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Background Addition of trastuzumab to first-line palliative chemotherapy in esophagogastric cancer patients with HER2 overexpression has shown to improve survival and is therefore considered standard of care. The aim of this study was to assess HER2 testing, trastuzumab administration and overall survival (OS) in a nationwide cohort of metastatic esophagogastric cancer patients. Methods Patients with synchronous metastatic esophagogastric adenocarcinoma diagnosed between 2010-2016 that received palliative systemic treatment (N = 2846) were identified from the Netherlands Cancer Registry. Details on HER2 assessment were extracted from pathology reports from the Dutch Pathology Registry. For determination of HER2 positivity or negativity, the criteria on HER2 assessment of the ToGA trial were used. Proportions of HER2 tested patients were analyzed between hospital volume categories using Chi-square tests, and over time using trend analysis. OS was tested using the Kaplan Meier method and log rank test. Results HER2 assessment was performed in 54% of all 2846 patients that received palliative chemotherapy, and increased from 18% to 88% between 2010 and 2016 (P Conclusions Daily practice management of metastatic esophagogastric cancer patients has changed due to increased determination of HER2 status and administration of trastuzumab, which might have contributed to the improved survival in these patients. Advances in clinical practice could include a further increase in awareness of HER2 testing among pathologists and clinicians, especially in low-volume hospitals, and in the administration of trastuzumab in case of HER2 overexpression. Legal entity responsible for the study The authors. Funding Roche. Disclosure R.H.A. Verhoeven: Research grant / Funding (institution): BMS; Research grant / Funding (institution): Roche. N. Haj Mohammad: Advisory / Consultancy: BMS; Advisory / Consultancy: MSD. J. de Vos-Geelen: Non-remunerated activity/ies: BTG; Research grant / Funding (institution), Non-remunerated activity/ies: Servier; Advisory / Consultancy: Shire. T. Van Voorthuizen: Non-remunerated activity/ies: Astellas; Non-remunerated activity/ies: Ipsen; Non-remunerated activity/ies: Roche; Non-remunerated activity/ies: Bayer. M. van Oijen: Research grant / Funding (institution): Roche; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): Nordic; Research grant / Funding (institution): Servier; Research grant / Funding (institution): Amgen. H.W.M. van Laarhoven: Research grant / Funding (institution): Bayer; Advisory / Consultancy, Research grant / Funding (institution): BMS; Advisory / Consultancy, Research grant / Funding (institution): Celgene; Advisory / Consultancy, Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Merck Serono; Research grant / Funding (institution): MSD; Advisory / Consultancy, Research grant / Funding (institution): Nordic; Research grant / Funding (institution): Philips; Research grant / Funding (institution): Roche. All other authors have declared no conflicts of interest.

Item does not contain fulltext BACKGROUND: The effect of extended adjuvant aromatase inhibition in hormone receptor-positive breast cancer after sequential endocrine therapy of tamoxifen followed by an aromatase inhibitor for a 5-year treatment period still needs clarification. To address this issue, we began the DATA study to assess different durations of anastrozole therapy after tamoxifen. METHODS: DATA was a prospective, randomised, open-label, multicentre, phase 3 study done in 79 hospitals in the Netherlands. We randomly assigned postmenopausal women with hormone receptor-positive early breast cancer with no signs of disease recurrence after 2-3 years of adjuvant tamoxifen to either 3 or 6 years of anastrozole treatment (1 mg orally once a day) in a 1:1 ratio. We used TENALEA (Trans European Network for Clinical Trials Services) for the randomisation procedure. Stratification factors were nodal status, hormone receptor status, HER2 status, and tamoxifen treatment duration. The primary study endpoint of this analysis was disease-free survival starting beyond 3 years after randomisation (adapted disease-free survival). Here we report the final analysis from the DATA trial, which is registered with ClinicalTrials.gov, number NCT00301457. FINDINGS: Between June 28, 2006, and Aug 10, 2009, we screened 1912 patients of whom 955 were assigned to the 3-year group and 957 to the 6-year anastrozole treatment group. 1860 patients were eligible (931 in the 6-year group and 929 in the 3-year group) and 1660 were disease free 3 years after randomisation. The 5-year adapted disease-free survival was 83.1% (95% CI 80.0-86.3) in the 6-year group and 79.4% (76.1-82.8) in the 3-year group (hazard ratio [HR] 0.79 [95% CI 0.62-1.02]; p=0.066). Patients in the 6-year treatment group had more adverse events than those in the 3-year treatment group, including all-grade arthralgia or myalgia (478 [58%] of 827 in the 6-year treatment group vs 438 [53%] of 833 in the 3-year treatment group) and osteopenia or osteoporosis (173 [21%] vs 137 [16%]). INTERPRETATION: We cannot recommend the use of extended adjuvant aromatase inhibition after 5 years of sequential endocrine therapy in all postmenopausal women with hormone receptor-positive breast cancer. FUNDING: AstraZeneca.

Background SALTO is a multi-center, open-label phase III trial in which 161 Western patients with metastatic colorectal cancer (mCRC) were randomized between capecitabine and S-1. The primary endpoint, a lower incidence of hand-foot syndrome (HFS) for S-1, was met (all grade 73% for capecitabine versus 45% for S-1, odds ratio 0.31 [95% confidence interval (CI) 0.16-0.60], p = 0.0005; grade 3 21% for capecitabine versus 4% for S-1, p = 0.003). There was no significant difference in median progression-free survival (PFS), data on overall survival (OS) were immature. We here present updated results on survival. Methods mCRC patients in whom first-line fluoropyrimidine monochemotherapy was indicated were randomized between capecitabine twice-daily on day 1 to 14 at a dose of 1250 mg/m2 for patients Results A total of 161 patients were randomized between January 2014 - July 2015, 81 in the capecitabine group and 80 in the S-1 group. Bevacizumab was administered to 59% of patients in both arms. At data cut-off (6 August 2018, median follow-up 40.3 months), 71 (88%) patients in the capecitabine group and 68 (85%) patients in the S-1 group had died. Median PFS was 8.2 months (95% CI 6.4-10.3) for capecitabine and 8.4 months (95% CI 6.4-10.6) for S-1 (HR 1.02, 95% CI 0.75-1.40, p = 0.89). Median OS was 17.1 months (95% CI 14.3-23.5) and 17.0 months (13.0-20.1), respectively (HR 1.07, 95% CI 0.76-1.49, p = 0.70). Conclusions This study demonstrated a significantly lower incidence of HFS for S-1 compared to capecitabine in Western mCRC patients. Although the study was not powered to demonstrate non-inferiority, these data suggest comparable efficacy of S-1 and capecitabine in terms of PFS and OS. Clinical trial identification NCT01918852. Legal entity responsible for the study Dutch Colorectal Cancer Group. Funding Nordic Pharma. Disclosure J.J. Kwakman: Honoraria (self), Research grant / Funding (institution): Nordic Pharma; Advisory / Consultancy, Research grant / Funding (institution): Servier. R. van Alphen: Advisory / Consultancy: Nordic Pharma; Travel / Accommodation / Expenses: Roche. C.J.A. Punt: Advisory / Consultancy: Nordic Pharma; Advisory / Consultancy: Servier. All other authors have declared no conflicts of interest.

Contains fulltext : 193309.pdf (Publisher’s version ) (Open Access) BACKGROUND: Biliary tract cancer (BTC) is an uncommon cancer with an unfavorable prognosis. Since 2010, the standard of care for patients with unresectable BTC is palliative treatment with gemcitabine plus cisplatin, based on the landmark phase III ABC-02 trial. This current study aims to evaluate the efficacy and safety of gemcitabine and cisplatin in patients with unresectable cholangiocarcinoma and gallbladder cancer in daily practice that meet the criteria for the ABC-02 trial in comparison to patients who did not. METHODS: Patients diagnosed with unresectable BTC between 2010 and 2015 with an indication for gemcitabine and cisplatin were included. We divided these patients into three groups: (I) patients who received chemotherapy and met the criteria of the ABC-02 trial, (II) patients who received chemotherapy and did not meet these criteria and (III) patients who had an indication for chemotherapy, but received best supportive care without chemotherapy. Primary outcome was overall survival (OS) and secondary outcome was progression-free survival (PFS). RESULTS: We collected data of 208 patients, of which 138 (66.3%) patients received first line chemotherapy with gemcitabine and cisplatin. Median OS of 69 patients in group I, 63 patients in group II and 65 patients in group III was 9.6 months (95%CI = 6.7-12.5), 9.5 months (95%CI = 7.7-11.3) and 7.6 months (95%CI = 5.0-10.2), respectively. Median PFS was 6.0 months (95%CI = 4.4-7.6) in group I and 5.1 months (95%CI = 3.7-6.5) in group II. Toxicity and number of dose reductions (p = .974) were comparable between the two chemotherapy groups. CONCLUSION: First-line gemcitabine and cisplatin is an effective and safe treatment for patients with unresectable BTC who do not meet the eligibility criteria for the ABC-02 trial. Median OS, PFS and treatment side effects were comparable between the patients who received chemotherapy (group I vs. group II).