Purpose Surgical complications such as hypoparathyroidism (HPT) or vocal cord palsy are seldom assessed when the quality of life (QOL) in thyroid cancer patients is investigated. The aim of this study was to measure the QOL difference in thyroid cancer survivors with and without HPT. Methods Participants for this analysis were enrolled in 13 countries from a study which pilot-tested a thyroid cancer specific QOL instrument. They were included if they had been diagnosed with thyroid cancer at least nine months previously. QOL was measured using the EORTC QLQ-C30 and some items on HPT symptoms (e.g. tingling in fingers or toes). HPT status and other clinical data were extracted from the patients’ medical charts. Comparisons of QOL domains between patients with and without HPT were performed using Mann-Whitney U test. The occurrence of HPT-related symptoms was compared using Chi-Square-Tests. Multiple ordinal regression analysis was performed to evaluate factors which might have an impact on QOL. Results Eighty-nine patients participated in this study, 17 of whom were considered to have HPT. Patients in the HPT group reported significantly reduced QOL in nine of the 15 scales of the EORTC QLQ-C30 compared to patients without HPT. Regression analysis showed that HPT was independently negatively associated with various scales of the QLQ-C30. Both groups showed a high prevalence of typical HPT symptoms. Conclusion Thyroid cancer patients with HPT report significantly impaired QOL compared to thyroid cancer survivors without HPT. The assessment of HPT should be considered when measuring QOL in thyroid cancer patients.

The purpose of the study was to pilot-test a questionnaire measuring health-related quality of life (QoL) in thyroid cancer patients to be used with the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire EORTC QLQ-C30. A provisional questionnaire with 47 items was administered to patients treated for thyroid cancer within the last 2 years. Patients were interviewed about time and help needed to complete the questionnaire, and whether they found the items understandable, confusing or annoying. Items were kept in the questionnaire if they fulfilled pre-defined criteria: relevant to the patients, easy to understand, not confusing, few missing values, neither floor nor ceiling effects, and high variance. A total of 182 thyroid cancer patients in 15 countries participated ( = 115 with papillary, = 31 with follicular, = 22 with medullary, = 6 with anaplastic, and = 8 with other types of thyroid cancer). Sixty-six percent of the patients needed 15 min or less to complete the questionnaire. Of the 47 items, 31 fulfilled the predefined criteria and were kept unchanged, 14 were removed, and 2 were changed. Shoulder dysfunction was mentioned by 5 patients as missing and an item covering this issue was added. To conclude, the EORTC quality of life module for thyroid cancer (EORTC QLQ-THY34) is ready for the final validation phase IV.

Purpose: Radiotherapy with concurrent temozolomide (TMZ), followed by 6 cycles of adjuvant TMZ, is the standard of care for newly diagnosed Glioblastoma Mulltiforme (GBM). However tumor progression is the role with median survival of almost 14 months. With lack of effective second line chemotherapy, many physicians and some guidelines advocate prolonged use of adjuvant TMZ more than 6 months. We conduct this study to test the efficacy of protracted adjuvant conventional dose TMZ over the standard 6 doses of adjuvant TMZ. Material and Methods: This phase II trial enrolled patients newly diagnosed as GBM, older than age 18 years, with a Karnofsky performance score (KPS) of ≥60, Neurological Performance Scale (NPS) of ≤3. Patients were randomly assigned to the standard concurrent chemoradiotherapy (CCRT) followed by 6 cycles of adjuvant TMZ or the same treatment with more than 6 cycles of adjuvant chemotherapy extended as long as the patient in good performance, with no unacceptable toxicity, no signs of disease progression. The primary end point was OS. Results: A total of 59 patients were recruited in the study and were randomized in two arms. 29 patients joined arm 1 aiming at receiving CCRT followed by adjuvant 6 cycles TMZ (6 cycles arm) and 30 joined arm 2 aiming at receiving the same treatment with more than 6 cycles of TMZ (>6 cycles). 16 patients managed to complete the adjuvant 6 cycles in arm 1. 19 patients in arm 2, completed the 6 cycles with additive more doses with a median of 11 cycles (range: 8-23 cycles). Median PFS was 12.1 months for (6 cycles) arm, and 18.8 months for (>6 cycles) arm, HR 0.88 (95% CI: 1.185-4.901) (P 0.015); the overall survival for (6 cycles) arm was 18.1 months, versus 24.1 months, HR 0.70 (95% CI: 1.007-4.037) (P 0.048). No significant added toxicity was notice and the 4 weekly TMZ was well tolerated. Conclusion: This study concluded that protracted adjuvant TMZ after concurrent chemoradiotherapy could be a feasible strategy for GBM. This strategy warrants a large phase III randomized trial.

Background: PD-L1 expression differs from 19 to 92% in various cancer subtypes. Its expression carries a worse prognostic value in various malignancies and could also be used as a predictive marker for immune checkpoint inhibitor response. This study aimed to explore the prevalence of PD-L1 expression in soft tissue sarcomas and the correlation of PD-L1 expression with clinicopathological features.Patients and Methods: The tissue samples of 50 patients with STS were tested for PD-L1 expression using immunohistochemistry (IHC). We followed a 6-step proportional scoring system. The patients were treated at Ain Shams University Hospital from 2011 to 2017. We also explored the correlation of PD-L1 expression with different clinical features of the patients. The chi-square test was used to calculate the differences among variables.Results: Twelve cases (24%) showed positive PD-L1 expression with the highest prevalence in rhabdomyosarcoma and desmoid tumors (2/2 and 2/3 cases, respectively), followed by GIST in 2/4 cases and liposarcoma in 3/11 cases. Patients with positive PD-L1 expression showed a trend for worse survival, with a median overall survival of 11 months vs. 19 months for patients with negative PD-L1 expression (p-value = 0.1) and a mean PFS of 6 months vs. 11 months for patients with negative PD-L1 expression (p-value = 0.1). However, these findings did not reach statistical significance.Conclusion: Although the results did not reach statistical significance due to the small number of cases, PD-L1 expression could represent a prognostic factor for poor outcome. Larger clinical trials are recommended for the validation of PD-L1 as a poor prognostic biomarker.

Purpose The aim of this study was to explore what methods should be used to determine the minimal important difference (MID) and minimal important change (MIC) in scores for the European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43. Methods In an international multi-centre study, patients with head and neck cancer completed the EORTC QLQ-HN43 before the onset of treatment (t1), three months after baseline (t2), and six months after baseline (t3). The methods explored for determining the MID were: (1) group comparisons based on performance status; (2) 0.5 and 0.3 standard deviation and standard error of the mean. The methods examined for the MIC were patients' subjective change ratings and receiver-operating characteristics (ROC) curves, predictive modelling, standard deviation, and standard error of the mean. The EORTC QLQ-HN43 Swallowing scale was used to investigate these methods. Results From 28 hospitals in 18 countries, 503 patients participated. Correlations with the performance status were |r|< 0.4 in 17 out of 19 scales; hence, performance status was regarded as an unsuitable anchor. The ROC approach yielded an implausible MIC and was also discarded. The remaining approaches worked well and delivered MID values ranging from 10 to 14; the MIC for deterioration ranged from 8 to 16 and the MIC for improvement from − 3 to − 14. Conclusions For determining MIDs of the remaining scales of the EORTC QLQ-HN43, we will omit comparisons of groups based on the Karnofsky Performance Score. Other external anchors are needed instead. Distribution-based methods worked well and will be applied as a starting strategy for analyses. For the calculation of MICs, subjective change ratings, predictive modelling, and standard-deviation based approaches are suitable methods whereas ROC analyses seem to be inappropriate.

Introduction: One of the most important regulators of immune response is the programmed death receptor 1 (PD-1) and its interaction with its ligand (PD-L1), which negatively influences the immune response. Objectives: This study aims to clarify PD-L1 expression levels and the associated tumor infiltrating lymphocytes (TILs) in patients with metastatic breast cancer, and to assess their influence on the prognosis of these patients and the association with clinico-pathologic criteria. Patients and Methods: PD-L1 expression was analyzed using immunohistochemistry (IHC) while TILs count was assessed by histopathological examination of the hematoxylin and eosin (H & E) stained full tumor sections from 50 patients diagnosed with stage IV breast cancer at Ain Shams University hospital, Cairo, Egypt. Results: PD-L1 expression was demonstrated on TILs in 21 of 50 specimens, and on tumor cells in 13 of 50 specimens. Triple negative breast cancer (TNBC) and ER-/Her2+ subtypes were significantly associated with TIL infiltration and PD-L1 expression (on TILs and tumor cells). High TIL infiltration was significantly associated with worse overall survival (OS) and progression free survival (PFS) (P=0.0238 [HR 4.7, 95% CI: 1.22-18.11] and P=0.0262 [HR 3.1, 95% CI: 1.14-8.59] respectively). No correlation was found between PD-L1 expression (on tumor or TILs) and the survival of the patients (OS nor PFS). Conclusion: High TIL count infiltrating the breast tumor is associated with worse OS and PFS in patients with metastatic breast cancer. High PD-L1 expression correlated with high counts of TIL levels around the tumor. These findings have major clinical implications in using immune-checkpoint inhibitors in treating breast cancer patients.

e14261 Background: The expression rate of PD-L1 in human malignant tumors paid a lot of attention and has been reported to vary from 19% to 92%, and the expression of PD-L1 was associated with poor prognosis of various human and may predicted the response to immune checkpoint inhibitors. The purpose of this study to investigate the expression of PD-L1 and its clinic-pathological feature in soft tissue sarcomas (STS). Methods: We collected Paraffin embedded tissue of 50 Patients with STS retrospectively from the archives of Pathology and oncology Department, Ain Shams University Hospitals from 2011-2017.then we correlated between PD-L1 expression and the clinico-pathological features. For PD-L1 expression we followed the Cologne 6-step proportional scoring system, using the rabbit monoclonal antibody (E1L3N 13684) and Tumors with > /10% membranous stained cells were considered to be positive for expression. The differences among variables were calculated by chi-square test. Results: PD-L1 expression was found in 12 (24%) of cases. Of all sarcoma subtypes , desmoid tumors had the highest prevalence of PD-L1 expression noted in 2/3 (66%) of samples followed by GIST 2/4(50%), then liposarcoma 3/11(27%). In addition, there were 2 rhabdomyosarcoma cases with tumor positivity for PD-L1 expression. We found that STS patients with PD-L1 expression have shorter survival with a median OS 11 vs 19 months (p-value = 0.1) as well as a mean PFS 6 vs 11 months (p-value = 0.1) in PD-L1 positive and negative respectively; this finding considered as clinically significant, but not reached to statistical significant . Conclusions: We report here that PD-L1 expression is as prognostic factor for poorer outcome. This finding may be clinically significant but does not reach the statistically significant levels due to small number of samples included. Its role beyond that of a prognostic biomarker remains to be established in the context of larger clinical trials. Clinical trial information: 31/2017.

Results: Fifty-one patients were included with a median age of 53 (37-77), of which 24 (45%) were premenopausal. The median tumour size was 29 mm (17-48). Ten patients had lymph node-positive disease. Based on the St. Gallen criteria. 30 patients were classified as luminal A and 21 as luminal B. Tamoxifen was started in pre-and an aromatase inhibitor in postmenopausal patients, with a median duration of 8 months (4-14) until surgery. Four patients switched therapy because of stable or progressive disease at 3-month evaluation. Radiological complete response was observed in seven patients (14%), partial response in 32 (64%) and stable disease in 10 (20%) patients. Major pathological response was observed in 12.5% of the cases. Of the eleven patients in whom mastectomy had been indicated initially, seven (7/11; 64%) were eligible for BCS after NET. Because of lymph node-positive disease or a second progressive lesion found post-operatively, five (10%) patients received adjuvant chemotherapy.Conclusions: Based on this relatively small series, treating patients with a low-risk 70gene signature with neoadjuvant endocrine therapy seems feasible. The pathological response rate and conversion to breast-conserving surgery are of clinical relevance and deserve validation in a larger study.Legal entity responsible for the study: Netherlands Cancer Institute/Antoni van Leeuwenhoek hospital (NKI-AVL).