scholarly journals Efficacy and Safety of Irinotecan-Based Chemotherapy for Advanced Colorectal Cancer outside Clinical Trials: An Observational Study

Onkologie ◽  
2010 ◽  
Vol 33 (12) ◽  
pp. 684-690 ◽  
Author(s):  
Markus Moehler ◽  
Younes Ababneh ◽  
Karl Verpoort ◽  
Burghard Schmidt ◽  
Reinhard Musch ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Observational Study ◽  
Advanced Colorectal Cancer ◽  
Efficacy And Safety

scholarly journals Regorafenib in metastatic colorectal cancer: more data for clinical decisions

2021 ◽  
Vol 23 (3) ◽  
pp. 436-441
Author(s):  
Vladislav V. Petkau ◽  
Alisa A. Karimova ◽  
Zinaida V. Akishina
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Tumor Microenvironment ◽  
Metastatic Colorectal Cancer ◽  
Kinase Inhibitor ◽  
Cancer Drug ◽  
Efficacy And Safety ◽  
Tumor Immunogenicity ◽  
Metastatic Activity ◽  
Multiple Kinase Inhibitor

Regorafenib is a multiple kinase inhibitor. It influences/blocks angiogenesis (VEGFR1-3, TIE2), proliferation (KIT, RET, RAF-1, BRAF), metastatic activity (VEGFR2-3, PDGFR), tumor immunogenicity (CSF1R), tumor microenvironment (PDGFR-, PDGFR-, FGFR1-2). Regorafenib has several indications including metastatic colorectal cancer. Efficacy and safety of regorafenib data from clinical trials (CORRECT, CONCUR, CONSIGN) and observational trials from real world (REBECCA, CORRELATE, RECORA, PMS, REGOTAS) are summarized and presented in this issue. State of the matter of molecular-biologic predictors (KRAS, PIK3CA ANG-2, VEGF-A, LDH, CCL5/CCR5, CA 19-9) and radiological predictors (RadioCORRECT and other trials) is highlighted. Regimens with dose modification and its influence on effectiveness and tolerability of regorafenib are described according to the data from ReDOS, RESET, REARRANGE trials. The results from retrospective trials comparing regorafenib and another approved for refractory metastatic colorectal cancer drug trifluridine/tipiracil are presented.

scholarly journals Efficacy and safety of ramucirumab treatment in patients with advanced colorectal cancer

Medicine ◽  
2020 ◽  
Vol 99 (24) ◽  
pp. e20618
Author(s):  
Man Ju ◽  
Honggang Cheng ◽  
Kai Qu ◽  
Xiangqian Lu
Keyword(s):  
Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Efficacy And Safety

scholarly journals Clinical efficacy and safety of apatinib in patients with advanced colorectal cancer as the late-line treatment

Medicine ◽  
2018 ◽  
Vol 97 (50) ◽  
pp. e13635 ◽  
Author(s):  
Xiaoli Liao ◽  
Hualan Li ◽  
Zhihui Liu ◽  
Sina Liao ◽  
Qian Li ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Efficacy ◽  
Advanced Colorectal Cancer ◽  
Line Treatment ◽  
Efficacy And Safety

scholarly journals Clinical efficacy and safety of nimotuzumab plus chemotherapy in patients with advanced colorectal cancer: a retrospective analysis

2020 ◽  
Vol 48 (1) ◽  
pp. 030006051989585
Author(s):  
Sai-xi Bai ◽  
Ruo-rong Zhang ◽  
Wang-hua Chen ◽  
Hong-min Dong ◽  
Gang Wang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Retrospective Analysis ◽  
Clinical Efficacy ◽  
Advanced Colorectal Cancer ◽  
Efficacy And Safety

Target-based therapeutic matching in early-phase clinical trials in patients with advanced colorectal cancer and PIK3CA mutations.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 459-459
Author(s):  
Filip Janku ◽  
Aung Naing ◽  
Gerald Steven Falchook ◽  
Apostolia Maria Tsimberidou ◽  
Vanda M. T. Stepanek ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trials ◽  
Early Phase ◽  
Advanced Colorectal Cancer ◽  
Mtor Inhibitors ◽  
Mtor Pathway ◽  
Kras Mutations ◽  
Pik3ca Mutations ◽  
Molecular Abnormalities ◽  
Early Phase Clinical Trials

459 Background: Therapeutic matching based on underlying molecular abnormalities showed promising results in patients with diverse advanced cancers in early phase clinical trials. PIK3CA mutations may predict response to therapies with PI3K/AKT/mTOR inhibitors. Methods: Tumors from patients with colorectal cancer referred to the Clinical Center for Targeted Therapy (Phase I Program) were analyzed for PIK3CA mutations. Patients with PIK3CA mutations were treated, whenever feasible, with agents targeting the PI3K/AKT/mTOR pathway. Results: Of 194 patients analyzed, 31 (16%) had PIK3CA mutations. Of 194 patients 175 (90%) were assessed for the presence of KRAS mutation. Patients with PIK3CA mutations had higher prevalence of simultaneous KRAS mutations than patients with wild-type (wt) PIK3CA (21/30, 70% vs. 63/145, 43%; p=0.009). Of the 31 patients with PIK3CA mutations, 17 (55%) were treated in clinical trials containing a PI3K/AKT/mTOR pathway inhibitor (median age, 57; median number of prior therapies, 4). Of these 17 patients, none achieved a partial or complete response (PR/CR) and only 1 (6%, 95% CI 0.01-0.27) patient had stable disease for more than 6 months (SD>6), which was not significantly different from the SD>6/PR/CR rate of 16% (11/67; 95% CI 0.09-0.27) in colorectal cancer patients without PIK3CA mutations treated on the same protocols targeting the PI3K/AKT/mTOR pathway (p=0.44). The median progression-free survival was only 1.9 months (95% CI 1.5-2.3). Conclusions: Heavily pretreated patients with PIK3CA-mutant advanced colorectal cancer do not seem to benefit from protocols incorporating PI3K/AKT/mTOR inhibitors. PIK3CA mutations are associated with simultaneous KRAS mutations, which might account for therapeutic resistance.

scholarly journals An observational study «FOLLITROPIN» comparing the efficacy of follitropin alpha biosimilar: the real-world data

2021 ◽  
Vol 15 (1) ◽  
pp. 5-21
Author(s):  
D. P. Kamilova ◽  
M. M. Ovchinnikova ◽  
E. Sh. Ablyaeva ◽  
M. M. Leviashvili ◽  
N. S. Stuleva ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Observational Study ◽  
Clinical Efficacy ◽  
Real World ◽  
Ovarian Stimulation ◽  
Successful Implementation ◽  
Efficacy And Safety ◽  
The Real ◽  
Real Clinical Practice

Introduction. The efficacy and safety of biosimilar follitropin alpha have been demonstrated in randomized blinded prospective clinical trials of phases I and III. Unfortunately, there is a gap between the clinical trials and real clinical practice data. The real-world patient data helps to create an evidence-based background for successful implementation of medicine at everyday practice in a nonselected population.Aim: to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.Materials and Methods. A retrospective observational anonymized cohort study of follitropin alpha biosimilar (Primapur®) as a pre-filled pen injector with a dose adjustment of 5 IU, aimed to investigate its efficacy and safety in a nonselected population with indications to assisted reproductive technologies (ART) was carried out. The ovarian stimulation (OS) protocols included: monotherapy protocols with using only Primapur®; mixed protocols (recombinant and urinary-derived gonadotropins); short protocols with using antagonists of gonadotropin-releasing hormone (GnRH) and long protocols with GnRH agonists. The stimulation protocols were analyzed with Primapur® application for at least 5 days.Results. The overall clinical efficacy of ovarian stimulation cycles (N = 5484) was: oocytes retrieved - 9.5 ± 7.2, mature (MII) - 6.8 ± 6.6, fertilized (2PN) - 6.1 ± 5.8, clinical pregnancy per ET (PR) - 38.4 %. Mixed gonadotropin protocols (N = 2625) vs. monotherapy with Primapur® (N = 2859): oocytes retrieved - 8.6 ± 6.8 vs. 10.3 ± 7.4 (p < 0.001), mature (MII) - 6.7 ± 6.2 vs. 7.7 ± 6.9 (p < 0.001), fertilized (2PN) - 5.8 ± 5.2 vs. 7.2 ± 6.2 (p < 0.001). There were statistically significant differences between oocyte yields in mixed vs. monotherapy protocols due to subgroup differences, including age, body mass index (BMI) and IVF/ICSI attempts. No statistically significant differences were found for PR: 39.3 % vs. 37.6 % (p = 0.314). Monotherapy protocols with GnRH antagonist OS (N = 2183) vs. GnRH agonist (N = 676) revealed: oocytes retrieved - 10.5 ± 7.5 vs. 9.6 ± 7.0 (p = 0.032), mature (MII) - 7.6 ± 6.9 vs. 6.7 ± 5.7 (p < 0.001), fertilized (2PN) - 7.3 ± 6.3 vs. 5.7 ± 5.0 (p < 0.001). There were statistically significant differences between BMI and IVF/ICSI attempts. No statistically significant differences were found for PR: 37.9 % vs. 35.9 % (p = 0.482). All medicines were well tolerated and no serious adverse reactions were reported.Conclusion. This was the largest retrospective observational study conducted in the field of fertility in Russia and involved 5484 ovarian stimulation protocols at 35 IVF clinics. The obtained results demonstrated similar clinical efficacy for follitropin alpha biosimilar Primapur® in different OS protocols in real clinical practice. 

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