scholarly journals Adverse Events of Bevacizumab in Patients with Metastatic Colorectal Cancer

2020 ◽  
Vol 71 (1) ◽  
pp. 140-144
Author(s):  
Andreea-Daniela Gheorghe ◽  
Daniela Zob ◽  
Dana-Lucia Stanculeanu
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Chemotherapy Regimen ◽  
Stage Iv ◽  
Bevacizumab Treatment ◽  
Significant Difference ◽  
Stage Iv Disease ◽  
Localized Disease ◽  
Grade 3

Even with the decreasing incidence of colorectal cancer (CRC), data showing that the rate of incidence of CRC is declining with 2.9% every year starting with 2005 until 2014, CRC remains one of the most frequent neoplasia all over the world. Almost a quarter of patients with CRC present with stage IV disease at diagnosis and nearly 30% of patients with localized disease will progress within 5 years. Our study included 129 patients with metastatic CRC that received chemotherapy � bevacizumab, from January 2017 until December 2018. Patients received fluropirimidine-based chemotherapy plus or minus bevacizumab. No significant differences was registered between groups with respects of age, sex, tumor localization, chemotherapy regimen used. Also no significant difference was found in our groups regarding risk factors for bleeding and medical history. No remarkable differences were registered between the two groups regarding common adverse reactions to chemotherapy, with the exception of physical asthenia which was found in a greater proportion of patients that received bevacizumab in combination with chemotherapy. In our study most frequent adverse events related to bevacizumab were grade 1 or 2, only few adverse events were grade 3 or 4 and lead to discontinuation of bevacizumab treatment, and these were mainly thromboembolic events and bleeding.

scholarly journals Predictive Value of Clinical Toxicities to Chemotherapy with Fluoropyrimidines and Oxaliplatin in Colorectal Cancer by DPYD and GSTP1 Genes Polymorphisms

2020 ◽  
Author(s):  
Xunwei Deng ◽  
Jingyuan Hou ◽  
Qiaoting Deng ◽  
Zhixiong Zhong
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Direct Sequencing ◽  
Dihydropyrimidine Dehydrogenase ◽  
Severe Neutropenia ◽  
Severe Toxicity ◽  
Nucleotide Polymorphisms ◽  
Significant Difference ◽  
Grade 3 ◽  
Colorectal Cancer Patients

Abstract Background: Fluoropyrimidines and platinum are still widely used for colorectal cancer (CRC) management. Several studies have reported that mutations of dihydropyrimidine dehydrogenase (DPYD) and glutathione S-transferase pi-1 (GSTP1) polymorphisms are related to Chemotherapy-related adverse events. The present study was aimed to determine the role of DPYD and GSTP1 variants on patient chemotherapy toxicity risk among the Hakka population, minimize adverse events and in order to maximize therapy outcome for individualized treatment.Methods: Genotyping was examined in 104 patients diagnosed with CRC cases and receiving fluoropyrimidine and platinum drugs based chemotherapy regimen by direct sequencing of DPYD and GSTP1 polymorphisms. Three DPYD variants including *2A, *5A, *9A and GSTP1 c.313A>G were analyzed and clinical outcomes were assessed. Results: The data suggest that the incidence of DPYD*5A, DPYD*9A and GSTP1 c.313A>G variants were 37.5%, 24% and 31.7%, respectively. DPYD*2A variant was not found. A total of 38 patients (36.5%) suffered severe neutropenia and 23 patients (22.1%) suffered severe vomiting. DPYD*5A polymorphism was found significantly associated with grade 3/4 ulceration (p = 0.001). GSTP1 was determined to be an independent risk factor for severe neutropenia and ulceration (p = 0.010 and p = 0.034, respectively). Patients with GSTP1 c.313A>G wild type contributed to higher risk for grade severe toxicity compared with A/G + G/G genotype (p = 0.024). However, there was no significant difference between patients with DPYD*9A T/T and T/C + C/C genotype for chemotherapeutic toxicity.Conclusions: The results demonstrated that DPYD*5A and GSTP1 polymorphisms were useful predictors for severe events. Screening of single nucleotide polymorphisms of DPYD and GSTP1 in colorectal cancer patients prior to chemotherapy may help to realize personalized therapy.

Patient-reported outcomes in cancer patients admitted during the COVID 19 pandemic in a tertiary Spanish hospital.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e24098-e24098
Author(s):  
Veronica Velasco Durantez ◽  
Adán Rodríguez González ◽  
Maria Pilar Solis-Hernandez ◽  
Clara Iglesias Gomez ◽  
Alfonso Revuelta ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Patient Reported Outcomes ◽  
Advanced Disease ◽  
Stage Iv ◽  
Spanish Hospital ◽  
Patient Reported ◽  
Stage Iv Disease ◽  
Localized Disease ◽  
Grade 3 ◽  
Time Of Admission

e24098 Background: Patient reported outcomes measures (PROMs) represent a tool to objectively assess the health of cancer patients. PROMs may complement oncological evaluations by adding patients’ perspectives on their care priorities. Aim: to address more accurately the management of tumor related symptoms or drug related toxicities to bring he therapies more accurately to bring patients the best quality of life possible. Methods: Data was collected from our electronic registry after proper authorization and corresponding anonymization. Patients were systematically asked for symptoms as fever, diarrhea, dyspnea, vomiting and nausea. These symptoms were graded according to their severity using the Common Toxicity Criteria v5.0. Results: 49 patients admitted to Medical Oncology Hospitalization were included from July of 2020 to January 2021, 80% in advanced disease. Median age 63yo, 32% above 70 yo. Baseline data showed that 27% patients (19% stage IV) had fever at admission, decreasing at 48h to 4%. Patients who had vomiting at admission were 33% (28% stage IV) median grade 2 becoming 20% and grade 1 at 48h. Nausea was present in 49% patients (35% stage IV) at the time of admission with a median grade 1.5, and it decreased to 16% at 48h with a median grade 2. Diarrhea was reported in 12% patients (6% stage IV) median grade 2 at baseline and it was reduced to 10% median grade 1 at 48h. The median severity of diarrhea at admission was 2 and only 1 at 48h. At admission, 33% (all stage IV) of patients presented dyspnea with a median grade 3, while at 48h it was present in 26% of patients and reduced to median grade 2. Conclusions: By systematically measuring symptoms, patients achieved better control of diarrhea, dyspnea, vomiting and nausea after admission. It should be noted that nausea was the variable that decreased the most at 48h, followed by fever, vomiting, dyspnea and diarrhea. All patients with stage IV disease had dyspnea and most of them had nausea and vomiting. These results reflect that these symptoms are more usual in patients with advanced disease compared to those with localized disease. PROMS also help us educate patients by teaching them how to manage treatments, thus improving therapeutic adherence.

A pooled safety and efficacy analysis of the FOLFOX4 regimen (bi-monthly oxaliplatin plus fluorouracil/leucovorin) in elderly compared to younger patients with colorectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 3517-3517 ◽  
Author(s):  
D. J. Sargent ◽  
R. M. Goldberg ◽  
H. Bleiberg ◽  
A. De Gramont ◽  
C. Tournigand ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Elderly Patients ◽  
Response Rate ◽  
Advanced Disease ◽  
Dose Intensity ◽  
Younger Patients ◽  
Metastatic Relapse ◽  
Significant Difference ◽  
Grade 3

3517 Background: The combination of oxaliplatin, fluorouracil, and leucovorin is effective in many patients with colon cancer treated in either the advanced or adjuvant disease setting. To better identify the risks & benefits of this regimen for elderly patients we compared safety & efficacy data for the FOLFOX4 regimen (oxaliplatin plus fluorouracil/leucovorin administered bimonthly) in patients over & under 70 years of age. Methods: We conducted a retrospective analysis of 3742 patients (614 aged ≥ 70) with colorectal cancer enrolled in four clinical trials using the same FOLFOX4 regimen as adjuvant therapy, or as first- or second-line therapy in advanced disease. Endpoints included grade ≥ 3 adverse events, response rate (RR) (in studies of advanced disease), progression (metastatic)/relapse free (adjuvant) survival (P/RFS), overall survival (OS), and dose intensity. Results: Age ≥ 70 was associated with slightly higher rates of neutropenia and thrombocytopenia but no other grade ≥ 3 adverse events (see table). There was no difference in 60-day mortality (1.1% vs 2.3%, p=0.20). We observed no significant difference in any measure of therapeutic impact of FOLFOX based on age, including P/RFS, OS, response rate, or dose intensity (see table). Conclusions: The FOLFOX4 regimen maintains its efficacy/safety ratio in elderly patients with colorectal cancer, and was administered per protocol at similar drug doses compared to the younger patients enrolled on these trials. Age alone should not be a factor limiting the use of FOLFOX4 provided patients are carefully evaluated and monitored. This analysis was supported by Sanofi-Aventis [Table: see text] [Table: see text]

Results of a phase II trial of cetuximab+XELIRI as first-line therapy of patients with advanced and/or metastatic colorectal cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13502-13502
Author(s):  
T. H. Cartwright ◽  
P. Kuefler ◽  
A. Cohn ◽  
W. Hyman ◽  
K. A. Boehm ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Stage Iv ◽  
First Line ◽  
Patient Request ◽  
Prior Therapy ◽  
First Line Therapy ◽  
Stage Iv Disease ◽  
Grade 3 ◽  
Ecog Ps

13502 Background: We have previously shown that capecitabine/irinotecan (XELIRI) is effective and well-tolerated in metastatic colorectal cancer (mCRC). Cetuximab targets EGFR and is active in mCRC either alone or combined with chemotherapy. This study evaluated potential improved outcomes with cetuximab+XELIRI in first-line treatment of mCRC. Subjects and Methods: Subjects had histologically confirmed colorectal adenocarcinoma with T4 lesions that were deemed unresectable after preoperative chemoradiation and/or metastatic disease. Treatment: capecitabine 1700 mg/m2 (850 mg/m2 PO BID Days 1–14), irinotecan 200 mg/m2 IV Day 1 every 3 weeks, and weekly cetuximab (initial dose 400 mg/m2 IV over 120 minutes, subsequent doses 250 mg/m2 over 30 minutes). Toxicity was assessed at each visit. Results: Between February and October 2005, 70 subjects enrolled. Baseline characteristics: 43 males (61%), 79% White, median age 61.5 years (range, 32.2 - 85.4), and ECOG PS 0/1= 66%/34%. 63% of subjects had Stage IV disease at diagnosis; 87% of subjects had adenocarcinoma. Prior therapy: surgery (n=60, 86%), chemotherapy (n=14, 20%), and radiotherapy (n=5, 7%). Grade 3–4 treatment-related toxicities in >1 subject included diarrhea (17%); neutropenia and rash (8.5% each); dehydration (7%); nausea/vomiting (5%); and anorexia, dyspepsia, and hypokalemia (3% each). 30 subjects discontinued due to progressive disease (PD) (n=9), toxicity (n=12), MD decision (n=2), patient request/withdrew consent (n=3), death (n=1) and other (n=3; doses delayed >3 weeks). To date 5 subjects have died; no death was treatment-related. Evaluation of tumor responses is ongoing. Conclusions: The combination of cetuximab+XELIRI is feasible and well-tolerated in first-line mCRC. Updated safety and efficacy data will be presented. Funded in part by Bristol-Myers Squibb, Plainsboro, NJ. [Table: see text]

scholarly journals Rheumatological Adverse Events Following Immunotherapy for Cancer

Medicina ◽  
2022 ◽  
Vol 58 (1) ◽  
pp. 94
Author(s):  
Ioana Cretu ◽  
Bogdan Cretu ◽  
Catalin Cirstoiu ◽  
Adrian Cursaru ◽  
Mihaela Milicescu ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Adverse Reactions ◽  
Cancer Treatments ◽  
Treatment Conditions ◽  
Clinical Presentations ◽  
Rheumatic Manifestations ◽  
Grade 3 ◽  
Dose Dependent ◽  
Rheumatological Manifestations

Background and Objectives: The occurrence of rheumatological side effects in a patient after receiving immunotherapy for cancer is becoming increasingly common. Oncologists often fail to diagnose and refer affected patients to rheumatologists. This paper presents the various rheumatological adverse events that occur after immunotherapy in patients as well as their treatment and evolution. Materials and Methods: A total of 36 patients were monitored between November 2018 and March 2020. The oncologist monitoring the immunotherapy-treated patients identified the occurrence of musculoskeletal side effects. The grading of toxicities was performed by both the oncologist and the rheumatologist using common terminology criteria for adverse events (CTCAE). Rheumatological treatment was administered, and for some patients, immunotherapy was discontinued. Results: The clinical presentations of the patients varied. Mild side effects (grade 1–2) were reported in a higher proportion than severe side effects (grade 3–5). Therefore, thirty-one patients had mild-to-moderate side effects, and five patients had severe side effects. Adverse reactions occurred, on average, 10 weeks after the initiation of immunotherapy; this indicated that the severity of the toxicity was dose dependent. Patients were treated with NSAIDs or prednisone, depending on the severity of the side effects, and for patients with severe manifestations, immunotherapy was discontinued. The remission of rheumatic manifestations varied depending on the grade of the manifestations. Conclusions: The clinical, biological, and ultrasound presentations of the patients with adverse events followed by cancer treatments differed from classic rheumatological manifestations. Thorough examinations of these patients by both oncologists and rheumatologists are needed in order to correctly diagnose and treat rheumatological adverse events. Multiple studies that include a larger number of participants are needed in order to better understand the pathogenesis and clinical evolution of these patients under different treatment conditions.

scholarly journals A Postauthorization Survey to Document the Therapeutic Management of Oxaliplatin as a First-Line Chemotherapy Regimen in South Africa in Patients with Metastatic Colorectal Cancer

2014 ◽  
Vol 2014 ◽  
pp. 1-8
Author(s):  
Lydia M. Dreosti ◽  
Alicia McMaster ◽  
Rashem Mothilal
Keyword(s):  
Colorectal Cancer ◽  
South Africa ◽  
Survival Rate ◽  
Metastatic Colorectal Cancer ◽  
Chemotherapy Regimen ◽  
Stage Iv ◽  
Sensory Neuropathy ◽  
Therapeutic Management ◽  
First Line ◽  
Open Label

Oxaliplatin is a standard first-line treatment for metastatic colorectal cancer. The objectives were to document the therapeutic management of oxaliplatin in South Africa, determine the incidence and severity of sensory neuropathy, and record the 2-year survival rate. Meccelox was a prospective, noncontrolled, open label, multicentre, observational survey of adult patients with stage IV metastatic colorectal cancer treated with oxaliplatin-based chemotherapeutic regimens. The study was conducted from August 2007 to November 2011 in 29 sites in South Africa by 66 participating treating physicians. Among the 195 enrolled patients, 61% were treated with FOLFOX regimen (5-fluorouracil/folinic acid plus oxaliplatin) for an average of 12 cycles and 32% patients were treated with XELOX (capecitabine plus oxaliplatin) for an average of 6–8 cycles, with the main reason for discontinuation being completion of the preplanned prescribed regimen. In Meccelox survey, 80% of patients were treated with intent of palliation. Overall 64% of patients reported symptoms of sensory neuropathy. The 2-year survival rate was 30%. Conclusions. Patients received a specified preplanned number of chemotherapy cycles rather than being treated until disease progression or toxicity. Both the incidence of neuropathy and the 2-year survival rate were less than previous reports.

scholarly journals Adverse reactions to docetaxel: an active survey

2015 ◽  
Vol 51 (3) ◽  
pp. 551-559
Author(s):  
Leandro Cabral Pereira ◽  
Thaísa Amorim Nogueira ◽  
Leandro Augusto de Oliveira Barbosa ◽  
Sabrina Calil-Elias ◽  
Selma Rodrigues de Castilho
Keyword(s):  
Breast Cancer ◽  
Adverse Reactions ◽  
Breast Cancer Mortality ◽  
World Health ◽  
Healthcare Team ◽  
The Third ◽  
Naranjo Algorithm ◽  
Significant Difference ◽  
Grade 3 ◽  
Health Organization

The rates of breast cancer mortality remain high in Brazil. Docetaxel is a semi-synthetic taxane used to treat various tumors, particularly tumors of the breast, lung and prostate. In this study ADR that occurred in 45 docetaxel users with breast cancer were surveyed. They were identified by type, causality (Naranjo algorithm and World Health Organization categories) and, if considered probable or defined, rated for severity according to SOBRAFO proposal (2007). A total of 325 ADR were observed: 165 in the first, 137 in the second and 23 in the third cycle. Fifty seven ADR were immediate and the others, late. Fatigue and exhaustion for more than five days, classified as Grade 3 by SOBRAFO (2007), were reported as the primary late RAM. There was no significant difference in the occurrence of immediate and late ADR between cycles (p=1 and p=0.3577, respectively). The presence of a pharmacist gave the patients a better understanding of the occurrence of RAM, especially those that occur outside the hospital, between chemotherapy cycles and are often not reported to the healthcare team, creating institutional demands and reaching the goal to track, observe and correlate the RAM for each user.

Phase II study of irinotecan in the treatment of advanced colorectal cancer in chemotherapy-naive patients and patients pretreated with fluorouracil-based chemotherapy.

1997 ◽  
Vol 15 (1) ◽  
pp. 251-260 ◽  
Author(s):  
P Rougier ◽  
R Bugat ◽  
J Y Douillard ◽  
S Culine ◽  
E Suc ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Events ◽  
Metastatic Colorectal Cancer ◽  
Advanced Colorectal Cancer ◽  
Response Rate ◽  
Objective Response ◽  
World Health ◽  
Who Grade ◽  
Pretreated Patients ◽  
Grade 3

PURPOSE To assess the efficacy of irinotecan (CPT-11) in the treatment of advanced colorectal cancer in both chemotherapy-naive and pretreated patients. PATIENTS AND METHODS Two hundred thirteen patients (aged 18 to 75 years) with metastatic colorectal cancer, World Health Organization (WHO) performance status < or = 2, and life expectancy > or = 3 months were treated with CPT-11 350 mg/m2 every 3 weeks. All 178 patients eligible for efficacy analysis had not received more than one prior fluorouracil (5-FU)-based chemotherapy regimen (adjuvant or palliative) and had adequate hematologic, renal, and hepatic function. RESULTS Primary tumor sites were the colon (71%) and rectum (28%). Sixty-six percent of the patients had > or = two metastatic sites. Ninety-eight percent of the patients had undergone previous surgery, and 77.5% had received prior chemotherapy. Thirty-two of 178 eligible patients achieved on objective response (four complete responses [CRs] and 28 partial responses [PRs]; response rate, 18%; 95% confidence interval, 12.6% to 24.4%), 65 were stable, and 59 progressed. The response rate was 17.7% in the pretreated group and 18.8% in the chemotherapy-naive group. Within the former subgroup, response rates of 16.1% were reported in patients who were progressive on prior 5-FU chemotherapy and 19.1% in patients who were progressive off such treatment. The median duration of objective response (9.1 months) and median time to achievement of a response (9.3 weeks) did not differ between chemotherapy-naive and pretreated patients. The most frequent adverse events were neutropenia, which developed in 80% of the patients, delayed diarrhea (87%), alopecia (88%), fatigue (81%), and nausea/vomiting (77%). All these adverse events were manageable. Severe (WHO grade 3 or 4) neutropenia was only observed in 18% of the cycles, leukopenia in 11%, delayed diarrhea in 11%, and nausea and vomiting in 3%. Development of simultaneous grade 3 or 4 neutropenia and delayed diarrhea during 4% of the cycles was the safety issue of greatest concern. CONCLUSION CPT-11 has definite activity in the treatment of advanced metastatic colorectal cancer both in chemotherapy-naive and in pretreated patients who experienced disease progression on 5-FU, which suggests a lack of cross-resistance between CPT-11 and 5-FU. Diarrhea and neutropenia, the major toxicities of CPT-11, contribute to the risk to develop febrile neutropenic sepsis.

scholarly journals EPID-07. HEMATOLOGICAL ADVERSE EVENTS IN GLIOBLASTOMA PATIENTS TREATED WITH TEMOZOLOMIDE

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi75-vi76
Author(s):  
Catherine Garcia ◽  
Zin Myint ◽  
Rani Jayswal ◽  
Allison Butts ◽  
Heidi Weiss ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Protective Factor ◽  
Significant Proportion ◽  
Progression Free Survival ◽  
Free Survival ◽  
Significant Difference ◽  
History Of ◽  
Grade 3 ◽  
Severe Grade

Abstract BACKGROUND Temozolomide (TMZ) is the cornerstone for glioblastoma (GBM) treatment. A significant proportion of patients develops hematologic toxicities with limited investigations on outcomes and risk factors for their development. METHODS Our study combines data from the two largest group trials, RTOG 0525 and RTOG 0825, to analyze serious hematologic adverse events (HAE) associated with TMZ therapy for GBM. We analyzed frequency and outcomes of HAE during chemoradiation. RESULTS 1154 patients were evaluated with a median age of 57 years. Over 79% of patients developed HAE during the entire course of GBM treatment. During chemoradiation the most common HAE during chemoradiation was lymphopenia (41.5%), followed by thrombocytopenia (39.0%), and anemia (35.3%). Of these, 34.1% were severe (Grade 3 or 4) and 65.9% were mild (grade 1 or 2). During maintenance the most common HAE was leukopenia (50.7%), followed by neutropenia (50.4%), and lymphopenia (45.3%). MGMT methylation was not associated with HAEs. A history of HAEs during chemoradiation was a protective factor for developing HAEs during maintenance. MGMT methylated and age younger than 50 were protective factors for mortality. Patients that presented HAEs anytime during treatment had a longer overall survival and progression free survival. There was no significant difference in survival between mild or severe HAEs. CONCLUSION HAE are common during chemoradiation with TMZ for GBM, but are more commonly grade 1 or 2 per CTCAE. HAE during GBM treatment is associated with decreased progression free survival and overall survival.

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