The prospective cohort study had the objective to evaluate the effectiveness and safety of intravenous i. No study-specific treatments or assessments were scheduled. A study observation interval of maximally six cycles of chemotherapy plus bevacizumab, followed by bevacizumab maintenance therapy until disease progression was recommended.
However, according to the non-interventional approach, actual treatment decisions were at the discretion of the treating physicians. Normal merchandise was used and reimbursed by the respective national or private health insurance. The study was conducted across institutions in Germany medical oncologists and pneumologists in hospitals and private practices between September and October Patients were followed until progression or intolerable toxicity, whichever occurred first.
No long-term follow-up information on deaths was collected. Quality control procedures were applied to each stage of data entry and data handling to ensure that all data were reliable and processed correctly. A data review meeting was held prior to database lock. Safety endpoints comprised occurrence and frequency of adverse drug reactions ADRs; also ADRs of special interest; see next section including seriousness, relatedness to bevacizumab and severity.
Additional safety endpoints were the occurrence of any new or rare bevacizumab-related ADRs as well as ADRs leading to treatment discontinuation. Differences between groups were not tested for statistical significance.
Further research questions included patient characteristics at baseline e. Baseline information collected prospectively per patient included demographics and cancer history, current tumor status, previous treatment, and relevant concomitant diseases. The initial diagnosis including adenocarcinoma had to be confirmed histopathologically. Vital signs, standard laboratory assessments, and general condition were also captured at baseline.
Best tumor response over time, reasons for end of therapy, and further antineoplastic therapy were documented at an end of study visit. Data were evaluated using descriptive statistical methods. Missing values were not replaced. Specification of the complete analysis was laid down in detail in the statistical analysis plan, which was finalized prior to database lock.
PFS was defined as time from start of therapy to investigator-assessed disease progression or death from any cause. OS was defined as time from treatment start to death if death occurred within the time window between start of therapy and up to four weeks after last bevacizumab administration final documentation. Patients without event progression or death were censored at the end of study or data cut-off date whichever occurred first.
PR vs. CR , number of cycles with bevacizumab, and number of cycles with maintenance therapy. Male patients accounted for The average body weight of all patients was A proportion of patients had bone metastases Recorded separately, Overall For all treatment cycles combination and bevacizumab maintenance therapy the number of patients per cycle decreased from Bevacizumab doses per infusion were mostly 5, 7.
The main therapy combination used was bevacizumab plus carboplatin and paclitaxel In a smaller proportion of patients, bevacizumab was combined with carboplatin and pemetrexed Besides these three most commonly used regimens, other platinum combinations were used as well.
All these regimens are following current recommendations for doublet therapy with platinum including third-generation drugs [ 3 ]. Only 9. Within the analysis population, the majority of patients achieved PR Kaplan Meier estimate of time-to-progression resulted in a median PFS of 7. The only follow-up was performed four weeks after the end of treatment with bevacizumab. At that time, the mean OS was However, Therefore, the OS estimate is based on a low number of events and does not allow for a meaningful interpretation.
Subgroup analyses performed for patients with NSCLC other than predominantly squamous cell histology revealed that longer PFS was associated with the presence of adenocarcinoma at baseline in comparison with other histological NSCLC subgroups Table 3.
For patients receiving maintenance therapy with bevacizumab, the median PFS was Incidences of bevacizumab-related ADRs of special interest were: hypertension 7. The main reason for the end of therapy was disease progression in No new safety signals were observed in this NIS. Of note, no new safety signals were observed in this NIS. During controlled clinical trials, usually all adverse events are reported regardless of causal relationship to study treatment. Results from clinical trials are prone to selection bias due to specific inclusion and exclusion criteria.
Moreover, their pre-specified diagnostic and follow-up measures are not always representative approaches of day-to-day practice [ 22 ].
Avastin produces its anticancer effects by targeting vascular endothelial growth factor VEGF and preventing the interaction of VEGF with its receptors to reduce the growth and spread of cancer cells. VEGF, a type of protein, is important in a process leading to cellular growth, replication, and spread and to new blood vessel formation. Avastin binds to VEGF and reduces its normal activity. It lessens the growth and spread of cancer cells by inhibiting the growth of new blood vessels and depriving the cancer of nutrients and oxygen and inhibits its growth.
Avastin has been approved for the treatment of selected patients with breast cancer, lung cancer, colorectal cancer, kidney cancer, or glioblastoma. The interim analysis published in May reported that, the median PFS was Individuals were treated with either one of 3 regimens and directly compared.
The result of the study demonstrated that individuals treated with Tecentriq in combination with Avastin and chemotherapy were more likely to respond to treatment and survive compared to Avastin and chemotherapy.
The median survival was improved from 14 to 19 months. The rationale for combining Tecentriq and Avastin with chemotherapy is to target the cancer simultaneously with different medications and to enhance the potential of the immune system to combat the cancer by priming and activating a T cell response against cancer cell antigens.
Precision cancer medicines and immunotherapy are the mainstay of stage IV Kidney Cancer treatment. Understand all the treatment options for advanced kidney or renal cell carcinoma. Combination immunotherapy prolongs survival and is the new "standard of care" for stage IV Melanoma. Researchers evaluated the chemotherapy combination of Avastin, Gemzar, and Platinol. A biosimilar is a biological product that is approved based on data showing that it is highly similar to an already-approved biological product and has no clinically meaningful differences in terms of safety, purity and potency i.
The FDA's approval of Mvasi is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Mvasi is biosimilar to Avastin. It has been approved as a biosimilar, not as an interchangeable product. Common expected side effects of Mvasi include nose bleeds epistaxis , headache, high blood pressure hypertension , inflammation of the nasal cavity rhinitis , high levels of protein in the urine proteinuria , taste alteration, dry skin, rectal bleeding hemorrhage , excessive tear production lacrimation disorder , back pain and skin irritation exfoliative dermatitis.
Serious expected side effects of Mvasi include holes in or abnormal connection between two organs perforation or fistula , blood clot formation arterial and venous thromboembolic events , hypertension, problems in brain function or structure posterior reversible encephalopathy syndrome , high levels of protein in the urine proteinuria , infusion-related reactions and loss of function of the ovaries ovarian failure.
Patients should stop using Mvasi if these side effects become severe or life-threatening. Women who are pregnant should not take Mvasi because it may cause harm to a developing fetus. Like Avastin, the labeling for Mvasi contains a Boxed Warning to alert health care professionals and patients about an increased risk of holes in the stomach and intestines gastrointestinal perforations ; surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding hemorrhage.
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