Recombinant erythropoietin (Epo)/darbepoetin (Darb) associated venous thromboembolism (VTE) in the oncology setting: Findings from the Research on Adverse Drug Events And Reports (RADAR) project

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2552-2552 ◽  
Author(s):  
K. Gleason ◽  
C. Tigue ◽  
P. Yarnold ◽  
J. McKoy ◽  
C. Angelotta ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Adverse Drug Events ◽  
Phase Iii ◽  
Recombinant Erythropoietin ◽  
Two Phase ◽  
Off Label ◽  
Fda Approval ◽  
Increased Risk ◽  
Phase Iii Trials ◽  
Meta Analyses

2552 Background: Cancer patients are at increased risk for VTE as compared to the general population, making VTE as a sADR difficult to detect in the oncology setting. In 2004, two phase III trials identified higher mortality rates among epo-treated cancer patients who were receiving chemotherapy in “off-label” settings- with these studies identifying higher VTE rates in the treatment arms. We reviewed data on epo/darb-associated VTE in the oncology setting. Methods: Data sources were meta-analyses and the FDA’s MedWatch database. Results: Since 1996, only 259 VTE reports (darb: n=30, epo: n=229) of VTE in the setting of chemotherapy and epo/darb were reported to MedWatch. Meta-analyses findings are tabulated below: Conclusions: In 2004, package inserts for Epo/Darb were revised, identifying increased risks of VTE with these agents in the oncology setting. Identification of this adverse drug reaction thirteen years after Epo received FDA approval for this indication (and had been prescribed to > 500,000 cancer patients) illustrates difficulties inherent with current pharmacovigilance efforts. [Table: see text] No significant financial relationships to disclose.

Osteonecrosis of the jaw (ONJ) in androgen-independent prostate cancer (AIPC) patients receiving ATTP (bevacizumab, docetaxel, thalidomide, and prednisone)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19594-19594 ◽  
Author(s):  
J. B. Aragon-Ching ◽  
Y. M. Ning ◽  
L. Latham ◽  
J. Guadagnini ◽  
P. M. Arlen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Risk Factor ◽  
Cancer Patients ◽  
Oral Surgery ◽  
Osteonecrosis Of The Jaw ◽  
Phase Iii ◽  
Additional Risk Factor ◽  
Increased Risk ◽  
Vascular Insufficiency ◽  
Phase Iii Trials

19594 Background: ONJ has been associated with IV bisphosphonate use in cancer patients (pts) and chemotherapy may be an additional risk factor. ONJ is believed to result from localized vascular insufficiency due to faulty bone remodeling. ONJ incidence in pts not receiving chemotherapy (e.g. Paget's disease) is reportedly only 0.8%; prostate cancer pts have an incidence of 6.5%. Methods: We reviewed data from pts with advanced AIPC who developed ONJ while being treated on a Phase II study of ATTP. Results: Six of 36 (17%) pts treated with ATTP had ONJ confirmed by oral surgery. Four of the 6 pts presented with pain and, in five, the ONJ was mandibular in location. All pts were treated conservatively with either sequestrectomy or oral cleansing with chlorhexidine. All pts had been treated monthly with IV zoledronic acid (ZA). The mean duration of ZA use before diagnosis of ONJ was 20 months (mos). One patient had been treated with oral alendronate for 3 years and then developed ONJ after 5 mos of ZA. Of the 36 pts on-study, previous dental history could be verified in 24 pts. ONJ was diagnosed in 4 of the 5 pts with a prior dental infection or invasive dental procedure. Pts received an average of 11 cycles of ATTP before ONJ was diagnosed. All pts with ONJ had received full doses of bevacizumab and most had received full doses of all medications for all cycles. Conclusions: The possibility exists that the risk for ONJ may be higher with specific chemotherapy regimens, particularly those that include steroids or anti-angiogenic agents. However, at this time prior dental infections or procedures remain the greatest known risk factor. It is also possible that the relatively high incidence of ONJ in prostate cancer patients may reflect increased awareness in this population. Randomized phase III trials in AIPC, specifically addressing the incidence of ONJ, are needed to determine whether specific chemotherapy regimens are associated with an increased risk of this complication. No significant financial relationships to disclose.

Antiemetics: ASCO Guideline Update

2020 ◽  
Vol 38 (24) ◽  
pp. 2782-2797 ◽  
Author(s):  
Paul J. Hesketh ◽  
Mark G. Kris ◽  
Ethan Basch ◽  
Kari Bohlke ◽  
Sally Y. Barbour ◽  
...  
Keyword(s):  
Systematic Review ◽  
Anticancer Agents ◽  
Checkpoint Inhibitors ◽  
Phase Iii ◽  
Two Phase ◽  
Hematopoietic Stem ◽  
Lung Cancers ◽  
Additional Information ◽  
Phase Iii Trials ◽  
Meta Analyses

PURPOSE To update the guideline to include new anticancer agents, antiemetics, and antiemetic regimens and to provide recommendations on the use of dexamethasone as a prophylactic antiemetic in patients receiving checkpoint inhibitors (CPIs). METHODS ASCO convened an Expert Panel and updated the systematic review to include randomized controlled trials (RCTs) and meta-analyses of RCTs published between June 1, 2016, and January 24, 2020. To address the dexamethasone and CPI question, we conducted a systematic review of RCTs that evaluated the addition of a CPI to chemotherapy. RESULTS The systematic reviews included 3 publications from the updated search and 10 publications on CPIs. Two phase III trials in adult patients with non–small-cell lung cancers evaluating a platinum-based doublet with or without the programmed death 1 (PD-1) inhibitor pembrolizumab recommended that all patients receive dexamethasone as a component of the prophylactic antiemetic regimen. In both studies, superior outcomes were noted in the PD-1 inhibitor–containing arms. Other important findings address olanzapine in adults and fosaprepitant in pediatric patients. RECOMMENDATIONS Recommendations for adults are unchanged with the exception of the option of adding olanzapine in the setting of hematopoietic stem cell transplantation. Dosing information now includes the option of a 5-mg dose of olanzapine in adults and intravenous formulations of aprepitant and netupitant-palonosetron. The option of fosaprepitant is added to pediatric recommendations. There is no clinical evidence to warrant omission of dexamethasone from guideline-compliant prophylactic antiemetic regimens when CPIs are administered to adults in combination with chemotherapy. CPIs administered alone or in combination with another CPI do not require the routine use of a prophylactic antiemetic. Additional information is available at www.asco.org/supportive-care-guidelines .

Antiemese: Die Neuerungen der ASCO-Guideline im Überblick

2021 ◽  
pp. 1-3
Author(s):  
Hartmut Link
Keyword(s):  
Systematic Review ◽  
Anticancer Agents ◽  
Checkpoint Inhibitors ◽  
Phase Iii ◽  
Two Phase ◽  
Hematopoietic Stem ◽  
Lung Cancers ◽  
Additional Information ◽  
Phase Iii Trials ◽  
Meta Analyses

<b>Purpose:</b> To update the guideline to include new anticancer agents, antiemetics, and antiemetic regimens and to provide recommendations on the use of dexamethasone as a prophylactic antiemetic in patients receiving checkpoint inhibitors (CPIs). <b>Methods:</b> ASCO convened an Expert Panel and updated the systematic review to include randomized controlled trials (RCTs) and meta-analyses of RCTs published between June 1, 2016, and January 24, 2020. To address the dexamethasone and CPI question, we conducted a systematic review of RCTs that evaluated the addition of a CPI to chemotherapy. <b>Results:</b> The systematic reviews included 3 publications from the updated search and 10 publications on CPIs. Two phase III trials in adult patients with non–small-cell lung cancers evaluating a platinum-based doublet with or without the programmed death 1 (PD-1) inhibitor pembrolizumab recommended that all patients receive dexamethasone as a component of the prophylactic antiemetic regimen. In both studies, superior outcomes were noted in the PD-1 inhibitor–containing arms. Other important findings address olanzapine in adults and fosaprepitant in pediatric patients. <b>Recommendations:</b> Recommendations for adults are unchanged with the exception of the option of adding olanzapine in the setting of hematopoietic stem cell transplantation. Dosing information now includes the option of a 5-mg dose of olanzapine in adults and intravenous formulations of aprepitant and netupitant-palonosetron. The option of fosaprepitant is added to pediatric recommendations. There is no clinical evidence to warrant omission of dexamethasone from guideline-compliant prophylactic antiemetic regimens when CPIs are administered to adults in combination with chemotherapy. CPIs administered alone or in combination with another CPI do not require the routine use of a prophylactic antiemetic. Additional information is available at www.asco.org/supportive-care-guidelines.

scholarly journals COVID-19 Vaccine Safety in Cancer Patients: A Single Centre Experience

Cancers ◽  
2021 ◽  
Vol 13 (14) ◽  
pp. 3573
Author(s):  
Alfred Chung Pui So ◽  
Harriet McGrath ◽  
Jonathan Ting ◽  
Krishnie Srikandarajah ◽  
Styliani Germanou ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Safety Data ◽  
Vaccine Safety ◽  
Phase Iii ◽  
Solid Malignancy ◽  
Common Grade ◽  
Phase Iii Trials ◽  
Oncology Care ◽  
Grade 3 ◽  
Oncology Centre

Emergency approval of vaccines against COVID-19 provides an opportunity for us to return to pre-pandemic oncology care. However, safety data in cancer patients is lacking due to their exclusion from most phase III trials. We included all patients aged less than 65 years who received a COVID-19 vaccine from 8 December 2020 to 28 February 2021 at our London tertiary oncology centre. Solicited and unsolicited vaccine-related adverse events (VRAEs) were collected using telephone or face-to-face consultation. Within the study period, 373 patients received their first dose of vaccine: Pfizer/BioNTech (75.1%), Oxford/AstraZeneca (23.6%), Moderna (0.3%), and unknown (1.1%). Median follow-up was 25 days (5–85). Median age was 56 years (19–65). Of the patients, 94.9% had a solid malignancy and 76.7% were stage 3–4. The most common cancers were breast (34.0%), lung (13.4%), colorectal (10.2%), and gynaecological (10.2%). Of the patients, 88.5% were receiving anti-cancer treatment (36.2% parenteral chemotherapy and 15.3% immunotherapy), 76.1% developed any grade VRAE of which 2.1% were grade 3. No grade 4/5 or anaphylaxis were observed. The most common VRAEs within 7 days post-vaccination were sore arm (61.7%), fatigue (18.2%), and headaches (12.1%). Most common grade 3 VRAE was fatigue (1.1%). Our results demonstrate that COVID-19 vaccines in oncology patients have mild reactogenicity.

Bezlotoxumab: Could This be the Answer for Clostridium difficile Recurrence?

2017 ◽  
Vol 51 (9) ◽  
pp. 804-810 ◽  
Author(s):  
Ryan W. Chapin ◽  
Tiffany Lee ◽  
Christopher McCoy ◽  
Carolyn D. Alonso ◽  
Monica V. Mahoney
Keyword(s):  
Monoclonal Antibody ◽  
Clostridium Difficile ◽  
English Language ◽  
Adverse Drug Events ◽  
Data Extraction ◽  
Standard Of Care ◽  
Phase Iii ◽  
Relative Reduction ◽  
Two Phase ◽  
Mesh Terms

Objective: To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of bezlotoxumab (BEZ), a novel monoclonal antibody against Clostridium difficile toxin B. Data Sources: A PubMed search was conducted for data between 1946 and April 2017 using MeSH terms bezlotoxumab, MK-6072, or MDX-1388 alone and the terms Clostridium difficile combined with monoclonal antibody or antitoxin. Study Selection and Data Extraction: The literature search was limited to English-language studies that described clinical efficacy, safety, and pharmacokinetics in humans and animals. Abstracts featuring prepublished data were also evaluated for inclusion. Data Synthesis: BEZ is indicated for adult patients receiving standard-of-care (SoC) antibiotics for C difficile infection (CDI) to prevent future recurrence. Two phase III trials—MODIFY I (n = 1452) and MODIFY II (n = 1203)—demonstrated a 40% relative reduction in recurrent CDI (rCDI) with BEZ compared with placebo (16.5% vs 26.6%, P < 0.0001). The most common adverse drug events associated with BEZ were mild to moderate infusion-related reactions (10.3%). Conclusions: In patients treated with SoC antibiotics, BEZ is effective in decreasing rCDI. BEZ has no apparent effect on treatment of an initial CDI episode. In light of increasing rates of CDI, BEZ is a promising option for preventing recurrent episodes. The greatest benefit has been demonstrated in high-risk patients, though the targeted patient population is yet to be defined.

National Cancer Institute–United States strategy regarding intraperitoneal chemotherapy for ovarian cancer

2008 ◽  
Vol 18 (Suppl 1) ◽  
pp. 26-28 ◽  
Author(s):  
E. L. Trimble ◽  
M. C. Christian
Keyword(s):  
Ovarian Cancer ◽  
National Cancer Institute ◽  
Phase Iii ◽  
Cooperative Groups ◽  
Advocacy Organizations ◽  
Increased Risk ◽  
Phase Iii Trials ◽  
Educational Campaign ◽  
Clinically Significant ◽  
Further Development

On the basis of three large randomized phase III trials, the National Cancer Institute (NCI) issued a Clinical Announcement in January 2006 recommending that women with optimally debulked stage III ovarian cancer and their physicians consider a combination of intravenous (IV) and intraperitoneal (IP) chemotherapy. The combination of IV and IP chemotherapy is associated with a clinically significant benefit in survival, although it does also confer an increased risk of toxicity compared to IV chemotherapy alone. The NCI Clinical Announcement was issued as part of a broader educational campaign, designed in conjunction with professional societies, cancer centers, Clinical Trials Cooperative Groups, and cancer advocacy organizations. The further development of IP chemotherapy in ovarian cancer requires additional clinical and translational research

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

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