Despite the availability of effective antiemetics and evidence-based guidelines, up to 40% of cancer patients receiving chemotherapy fail to achieve complete nausea and vomiting control. In addition to type of chemotherapy, several patient-related risk factors for chemotherapy-induced nausea and vomiting (CINV) have been identified. To incorporate these factors into the optimal selection of prophylactic antiemetics, a repeated measures cycle-based model to predict the risk of ≥ grade 2 CINV (≥2 vomiting episodes or a decrease in oral intake due to nausea) from days 0 to 5 post-chemotherapy was developed. Data from 1198 patients enrolled in one of the five non-interventional CINV prospective studies were pooled. Generalized estimating equations were used in a backwards elimination process with the P-value set at <0.05 to identify the relevant predictive factors. A risk scoring algorithm (range 0–32) was then derived from the final model coefficients. Finally, a receiver-operating characteristic curve (ROCC) analysis was done to measure the predictive accuracy of the scoring algorithm. Over 4197 chemotherapy cycles, 42.2% of patients experienced ≥grade 2 CINV. Eight risk factors were identified: patient age <60 years, the first two cycles of chemotherapy, anticipatory nausea and vomiting, history of morning sickness, hours of sleep the night before chemotherapy, CINV in the prior cycle, patient self-medication with non-prescribed treatments, and the use of platinum or anthracycline-based regimens. The ROC analysis indicated good predictive accuracy with an area-under-the-curve of 0.69 (95% CI: 0.67–0.70). Before to each cycle of therapy, patients with risk scores ≥16 units would be considered at high risk for developing ≥grade 2 CINV. The clinical application of this prediction tool will be an important source of individual patient risk information for the oncology clinician and may enhance patient care by optimizing the use of the antiemetics in a proactive manner.

This study describes a repeated measures prediction index to identify patients at high risk of ≥ grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy. Data from 451 patients who received a sorafenib (400 mg bid) as part of a clinical trial were reviewed (Escudier B, Eisen T, Stadler WM et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007; 356: 125–134). Generalized estimating equations were used to develop the final risk model. A risk-scoring algorithm (range 0–58) was then derived from the final model coefficients. External validation was then carried out on a new sample of 1145 patients who received sorafenib under an expanded access program. Pretreatment white blood cell count, female gender, good performance status, presence of lung and liver metastases and number of affected organs were predictors for ≥ grade 2 HFSR. A nonlinear association between HFSR risk and treatment duration was also identified where risk was maximized at week 5 followed by a gradual decline. Before each week of therapy, patients with risk scores >40 would be considered at high risk for developing ≥ grade 2 HFSR. The application and planned continued refinement of this prediction tool will be an important source of patient-specific risk information for the development of moderate to severe HFSR.

Rationale, aims and objectives: The standard of preventive care for poorly controlled seasonal allergic rhinitis (AR) is subcutaneous immunotherapy (SCIT) with allergen extracts, administered in a physician's office. As an alternative to SCIT, sublingual immunotherapy (SLIT) is now an option for patients with seasonal AR. Oralair™, a SLIT tablet containing freeze‐dried allergen extracts of five grasses [cocksfoot (Dactylis glomerata), meadow grass (Poa pratensis), rye grass (Lolium perenne), sweet vernal grass (Anthoxanthum odoratum) and timothy grass (Phleum pratense)], and Grazax™, a SLIT tablet containing a standardized extract of grass pollen allergen from timothy grass (P pratenase), are two such agents currently available in many countries. However, head‐to‐head comparative data are not available. In this study, an indirect comparison on efficacy, safety and cost was undertaken between Oralair™, Grazax™ and SCIT.Methods: A systematic review was conducted for double‐blind placebo‐controlled randomized trials evaluating Oralair™, Grazax™ or SCIT in patients with grass‐induced seasonal AR. Using placebo as the common control, an indirect statistical comparison between treatments was performed using meta regression analysis with active drug as the primary independent variable. An economic analysis, which included both direct and indirect costs for the Canadian setting, was also undertaken.Results: Overall, 20 placebo‐controlled trials met the study inclusion criteria. The indirect analysis suggested improved efficacy with Oralair™ over SCIT [standardized mean difference (SMD) in AR symptom control = −0.21; P = 0.007] and Grazax™ (SMD = −0.18; P = 0.018). In addition, there were no significant differences in the risk of discontinuation due to adverse events between therapies. Oralair™ was associated with cost savings against year‐round SCIT ($2471), seasonal SCIT ($948) and Grazax™ ($1168) during the first year of therapy.Conclusions: Oralair™ has at least non‐inferior efficacy and comparable safety against SCIT and Grazax™ at a lower annual cost.

Abraxane® and Taxol® are both effective drugs for the treatment of advanced stage breast cancer. However, each agent possesses unique drug delivery characteristics with the former not requiring premedication and having a considerably shorter recommended infusion time (i.e. 30 min vs. 2–4 h). To measure the overall efficiency and cost-saving potential associated with Abraxane® relative to Taxol®, a time and motion study was undertaken in breast cancer patients treated in China. Baseline patient data collection included age, disease stage, number and sites of metastatic disease, and performance status. Time and resource use data were then collected from breast patients being treated with Abraxane® (n = 12) or Taxol® (n = 15) in one of three cancer clinics located in Jiangsu, Shanghai, and Beijing. Resource use and time impact on clinical staff were quantified using unit cost estimates. This included costs for drug preparation, administration, materials and supplies, premedication, patient chair time, labor costs, and all acute adverse drug reactions. Outcomes were presented as a mean total time and cost for delivering a dose of Abraxane® or Taxol® and were compared using parametric and non-parametric statistical tests where appropriate. All costs were reported in US dollars (US$1 = 6.1 RMB, as of January 2014). Patients were comparable with respect to mean age, number of metastatic sites, and performance status. Approximately 9 of 12 (75%) patients received Abraxane® as on a weekly schedule (vs. every 3 weeks) compared to 6 of 15 (40%) with Taxol®. There were 5 (33.3%) acute adverse drug reactions with Taxol®, 3 of which required a physician visit and the initiation of supportive interventions. In contrast, there was only one minor event with Abraxane® (8.3%), which was easily managed with a temporary stoppage of the infusion. From the time and motion study, the mean total time for Abraxane® and Taxol® delivery (preparation, administration, premedication, total chair time, and adverse effects management) was 84 and 282 min respectively (p < 0.001), with the associated costs being US$59 and US$254 respectively per dose (p < 0.001). To our knowledge, this is first such study in breast cancer patients to be undertaken in China. Abraxane® was associated with fewer acute adverse drug reactions and significant reductions in health care resources, physician/nurse time and overall drug delivery costs compared to Taxol®.