We aimed to evaluate the efficacy and safety of trastuzumab emtansine in patients with metastatic breast cancer previously treated with pertuzumab plus trastuzumab and taxane. We reviewed the medical ...records of patients who were diagnosed with Human Epidermal Growth Factor Receptor 2 (HER-2) positive metastatic breast cancer and received pertuzumab and then TDM-1 between January 2014 and January 2021 from twenty- five cancer centers. The Kaplan- Meier method estimated progression-free survival (PFS) and overall survival (OS). Additionally, objective response rate (ORR), clinical benefit rate (CBR), and safety were evaluated. One hundred fifty-three patients were included,79.1% of the patients received TDM-1 in the second line, 90.8% had visceral metastasis, and 30.7% had central nervous system involvement. The PFS and OS of TDM-1 were evaluated according to the number of previous lines (on the 2nd line or more than two lines) metastatic sites (visceral and non-visceral) and the presence of central nervous metastasis. In TDM-1 therapy, PFS in second line therapy was ten months (95% CI: 7.7 - 12.2); this was statistically higher than later-line PFS, which was six months (95% CI: 3.3 to 8.6) (p = 0.004). The median OS time was 25 months (95% CI: 21.0 to 28.9) in patients treated with TDM-1 in the second line and 19 months (95% CI: 12.3 to 25.6) in patients who received later than the second line(p = 0.175). There were no significant differences in PFS time of patients with and without visceral and central nervous metastases. Our study showed that TDM-1 was also effective in patients using pertuzumab, contributes significantly to PFS when used in the second line compared to its use in the later line, and does not make any difference in OS.We aimed to evaluate the efficacy and safety of trastuzumab emtansine in patients with metastatic breast cancer previously treated with pertuzumab plus trastuzumab and taxane. We reviewed the medical records of patients who were diagnosed with Human Epidermal Growth Factor Receptor 2 (HER-2) positive metastatic breast cancer and received pertuzumab and then TDM-1 between January 2014 and January 2021 from twenty- five cancer centers. The Kaplan- Meier method estimated progression-free survival (PFS) and overall survival (OS). Additionally, objective response rate (ORR), clinical benefit rate (CBR), and safety were evaluated. One hundred fifty-three patients were included,79.1% of the patients received TDM-1 in the second line, 90.8% had visceral metastasis, and 30.7% had central nervous system involvement. The PFS and OS of TDM-1 were evaluated according to the number of previous lines (on the 2nd line or more than two lines) metastatic sites (visceral and non-visceral) and the presence of central nervous metastasis. In TDM-1 therapy, PFS in second line therapy was ten months (95% CI: 7.7 - 12.2); this was statistically higher than later-line PFS, which was six months (95% CI: 3.3 to 8.6) (p = 0.004). The median OS time was 25 months (95% CI: 21.0 to 28.9) in patients treated with TDM-1 in the second line and 19 months (95% CI: 12.3 to 25.6) in patients who received later than the second line(p = 0.175). There were no significant differences in PFS time of patients with and without visceral and central nervous metastases. Our study showed that TDM-1 was also effective in patients using pertuzumab, contributes significantly to PFS when used in the second line compared to its use in the later line, and does not make any difference in OS.
Amaç: Bu araştırmada, sosyal görünüş kaygı düzeyi yüksek ve düşük ebeveynlerin, çocuklarının sosyal görünüşlerine ilişkin tutum ve davranış farklılıklarının incelenmesi amaçlanmıştır.
Gereç ve ...Yöntem: Bu araştırmada, nitel araştırma yöntemlerinden bütüncül çoklu durum çalışması kullanılmıştır. Araştırmanın katılımcılarını Adana ili Yüreğir ilçesinde yaşayan okul öncesi dönemde çocuğu olan 16 ebeveyn oluşturmaktadır. Katılımcıların belirlenmesinde, aykırı durum örnekleme yöntemi kullanılmıştır. Araştırmada ebeveynlerin sosyal görünüş kaygı düzeylerini belirlemek için, Sosyal Görünüş Kaygısı Ölçeği (SGKÖ) kullanılmış ve 100 katılımcıya uygulanmıştır. Elde edilen veriler IBM SPSS 25 programıyla analiz edilerek, katılımcılardan en yüksek ve en düşük puan alan sekizer kişi olmak üzere toplam 16 ebeveyn belirlenmiştir. Araştırmacı tarafından oluşturulan yarı yapılandırılmış görüşme formu kullanılarak, ebeveynlerle görüşmeler yapılmıştır. Görüşmeler ses kaydı alınarak yapılmış ve ses kayıtları metne dönüştürülerek, metinler içerik analizine tabii tutulmuştur.
Bulgular: Çalışmada, katılımcı grupta SGKÖ puanı en yüksek 66, en düşük 24, ortalama puan 35,71 ± 9,98 olarak elde edilmiştir. SGKÖ puan düzeyi düşük ebeveynlerin yaş ortalaması 34,75 ± 5,57’dir. SGKÖ puan düzeyi yüksek ebeveynlerin ise yaş ortalaması 31,62 ± 2,38’dir. Ebeveynlerin SGKÖ puan düzeylerine göre çocuklarının sosyal görünüşleri hakkındaki düşüncelerinde, çocuklarının bedenlerine yönelik beklentilerinde ve ideal çocuk bedeni tanımlamalarında farklılıklar belirlenmiştir. SGKÖ puanı yüksek ebeveynler, daha çok estetik görünüme ilişkin tanımlamalar yapmışlardır. Ayrıca SGKÖ puanı yüksek ebeveynlerin çocuklarının Beden Kitle İndeksi (BKİ) ile uyumsuz tanımlamalara sahip oldukları görülmüştür. Aksine SGKÖ puan düzeyi düşük olan ebeveynlerin ise çocuklarının bedenlerine ilişkin idealleştirmeye gitmedikleri anlaşılmıştır. Düşük ve yüksek SGKÖ puan düzeylerine sahip ebeveynlerin, çocuklarının sosyal görünüşlerine müdahalelerinde; fiziksel etkinliklerde, kıyafet tercihleri ve fiziksel görünüş uygulamalarında da farklılıklar bulunmuştur.
Sonuç: SGKÖ puan düzeyleri düşük ebeveynler, çocuklarının bedenine ilişkin idealleştirmeye gitmezken, SGKÖ puanı yüksek ebeveynlerin estetik görünüme ilişkin tanımlamalar yaptıkları görülmektedir. Bunun yanı sıra, SGKÖ puanı yüksek ebeveynlerin çocuklarının BKİ ile uyumsuz tanımlamalara sahip olduğu görülmüştür. SGKÖ puan düzeylerindeki farklılığın, ebeveynlerin çocuk yetiştirme tutum ve davranışlarında da farklılıklara sebep olduğu belirlenmiştir. Çalışmamıza göre, SGKÖ puan düzeyi yüksek olan ebeveynler çocuklarının beden görünümlerine daha fazla müdahale etmektedirler. Yeme kısıtlamaları, harekete teşvik ve akranları ile kıyaslama şeklinde tutum ve davranışları daha fazla göstermektedirler.
Purpose: The aim of this study was to examine the attitudes and behaviors of parents with high and low social appearance anxiety levels regarding their children's social appearance.
Materials and Methods: In this study, a holistic multiple case study, one of the qualitative research methods, was used. The participants of the research are 16 parents who have a child in the preschool period living in Yüreğir district of Adana province. The outlier sampling method was used to determine the participants. In the study, Social Appearance Anxiety Scale (SSAS) was used and applied to 100 participants to determine the social appearance anxiety levels of parents. The data obtained were analyzed with the IBM SPSS 25 program, and a total of 16 parents, eight of whom had the highest and the lowest scores, were determined. Interviews were conducted with the parents using the semi-structured interview form created by the researcher. The interviews were made with audio recordings and the audio recordings were converted into texts and the texts were subjected to content analysis.
Results: The highest SSAS score in the participant group was 66, the lowest was 24, and the mean score was 35.71 ± 9.98. The mean age of parents with low SSAS scores is 34.75 ± 5.57. The mean age of parents with high SSAS scores is 31.62 ± 2.38. Differences were determined in the opinions of the parents about their children's social appearance, their expectations for their children's bodies, and the ideal child body definitions according to the SSAS score levels of the parents. Parents with high SSAS scores made more definitions of aesthetic appearance. In addition, it was observed that the children of parents with high SSAS scores had incompatible definitions with Body Mass Index (BMI). On the contrary, it was understood that parents with low SSAS scores do not idealize their children's bodies. In the interventions of parents with low and high SSAS scores on their children's social appearance; Differences were also found in physical activities, clothing preferences and physical appearance practices.
Conclusion: While parents with low SSAS scores do not idealize their children's body, it is seen that parents with high SSAS scores make definitions regarding aesthetic appearance. In addition, it was observed that the children of parents with high SSAS scores had definitions that were incompatible with BMI. According to study, parents with high SSAS scores interfere more with their children's body appearance. They show more attitudes and behaviors in the form of eating restrictions, encouragement to action, and comparison with their peers.
This investigation aimed to determine the impacts of concurrent proton pump inhibitors (PPIs) on progression-free survival (PFS) in patients with hormone receptor-positive and HER2-negative ...metastatic breast cancer managed with palbociclib or ribociclib as either the initial or subsequent line of therapy option.
In this retrospective study, patients were classified as "concurrent PPIs" if PPIs were given for at least two-thirds of the palbociclib or ribociclib therapy period, and "no concurrent PPIs" if no PPIs were given during the period of palbociclib or ribociclib therapy. Each patient was also classified as endocrine-sensitive or endocrine-resistant according to the duration of previous endocrine responses. "Concurrent PPIs" and "no concurrent PPIs" groups were compared with each other in terms of PFS. This comparison was performed for both ribociclib and palbociclib groups.
: The research included 220 patients in total. The PFS of 57 patients on palbociclib using concomitant PPIs was 14.4 months. Among 63 patients using palbociclib without concomitant PPIs, the PFS was 15.8 months. No statistically significant difference was found with PPI use (
= 0.82). Among 29 patients using ribociclib concurrently with PPIs, the PFS was 22.4 months. Among 71 patients using ribociclib without PPIs, the PFS was 20.2 months. No statistically significant difference was found with PPI use (
= 0.40).
: The results of our investigation showed that concomitant use of the most commonly used PPIs in the study (lansoprazole, pantoprazole, and esomeprazole) with palbociclib or ribociclib did not have any detrimental effects on PFS. Where appropriate, PPIs can be used concurrently with palbociclib and ribociclib. However, the effect of PPIs on cycling-dependent kinase 4/6 inhibitors deserves further investigation.
Background: Programmed death-ligand 1 (PD-L1) has been determined as a reliable prognostic factor for various malignancies. In this study, we aimed to determine the prognostic effect of PD-L1 ...expression in tumor-infiltrating immune cells (TIICs) of nasopharyngeal carcinoma (NPC) patients.
Methods: Seventy patients diagnosed with non-metastatic NPC were included in the study. PD-L1 expression on immune cells was analyzed by immunohistochemical method. Patients were categorized into two groups according to the PD-L1 expression level in TIICs (level of PD-L1 staining ≥5% positive vs <5% negative).
Results: Median follow-up period was 34 months (range = 1 - 188). 1 and 2 years survival rate were found as 75% and 63% in PD-L1 negative TIICs group (47%), and 85% and 83% in PD-L1 positive TIICs group (53%), respectively. PD-L1 positivity in immune cells (ICs) was detected in 53% of the patients. The survival rate was found better in the PD- L1 positive group compared to the negative group (P = 0.049).
Discussion: In conclusion, the survival rate was found significantly better in the PD-L1 positive TIICs group, compared to the negative group.
In the KEYNOTE-826 study, the addition of the anti-PD-1 monoclonal antibody pembrolizumab to chemotherapy with or without bevacizumab improved overall survival and progression-free survival (primary ...endpoints) versus placebo plus chemotherapy with or without bevacizumab, with manageable toxicity, in patients with persistent, recurrent, or metastatic cervical cancer. In this Article, we report patient-reported outcomes (PROs) from KEYNOTE-826.
KEYNOTE-826 is a multicentre, randomised, phase 3 trial in 151 cancer treatment centres in 19 countries. Eligible patients were aged 18 years or older with persistent, recurrent, or metastatic cervical cancer not previously treated with systemic chemotherapy (previous radiosensitising chemotherapy was allowed) and not amenable to curative treatment and had an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (1:1) centrally by means of an interactive voice response system in a double-blind manner to receive either pembrolizumab 200 mg or placebo every 3 weeks intravenously for up to 35 cycles plus chemotherapy (paclitaxel 175 mg/m2 plus cisplatin 50 mg/m2 or carboplatin area under the curve 5 mg/mL per min, intravenously) with or without bevacizumab 15 mg/kg every 3 weeks intravenously. Randomisation (block size of 4) was stratified by metastatic disease at diagnosis, planned bevacizumab use, and PD-L1 combined positive score. Patients, investigators, and other study personnel involved in study treatment administration or clinical evaluation of patients were unaware of treatment group assignments. PRO instruments were the EORTC Quality-of-Life-Core 30 (QLQ-C30), the EORTC cervical cancer module (QLQ-CX24), and the EuroQol-5 dimension-5 level (EQ-5D-5L) visual analogue scale, each collected before treatment at cycles 1–14 and every other cycle thereafter. Primary endpoints were overall survival and progression-free survival per RECIST version 1.1 by investigator review. Change from baseline in QLQ-C30 global health status (GHS)–quality of life (QoL) was a prespecified secondary endpoint and was assessed in the PRO full analysis population (all patients who received at least one dose of study treatment and completed at least one post-baseline PRO assessment). Other PRO analyses were protocol-specified exploratory endpoints. The study is registered with ClinicalTrials.gov, NCT03635567, and is ongoing.
Between Nov 20, 2018, and Jan 31, 2020, of 883 patients screened, 617 were randomly assigned (pembrolizumab group, n=308; placebo group, n=309). 587 (95%) of 617 patients received at least one dose of study treatment and completed at least one post-baseline PRO assessment and were therefore included in the PRO analyses (pembrolizumab group, n=290; placebo group, n=297). Median follow-up was 22·0 months (IQR 19·1–24·4). At week 30, QLQ-C30 completion was 199 (69%) of 290 patients in the pembrolizumab group and 168 (57%) of 297 patients in the placebo group; compliance was 199 (94%) of 211 and 168 (90%) of 186, respectively. The least squares mean change in QLQ-C30 GHS–QoL score from baseline to week 30 was −0·3 points (95% CI −3·1 to 2·6) in the pembrolizumab group and −1·3 points (−4·2 to 1·7) in the placebo group, with a between-group difference in least squares mean change of 1·0 point (95% CI −2·7 to 4·7). Median time to true deterioration in GHS–QoL was not reached (NR; 95% CI 13·4 months–NR) in the pembrolizumab group and 12·9 months (6·6–NR) in the placebo group (hazard ratio 0·84 95% CI 0·65–1·09). 122 (42%) of 290 patients in the pembrolizumab group versus 85 (29%) of 297 in the placebo group had improved GHS–QoL at any time during the study (p=0·0003).
Addition of pembrolizumab to chemotherapy with or without bevacizumab did not negatively affect health-related quality of life. Along with the efficacy and safety results already reported from KEYNOTE-826, these data support the benefit of pembrolizumab and the value of immunotherapy in patients with recurrent, persistent, or metastatic cervical cancer.
Merck Sharp & Dohme.
JCO
The phase III, double-blind KEYNOTE-826 trial of pembrolizumab 200 mg or placebo once every 3 weeks for up to 35 cycles plus platinum-based chemotherapy, with or without bevacizumab, showed ...statistically significant survival benefits with the addition of pembrolizumab for patients with persistent, recurrent, or metastatic cervical cancer (primary data cutoff: May 3, 2021). This article reports the protocol-specified final overall survival (OS) results tested in the PD-L1 combined positive score (CPS) ≥1, all-comer, and CPS ≥10 populations. At the final data cutoff (October 3, 2022), the median study follow-up duration was 39.1 months (range, 32.1-46.5 months). In the PD-L1 CPS ≥1 (N = 548), all-comer (N = 617), and CPS ≥10 (N = 317) populations, median OS with pembrolizumab-chemotherapy versus placebo-chemotherapy was 28.6 months versus 16.5 months (hazard ratio HR for death, 0.60 95% CI, 0.49 to 0.74), 26.4 months versus 16.8 months (HR, 0.63 95% CI, 0.52 to 0.77), and 29.6 months versus 17.4 months (HR, 0.58 95% CI, 0.44 to 0.78), respectively. The incidence of grade ≥3 adverse events was 82.4% with pembrolizumab-chemotherapy and 75.4% with placebo-chemotherapy. These results show that pembrolizumab plus chemotherapy, with or without bevacizumab, continued to provide clinically meaningful improvements in OS for patients with persistent, recurrent, or metastatic cervical cancer.
Background and Objectives: Small bowel adenocarcinomas (SBAs) are rare tumors of the gastrointestinal system. Lymph node metastasis in patients with curatively resected SBAs is associated with poor ...prognosis. In this study, we determined the prognostic utility of the number of removed lymph nodes and the metastatic lymph node ratio (the N ratio). Materials and Methods: The data of 97 patients who underwent curative SBA resection in nine hospitals of Turkey were retrospectively evaluated. Univariate and multivariate analyses of potentially prognostic factors including the N ratio and the numbers of regional lymph nodes removed were evaluated. Results: Univariate analysis showed that perineural and vascular invasion, metastatic lymph nodes, advanced TNM stage, and a high N ratio were significant predictors of poor survival. Multivariate analysis revealed that the N ratio was a significant independent predictor of disease-specific survival (DSS). The group with the lowest N ratio exhibited the longest disease-free survival (DFS) and DSS; these decreased significantly as the N ratio increased (both, p < 0.001). There was no significant difference in either DFS or DSS between groups with low and high numbers of dissected lymph nodes (i.e., <13 and ≥13) (both, p = 0.075). Conclusions: We found that the N ratio was independently prognostic of DSS in patients with radically resected SBAs. The N ratio is a convenient and accurate measure of the severity of lymph node metastasis.
Background: This study was designed to estimate economic burden of lung cancer in Turkey from payer perspective based on expert panel opinion on practice patterns in clinical practice. Methods: In ...this cost of illness study, direct medical cost was calculated based on cost items related to outpatient visits, laboratory and radiological tests, hospitalizations/interventions, drug treatment, adverse events and metastasis. Indirect cost was calculated based on lost productivity due to early retirement, morbidity and premature death resulting from the illness, the value of lost productivity due to time spent by family caregivers and cost of formal caregivers. Results: Cost analysis revealed the total per patient annual direct medical cost for small cell lung cancer to be €8772), for non-small-cell lung cancer to be €10,167. Total annual direct medical cost was €497.9 million, total annual indirect medical cost was €1.1 billion and total economic burden of lung cancer was €1.6 billion. Hospitalization/interventions (41%) and indirect costs (68.6%) were the major cost drivers for total direct costs and the overall economic burden of lung cancer, respectively. Conclusions: Our findings indicate per patient direct medical costs of small cell lung cancer and non-small-cell lung cancer to be substantial and comparable, indicating the substantial economic burden of lung cancer in terms of both direct and indirect costs. Our findings indicate that hospitalization/interventions cost item and indirect costs were the major cost drivers for total direct costs and the overall economic burden of lung cancer, respectively. Our findings emphasize the potential role of improved cancer prevention and early diagnosis strategies, by enabling cost savings related to drug treatment and metastasis management cost items, in sustainability of cancer treatments.
This consensus report includes expert opinions and recommendations regarding the screening, and if necessary, the follow-up, prophylaxis, and treatment of hepatitis B before the treatment in patients ...who will undergo immunosuppressive therapy due to an emergency risk of hepatitis B reactivation. To increase awareness regarding the risk of hepatitis B reactivation in immunosuppressive patients, academicians from several university health research and training centers across Turkey came together and discussed the importance of the subject, current status, and issues in accordance with the current literature data and presented solutions.
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