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Background Primary analysis of the phase III study WJTOG 3405 demonstrated superiority of progression-free survival (PFS) for gefitinib (G) in patients treated with the epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) gefitinib compared with cisplatin plus docetaxel (CD) as the first-line treatment of stage IIIB/IV or postoperative recurrent EGFR mutation-positive non-small-cell lung cancer. This report presents final overall survival (OS) data. Patients and methods Patients were randomized between G (250 mg/day orally) and cisplatin (80 mg/m2 intravenously) plus docetaxel (60 mg/m2 i.v.), administered every 21 days for three to six cycles. After the exclusion of 5 patients, 172 patients (86 in each group, modified intention-to-treat population) were included in the survival analysis. OS was re-evaluated using updated data (data cutoff, 30 September 2013; median follow-up time 59.1 months). The Kaplan–Meier method and the log-rank test were used for analysis, and hazard ratios (HRs) for death were calculated using the Cox proportional hazards model. Results OS events in the G group and CD group were 68 (79.1%) out of 86 and 59 (68.6%) out of 86, respectively. Median survival time for G and CD were 34.9 and 37.3 months, respectively, with an HR of 1.252 [95% confidence interval (CI): 0.883–1.775, P  = 0.2070]. Multivariate analysis identified postoperative recurrence and stage IIIB/IV disease as independent prognostic factors, with an HR of 0.459 (95% CI: 0.312–0.673, P  <   0.001). Median survival time (postoperative recurrence versus stage IIIB/IV disease) were 44.5 and 27.5 months in the G group and 45.5 and 32.8 months in the CD group, respectively. Conclusion G did not show OS benefits over CD as the first-line treatment. OS of patients with postoperative recurrence was better than that of stage IIIB/IV disease, even though both groups had metastatic disease. This study was registered with UMIN (University Hospital Medical Information Network in Japan), number 000000539. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: The velocities of the lateral shear waves (Vs; m s−1) generated by an acoustic radiation force impulse (ARFI) correlate with Young's modulus. Therefore, ARFI can be used as a new method to evaluate tissue elasticity. The aim of this study was to investigate the safety of ARFI imaging and the differences in placental elasticity in complicated cases. Methods: The study population included 115 patients between 26 and 41 weeks gestation, who were divided into three groups, namely normal, fetal growth restriction (FGR) and pregnancy-induced hypertension (PIH). After delivery, the Vs values of the placenta were measured ex vivo. After ARFI imaging, microscopic examination was performed, the Vs values were compared among the three groups and the relationship between the Vs values and neonatal birthweight Z-score was investigated. Results: No histological changes were noted even after ARFI imaging. The Vs values in the FGR group were significantly higher than those in the normal group (1.94 ± 0.74 and 1.31 ± 0.35 m s−1, respectively; p < 0.05). The Vs values demonstrated a significant negative correlation with the Z-score. Moreover, as the Z-score became lower, the Vs values became higher in the range of Z-scores under −0.5 standard deviation (SD). Discussion: We speculate that the increased Vs values in the FGR group may have been caused by histological changes, and that a more severe FGR might result in increased Vs values. Conclusion: ARFI imaging was observed to have no apparent histological damage to the placental tissue. Ex vivo placentas from the FGR group were significantly more firm. Moreover, Vs values and Z-scores of birthweight had a significant negative correlation. Additional investigations are needed about the utility of this method for the evaluation of placental function in vivo. [Copyright &y& Elsevier]

Background The emetogenic classification of antineoplastic agents has provided a framework for defining antiemetic treatment recommendations in international guidelines. The most widely used classification schema identified four emetic risk levels. However, information on the emetogenicity of each chemotherapeutic regimen is insufficient. We previously reported that the emetic risk of pemetrexed was higher than that of taxans. Risk factors for chemotherapy-induced nausea and vomiting (CINV) were also assessed in patients with lung cancer receiving carboplatin plus pemetrexed (CBDCA+PTX) or carboplatin plus paclitaxel (CBDCA+PEM), and the CINV incidence was compared between these two regimens. Methods Data were pooled from two prospective studies, and propensity score matching was used to compare the CINV incidence between CBDCA+PTX and CBDCA+PEM groups. Risk factors for CINV were identified using logistic regression models. The pattern of CINV occurrence was evaluated by 7-day patient diary for recording CINV after the commencement of chemotherapy. Results Among 240 evaluable patients, the CINV incidence was higher in the CBDCA+PEM group than in the CBDCA+PTX group at the delayed phase (nausea: 51.1% vs. 36.2%, P = 0.040; vomiting: 23.4% vs. 14.9%, P = 0.138). The pattern of delayed CINV occurrence peaked on days 5 and 4 for CBDCA+PEM and CBDCA+PTX regimens, respectively. Logistic regression analysis identified younger age, female sex, no alcohol consumption, two antiemetics, and CBDCA+PEM regimen as independent risk factors associated with delayed nausea, and female sex and two antiemetics for delayed vomiting. Conclusions The emetic risk of CDBCA+PEM regimen was higher than that of CBDCA+PTX regimen. More aggressive antiemetic prophylaxis such as quadruple therapy, including olanzapine, may be considered in patients receiving CDBCA+PEM regimen. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]

Background Delayed chemotherapy-induced nausea and vomiting (CINV) is not well controlled in patients with colorectal cancer (CRC) treated with oxaliplatin (L-OHP)-based chemotherapy. Whether adding a neurokinin-1 receptor antagonist to a first-generation 5HT3 antagonist (1st-5HT3RA) and dexamethasone (DEX) is beneficial in patients on L-OHP-based chemotherapy is controversial. It is unclear whether palonosetron (PALO) or aprepitant (APR) is more effective in controlling delayed CINV. We, therefore, investigated whether PALO+DEX (PALO group) or 1st-5HT3RA+DEX+APR (APR group) was more effective in controlling delayed CINV, as well as risk factors for delayed CINV, in patients with CRC treated with L-OHP-based chemotherapy. Methods We pooled data from two prospective observational studies in Japan and one phase III clinical trial and compared the incidence of CINV between the PALO and APR groups using propensity score-matched analysis. Risk factors for CINV were identified using logistic regression models. Results Among the 404 eligible patients, those in the PALO group showed a higher incidence of delayed CINV than those in the APR group (nausea: 43.4% vs. 32.4%, P = 0.061; vomiting: 12.5% vs. 4.4%, P = 0.017). The logistic regression analysis identified alcohol consumption, motion sickness, and PALO+DEX regimen as independent risk factors for delayed nausea, and female sex and PALO+DEX regimen as those for delayed vomiting. Conclusions Treatment with the three antiemetics, including APR, was more effective in controlling delayed CINV than prophylactic treatment with the two antiemetics, including PALO. Thus, patients with CRC receiving L-OHP-based chemotherapy should be treated with three antiemetics, including APR. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]

Poster: Clinical track: Head and Neck PO-0796: Observational study of radiotherapy plus cetuximab in patients with LA-SCCHN: JROSG12-2 Y. Ota, T. Kodaira, M. Shimokawa, H. Fujii, T. Nakashima, N. Monden, T. Yokota, A. Homma, S. Ueda, U. Takashi, J. Itami, S. Noda, Y. Nishimura, M. Someya, M. Kobayashi, A. Terahara, A. Yorozu, H. Onishi, T. Akimoto. [Extracted from the article]

Background Previous studies have developed risk stratification schemas to assess chemotherapy toxicity. However, the geriatric assessment variables that should be used to assess the individual risk of severe chemotherapy toxicity and clinical outcomes in elderly patients remain controversial. Methods Patients aged ≥70 years with advanced non-small cell lung cancer (NSCLC) who were treated at 24 National Hospital Organization institutions and completed a pre- first-line chemotherapy assessment were included in this study. The assessment included the following: patient characteristics, treatment variables (platinum doublet: PD, single agent: SA, tyrosine kinase inhibitor: TKI), laboratory test values, and geriatric assessment variables. We analyzed the correlations between each factor and clinical outcomes of chemotherapy and overall survival (OS). Results In total, 348 patients with advanced NSCLC, with a median age of 76 years (range, 70 to 95 years), joined this prospective study. In all patients, the best objective response rate and disease control rate were 35.6% and 81.0%, respectively. The median progression-free survival (PFS) and OS were 6.1 and 16.5 months, respectively. Performance status, treatment variables, and several laboratory test results (anemia, albumin, and C-reactive protein) affected the best response of chemotherapy (p = 0.0249, <0.001, <0.001, <0.001, and <0.001 respectively, between disease control and progressive disease cohorts). These factors also affected the PFS of first-line therapy (5.8 (PD) vs 3.5 (SA) vs 10.5 (TKI), and 2.9 vs 6.4, 2.9 vs 6.3, 3.0 vs 6.5, 3.0 vs 7.0 months respectively, between above or below each cutoff cohort) and OS (13.7 (PD) vs 10.4 (SA) vs 30.6 (TKI), and 7.0 vs 16.8, 6.3 vs 16.8, 6.6 vs 17.8, 6.2 vs 18.1 months, between above or below each cutoff cohort). Conclusions Performance status, treatment variables, and several laboratory test values independently predicted clinical outcomes of chemotherapy in elderly patients with advanced NSCLC. Clinical trial identification UMIN000010384. Legal entity responsible for the study National Hospital Organization. Funding National Hospital Organization. Disclosure All authors have declared no conflicts of interest. [ABSTRACT FROM AUTHOR]