Clinical outcomes of metastatic renal carcinoma following disease progression to programmed death (PD)-1 or PD-L1 inhibitors (I-O): A Meet-URO group real-world study (Meet-Uro 7).

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 691-691
Author(s):  
Daniele Santini ◽  
Marco Stellato ◽  
Ugo De Giorgi ◽  
Sandro Pignata ◽  
Francesco Pantano ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Outcome Data ◽  
First Line ◽  
Real World Data ◽  
Best Response ◽  
Ecog Ps ◽  
Immune Oncology

691 Background: In metastatic renal cell carcinoma (mRCC), immune-oncology (IO), alone or in combination, (IO-IO or IO-TKI) has changed the therapeutic scenario. Few real-world data are available about safety and outcome after IO progression. Methods: Baseline characteristics, outcome data including progression-free survival (PFS) and toxicities were retrospectively collected from 162 eligible pts treated in 16 Italian referral centers adhering to the Meet-Uro group and progressing to IO. Results: 111 pts (68,5%) were treated after progression to IO. 142 (87.6%) pts received IO as second line, 5 pts as first line and 16 pts as further line. Subsequent therapy included cabozantinib (n = 79, 48.0%), everolimus (n = 11, 6.7%), sunitinib (n = 6, 3.7%) and others (n = 15, 9.25%). Median IO-PFS was 4 months (95%CI 3.1-4.8) with no difference in pts pretreated with pazopanib or sunitinib (4 months (95%CI 2.4-5.5) vs 3,9 months (95%CI 2.9-4.9) p = 0.5). PFS tends to be longer in pts reporting adverse events of any grade (5.03 (95%CI 3.8-6.1) vs 2,99 (95%CI 2.4-3.5) months p = 0.004) or without nephrectomy (4.1 vs 2.9 months p = 0.071). Median PFS, in pts treated post-IO, was 6.5 months (95%CI 5.1-7.8). In term of best response, 55 pts (49%) had stability of disease/partial response and 29 pts (26%) had progressive disease, for the other pts treatment is still ongoing. Pts with ECOG PS 0 at progression to IO, had longer PFS, 11 months (95%CI 5.7-17.5) as well as those treated with cabozantinib (7.6 months, 95%CI 5.2-10.1) compared to everolimus, (3.2 months, 95%CI 1.8-4.5) or other drugs (4.3 months, 95%CI 1.3-7.4) p = 0.001. All grade adverse events were reported in 83 pts (74%) with G3-G4 adverse events in 39 pts (35%). Median overall survival, from first line, was 41,1 months (95%CI 30.4-51.8). Conclusions: In our real world experience after progression to IO, most pts received VEGF-TKI and mTOR inhibitors that showed to be active and safe choices. Cabozantinib was associated with a longer mPFS.

Patterns and management of progression on first-line ipilimumab combined with anti-PD-1 (IPI+PD1) in metastatic melanoma (MM) patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9533-9533
Author(s):  
Ines Pires Da Silva ◽  
Judith M. Versluis ◽  
Tasnia Ahmed ◽  
Douglas Buckner Johnson ◽  
Jennifer Soon ◽  
...  
Keyword(s):  
Lung Metastases ◽  
Acquired Resistance ◽  
Progression Free Survival ◽  
Initial Response ◽  
Best Supportive Care ◽  
First Line ◽  
Disease Characteristics ◽  
Best Response ◽  
Investigational Drugs ◽  
Ecog Ps

9533 Background: First line IPI+PD1 induces long-term response in 36% of MM patients (pts); however, the majority of pts will progress and may require further treatment, which is yet to be established. We studied the patterns of progressive disease (PD) on 1st line IPI+PD1, and the management and outcomes in MM pts. Methods: Demographics, disease characteristics, nature of PD, subsequent treatments and outcomes were examined in MM pts with PD on 1st line IPI+PD1. Multivariable analyses (MVA) identified factors associated with patterns of PD: innate resistance (IR) = PD as best response or stable disease (SD) < 6 mo; acquired resistance (AR) = PD after initial response or SD ≥ 6 mo. Results: 310 MM pts from 14 melanoma centres were included; 208 (67%) had PD during and 102 (33%) after ceasing IPI+PD1. Overall med. progression-free survival (mPFS) was 2.8 mo (CI 95% 2.7 – 3.0); 187 pts (60%) had IR (mPFS 2.2 [2.1 – 2.5]), 112 pts (36%) had AR (mPFS 8.5 [7.2 – 10.2]) and 11 pts (4%) had pseudoprogression, i.e. PD followed by response without changing treatment (mPFS 2.7 mo [1.4 – NA]). On MVA, pts with ECOG PS ≥ 1 were more likely to have IR vs AR; and within IR pts, those with head & neck primary melanomas and lung metastases were more likely to have PD < 1.5 mo. Most pts with IR (68%) had PD in multiple sites, while 61% AR pts had PD in a single site. Brain was most common site of single organ PD; 49% of IR and 41% of AR. Med. follow-up from PD was 32.7 mo (28.1 – 36.8). After PD, 61 pts (20%) had best supportive care (26% of IR and 11% of AR pts). 259 pts (80%) received further treatment: 39% IR pts had systemic treatment (ST) only and 27% had ST + local; 31% AR pts had ST only and 39% had ST + local. Of 200 pts (65%) who had ST(+/-local), 54% had 1 line of ST and 46% had ≥ 2; 1st line ST (ST1) was BRAF/MEKi in 36% of pts, PD1 in 32%, IPI+PD1 in 7%, investigational drugs in 11%, chemotherapy in 9% and others in 5%. ORR in IR pts was lower than in AR pts for every type of ST1 (see Table). Med. OS from PD was 11.4 mo (CI 95% 9.6 – 16.1); IR 6.4 mo (CI 95% 5.6 – 10.2) and AR 26.1 mo (CI 95% 17.1 – NA). Conclusions: These data suggest longer OS from PD for AR vs IR pts independent of ST type. BRAF/MEKi, rechallenge with PD1+/-IPI and investigational drugs showed activity after PD on IPI+PD1, while chemotherapy has no role in this context.[Table: see text]

Impact of previous nephrectomy on clinical outcome of metastatic renal carcinoma treated with immune-oncology (I-O):A real-world study on behalf of Meet-URO group (MeetUro-7b).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17088-e17088
Author(s):  
Marco Stellato ◽  
Daniele Santini ◽  
Ugo De Giorgi ◽  
Elena Verzoni ◽  
Chiara Casadei ◽  
...  
Keyword(s):  
Real World ◽  
Progression Free Survival ◽  
Outcome Data ◽  
Rank Test ◽  
Prognostic Impact ◽  
Curative Intent ◽  
Kaplan Meier ◽  
The Difference ◽  
Third Line ◽  
Ecog Ps

e17088 Background: Immuno-oncology (IO) treatment demonstrated to improve Overall Survival (OS) in metastatic renal cell carcinoma (mRCC). The prognostic impact of previous citoreductive nephrectomy (CN) and radical nephrectomy with curative intent in patients (pts) treated with IO is not well defined. Methods: 229 eligible pts, with a least one radiological assessment of response according to the RECIST 1:1 criteria, were retrospectively collected from 16 Italian referral centers. Baseline characteristics, outcome data including progression-free survival (PFS) and OS were collected. Kaplan-Meier method and log-rank test were performed to compare PFS and OS between groups. Results: 153(66.8%) pts received IO as second line, 61(26.6%) as third line and 15(6.6%) pts as further line. 54 pts (23.6%) were good risk, 144(62.9%) were intermediate and 31(13.5%) were poor risk according to IMDC score. 189(82.5%) pts underwent nephrectomy (of them 72(32.4%) pts had synchronous metastatic disease and underwent CN), while 40(17.4%) pts did not. Nephrectomy was performed before IO treatment. ECOG PS, at the beginning of IO, was 0 for 167 pts (72.9%), the other 62 (27.1%) had ECOG PS 1 or 2. At a median follow up time of 17.5 months (mo), 13 (5.7%) pts are still in treatment while 216 (94.3%) experienced progression. 81 (35.3%) pts were treated after IO progression with mTOR and VEGFR inhibitors. 63 (27.5%) pts continued IO beyond progression. G3-G4 iAE were reported in 46 pts (20%). Median IO-PFS was 4.5 months in pts who did not undergo nephrectomy and 2.9 mo in pts who did (HR log rank 0.713, 95%CI 0.4788 to 1.063; p= 0.0582). Median IO-OS was 18.4 mo in pts who underwent nephrectomy and 10.3 mo in pts who did not (HR log rank 1.915, 95%CI 1.118 to 3.281; p= 0.0024). The difference in OS was irrespective of the IMDC criteria and the lines of treatment. Conclusions: In our real world experience, in mRCC pts treated with IO, previous nephrectomy was associated with a better outcome in terms of OS with all the limitations of a retrospective collection.

scholarly journals Efficacy and Safety of Bevacizumab in Combination with Chemotherapy for Colorectal Cancer – A Real World Study in China

2020 ◽  
Author(s):  
Tao Shen ◽  
Xian-Shuo Cheng ◽  
Wei-Xun Chunyu ◽  
Hong-Tao Zhang ◽  
Cui-Feng Xia ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Real World ◽  
Large Scale ◽  
Progression Free Survival ◽  
Secondary Outcome ◽  
Second Line ◽  
Efficacy And Safety ◽  
First Line ◽  
Demographic Subgroups

Abstract Background Large scale randomized trials have demonstrated that bevacizumab in addition to chemotherapy as first-line or second-line treatment has significant survival benefits. We aim to explore the clinical impact of bevacizumab in combination with chemotherapy in first-line or second-line in patients with colorectal cancer (CRC). Methods The medical records of patients with CRC who received bevacizumab at first or second-line of treatment were collected retrospectively. The primary outcome of the study was to evaluate the efficacy of bevacizumab in combination with chemotherapy by survival endpoints i.e. overall survival (OS) and progression-free survival (PFS) and the secondary outcome was to evaluate its safety by incidence of adverse events (AE). Results Fifty-one patients with CRC had met the selection criteria for treatment with bevacizumab to either cetuximab or FOLFOX or both. The median age was 54 years. During follow-up, ten patients had exhibited progression after treatment while 5 patients died. The median OS and PFS of the overall population were not reached. The Cox proportional regression analysis revealed no significant prognostic factors of OS and PFS for treatment with bevacizumab in various demographic subgroups. The 1-year PFS rates of all 51 patients was 76%. The 1-year and 3-year OS rates for all 51 patients were 95% and 88%, respectively. Toxicities were usually mild in nature, with nausea, vomiting, hand and foot syndrome, neutropenia, asthenia and palpitation being the commonly reported adverse events. Conclusion In this real-world setting, the efficacy and safety of bevacizumab in combination with chemotherapy is limited and further research is warranted as to whether bevacizumab with chemotherapy is an optimal treatment as first-line or second-line therapy in Chinese CRC patients.

scholarly journals Outcome in patients of hormone receptor (HR) positive (Her 2) negative metastatic breast cancer treated with palbociclib – A real-world experience

2022 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
Ajay Bapna ◽  
A. Samar ◽  
Pulkit Nag ◽  
Sanjeev Patni ◽  
Nidhi Patni
Keyword(s):  
Breast Cancer ◽  
Metastatic Breast Cancer ◽  
Real World ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
Visceral Metastasis ◽  
First Line ◽  
Real World Data ◽  
Best Response ◽  
Line Setting

Objectives: We present real-world outcome with the use of palbociclib in patients with HR-positive Her2-negative breast cancer treated at single center in India. Material and Methods: We conducted a medical audit of consecutive patients with HR-positive Her2-negative metastatic breast cancer, who were treated with palbociclib at our center between November 2016 and May 2020. Palbociclib was commenced at a dose of 125 mg orally once daily and a schedule of 21 days on therapy followed by 7 days off therapy was followed. Survival analysis included the Kaplan–Meier method using Statistical Package for the Social Sciences software (Version 26). HRs were calculated using Cox proportional hazard regression models and 95% confidence intervals (CIs) for the incidence estimates. Results: A total of 67 female patients were commenced on treatment with palbociclib between November 2016 and May 2020. The median age was 55 years (range 29–78 years). A total of 51 (76%) of these patients were postmenopausal and the remaining 16 were premenopausal. Baseline metastatic disease involved one organ/site in 23 (34%), two organs/sites in 32 (48%), three or more in 12 (18%). Bony metastasis alone was seen in 17 (25%) patients, visceral alone in 30 (45%), and the remaining 20 had both bony and visceral metastases. For these 67 patients, palbociclib was commenced as 1st line systemic therapy in 24 (36%) cases. Amongst the remaining 43 cases, it was 2nd line in 21 (31%); 3rd line and beyond in 22 (33%). Median PFS was 16.1 months (95% CI: 9.6–22.8) and median OS was 20.7 months (95% CI: 14.1–27.3). Median PFS for palbociclib use in first line was 18.7 months (95% CI: 4.6–32.9) while in subsequent lines, it was 13.8 months (95% CI: 9.8–17.9; log-rank P = 0.228). Median OS in patients who received palbociclib in first line was 23.2 months (95 % CI 20.1–26.3) and for those why received it in subsequent lines was 16.3 months (95 % CI: 12.5–20.1; P = 0.069). In total population, best response on imaging was CR in 11 (16%) cases (06 in 1st line setting and 05 in subsequent line setting); PR in 33 (49%); SD in 03; and progressive disease in 20. Median PFS with bone only metastasis: 20.9 months (95 % CI: 5.9–36.0), while with visceral metastasis 16.1 months (95% CI: 9.8–22.5; P = 0.537). Median OS with bone only metastasis: 22.7 months (95% CI: 17.8–27.5), while with visceral metastasis, it was 18.5 months (95% CI: 13.6–23.4; P = 0.314). Conclusion: Palbociclib is a useful addition in the management of HR +ve Her2 –ve breast cancer patients. Its benefit is confirmed in our real-world setting, both in the first and subsequent lines of therapy and the data are on similar lines as the global real-world data on palbociclib effectiveness.

A randomized phase II study of AZ2014 versus everolimus in patients with VEGF refractory metastatic clear cell renal cancer (mRCC).

2015 ◽  
Vol 33 (7_suppl) ◽  
pp. 409-409 ◽  
Author(s):  
Thomas Powles ◽  
Matthew James Wheater ◽  
Omar Din ◽  
Thomas R. Geldart ◽  
Ekaterini Boleti ◽  
...  
Keyword(s):  
Adverse Events ◽  
Survival Data ◽  
Prognostic Score ◽  
Progression Free Survival ◽  
Mtor Inhibitors ◽  
Response Rates ◽  
Therapeutic Window ◽  
Best Response ◽  
Patient Will ◽  
Ethical Approval

409 Background: Dual TORC1 and 2 inhibitors such as AZD2014 have theoretical advantages over isolated TORC1 inhibitors such as everolimus in the treatment of mRCC. In this study we compare the activity of these drugs in patients with vascular endothelial growth factor (VEFG) refractory mRCC. Methods: Patients with measurable VEGF refractory mRCC were randomised (1:1) to AZD2014 or everolimus stratified by MSKCC prognostic score and 1st line targeted therapy. Progression free survival (PFS) measured by RECIST v1.1 was the primary endpoint. Adverse events (AE) (CTCAE v4.03), response rates (RR) and overall survival (OS) were reported. This was an investigator led study and had appropriate ethical approval. Results: The study was stopped early (May 2014) with the recommendation of the IDMC. At this point 48 patients were recruited and 40 (AZD2014 23 :everolimus 17) patients were assessable for efficacy. Patient’s demographics were similar in the 2 groups. The median PFS was shorter for AZD2014 than everolimus (2.0 [95% CI 1.6-3.2] months vs. 5.8 [95% CI 2.8-11.2] months: stratified HR [2.4 95% CI:1.0-5.7; p<0.05]). Progression of disease as a best response was higher for AZD2014 than everolimus (65% vs. 18%: p=0.03). Response rates for AZD2014 and everolimus were 0% and 12% respectively. There were 9 deaths in this patient group, 7 in AZD2014 and 2 in everolimus group, all were due to disease progression. Grade III-IV adverse events (AEs) occurred with AZD2014 and everolimus in 30% and 59% of patients respectively. Discontinuation for AEs did not occur with AZD. PK analysis revealed AZD2014 doses within therapeutic window. Results for the 48 patient will be presented along with the survival data. Conclusions: The PFS for AZD2014 is inferior to everolimus in this setting despite excellent tolerability. These results are consistent with previous results with broader spectrum mTOR inhibitors in VEGF refractory mRCC (GDC0890: HR2.04 [Powles et al ASCO 2014]). This approach appears to be flawed. Clinical trial information: NCT01793636.

Prospective, multicenter, noninterventional and registry clinical study of apatinib in patients with advanced gastric cancer.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 137-137 ◽  
Author(s):  
Chunmei Bai ◽  
Diansheng Zhong ◽  
Ruixing Zhang ◽  
Xiubao Ren ◽  
Likun Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Real World ◽  
Objective Response ◽  
Progression Free Survival ◽  
Similar Efficacy ◽  
Phase Iii ◽  
Efficacy Evaluation ◽  
Real World Data ◽  
Skin Reactions

137 Background: The aim of this study was to observe the safety of apatinib in the real world with wider inclusion criteria. The efficacy of apatinib was evaluated including overall survival (OS), progression-free survival (PFS), objective response rate (ORR) and disease control rate (DCR). Methods: This trial enrolled patients from 32 centers in china with advanced gastric adenocarcinoma who had progressed after undergoing at least two lines of systemic chemotherapy, or patients who were considered to benefit from the treatment. We recommended starting from oral administration of 500mg qd, 28 days for a cycle. Dose could be appropriately adjusted according to the patients’ physical condition. Results: Between March 2015 and September 2017, 326 patients were enrolled. The average age was 62 years old, and the ratio of male to female was about 2:1. Patients received perioperative, first-line, second-line, and third-line or more treatment were 1,39,69 and 217 people respectively. There were 192 patients received efficacy evaluation, 9 patients achieved partial response(PR), 125 had disease stability(SD). The ORR and DCR were 4.6% and 69.8% respectively. The median PFS and median OS were 3.7 months and 7.3 months respectively. In the 326 patients, there were 153 patients with initial dose of 500 mg, 3 and 55 patients achieved PR and SD, respectively. The ORR and DCR were 3.3% and 63.7%, respectively. The median PFS and median OS were 3.5 months and 8.4 months, respectively. There were 237 patients in all 326 patients received safety analysis. Common adverse events were hypertension (57%), hand-foot skin reactions (26.6%), fatigue (29.5%), proteinuria (19.0%), bleeding (10.1%) and diarrhea (8.0%). The grade 3 to 4 adverse events were hypertension (6.3%), hand-foot skin reactions (3.8%), proteinuria(3.0%) and bleeding (2.1%). Conclusions: This real-world data in which more patients were given apatinib 500mg or less qd showed similar efficacy to Phase III clinical trial (850mg qd).The incidence of adverse events was consistent with that of Phase III clinical data,there was no new adverse events had been seen. Clinical trial information: NCT02668380.

Real-world effectiveness of lenvatinib monotherapy among unresectable hepatocellular carcinoma patients treated in United States clinical practices.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 273-273
Author(s):  
Amit G. Singal ◽  
Saurabh P Nagar ◽  
Abigail Hitchens ◽  
Shrividya Iyer
Keyword(s):  
United States ◽  
Hepatocellular Carcinoma ◽  
Liver Disease ◽  
Portal Vein ◽  
Real World ◽  
Clinical Practices ◽  
First Line ◽  
Real World Data ◽  
Best Response

273 Background: In the United States (U.S.), lenvatinib monotherapy was approved in August 2018 for first-line treatment of patients with unresectable hepatocellular carcinoma (uHCC) based on the pivotal trial, REFLECT. Real-world data are essential to assess if this efficacy translates into effectiveness in clinical practice. The main objective of our real-world data (RWD) study was to assess clinical characteristics and effectiveness of lenvatinib among patients treated in U.S. clinical practices. Methods: A retrospective patient chart review study was conducted among adult patients (≥18 years) in the U.S. initiating lenvatinib monotherapy as first-line (1L) systemic therapy for uHCC between Aug 2018 and Sept 2019 and with ECOG status of 0 or 1. Data were extracted from individual patients’ electronic health records and captured in electronic case report forms. Clinical outcomes assessed include provider-reported best response, progression-free survival (PFS) and overall survival (OS). PFS and OS were estimated using Kaplan-Meier methods. For PFS, patients were censored at end of treatment or end of follow-up in case of ongoing treatment, while censoring occurred at end of follow-up for OS. Results: Among 233 patients treated with 1L lenvatinib monotherapy, majority were male (68%) and most were Caucasian (52%) or African American (25%). Median age was 63 years and median body weight was 76 kg. The most common etiologies of liver disease were hepatitis C (36%), alcohol-related liver disease (28%), hepatitis B (16%) and non-alcoholic steatohepatitis (14%). Most patients had compensated cirrhosis, with 49% Child Pugh A and 43% Child Pugh B. All patients had uHCC, with most having Barcelona Clinic Liver Cancer stage B (29%) or C (44%) disease. Portal vein invasion was reported in 19%, of whom7% had main portal vein involvement. The median starting dose of lenvatinib was 12 mg daily. Over a median follow-up period of 9 months from HCC diagnosis, median PFS and OS were not reached. At 6 and 12 months landmark PFS was 85% and 65%, respectively and landmark OS was 92% and 73%, respectively. In the overall cohort, provider-reported best response was complete response (CR): 21%, partial response (PR):44% and stable disease (SD): 26%. Based on RECIST 1.1 (n = 125) CR:16%, PR:54%, SD:26% and mRECIST (n = 11) CR:73%, PR:0% and SD:18% were reported. Average duration of lenvatinib treatment was 7.4 months (median: 6.7 months) with 61% of patients remaining on lenvatinib at end of follow-up. Second-line (2L) treatment was initiated in 32 patients, with immunotherapy (50%), sorafenib (31%) and regorafenib (9%) being most common. Median time to 2L treatment from initiation of lenvatinib was about 8 months. Conclusions: Results from this retrospective real-world study in an U.S. population affirm the clinical effectiveness of 1L lenvatinib monotherapy among patients with uHCC.

Correlation of patient characteristics with clinical outcomes of camrelizumab combined with apatinib for unresectable hepatocellular carcinma (uHCC): An observational retrospective analysis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e16120-e16120
Author(s):  
Gang Liu ◽  
Liansheng Gong ◽  
Wenxuan Zhou ◽  
Xiaoli Li ◽  
Fei Wang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Real World ◽  
Subgroup Analysis ◽  
Therapeutic Efficacy ◽  
Checkpoint Inhibitors ◽  
Objective Response ◽  
Therapeutic Effects ◽  
First Line ◽  
Real World Data ◽  
Baseline Serum

e16120 Background: There is limited data on clinical parameters to evaluate the therapeutic effects on immune checkpoint inhibitors (ICIs) combined with anti-angiogenic agent for uHCC. Here, we assessed efficacy and safety of camrelizumab combined with apatinib for uHCC from real-world data, and performed the retrospective subgroup analysis to investigate the potential factors related to therapy response and patients survival as well. Methods: We evaluated clinical data and outcome of 26 uHCC patients who received camrelizumab 200 mg intravenously every 2 weeks combined with apatinib 250 mg qd between May 2019 and Jul 2020. Objective response rate (ORR), disease control rate (DCR), progression free survival (PFS) and overall survival (OS) were evaluated using independent central review mRECIST and RECIST 1.1. Treatment related adverse events (TRAEs) and immune-related adverse events (irAEs) were evaluated. Results: The patients’ characteristics of our cohort are summarized in Table. Overall, our study shows that ORR was 57.7% (mRECIST), DCR was 84.62% (mRECIST), median PFS (mPFS) and OS (mOS) were 11 months and 18.2 months, respectively. For subgroup analysis, patients with first-line therapy (n=22) had dramatically better mPFS than non-first-line (15.0 vs. 4 months; p=0.01). Patients with baseline serum alpha-foetoprotein (AFP) > 400 ng/ml shows better therapeutic efficacy ( p<0.001). The patients with decreased AFP level after treatment had significantly longer mPFS (15.0 vs. 4 months; p<0.001) and mOS (NR vs. 5.7 months; p<0.001) than others. Overall, 14 (53.85%) patients had grade≥3 TRAEs, only 3 (11.54%) patients had grade≥2 irAEs. Conclusions: The first up-to-date real-world evidence indicates that both the baseline and post-treatment AFP level might be independent prognostic factors to evaluate the therapeutic efficacy and clinical outcome on the combination therapy of camrelizumab and apatinib. While larger sample sizes and longer follow-up study are needed to verify reliability of statistical results.[Table: see text]

scholarly journals STK11 and KEAP1 mutations as prognostic biomarkers in an observational real-world lung adenocarcinoma cohort

ESMO Open ◽  
2020 ◽  
Vol 5 (2) ◽  
pp. e000706 ◽  
Author(s):  
Simon Papillon-Cavanagh ◽  
Parul Doshi ◽  
Radu Dobrin ◽  
Joseph Szustakowski ◽  
Alice M Walsh
Keyword(s):  
Real World ◽  
Predictive Biomarkers ◽  
Progression Free Survival ◽  
Poor Response ◽  
Immune Checkpoint Blockade ◽  
First Line ◽  
Real World Data ◽  
Prognostic Effect ◽  
Programmed Death ◽  
Poor Outcomes

IntroductionSomatic mutations in STK11 and KEAP1, frequently comutated in non-squamous non-small cell lung cancer (NSQ NSCLC), have been associated with poor response to immune checkpoint blockade (ICB). However, previous reports lack non-ICB controls needed to properly ascertain the predictive nature of those biomarkers. The objective of this study was to evaluate the predictive versus prognostic effect of STK11 or KEAP1 mutations in NSQ NSCLC.MethodsPatients diagnosed with stage IIIB, IIIC, IVA or IVB NSQ NSCLC from a real-world data cohort from the Flatiron Health Network linked with genetic testing from Foundation Medicine were retrospectively assessed. Real-world, progression-free survival (rwPFS) and overall survival (OS) were calculated from time of initiation of first-line treatment.ResultsWe analysed clinical and mutational data for 2276 patients including patients treated with anti-programmed death-1 (PD-1)/anti-programmed death ligand 1 (PD-L1) inhibitors at first line (n=574). Mutations in STK11 or KEAP1 were associated with poor outcomes across multiple therapeutic classes and were not specifically associated with poor outcomes in ICB cohorts. There was no observable interaction between STK11 mutations and anti-PD-1/anti-PD-L1 treatment on rwPFS (HR, 1.05; 95% CI 0.76 to 1.44; p=0.785) or OS (HR, 1.13; 95% CI 0.76 to 1.67; p=0.540). Similarly, there was no observable interaction between KEAP1 mutations and treatment on rwPFS (HR, 0.93; 95% CI 0.67 to 1.28; p=0.653) or OS (HR, 0.98; 95% CI 0.66 to 1.45; p=0.913).ConclusionOur results show that STK11-KEAP1 mutations are prognostic, not predictive, biomarkers for anti-PD-1/anti-PD-L1 therapy.

scholarly journals Lidocaine 700 mg medicated plaster for postherpetic neuralgia: real-world data from the German Pain e-Registry

2021 ◽  
Author(s):  
Michael A Überall ◽  
Mariëlle Eerdekens ◽  
Els Hollanders ◽  
Irmgard Bösl ◽  
Ingo Sabatschus
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Medical Care ◽  
Real World ◽  
Postherpetic Neuralgia ◽  
First Line ◽  
Real World Data ◽  
World Data ◽  
Routine Medical Care

Aim: To provide real-world evidence for the effectiveness and tolerability of lidocaine 700 mg medicated plaster (LMP) compared with oral systemic first-line medications (OSM) in postherpetic neuralgia treatment. Patients & methods: Retrospective cohort study in patients refractory to at least one recommended OSM (single drug or a combination of drugs) using anonymized routine medical care data from the German Pain e-Registry. A matched pair approach using propensity score matching was employed. Results: A total of 1711 data sets of postherpetic neuralgia patients were identified per treatment group. The majority (>60%) had experienced pain for more than a year and reported a high burden of pain and reduced quality of life. Six months of LMP treatment provided significantly greater pain reductions, improvements in pain-related impairments and quality of life than OSM treatment (p < 0.001 for all parameters). Drug-related adverse events and treatment discontinuation due to drug-related adverse events also occurred less frequently under LMP treatment (p < 0.001). Conclusion: These real-world data confirm the effectiveness and good tolerability of LMP under routine medical care. The treatment was significantly more effective when compared with first-line oral systemic medications.

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