Median Progression-free Survival Time Research Articles

Clinical Importance of Regimens in Hepatic Arterial Infusion Chemotherapy for Advanced Hepatocellular Carcinoma with Macrovascular Invasion.

Simple SummaryAlthough various molecular targeted agents have been approved, the therapeutic outcomes in hepatocellular carcinoma (HCC) with macrovascular invasion (MVI) are still unsatisfactory. Locoregional treatment using hepatic arterial infusion chemotherapy is a promising treatment for MVI-HCC. In the study, we aimed to compare the therapeutic effects of low-dose cisplatin plus 5-fluorouracil (LFP), a conventional HAIC regimen, and New FP (a fine-powder cisplatin suspended with lipiodol plus 5-fluorouracil) for MVI-HCC with preserved liver function. New FP was significantly superior to LFP in all therapeutic outcomes. New FP is a recommended HAIC regimen for the treatment of patients with MVI-HCC.Macroscopic vascular invasion (MVI) is a poor prognostic factor in hepatocellular carcinoma (HCC). Hepatic arterial infusion chemotherapy (HAIC) is a promising treatment in MVI-HCC. However, it is not clear which regimens are suitable for HAIC. In this study, we aimed to compare the therapeutic effects between New FP (a fine-powder cisplatin suspended with lipiodol plus 5-fluorouracil) and low dose FP (LFP/cisplatin plus 5-fluorouracil) in the treatment of MVI-HCC patients with Child–Pugh class A. New FP is a regimen that consists of a fine-powder cisplatin suspended with lipiodol and 5-fluorouracil. Fifty-one patients were treated with LFP, and 99 patients were New FP. We compared the therapeutic effects of LFP and New FP and assessed factors that associated with the therapeutic effects. The median survival and progression-free survival times of LFP and New FP were 16.1/24.7 and 5.4/8.8 months, respectively (p < 0.05, p < 0.05). The complete response (29%) and objective response rate (76%) of New FP were significantly higher than those of LFP (p < 0.001, p < 0.01). Factors associated with better therapeutic response were better ALBI-grade and New FP treatment choice. New FP is a more powerful regimen than LFP in HAIC for MVI-HCC. New FP represents a recommended HAIC regimen for the treatment of patients with MVI-HCC.

Clinical Outcomes of Advanced-Stage Cutaneous Lymphoma under Low-Dose Gemcitabine Treatment: Real-Life Data from the German Cutaneous Lymphoma Network

Background: Gemcitabine is an effective single-agent chemotherapy used in advanced stages of cutaneous T-cell lymphoma (CTCL). However, gemcitabine used in the current standard regimen is frequently associated with adverse events (AE), such as an increased risk for myelosuppression and severe infections. Objectives: We investigated in this retrospective study the effect of low-dose gemcitabine in pretreated advanced-stage CTCL and in blastic plasmacytoid dendritic cell neoplasia (BPDCN) regarding overall response (OR), progression-free survival (PFS), and AE. Material and Methods: A retrospective, multicenter study was conducted on 64 CTCL and BPDCN patients treated with gemcitabine in average absolute dosage of 1,800 mg/m² per cycle, which is 50% lower compared to standard dosage of 3,600 mg/m² per cycle (1,200 mg/m² day 1, 8, 15). Evaluation of response to therapy and AE was done 4–6 weeks after the sixth cycle. Results: OR was 62% with 11% demonstrating a complete response. The median time of PFS was 12 months and median time to next treatment was 7 months. Only 3/63 patients showed serious side effects, e.g., port infection or acute renal failure. Almost 73% of the patients experienced minor to moderate side effects (CTCAE grade 0–2). Fatigue (27.2%), fever (22.7%), and mild blood count alteration (18.2%) were the most common AE. Conclusions: This retrospective analysis supports the use of low-dose gemcitabine therapy in CTCL, demonstrating with 62% OR and PFS of 12 months an almost identical response rate and survival as compared to the standard dose therapy reported in previous studies but with a significantly improved safety profile and tolerability.

Response of Canine Soft Tissue Sarcoma to Stereotactic Body Radiotherapy.

Canine soft tissue sarcoma (STS) has served as a preclinical model for radiation, hyperthermia, experimental therapeutics, and tumor microenvironmental research for decades. Stereotactic body radiotherapy (SBRT) demonstrates promising results for the control of various tumors in human and veterinary medicine; however, there is limited clinical data for the management of STS with SBRT. In this retrospective study, we aimed to define overall efficacy and toxicity of SBRT for the treatment of macroscopic canine STS to establish this preclinical model for comparative oncology research. Fifty-two canine patients met inclusion criteria. Total radiation dose prescribed ranged from 20-50 Gy delivered in 1-5 fractions. Median progression-free survival time (PFST) was 173 days and overall survival time (OST) 228 days. Best overall response was evaluable in 46 patients, with 30.4% responding to treatment (complete response n = 3; partial response n = 11). For responders, OST significantly increased to 475 days vs. 201 days (P = 0.009). Prognostic factors identified by multivariable Cox regressions included size of tumor and metastasis at presentation. Dogs were 3× more likely to progress (P = 0.009) or 3.5× more likely to experience death (P = 0.003) at all times of follow up if they presented with metastatic disease. Similarly, every 100-cc increase in tumor volume resulted in a 5% increase in the risk of progression (P = 0.002) and death (P = 0.001) at all times of follow up. Overall, 30.8% of patients developed acute toxicities, 7.7% grade 3; 28.8% of patients developed late toxicities, 11.5% grade 3. Increased dose administered to the skin significantly affected toxicity development. SBRT serves as a viable treatment option to provide local tumor control for canine macroscopic STS, particularly those with early-stage disease and smaller tumors. The results of this study will help to define patient inclusion criteria and to set dose limits for preclinical canine STS trials involving SBRT.

MP16-06 A NOVEL NOMOGRAM TO PREDICT BCG RESPONSE IN PATIENTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER

You have accessJournal of UrologyBladder Cancer: Non-invasive II (MP16)1 Sep 2021MP16-06 A NOVEL NOMOGRAM TO PREDICT BCG RESPONSE IN PATIENTS WITH HIGH-GRADE NON-MUSCLE INVASIVE BLADDER CANCER Kelly Bree, Patrick Hensley, Nathan Brooks, Lianchun Xiao, Yu Shen, Neema Navai, H. Barton Grossman, Colin Dinney, and Ashish Kamat Kelly BreeKelly Bree More articles by this author , Patrick HensleyPatrick Hensley More articles by this author , Nathan BrooksNathan Brooks More articles by this author , Lianchun XiaoLianchun Xiao More articles by this author , Yu ShenYu Shen More articles by this author , Neema NavaiNeema Navai More articles by this author , H. Barton GrossmanH. Barton Grossman More articles by this author , Colin DinneyColin Dinney More articles by this author , and Ashish KamatAshish Kamat More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002001.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Current risk tables for outcome prediction in patients with non-muscle invasive bladder cancer (NMIBC) are based upon studies comprised primarily of low-grade tumors. We developed nomograms that predict disease recurrence and progression in patients with high-grade NMIBC using a large institutional dataset. METHODS: The log rank test, univariate and multivariate Cox proportional hazards regression models were used to identify risk factors of histologically confirmed disease recurrence and progression using data on 519 patients treated with adequate induction bacillus Calmette-Guerin (BCG) at our institution from 2000 to 2018. The first set of models predicted bladder cancer recurrence free survival (RFS), and the second set predicted tumor progression (any upstaging) free survival (PFS). RESULTS: At an estimated median follow-up time was 60.4 months (95% CI: 54-66.2), recurrence or death, whichever occurred first was recorded in 248 patients (47.8%) with a median RFS time of 73 months (95% CI, 52.6-91.2). Recurrent tumors (HR 1.78, 95% CI 1.33-2.33, p<0.0001), larger tumor size (HR 1.07, 95% CI 1.00-1.15, p=0.0487), and diabetes mellitus (HR 1.57, 95% CI 1.14-2.15, p=0.0055) were significantly associated with a higher risk of recurrence or death. Conversely, the receipt of maintenance BCG (mBCG) (HR 0.46, 95% CI 0.29-0.73, p=0.0008) and number of doses of mBCG (HR 0.92, 95% CI 0.89-0.94, p<0.0001) were associated with lower risk of events. Progression or death occurred in 128 patients (24.7%) with a median PFS time of 151 months (95% CI, 121.32-NA). Prior BCG (HR 2.19, 95% CI 1.23-3.88, p=0.0075) and older age (HR 1.041, 95% CI 1.02-1.06, p<0.001) were associated with higher risk of progression or death, while BMI≥25 (HR 0.519, 95% CI 0.35-0.78, p=0.0015) and number of doses of mBCG (HR 0.88, 95% CI 0.86-0.91, p<0.0001) were associated with lower risk of progression or death. These prognostic factors were integrated to construct nomograms for prediction of PFS and RFS. CONCLUSIONS: These nomograms provide personalized prediction of recurrence and progression in patients with high-grade NMIBC treated with BCG, and may help identify patients who may benefit most from early radical cystectomy. Source of Funding: This research was supported by the Wayne B. Duddlesten Professorship in Cancer Research, the Raymond and Maria Floyd Bladder Cancer Research Foundation Grant to AMK, and NIH/NCI UTMD Anderson SPORE in Genitourinary Cancer (Bladder) (P50CA091846) to CPND © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e298-e298 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kelly Bree More articles by this author Patrick Hensley More articles by this author Nathan Brooks More articles by this author Lianchun Xiao More articles by this author Yu Shen More articles by this author Neema Navai More articles by this author H. Barton Grossman More articles by this author Colin Dinney More articles by this author Ashish Kamat More articles by this author Expand All Advertisement Loading ...

IBCL-060: Incidence and Survival of Patients with Waldenström Macroglobulinemia Treated at The National Cancer Institute in Peru from 1999 to 2018

Context Waldenstrom macroglobulinemia (WM) is a lymphoplasmacytic lymphoma (LPL) with a monoclonal immunoglobulin M. In Latin America, only two articles have been published, the first was of a Mexican population accounting for 0.18% of Hematological Malignancies (HM), and the second study was of Chileans. The incidence of WM in the Caucasian population according to the literature is 2% of HM. Objective To describe the incidence, clinical pathological characteristics, and survival of WM. Design Retrospective case series from 1999–2018. Setting National Cancer Institute in Peru. Patients All patients with diagnosis of WM (ICD-10 C880) and LPL (ICD-O 9671/3) to reclassify as WM if appropriate. Interventions RCHOP. Main Outcomes Measures Baseline characteristics (BCL), response rates, and survival; the latter was used in the Kaplan-Meier method for analysis. Results Thirteen patients with newly diagnosed WM were found during the study period. From 1999 to 2018, 24.744 patients were treated at the NCI. The incidence of WM was 0.052%, 38 times less frequent than in the Caucasian population. Eight patients had complete medical records and were evaluated for BCL and survival. However, the entire cohort had information for age and sex. The median age was 63 (range 24–76), and 62% (n=8) were male. B-symptoms were present in 50% of cases. Anemia was reported in 87.5% and thrombocytopenia in 38%. Fifty percent had B2 microglobulin >3 mg/dL, and 88% of patients had a high International Prognostic Scoring System for WM (IPSSWM). The most frequent front-line treatment was CVP with 38%, followed by R-CHOP and CHOP with 25% and 13%, respectively. No complete response was reported, and 88% achieved partial response. With a median follow-up time of 16 months, the median progression-free survival (PFS) time was 14 months. The 1-year PFS was 64.3% (95% CI, 15.2–90.2), and the 2-year PFS was 21.4% (95% CI, 8.9–60.5). The median overall survival (OS) time was not achieved. The 3- and 5-year OS was 71.4% (95% CI, 25.8–91.9). Conclusions WM is an extremely rare HM in the Peruvian population, 38 times less frequent than in Caucasians. Most patients have a high IPSSWM score. Although most patients did not use Rituximab, the OS was good considering the high IPSSWM score.

Efficacy and Safety of Ibrutinib Therapy in Patients with Chronic Lymphocytic Leukemia: Retrospective Analysis of Real-Life Data

Objective:This study aimed to retrospectively evaluate the efficacy, safety, and survival outcome of single-agent ibrutinib therapy in chronic lymphocytic leukemia patients.Materials and Methods:A total of 136 patients (mean age ± standard deviation: 64.6±10.3 years, 66.9% males) who had received at least one dose of ibrutinib were included in this retrospective multicenter, noninterventional hospital-registry study conducted at 33 centers across Turkey. Data on patient demographics, baseline characteristics, laboratory findings, and leukemia-cell cytogenetics were retrieved. Treatment response, survival outcome including overall survival (OS) and progression-free survival (PFS), and safety data were analyzed.Results:Overall, 36.7% of patients were categorized as Eastern Cooperative Oncology Group (ECOG) class 2-3, while 44.9% were in Rai stage 4. Fluorescence in situ hybridization revealed the presence of del(17p) in 39.8% of the patients. Patients received a median of 2.0 (range: 0-7) lines of pre-ibrutinib therapy. Median duration of therapy was 8.8 months (range: 0.4-58.0 months). The 1-year PFS and OS rates were 82.2% and 84.6%, respectively, while median PFS time was 30.0 (standard error, 95% confidence interval: 5.1, 20.0-40.0) months and median OS time was 37.9 (3.2, 31.5-44.2) months. Treatment response (complete or partial response), PFS time, and OS time were better with 0-2 lines versus 3-7 lines of prior therapy (p<0.001, p=0.001, and p<0.001, respectively), with ECOG class 0-1 versus class 2-3 (p=0.006, p=0.011, and p=0.001, respectively), and with Rai stage 0-2 versus 3-4 (p=0.002, p=0.001, and p=0.002, respectively). No significant difference was noted in treatment response rates or survival outcome with respect to the presence of comorbidity, bulky disease, or del(17p). While 176 adverse events (AEs) were reported in 74 (54.4%) patients, 46 of those 176 AEs were grade 3-4, including pneumonia (n=12), neutropenia (n=11), anemia (n=5), thrombocytopenia (n=5), and fever (n=5).Conclusion:This real-life analysis confirms the favorable efficacy and safety profile of long-term ibrutinib treatment while emphasizing the potential adverse impacts of poorer ECOG performance status, heavy treatment prior to ibrutinib, and advanced Rai stage on patient compliance, treatment response, and survival outcomes.

Gastric MALT Lymphoma: A 8-Year Experience.

Gastric mucosa-associated lymphoid tissue non-Hodgkin lymphoma (gMALT NHL) is the second most common gastrointestinal lymphoma (50% of all gastric lymphomas), being closely associated withHelicobacter pyloriinfection, justifying that antibiotic therapy is effective in over 75% of all cases. This is a retrospective study analyzing all adult gMALT NHL cases diagnosed and treated in a single center for 8years, focusing on demographic features, treatment outcomes, and survival analysis. Sixty patients with a median age of 61years (53.3% female gender) were analyzed. Most of the cases had localized disease (66.7% were Lugano stage I) and had low IPI scores (median: 1). There was a high prevalence ofHelicobacter pyloriinfection (68.3%). Nearly 97% of the cases received treatment for the disease, a median of one line; 55% of the patients treated endured complete response after first-line therapy (mostly antibiotics). Median overall survival time and median progression-free survival time were not reached. The mean follow-up time was 81.8months (95% CI: [73.3-90.3]). Thirty-six patients (60%) achieved a 3-year follow-up time; the mortality rate was 15% at the end of the study. Age superior to 65years and transformation into DLBCL were statistically significant negative prognostic markers for survival in this study (p = 0.006 and p = 0.033, respectively). Our study confirms that gMALT NHL is an indolent disease with long-term survival. Many patients, however, are exposed to several treatment lines along their disease course.

Intratumoral Delivery of STING Agonist Results in Clinical Responses in Canine Glioblastoma.

Activation of STING (stimulator of interferon genes) can trigger a robust, innate antitumor immune response in immunologically "cold" tumors such as glioblastoma. A small-molecule STING agonist, IACS-8779, was stereotactically administered using intraoperative navigation intratumorally in dogs with spontaneously arising glioblastoma. The phase I trial used an escalating dose design, ascending through four dose levels (5-20 μg). Treatment was repeated every 4-6 weeks for a minimum of two cycles. Radiographic response to treatment was determined by response assessment in neuro-oncology (RANO) criteria applied to isovoxel postcontrast T1-weighted MR images obtained on a single 3T magnet. Six dogs were enrolled and completed ≥1 cycle of treatment. One dog was determined to have an abscess and was removed from further analysis. One procedure-related fatality was observed. Radiographic responses were dose dependent after the first cycle. The first subject had progressive disease, whereas there was 25% volumetric reduction in one subject and greater than 50% in the remaining surviving subjects. The median progression-free survival time was 14 weeks (range: 0-22 weeks), and the median overall survival time was 32 weeks (range: 11-39 weeks). Intratumoral STING agonist (IACS-8779) administration was well tolerated in dogs with glioblastoma to a dose of 15 μg. Higher doses of IACS-8779 were associated with radiographic responses.

Prognostic value of the age-adjusted Charlson comorbidity index in patients over 60 years old with laryngeal squamous cell carcinoma

Objective: To evaluate the value of the age-adjusted Charlson comorbidity Index (ACCI) in predicting the prognosis and guiding the clinical treatment of laryngeal squamous cell carcinoma (LSCC) in patients over 60 years old. Methods: Retrospective analysis of 249 cases of LSCC in Shanxi Provincial Cancer Hospital and First Hospital of Shanxi Medical University from 2008 to 2015 was performed. There were 234 males and 15 females, aged from 60 to 88 years. The clinical characteristics, treatment information and follow-up data were collected. ACCI was used to score the comorbidities of the patients. Receiver operating characteristic (ROC) curve was drawn and the patients were divided into high ACCI group and low ACCI group according to the cut-off value of ACCI. Prognostic factors were analyzed. Kaplan-Meier method was used for survival analysis, rank sum test was used for comparison between groups, χ2 test was used for enumeration data. Results: Overall survival (OS) was 54.6%, progression-free survival (PFS) was 59.4%, and cancer-specific survival (CSS) was 58.6%. Both the median survival time and PFS time were 60 months. The best cutoff point of the ACCI group was 5. Cox multivariate analysis showed that ACCI was an independent risk factor for OS, PFS and CSS (OR=1.553, 1.499 and 1.534,respectively, all P<0.05). In the high ACCI group, OS (χ2=4.120 and 4.115,P<0.05) and CSS (χ2=4.510 and 5.009,P<0.05) of patients treated with surgery plus radiotherapy and patients with radiotherapy alone were better than those of patients with surgery alone (P<0.05). But in the low ACCI group, there was no significant difference in prognosis among the three treatment regimens (P>0.05). Conclusion: High ACCI offors important prognostic information for LSCC in patients over 60 years old, and can guide clinical treatment options.

Combination of Sorafenib, Camrelizumab, Transcatheter Arterial Chemoembolization, and Stereotactic Body Radiation Therapy as a Novel Downstaging Strategy in Advanced Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Case Series Study.

Background and AimAlthough the treatment effect and availability of therapeutic options for advanced hepatocellular carcinoma (HCC) are limited, the downstaging strategy may improve patient prognosis. This study aimed to investigate the potential of combination therapy as a downstaging strategy for treating advanced HCC with portal vein tumor thrombus (PVTT).MethodsThis retrospective case series included patients having advanced HCC with PVTT, who received the combination therapy of sorafenib, camrelizumab, transcatheter arterial chemoembolization (TACE), and stereotactic body radiation therapy (SBRT) from January 2019 to December 2019 in Xiangya Hospital, Central South University. The downstaging rate, treatment responses, progression-free survival (PFS), overall survival (OS), disease control rate, and toxicities were evaluated.ResultsOf the 13 patients, HCC downstaging was achieved in 4 (33.3%) patients who later received hepatectomy. The overall response rate was 41.7%, and the disease control rate was 50.0%. The median PFS time was 15.7 months, with a 1-year PFS rate of 58.3%, whereas the median OS was not reached after 1 year (1-year OS, 83.3%). No severe adverse events or grade 3–4 adverse effect was observed in 12 of the 13 enrolled patients; therapy had to be discontinued in only one patient due to adverse events, who was excluded from the study. The most common adverse effect was fever (n = 4, 33.3%), followed by skin reaction (n = 3, 25%).ConclusionA combination therapy comprising sorafenib, camrelizumab, TACE, and SBRT is an effective downstaging strategy for advanced HCC with PVTT and is associated with few adverse events.

Vascular normalization therapy with targeted localized vessel bevacizumab infusion in hepatocellular carcinoma after transarterial chemoembolization failure.

Hepatocellular carcinoma (HCC) is a highly vascularized tumor in which abnormal blood vessels contribute to poor treatment efficacy and prognosis. In this study, we assessed the efficacy, safety, and potential ability of bevacizumab to normalize tumor vascularity in patients with advanced HCC. Patients with histologically or clinically confirmed advanced HCC that were refractory to conventional transarterial chemoembolization (c-TACE) received a transarterial infusion of bevacizumab (5 mg/kg), followed by c-TACE (named as BEVA-TACE). The primary endpoint was overall survival (OS), which was defined as the time from a patient identified as TACE refractory to the occurrence of death. The secondary endpoints included progression-free survival (PFS) and the disease control rate (DCR). From January 2014 to December 2017, 20 patients with Barcelona Clinic Liver Cancer (BCLC) staging scores C (80.0%) or D (20.0%) received BEVA-TACE. The median OS time was 9.2 months [95% confidence interval (CI): 2.1-22.6 months]. The median PFS time was 6.3 months (95% CI: 1.0-10.5 months). Despite the late stage, 1 patient (5.0%) had a complete response (CR), 6 patients (30.0%) had a partial response (PR), and 10 patients (50.0%) had stable disease (SD) [overall response rate (ORR) 30.0%; DCR 85.0%]. The most common adverse events (AEs) were postembolic syndrome (25%), hyperbilirubinemia (10.0%), and melena (10.0%). Severe III-IV oral mucositis and hypertension were observed in only 1 patient (5.0%) during the follow-up period. BEVA-TACE showed clinical efficacy, and patients with TACE-refractory HCC had acceptable AE rates. A low dose of targeted localized vessel bevacizumab infusion may normalize the condition of tumor blood vessels in patients with advanced HCC.

Improvement of outcomes of an escalated high-dose methotrexate-based regimen for patients with newly diagnosed primary central nervous system lymphoma: a real-world cohort study.

PurposeHigh‐dose methotrexate (HD‐MTX)-based chemotherapy regimen is the first-line treatment of primary central nervous system lymphoma (PCNSL). At present, doses of MTX in the range of 3.5–8 g/m2 are frequently used. However, the optimal dose of methotrexate for PCNSL remains controversial. The purpose of this real-world study was to compare the efficacy and toxicity of HD-MTX in patients with untreated PCNSL.MethodsImmunocompetent adults with newly diagnosed PCNSL between January 2015 and December 2018 were investigated and followed up to June 2019. All patients’ initial treatments were based on HD‐MTX chemotherapy regimens.ResultsA total of 73 patients were reviewed. For patients who received HD-MTX at 8 g/m2 vs.3.5 g/m2, the complete response (CR) rates were 68.29% vs 43.75% (p = 0.03), and the median PFS times were 17.7 months vs 9.05 months (HR=0.455, 95% CI 0.239–0.865, p=0.016). There was no significant difference in OS between the two groups. Serious adverse effects were uncommon and clinically manageable.ConclusionThere is a correlation of treatment response and clinical outcomes between the dosage of MTX in initial induction therapy in newly diagnosed PCNSL. MTX dose of 8 g/m2 provided a higher CR rate and PFS benefits with acceptable adverse effects.

The Clinical Characteristics and Prognosis of Patients with Acute Myeloid Leukemia Combine Paroxysmal Nocturnal Hemoglobinuria

To investigate the clinical characteristics and prognosis of patients with acute myeloid leukemia(AML) combined with paroxysmal nocturnal hemoglobinuria(PNH). The clinical data of 13 AML combined with PNH patients treated in our hospital from January 2017 to May 2019 were collected and retrospective analyzed. The complete remission(CR) rate for induction chemotherapy was analyzed. The level of PNH+ cell before and after chemotherapy were tested by Paired t test. Kaplan-Meier method and multi-factorial Cox regression model were used to analyze the influencing factors of prognosis. Among the 13 patients, 11 (84.6%) cases were CR after first induction chemotherapy. The median overall survival(OS) time was 17 months(0-30 months), the median progression-free survival(PFS) time was 16 months(2-26 months). There were no significant difference in the number of PNH+ cell before and after chemotherapy (P＞0.05). Multivariate Cox regression analysis showed that age，sex，the level of hemoglobin, platelet were not related to the OS of the patients(P＞0.05), the level of WBC, LDH and risk stratification at first diagnosed were related to the OS of the patients（P＜0.05）. Kaplan-Meier survival analysis showed that the OS rate of AML combined with PNH patients with leukocyte lower than 10×109/L at first diagnosed was better than that of the patients with leukocyte higher than 10×109/L (P=0.0261). The OS rate of patients with low or standard risk was better than the patients with high risk group(P=0.0010). The patients of AML combined with PNH have higher CR rate after the first induction chemotherapy. The level of WBC and LDH at first diagnosed are the factors that affecting the OS of the patients. The OS of patients with WBC lower than 10×109/L, at first diagnosed low and medium risk are better than the other patients.

Clinical Efficacy of High Dose Methotrexate, Temozolomide and Rituximab in the Treatment of Patients with Primary Central Nervous System Lymphoma

To investigate the clinical efficacy of high dose methotrexate (HD-MTX), temozolomide (TMZ), and rituximab (R) in the treatment of patients with primary central nervous system lymphoma (PCNSL). Clinical data of patients with PCNSL diagnosed and treated in Guangdong Provincial People's Hospital from February 2010 to May 2017 were collected. First, patients were given 6-8 cycles of MTX (3.5 g/m2) for induction treatment, and then 12 cycles of TMZ (150 mg/m2) for maintenance treatment. The day before induction treatment, patients were given rituximab 375 mg/m2 according to their economic status. A retrospective cohort study was performed on patients receiving HD-MTX+TMZ or HD-MTX+TMZ+R to analyze the efficacy and survival. There were 42 patients enrolled in the study, 17 cases in HD-MTX+TMZ group and 25 cases in HD-MTX+TMZ+R group. The median PFS and OS times in HD-MTX+TMZ+R group were 56.7 months and N/A, respectively, while, 7.3 months and 34.7 months in HD-MTX+TMZ group, respectively. In addition, there was no significant difference in median survival between patients who received TMZ maintenance therapy and those who were only actively monitored. During the induction period, all the patients had grade 1-2 nausea and vomiting, while in the consolidation treatment period, no grade 3/4 toxicity was observed. The combination of HD-MTX+TMZ+R in the treatment of PCNSL patients shows a definite short-term effect, which can increase the survival rate of the patients. The side effects are mild, and the patients can generally tolerate.

Adjuvant radiotherapy for atypical meningiomas is associated with improved progression free survival

PurposeTo assess the progression-free survival benefits of adjuvant radiotherapy (ART) following surgical resection compared to surgery alone in high-grade meningioma patients. MethodsWe retrospectively identified 43 patients with atypical meningiomas, who underwent either radiotherapy post-surgical resection (Surgery+ART) or surgery alone (Surgery alone) at our institution between February 2007 to March 2019. GTR was achieved in 28 patients, and STR, in 11. Patient, meningioma, and treatment data were extracted from records and compared using Kaplan-Meier methodology, log-rank tests, and Cox proportional hazard models. Radiation complications were also evaluated. ResultsOverall 32.6% (n = 14) of patients, 6 patients in the Surgery+ART group and 8 in the Surgery alone group, experienced recurrence. In the Surgery+ART group, the median PFS time was 46.5 months (CI: [35.8–50.6]), compared to 24.5 months (CI: [18.3–32.9]) in the Surgery alone group. 2-year PFS for Surgery+ART was 100% vs. 69.0% for Surgery alone, and the 5-year PFS rate was 70.6% and 39.2%, respectively (log-rank p-value = .004). ConclusionsOur data revealed a significant PFS increase for those treated with adjuvant radiotherapy following surgery compared to surgery alone. Future prospective studies evaluating differing radiation modalities and dosages should be conducted.

Effectiveness and safety of ultrasound-guided ablation in treatment of primary liver cancer in dangerous areas

Objective To investigate the effectiveness and safety of ultrasound-guided percutaneous local ablation in the treatment of liver cancer in dangerous areas. Methods A total of 179 patients with primary liver cancer who were admitted to Tianjin Second People's Hospital from January 2014 to September 2017 and underwent ultrasound-guided ablation for the first time were enrolled, and according to tumor location, the patients were divided into dangerous area group with 134 patients and non-dangerous area group with 45 patients. All patients received ablation therapy. The patients were followed up to observe tumor recurrence and death, and the patients without recurrence or death were followed up to September 2019. The two groups were compared in terms of complications after ablation, complete tumor response rate, tumor recurrence or progression, and postoperative survival. The two-independent-samples t-test was used for comparison of normally distributed continuous data between two groups; The Mann-Whitney U test was used for comparison of non- normally distributed continuous data between two groups, and the chi-square test was used for comparison of categorical data between two groups; the Kaplan-Meier method was used to analyze local tumor progression rate and cumulative survival rate, and the log-rank test was used for comparison between two groups. Results There were no significant differences in baseline levels between the two groups. There were no significant differences between the dangerous area group and the non-dangerous area group in the incidence rates of mild complications (42.5% vs 51.1%, χ2=1.002, P=0.317) and severe complications (6.0% vs 2.22%, χ2=0.453, P=0.290) and the reduction rate and normalization rate of alpha-fetoprotein within 1 month after ablation (reduction rate: 75.0% vs 80.0%, χ2=0.464, P=0.496; normalization rate: 33.9% vs 26.3%, χ2=0.381, P=0.537), and there was also no significant difference in complete tumor response rate between the two groups (91.8% vs 93.3%, P=0.990). The dangerous area group had 1- and 2-year progression-free survival rates of 60.7% and 37.1%, respectively, and the non-dangerous area group had 1- and 2-year progression-free survival rates of 63.5% and 55.0%, respectively, with a median progression-free survival time of 18 months and 27 months, respectively, and there was no significant difference between the two groups (χ2=0.573, P=0.449). The dangerous area group had 1- and 2-year cumulative survival rates of 96.8% and 90.3%, respectively, and the non-dangerous area group had 1- and 2-year cumulative survival rates of 93.3% and 87.8%, respectively, with no significant difference between the two groups (χ2=0.110, P=0.731). Conclusion Ultrasound-guided percutaneous local ablation is a feasible, safe, and effective method for the treatment of liver cancer in dangerous areas.

Efficacy and Prognostic Factors of Trans-Arterial Chemoembolization Combined With Stereotactic Body Radiation Therapy for BCLC Stage B Hepatocellular Carcinoma.

PurposeThis study aimed to evaluate the efficacy and safety of trans-arterial chemoembolization (TACE) followed by stereotactic body radiation therapy (SBRT) in treating Barcelona Clinic Liver Cancer (BCLC) stage B hepatocellular carcinoma (HCC) not amenable to resection and radiofrequency ablation (RFA).MethodsFrom February 2012 to January 2017, a total of 57 BCLC stage B HCC patients who were unsuitable candidates for resection and RFA treated with TACE combined with CyberKnife SBRT were included in this retrospective study. Patients underwent TACE for a median of two times (1–5 times) before SBRT. SBRT prescription doses ranged from 30 Gy to 50 Gy in 3–5 fractions.ResultsThe median follow-up time was 42 months. The objective response rate (CR + PR) was 85.9%, and the disease control rate (CR + PR + SD) was 96.5%. The local control (LC) rates were 91.1% and 84.3% at 1 and 2 years, respectively. The 1-, 2-, 3-year overall survival (OS) and the median survival time were 73.2%, 51.4%, 32.4% and 26.6 months, respectively. The 1-, 2-, and 3-year progression-free survival (PFS) were 34.2%, 21.6%, and 9%, respectively, with a median PFS time of 9.7 months. A subgroup analysis was conducted in 32 patients with AFP ≥ 200 ng/ml before TACE. OS was significantly prolonged in those with AFP that decreased by more than 75% than those with AFP that decreased by less than 75% (P = 0.018) after SBRT. The treatment was well tolerated with only one patient (1.8%) developed grade 3 gastrointestinal toxicity, and another patient developed non-classical RILD. In multivariate analysis, tumor length ≥ 10 cm and AFP ≥ 200 ng/ml were independent poor prognostic factors for OS.ConclusionThe combination of TACE and Cyberknife SBRT showed optimal efficacy with acceptable toxicity for BCLC stage B HCC.

Outcome of patients with recurrent/metastatic squamous cell head and neck cancer treated with platinum-based chemotherapy with or without cetuximab in real-world practice.

Patients with recurrent or metastatic squamous cell head and neck cancer (R/M SCHNC) exhibit a poor prognosis with a median overall survival (OS) time of <1 year. Platinum-based chemotherapy with or without cetuximab has been the standard of care in the last decade. The aim of the current retrospective study was to evaluate the outcome and tolerability of treatment in patients with R/M SCHNC receiving platinum/5-fluorouracil/cetuximab (PFE) chemotherapy compared with platinum/5-fluorouracil (PF) chemotherapy in daily clinical practice. A retrospective analysis was performed using the data of patients treated at the Institute of Oncology Ljubljana between April 2008 and May 2018. Progression-free survival (PFS) and OS were calculated with the Kaplan-Meier method and compared with the log-rank test. Multivariate regression Cox analysis was used to determine independent prognostic factors. A total of 67 patients were treated at the aforementioned Institute: 34 patients received the PF and 33 the PFE regimen. The mean age of patients was 54.6 years and 91% of patients were male. Median PFS time was 6.6 vs. 7.1 months for the PF vs. PFE groups, respectively (P=0.852). Median OS time was 9.6 vs. 11.5 months for the PF vs. PFE groups, respectively (P=0.029). The prognostic factor for PFS was partial remission [hazard ratio (HR), 0.32; 95% CI, 0.15-0.70; P=0.004]. Prognostic factors for OS were partial remission (HR, 0.15; 95% CI, 0.06-0.38; P<0.001) or stable disease (HR, 0.28; 95% CI, 0.13-0.64; P=0.002), and a subsequent line of treatment upon progression (HR, 0.28; 95% CI, 0.15-0.52; P<0.001). In the PFE group, 15.4% of patients had a grade >2 infusion reaction to cetuximab and 27.3% had grade 3 skin rash. There were no differences in diarrhoea, hypomagnesaemia, infections and febrile neutropenia; however, the mortality on active treatment was high (13.4%). In conclusion, patients treated with PFE had similar PFS, but improved OS compared with patients treated with the PF protocol. The proportion of patients who died under treatment due to disease progression and toxicity was high in both treatment arms. A thorough selection of patients for this treatment is crucial.

Anti-HER2 antibody prolongs overall survival disproportionally more than progression-free survival in HER2-Positive metastatic breast cancer patients

BackgroundThis meta-analysis aimed to test the hypothesis that the HER2-positive metastatic breast cancer (mBC) patients treated with anti-HER2 antibodies in trial intervention arms have a greater prolongation of overall survival (OS) than of progression-free survival (PFS) and this extra-prolongation of median survival time in OS relates specifically to the anti-HER2 antibody. MethodsThe NCBI/Pubmed and Cochrane databases were searched systematically for HER2-positive or mBC trials published in English during January 1999–November 2017. Treatment arms with shorter PFS were considered as the “control” arm, whereas those with longer PFS as the “test” arm. The between-treatment drug differences were grouped into nine categories. Groups with or without anti-HER2 antibodies were pooled respectively for comparisons. The interrelationships between PFS and OS hazard ratios (HRs) and median survival time differences were investigated by conducting fixed-effects and mixed-effects linear meta-regression analyses. ResultsTwenty-eight trials (10,928 patients) from 438 articles were collected, and four with missing data were excluded in meta-regression analysis. Overall median PFS (HR = 0.73, 95% CI: 0.68–0.78) and median OS (HR = 0.82, 95% CI: 0.77–0.87) weakly favored the longer PFS arm with a weak correlation between the PFS and OS HRs. However, the between-treatment drug difference was anti-HER2 antibody, the absolute increment in median OS time was double that of median PFS time (p < 0.001) and linearly correlated, which was not found with any non-anti-HER2 antibody drug differences. ConclusionsAnti-HER2 antibody in patients with HER2-positive mBC prolonged OS more than PFS and mandates further investigation.

Treatment Patterns and Survival Outcomes in Latin American Patients with Newly Diagnosed Multiple Myeloma: A Retrospective Medical Chart Review Study, 2008-2016

Background: Recent advances in multiple myeloma (MM) treatment have led to overall improvement in patient outcomes around the world, although the incorporation of novel therapies is generally slow in Latin American countries. Currently, there is limited real-world evidence on available therapies and associated patient outcomes in this region.Objective: To evaluate the treatment landscape by examining up to 3 lines of therapy (LOTs) in Latin American patients with MM diagnosis and the impact of therapies on outcomes of progression-free survival (PFS) and overall survival (OS).Methods: Medical chart review was performed for patients with newly diagnosed MM at 30 participating clinical sites in 7 Latin American countries: Argentina, Brazil, Chile, Colombia, Mexico, Panama and Guatemala. All patients were followed from initiation of 1st LOT to the earliest of end of follow-up or death date (OS). PFS in each LOT was determined from initiation of each LOT until the earliest of end of follow-up, relapse date or death date. A multivariable Cox proportional hazard regression model was used to assess the association of therapy choice in 1st and 2nd LOTs with risk for disease progression or death, comparing patients with bortezomib (V)-based therapy against patients with other therapies. Patients receiving stem cell transplant were excluded from the analysis.Results: We identified1104 MM patients at initiation of 1st LOT with median age at diagnosis of 61 years. Median follow-up was 27 months; 48% patients had a history of cardio-related disease and 12% had a history of renal impairment. During the follow-up, 504 (46%) patients subsequently received a 2nd LOT, and 133 (12%) patients received additional 3rd LOT.Across all 1st, 2nd and 3rd LOTs, the 3 most commonly used regimens were thalidomide (T)-based regimen (excluding bortezomib), V-based regimen (excluding immunomodulators), and chemotherapy alone, accounting for 94%, 84% and 74% of 1st, 2nd and 3rd LOTs, respectively. T-based therapy was predominantly used in the 1st LOT and less often in subsequent LOTs, whereas use of V-based regimen and chemotherapy remained constant across the 3 LOTs (Table 1). Only a small proportion of patients were retreated by the same therapy, with 92 (18%) T-based patients, 28 (6%) V-based patients and 14 (3%) chemotherapy patients in both 1st and 2nd LOTs.With a median PFS time of 19 months in the 1st LOT, landmark PFS at year 1, 2, and 3 was 62%, 31% and 16%, respectively. Patients with T-based or chemo-therapy in their 1st LOT had ≥41% increased risk for relapse during 1st LOT than those with V-based therapy (p<0.01, Table 2a). In 2nd LOT, the median PFS was 10 months; landmark PFS at year 1, 2 and 3 was 36%, 13% and 5%, respectively. No statistical differences in landmark PFS for 2nd LOT were observed among the 3 treatments (p≥0.09, Table 2b).Following initiation of 1st LOT, 357 (32%) patients died. In 1st LOT, OS rate at year 1, 2, and 3 was 84%, 55% and 35%. There was no difference in mortality risk between patients using T- and V-based therapy (p=0.95), although chemotherapy patients had 43% increased mortality relative to V-based patients (p<0.05, Table 2c). Similar association was also observed in 2nd LOT (Table 2d), with median OS time of 17 months.When individual countries were assessed in 1st LOT, Brazilian patients, relative to those in other 6 countries, had shorter median PFS (10 months) and median OS time (23 months). Common treatments in Brazil across the 3 LOTs were similar to those in other countries. Also, a somewhat stronger association between treatment choice and outcomes of PFS and OS was seen in Brazil (Table 3).Conclusion: This study shows the latest findings of treatment patterns and associated outcomes in MM patients from 7 Latin American countries. The continued high prevalence of T-based therapy use after 2008 in these patients suggests that several Latin American countries have limited treatment options. Following initiation of 1st LOT, ~70% patients experienced 1st disease progression within 2 years and >40% of patients died from the disease. Brazilian patients appear to have worse PFS and OS in 1st LOT than patients from other countries, likely attributable to treatment choice. Better management of care for MM, such as increased use of novel agents and new treatment sequence are needed to prolong PFS and OS in these patients. [Display omitted] DisclosuresHungria:Celgene, Roche, Takeda, Janssen, Amgen: Honoraria. Miguel:Janssen: Speakers Bureau. Silvana Cugliari:Roche, Raffo, Abbvie: Honoraria, Membership on an entity's Board of Directors or advisory committees. Santos:Janssen: Employment. Santos:Janssen: Employment. Machnicki:Janssen: Employment. Lin:Janssen: Employment. Chen:Janssen: Employment. Barreyro:Janssen: Employment.