Real-world evaluation of nivolumab in patients with non-nasopharyngeal recurrent or metastatic head and neck cancer: a retrospective multi-center study by the Turkish Oncology Group (TOG).

OBJECTIVES: Head and neck cancers (HNCs) represent a significant global health concern due to high morbidity and mortality rates. Despite therapeutic advances, the prognosis for advanced or recurrent cases remains challenging. Nivolumab obtained approval for recurrent or metastatic HNC based on the Phase III CheckMate 141 trial. This study aimed to evaluate the real-world outcomes of nivolumab in patients with non-nasopharyngeal HNC. DESIGN: In this multicenter retrospective study, we analyzed 124 patients with recurrent or metastatic non-nasopharyngeal HNC who received nivolumab in the second-line setting and beyond. Data were collected from 20 different cancer centers across Turkey. The effectiveness and safety of the treatment and survival outcomes were evaluated. RESULTS: Nivolumab exhibited favorable clinical responses, yielding an objective response rate of 29.9% and a disease control rate of 55.7%. Safety assessments revealed a generally well-tolerated profile, with no instances of treatment discontinuation or mortality due to side effects. Survival analysis disclosed a median overall survival (OS) of 11.8 (95% CI 8.4-15.2) months. Multivariate analysis revealed that ECOG-PS ≥ 1 (HR: 1.64, p = 0.045), laryngeal location (HR: 0.531, p = 0.024), and neutrophil-to-lymphocyte ratio > 3.5 (HR: 1.97, p = 0.007) were independent predictors of OS. CONCLUSIONS: Nivolumab is an effective and safe treatment option for patients with recurrent or metastatic non-nasopharyngeal HNC in real-world settings. Further studies are needed on factors affecting response to treatment and survival outcomes.

Comparison of the Efficacy and Safety of 3 Months of CAPOX Followed by 3 Months of Capecitabine and 6 Months of CAPOX/FOLFOX in the Adjuvant Treatment of Low-Risk Stage III Colon Cancer Treated Surgically.

INTRODUCTION: In the adjuvant treatment of low-risk stage III colon cancer treated surgically, 3 months of CAPOX followed by 3 months of capecitabine is not a common clinical practice. Since there are no data on this practice in the literature, we have no idea how often it is used. However, it should be noted that this application is used in some centers due to the cumulative neurotoxicity of oxaliplatin but there are insufficient data in the literature on its efficacy. METHODS: The data of patients with colon cancer treated surgically who were followed up in 12 different oncology centers in Turkey between November 2004 and June 2022 were analyzed retrospectively. RESULTS: The study included 194 patients. The treatment arms were as follows: 3 months of CAPOX followed by 3 months of capecitabine = arm A and CAPOX/FOLFOX (6 months) = arm B. There were 78 patients (40.2%) in arm A and 116 patients (59.8%) in arm B. The median age and sex distribution were similar between the treatment arms. The median follow-up period of all patients was 34.4 months (95% confidence interval, 29.1-39.7). When arm A was compared with arm B, 3-year disease-free survival (DFS) was 75.3% versus 88.4% and 5-year DFS was 75.3% versus 82.8%, respectively. There were similar DFS outcomes between the treatment arms (p = 0.09). Rates of any grade of neuropathy were numerically lower in arm A, but the difference between the treatment arms was not statistically significant (51.3% vs. 56.9%; p = 0.44). The frequency of neutropenia was similar between the treatment arms. CONCLUSION: In this study, the efficacy and safety of the 3 months of CAPOX followed by 3 months of capecitabine chemotherapy regimen in the adjuvant treatment of low-risk stage III colon cancer treated surgically were proven. This result may also support the discontinuation of oxaliplatin at 3 months while continuing fluoropyrimidines, which is a common clinical practice but lacks sufficient data.

Efficacy of subsequent treatments in patients with hormone-positive advanced breast cancer who had disease progression under CDK 4/6 inhibitor therapy.

BACKGROUND: There is no standard treatment recommended at category 1 level in international guidelines for subsequent therapy after cyclin-dependent kinase 4/6 inhibitor (CDK4/6) based therapy. We aimed to evaluate which subsequent treatment oncologists prefer in patients with disease progression under CDKi. In addition, we aimed to show the effectiveness of systemic treatments after CDKi and whether there is a survival difference between hormonal treatments (monotherapy vs. mTOR-based). METHODS: A total of 609 patients from 53 centers were included in the study. Progression-free-survivals (PFS) of subsequent treatments (chemotherapy (CT, n:434) or endocrine therapy (ET, n:175)) after CDKi were calculated. Patients were evaluated in three groups as those who received CDKi in first-line (group A, n:202), second-line (group B, n: 153) and ≥ 3rd-line (group C, n: 254). PFS was compared according to the use of ET and CT. In addition, ET was compared as monotherapy versus everolimus-based combination therapy. RESULTS: The median duration of CDKi in the ET arms of Group A, B, and C was 17.0, 11.0, and 8.5 months in respectively; it was 9.0, 7.0, and 5.0 months in the CT arm. Median PFS after CDKi was 9.5 (5.0-14.0) months in the ET arm of group A, and 5.3 (3.9-6.8) months in the CT arm (p = 0.073). It was 6.7 (5.8-7.7) months in the ET arm of group B, and 5.7 (4.6-6.7) months in the CT arm (p = 0.311). It was 5.3 (2.5-8.0) months in the ET arm of group C and 4.0 (3.5-4.6) months in the CT arm (p = 0.434). Patients who received ET after CDKi were compared as those who received everolimus-based combination therapy versus those who received monotherapy ET: the median PFS in group A, B, and C was 11.0 vs. 5.9 (p = 0.047), 6.7 vs. 5.0 (p = 0.164), 6.7 vs. 3.9 (p = 0.763) months. CONCLUSION: Physicians preferred CT rather than ET in patients with early progression under CDKi. It has been shown that subsequent ET after CDKi can be as effective as CT. It was also observed that better PFS could be achieved with the subsequent everolimus-based treatments after first-line CDKi compared to monotherapy ET.

Exploring the potential of humanin as a biomarker for early breast cancer detection: a study of serum levels and diagnostic performance.

INTRODUCTION: Breast cancer is a leading cause of cancer death in women worldwide, and early detection is crucial for effective treatment. Mitochondrial dysfunction has been linked to cancer development and progression. Humanin, a mitochondrial-derived peptide, has been shown to have cytoprotective effects and may be involved in breast cancer development. In this study, we aimed to investigate the potential of humanin as a biomarker for breast cancer. METHODS: We recruited 45 female patients diagnosed with primary invasive ductal breast cancer and 45 healthy volunteers. Serum humanin levels were measured using ELISA, and other cancer markers were measured using an Advia Centaur Immunology Analyser. RESULTS: Our results showed that serum humanin levels were significantly higher in breast cancer patients than in healthy controls (p = 0.008). ROC curve analysis indicated that humanin could effectively discriminate between patients and healthy individuals, with a sensitivity of 62.5% and a specificity of 77.5%. CONCLUSION: This suggests that humanin may be a potential new biomarker for breast cancer screening and early detection. Further research is needed to fully understand the relationship between humanin and breast cancer and to develop new diagnostic and therapeutic strategies.

Treatment efficacy of ribociclib or palbociclib plus letrozole in hormone receptor-positive/HER2-negative metastatic breast cancer.

Background: Ribociclib, palbociclib and abemaciclib are currently approved CDK4/6 inhibitors along with aromatase inhibitors as the first-line standard-of-care for patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Methods: The authors report retrospective real-life data for 600 patients with estrogen receptor- and/or progesterone receptor-positive and HER2-negative metastatic breast cancer who were treated with ribociclib and palbociclib in combination with letrozole. Results & conclusion: The results demonstrated that the combination of palbociclib or ribociclib with letrozole has similar progression-free survival and overall survival benefit in real life for the patient group with similar clinical features. Specifically, endocrine sensitivity may be a factor to be considered in the treatment preference.

Risk factors for hypertensive phase after Ahmed glaucoma valve implantation.

PURPOSE: To investigate the risk factors and the clinical characteristics of the hypertensive phase (HP) after Ahmed glaucoma valve (AGV) implantation. METHODS: This retrospective study included 60 eyes of 57 patients who underwent AGV implantation and with at least 1-year follow-up. HP was defined as intraocular pressure (IOP) > 21 mmHg in the first 3 months after the surgery. Independent samples t-test and Chi-square test were used to compare differences in patients with the HP and the non-HP groups. Univariable and multivariable logistic regression analyses were used to determine the risk factors for the development of the HP. Statistical significance was assumed at p < 0.05 level. RESULTS: HP was observed in 31 eyes (51.7%) with an average peak IOP of 27.6 ± 4.5 mmHg (range 22-40 mmHg). The resolution of HP was noted in 27 eyes (87.1%) at the 3rd month postoperative visit. The number of glaucoma medications at the last postoperative visit and IOP values from 1 month to 1 year were significantly higher in the HP group (all p < 0.05). Patients with traumatic glaucoma showed the highest rate (83.3%) of HP development. In the multivariable analysis, a preoperative IOP > 30 mmHg (p = 0.03, OR:5.82; reference: ≤ 25 mmHg) and younger age (41-64 years, p = 0.02, OR:8.49; ≤ 40 years, p = 0.001, OR:19.62; reference: ≥ 65 years) were independently associated with the occurrence of HP. CONCLUSION: Hypertensive phase was observed in half of the patients undergoing AGV implantation. A higher mean preoperative IOP and younger age were risk factors for HP development. Although the majority resolved at the 3-month visit, eyes with HP had higher mean IOPs and required more IOP lowering medications.

Efficacy and Safety of Trastuzumab Emtansine in Her2 Positive Metastatic Breast Cancer: Real-World Experience.

AIM: The aim of this study is to evaluate the efficacy and toxicity of trastuzumab emtansine (T-DM1) in cases with metastatic breast cancer (mBC) in different lines of treatment. METHOD: Retrospective analysis of T-DM1 results of human epidermal growth factor receptor 2 (Her2) positive 414 cases with mBC from 31 centers in Turkey. FINDINGS: Except 2, all of the cases were female with a median age of 47. T-DM1 had been used as second-line therapy in 37.7% of the cases and the median number of T-DM1 cycles was 9. Progression-free survival (PFS) and overall survival (OS) times were different according to the line of treatment. The median OS was found as 43, 41, 46, 23 and 17 months for 1st, 2nd, 3rd, 4th and 5th line, respectively (p = 0.032) while the median PFS was found as 37, 12, 8, 8 and 8 months, respectively (p = 0.0001). Treatment was well tolerated by the patients. The most common grade 3-4 adverse effects were thrombocytopenia (2.7%) and increased serum gamma-glutamyl transferase (2%). DISCUSSION: The best of our knowledge this is the largest real-life experience about the safety and efficacy of T-DM1 use in cases with mBC after progression of Her2 targeted treatment. This study suggests and supports that T-DM1 is more effective in earlier lines of treatment and is a reliable option for mBC.

Predictive clinical factors of chronic peripheral neuropathy induced by oxaliplatin.

PURPOSE: We aimed to identify potential clinical parameters that can be easily obtained by a pre-treatment clinicopathological evaluation and whole blood test to estimate the development of oxaliplatin-induced peripheral neuropathy (OIPN). METHODS: This study was conducted retrospectively. For the FOLFOX regimen, patients received oxaliplatin, 85 mg/m2, every 2 weeks for 12 courses, and with the XELOX regimen, oxaliplatin was 130 mg/m2, every 3 weeks for 6-8 courses. The incidence and degree of neuropathy (NCI-CTCAE v.3) were recorded. RESULTS: A total of 186 patients were included in the study. There were 108 (58%) patients in the grade 0-1 (G0-G1) neuropathy group (mean age 50.5 ± 11.5; 63% men), and 78 (42%) patients in the grade 2-3 (G2-G3) neuropathy group (mean age 58.0 ± 10.8; 46.2% men). The relationship between G2-G3 OIPN development and age (p < 0.001), gender (p = 0.02), and ECOG performance status (p = 0.007) was statistically significant. In the G2-G3 neuropathy group, serum gamma-glutamyl transferase (GGT) (p < 0.001) and glucose (p = 0.007) levels were higher, whereas vitamin D (p < 0.001), hemoglobin (Hgb) (p < 0.001), serum albumin (p = 0.001), and serum magnesium (p = 0.035) levels were lower compared with the G0-G1 neuropathy group. G2-G3 neuropathy was observed in 88% of patients with mucinous carcinoma pathologic type (p < 0.001). CONCLUSION: This study demonstrated that age, histopathologic type, albumin, GGT, glucose, vitamin D, and Hgb levels were the effective factors in prediction of the development of OIPN. In addition, GGT, vitamin D, and Hgb levels were the most effective factor to predict development of OIPN.

The influence of corneal geometrical and biomechanical properties on tonometry readings in keratoconic eyes.

PURPOSE: To identify the effect of corneal geometrical and biomechanical parameters on the intraocular pressure (IOP) measurements obtained by Goldmann Applanation Tonometer (GAT), non-contact tonometer, iCare Pro Rebound Tonometer (IRT), Tonopen and Ocular Response Analyzer (ORA, Goldmann-correlated IOP: IOPg, corneal compensated IOP: IOPcc). METHODS: We prospectively recruited patients with a tomographically confirmed diagnosis of keratoconus. IOP measurements were performed in the following order: non-contact tonometry, ORA, IRT, GAT and Tonopen. The means of the three IOP measurements were used for the analysis. Correlation analyses were performed to assess the association between tonometer readings and the corneal geometrical and biomechanical parameters including ORA waveform parameters. Tonometer variability was assessed using a stepwise linear regression analysis. RESULTS: Fifty-one patients with keratoconus (27 females, mean age 30.8 ± 8.7 years) were evaluated. The highest mean IOP was measured by IOPcc (14.6 ± 2.3 mmHg) followed by IRT IOP (13.0 ± 3.2 mmHg), Tonopen IOP 12.0 ± 2.6 mmHg), GAT IOP (11.7 ± 3.1 mmHg), NCT IOP (10.2 ± 3.2 mmHg) and IOPg (10.2 ± 3.6 mmHg). NCT and IOPg were affected from all corneal parameters including thickness, curvature and biomechanical parameters. While GAT and IRT had significant correlations with corneal resistance factor (CRF) and corneal hysteresis, IOPcc only had a significant correlation with CRF. None of the corneal factors had any statistically significant correlation with Tonopen. CRF predicted tonometer measurement variability in 7 of the 15 inter-device variability assessments. CONCLUSION: Tonopen was the least affected from the corneal parameters followed by IOPcc and GAT. CRF was a strong determinant of tonometer variability.

SLC4A4 compound heterozygous mutations in exon-intron boundary regions presenting with severe proximal renal tubular acidosis and extrarenal symptoms coexisting with Turner's syndrome: a case report.

BACKGROUND: Congenital NBCe1A deficiency with the SLC4A4 mutation causes severe proximal renal tubular acidosis, which often comprises extrarenal symptoms, such as intellectual disability and developmental delay, glaucoma, cataract and band keratopathy. To date, almost all mutations have been found to be homozygous mutations located in exons. CASE PRESENTATION: We performed direct nucleotide sequencing analysis of exons and exon-intron boundary regions of the SLC4A4 in a patient presenting with severe renal proximal tubule acidosis, glaucoma and intellectual disability and her parents without these signs. The examination revealed compound heterozygous mutations in exon-intron boundary regions, c.1076 + 3A > C and c.1772 - 2A > T, neither of which have been reported previously. While the former mutation was found in the mother, the latter was found in the father. The transcript of the SLC4A4 gene was almost undetectable, and the patient was also diagnosed with Turner's syndrome. CONCLUSIONS: We identified two novel SLC4A4 mutations, c.1076 + 3A > C and c.1772 - 2A > T. When presented in a compound heterozygous state, these mutations caused a phenotype of severe renal proximal tubular acidosis along with glaucoma and mental retardation. This is the first report of congenital proximal renal tubular acidosis carrying compound heterozygous SLC4A4 mutations in exon-intron boundary regions. We suggest that an mRNA surveillance mechanism, nonsense-mediated RNA decay, following aberrant splicing was the reason that the SLC4A4 transcript was almost undetectable in the proband.

Use of pertuzumab and trastuzumab during pregnancy.

Trastuzumab and pertuzumab are monoclonal antibodies used for the treatment of breast cancer. Until now, there have been no reports on the use of pertuzumab during pregnancy and on its potential effects on the fetus. Herein, we present a breast cancer patient who received trastuzumab and pertuzumab treatment during the first 20 weeks of pregnancy. This 22-year-old patient initially diagnosed with invasive ductal carcinoma of the breast was found to be negative for estrogen receptor and progesterone receptor and positive for human epidermal growth factor receptor in the immunohistochemical examination. At the time of diagnosis, she had metastatic lesions and a protocol of docetaxel, trastuzumab, pertuzumab, q21, and zolendronic acid 4 mg every month was started. Following six courses of therapy, she had near-complete response, and, after administration of the same course of treatment for two additional cycles, treatment with pertuzumab plus trastuzumab was continued. While she was being followed-up with remission, a 20-week pregnancy was detected. A fetal ultrasound examination showed oligohydramnios and right renal agenesis. Treatment was stopped, and the fetus was monitored. After 7 weeks of follow-up, fetal growth retardation and anhydramnios were detected. The pregnancy was terminated. Fetal autopsy showed no urinary system pathology, but macroscopic and microscopic hyperplasia of the right adrenal gland was identified. Concomitant use of pertuzumab and trastuzumab during pregnancy may be associated with an unresolved oligohydramnios and/or anhydramnios risk. Extreme caution should be used when these monoclonal antibodies are administered during pregnancy.

Pupillometry as a Screening Tool to Detect Pseudoexfoliation Syndrome.

PURPOSE: Our objective was to evaluate the diagnostic value of a handheld pupillometer in differentiating eyes with pseudoexfoliation syndrome (PXS) from healthy controls. METHODS: This population-based, cross-sectional study was conducted in the province of Eskisehir, Turkey. Subjects 40 years of age and older were randomly recruited using stratified two-stage cluster sampling from the database of the Turkish Statistical Institute office in Eskisehir. Recruitment took place between June and October 2014. The inclusion criteria were healthy subjects who did not have a previous diagnosis of glaucoma or other issues affecting pupil dynamics. After an extensive ophthalmic examination, pupillometry was performed under standard photopic room lighting conditions. After pupillometry, the pupil was dilated and digital images of the anterior segment were taken for confirmation of PXS. An inter-eye pupil diameter difference of ≥0.4 mm was defined as pupil asymmetry. RESULTS: Of the 2356 invited subjects, 2017 agreed to participate (85.6%), and 1559 subjects were eligible for the study. An age-matched subgroup consisting of 529 healthy controls was randomly selected to compare with the 60 subjects who were diagnosed with PXS. The mean pupil diameters of subjects with PXS and healthy controls were 3.57 ± 0.68 mm and 3.68 ± 0.63 mm, respectively (P = .652). In the ROC analysis, the precision of pupil diameter in discriminating PXS was low (AUC 0.56, sensitivity 14%, specificity 94%). Pupil asymmetry increased the chances of having PXS by 3.46-fold. CONCLUSIONS: Pupillometry performed poorly in the detection of PXS scoring a positive predictive value of 26%.

Is multifocal electroretinography an early predictor of glaucoma?

PURPOSE: To investigate the potential use of mfERG as an objective functional test that can express inner and outer retinal changes during the early stages of glaucoma. METHODS: One hundred and twenty-six eyes of 126 patients were included. There were 30 healthy (Group 1), 28 glaucoma suspect (Group 2), 48 early glaucoma (Group 3), and 20 advanced glaucoma cases (Group 4). After complete ophthalmic examination, Humphrey visual field analysis and mfERG were performed. These examinations were performed three times at 6-month intervals, and only the last examination results were used for the analysis. Visual fields global indices and mfERG implicit time and amplitudes were evaluated and analyzed by ring system (central 5°, 5°-10°, 10°-15° and >15°). One-way ANOVA and ROC curve analysis were used for statistical analysis. RESULTS: There was no statistically (one-way ANOVA) significant differences in patient age between groups (p = 0.126). For all rings, we detected statistically significant differences for the mean implicit time (latency) of the N1, P1, and N2 components between the advanced glaucoma and control subjects and between the advanced glaucoma and glaucoma suspects. The N2 amplitudes were significantly decreased in all rings in the advanced glaucoma patients when compared with control subjects. The N2 amplitude was significantly different between healthy subjects (Group 1) and early glaucoma subjects (Group 3) in the central 2° and 2°-5° rings. We used MedClac ROC curve analysis to identify the best parameters for discriminating between control subjects (Group 1) and early glaucoma patients (Group 3). The N2 implicit time for the central 2° ring (p < 0.0001), N2 amplitude for the central 2° ring (p = 0.0001), P1 implicit time for the 2°-5° ring (p = 0.0001), N2 implicit time for the 2°-5° ring (p = 0.0003), and N2 amplitude for the 2°-5° ring (p = 0.001) had ≥0.7 AUC values and were the best parameters in the ROC curve analyses that included the VFA parameters CONCLUSION: Alterations of amplitudes and implicit times of N2 response in the central area may be able to detect glaucoma earlier than VFA. In addition, with progression to advanced glaucoma these changes can be significant in all retinal areas. Although implicit times of all mfERG components are significantly delayed in glaucoma, both delayed implicit time and decreased amplitude of N2 wave in the central area are effective predictors in early glaucoma diagnosis.

A Rare False-Positive Whole-Body Scan in a Patient With Differentiated Thyroid Cancer: Unilateral Conjunctival Concretions.

ABSTRACT: 131 I has been used effectively over the years in both diagnosis and therapy of differentiated thyroid cancer (DTC). Although whole-body scan with 131 I is a highly sensitive tool for detecting normal thyroid tissue and metastasis of DTC, it is not specific; therefore, false-positive images can be seen in clinical practice, and their recognition is critical for correct management. Evaluation of false-positive uptake is important because it may be confused with metastatic involvement. Here, we present a rare false-positive result of whole-body scan in a patient with DTC. To our knowledge, it is the first report on 131 I uptake of conjunctival concretions.

Elevated Asprosin Levels in Breast Cancer: Insights from a Comparative Study.

Background: Breast cancer (BC) is the most common type of cancer in women. Diagnosis in the early stage is very important for cancer treatment. There is no good biomarker to diagnose BC in T1-T2 or N0 stage. This study aimed to evaluate asprosin (ASP) levels of BC compared with non-cancer. Materials and Methods: An enzyme-linked immunosorbent assay was used to evaluate serum ASP levels in 40 patients with BC and 40 healthy women. The cancer group included T1-T4, N1-N3, and M0-M1 patients. T stages were divided into groups as T1-T2 and T3-T4. N stages were divided into groups as N (0) and N (+). Results: ASP showed good discrimination (area under the curve = 0.767, 95% confidence interval: 0.657-0.878) between the BC group and the healthy group and acceptable discriminating ability (sensitivity = 0.825; specificity = 0.750) at the optimal cutoff value of 1.82 ng/mL. ASP indicated no difference for T, N, and M stages (p = 0.919, p = 0.859, and p = 0.225, respectively). There was a significant difference between grades within cancer patients in terms of ASP (p = 0.025). Conclusions: These findings provide evidence of a potential association between elevated ASP levels and the presence of BC. The observed higher levels of ASP in women with BC compared with healthy individuals suggest that ASP could potentially serve as a biomarker for distinguishing between the two groups. These results may contribute to our understanding of the potential role of ASP in BC detection and highlight its potential as a diagnostic marker. Further studies are required to establish whether ASP can be used to diagnose BC.

Comparison of Tenon duplication with dura mater covering technique for Ahmed glaucoma valve implantation.

PURPOSE: To compare the efficacy and complications of Tenon duplication with dura mater covering technique for Ahmed glaucoma valve (AGV) implantation. METHODS: This retrospective study included 44 refractory glaucoma patients (44 eyes) who underwent AGV implantation from 2017 to 2020 in the Ophthalmology Clinic of Eskisehir Osmangazi University Hospital and attended regular postoperative follow-ups. The patients were divided based on whether they underwent Tenon duplication technique (group 1: n = 20) or dura mater covering technique (group 2: n = 24) during surgery. The patients' age, gender, systemic diseases, glaucoma type, pre-op intraocular pressure (IOP), and ocular surgeries were recorded. The groups were compared for IOP level control, early and late complications, postoperative antiglaucomatous medication requirements, glaucoma surgery requirements, presence of postoperative hypertensive phase (HP), and surgical success which was defined as an IOP ≥5 and ≤21 mmHg, with or without antiglaucoma medication. RESULTS: By the end of the mean follow-up (22.6 ± 10.6 months), the success rates were 95% (group 1) and 96% (group 2). The groups showed no differences in postoperative complications, postoperative antiglaucomatous drugs' onset time, additional glaucoma surgery, need for needling, presence of HP at 6 months postoperatively, and relationship between the glaucoma type and success rates ( P values: 0.86, 0.9, 0.48, 0.12, 0.36, and 0.8, respectively). The IO P values at the last follow-up were 15.2 ± 4.1 in group 1 and 14.7 ± 4.8 in group 2. The IOP reduction rates showed no significant differences. CONCLUSION: Since success and complications are similar in both Tenon duplication and dura mater covering technique, unique grafting materials may not be needed in AGV implantation surgery, except in special cases.

Comparison of the second-line treatment efficacy in advanced gastric cancer patients previously treated with taxane-based triplet chemotherapy: a Turkish Oncology Group Study.

OBJECTIVE: This study aimed to assess the efficacy and safety of FOLFIRI and paclitaxel in patients with advanced gastric cancer (AGC) who were previously treated with first-line modified docetaxel, cisplatin, 5-fluorouracil (mDCF), or 5-fluorouracil, oxaliplatin, docetaxel (FLOT). METHODS: Patients who received a triplet regimen in the first line setting and were treated with FOLFIRI or paclitaxel in the second-line treatment were included. RESULTS: The study included 198 patients, with 115 receiving FOLFIRI and 83 receiving paclitaxel. The median age was 58 (range = 24-69). The median progression-free survival (mPFS) was 5.2 [95% confidence interval (CI) = 4.4-5.5] months in the FOLFIRI arm, and 4.1 (95% CI = 3.3-4.6) months in the paclitaxel arm (p = .007). The median overall survival (mOS) was 9.4 (95% CI = 7.4-10.5) months in the FOLFIRI arm and 7.2 (95% CI = 5.6-8.3) months in the paclitaxel arm (p = .008). Grade 3-4 neuropathy was higher in patients receiving paclitaxel compared to those receiving FOLFIRI (p = .04). Grade 3-4 diarrhea was 8% in the FOLFIRI arm and 2.4% in the paclitaxel arm (p = .02). CONCLUSION: Beyond progression with docetaxel-based triplet chemotherapy, FOLFIRI may be preferred as a second-line treatment over paclitaxel due to its longer mPFS and mOS.

Efficacy of adjuvant capecitabine in residual triple negative breast cancer: a multicenter observational Turkish Oncology Group (TOG) study.

BACKGROUND: Triple negative breast cancer (TNBC) is characterized by high rates of recurrence, especially in patients with residual disease after neoadjuvant chemotherapy (NAC). Capecitabine is being used as standard adjuvant treatment in residual TNBC. We aimed to investigate the real-life data regarding the efficacy of capecitabine in residual TNBC. DESIGN AND METHODS: In this retrospective multicenter study, TNBC patients with residual disease were evaluated. Patients, who received standard anthracycline and taxane-based NAC and adjuvant capecitabine were eligible. Overall survival (OS), disease free survival (DFS) and toxicity were analyzed. RESULTS: 170 TNBC patients with residual disease were included. Of these, 62.9% were premenopausal. At the time of analysis, the recurrence rate was 30% and death rate was 18%. The 3-year DFS and OS were 66% and 74%, respectively. In patients treated with adjuvant capecitabine, residual node positive disease stood out as an independent predictor of DFS (p = 0.024) and OS (p = 0.032). Undergoing mastectomy and the presence of T2 residual tumor was independent predictors of DFS (p = 0.016) and OS (p = 0.006), respectively. CONCLUSION: The efficacy of capecitabine was found lower compared to previous studies. Selected patients may have further benefit from addition of capecitabine. The toxicity associated with capecitabine was found lower than anticipated.

Efficacy of first-line CDK 4-6 inhibitors in premenopausal patients with metastatic breast cancer and the effect of dose reduction due to treatment-related neutropenia on efficacy: a Turkish Oncology Group (TOG) study.

The only phase 3 study on the effectiveness of CDK 4-6 inhibitors in first-line treatment in premenopausal patients with hormone receptor (HR) positive, HER2 negative metastatic breast cancer is the MONALEESA-7 study, and data on the effectiveness of palbociclib is limited. Data are also limited regarding the effectiveness of CDK 4-6 inhibitors in patients whose dose was reduced due to neutropenia, the most common side effect of CDK 4-6 inhibitors. In our study, we aimed to evaluate the effectiveness of palbociclib and ribociclib in first-line treatment in patients with premenopausal metastatic breast cancer and the effect of dose reduction due to neutropenia on progression-free survival. Our study is a multicenter, retrospective study, and factors affecting progression-free survival (PFS) were examined in patients diagnosed with metastatic premenopausal breast cancer from 29 different centers and receiving combination therapy containing palbociclib or ribociclib in the metastatic stage. 319 patients were included in the study. The mPFS for patients treated with palbociclib was 26.83 months, and for those receiving ribociclib, the mPFS was 29.86 months (p = 0.924). mPFS was 32.00 months in patients who received a reduced dose, and mPFS was 25.96 months in patients who could take the initial dose, and there was no statistical difference (p = 0.238). Liver metastasis, using a fulvestrant together with a CDK 4-6 inhibitor, ECOG PS 1 was found to be a negative prognostic factor. No new adverse events were observed. In our study, we found PFS over 27 months in patients diagnosed with premenopausal breast cancer with CDK 4-6 inhibitors used in first-line treatment, similar to post-menopausal patients. We did not detect any difference between the effectiveness of the two CDK 4-6 inhibitors, and we showed that there was no decrease in the effectiveness of the CDK 4-6 inhibitor in patients whose dose was reduced due to neutropenia.