Real-world treatment outcomes from nationwide Onco-colon Turkey registry in RAS wild-type patients treated with biologics second-line mCRC.

BACKGROUNDS AND OBJECTIVES: Colorectal cancer is one of the leading causes of mortality both globally and in our country. In Turkey, we conducted a multicenter investigation into the effectiveness of second-line treatments and real-life data for patients with RAS wild-type metastatic colorectal cancer (NCT04757311). MATERIALS AND METHODS: In this retrospective analysis, records from 28 centers were collected, and histopathological, molecular, and clinical characteristics were documented. Patients were categorized into groups based on their second-line biological treatments: anti-EGFR (Group A and Group B, panitumumab and cetuximab) and anti-VEGF (Group C, bevacizumab and aflibercept). They were then compared within these groups. RESULTS: A total of 588 patients with documented RAS wild-type status were evaluated. The median OS was 15.7, 14.3 and 14.7 months in Group A, Group B and Group C, respectively (p = 0.764). The median PFS of the patients in second-line setting that received panitumumab, cetuximab and bevacizumab/aflibercept were 7.8, 6.6 and 7.4 months, respectively (p = 0.848). CONCLUSION: According to the results of our real-life data study, there is no significant difference in efficiency between the combination of biological agent and chemotherapy used in the second-line treatments.

Causes of liver test abnormalities in newly diagnosed cancer patients and the investigation of etiological factors.

OBJECTIVES: In this study, we aimed to investigate the causes of liver test abnormalities in newly diagnosed patients naive to anti-tumoral therapy. METHOD: This study included a total of 490 patients with ALT levels > 5X ULN on liver function tests at the initial presentation to our clinic. Data from 247 (50.4%) patients diagnosed with cancer (cohort A) and 243 (49.6%) patients without cancer (cohort B) were compared with regard to the etiology of liver test abnormalities and the risk factors. RESULTS: The most common etiological factor in cohort A was presence of liver metastasis (31.2%, n = 77). In the comparison of the two groups with regard to etiological factors; the rates of liver metastasis [31.2% vs 0%, (p < 0.001)], drug-induced liver toxicity [30/4% vs 19.8%, (p = 0.007)], pancreaticobiliary pathology [21.5% vs 14%, (p = 0.03)] and chronic viral hepatitis [14.2% vs 7.4%, (p = 0.02)] were higher in the cohort A. The rate of NAFLD was higher in the cohort B [6.9% vs 42.2% (p < 0.001). CONCLUSION: In our study, the most common cause of liver test abnormalities was the presence of liver metastasis in cohort A and NAFLD in cohort B.

Efficacy and safety of bevacizumab in patients with low-grade serous ovarian cancer.

Aim: To investigate the efficacy and safety of bevacizumab in patients with recurrent low-grade serous ovarian carcinoma. Materials & methods: The data of patients who received at least two cycles of bevacizumab in combination with chemotherapy were retrospectively recorded. Results: The median age of 51 patients was 56 (range: 33-75) years. The complete response rate was 10.4% and the partial response rate was 43.7%. The objective response rate was 54.1%. Median progression-free survival was 15.9 months (95% CI: 9.1-22.6) and median overall survival was 42.5 months (95% CI: 37.2-47.8). Conclusion: Bevacizumab with chemotherapy is an effective option for treating recurrent ovarian low-grade serous carcinoma.

Comparison of Two Chemotherapy Regimens After First-Line Treatment for HER2-Negative Metastatic Gastric Cancer.

AIM: Metastatic stage gastric cancer is a disease with a poor prognosis and the likelihood of achieving a cure in these patients is low. Treatment response to subsequent-line treatments is poor. We aimed to investigate the effectiveness of the folinic acid, fluorouracil and irinotecan (FOLFIRI) and paclitaxel+carboplatin regimens, which are used in subsequent lines of therapy in advanced-stage gastric cancer. MATERIALS AND METHODS: This study included 40 patients who have metastatic stage gastric cancer and received FOLFIRI or paclitaxel+carboplatin therapy in subsequent lines of therapy between 2017 and 2022. The data of the patients were analyzed retrospectively. RESULTS: At diagnosis median age was 51 (23-88) years. The tumor was localized in the gastroesophageal junction in eight (20%) patients and in other gastric locations in 32 (80%) patients. At diagnosis, 75% (n=30) of the patients presented with the disease in the metastatic stage, while 25% (n=10) presented with stage II-III disease. Regarding the treatments received in the second and further lines of therapy, 18 (45%) patients received paclitaxel+carboplatin and 22 (55%) patients received a FOLFIRI regimen. Of these treatments, 67.5% (n=27) were given as the second line and 32.5% (n=13) were given as third-line therapy. The objective response rate (ORR) was 45.5% in the FOLFIRI arm compared to 16.7% in the paclitaxel+carboplatin arm (p=0.05). Both treatment arms had a median progression-free survival (PFS) of three months (p=0.82). The median overall survival (OS) time was seven months in the FOLFIRI arm compared to eight months in the paclitaxel+carboplatin arm (p=0.71). Side effects were similar between both treatment arms. CONCLUSION: This study determined that FOLFIRI and paclitaxel+carboplatin treatments have similar OS, PFS, and side effect profiles in subsequent line treatment of gastric cancer. The FOLFIRI treatment regimen yielded a higher ORR.

Prognostic factors and the prognostic role of inflammation indices in malignant pleural mesothelioma.

Background: In this study, we aimed to investigate the prognostic factors of malignant pleural mesothelioma and the prognostic value of inflammation indices in malignant pleural mesothelioma. Methods: Between January 2002 and December 2019, a total of 132 patients (74 males, 58 females; mean age: 55 years; range, 31 to 79 years) diagnosed with malignant pleural mesothelioma were retrospectively analyzed. Patients" demographic data and laboratory results were recorded. The prognostic value of the following five inflammation indices was evaluated: neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, advanced lung cancer inflammation index, C-reactive protein/albumin ratio, and prognostic nutritional index. Results: Of all patients, 81% (n=107) were aged 65 or older and 61.4% (n=81) had an epithelioid histology. Of 12 variables examined in the multivariate analysis for their relationship with survival, age ≥65 years, non-epithelioid subtype, and prognostic nutritional index <40 were found to be poor prognostic factors. Based on the score constructed from these factors, the good prognostic group (score 0-1) had a median overall survival of 21 months and a one-year survival rate of 77.9%, while the poor prognostic group (score 2-3) had a median overall survival of nine months and a one-year survival rate of 29.7%. Conclusion: Our study results indicate that age ≥65 years, prognostic nutritional index <40, and non-epithelioid histological subtype are poor prognostic factors of malignant pleural mesothelioma.

Neoadjuvant Therapy and Factors Influencing Survival in Locally Advanced Non-Small Cell Lung Cancer.

AIM: We aimed to investigate the effectiveness of neoadjuvant therapy (NAT) and clinicopathological characteristics in locally advanced non-small cell lung cancer (NSCLC) (IIIA-IIIB), as well as the influence of the post-NAT treatment modalities on survival. MATERIALS AND METHODS: This study included patients who presented to the Dicle University Medical Oncology Clinic and received NAT for a diagnosis of locally advanced NSCLC between 2004 and 2020. Clinicopathological and radiological data of the 57 patients whose data could be retrieved from the hospital archive system were retrospectively reviewed. Patients' overall survival (OS) and failure-free survival (FFS) times and the factors influencing these times were evaluated. RESULTS: This study included a total of 57 patients consisting of five (8.8%) females and 52 (91.2%) males. The median patient age at diagnosis was 58 (30-75) years. All patients had received four courses of chemotherapy during the neoadjuvant period. When the factors influencing OS were evaluated, the post-NAT modality was found to have a statistically significant effect on survival. FFS times were 12, 13, and 16 months in the chemotherapy, chemoradiotherapy, and surgery arms, respectively (log-rank p=0.035). FFS was longer in those who underwent surgery (Hazard ratio (HR): 0.33, 95 % CI: 0.14-0.77, (p=0.01)). OS times were 20, 21, and 55 months in the chemotherapy, chemoradiotherapy, and surgery arms, respectively (log-rank p=0.05). OS was longer in the arm undergoing surgery compared to the other arms (HR: 0.36, 95% CI: 0.14-0.87, (p=0.02)). Five-year survival rates for the chemotherapy, chemoradiotherapy, and surgery arms were 14.3%, 21.4%, and 40%, respectively. CONCLUSIONS: This study shows that achieving an operable status is the most important indicator of survival and that patients undergoing surgery have a marked advantage in OS and FFS compared with patients receiving chemoradiotherapy or palliative chemotherapy.

18 F-FDG PET/CT parameters for prediction of response to neoadjuvant therapy and prognosis in rectal cancer.

OBJECTIVE: This study aims to investigate the role of F-18 fluorodeoxyglucose PET/computed tomography (18F-FDG PET/CT) parameters in the prediction of treatment response and the prognosis in locally advanced rectal cancer. METHODS: We investigated the relationship of 18F-FDG PET/CT parameters [rectal metabolic tumor volume (MTV), rectal total lesion glycolysis (TLG), rectal standard uptake value (SUV) max, rectal highest peak SUV, lymph node MTV, lymph node TLG, lymph node highest peak SUV] with the pathological response and disease-free survival (DFS) in 60 patients who received neoadjuvant therapy for a diagnosis of locally advanced rectal cancer. Patients with a total score of 0 were assigned to the low-risk group, patients with a score of 1 were assigned to the intermediate-risk group and patients with a score of 2 were assigned to the high-risk group. RESULTS: The multivariate analysis revealed that, from baseline PET CT parameters, lymph node highest peak SUV strongly predicted the pathological response at a cutoff value of 2.23. DFS was predicted by the lymph node highest peak SUV at a cutoff value of 3.13 and by the MTV value at a cutoff value of 27 cm 3 . The risk scoring performed with regard to rectal MTV and lymph node highest peak SUV values determined a median DFS of 19 months in patients with a risk score of 2, whereas the median DFS was not reached in patients with risk scores of 0 and 1 (P < 0.001). CONCLUSION: This study determined that rectal MTV and lymph node highest peak SUV predicted the response to neoadjuvant therapy and DFS.

Factors influencing HER2 discordance in nonmetastatic breast cancer and the role of neoadjuvant therapy.

Objective: The rates of and the factors influencing HER2 discordance in patients receiving neoadjuvant therapy for breast cancer are investigated. Methods: This study retrospectively examines the rates of HER2 and hormone receptor discordance between the biopsy and postoperative resection specimens of 400 female early-stage breast cancer patients. Results: 133 (33.3%) patients had received neoadjuvant therapy. The rate of HER2 discordance between biopsy and resection specimens was 1.7% in the control group and 5.3% in the neoadjuvant therapy group (p = 0.018). The rate of HER2 discordance was higher in younger patients and in patients with T1 tumors in the neoadjuvant therapy group. Conclusion: Neoadjuvant therapy, age <40 years and smaller tumor size were independent risk factors for HER2 discordance.

HER2 is an important and targetable molecule in breast cancer. In the early stages of breast cancer, a treatment modality called neoadjuvant therapy, which now includes anti-HER2 therapies, is administered before surgery in order to achieve disease regression and make the patient suitable for a more minor operation. In breast cancer, HER2 status may be positive in the initial biopsy specimen and negative in the surgical specimen. HER2 status plays an important role in treatment decisions. In this study, we investigated the factors causing HER2 status to change in early-stage breast cancer. This study has a retrospective design and includes 400 female patients with early-stage breast cancer. The results of the study identified the factors causing HER2 status to change to negative as receipt of neoadjuvant therapy, small tumor size and younger age.

Evaluation of Factors Predicting the Effectiveness of Regorafenib in the Treatment of Metastatic Colorectal Cancer.

OBJECTIVE: Regorafenib is a multikinase inhibitor, the effectiveness of which was demonstrated in metastatic colorectal cancer. This study aimed to investigate the factors that could predict the effectiveness of regorafenib. MATERIALS AND METHODS: This study retrospectively reviewed the clinical characteristics, tumor characteristics, and previous therapies in 62 patients who presented to our center between 2016 and 2020 and used regorafenib for metastatic colorectal cancer. The effects of the investigated variables on the response obtained with regorafenib use were evaluated. RESULTS: This study included a total of 62 patients diagnosed with metastatic colorectal cancer, of whom 30 (48.4%) were males and 32 (51.6%) were females. Patients' median age at diagnosis was 49 years (18- 68). Regorafenib therapy yielded a disease control rate of 64% [complete response=0, partial response= 14 (28%), and stable disease=18 (36%)]. Objective response was obtained in 28% of patients [complete response=0 and partial response=14 (28%)]. Progression-free survival was 4 months. The evaluation of the effects of patients' age, sex, performance status, previous treatments, metastatic sites, and RAS mutation status on the disease control rate and progression-free survival did not determine any positive or negative effects on progression-free survival. However, left-sided tumors had a positive effect on disease control rate (69.8% vs. 28.6%, P=.029). and previous use of cetuximab had a negative effect on disease control rate [76.5% vs. 37.5% (P=.007)]. CONCLUSION: In our study, tumor localization and previous cetuximab use were found to be correlated with the disease control rate in patients on regorafenib. However, the need for novel biomarkers that will predict the effectiveness of regorafenib in metastatic colorectal cancer treatment persists.

A Low Body Fat Mass Ratio Predicts Poor Prognosis in Patients with Advanced Non-Small Cell Lung Cancer.

PURPOSE: The aim of this study was to investigate the effect of the body fat mass ratio on survival and prognosis in advanced non-small-cell lung cancer patients. METHODS: The study includes 200 patients who were diagnosed with advanced non-small-cell lung cancer between 2014 and 2018 and whose body fat mass percentage and body mass index (BMI) were determined using the Tanita Body Composition Analyzer during admission. RESULTS: All patients had advanced incurable non-small-cell lung cancer (30% had locally advanced disease, 70% were stage IV). In the univariate and multivariate analyses, age, gender, histopathological type, smoking history, comorbidities, weight loss in the last six months and body mass index had no statistically significant effect on survival (p > 0.05). However, the performance status (p = 0.008), metastatic status (p = 0.003) and body fat mass ratio (p = 0.01) were found to have a significant effect on overall survival (OS): the median OS was 16.4 mo, in patients with the BFM ratio ≤ 22% and 29.2 mo, in those with > 22% (p = 0.01). CONCLUSION: In this study, it was found that the body fat mass ratio was an important prognostic factor in patients with advanced non-small-cell lung cancer.

The prognostic role of baseline 18F-FDG PET/CT SUVmax and SUVmax change in patients with node-positive breast cancer receiving neoadjuvant chemotherapy.

OBJECTIVE: This study aimed to determine the prognostic role of baseline maximum standardized uptake value (SUVmax) obtained by pretreatment PET/CT and the change in SUVmax (ΔSUVmax [%]) in patients with axillary lymph node-positive breast cancer receiving neoadjuvant chemotherapy (NAC). METHODS: One hundred and eighty patients with baseline SUVmax and 121 patients with SUVmax measurement after treatment were evaluated in the study. The baseline SUVmax value of the breast (SUVmaxBI) and axilla (SUVmaxAI) and the change in the SUVmax of the breast (ΔSUVmaxB) and axilla (ΔSUVmaxA) were measured. The optimal cut-off value of SUVmax and ΔSUVmax were determined by ROC curve analysis. Disease-free survival (DFS) and overall survival (OS) were calculated using Kaplan-Meier curves. RESULTS: ΔSUVmaxB, pCRB, pCRA, and pCR parameters were found to be associated with relapse (P < .001, P = .033, P = .016, and P = .013, respectively). ΔSUVmaxB and SUVmaxAI were associated with mortality (P = .001 and P = .006, respectively). Multiple Cox regression analyses revealed that ΔSUVmaxB value was an independent prognostic factor for relapse and mortality (P = .013 and P = .010, respectively). CONCLUSION: The results showed that ΔSUVmaxB was an independent prognostic factor for relapse and mortality in patients with axillary lymph node-positive breast cancer who received NAC.

Predictive and prognostic effect of ABO blood group on immune checkpoint inhibitors.

BACKGROUND: The relationship of the ABO blood group system with the immune response is known, but its relationship with immune checkpoint inhibitors (ICIs) has not been clearly investigated until now. OBJECTIVE: In this study, the relationship between different blood groups and nivolumab treatment response in patients with advanced malignant melanoma was investigated. METHODS: The data of patients who used nivolumab for advanced malignant melanoma between April 2018 and April 2021 were retrospectively reviewed. RESULTS: A total of 73 patients were included in the study. In the progression-free survival (PFS) analysis according to blood groups, it was 3.9 months, 16.1 months, 20.0 months and 3.0 months for A, B, AB and O, respectively (p= 0.1). Overall survival (OS) analysis according to blood groups was 5.1 months, 25.0 months, 20.0 months and 9.3 months for A, B, AB and O, respectively (p= 0.1). The B antigen group (B or AB) had significantly longer PFS and OS than the non-B antigen group (A or O) (16.1 vs. 3.5 months for PFS, respectively, p= 0.03; 20.0 vs. 7.4 months for OS, respectively, p= 0.02). CONCLUSIONS: The presence of B antigen provides a significant advantage in terms of survival in patients using ICIs for advanced melanoma.

The effect of exercise on disease-free survival and overall survival in patients with breast cancer.

BACKGROUND: Positive effects of exercise in cancer patients have been reported. AIM: To investigate whether intensity, duration, and timing of exercise affect disease relapse and mortality risk in patients with breast cancer (BC). METHODS: Patients with local or locally advanced stages of BC between January 2018 and January 2020 were recruited in the study. Sociodemographic and clinicopathological characteristics of patients were recorded. Exercise evaluation was performed by preparing a questionnaire and asking the patients face-to-face questions in the outpatient clinic. RESULTS: Risk of relapse was 58% lower in patients who exercised than inactive patients (p = 0.004). Patients who exercised for 2 to 5 days per week had a 63% lower relapse risk than inactive patients (p = 0.010). Risk of relapse was 66% lower in the patients who exercised for less than 1 h or 3 metabolic equivalent of task (MET)-hours per week when compared to inactive patients (p = 0.037). Similarly, relapse risk was 62% lower in patients who exercised between 1 to 3 h or 3 to 8.9 MET-hours per week than inactive patients (p = 0.026). Mortality risk was lower in patients who exercised than patients who did not (p = 0.027). A significantly decreased mortality risk was found in both groups that included patients who exercised for 1 to 5 days per week and patients who exercised for less than 3 h or 9 MET-hours per week when compared to inactive patients. CONCLUSION: Exercise was associated with decreased relapse and mortality rates in patients with BC. Therefore, exercise should be recommended to BC patients as a significant component of the treatment.

The Efficacy and Safety of Treatment Regimens Used in the First-Line Setting in Metastatic Pancreatic Cancer Patients: A Multicenter Real-Life Study.

OBJECTIVE: The aim of the study is to compare the efficacy and safety of 3 chemotherapy regimens used as first-line treatments in the real-life management of metastatic pancreatic cancer. METHODS: A total of 218 patients were included in this multicenter study. Gemcitabine (Gem, n = 71), gemcitabine-cisplatin (Gem-Cis, n = 91), and FOLFIRINOX (a combination of leucovorin, 5-fluorouracil, irinotecan, and oxaliplatin [FFX], n = 56) treatments were compared. RESULTS: Overall response rate was significantly higher in the FFX group (50.0%) than in the Gem (28.2%) and Gem-Cis (27.5%) groups (P = 0.010). Median progression-free survival (8.4 vs 4.6 and 5.5 months, respectively, P < 0.001) and overall survival (16.4 vs 8.1 and 8.7 months, respectively, P = 0.002) were significantly longer in the FFX group than in the Gem and Gem-Cis groups. Toxicity of any grade was noted in 46 (64.8%), 56 (61.5%), and 49 (87.5%) patients in the Gem, Gem-Cis, and FFX groups, respectively (P = 0.003). CONCLUSIONS: In our study, FFX regimen provides a significant advantage over the other treatment regimens in terms of response rates and survival. Treatment toxicity was more frequent but manageable with the FFX regimen.

Survival impact of optimal treatment for elderly patients with colorectal cancer: A real world study.

BACKGROUND: In this real-life practice study, we aimed to find whether elderly colorectal cancer (CRC) patients in our center were treated optimally and also if this has an effect on overall survival (OS) or not. METHODS: We have retrospectively screened 150 CRC patients older than 65 years, diagnosed in our institution between 2010 and 2018. As study variables, patient characteristics, tumor location, tumor, nodes, metastases stage, Eastern Cooperative Oncology Group performance status (ECOG PS), comorbidities, adjuvant or metastatic chemotherapy regimens, and treatment toxicity were recorded, and the OS rate of patients was assessed. RESULTS: The median age was 72 (range 65 - 89) years and 48 (32%) patients had metastatic disease at the time of diagnosis. The median OS (mOS) in the suboptimal adjuvant treatment group was 31.5 (range 20.7-42.3) months, whereas mOS was not reached during the median follow-up time in the optimal treatment group (P = 0.036). The addition of oxaliplatin to chemotherapy had no benefit on mOS (P = 0.318). In the metastatic setting, the mOS in the optimal and suboptimal treatment group was 27.2 (range 10.7-43.7) months and 13.4 (range 7.5-18.8) months respectively, and was statistically significant (P = 0.001). CONCLUSION: Our study revealed that optimal treatment had a significant effect on the mOS of elderly CRC patients and it was well tolerated. Advanced age alone is not a sufficient parameter for precluding effective therapy in elderly patients with CRC.

Efficacy of 68Ga-PSMA PET/CT-derived whole-body volumetric parameters in predicting response to second-generation androgen receptor axis-targeted therapy, and the prognosis in metastatic hormone-refractory prostate cancer patients.

INTRODUCTION: The present study investigates the role of 68Ga-PSMA PET/CT-derived whole-body metabolic and volumetric parameters in the prediction of treatment response and prognosis among metastatic hormone-refractory prostate cancer patients undergoing second-generation androgen receptor axis-targeted therapy (abiraterone or enzalutamide). MATERIALS AND METHODS: This retrospective study included 44 metastatic hormone-refractory prostate cancer patients undergoing 68Ga-PSMA PET/CT, including 29 enzalutamide-treated and 15 abiraterone-treated patients. RESULTS: Of the 44 patients included in the study, 29 received enzalutamide and 15 received abiraterone. During treatment, the changes in PET parameters were correlated with the PSA (biochemical) response. More specifically, a positive correlation was noted between PSA response and percent change in TLP (ΔTLP) response, and there was concordance between the results (r = 0.652, k = 0.42, P < 0.001). Baseline PSA (P =0.05), high MTVw (P = 0.005), the increase in ΔPSA (P = 0.036), ΔTLP (P = 0.039) and percent change in MTV (ΔMTV) (P = 0.049) values were identified as factors associated with mortality risk.Multivariate analysis showed that PSA1 [odds ratio (OR): 1.005, 95% confidence interval (CI) 1.002-1.008, P = 0.004], ΔPSA (OR: 14.7, 95% CI 1.50-143.7, P = 0.02) and MTVw1 (OR: 11.4, 95% CI 1.11-116, 6, P = 0.04) were independent prognostic factors associated with mortality risk. CONCLUSION: A statistically significant concordance and correlation was noted between 68Ga-PSMA PET/CT-derived whole-body metabolic parameters (ΔTLP and ΔMTV) and ΔPSA. In addition, the baseline PSA, ΔPSA, ΔTLP, ΔMTV and TMTV were identified as predictive factors for mortality risk.

Efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer.

Aim: To evaluate the efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer. Methods: We retrospectively included 138 patients who were given trastuzumab-based chemotherapy as first-line treatment and analyzed the relationship between clinical response rates and maintenance treatment status and survival outcomes. Results: In the whole group, the median progression-free survival and overall survival were 10.2 and 16 months, respectively. Clinical response was obtained in 79% of patients. The median overall survival was 16.9 months in follow-up group and 19.0 months in the maintenance group in patients with clinical response. Continuation of maintenance trastuzumab created a significant survival advantage (p = 0.021). Eastern Cooperative Oncology Group performance status 2 (hazard ratio [HR]: 2.02), grade 3 (HR: 1.78) and more than four metastatic lesions (HR: 1.67) were determined as risk factors for death. Conclusion: We recommend the continuation of maintenance trastuzumab in patients with clinical response, but those with identified risk factors may not benefit from treatment because life expectancy may be low.

Gastric cancer has a poor prognosis despite available treatments. Inclusive studies are still needed with real-life data. Our research retrospectively evaluated the efficacy of trastuzumab and potential risk factors on survival in patients with HER2-positive metastatic gastric cancer who received trastuzumab-based chemotherapy as first-line therapy. In total, 138 patients were included in this study. Clinical response to trastuzumab-based chemotherapy was obtained in 79% of the patients. We also divided the patients who had a clinical response into two groups according to whether they received maintenance therapy. In the present study, trastuzumab administration had compatible survival outcomes with recent studies. Continuation of trastuzumab maintenance treatment provided a survival advantage in patients with clinical response. We suppose that maintenance trastuzumab may be recommended in patients with clinical responses to the first-line treatment. Furthermore, Eastern Cooperative Oncology Group Performance Status 2, grade 3 and having more than four metastatic lesions were determined as risk factors for death. Therefore, although we recommend maintenance of trastuzumab in patients with clinical response, those with identified risk factors may not benefit from treatment.

Prognostic factors in patients with metastatic urothelial carcinoma who have treated with Atezolizumab.

BACKGROUND: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies of patients with metastatic platinum-resistant urothelial carcinoma. However, the response rate of Atezolizumab was modest. In the current study, we evaluated the pretreatment prognostic factors for overall survival in patients with metastatic urothelial carcinoma who have progressed after first-line chemotherapy in the Expanded-Access Program of Atezolizumab. PATIENTS AND METHODS: In this study, we present a retrospective analysis of 113 patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy. Data of the patients was obtained from patient files and hospital records. Eligible patients included metastatic urothelial carcinoma patients treated with at least one course of ATZ. Univariate analysis was used to identify clinical and laboratory factors that significantly impact OS. Variables were retained for multivariate analysis if they had a statistical relationship with OS (p < 0.1), and then included a final model of p < 0.05. RESULTS: The median follow-up duration was 23.5 months. Of the patients, 98 (86.7%) were male and 13.3% were female. The median age was 65 years of age (37-86). In univariate analysis, primary tumor location in the upper tract, increasing absolute neutrophil count (ANC), increasing absolute lymphocyte count, neutrophil-to-lymphocyte ratio (NLR) > 3, liver metastases, baseline creatinine clearance less (GFR) than 60 ml/min, Eastern Cooperative Oncology Group (ECOG) performance status (1 ≥), and hemoglobin levels below 10 mg/dl were all the significantly associated with OS. Three of the five adverse prognostic factors according to the Bellmunt criteria were independent of short survival: liver metastases HR 3.105; 95% CI 1.673-5.761; p < (0.001), ECOG PS (1 ≥) HR 2.184; 95% CI 1.120-4.256; p = 0.022, and Hemoglobin level below 10 mg/dl HR 2.680; 95% CI 1.558-4.608; p < (0.001). In addition, NLR > 3 hazard ratio [HR] 2.092; 95% CI 1.031-4.243; p = 0.041 and GFR less than 60 ml/min HR 1.829; 95% CI 1.1-3.041; p = 0.02, maintained a significant association with OS in multivariate analysis. CONCLUSIONS: This model confirms the Bellmunt model with the addition of NLR > 3 and GFR less than 60 ml/min and can be associated with clinical trials that use immunotherapy in patients with bladder cancer.

The comparison of FOLFOX regimens with different doses of 5-FU for the adjuvant treatment of colorectal cancer: a multicenter study.

PURPOSE: We aim to compare the efficiency and toxicity of three different 5-fluorouracil (5-FU) administration types in 5-FU, leucovorin, and oxaliplatin (FOLFOX) combination treatment for adjuvant therapy in colorectal cancer (CRC). METHODS: Five hundred and seventy patients with stage III colorectal carcinoma who received different FOLFOX regimens after curative resection were included. Patients were divided into three groups as FOLFOX-4, modified FOLFOX-6 (mFOLFOX-6), and mFOLFOX-4 for comparison of toxicity and disease-free survival (DFS) and overall survival (OS) times. RESULTS: Three-year DFS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 65%, 72%, and 72%, respectively. Five-year OS rates for FOLFOX-4, mFOLFOX-6, and mFOLFOX-4 groups were 69%, 75%, and 67%, respectively. There was no statistically significant difference between the three treatment groups in terms of DFS and OS (p = 0.079, and p = 0.147, respectively). Among grade 1-2 adverse events (AE), thrombocytopenia, neuropathy, and stomatitis were more common in the mFOLFOX-6-treated group. The frequency of grade 1-2 nausea and vomiting were similar in mFOLFOX-6 (36.3% and 24%, respectively) and mFOLFOX-4 (32.4% and 24.7%, respectively) groups but were higher than that in the FOLFOX-4 (19.5% and 11.3%, respectively) group. Among the most common grade 3-4 AE, neutropenia (53.4%, 9%, and 13.5%, respectively) and diarrhea (10.5%, 2.2%, and 2.4, respectively) were more common in FOLFOX-4. The rate of anemia and febrile neutropenia was similar in treatment groups (p = 0.063, and p = 0.210, respectively). CONCLUSION: In the adjuvant treatment of stage III CRC patients, three different 5-FU administration types in FOLFOX combination treatment can be used with similar efficiency and manageable toxicity.

Atezolizumab in Patients with Metastatic Urothelial Carcinoma Who Have Progressed After First-line Chemotherapy: Results of Real-life Experiences.

BACKGROUND: Atezolizumab (ATZ) has demonstrated antitumor activity and manageable safety in previous studies in patients with locally advanced or metastatic platinum-resistant urothelial carcinoma. OBJECTIVE: To compare the real-life experience and data of clinical trials on ATZ treatment in metastatic urothelial carcinoma. DESIGN, SETTING, AND PARTICIPANTS: Patients with urothelial cancer treated with ATZ after progression on first-line chemotherapy from an expanded access program were retrospectively studied. Data of patients were obtained from their files and hospital records. Safety was evaluated for patients treated with at least one cycle of ATZ. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was objective response rate (ORR). The secondary endpoints are overall survival (OS), progression-free survival (PFS), duration of response, and safety profile of patients. Kaplan-Meier methods were used to calculate median follow-up and estimate PFS and OS. RESULTS AND LIMITATIONS: Data of 115 enrolled patients were analyzed. Most of the patients (92.3%, n = 106) had received chemotherapy regimen only once prior to ATZ. The median follow-up duration was 23.5 mo. The complete response rate, partial response rate, and ORR were 8.7% (n = 10), 20.0% (n = 23), and 28.7% (n = 33), respectively. The median duration of response was 20.4 mo (95% confidence interval [CI], 6.47-28.8). Of the 33 patients who responded to treatment, 60% (n = 20) had an ongoing response at the time of the analysis. PFS and OS with ATZ were 3.8 mo (95% CI, 2.25-5.49) and 9.8 mo (95% CI, 6.7-12.9), respectively. All-cause and any-grade adverse events were observed in 113 (98%) patients. Of the patients, 64% experienced a treatment-related adverse event of any grade and 24 (21.2%) had a grade 3-4 treatment-related adverse event. Limitations of the study included its retrospective design, and determination of treatment response based on clinical notes and local radiographic studies. CONCLUSIONS: In these real-life data, ATZ was effective and well tolerated in patients with metastatic urothelial carcinoma who have progressed with platinum-based first-line chemotherapy. ATZ is an effective and tolerable treatment for patients with locally advanced or metastatic platinum-resistant urothelial carcinoma in our study, similar to previously reported trials. PATIENT SUMMARY: Atezolizumab is effective and well-tolerated in patients with metastatic urothelial cancer who progressed with first-line chemotherapy, consistent with the outcomes of the previous clinical trials in this setting.