Rate Of Mucositis Research Articles

Palifermin reduces infection rate and hyperfibrinogenemia in patients treated with high-dose chemotherapy based on beam or BU-thiothepa.

We performed a retrospective study in patients who underwent high-dose chemotherapy and auto-SCT because of haematological malignancies. Forty patients were treated with palifermin while 80 were controls selected after being matched for diagnosis and length of neutropenia. Patients treated with BEAM or BU-CY or THIO-CY (BEAM/BUS) displayed, after palifermin, a lower rate of severe oral mucositis (P=0.03). This beneficial effect of palifermin was not evident in the stratum of patients treated with high-dose melphalan (HD-PAM). After palifermin, we observed in the whole treated population a reduced rate of 'fever of unknown origin' (FUO, P=0.02) and of severe infections not related to Gram-positive bacteria (FUO, Gram-negative bacteremia or pneumonia) (P=0.003). This effect of palifermin on infections not related to Gram-positive bacteria was evident only in patients receiving BEAM/BUS (P=0.01) and not in patients treated with HD-PAM (P=0.11). Fibrinogen peak in plasma was found to be reduced after palifermin in the whole population (P=0.01) and in the stratum who received BEAM/BUS (P=0.02) but not in the stratum of HD-PAM. In conclusion, anti-infectious beneficial effects of palifermin are more evident in BEAM/BUS-treated patients and toward some types of infections. Reduction of fibrinogen level after palifermin suggests that this agent reduces not only the rate of infections but also their severity.

Phase II multicenter trial of Caphosol for the reduction of mucositis in patients receiving radiation therapy for head and neck cancer

We conducted a phase II multicenter study evaluating Caphosol in patients receiving head and neck radiation (H/N RT) +/- chemotherapy or biologic sensitizer. The primary endpoint of the study tested the rate of functional mucositis (WHO grade > or equal to 2) with the hypothesis that <75% of patients would develop > or equal to 2 mucositis with Caphosol compared with a historical rate of >90%. New methods were applied with higher than historic rigor. 5 Institutions were included in this study: Moffitt Cancer Center (MCC), MD Anderson Cancer Center (MDACC), Duke University Cancer Center (DUCC), University of Florida (UF) and Temple University Cancer Center (TUCC). Caphosol was taken by patients at least 4 times a day and up to 10 times per day commencing with day 1 of RT and for a total duration of 8 weeks after completion of RT. Detailed questionnaires were completed weekly by patients and a unique algorithm was used to generate the WHO grade of mucositis. 98 Patients were enrolled in the study. 59/98 (60%) patients were evaluable for the primary endpoint giving us 80% power. All evaluable patients experienced WHO grade > or equal to 2 mucositis and the trial failed to reject the null hypothesis. > or equal to 2 mucositis rates at weeks 2, 4, 6, 11 and 15 were as follows: 45%, 90%, 98%, 71%, 50%. We were unable to demonstrate that Caphosol significantly reduced WHO grade 2 or higher mucositis below a 90% historic rate. We are not surprised with this finding given our rigorous methodology in grading.

Randomized Double-Blind Clinical Trial Comparing Clobetasol and Dexamethasone for the Topical Treatment of Symptomatic Oral Chronic Graft-Versus-Host Disease

Patients who undergo allogeneic stem cell transplantation frequently develop an immunologic disease caused by the reactivation of the graft to the host tissues. This disease is called graft-versus-host disease (GVHD) and it is usually a systemic disorder. In a large proportion of cases, oral disorders that are related to a chronic phase of GVHD (cGVHD) occur, and their treatment involves the use of topical immunosuppressive drugs. Several medications have been studied for this purpose, but only a small number of clinical trials have been published. The present study is a randomized, double-blind clinical trial that compares topical clobetasol and dexamethasone for the treatment of symptomatic oral cGVHD. Patients were randomly assigned to treatment with clobetasol propionate .05% or dexamethasone .1 mg/mL for 28 days. In both arms, nystatin 100,000 IU/mL was administered with the corticosteroid. Oral lesions were evaluated by the modified oral mucositis rating scale (mOMRS) and symptoms were registered using a visual analogue scale. Thirty-five patients were recruited, and 32 patients were randomized into the study groups: 18 patients (56.3%) to the dexamethasone group and 14 patients (43.8%) to the clobetasol group. The use of clobetasol resulted in a significant reduction in mOMRS total score (P = .04) and in the score for ulcers (P = .03). In both groups, there was significant symptomatic improvement but the response was significantly greater in the clobetasol group (P = .02). In conclusion, clobetasol was significantly more effective than dexamethasone for the amelioration of symptoms and clinical aspects of oral lesions in cGVHD.

Intervention efficacy of holding ice cream in the mouth for radioactive oral mucositis prevention and treatment

Objective To explore the effect of oral ice cream holding for prevention and treatment of radioactive oral mucositis .Methods Sixty patients with oral and maxillofacial carcinoma were included and divided into control group and intervention group through a random number table , with 30 cases in each group . Patients in the control group accepted routine oral care after radiotherapy daily .Besides that , patients in intervention group hold the ice cream in the mouth 30 min before and after radiotherapy daily .The occurrence of radioactive oral mucositis was recorded .Results From 0 to IV degree, oral mucositis occurred in twelve , eight, four, four, two cases respectively in control group;but that in the control group was nineteen ,five,three,two, one cases respectively .There were three cases in the control group eventually who stopped radiotherapy for oral mucositis, only one case to stop radiotherapy in the intervention group .The difference of the rate of radioactive oral mucositis between the two groups was statistically significant （H=14.1, P=0.00）.The average time of the first appearance of oral mucositis in each degree in the intervention group were shorten than those of the control group, which showed statistically significant differences （ t =6.7, 3.8, 11.2, 33.1, 19.3, respectively;P<0.05）.Conclusions Holding ice cream in the mouth after radiotherapy is an effective way to prevent and treat oral mucositis , and it is a simple , practicable , and acceptable way for patients . Key words: Oral ice cream holding; Maxillofacial carcinoma; Radioactive oral mucositis

The Choice of Multiple Myeloma Induction Therapy Affects the Frequency and Severity of Oral Mucositis After Melphalan-Based Autologous Stem Cell Transplantation

Mucositis is a common complication of high-dose melphalan (HDM) used before autologous stem cell transplantation (ASCT) for multiple myeloma (MM). Mucositis rates are influenced by previous chemotherapy (CT) exposure. We examined the effect of induction therapy before ASCT on ASCT mucositis rates. Patients undergoing first 200 mg/m(2) HDM ASCT were assessed. Those receiving < 200 mg/m(2), or those with previous ASCT were excluded. Patients were evaluated depending on type of induction therapy (CT, immunomodulatory drug [IMiD], or proteasome inhibitor [PI]) before ASCT. A case record review was performed and data collected on response to induction, rates of Grade 3/4 mucositis, and days of total parenteral nutrition (TPN) or parenteral opiate analgesia. One hundred twenty-eight patients with ASCT were assessed. Induction therapy was CT- (n = 62), IMiD- (n = 51), or PI-based (n = 15) therapy. Patient characteristics were overall similar, including median age, MM stage, and CD34(+) cell dose. IMiD-based therapy patients had lower rates of mucositis (33% vs. 53%; P = .03) and less opiate requirements (10% vs. 31%; P = .02) compared with those treated with CT. Rates of mucositis and opiate use in the PI group were not different to the CT cohorts (33% vs. 53%; P = .6 and 13% vs. 31%; P = .13), likely due to concurrent anthracycline exposure. TPN usage was similar (CT, 42%; IMiD, 35%; and PI, 20%), as was neutropenia duration and antibiotic usage. Patients treated with IMiD-based regimens before HDM ASCT had significantly lower rates of mucositis than those treated with CT-based therapy. There were too few patients who received PI therapy to evaluate the effect.

The Effect of Keratinized Mucosa Width on Peri‐Implant Outcome under Supportive Postimplant Therapy

AbstractBackgroundLong‐ranging data on the influence of keratinized mucosa (KM) on peri‐implant tissue status have been scarce.PurposeRetrospective evaluation of peri‐implant diseases and KM width in patients with versus without mucogingival surgery.Materials and MethodsUnder supportive postimplant therapy (SIT) in a private practice, 68 patients with peri‐implant KM widths &lt;1 mm were identified between 1992 and 2011 (eight dropouts). Thirty patients rejected surgery (control [C] group), and 30 patients agreed (intervention [I] group). After at least 1 year, KM width, mucositis, and peri‐implant conditions were assessed.ResultsSixty nonsmoking patients (n = 105 implants) were available for assessment after 12.10 ± 4.93 years. No implants were lost (survival rate: 100%). An average of 10.69 years after surgery, the I group implants showed a mean KM gain of 3.10 ± 1.43 mm (C group: 0 mm).The mucositis rates were as follows: I group: 38.98%; C group: 31.91%. Peri‐implantitis was detected in two implants (1.87%) and two individuals (6.67%) in the I group.No significant differences between groups were found, except that the KM width values were significantly greater in the I group (p &lt; 0.001).ConclusionsLow incidences of peri‐implant diseases over long periods can be expected in patients attending SIT programs, independent of the absence or presence of KM.

A phase III randomized study comparing neoadjuvant chemotherapy with concurrent chemotherapy combined with radiotherapy for locoregionally advanced nasopharyngeal carcinoma: Updated long-term survival outcomes

To determine whether concurrent chemoradiotherapy (CCRT) can improve survival rates compared to the neoadjuvant chemotherapy (NACT) regimen in locoregionally advanced nasopharyngeal carcinoma (NPC) patients. A total of 338 patients with biopsy-proven NPC were randomly assigned to receive NACT followed by radical radiotherapy (RT) then adjuvant chemotherapy (AC) or CCRT followed by AC. With a median follow-up of 60 months, the 5-year overall survival (OS) rate did not differ significantly between two groups (75.5% vs 79.4% in CCRT and NACT group respectively, P=0.47, HR=0.84, 95%CI 0.53-1.33). Metastasis-free survival (MFS) rate was significantly improved by the CCRT (79.0% vs 86.9%, P=0.05, HR=0.59, 95%CI 0.35-1.00). Subgroup analysis indicated that the benefit of CCRT was derived from N0/N1 tumors (78.0% vs 93.5%, P=0.05, HR=0.35, 95%CI 0.12-0.99). Higher rates of mucositis (52.4% vs. 35.9% P=0.02) and vomiting (13.7% vs. 4.7% P=0.00) were noted in the CCRT arm. Late toxicities were similar in two groups. The updated results demonstrated no significant survival benefit of CCRT over NACT in patients with locoregionally advanced NPC. CCRT only showed significant MFS efficacy in T3-4N0-1 populations.

The Effect of Education and Communication for Self-Oral Care in Cancer Patients Undergoing Chemotherapy

Purpose: Oral mucositis can be occurred very often in cancer patients w ho are undergoing chemotherapy. It is very troublesome to cancer patients because it causes pai n, gingival bleeding, nutritional imbalance due to poor oral intake, and sometimes leads to longer hospital stay and poor quality of life. However, it can be prevented or ameliorated by active oral care. This study was designed to improve chemotherapy-induced oral mucositis by means of active education and communication activity according to a standardized protocol for self-oral care. Methods: Seventy cancer patients who were admitted to hospital for chem otherapy and had grade I oral mucositis were enrolled. These patients were educated with one to one method for self-oral care including concept of mucositis along with the importance of self-oral care, and the method of brushing teeth and gargling, etc. Communication activity for it was performed by nurses and physician together, giving feedback and reeducation to patients. The effect of education and communicat ion activity was assessed by the survey from patients. Results: The survey showed that the level of awareness for oral mucositis, the method of brushing and gargling were improved significantly after education and communication activity. The rate of oral mucositis was also reduced after these activity. Conclusion: We conclude that education and communication activity enable cancer patients to do more effective self-oral care and to reduce oral mucositis.

Oral microbiota: An overlooked etiology for chemotherapy-induced oral mucositis?

Oral mucositis, characterized by inflammatory response and cell loss in the epithelial cells lining of the oral cavity, is one of the most debilitating adverse effects of chemotherapy. In patients undergoing high-dose myeloablative therapies, the incidence rate of oral mucositis is almost 100%, and in cancer patients undergoing standard-dose chemotherapy the rate is 40e60%. Chemotherapeutic agents with pronounced stomatotoxic effects are listed in Table 1. Pain, odynophagia, dysguesia, and subsequent malnutrition of oral mucositis have become a common reason for decreasing the dosages of antineoplastic agents, necessitating deference or cessation of antineoplastic treatments, and preventing patients from optimal chemotherapy regimens, ultimately leading to higher mortality in cancer patients. In addition, a vast variety of microorganisms including bacteria, fungi, and viruses in the oral cavity may enter the bloodstream because of the loss of mucosal integrity, leading to systemic infections that interrupt antineoplastic treatments, or even jeopardize patients’ lives. Historically, chemotherapy-induced mucositis was thought to occur solely because of the basal cell damage of the epithelium when drugs permeate into these cells via

Oral Cryotherapy For The Prevention Of Mucositis Following Myeloablative Conditioning and Hematopoietic Stem Cell Transplantation

PurposeTo investigate the effect of oral cryotherapy for the prevention of oral mucositis in recipients of Hematopoietic Stem Cell Transplantation(HSCT) after myeloablative conditioning and to specify its best timing and duration. MethodsThis study was a prospective randomized controlled clinical study, involving 37 patients from the bone marrow transplantation unit of the First Affiliated Hospital of Soochow University. In addition to the basic oral care given to all patients, study participants were divided into two experimental groups given oral cryotherapy and one control group. Optimal timing of the oral cryotherapy intervention was explored, based on pharmacokinetics of drug elimination. During the period of conditioning, experimental group 1(Exp.1) received oral cryotherapy from the beginning of drug infusion continuously until the end of drug infusion; experimental group 2 (Exp.2) received oral cryotherapy starting half way through the infusion of the drug. The rate and severity of mucositis was evaluated according to the National Cancer Institute-Common Toxicity Criteria. Data were then analyzed using SPSS15.0. ResultsOral mucositis occurred on cheeks (43.9%), tongue (27.57%) and lips (15.7%). There was no difference regarding the incidence of severe mucositis ≥ Grade 3 (33% in Exp.1 group, 15% in Exp.2 group, and 25% in the control group, p = ns) and its duration (8 days in Exp.1 group, 2.5 days in Exp.2 group, and 7 days in the control group, p = ns). However, the frequency of vomiting episodes was significantly reduced in Exp.2 with 10 episodes (2-28) versus 21 (2-60) in the control group (p=0.01) and 12.5 (2-39) in exp 1. [Conclusions] A short duration of oral cryotherapy beginning at midpoint of infusing the chemotherapy schedule significantly reduced vomiting associated with myeloablative conditioning. These preliminary results in view of the low statistical power of the study justify further trials. Disclosures:No relevant conflicts of interest to declare.

Comparison of Dental Health of Patients with Head and Neck Cancer Receiving IMRT vs Conventional Radiation

To analyze the dental health of patients with head and neck cancer who received comprehensive dental care after intensity-modulated radiation therapy (IMRT) compared with radiation therapy (RT). Historical cohort study. Veteran Affairs (VA) hospital. In total, 158 patients at a single VA hospital who were treated with RT or IMRT between 2003 and 2011 were identified. A complete dental evaluation was performed prior to radiation treatment, including periodontal probing, tooth profile, cavity check, and mobility. The dental treatment plan was formulated to eliminate current and potential dental disease. The rates of dental extractions, infections, caries, mucositis, xerostomia, and osteoradionecrosis (ORN) were analyzed, and a comparison was made between patients treated with IMRT and those treated with RT. Of the 158 patients, 99 were treated with RT and 59 were treated with IMRT. Compared with those treated with IMRT, significantly more patients treated with RT exhibited xerostomia (46.5% vs 16.9%; P < .001; odds ratio [OR], 0.24; 95% confidence interval [CI], 0.11-0.52), mucositis (46.5% vs 16.9%; P < .001; OR, 0.24; 95% CI, 0.11-0.52), and ORN (10.1% vs 0%; P = .014; OR, 0.07; 95% CI, 0.00-1.21). However, significantly more patients treated with IMRT were edentulous by the conclusion of radiation treatment (32.2% vs 11.1%; P = .002; OR, 3.8; 95% CI, 1.65-8.73). Patients who were treated with IMRT had fewer instances of dental disease, more salivary flow, and fewer requisite posttreatment extractions compared with those treated with RT. The number of posttreatment extractions has been reduced with the advent of IMRT and more so with a complete dental evaluation prior to treatment.

The effect of olive leaf extract in decreasing the expression of two pro-inflammatory cytokines in patients receiving chemotherapy for cancer. A randomized clinical trial

Oral mucositis is the most common side effects of chemotherapy of all cancer with intensive treatments regimen, and is the most common side effects of head and neck radiation therapy. For steam cell transplantation, its also regarded as the most debilitating side effects. The objectives of this study were to assess the effect of a mouth rinse containing olive leaf extract (OLE) in preventing severe oral mucositis in patients receiving chemotherapy, and to estimate its effect in decreasing pro-inflammatory cytokine production after chemotherapy. This study utilized a placebo-controlled, randomized, double-blind, and cross-over design. Twenty-five patients undergoing intensive chemotherapy were randomly assigned to receive a mouth wash containing OLE, benzydamine hydrochloride, or placebo in 3 different cycles of chemotherapy. Oral mucositis severity was assessed using the World Health Organization criteria and Oral Mycositis Assessment Scale. Patients were evaluated weekly until 15days after chemotherapy for each cycle. Salivary levels of interleukin-1 beta (IL-1β) and tumor necrosis factor-alpha (TNF-α) were evaluated by enzyme-linked immunosorbant assay. Oral mucositis rates and severity after 2weeks were significantly lower in the OLE and benzydamine groups compared to the placebo group. The IL-1β and TNF-α levels were significantly decreased in the OLE group compared to the other groups. Preliminary findings indicate that OLE is effective in reducing IL-1β and TNF-α levels after chemotherapy and exert a therapeutic effect and prevent development of severe oral mucositis.

Acute Hematologic and Mucosal Toxicities in Head and Neck Cancer Patients Undergoing Chemoradiotherapy: A Comparison of 3D-CRT, IMRT, and Helical Tomotherapy

IMRT and helical tomotherapy for head and neck cancer (HNC) treatment are associated with higher doses to certain non-target tissues than traditional static beam techniques. We hypothesized that this may lead to higher acute mucosal and hematologic toxicities. This analysis was limited to 178 patients receiving ≥60 Gy with concurrent weekly cisplatin. Radiation delivery used 3D-CRT in 41 patients (23%), conventional IMRT in 56 patients (31%), and helical tomotherapy in 81 patients (46%). Acute mucositis rates, weekly hematologic parameters, and ability to deliver planned chemotherapy cycles were examined for each patient during their course of chemoradiotherapy. Analysis showed patients were well balanced with regard to sex, age, and stage. Treatment time, as assessed by delivered monitor units, varied significantly between the 3D-CRT (median = 502), IMRT (median = 1087), and tomotherapy (median = 6757) cohorts. Acute mucositis grades did not significantly differ between the three subsets. Through six weeks of chemoradiotherapy, the median decline in hemoglobin was 15.6%, the median decline in platelets was 30.6%, and the median decline in leukocytes was 51.5%, but these drops were not significantly different between treatment cohorts. Chemotherapy was discontinued or held secondary to hematologic toxicity in 12% of 3D-CRT patients, 5% of IMRT patients and 15% of tomotherapy patients (p = 0.14). In conclusion, HNC patients undergoing high dose radiation with concurrent weekly cisplatin chemotherapy, the longer beam-on times and larger volumes of low-to-moderate radiation doses to non-target tissues associated with modern IMRT delivery techniques do not appear to result in increased acute hematologic or mucosal toxicities.

Mucositis as a Complication of Radiation Therapy in Nasopharyngeal Carcinoma: A Systematic Review

Objectives: 1) Review the current literature on mucositis in patients with nasopharyngeal carcinoma (NPC) treated with radiation therapy. 2) Describe the rate of mucositis, grade, mucositis sequelae, dose-limiting mucositis toxicity, and overall survival during radiation therapy for NPC. Methods: A systematic review of studies published regarding the treatment of NPC from 1990 to 2012 was conducted. A PubMed search for articles using the search terms “mucositis,” “radiation therapy,” and “nasopharyngeal carcinoma,” along with a review of the articles’ bibliographies was performed. Criteria for inclusion were clinical trials that reported radiation therapy as a treatment modality, and mucositis as a complication. Demographics, treatment type, treatment order, mucositis grade, percentage of mucositis sufferers, mucositis sequelae, dose-limiting mucositis toxicity, and overall survival rates were recorded. Results: A total of 50 journal articles were included representing 4621 patients. Radiation therapy only was used in 1942 patients, and some combination of radiation therapy and chemotherapy was seen in 2679 patients. Grade 1 or higher mucositis was reported in 3441 patients, and 1588 patients reported Grade 3 or higher mucositis. On average, 76.8% of patients treated for NPC developed some level of mucositis. Dose-limiting mucositis toxicity was reported in 95 patients. Alternate feeding methods due to mucositis (nasogastric tube placement or percutaneous endoscopic gastrostomy) were needed in 99 patients. Conclusions: This study is the first to examine mucositis as a complication of radiation therapy specifically for NPC. Mucositis is a serious complication in treatment of NPC, affecting the majority of patients and limiting their treatment.

Antimicrobial Activity of Natural Honey: Topical Application of Pure Natural Honey in Prevention of Chemotherapy Induced Oral Mucositis

Background: Oral mucositis is a frequent problem after high-dose chemotherapy which could impair patient’s quality of life, higher rates of infections, and delay in subsequent chemotherapy. Objectives: The present study was performed to assess the effect of topical application of pure natural honey in prevention of chemotherapy induced mucositis in patients with cancer. Patients and Methods: In this randomized clinical trial 48 patients with acute leukemia requiring chemotherapy were assigned to three equal groups. During induction or reinduction period of chemotherapy, first group received honey plus normal saline; the second one received just normal saline and third, (in control group) did not receive any prophylaxis. Patients were evaluated weekly for progression of mucositis according to the WHO mucositis scale. Data were analyzed with the Pearson Chi-Square and Fisher Exact test, by fifteen edition of SPSS software. Results: In group of ‘honey plus normal saline’ no patients developed mucositis, while in normal saline group 4 patients and in control group 12 patients developed mucositis. The rate of mucositis was significantly lower in both intervention groups compared to control (P < 0.001). Conclusions: This study demonstrates that using either honey or normal saline can reduce the rate and severity of chemotherapy induced mucositis.

High-dose methotrexate in adult oncology patients: A case-control study assessing the risk association between drug interactions and methotrexate toxicity

High-dose methotrexate, defined as dose ≥1 g/m(2), is commonly used in chemotherapy protocols. Certain drugs such as acyclovir, allopurinol, proton pump inhibitors and some antibiotics have been associated with delayed renal clearance of methotrexate and may predispose patients to toxicities. Currently, no specific recommendations exist on adjusting the high-dose methotrexate regimen in the presence of potential interacting drugs. This study aims to determine whether presence of interacting drugs is associated with delayed methotrexate clearance. This was a case-control study of adult oncology patients who received their first cycle of high-dose methotrexate. Cases were defined as patients who experienced delayed methotrexate clearance, as indicated by serum methotrexate level ≥ 0.1 umol/L at 72 h. The primary endpoint was the frequency of presence of interacting drugs between cases and controls. These were compared using Fisher's exact test. Where possible, adjustment for significant baseline differences that can affect methotrexate clearance was made using logistic regression. The secondary endpoint was frequency of methotrexate-related clinical toxicities between groups and included myelosuppression, nephrotoxicity, hepatotoxicity and mucositis. From January 2004 to March 2011, 73 patients met study criteria, of which 23 were defined as cases. Significant baseline differences were methotrexate dose received (9116 mg ± 4339 versus 6054 mg ± 2874, p=0.012) and renal impairment (5 versus 0, p = 0.002). The presence of interacting drugs was not associated with delayed methotrexate clearance (OR 0.91, 95% CI 0.24-3.38, p > 0.999). After adjusting for methotrexate dose, drugs observed more frequently (allopurinol, proton pump inhibitors and sulfamethoxazole/trimethoprim) were not associated with delayed methotrexate clearance (p = 0.95, 0.59 and 0.20, respectively). Cases experienced more severe anemia (grade 2.52 versus 1.68, p = 0.007) and higher rates of mucositis (65.2% versus 20.0%, p < 0.001). This study showed no significant association between presence of interacting drugs and delayed methotrexate clearance. Patients who experienced delayed methotrexate clearance had higher incidence of severe anemia and mucositis.

GRP-168 Safety of Sunitinib Versus Pazopanib in Metastatic Renal Cancer in a Tertiary Hospital

BackgroundSunitinib and pazopanib are tyrosine kinase inhibitors used in the treatment of metastatic renal cancer. Pazopanib has been approved more recently, so the user experience is not as extensive as...

A study of docetaxel weekly or every three weeks in combination with carboplatin as first line chemotherapy in epithelial ovarian cancer: Hematological and non-hematological toxicity profiles

The purpose of this study was to compare the toxicity profiles of docetaxel administered on a weekly schedule and the standard three-week schedule in the treatment of advanced primary ovarian carcinoma. Eligible patients were treated with intravenous docetaxel (30 mg/m2) on days 1, 8 and 15, and carboplatin (AUC 5) on day 1 or with docetaxel (75 mg/m2) and carboplatin (AUC 5) on day 1; Q21 days for 6 cycles. This study was a pooled study of two primary phase II studies. A total of 108 patients received the weekly schedule and 59 patients received the three-week schedule. All patients were evaluated for toxicity. The overall response rate was 79% and the biochemical response 93% for the weekly schedule. The median overall survival rate was 35.3 months. Neutropenia was significantly more common (ANOVA; p<0.0001) in the three-week group than in the weekly group during all six courses of chemotherapy. Fever and infections were also more common in this group. Thrombocytopenia and anemia were slightly more common in the weekly group. Fatigue, epiphora, nail changes and taste disturbances were specific side-effects following weekly docetaxel. Peripheral sensory neuropathy (grade 1–2) increased with every cycle of treatment, but in a similar manner in the two groups. Grade 3–4 neuropathy was not recorded. Oral mucositis and myalgia were two side-effects associated with the three-week schedule. Nausea and vomiting, diarrhea and dyspnea were a limited problem in both groups. Cardiac toxicity was rare and did not differ between the two docetaxel schedules. The weekly administration was favored due to the lower rates of neutropenia, fever, infections, oral mucositis and myalgia. However, epiphora and nail changes were specific side-effects of the weekly treatment. Both regimens appeared to be rather well tolerated with similar compliance (66 and 70%) with regard to completion of the planned six courses of chemotherapy.

A systematic review of the effectiveness of therapeutic education for children diagnosed with cancer and their families on behavioural and health-related outcomes

Background Children with cancer may experience considerable psychological and physiological complications. The aim of patient therapeutic education is to improve quality of life, through developing knowledge and management skills, for both the child and the parents. Objectives To determine the best available evidence related to the use of patient therapeutic education, in which at least one nurse has been involved in the intervention, for children with cancer and their families. Inclusion criteria Types of participants Children diagnosed with cancer aged 0 to 21 years and their families, parents (or guardian) and siblings. Types of intervention The review focused on various forms of therapeutic educational intervention that included one or more of the following dimensions: 1.Cognitive 2.Perceptive 3.Infra-cognitive 4.Meta-cognitive and 5.Emotional/affective. Types of studies Randomised controlled trials and quasi-randomised controlled trials. Types of outcomes Self-efficacy, coping and psychological assessment, health-related quality of life, health care utilisation, symptom management, adverse effects, adherence, biological markers, and family functioning in children diagnosed with cancer and their families. Search strategy A systematic search was conducted across 13 databases to identify published and unpublished studies in English and French between the years 1980-2010. Methodological quality Critical appraisal was undertaken by two independent reviewers using the Joanna Briggs Institute critical appraisal checklist. Data collection/extraction Data were extracted using standardised data extraction forms provided by the Joanna Briggs Institute. Data synthesis Meta-analysis was performed with two studies. Regarding all other studies, pooling of the results was not possible due to the diversity of interventions and outcomes. Hence, the study findings are reported in narrative form. Results Six studies were included in the final review, providing a total of 244 patients. Five out of the six studies were randomised controlled trials and one was a pseudo-randomised controlled trial. The effectiveness of therapeutic education using an interactive CD-ROM on health locus of control was not statistically significant (overall effect size = 0.37, [95% CI -0.04-0.78]). The effectiveness of therapeutic education on quality of life, coping style, cancer knowledge and task-specific self-efficacy was not statistically significant. Therapeutic education reduced pain intensity (-0.65, p < .001) and oral mucositis (-1.85, p<.001) in patients, who were instructed on protocolised mouth wash utilisation. One study assessed the effectiveness of two behavioural interventions, matched with two coping styles during invasive procedures. The results showed a significant difference in anticipatory heart rate when not divided by coping style for the information group. One study reporting results of an educational intervention designated to facilitate self-care coping demonstrated no effect on hopefulness, self-esteem, general self-efficacy and treatment toxicity. No experimental or quasi-experimental studies involving therapeutic education targeted to both the child and one of their parents were found. Although the review aimed to investigate the effectiveness of patient therapeutic education on both children and parents, no studies with parent-related outcomes could be included. Conclusions This review identified six studies that tested therapeutic education on health locus of control, quality of life, coping, cancer knowledge, task-specific self-efficacy, pain, and rate of mucositis. It revealed that therapeutic education has a positive effect on the reduction of pain and mucositis, only. This review also highlighted the paucity of high level evidence research in patient therapeutic education in the nursing field. Implication for practice Teaching self-care is crucial for appropriate symptom management of cancer and cancer treatment. It is recommended that the role of nurses delivering patient therapeutic education is clarified to inform nursing practice and education. Implication for research Further research is warranted before it is possible to show the effect of patient therapeutic education as a nursing intervention. There is a need to define the core measures to test the effect of patient therapeutic education in children and parents.

Mycophenolate Mofetil Vs. Methotrexate for the Prophylaxis of Graft-Versus-Host-Disease - Systematic Review and Meta-Analysis of All Comparative Trials

AbstractAbstract 4169 Background:Mycophenolate mofetil (MMF) has emerged as a potential substitute to methotrexate in patients given calcineurin inhibitors for the prophylaxis of GVHD prior to allogeneic hematopoietic cell transplantation. However, a comprehensive literature evaluation of MMF vs. methotrexate is lacking. Objectives:This study aims to compare the efficacy and safety of MMF vs. methotrexate as part of the GVHD prophylaxis regimen in patients given allografts. Methods:Systematic review and meta-analysis of all comparative trials of patients given allografts and administered GVHD prophylaxis with a regimen containing MMF or methotrexate. Electronic search was conducted until June 2012. Primary outcome was acute GVHD. Secondary outcomes were all-cause mortality, relapse rate, non-relapse mortality, chronic GVHD, rate of mucositis, and the time to neutrophil and platelet engraftment. For dichotomous data, relative risks (RR) with 95% confidence intervals (CIs) were estimated and pooled. For continuous variables we calculated weighted mean difference (WMD). Results:Our search yielded 11 trials, 3 were randomized control trials (RCTs) and 8 were either one arm intervention trials compared to historical controls or retrospective studies. There was no difference in the overall incidence of acute GVHD (RR 1.06; 95% CI 0.93–1.21, 11 trials) with similar results in a sensitivity analysis including only RCTs. Conversely, incidence of grade 3–4 acute GVHD was higher in patients given MMF (RR 1.61; 95% CI 1.18–2.20, 6 trials, Figure). However, this association was no longer statistically significant when only patients given allografts from matched siblings or those given myloablative conditioning were analyzed (RR 1.56; 95% CI 0.95–2.55, 5 trials and RR 1.40; 95% CI 0.82–2.39, 4 trials). All cause mortality, non relapse mortality, relapse rate and the incidence of chronic GVHD were comparable between the two groups. Incidence of mucositis was significantly lower in patients given MMF (RR 0.35; 95% CI 0.25–0.49, 8 trials) and the time to neutrophil and platelet engraftment was shorter in the MMF arm (WMD (−4.05); 95% CI (−6.17) – (−1.3), 6 trials and WMD (−3.74); 95% CI (−6.3) – (−1.18), 4 trials, respectively). Conclusions:MMF, compared to methotrexate, given as GVHD prophylaxis is associated with reduced transplantation associated toxicities, however with increased severity of acute GVHD. Further RCTs to identify the subgroups of patients who will benefit the most from MMF are warranted. [Display omitted] Disclosures:No relevant conflicts of interest to declare.