Transition probabilities including disease progression, survival, and toxicity were derived from clinical trial data, while costs (in 2016 US dollars) and health utilities were estimated from the literature. Incremental cost-effectiveness ratios (ICERs), expressed as dollar per quality-adjusted life-year (QALY), were calculated with values less than $100,000/QALY considered cost-effective from a healthcare payer perspective. We conducted one-way and probabilistic sensitivity analyses to examine model uncertainty. Results: Our base-case model found that treatment with nivolumab increased overall cost by $59,000 and improved effectiveness by 0.2443 QALYs compared to single-agent therapy, leading to an ICER of $241,100/QALY. In sensitivity analyses, the model was most sensitive to the cost of nivolumab and assumptions about survival. Nivolumab would become cost-effective if the cost per cycle decreased from $13,432 to $5,716. If we assumed that all patients alive at the end of the Checkmate 141 trial were cured of their disease then nivolumab was still not considered cost-effective (ICER $160,000/QALY). Probabilistic sensitivity analysis also demonstrated relative stability of the cost-effectiveness model and found that treatment with nivolumab was cost-effective 0% of the time at a willingness-to-pay threshold of $100,000/QALY. Conclusions: While nivolumab significantly improves overall survival, at the current cost it would not be considered a cost-effective treatment option for patients with R/M SCCHN.

scholarly journals Prognostic Significance of CD4+ and CD8+ Tumor-Infiltrating Lymphocytes in Head and Neck Squamous Cell Carcinoma: A Meta-Analysis

Cancers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 781
Author(s):  
Daniele Borsetto ◽  
Michele Tomasoni ◽  
Karl Payne ◽  
Jerry Polesel ◽  
Alberto Deganello ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Meta Analysis ◽  
Prognostic Significance ◽  
Tumor Infiltrating Lymphocytes ◽  
Neck Squamous Cell Carcinoma ◽  
Risk Of Death ◽  
Infiltrating Lymphocytes

Objective: It has been suggested that the presence of tumor-infiltrating lymphocytes (TILs) in the tumor microenvironment is associated with a better prognosis in different types of cancer. In this systematic review and meta-analysis, we investigated the prognostic role of CD4+ and CD8+ TILs in head and neck squamous cell carcinoma (HNSCC). Methods: PubMed, Cochrane, Embase, Scopus, and Web of Science were searched up to September 2020. This study was conducted following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) checklist. Risk ratios from individual studies were displayed in forest plots and the pooled hazard ratios (HR) of death and corresponding confidence intervals (CI) were calculated according to random-effects models. Risk of bias of the included studies was assessed through the Newcastle–Ottawa scale. Results: 28 studies met the inclusion criteria. Studies conducted on HNSCC subsites combined reported a significant reduction in the risk of death for both high CD4+ (HR: 0.77; 95% CI: 0.65–0.93) and high CD8+ TILs (HR: 0.64; 95% CI: 0.47–0.88). High CD4+ TILs were associated with significantly better overall survival among oropharyngeal HNSCC (HR: 0.52; 95% CI: 0.31–0.89), as well as high CD8+ TILS in Human papillomavirus −ve and +ve cancers (HR: 0.39; 95% CI: 0.16–0.93 and HR: 0.40; 95% CI 0.21–0.76 respectively). CD8+ TILs were also associated with improved survival in hypopharyngeal cancers (HR = 0.43 CI: 0.30–0.63). No significant association emerged for patients with cancer of the oral cavity or larynx. Conclusions: The findings from this meta-analysis demonstrate the prognostic significance of CD8+ and CD4+ TILs in HNSCC and variation in tumor subsite warrants further focused investigation. We highlight how TILs may serve as predictive biomarkers to risk stratify patients into treatment groups, with applications in immune-checkpoint inhibitors notable areas for further research.

Early diagnosis of radiotherapy failure for patients with head and neck cancer: the role of biochemical markers

2018 ◽  
Vol 104 (4) ◽  
pp. 273-279 ◽  
Author(s):  
Jolanta Mrochem-Kwarciak ◽  
Tomasz Rutkowski ◽  
Andrzej Wygoda ◽  
Regina Deja ◽  
Agata Hajduk ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Head And Neck Cancer ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Neck Cancer ◽  
Squamous Cell ◽  
Survival Ratio ◽  
Early Assessment ◽  
Risk Of Death ◽  
Radiotherapy Failure

Purpose: There is a lack of effective diagnostic tools for early assessment of radiotherapy (RT) outcome in patients with head and neck cancer (HNC). The timely diagnosis of treatment failure may facilitate use of salvage procedures to prevent disease progression. We assessed squamous cell carcinoma antigen and CYFRA 21-1 as early markers of radiotherapy failure in patients with HNC. Methods: Between January 2009 and February 2012, 185 patients (median age 59 years) with squamous cell carcinoma were treated with curative intent with RT alone or combined with chemotherapy (ChT). Markers were estimated in the serum 2 times: before RT and after completion of treatment. Results: The median of follow-up was 40 months. Locoregional control (LRC) was 53% and locoregional failure (LRF) was 31%. When comparing LRC and LRF, there were no significant differences between markers concentration obtained before RT. After RT, CYFRA 21-1 (p = 0.018) was significantly elevated in the LRF group. Patients with CYFRA 21-1 <1.79 ng/mL had a higher disease-free survival rate compared to patients with CYFRA 21-1 ≥1.79 ng/mL (74% vs 53%, respectively). After RT, CYFRA 21-1 was significantly related to the overall survival ratio in both univariate (p = 0.049) and multivariate analysis (p = 0.019). Conclusions: CYFRA 21-1 assessed at the end of RT or ChT seems to be a prognostic marker for tumor response. A high concentration of CYFRA 21-1 after treatment increases the risk of death. CYFRA 21-1 might be suggested in the monitoring of carcinomas of HNC.

scholarly journals Long-term survival in patients with metastatic head and neck squamous cell carcinoma treated with metastasis-directed therapy

2019 ◽  
Vol 121 (11) ◽  
pp. 897-903 ◽  
Author(s):  
Thomas H. Beckham ◽  
Jonathan E. Leeman ◽  
Peng Xie ◽  
Xiaolin Li ◽  
Debra A. Goldman ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Metastatic Disease ◽  
Squamous Cell ◽  
Disease Burden ◽  
Neck Squamous Cell Carcinoma ◽  
Risk Of Death ◽  
Definitive Therapy ◽  
Limited Metastatic Disease

Abstract Background Our objective was to evaluate the outcomes of metastatic head and neck squamous cell carcinoma (HNSCC) by disease burden with an emphasis on metastasis-directed therapy (MDT) in patients with limited metastatic disease burden. Methods In total, 186 patients who developed metastatic disease after definitive therapy for HNSCC were included. Clinically and radiographically apparent metastases were enumerated. Kaplan–Meier methods were used to estimate survival. Cox regression was used to assess the association between clinical variables. Results Patients with a single metastasis had a 5-year overall survival (OS) of 35% (95% CI 16–54%) in contrast to patients with multiple metastases with a 5-year OS of 4% (95% CI 2–9%). Thirty patients (16.1%) underwent MDT. On multivariable analysis, oral cavity or sinonasal primary (HR 2.22 95% CI 1.16–4.25, p = 0.015; HR 4.88, 95% CI 1.10–21.70, p = 0.037, respectively) were associated with higher risk of death, whereas receipt of MDT (HR 0.36, 95% CI 0.17–0.74, p = 0.006) was associated with lower hazard of death. Median subsequent metastasis-free survival and 5-year survival after MDT (n = 30) were estimated at 26.4 months (95% CI: 9.8–54.0) and 31%, (95% CI: 15–48%). Conclusions HNSCC patients with limited metastatic disease may derive significant benefit from MDT. Prospective trials evaluating MDT in HNSCC are warranted.

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