Best Practices in the Management of Infectious Complications for Patients With Cancer
Subscribe Register Login. Your Name: optional. Your Email:. Colleague's Email:. Separate multiple e-mails with a ;. Send a copy to your email. Some error has occurred while processing your request. Please try after some time. The authors have no funding or conflicts of interest to disclose. Online date: August 7, Infectious Diseases in Clinical Practice27 5 , September Add Item s to:. An Existing Folder. A New Folder. The item s has been successfully added to " ". Thanks for registering! Be sure to verify your new user account in the next 24 hours, by checking your email and clicking the "verify" link.
This article has been saved into your User Account, in the Favorites area, under the new folder " ". Table 4 shows the infection rates for patients in each of the two groups after propensity score stratification. In most situations, patients with cetuximab therapy had higher infection rates. Figure 2 shows that most of the prognostic characteristics were well balanced within each propensity quintile.
The P-value for Cochran-Mantel-Haenszel statistics comparing infection rates in patients receiving cetuximab therapy with infection rates among those not receiving cetuximab therapy, controlling for propensity scores, was 0. Patients treated with cetuximab had higher infection rates. The adjusted infection rates for patients treated with cetuximab were higher than for patients without cetuximab therapy Propensity score analysis is unable to adjust for unmeasured confounders and selection biases, such as higher-risk patients who may be preferentially selected for cetuximab, thus producing apparently adverse outcomes for these groups.
By using IVA and the two-stage least squares analysis, we showed that cetuximab use was not statistically associated with infection events OR, 0. Limited data exist regarding whether cetuximab increases the rate of infections in patients with head and neck cancer. Most of the little information derived from randomized-controlled trials that were not designed to compare the infection rates among different treatment modalities, and many patients were often excluded from clinical trials.
Data from day-by-day medical practices in the real world may reflect the true information. In propensity score analysis with adjusting observable confounding factors, the likelihood of developing infection events among head and neck cancer patients treated with cetuximab was 2. Using IVA with adjusting measured and unmeasured confounding factors, the average treatment effect of cetuximab was not statistically associated with an increased risk of infection events in head and neck cancer patients.
Compared with randomized-controlled series or meta-analyses, the NHIRD is a real medical practice record that reflects the day-by-day medical care. Our series used two statistical methods, propensity score analysis and instrumental variable analysis. The propensity scores were used to stratify patients into five groups with similar propensity scores in order to reduce the effects of selection bias between the different treatment groups  ,  , .
HNC patients treated with cetuximab were found to have increased rates of infection. Using IVA to control both the measured and unmeasured confounding factors, we did not find statistically differences between cetuximab and the rate of infections. The severity of comorbidities, the cancer stage, certain social factors such as employment, and patient preferences were difficult to capture correctly from the dataset.
Referral selection may depend on the interactions between the comorbidities and cancer stage. All these unmeasured factors could produce significant bias using traditional approaches. Despite the efforts to simulate the randomization situation, propensity scores only adjusted for observable confounding variables. These observations imply that significant unaccounted residual bias exists among the propensity score methods and that IVA may be superior. The instrumental variable analysis was performed by comparing the baseline characteristics, and found that these factors were similar between the high- and low-use cetuximab institutions.
The instrumental variable analysis produced less biased estimates.
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There are few data evaluating the association between the infection rate and cetuximab therapy in patients with head and neck cancer. Increased risk for dyspnea and respiratory insufficiency had been reported in head and neck cancer patients treated with cetuximab .
Bonner et al. This suggested that there are several plausible mechanisms to explain the increased rate of infectious complications in advanced cancer patients treated with cetuximab. Cetuximab may target the bone marrow EGF receptors, which are expressed on he surface of neutrophils and play key roles in their proliferation and differentiation. The suppressed bone marrow may further lead to neutropenia and increase the risk of infection. This process could be suppressed by EGF receptor-selective tyrosine kinase inhibitors. Besides the propensity score analysis, we tried to simulate a randomized study and balanced both the measured and the unmeasured characteristics in the different treatment groups with IVA.
Using IVA and the two-stage least squares analysis, our series revealed that cetuximab was not associated, in a statistically significant way, with infection events. Randomized-controlled trials cannot be undertaken in all situations where evidence is needed to provide treatment guidelines. Observational studies with adequate statistical analysis that have least bias are necessary to evaluate population effectiveness.
Infections in People With Cancer
Post-marketing surveillance is an important issue that could provide physicians, patients, and pharmaceutical companies with useful information about severe adverse effects. Propensity score analysis simulated the randomization process and tried to eliminate the selection bias for observable factors, and revealed an approximately two-fold increased risk of infection in patients receiving cetuximab.
However, functional status and unmeasured factors were not adjusted in propensity score analysis and the association between the cetuximab and infection rate may be overestimated. Instrumental variable analyses could decrease or eliminate the measured and unmeasured biases, and they showed that no statistically significant differences existed between the rate of infections and the average treatment effect of cetuximab. This study has several limitations. First, the diagnoses of head and neck cancer, infection events, and any other co-morbid conditions are completely dependent on ICD codes.
Nonetheless, the National Health Insurance Bureau of Taiwan randomly reviews the charts and interviews patients in order to verify the accuracy of diagnosis. The head and neck cancer patients are further verified by the registry for catastrophic illness patient database. Second, radiotherapy dose and type, cancer stage, and the severity of the infection events cannot be precisely extracted from the NHIRD, which prevented further sub-group analysis.
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Instrumental variable analysis could eliminate the selection biases from the unmeasured factors. However, it is possible that instrumental variables do not adequately control for unknown confounding factors. Third, chemotherapy that was not approved by the NHI before but was self-paid by patients, such as taxol approved on Jan 1 st , by the NHI in Taiwan cannot be extracted from the dataset.
Further research studies linking primary hospitalization or ambulatory settings information, such as infection severity, with detailed risk factors, are worth performing in the future. This study shows that during a one-year follow-up period, cetuximab was not statistically associated with an increased risk of infection by using an instrumental variable analysis. Therefore, particular attention should focus on older head and neck cancer patients treated with cetuximab. Browse Subject Areas?
Click through the PLOS taxonomy to find articles in your field. Abstract Background To compare the infection rates between cetuximab-treated patients with head and neck cancers HNC and untreated patients. Conclusions Cetuximab therapy was not statistically associated with infection rate in HNC patients. Introduction The epidermal growth factor receptor EGFR -targeting IgG1 monoclonal antibody, cetuximab, is a breakthrough in targeted therapy for head and neck cancers, especially among patients with recurrent or metastatic disease . Download: PPT. Table 1. Figure 1. Infectious complications in head and neck cancer patients.
Figure 2. Distribution of explanatory variables between patients receiving cetuximab and those not receiving cetuximab for propensity score quintiles ranging from 1 least likely to receive cetuximab to 5 most likely to receive cetxuimab. Measurements A total of patients who met the inclusion and exclusion criteria were identified.
Infectious Complications of Cancer | J. Klastersky | Palgrave Macmillan
Table 3. Infection rate head and neck cancer patients treated with different treatment modality. Table 4. Figure 3. Distribution of explanatory variables between patients in high-use and low-use cetuximab hospitals a and infection rates b. Table 5. Table 6. Results In head and neck cancer patients, the median duration of follow-up was 6.
Discussion Limited data exist regarding whether cetuximab increases the rate of infections in patients with head and neck cancer. References 1.
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