Validation of the ONKOTEV Risk Prediction Model for Venous Thromboembolism in Outpatients With Cancer

Importance: The assessment of the risk of venous thromboembolism (VTE) among outpatients with cancer represents an unsolved topic. Current international guidelines recommend primary prophylaxis for patients at intermediate to high risk of VTE, indicated by a Khorana score of 2 or more. A previous prospective study developed the ONKOTEV score, a 4-variable risk assessment model (RAM) consisting of a Khorana score of more than 2, metastatic disease, vascular or lymphatic compression, and previous VTE event. Objective: To validate the ONKOTEV score as a novel RAM to assess the risk of VTE among outpatients with cancer. Design, setting, and participants: ONKOTEV-2 is a noninterventional prognostic study conducted in 3 European centers located in Italy, Germany, and the United Kingdom among a prospective cohort of 425 ambulatory patients with a histologically confirmed diagnosis of a solid tumor who were receiving active treatments. The total study duration was 52 months, with an accrual period of 28 months (from May 1, 2015, to September 30, 2017) and an overall follow up-period of 24 months (data were censored September 30, 2019). Statistical analysis was performed in October 2019. Exposures: The ONKOTEV score was calculated for each patient at baseline by collecting clinical, laboratory, and imaging data from tests performed for routine practice. Each patient was then observed to detect any thromboembolic event throughout the study period. Main outcomes and measures: The primary outcome of the study was the incidence of VTE, including deep vein thrombosis and pulmonary embolism. Results: A total of 425 patients (242 women [56.9%]; median age, 61 years [range, 20-92 years]) were included in the validation cohort of the study. The cumulative incidences for the risk of developing VTE at 6 months were 2.6% (95% CI, 0.7%-6.9%), 9.1% (95% CI, 5.8%-13.2%), 32.3% (95% CI, 21.0%-44.1%), and 19.3% (95% CI, 2.5%-48.0%), respectively, among 425 patients with an ONKOTEV score of 0, 1, 2, and greater than 2 (P < .001). The time-dependent area under the curve at 3, 6, and 12 months was 70.1% (95% CI, 62.1%-78.7%), 72.9% (95% CI, 65.6%-79.1%), and 72.2% (95% CI, 65.2%-77.3%), respectively. Conclusions and relevance: This study suggests that, because the ONKOTEV score has been validated in this independent study population as a novel predictive RAM for cancer-associated thrombosis, it can be adopted into practice and into clinical interventional trials as a decision-making tool for primary prophylaxis

Quality of Life of Patients with Head and Neck Cancer Receiving Cetuximab, Fluorouracil, Cisplatin Comparing to Cetuximab, Fluorouracil, Cisplatin, and Docetaxel within the CEFCID Trial

Introduction: CeFCiD was a multicenter phase II study comparing the efficacy of cetuximab (C), 5-flourouracil, and cisplatin with the same regimen adding docetaxel (D) in recurrent/metastatic head and neck cancer. The primary analysis trial did not demonstrate survival benefit from therapy intensification in first-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). The current analysis of the trial assessed the impact of treatment on quality of life (QoL). Methods: The European Organization for Research and Treatment of Cancer Quality of life Questionnaire QLQ-C30 and the tumor-specific module for head and neck cancer (QLQ-H&N35) were used to assess QoL at baseline (visit 1), after 2 (visit 3), 4 (visit 5), and 6 (visit 7) cycles of chemotherapy. Results: Of 180 patients included in this study, 86 patients (47.8%) completed the questionnaires at baseline. Considering selected scores over treatment time, there was no difference in global QoL, dyspnea, swallowing, and speech between the treatment arms in the course. For fatigue, a significant increase from baseline to visit 3 (p = 0.02), visit 5 (p = 0.002), and to visit 7 (p = 0.003) was observed for patients receiving D, cisplatin or carboplatin (P), 5-fluorouracil (F), and C. At the end of chemotherapy, the manifestation of fatigue was similar compared in the 2 treatment arms. Discussion/Conclusion: Therapy intensification not adversely affects selected scores of QoL of patients with recurrent and/or metastatic SCCHN. Nevertheless, fatigue seems to be pronounced in patients treated with D

Risk factors for cancer-related venous thromboembolism in ambulatory patients.

Background: The awareness of venous thromboembolism (VTE) burden in ambulatory cancer patients is growing. Due to the heterogeneity in the individual risk profile, predictive risk scores have been proven to be useful in the identification of high-risk patients for targeting thromboprophylaxis. The first validated risk score, the Khorana score, identified four factors resulting in an increased risk for cancer patients to develop VTE. In our study, we tried to identify additional factors associated with VTE to improve the prediction of high-risk patients. Methods: We performed a prospective, observational study in 544 ambulatory patients (56 ± 12 SD y, BMI 27 ± 5 kg/m?, 382 female [70 %]) with solid tumors and ongoing antineoplastic treatments. Tumor sites were breast n=216 (40 %), colo-rectal n=115 (21 %), gyn/uro n=76 (14 %), pancreas n=45 (8 %), gastric n=22 (4 %), lung n=15 (3 %) and others tumors n=55 (10 %). In 264 (52 %) patients there was metastatic disease. We screened for VTE with ultrasound of the upper and lower extremities and correlated cancer-, treatment- and patient-related conditions with the incidence of VTE. Results: We found a VTE incidence of 10 % (n=54), over a median follow up of 10.1 months. According to Khorana score, 51 % of patients (n=247) belonged to the low-risk (score=0), 44 % (n=213) to intermediate-risk (score=1-2) and 6 % (n=27) to high-risk (score?3) class. Odds Ratio for intermediate risk was 1.18 (95% CI 0.65-2.15, p=.588) and 2.66 (95% CI 1.14-6.17, p=.030) for high-risk patients. In our analysis we identified previous VTE (p<.001), metastatic disease (p<.001), vascular/lymphatic compression by the tumor (p=.002), edema of extremities (p=.005), surgery in last 6 months (p=.003) and presence of central venous catheters (p=.013) to be additional significant risk factors for VTE. Conclusions: Khorana score showed a good predictive value for VTE in ambulatory cancer patients. We found other clinical conditions to be associated with VTE events. These data could implement the existing predictive scores with new clinical risk factors, and refine the decision making in the oncologic clinical practice