A randomised prospective study of prolonged treatment with tocopherol and pentoxifylline, in addition to carbogen in the management of radiation late effects

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19682-19682
Author(s):  
S. M. Brennan ◽  
C. O Shea ◽  
O. Salib ◽  
M. Moriarty
Keyword(s):  
Treatment Duration ◽  
Radiation Effects ◽  
Negative Impact ◽  
Prolonged Treatment ◽  
Exact Test ◽  
Randomised Study ◽  
Ethical Approval ◽  
Radiation Late Effects ◽  
Grade 3 ◽  
Toxicity Scores

19682 Background: Pentoxifylline (PTX) and tocopherol (Vitamin E) are antioxidants previously shown to be useful in combination in the treatment of late radiation effects. To our knowledge, this is the first study to examine the clinical benefit of combination therapy with carbogen, tocopherol and pentoxifylline in the mitigation of late radiation effects. The optimal duration of PTX and tocopherol treatment has not been fully established. Therefore, we also studied short versus extended treatment duration. Methods: We conducted a phase II prospective randomised study of inhaled carbogen (95% oxygen + 5% carbon dioxide) over 90 minutes, 5 days per week for 3 weeks in addition to short versus prolonged treatment with pentoxifylline (800 mg) and tocopherol (1,000 IU) orally once daily. All 18 patients received carbogen therapy. Patients with grade 3 toxicity post radical radiotherapy for a variety of cancer primaries were eligible for the trial. The primary endpoint was improvement in maximum Lent-Soma toxicity scores. Ethical approval was obtained. Results: Maximum Lent-Soma scores improved with treatment in six of the eighteen patients giving a 33% response rate. The proportion of patients responding to treatment in the prolonged treatment arm B was more than double than in the shorter arm A (Fisher’s exact test: p = 0.321). Two patients in arm B had complete resolution of their symptoms, which was maintained at 2 and 3 years follow up. Conclusions: As late radiation effects are progressive by nature and have such a negative impact on quality of life in long-term cancer survivors, any treatment, which may ameliorate their symptoms, should be considered of benefit. This study confirms the benefit of prolonged treatment and we would recommend clinical use of these agents with treatment duration of at least 12 months, in the management of late radiation effects. No significant financial relationships to disclose.

Results of a longitudinal survey on quality of life (QoL) in 935 patients with supradiaphragmatic early stage Hodgkin lymphoma (HL) enrolled in the EORTC-GELA H8 trial (# 20931)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8582-8582
Author(s):  
N. Heutte ◽  
N. Mounier ◽  
H. Flechtner ◽  
A. M. Mellink ◽  
J. H. Meerwaldt ◽  
...  
Keyword(s):  
Treatment Duration ◽  
Negative Impact ◽  
Early Stage ◽  
Disease Free Survival ◽  
Eortc Qlq C30 ◽  
Grade 3 ◽  
Eortc Qlq ◽  
Involved Field ◽  
The Impact

8582 Background: To study the change in posttreatment QoL and fatigue in patients with supradiaphragmatic early stage HL. Methods: QoL assessment was made using the EORTC QLQ-C30 core questionnaire and fatigue was assessed using the MFI-20 questionnaire. Questionnaires were given immediately after treatment completion and every 6 months thereafter for at least a period of 5 years. Mixed models (Med Decis Making 2003;3:54–66) were used to assess statistically reliable changes of the variables tested with time because they allow unequal number of assessments per patients. Variables tested were the 7 functioning scales and the fatigue scale of the QLQ-C30 questionnaire, the 5 MFI-20 fatigue scales, and time using 6 time periods: 0–6, 7–14, 15–21, 22–32, 33–47, ≥48 months following the end of treatment. The impact of gender, age (<30, 30–49, ≥50 years), treatment (mantle-field irradiation, subtotal nodal irradiation (STNI), 3, 4 or 6 MOPP-ABV and involved-field irradiation or 4 MOPP-ABV and STNI) and treatment-related acute grade 3–4 toxicity was also tested. Patients were censored at relapse when occurred. Results: Of the 1577 patients enrolled in the trial (1993–1998), 935 (59%, median follow-up 7 years) participated for a total of 3,227 assessments. Main clinical characteristics did not differ between patients with missing QoL forms and those with complete data. There were no significant differences in disease-free survival between treatment arms. Significant (P<0.001) improvement with time was observed for all QoL and fatigue variables tested. Overall, young age and male sex significantly (P<0.01) correlated with improvement in all QLQ-C30 dimensions except cognitive functioning. Treatment duration ≥6 months had a significant (P<0.005) negative impact on global QoL. Age≥30 years and treatment duration ≥2 months negatively (P<0.05) influenced MFI-20 variable changes. Previous toxicity and age ≥30 years altered mental fatigue and motivation. Conclusions: QoL data from the reintegration process of patients into normal life during the first follow-up years show substantial limitations. The impact of treatment is limited. Fatigue remains of great concern in these patients. No significant financial relationships to disclose.

scholarly journals Pengaruh perilaku pedagang es campur terhadap penggunaan bahan kimia

2018 ◽  
Vol 3 (1) ◽  
pp. 82
Author(s):  
Fajriansyah Fajriansyah
Keyword(s):  
Negative Impact ◽  
Fisher Exact Test ◽  
Cross Sectional ◽  
Exact Test ◽  
Food Dyes ◽  
Chemical Content ◽  
Cross Sectional Design ◽  
Counseling And Guidance ◽  
Rhodamin B ◽  
Banda Aceh

Es campur merupakan salah satu makanan jajanan yang sangat umum dimasyarakat. Es campur yang dijual bebas dipasar mempunyai kandungan zat warna yang sangat berbahaya bagi masyarakat. Rendahnya pengetahuan pedagang serta tindakan mereka berdampak negatif bagi konsumen. Penelitian ini bertujuan untuk mengukur hubungan pengetahuan dan tindakan pedagang es campur terhadap penggunaan bahan kimia di Kota Banda Aceh. Penelitian menggunakan desain potong lintang yang dilakukan pada 23 pedagang es campur di Kota Banda Aceh. Data yang dikumpulkan meliputi data pengetahuan, tindakan dan data penggunaan bahan kimia. Pengumpulan data dlakukan secara wawancara dan pengujian laboratorium. Uji statistik yaitu fisher ecxact test pada CI95%. Hasil penelitian menunjukan rendahnya pengetahuan (60,9%) dan tindakan (69,6%) pada pedagang, serta tingginya kandungan Rhodamin pada es campur (52,2%). Pengentahuan dan tindakan pedagang mempunyai hubungan signifikan dengan tingginya kandungan bahan kimia pada es campur (p < 0,05). Kesimpulan, rendahnya pengetahuan dan kurang baiknya tindakan pedagang sangat signifikan terhadap tingginya kandungan bahan kimia Rhodamin B pada es campur. Saran, perlu penyuluhan dan pembinaan secara rutin kepada pedagang tentang bahaya zat warna non pangan dan akibatnya terhadap kesehatan. Kata Kunci : Pengetahuan, tindakan, Rhodamin B, es campur  Ice mix is one of the most common food snacks in the community. The mixed free-mixed ice on the market has a very dangerous dye content for the community. The low knowledge of traders, as well as their actions, have a negative impact on consumers. This study aims to measure the correlation of knowledge and action of the merchant of mixed ice against the use of chemicals in Banda Aceh. The study used a cross-sectional design performed on 23 ice-mix traders in Banda Aceh City. The data collected includes data on knowledge, action, and data on the use of chemicals. Data collection was conducted by interview and laboratory testing. The statistical test is Fisher exact test at CI95%. The results showed low knowledge (60.9%) and action (69.6%) on traders, as well as the high content of Rhodamine on mixed ice (52.2%). Trader's knowledge and actions have a significant relationship with the high chemical content in the mixed ice (p <0.05). Conclusion, low knowledge and lack of merchant action are very significant to the high content of Rhodamin B chemicals on the mixed ice. Advice, need counseling and guidance on a regular basis to the trader about the dangers of non-food dyes and the consequences on health. Keywords: Knowledge, action, Rhodamine B, mixed ice

Optimising pyrazinamide for the treatment of tuberculosis

2021 ◽  
pp. 2002013
Author(s):  
Nan Zhang ◽  
Radojka M. Savic ◽  
Martin J. Boeree ◽  
Charles Peloquin ◽  
Marc Weiner ◽  
...  
Keyword(s):  
Treatment Duration ◽  
Liver Toxicity ◽  
Liver Function Tests ◽  
P Value ◽  
Pharmacokinetic Data ◽  
Drug Concentrations ◽  
High Doses ◽  
Grade 3 ◽  
Parametric Survival ◽  
Culture Conversion

Pyrazinamide is a potent sterilising agent that shortens the treatment duration needed to cure tuberculosis. It is synergistic with novel and existing drugs for tuberculosis. The dose of pyrazinamide that optimises efficacy while remaining safe is uncertain, as is its potential role in shortening treatment duration further.Pharmacokinetic data, sputum culture, and safety laboratory results were compiled from TBTC Studies 27 and 28 and PanACEA MAMS-TB, multi-center Phase 2 trials in which participants received rifampicin (range 10–35 mg·kg−1), pyrazinamide (range 20–30 mg·kg−1), plus two companion drugs. Pyrazinamide pharmacokinetic-pharmacodynamic (PK/PD) and PK-toxicity analyses were performed.In TBTC studies (n=77), higher pyrazinamide maximum concentration (Cmax) was associated with shorter time to culture conversion (TTCC) and higher probability of two-month culture conversion (p-value<0.001). Parametric survival analyses showed that relationships varied geographically, with steeper PK-PD relationships seen among non-African than African participants. In PanACEA MAMS-TB (n=363), TTCC decreased as pyrazinamide Cmax increased and varied by rifampicin Cmax (p-value<0.01). Modeling and simulation suggested that very high doses of pyrazinamide (>4500 mg) or increasing both pyrazinamide and rifampicin would be required to reach targets associated with treatment shortening. Combining all trials, liver toxicity was rare (3.9% with Grade 3 or higher liver function tests, LFT), and no relationship was seen between pyrazinamide Cmax and LFT levels.Pyrazinamide's microbiologic efficacy increases with increasing drug concentrations. Optimising pyrazinamide alone, though, is unlikely to be sufficient to allow tuberculosis treatment shortening; rather, rifampicin dose would need to be increased in parallel.

scholarly journals Sorafenib treatment by Child–Pugh score in Latin American patients with hepatocellular carcinoma

2020 ◽  
Vol 16 (31) ◽  
pp. 2511-2520
Author(s):  
Laura L de Guevara ◽  
Lucy Dagher ◽  
Vanessa MV Arruda ◽  
Keiko Nakajima ◽  
Masatoshi Kudo
Keyword(s):  
Hepatocellular Carcinoma ◽  
Adverse Events ◽  
Latin American ◽  
Treatment Option ◽  
Real World ◽  
Safety Profile ◽  
Treatment Duration ◽  
Sorafenib Treatment ◽  
Safety And Efficacy ◽  
Grade 3

Aim: To evaluate sorafenib treatment in Latin American patients with unresectable hepatocellular carcinoma in the real-world GIDEON study. Patients & methods: Sorafenib administration, safety and efficacy were analyzed by Child–Pugh status. Results: Of 90 evaluable patients (37% Child–Pugh A, 46% Child–Pugh B and 3% Child–Pugh C at study entry), 97% started sorafenib at 800 mg/day. Patients with Child–Pugh B7 had the longest median treatment duration of sorafenib (33.1 weeks). Sorafenib-related adverse events occurred in 58% of patients with Child–Pugh A (21% grade 3/4) and 46% with Child–Pugh B (7% grade 3/4). Conclusion: Sorafenib had a similar safety profile across patients with Child–Pugh A and B and is a treatment option for both groups.

scholarly journals The Evaluation of Dental Anxiety in Primary School Children: A Cross-Sectional Study from Romania

Children ◽  
2020 ◽  
Vol 7 (10) ◽  
pp. 158
Author(s):  
Ramona Vlad ◽  
Anca Maria Pop ◽  
Peter Olah ◽  
Monica Monea
Keyword(s):  
Salivary Cortisol ◽  
Negative Impact ◽  
Dental Anxiety ◽  
Cross Sectional Study ◽  
Current Data ◽  
Primary School Children ◽  
Cross Sectional ◽  
Exact Test ◽  
Salivary Cortisol Level ◽  
Cortisol Levels

Current data report that high levels of dental anxiety in children have a negative impact on oral health. The aim of this study was to measure dental anxiety, based on the Abeer Children Dental Anxiety Scale (ACDAS) used as a self-reported measure and to correlate its values with the salivary cortisol levels. The study was conducted in 2019 and included 389 children aged 6–9 years old; evaluation of dental anxiety and saliva sampling were performed. The influence of gender on the presence of dental anxiety was analyzed using Fisher’s exact test, the salivary cortisol level was compared between anxious and non-anxious children and was further correlated with the ACDAS score (p < 0.05). Girls had higher odds of experiencing dental anxiety (odds ratio: 1.533, p = 0.041). Salivary cortisol levels were higher in anxious compared to non-anxious children (median 1.251 vs. 1.091 ng/mL, p < 0.001) and showed a positive moderate correlation with the ACDAS score (r = 0.411, p < 0.001). Children aged 6–9 years have a high prevalence of dental anxiety, with girls being more susceptible to this condition. Salivary cortisol levels are higher in anxious children and correlate positively with the ACDAS score, proving that ACDAS can be used for the detection of dental anxiety.

scholarly journals The impact of anthropogenic factors on the natural values of the water reservoirs in Sosnowiec (Poland)

2015 ◽  
Vol 3 (1) ◽  
pp. 20-25 ◽  
Author(s):  
Dominika Dąbrowska ◽  
Marek Sołtysiak
Keyword(s):  
Open Space ◽  
Negative Impact ◽  
Rank Correlation ◽  
Anthropogenic Factors ◽  
Water Reservoirs ◽  
Amphibian Species ◽  
Exact Test ◽  
Positive Correlations ◽  
The Impact

Abstract Many plant and animal species are closely related to the aquatic environment. Small reservoirs are a place of the biodiversity concentration. Reservoirs are especially important for amphibian species as a place of feeding, shelter and wintering. Many anthropogenic factors has a significant impact on the natural values of water reservoirs (surroundings of the water reservoirs, the shore`s type, distance from roads and buildings, the role of the object and the chemical status). They can eliminate or change amphibian population. The effect of three such factors was determined for one of the cities in the Upper Silesian Agglomeration - Sosnowiec (91 km2). The paper presents an assessment of the impact of the type of surroundings, the percentage share of the open space around water reservoirs and the distance from roads and buildings on the number of amphibian species present in the reservoir. In the analysis were taken into account 20 reservoirs, in which amphibian species were found. This analysis indicates the influence urban factors on the number of amphibian species in water reservoirs based on positive correlations in the case of Spearman Rank correlation and the Fisher’s exact test. Results of these calculations highlight the negative impact of the anthropopressure (the changes in the environment) on the amphibian breeding places and the biodiversity.

Expression of Inhibitory Fc Receptor (FcγRIIB) Is a Marker of Poor Response to Rituximab Monotherapy in Follicular Lymphoma (FL).

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2747-2747
Author(s):  
Chern Siang Lee ◽  
Margaret Ashton-Key ◽  
Sergio Cogliatti ◽  
Susanne Crowe ◽  
Mark S Cragg ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Single Agent ◽  
Poor Response ◽  
Prolonged Treatment ◽  
Induction Treatment ◽  
Type Ii ◽  
Exact Test ◽  
Fisher's Exact Test ◽  
Significant Difference ◽  
Fisher’S Exact Test

Abstract Abstract 2747 Background: Single-agent immunotherapy with rituximab is a viable treatment option for low risk FL, with limited toxicity and a long duration of response in some patient subsets. We have previously shown that high expression of FcγRIIB promotes rituximab internalisation on various B cell targets, including FL (Blood 2011 118:2530–2540), something not seen with type II anti-CD20 antibodies. The SAKK 35/98 trial examined rituximab monotherapy in FL and now has long-term follow-up data of almost 10 years (JCO 2010 28:4480–4484). We analysed diagnostic tumour samples from this trial to determine the relationship of FcγRIIB expression to responses and clinical outcomes after rituximab treatment in FL. Methods: 202 patients (pts) with newly diagnosed or relapsed FL received induction treatment with rituximab 375 mg/m2 weekly for 4 weeks. Pts with stable or responding disease at week 12 were randomized into 2 groups: no further treatment or prolonged treatment with single infusions of rituximab 375 mg/m2 at weeks 12, 20, 28 and 36. Archived tissue samples from 135 evaluable pts were stained using an anti-human FcγRIIB antibody (clone EP888Y, Abcam) at a dilution of 1:3000 on a Dako autostainer. The samples were pretreated with the Dako EnVisionFLEX target retrieval solution high pH and detection using the Dako AS-Link 48 with Dako EnVision flex plus detection kit. Positive samples were graded into negative/low intensity staining (n=120) versus medium/high (n=13) by an expert lymphoma histopathologist blinded to the clinical outcomes. Data from 2 slides and response at week 12 data for 4 pts were unavailable (1 of whom also has missing slide data), resulting in 130 pts available for analysis. Failure-free survival (FFS) was defined as time from registration until failure to achieve complete/partial response at week 12, progression, relapse, a second cancer or death from any cause. Objective response rate (ORR) was associated with intensity staining levels using Fisher's exact test. All time-to-event endpoints were evaluated using the Kaplan-Meier method; groups were compared using the log-rank test. The hazard ratio (HR) was assessed using Cox proportional hazards models. Results: Registered and randomised pts had very similar baseline characteristics; previously untreated pts had slightly more favourable characteristics but were balanced between the 2 treatment arms. Pts expressing medium/high levels of FcγRIIB were less likely to respond to rituximab by week 12 (ORR 58.1% vs 23.1%, Fisher's exact test, p=0. 02), a finding independent of prior therapy. For FFS, there was a statistically significant difference (p=0.001; HR=0.42; 95% confidence interval (C.I.): 0.23–0.77) between the negative/low staining group (median: 21.4 months; 95% C.I.: 7.0–34.2) and the medium/high staining group (median: 7.0 months; 95% C.I.: Not calculable). The interaction between staining levels and randomised treatment groups for FFS was not statistically significant. There was a non-significant trend towards better overall survival in the low/negative group (median: 140.0 vs 50.0 months; p=0.15; HR=0.57; 95% C.I.: 0.27–1.23); however the event rate was lower (36.8% vs 61.5%). Conclusion: Elevated FcγRIIB expression level is associated with poor response to rituximab in pts with FL. This group may show better results with non-internalising type II antibodies, a hypothesis for validation in future prospective clinical trials. Disclosures: Ghielmini: Roche: Honoraria, Speakers Bureau. Johnson:Roche: Honoraria.

A phase I trial of PEGylated glutaminase (PEG-PGA) in combination with 6-diazo-5-oxo-L-norleucine (DON) in advanced, refractory, solid tumors

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14040-14040
Author(s):  
C. Mueller ◽  
S. Al-Batran ◽  
E. Jaeger ◽  
M. Bausch ◽  
N. Sethuraman ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Treatment Duration ◽  
Phase I Trial ◽  
Small Cell ◽  
Toxicity Profile ◽  
Small Cell Lung ◽  
Competitive Mechanism ◽  
Grade 3 ◽  
Tolerable Dose ◽  
Favorable Toxicity Profile

14040 Background: Tumor cells are avid glutamine consumers and highly dependent on extracellular glutamine supply. Based on a competitive mechanism, the effectiveness of the glutamine analogue DON is enhanced if the available pool of glutamine is significantly (below 10% of baseline) depleted by PEG-PGA. Methods: The study was designed to determine the maximal tolerable dose (MTD) of DON in combination with PEG-PGA. The patients received intravenous PEG-PGA 120 I.U./m2 in combination with DON twice weekly for six weeks followed by a tumor assessment according to RECIST. DON dose was escalated from 5 to 185 mg/m2 using modified Fibonacci design and traditional 3-patient cohorts. Results: Fifty-eight pts (23f/35m) received at least 1 drug administration and were evaluable for the analysis. Median age was 62 (range 43–79) and median Karnofsky PS was 90% (range 70%-100%). Median treatment duration was 29 days (range 1–106). Nausea and vomiting represented the most common non-hematological grade 3 toxicities, being observed in 6.9% and 10.3% of pts, respectively. Hematological side effects were G4 leuco- and neutropenia (1.7%) and G3 thrombocytopenia (1.7%). The treatment was very well tolerated with all other grade 3 or 4 toxicities affecting less than 5% of patients. Forty-six pts were evaluable for efficacy. Stable disease was observed in 20 (43.5%) pts, including MR (>10%) in 5 (10.8%) pts. The efficacy was dose depended. Conclusions: The combination of PEG-PGA and DON is active and has a favorable toxicity profile. The MTD is now investigated in a Phase IIa trial in patients with refractory colorectal, renal or non small cell lung cancer. The accrual will be finished by January 2007. No significant financial relationships to disclose.

Association of a 2-weeks-on and 1-week-off schedule of sunitinib with decreased toxicity in metastatic renal cell carcinoma.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 406-406 ◽  
Author(s):  
Yana George Najjar ◽  
Paul Elson ◽  
Laura S. Wood ◽  
Jorge A. Garcia ◽  
Robert Dreicer ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Metastatic Renal Cell Carcinoma ◽  
Renal Cell ◽  
Treatment Duration ◽  
Optimal Schedule ◽  
Cleveland Clinic ◽  
Hand Foot Syndrome ◽  
Prior Systemic Therapy ◽  
Grade 3

406 Background: Treatment of metastatic renal cell carcinoma (mRCC) with sunitinib can be associated with toxicity leading to dose reduction. Maintaining adequate sunitinib dosing and avoiding dose interruptions that lower drug levels are essential for optimizing clinical efficacy. Standard sunitinib schedule is 4 weeks of treatment and 2 weeks of rest (schedule 4/2). Empirically in clinical practice, several metastatic RCC patients at The Cleveland Clinic (CCF) have been changed from a 4/2 schedule to a 2 weeks on /1 week off (2/1) schedule after experiencing toxicity in an attempt to maintain daily dose but reduce toxicity. Methods: The medical records of mRCC patients who were changed to a 2/1 schedule of sunitinib at CCF were retrospectively reviewed. Patient toxicity on each schedule was recorded during routine clinic visits and graded according to the Common Toxicity Criteria, version 4.0. Results: 21 patients were identified: 71% male, 78% clear cell histology, and 29% prior systemic therapy. All but one had prior nephrectomy. 95% of patients on the 4/2 schedule had grade 3 or 4 toxicity which led to the schedule change to 2/1. No grade 4 toxicities were observed on the 2/1 schedule, and 33% of patients experienced grade 3 toxicity (p = 0.0001 for comparison of worst grade toxicity on 4/2 versus 2/1). Two of the most common toxicities, fatigue and hand-foot syndrome (HFS), were significantly less frequent on the 2/1 schedule than on the 4/2 schedule (fatigue 52% all grade/33% grade 3 on 4/2 versus 33%/14% on 2/1; HFS 33%/29% on 4/2 versus 14%/0% on 2/1; p =.04 for both). Median overall treatment duration on the 4/2 schedule was 13.5 months (range 1.1-60.6 months) and median overall treatment duration on the 2/1 schedule was 24.4 months (range 1.3 to 67.6+ months). Conclusions: Treatment with sunitinib on a 2/1 schedule is associated with significantly decreased toxicity in patients who initially experience grade 3 or greater toxicity on the 4/2 schedule and can extend treatment duration considerably. Prospective clinical trials are required to define the optimal schedule of sunitinib to balance efficacy and toxicity.

Adjuvant chemotherapy related toxicities and their impact on treatment cessation in elderly patients with breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21527-e21527
Author(s):  
Muhammad Iqbal ◽  
Sukesh Manthri ◽  
Kathy Robinson ◽  
Robert S. Mocharnuk ◽  
Meghna R. Desai
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Bone Pain ◽  
Binary Logistic Regression ◽  
Breast Cancer Patients ◽  
Cognitive Changes ◽  
Exact Test ◽  
Therapy Termination ◽  
Conflicting Evidence ◽  
Grade 3

e21527 Background: Data from the National Cancer Institute’s Surveillance Epidemiology and End Results program show that the incidence of breast cancer is 243.1 per 100,000 in women 65 years of age and older. Guidelines regarding the management of older breast cancer patients are lacking due to their underrepresentation in adjuvant therapy trials and conflicting evidence regarding the benefits of therapy. The objective of this study was to investigate the frequency of adjuvant chemotherapy related side effects and their correlation with early termination of therapy in elderly breast cancer. Methods: We collected retrospective data in patients with in situ or invasive breast cancer diagnosed after the age of 65.Docetaxel & cyclophosphamide, doxorubicin & cyclophosphamide, tratuzumab in combination and other regimens were studied. Fisher’s exact test was used to determine an association between grade 3 or 4 toxicities and therapy termination. Binary logistic regression was used to assess whether a specific toxic effect could predict for early discontinuation of therapy. Treatment termination was defined as inability to tolerate the proposed number of chemotherapy treatment cycles. Results: Among 269 eligible cases, 72 (26.76%) patients were offered adjuvant chemotherapy. Most patients (n = 58, 80.55%) accepted chemotherapy but 14 (19.44%) refused. Nausea (n = 16, 27.6%), vomiting (n = 8, 13.8%), diarrhea (n = 12, 20.7%), stomatitis (n = 3, 5.2%), hypersensitivity (n = 3, 5.2%), rash (n = 10, 17.2%), hepatotoxicity (n = 1, 1.7%), neuropathy (n = 12, 20.7%), cognitive changes (n = 3, 5.2%), bone pain (n = 5, 8.6%), anemia (n = 15, 25.9%), thrombocytopenia (n = 7, 12.1%), neutropenia (n = 16, 27.6%), cardiotoxicity (n = 1, 1.7%), hospitalization due to neutropenic fever (n = 5, 8.6%) and pneumonia (n = 2, 3.4%) were observed. Among 17 patients who discontinued chemotherapy, 23.5% reported bone pain (OR = 12, 95%CI:1.22-117.2, p = 0.024) and 47.1% developed neutropenia (OR = 3.55, 95%CI:1.04-12.13, p = 0.054). Other toxicities were not significantly associated with therapy discontinuation. Conclusions: The odds of terminating chemotherapy early increases for those who experience grade 3 or 4 bone pain and neutropenia.

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