Real world treatment patterns of first-line combination therapies among BRAF+ metastatic melanoma patients.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 197-197
Author(s):  
Sameer Ghate ◽  
Jackson Tang ◽  
Zhiyi Li ◽  
Antonio Reis Nakasato
Keyword(s):  
Metastatic Melanoma ◽  
Real World ◽  
Performance Status ◽  
Treatment Patterns ◽  
Toxic Effects ◽  
First Line ◽  
Ecog Performance Status ◽  
Status Score ◽  
Study Results ◽  
Performance Status Score

197 Background: For patients (pts) with metastatic melanoma (MM) and BRAF V600 mutation (BRAF+), options for first-line (1L) systemic combination therapy include immunotherapy (IO) or targeted therapy (TT). This study describes real world treatment patterns among BRAF+ MM pts treated with 1L ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T). Methods: This retrospective observational analysis used Flatiron Health’s electronic health record-derived database from Oct 2015 - Jul 2016. Oct 2015 was chosen as the start date as both combo use of I+N and D+T had been approved by the FDA. Pts were aged ≥18 years with a MM diagnosis, tested BRAF+ prior to therapy, and treated with either I+N or D+T as 1L therapy. Baseline demographic and clinical characteristics, and treatment patterns were collected from structured data and unstructured data in physician notes, and were descriptively assessed. Kaplan-Meier (KM) analysis measured time to discontinuation. Statistical inferences were not planned in this study. Results: Among 76 BRAF+ pts, 62% (47) were treated with D+T as 1L, and 38% (29) were treated with I+N as 1L. Compared to D+T pts, lower proportion of I+N pts had a history of brain metastases (31% vs. 34%) and elevated ( > 333 IU/L) lactate dehydrogenase (10% vs. 19%), while a higher proportion of I+N pts reported ECOG performance status score of zero (38% vs. 23%). The two cohorts were similar in age, gender and baseline comorbidities. Discontinuation among D+T and I+N was 43% (20) and 48% (14) respectively. The primary reason for discontinuation was progression among D+T pts (10/20) vs. toxic effects of therapy among I+N pts (8/14). KM median time to discontinuation was 213 days for D+T pts vs. 196 days for I+N pts. 55% of I+N pts did not complete full induction of 4 doses of ipilimumab, citing toxic effects of therapy. Conclusions: 1L D+T patients had higher tumor burden, elevated LDH levels, and higher ECOG performance status score, but lower discontinuation rate and longer time to treatment discontinuation relative to BRAF+ 1L I+N pts.

scholarly journals 418 Phase 1b/2 KEYNOTE-365 cohort I: platinum-containing chemotherapy alone or in combination with pembrolizumab for treatment-emergent neuroendocrine prostate carcinoma

2021 ◽  
Vol 9 (Suppl 3) ◽  
pp. A448-A448
Author(s):  
Johann De Bono ◽  
Neal Shore ◽  
Gero Kramer ◽  
Anthony Joshua ◽  
Xin Tong Li ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Carcinoma ◽  
Response Rate ◽  
Performance Status ◽  
Ecog Performance Status ◽  
End Points ◽  
Status Score ◽  
Modified Recist ◽  
Phase 1B ◽  
Performance Status Score

BackgroundTreatment-emergent neuroendocrine prostate carcinoma (t-NE) can occur de novo or after diagnosis of prostate adenocarcinoma. Treatment often includes platinum-containing chemotherapy because of t-NE’s histologic similarity to small cell lung cancer. The PD-1 inhibitor pembrolizumab has shown promising efficacy and acceptable safety when combined with olaparib, docetaxel, or enzalutamide for treatment of metastatic castration-resistant prostate cancer (mCRPC) in the multicohort phase 1b/2 KEYNOTE-365 study (NCT02861573). Cohort I will be used to compare platinum-containing chemotherapy alone with chemotherapy + pembrolizumab as treatment for t-NE.MethodsPatients who have t-NE (≥1% neuroendocrine cells in a recent biopsy specimen confirmed by central histology review); experienced progression within 6 months of starting a next-generation hormonal agent (NHA) for mCRPC or hormone-sensitive prostate cancer and experienced progression within 6 cycles of docetaxel treatment for mCRPC; and have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 are eligible. Prior therapy with ≤2 NHAs and 1 other chemotherapy for mCRPC is permitted. Patients will be randomly assigned 1:1 to receive pembrolizumab 200 mg IV on day 1 of each cycle every 3 weeks + carboplatin AUC of 5 IV on day 1 + etoposide 100 mg/m2 IV on days 1, 2, and 3 of each 21-day cycle for 4 cycles (arm 1) or the same chemotherapy regimen without pembrolizumab (arm 2); in each arm 40–100 patients will be enrolled. Pembrolizumab treatment will continue up to 2 years until disease progression, unacceptable toxicity, or withdrawal of consent. Patients will be stratified by ECOG performance status score (0 or 1). Computed tomography or magnetic resonance imaging will be performed every 9 weeks through week 54 and every 12 weeks thereafter. Primary end points are safety and tolerability, prostate-specific antigen (PSA) response rate, and objective response rate (ORR) per RECIST v1.1 by blinded independent central review (BICR). Secondary end points are time to PSA progression; ORR and radiographic progression-free survival (PFS) per PCWG3-modified RECIST v1.1 by BICR; duration of response and disease control rate per RECIST v1.1 by BICR and PCWG3-modified RECIST v1.1 by BICR; and overall survival. End points will be summarized for each arm without formal hypothesis testing.AcknowledgementsMedical writing and/or editorial assistance was provided by Matthew Grzywacz, PhD, of ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. Funding for this research was provided by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Trial RegistrationClinicaltrials.gov, NCT02861573Ethics ApprovalThe study and the protocol were approved by the Institutional Review Board or ethics committee at each site.

Bevacizumab in combination with first-line metastatic chemotherapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC): Results from the cohort study EOLE.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e18005-e18005
Author(s):  
Christos Chouaid ◽  
Roland Schott ◽  
Lionel Falchero ◽  
Franck Bonnetain ◽  
Julien Neaume ◽  
...  
Keyword(s):  
Cohort Study ◽  
Performance Status ◽  
Locally Advanced ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Large Cell Carcinoma ◽  
First Line ◽  
Ecog Performance Status ◽  
Study Results ◽  
Chi2 Test

e18005 Background: EOLE, a large cohort of 423 patients included in 1 year (July 2010 – July 2010) with locally advanced, metastatic or recurrent non-squamous NSCLC, aimed to describe the targeted population receiving first-line bevacizumab (Bev) in addition to chemotherapy with regards to progression-free survival, overall survival, safety and quality of life in real clinical practice. Methods: Patients who received physician’s choice of 1st-line Bev-containing treatment were included in this cohort study. Results: This analysis describes the inclusion data of 417 patients consisting of adenocarcinoma (92%), large cell carcinoma (4%), undifferentiated carcinoma in predominantly non-squamous (3%), bronchoalveolar carcinoma (1%). Patient characteristics were as follow: the median age being 60 (years) [32; 84], more males than females (68%), 40% had a baseline ECOG Performance Status (PS) 0, 47% of PS 1 and 12% of PS 2, most patients had Stage IV disease (91%), 13% of patients had never smoked. Tumor location was reported as central for 17% of patents and among them 4% was in contact with the large vessels. For 3% of the lesions a cavitation was notified; and 20% of included patients had brain metastases. The main comorbidities at the inclusion were: cardiovascular (45%), arterial thromboembolic and /or venous (20%) with pulmonary embolism (3%); related to the tumor lesion - bloody sputum (4%) and hemoptysis (1%). 68% of patients have received the dose of Bev 7.5mg/kg q3w; for 49% of patients Bev was combined with cisplatin/pemetrexed, 24% with carboplatin/paclitaxel, 13% with carboplatin/pemetrexed and 7% with cisplatin/gemcitabine. The EGFR mutation analysis was carried out for about 50% of patients. Conclusions: Compared to AVAil and SAil studies, EOLE cohort included more patients classified as having: a baseline PS of 2 (p <0.0001, Fisher test), a never smoked status (p<0.0001, chi2 test) and an adenocarcinoma (92%) (p<0.0001, chi2 test). Around a half of included patients received combination Bev - cisplatin /pemetrexed.

An observational study of patients with advanced melanoma receiving pembrolizumab in a real-world U.S. community oncology practice.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21015-e21015
Author(s):  
Charles Lance Cowey ◽  
Frank Xiaoqing Liu ◽  
Jenny Black-Shinn ◽  
Kendall Lee Stevinson ◽  
Marley Boyd ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Brain Metastases ◽  
Real World ◽  
Performance Status ◽  
Progression Free Survival ◽  
Advanced Melanoma ◽  
Ecog Performance Status ◽  
Study Results ◽  
Line Of Therapy ◽  
Oncology Practice

e21015 Background: PD-1 monoclonal antibodies are promising immunotherapies approved for treatment of patients (pts) with advanced melanoma. As the first US FDA approved PD-1 antibody, pembrolizumab (pembro) has demonstrated efficacy and safety in clinical trial settings. However, patterns of real world utilization and pt outcomes associated with pembro are limited. Methods: Adult pts with advanced melanoma who initiated pembro between 9/1/ 2014-3/31/2016 were identified retrospectively fromelectronic health records (EHR) of McKesson Specialty Health and followed through 9/ 30/2016. Pts in clinical trials were excluded. Demographic, disease, treatment characteristics and reasons for treatment discontinuation of pembro were abstracted from structured data elements of the EHR with further supplementation of unstructured data within the patient chart (progress notes, radiology scan reports). Overall survival (OS) and physician-reported progression free survival (PFS) from pembro initiation were analyzed using Kaplan Meier analysis. Results: 182 pts, with a median follow-up of 9.9 mos (range = 0.0-25.0), were included. Median age at pembro initiation was 66.0 yrs; 30.8% had an elevated lactate dehydrogenase (LDH); 23.6% had brain metastases and 65.4% had an ECOG performance status of 0 or 1. The most common reason for pembro discontinuation was progression (45.5%) followed by treatment-related toxicity (24.4%). In the overall population, median PFS from pembro initiation was 4.2 mos (95% CI = 3.2-5.3). Median OS was 19.4 mos (14.0-NR) with 12 and 24-month survival probabilities of 61.4% (95% CI = 53.4-68.5) and 43.9% (95% CI = 31.1-55.9). In multivariable analyses, characteristics predictive of worse survival included receipt of pembro at a later line of therapy (HR = 3.36, p = 0.0013 for 3L+), presence of brain metastases (HR = 2.67, p = 0.0007) and elevated LDH (HR = 4.10, p < 0.0001). Conclusions: The study results are consistent with those from pembro clinical trials (KeyNote001) and are in support of the effectiveness of pembro in real world treatment of advanced melanoma. Presence of brain metastases, elevated LDH, and use of pembro 3L+ were associated with worse survival outcome.

Real world treatment patterns of first-line combination therapies among BRAF+ metastatic melanoma patients stratified by tumor burden.

2018 ◽  
Vol 36 (5_suppl) ◽  
pp. 198-198
Author(s):  
Sameer Ghate ◽  
Jackson Tang ◽  
Zhiyi Li ◽  
Antonio Reis Nakasato
Keyword(s):  
Brain Metastasis ◽  
Metastatic Melanoma ◽  
Real World ◽  
Tumor Burden ◽  
Treatment Patterns ◽  
Discontinuation Rate ◽  
First Line ◽  
High Tumor Burden ◽  
Kaplan Meier ◽  
Measured Time

198 Background: For patients (pts) with metastatic melanoma (MM) and BRAF V600 mutation (BRAF+), options for first-line (1L) systemic combination therapy include immunotherapy (IO) or targeted therapy (TT). This study describes real world treatment patterns among BRAF+ MM pts treated with 1L ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T), stratified by tumor burden. Methods: A retrospective observational analysis used Flatiron Health’s electronic health record-derived database from Oct ’15 - Jul ’16. Pts were aged ≥18 years with a MM diagnosis, tested BRAF+ prior to therapy, and treated with ipilimumab+nivolumab (I+N) or dabrafenib+trametinib (D+T) as 1L therapy. Low tumor burden was defined as low/normal LDH (≤ 333 IU/L) and no brain metastasis. High tumor burden was defined as high LDH ( > 333 IU/L) or brain metastasis. Baseline characteristics and treatment patterns were descriptively assessed. Kaplan-Meier (KM) analysis measured time to discontinuation. Results: Among 76 BRAF+ pts, 38% (29) were treated with I+N as 1L, and 62% (47) were treated with D+T as 1L. Of these, 45% (13/29) of I+N vs. 32% (15/47) of D+T had low tumor burden, while 41% (12/29) of I+N vs. 49% (23/47) of D+T had high tumor burden. The two cohorts did not differ by age or gender. Treatment patterns are summarized below. Conclusions: Among pts with low tumor burden, I+N demonstrated shorter time to discontinuation and higher discontinuation rate relative to D+T. Treatment toxicity and progression was the main reason for discontinuation of I+N and D+T, respectively. Among pts with high tumor burden, I+N demonstrated longer time to discontinuation but higher discontinuation rate relative to D+T. Progression was the main reason for discontinuation of both I+N and D+T. [Table: see text]

scholarly journals Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A retrospective multicenter study

Liver Cancer ◽  
2022 ◽  
Author(s):  
Sabrina Welland ◽  
Catherine Leyh ◽  
Fabian Finkelmeier ◽  
André Jefremow ◽  
Kateryna Shmanko ◽  
...  
Keyword(s):  
Overall Survival ◽  
Real World ◽  
Median Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Inclusion Criteria ◽  
First Line ◽  
Ecog Performance Status ◽  
Free Survival ◽  
First Line Treatment

Background Lenvatinib is approved as first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multi-center cohort (ELEVATOR) from Germany and Austria. Methods A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed. Results Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs 10.2 months, HR 0.55, 95% CI 0.38-0.81, p=0.002; mPFS 8.1 vs 4.8 months HR 0.65, 95% CI 0.46-0.91, p=0.0015). For patients with an impaired liver function according to the Albumin-Bilirubin (ALBI) grade, or reduced ECOG performance status ≥2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI 1.07-2.66, p=0.023; HR 2.25, 95% CI 1.19-4.23, p=0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI 1.02-2.37, p=0.041) and an AFP ≥200 ng/mL (HR 1.56, 95% CI 1.03-2.34, p=0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC. Conclusion Overall, our data confirm the efficacy of lenvatinib as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.

scholarly journals Prediction of patients with a tumor proportion score >50% who do not respond to first-line monotherapy with pembrolizumab

2020 ◽  
Author(s):  
Mitsunori Morita ◽  
Motohiro Tamiya ◽  
Daichi Fujimoto ◽  
Akihiro Tamiya ◽  
Hidekazu Suzuki ◽  
...  
Keyword(s):  
Pleural Effusion ◽  
Malignant Pleural Effusion ◽  
Group Performance ◽  
Performance Status ◽  
Univariate Analysis ◽  
Response To Treatment ◽  
Smoking History ◽  
First Line ◽  
Status Score ◽  
Performance Status Score

Abstract Background: Pembrolizumab is effective as first-line therapy against advanced non-small cell lung cancer (NSCLC) in patients with programmed death ligand-1 (PD-L1) expression levels ≥50%. However, it is not effective in all patients, and the factors predicting responses among this population remain unknown. Methods: We retrospectively analyzed patients with NSCLC and a PD-L1 tumor proportion score (TPS) >50%, who received first-line monotherapy with pembrolizumab from February 1, 2017 to April 30, 2018. The study included 11 hospitals, which participated in the Hanshin Oncology clinical Problem Evaluation group (HOPE). We analyzed the differences between responders and non-responders in terms of age, sex, performance status score, degree of progression, histological type, smoking history, expression of PD-L1, use of steroids prior to treatment, metastasis site, and laboratory data. Results: A total of 205 patients were included in this study. Of those, 108 patients exhibiting complete or partial response were defined as responders. Those exhibiting progressive disease (N=52) were defined as non-responders. In the univariate analysis, Eastern Cooperative Oncology Group performance status score ≥2 (p=0.0832), stage IV disease or recurrence (p=0.0487), PD-L1 TPS 50–89% (p=0.0657), use of steroids prior to the administration of pembrolizumab (p=0.0243), malignant pleural effusion (p=0.0032), and baseline C-reactive protein (CRP) levels >1.0 mg/dL (p=0.0390) were significantly associated with non-response to treatment. In the multivariate analysis, use of steroids prior to the administration of pembrolizumab (odds ratio [OR]: 5.86; 95% confidence interval [CI]: 1.32–31.8; p=0.0200), malignant pleural effusion (OR: 2.68; 95% CI: 1.15–6.35; p=0.0228), and baseline CRP >1.0 mg/dL (OR: 2.17; 95% CI: 1.03–4.68; p=0.0402) were significantly associated with non-response to treatment. Conclusion: In real-world patients with NSCLC and a PD-L1 TPS ≥50%, use of steroids prior to treatment, malignant pleural effusion, and baseline CRP levels >1.0mg/dL reduced the response of first-line monotherapy with pembrolizumab.

scholarly journals Prediction of patients with a tumor proportion score >50% who do not respond to first-line monotherapy with pembrolizumab

2019 ◽  
Author(s):  
Mitsunori Morita ◽  
Motohiro Tamiya ◽  
Daichi Fujimoto ◽  
Akihiro Tamiya ◽  
Hidekazu Suzuki ◽  
...  
Keyword(s):  
Pleural Effusion ◽  
Malignant Pleural Effusion ◽  
Group Performance ◽  
Performance Status ◽  
Univariate Analysis ◽  
Response To Treatment ◽  
Smoking History ◽  
First Line ◽  
Status Score ◽  
Performance Status Score

Abstract Background: Pembrolizumab is effective as first-line therapy against advanced non-small cell lung cancer (NSCLC) in patients with programmed death ligand-1 (PD-L1) expression levels ≥50%. However, it is not effective in all patients, and the factors predicting responses among this population remain unknown. Methods: We retrospectively analyzed patients with NSCLC and a PD-L1 tumor proportion score (TPS) >50%, who received first-line monotherapy with pembrolizumab from February 1, 2017 to April 30, 2018. The study included 11 hospitals, which participated in the Hanshin Oncology clinical Problem Evaluation group (HOPE). We analyzed the differences between responders and non-responders in terms of age, sex, performance status score, degree of progression, histological type, smoking history, expression of PD-L1, use of steroids prior to treatment, metastasis site, and laboratory data. Results: A total of 205 patients were included in this study. Of those, 108 patients exhibiting complete or partial response were defined as responders. Those exhibiting progressive disease (N=52) were defined as non-responders. In the univariate analysis, Eastern Cooperative Oncology Group performance status score ≥2 (p=0.0832), stage IV disease or recurrence (p=0.0487), PD-L1 TPS 50–89% (p=0.0657), use of steroids prior to the administration of pembrolizumab (p=0.0243), malignant pleural effusion (p=0.0032), and baseline C-reactive protein (CRP) levels >1.0 mg/dL (p=0.0390) were significantly associated with non-response to treatment. In the multivariate analysis, use of steroids prior to the administration of pembrolizumab (odds ratio [OR]: 5.86; 95% confidence interval [CI]: 1.32–31.8; p=0.0200), malignant pleural effusion (OR: 2.68; 95% CI: 1.15–6.35; p=0.0228), and baseline CRP >1.0 mg/dL (OR: 2.17; 95% CI: 1.03–4.68; p=0.0402) were significantly associated with non-response to treatment. Conclusion: In real-world patients with NSCLC and a PD-L1 TPS ≥50%, use of steroids prior to treatment, malignant pleural effusion, and baseline CRP levels >1.0mg/dL reduced the effectiveness of first-line monotherapy with pembrolizumab.

scholarly journals Prediction of patients with a tumor proportion score >50% who do not respond to first-line monotherapy with pembrolizumab

2019 ◽  
Author(s):  
Mitsunori Morita ◽  
Motohiro Tamiya ◽  
Daichi Fujimoto ◽  
Akihiro Tamiya ◽  
Hidekazu Suzuki ◽  
...  
Keyword(s):  
Pleural Effusion ◽  
Malignant Pleural Effusion ◽  
Group Performance ◽  
Performance Status ◽  
Univariate Analysis ◽  
Response To Treatment ◽  
Smoking History ◽  
First Line ◽  
Status Score ◽  
Performance Status Score

Abstract Background: Pembrolizumab is effective as first-line therapy against advanced non-small cell lung cancer (NSCLC) in patients with programmed death ligand-1 (PD-L1) expression levels ≥50%. However, it is not effective in all patients, and the factors predicting responses among this population remain unknown. Methods: We retrospectively analyzed patients with NSCLC and a PD-L1 tumor proportion score (TPS) >50%, who received first-line monotherapy with pembrolizumab from February 1, 2017 to April 30, 2018. The study included 11 hospitals, which participated in the Hanshin Oncology clinical Problem Evaluation group (HOPE). We analyzed the differences between responders and non-responders in terms of age, sex, performance status score, degree of progression, histological type, smoking history, expression of PD-L1, use of steroids prior to treatment, metastasis site, and laboratory data. Results: A total of 205 patients were included in this study. Of those, 108 patients exhibiting complete or partial response were defined as responders. Those exhibiting progressive disease (N=52) were defined as non-responders. In the univariate analysis, Eastern Cooperative Oncology Group performance status score ≥2 (p=0.0832), stage IV disease or recurrence (p=0.0487), PD-L1 TPS 50–89% (p=0.0657), use of steroids prior to the administration of pembrolizumab (p=0.0243), malignant pleural effusion (p=0.0032), and baseline C-reactive protein (CRP) levels >1.0 mg/dL (p=0.0390) were significantly associated with non-response to treatment. In the multivariate analysis, use of steroids prior to the administration of pembrolizumab (odds ratio [OR]: 5.86; 95% confidence interval [CI]: 1.32–31.8; p=0.0200), malignant pleural effusion (OR: 2.68; 95% CI: 1.15–6.35; p=0.0228), and baseline CRP >1.0 mg/dL (OR: 2.17; 95% CI: 1.03–4.68; p=0.0402) were significantly associated with non-response to treatment. Conclusion: In real-world patients with NSCLC and a PD-L1 TPS ≥50%, use of steroids prior to treatment, malignant pleural effusion, and baseline CRP levels >1.0mg/dL reduced the effectiveness of first-line monotherapy with pembrolizumab.

The efficacy and safety analysis of PD-1 inhibitor combined with interferon-α1b: A real-world study in Chinese metastatic melanoma patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21507-e21507
Author(s):  
Guannan Zhu ◽  
Qiong Shi ◽  
Chunying Li ◽  
Tianwen Gao
Keyword(s):  
Combination Therapy ◽  
Metastatic Melanoma ◽  
Real World ◽  
Performance Status ◽  
Objective Response ◽  
Evaluation Criteria ◽  
Efficacy And Safety ◽  
Ecog Performance Status ◽  
Melanoma Patients ◽  
Grade 3

e21507 Background: Clinical data on PD-1 inhibitor combined with interferon in metastatic melanoma treatment were still limited. The objective of this study was to assess the efficacy and safety of PD-1 inhibitor/interferon-α1b combination therapy for Chinese metastatic melanoma patients in the real world. Methods: We reviewed patients diagnosed as metastatic melanoma and had received PD-1 inhibitor (pembrolizumab, 2 mg/kg, every 3 weeks, intravenously or toripalimab 240mg every 2 weeks, intravenously) combined with interferon-α1b(10μg/kg, every other day, subcutaneously) in Xijing Hospital from Dec 2018 to Nov 2020. Efficacy and safety profiles were evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 and Common Terminology Criteria for Adverse Events version 5.0, respectively. Results: In total 65 patients were reviewed in this study, including 13 cases with ECOG performance status ≥2. Acral and mucosal cases accounted for 47.7% and 23.1% respectively. In 27(41.5%) patients, the combination therapy was used as the first line treatment, whereas in the rest 38 patients as second or subsequent lines. The median follow-up period was 8 months (1.5-21 months). Median OS was 15 months (95CI%: 10.62-19.38 months). Median PFS was 6 months (95CI%: 2.54-9.46 months). 6-month and 1-year PFS rate were 48.1% and 35.3%. 6-month and 1-year OS rate were 80.9% and 59.8%. Objective response was seen in 18.46% cases, with 12.31% of patients exhibiting ongoing response. The best confirmed disease control rate was 73.85%. Multivariate analysis demonstrated that overall survival was significantly associated with ECOG performance status ≥2 (OR=3.32，95%CI=1.14-9.66 ), regardless of age(≥65), elevated LDH, PD-1 inhibitor type and the line of the combination therapy. Select treatment related AEs (TRAEs) of any grade were observed in 57(87.69%) patients. The leading 3 TRAEs were lymphopenia, fatigue and fever. Grade 3 to 4 TRAEs were recorded in 2 cases. Grade 4 hyponeutrophilia occurred in a patient with ECOG status 3 using interferon-α1b plus toripalimab and resulted in discontinuation of both PD-1 inhibitor and IFN-α1b. Grade 3 headache was reported by one patient using interferon-α1b plus pembrolizumab and was solved with celecoxib 200mg daily. No drug-related deaths were reported. Conclusions: PD-1 inhibitor combining interferon-α1b therapy shows promising efficacy and acceptable toxicity in this real-world cohort of Chinese metastatic melanoma patients.[Table: see text]

Prognosis of advanced hepatocellular carcinoma (HCC) in patients undergoing surgery combined with peri- or postoperative treatment with sorafenib.

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 377-377
Author(s):  
Liqun Wu ◽  
Xufeng Pang ◽  
Jingyu Cao ◽  
Zusen Wang
Keyword(s):  
Hepatocellular Carcinoma ◽  
Liver Resection ◽  
Tumor Volume ◽  
Performance Status ◽  
Primary Hepatocellular Carcinoma ◽  
Postoperative Treatment ◽  
Ecog Performance Status ◽  
Status Score ◽  
Performance Status Score

377 Background: Liver resection/transplantation are effective therapies for primary hepatocellular carcinoma (HCC), but high relapse rates can significantly impact long term survival, especially for patients with advanced disease. The objective of this study was to investigate the effects of surgery plus sorafenib on the prognosis of patients with advanced HCC. Methods: 36 male and 2 female patients of mean age 52.6 (range 36-65) years and an ECOG performance status score 0-1 (n=26) or 2 (n=12), received surgical therapy (28 liver resection and 10 liver transplantation) plus sorafenib for treatment of HCC with a high risk of relapse (n=3) or had relapsed. Sorafenib was administered orally 400 mg once or twice daily, and the dose was reduced or the treatment temporarily discontinued if a grade 3 or worse adverse event occurred. Treatment duration was >3 months and patients were evaluated every 4 weeks. The main endpoints were overall survival (OS) and time to progression (TTP). Results: Median follow-up time was 12.9 (range 4-59) months. Kaplan-Meier analysis demonstrated that median OS was 17 months (95%CI: 11.6-22.4), median TTP was 15 months (95%CI: 11.6-18.4). During follow-up, 20 patients died (18 from disease progression, 1 from a lung infection, and 1 accidently). Univariate analysis demonstrated that serum ALT >60 U/L at the beginning of treatment, Child-Pugh grade B, ECOG performance status score 2, tumor cell embolism in blood vessels, tumor volume ≥3 liver segments, and a tumor involving 2 vital organs were important factors affecting OS. The median OS of patients with a tumor volume ≥3 liver segments vs. patients with tumor volume <3 liver segments was 8 vs. 28 months (log-rank test, p<0.001), and median TTP was 5 vs. 24 months (p<0.001). Conclusions: Surgical resection in combination with sorafenib helped prolong OS and TTP in patients with advanced or relapsed HCC. OS for patients treated with sorafenib peri-operatively was longer than that for patients who received therapy after a relapse had occurred. Decreasing tumor burden and administering sorafenib as early as possible are helpful strategies to improve prognosis in patients with HCC.

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