scholarly journals Initial evaluation of nivolumab in patients with post-operative recurrence of malignant pleural mesothelioma

2020 ◽  
Vol 50 (8) ◽  
pp. 920-925 ◽  
Author(s):  
Akifumi Nakamura ◽  
Nobuyuki Kondo ◽  
Toru Nakamichi ◽  
Ayumi Kuroda ◽  
Masaki Hashimoto ◽  
...  
Keyword(s):  
Adverse Events ◽  
Malignant Pleural Mesothelioma ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Complete Response ◽  
Post Treatment ◽  
Pleural Mesothelioma ◽  
Serious Adverse Events ◽  
Treatment Data

Abstract Background Limited options exist for treating post-recurrence patients with malignant pleural mesothelioma (MPM). This study aimed to evaluate the efficacy and feasibility of nivolumab in patients with post-operative recurrence of MPM in a real-world setting. Methods This study included 35 patients with post-operative recurrence of MPM. Treatment consisted of 240-mg intravenous nivolumab administration every 2 weeks until progressive disease (PD) or serious adverse events (AEs). Additional post-treatment data were evaluated, including objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), post-treatment survival and AEs. Tumor response was assessed using the modified Response Evaluation Criteria in Solid Tumors. Survival analysis was performed using the Kaplan–Meier method. The feasibility analysis including AEs was performed with the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Results Of the 35 patients who received nivolumab, median follow-up was 6 months. The median treatment duration was 3 months (range: 1–14 months), and median of 8 cycles (range: 2–32 cycles) was administered. Best overall responses were follows: 1 patient had complete response, 6 had partial response, 18 had stable disease and 8 had PD. The ORR was 20.0%, and the DCR was 77.1%. The median overall survival and PFS were 13.1 and 4.4 months, respectively. There were grade-3 AEs in four patients (11.4%). No grade-4 or -5 AEs were observed. Conclusion Nivolumab treatment in patients with post-operative recurrence of MPM seems safe and clinical efficacy.

Prospective observational study on pazopanib in patients treated for advanced/metastatic renal cell carcinoma (RCC): APOLON Study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 629-629
Author(s):  
Philippe Barthelemy ◽  
Laurence Albiges ◽  
Bernard Escudier ◽  
Thierry Lebret ◽  
Pierre Bigot ◽  
...  
Keyword(s):  
Adverse Events ◽  
Objective Response ◽  
Real Life ◽  
Progression Free Survival ◽  
Serious Adverse Events ◽  
Private Practitioners ◽  
Real World Evidence ◽  
Treatment Data ◽  
History Of ◽  
Ecog Ps

629 Background: Pazopanib (PZP), has been granted for advanced or metastatic RCC. In addition to pivotal clinical trials, real-world evidence (RWE) is required to evaluate effectiveness and safety in clinical routine practices. Methods: APOLON is a non-interventional, multicentric prospective study to assess PZP Progression-Free Survival (PFS) (8-month PFS rate as primary endpoint), Overall Survival (OS), Objective Response Rate (ORR), tolerability, subsequent post-pazopanib therapy sequences. It is conducted in France with 55 sites (hospital or private practitioners) in patients with mRCC, naïve to anti-VEGF therapy, who initiated PZP treatment. Data are collected at baseline and at 1, 2-3, 6, 9, 12, 18, 24, 30, 36 months (mo). Patients (n= 218) were recruited from Nov 2017 to Jan 2019. This interim analysis presents results 6 months after last patient was enrolled. Results: Patients were 71,1% males, with a median age of 69.6 years. They had clear-cell type RCC for 97.7% with a favourable (26.4%), intermediate (52.9%) or poor (20.7%) IMDC risk score. Comorbidities were: hypertension (75.1%), diabetes (26%), arterial disorders (20.1%), other pathologies (47.3%); 81.7% received co-medications. ECOG-PS was 0 (42.9%), 1 (40%), 2 (15.7%), Metastases were mainly located in lungs (62.8%), bones (28.9%), mediastinal (17.9%)/abdominal (17%) lymph nodes, glands (pancreas, thyroid, adrenals) (17.4%). Of them, 56% had an history of partial/total nephrectomy, 28.1% previous local treatments for metastases. Median PFS, assessed by investigator, was 11.3 mo (95%CI: 8.7-13), with an 8-mo PFS rate at 62.9%. ORR was 47.2% and 1-year OS rate was 71.2%. Treatment-related serious adverse events were reported in 17.3% of patients. No new safety signal was identified. After a median follow-up of 8.8 mo, of the 121 patients with discontinuation, 74 received post-PZP lines comprising firstly nivolumab (67.6%), cabozantinib (16.2%), sunitinib (10.8%), other (5.6%). Conclusions: APOLON study represents real-life population including elderly and frail patients with clinically meaningful ORR and PFS with PZP. Reported adverse events were consistent with known safety PZP profile.

scholarly journals Correlation between immune-related adverse events and therapeutic effects of nivolumab in patients with malignant pleural mesothelioma

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hiroto Yoneda ◽  
Hiroshi Nokihara ◽  
Atsushi Mitsuhashi ◽  
Ryohiko Ozaki ◽  
Yohei Yabuki ◽  
...  
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Malignant Pleural Mesothelioma ◽  
Objective Response ◽  
Progression Free Survival ◽  
University Hospital ◽  
Therapeutic Effects ◽  
Pleural Mesothelioma ◽  
Therapeutic Benefits ◽  
Favorable Clinical Outcome

Abstract Background Nivolumab is used for the treatment of malignant pleural mesothelioma (MPM). However, immune-related adverse events (irAEs) occur in patients treated with nivolumab. Several studies have reported the correlation between irAEs and therapeutic effects of immune checkpoint inhibitor, but none have reported the correlation in MPM. Here we report a retrospective study which shows the correlation between irAEs and therapeutic effects of nivolumab in patients with MPM. Methods This study included patients treated with nivolumab at Tokushima University Hospital from February 2009 to September 2021. We retrospectively reviewed the medical records to evaluate the several clinical factors, such as the presence or absence of irAEs, their severities, progression-free survival (PFS), overall survival (OS) or objective response to the treatment. Results Eleven patients received treatment with nivolumab. Objective response rate was 18.2% and the disease control rate was 90.9%. Median PFS was 6.8 months (95% confidence interval, 1.3 to 11.9 months) and median OS was 15.2 months (95% confidence interval, 8.9 to 21.5 months). IrAEs occurred in eight patients (72.7%), and grade ≥ 2 irAEs occurred in six patients (54.5%). PFS and OS were significantly longer in the grade ≥ 2 irAEs group than in grade < 2 irAEs group (median PFS 13.6 vs. 3.8 months, p = 0.0093; median OS not reached vs. 8.6 months, p = 0.0108). Conclusions This is the first study to report the correlation between irAEs and therapeutic effects in patients with MPM. Because the presence of irAEs may be associated with a favorable clinical outcome, early detection and appropriate management of irAEs will increase the therapeutic benefits to patients.

scholarly journals Irinotecan Plus Doxorubicin Hydrochloride Liposomes for Relapsed or Refractory Wilms Tumor

2021 ◽  
Vol 11 ◽  
Author(s):  
Juan Wang ◽  
Lian Zhang ◽  
Lanying Guo ◽  
Yi Que ◽  
Yu Zhang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Wilms Tumor ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Complete Response ◽  
Cancer Center ◽  
Refractory Disease ◽  
Doxorubicin Hydrochloride ◽  
Relapsed Disease

PurposeThe prognosis of relapsed or refractory pediatric Wilms tumor (WT) is dismal, and new salvage therapies are needed. This study aimed to evaluate the efficacy of the combination of irinotecan and a doxorubicin hydrochloride liposome regimen for relapsed or refractory pediatric WT.Patients and MethodsThe present study enrolled relapsed or refractory pediatric WT patients who were treated with the AI regimen (doxorubicin hydrochloride liposomes 40 mg/m2 per day, day 1, and irinotecan 50 mg/m2 per day with 90-min infusion, days 1–5; this regimen was repeated every 3 weeks) at Sun Yat-sen University Cancer Center from July 2018 to September 2020. The response was defined as the best-observed response after at least two cycles according to the Response Evaluation Criteria of Solid Tumors (RECIST 1.1), and toxicity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE 4.03).ResultsA total of 16 patients (male:female, 8:8) with a median age of 4.2 years (0.5–11 years) with relapsed or refractory disease were enrolled in this study, including 14 patients with relapsed disease and two patients with refractory disease. These patients received 1–8 courses (median, 3 courses) of the AI regimen. Fourteen patients were assessable for response: two with complete response (CR), five with partial response (PR), two with stable disease (SD), and five with progressive disease (PD). The objective response rate was 50% (two CR, five PR), and the disease control rate was 64% (two CR, five PR, and two SD). Seven out of 14 patients (50%) were alive at the last follow-up, ranging from 2.6 to 32.4 months. The median progression-free survival and median overall survival were 3.5 months (range 0.5–12 months) and 8 months (range 1–28 months), respectively. Sixteen patients were assessable for toxicity, with the most common grade 3 or 4 adverse events being alopecia (62%), leukopenia (40%), abdominal pain (38%), diarrhea (23%), and mucositis (16%), etc. No fatal adverse events have been observed, and modest adverse effects can be administered.ConclusionIrinotecan and doxorubicin hydrochloride liposome regimens have positive efficacy on relapsed or refractory pediatric WT with well-tolerated toxicity. A prospective clinical trial is warranted.

scholarly journals Correlation Between Immune-related Adverse Events and Therapeutic Effects of Nivolumab in Patients With Malignant Pleural Mesothelioma

2021 ◽  
Author(s):  
Hiroto Yoneda ◽  
Hiroshi Nokihara ◽  
Atsushi Mitsuhashi ◽  
Ryohiko Ozaki ◽  
Yohei Yabuki ◽  
...  
Keyword(s):  
Adverse Events ◽  
Confidence Interval ◽  
Malignant Pleural Mesothelioma ◽  
Objective Response ◽  
Progression Free Survival ◽  
University Hospital ◽  
Therapeutic Effects ◽  
Pleural Mesothelioma ◽  
Therapeutic Benefits ◽  
Favorable Clinical Outcome

Abstract Background: Nivolumab is used for the treatment of malignant pleural mesothelioma (MPM). However, immune-related adverse events (irAEs) occur in patients treated with nivolumab. Several studies have reported the correlation between irAEs and therapeutic effects of immune checkpoint inhibitor, but none have reported the correlation in MPM. Here we report a retrospective study which shows the correlation between irAEs and therapeutic effects of nivolumab in patients with MPM. Methods: This study included patients treated with nivolumab at Tokushima University Hospital from February 2009 to December 2019. We retrospectively reviewed the medical records to evaluate the several clinical factors, such as the presence or absence of irAEs, their severities, progression-free survival (PFS), overall survival (OS) or objective response to the treatment.Results: Eight patients received treatment with nivolumab. Overall response rate was 14.3% and the disease control rate was 87.5%. Median PFS was 6.6 months (95% confidence interval, 2.4 to 10.8 months) and median OS was 15.2 months (95% confidence interval, 11.1 to 19.4 months). IrAEs occurred in six patients (85.7%), and grade 2 ≤ irAEs occurred in four patients (50.0%). Median PFS was significantly longer in the grade 2 ≤ irAEs group (16.3 months) than in their counterpart (3.8 months; p = 0.0266).Conclusions: This is the first study to report the correlation between irAEs and therapeutic effects in patients with MPM. Because the presence of irAEs may be associated with a favorable clinical outcome, early detection and appropriate management of irAEs will increase the therapeutic benefits to patients.

Retrospective Review of Safety and Efficacy of Anlotinib in Advanced Osteosarcoma With Metastases After Failure of Standard Multimodal Therapy

2021 ◽  
Author(s):  
Hanqing Li ◽  
Yang Li ◽  
Lei Song ◽  
Qiuchi Ai ◽  
shuai zhang
Keyword(s):  
Adverse Events ◽  
Multimodal Therapy ◽  
Objective Response ◽  
Progression Free Survival ◽  
Complete Response ◽  
Free Survival ◽  
Safety And Efficacy ◽  
Common Drug ◽  
Grade 3 ◽  
Therapeutic Doses

Abstract To study and observe the safety and efficacy of anlotinib in the treatment of advanced osteosarcoma with metastases. We retrospectively studied patients with advanced osteosarcoma and metastases who received anlotinib treatment in our hospital from June 2018 to April 2020. All patients had received standard multimodal therapies, before taking anlotinib. Therapeutic doses of anlotinib were 12 mg for adults and 10 mg for children and adolescents once a day for 2 consecutive weeks, followed by a week of withdrawal. This 3-week cycle of treatment was continued until the tumor progressed rapidly or the patients failed to tolerate the side effects. Adverse drug reactions were recorded, and therapeutic efficacy was evaluated based on progression free survival (PFS), disease control rate (DCR), overall survival (OS), and objective response rate (ORR). The median PFS was 9.81 ± 0.9 months, and the 6-month and 10-month PFS rates were 73.3% and 33.3%, respectively. The median OS was 11.43 ± 0.58 months. No patients achieved complete response. After 6 months of treatment, the DCR and ORR were 80% and 13.3%, respectively. No drug-related deaths or Grade 4 adverse events occurred in the patients. Five patients (33.3%) had Grade 3 adverse events. The most common drug-related adverse events were hand-food syndrome, fatigue, high blood pressure, anorexia, and pneumothorax. Anlotinib had a certain curative effect on patients with advanced osteosarcoma and metastases after failure of standard treatment. The adverse events were mostly tolerable or relieved after treatment.

scholarly journals The efficacy and adverse events of anlotinib plus PD-1 inhibitor for metastatic solid tumors

2021 ◽  
Author(s):  
Hao Lin ◽  
Tao Liu ◽  
Xinli Zhou ◽  
Xiaohua Liang
Keyword(s):  
Adverse Events ◽  
Solid Tumors ◽  
Kinase Inhibitors ◽  
Response Rate ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Kaplan Meier ◽  
Hemorrhagic Events ◽  
Tumor Immune Microenvironment

Abstract Background Several antiangiogenic tyrosine kinase inhibitors (TKIs) have the potential to modulate the tumor immune microenvironment and improve immunotherapy effect Of these, anlotinib has demonstrated antitumor efficacy in clinical trials. However, its role in immune regulation and the potential synergistic antitumor effect of its combination with PD-1 inhibitor remain unclear. This study investigated the efficacy and adverse events (AEs) of the combination of anlotinib and PD-1 inhibitor for solid tumors in real-world settings. Methods This retrospective study included patients with metastatic solid tumors treated with anlotinib plus PD-1 inhibitor at Huashan hospital, Fudan University between October 1, 2018 and August 31, 2020. The objective response rate was assessed using the response evaluation criteria in solid tumors v1.1. Descriptive statistics were performed using the Kaplan–Meier method, and any AEs were noted. Results Partial response was achieved in 13 patients, and 8 patients showed stable disease, representing a response rate of 43.3% and a disease control rate of 70%. The median progression-free survival was 3.8 months. Although AEs were observed in 50% of patients, most of them were Grades 1–2 and well tolerated. The most common AEs were thrombocytopenia (16%), thromboembolic or hemorrhagic events (16%), and rash (13%). Conclusions Anlotinib plus PD-1 inhibitor is an alternative salvage treatment choice in metastatic solid tumors with Favorable efficacy and tolerable toxicities.

scholarly journals Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response

2020 ◽  
Vol 52 (2) ◽  
pp. 594-603 ◽  
Author(s):  
Junho Kang ◽  
Jae Ho Jeong ◽  
Hee-Sang Hwang ◽  
Sang Soo Lee ◽  
Do Hyun Park ◽  
...  
Keyword(s):  
Biliary Tract ◽  
Biliary Tract Cancer ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Complete Response ◽  
Current Standard ◽  
Durable Response ◽  
Tract Cancer ◽  
Potential Biomarker

Purpose The current standard chemotherapy for advanced biliary tract cancer (BTC) has limited benefit, and novel therapies need to be investigated. Materials and MethodsIn this prospective cohort study, programmed death ligand-1 (PD-L1)–positive BTC patients who progressed on first-line gemcitabine plus cisplatin were enrolled. Pembrolizumab 200 mg was administered intravenously every 3 weeks. ResultsBetween May 2018 and February 2019, 40 patients were enrolled. Pembrolizumab was given as second-line (47.5%) or ≥ third-line therapy (52.5%). The objective response rate was 10% and 12.5% by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 and immune- modified RECIST (imRECIST) and median duration of response was 6.3 months. Among patients with progressive disease as best response, one patient (1/20, 5.0%) achieved complete response subsequently. The median progression-free survival (PFS) and overall survival (OS) were 1.5 months (95% confidence interval [CI], 0.0 to 3.0) and 4.3 months (95% CI, 3.5 to 5.1), respectively, and objective response per imRECIST was significantly associated with PFS (p < 0.001) and OS (p=0.001). Tumor proportion score ≥ 50% was significantly associated with higher response rates including the response after pseudoprogression (vs. < 50%; 37.5% vs. 6.5%; p=0.049). Conclusion Pembrolizumab showed modest anti-tumor activity in heavily pretreated PD-L1–positive BTC patients. In patients who showed objective response, durable response could be achieved.

Maintenance chemotherapy with pemetrexed in epiteliomorfe malignant pleural mesothelioma.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e18545-e18545
Author(s):  
Angelo Nacci ◽  
Claudio Lotesoriere ◽  
Michele Montrone ◽  
Salvatore Pisconti ◽  
Laura Orlando ◽  
...  
Keyword(s):  
Overall Survival ◽  
Malignant Pleural Mesothelioma ◽  
Induction Therapy ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Complete Response ◽  
Pleural Mesothelioma ◽  
Maintenance Chemotherapy ◽  
Free Survival ◽  
Vitamin B12 Supplementation

e18545 Background: Maintenance chemotherapy with pemetrexed is not the standard treatment of choice in patients with locally advanced or metastatic epiteliomorfe malignant pleural mesothelioma (EMPM). We would assess the safety and efficacy of a treatment with pemetrexed until progression disease after 4 or 6 cycles of induction therapy with or without platin. Methods: From July 2008 to September 2012, 21 patients (18 males and 3 females with a median age of 67 years range 58-84) with locally advanced or metastatic epiteliomorfe malignant pleural mesothelioma (EMPM) were enrolled. In all patients histology was epiteliomorfe malignant mesothelioma. Only 15 patients (71,4%) had a PS 0 whereas 6 (28,6%) had a PS 1. All patients received an induction therapy with or without platin. Each patient received an average of 5,6 cycles of induction chemotherapy. Then all patients received a maintenance chemotherapy with pemetrexed 500 mg/mq intavenously over 10 minutes every 3 weeks. Each patient received an average of 7,3 cycles of maintenance chemotherapy. All patients received folic acid and vitamin B12 supplementation to improve safety. Results: At the time of analysis all patients were evaluable for response. Fourteen patients (66,6 %) had a partial response and two of these underwent surgery and obtained a complete response. Six patients (28,5%) had a stable disease. The median overall survival was 13 months, while median progression-free survival was 11 months. Grade 2-3 of WHO haematological toxicities (anemia and neutropenia) occurred in 4 patient (19%). We also observed grade 2-3 of WHO gastrointestinal toxicities (diarrhea, nausea and vomiting) in 2 patient (9.5%). Grade 2 of lack of appetite and asthenia occurred in 3 patients (14.3%). Conclusions: Our data show that a maintenance chemotherapy with pemetrexed in EMPM resulted in a moderate overall survival (13 months). These results indicate that patients with EMPM could benefit from a maintenance treatment with pemetrexed.

Lenvatinib plus pembrolizumab combination therapy in patients with radioiodine-refractory (RAIR), progressive differentiated thyroid cancer (DTC): Results of a multicenter phase II international thyroid oncology group trial.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6512-6512 ◽  
Author(s):  
Bryan Haugen ◽  
Jena French ◽  
Francis P. Worden ◽  
Bhavana Konda ◽  
Eric Jeffrey Sherman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Median Time ◽  
Phase Ii ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Complete Response ◽  
Maculopapular Rash ◽  
Multicenter Phase ◽  
Secondary Endpoints ◽  
Grade 3

6512 Background: Lenvatinib is an approved therapy for patients with RAIR DTC. While the overall response rate (ORR) is high, few patients achieve a complete response (CR) and most patients eventually have progressive disease (PD). Combination lenvatinib and pembrolizumab is being explored in many different cancers, and this combination has been approved for advanced endometrial carcinoma. Methods: Patients with RAIR DTC with Response Evaluation Criteria in Solid Tumor (RECIST v1.1) measurable PD (<14 months (mo) prior to registration) were enrolled in this single-arm multicenter phase II study. Patients were excluded if they had received previous VEGFR-directed multikinase therapy. The lenvatinib starting dose was 20 mg/day orally and pembrolizumab was 200mg IV every 3 weeks. The primary endpoint was CR. ORR, progression-free survival (PFS) and safety graded by Common Terminology Criteria for Adverse Events v4.0 were secondary endpoints. Results: Thirty patients were enrolled. The median age was 62.5 years, and 53% of the patients were women. Seventy percent of patients had grade 3 adverse events (AEs) and 10 percent had grade 4 AEs. There were no treatment-related deaths. The most common > grade 3 AEs were hypertension (47%), weight loss (13%), maculopapular rash (13%), leukopenia (7%), diarrhea (7%) and oral mucositis (7%). Twenty-one patients (70%) required lenvatinib dose reduction. Of 29 evaluable patients, 18 (62%) had a partial response (PR) and 10 (35%) had stable disease (SD). The clinical benefit rate (ORR +SD) was 97%. Median time to tumor nadir was 7.4 mo (1.6-17.8 mo). Median PFS was not yet reached. The PFS at 12 months was 74%. Median time on therapy was 9.9 mo (3.2-18.9 mo). Fourteen patients are continuing therapy (7.6-18.9 mo). Six of these patients (43%) have not yet reached tumor size nadir. Three patients (10%) had > 80% target tumor shrinkage. Conclusions: Lenvatinib plus pembrolizumab is reasonably tolerated in patients with RAIR DTC. To date, there have been no documented complete responses. Combination lenvatinib plus pembrolizumab therapy has a high ORR in patients with RAIR DTC. Continuation of this study will help determine the depth and length of the responses. Clinical trial information: NCT02973997 .

scholarly journals Balloon occluded TACE (B-TACE) vs DEM-TACE for HCC: a single center retrospective case control study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Pierleone Lucatelli ◽  
Gianluca De Rubeis ◽  
Bianca Rocco ◽  
Fabrizio Basilico ◽  
Alessandro Cannavale ◽  
...  
Keyword(s):  
Adverse Events ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Complete Response ◽  
Case Control ◽  
Single Center ◽  
Retrospective Case ◽  
Time To Recurrence ◽  
Cox's Regression ◽  
Micro Catheter

Abstract Background To compare oncological results and safety profile of balloon micro-catheter trans-arterial chemoembolization (b-TACE) and drug-eluting-microsphere (DEM-TACE) in patients with hepatocellular-carcinoma (HCC). Methods This is a case–control, retrospective, single-center study. Between January-2015/March-2019, 149 patients (131 males [87.9%]) with 226 HCC were treated, 22 patients (35 HCC; 19 [86.4%] males) with b-TACE and 127 with DEM-TACE (191 HCC, 112 [88.2%] males). Embolization protocol was standardized (sequential 100 ± 25 and 200 ± 25 μm microspheres). Results were evaluated by modified-response-evaluation-criteria-in-solid-tumor [mRECIST] at 1, 3–6 and 9–12 months and time to recurrence after complete response [TTR] at 1 years. Cox’s regression weighted with tumor dimensions was performed. Adverse events (AEs) were recorded. Results mRECIST oncological response at all time points (1, 3–6 and 9–12 months) for both treatments were similar, with the exception of Objective response rate at 9-12 months. Objective response at 1 and 3–6 months between b-TACE vs DEM-TACE [23/35 (65.7%) vs 119/191 (62.3%), 21/29 (72.4%) vs 78/136 (57.4%) (p > 0.05), respectively]. On the contrary, at 9–12 months, it was significantly higher in b-TACE subgroup than DEM-TACE (15/19 [78.9%] vs 48/89 [53.9%], p = 0.05). TTR for complete response at 1 year had a better trend for b-TACE vs DEM-TACE (278.0 days [196.0–342.0] vs 219.0 days [161.0–238.0], OR 0.68 [0.4–1.0], p = 0.10). The use of balloon micro-catheter reduced the relative risk of the event of recurrence by 0.63 [CI95% 0.38–1.04]; p = 0.07). No significant differences were found in AEs rate. Conclusion b-TACE showed a trend of better oncological response over DEM-TACE with and longer TTR with a similar adverse events rate, in patients presenting with larger tumors.

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