Double blind, placebo-controlled randomized study of chlorhexidine prophylaxis for chemotherapy-induced oral mucositis with nonblinded randomized comparison to oral cooling (cryotherapy)

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8508-8508
Author(s):  
J. Sorensen ◽  
T. Skovsgaard ◽  
E. Bork ◽  
L. Damstrup ◽  
S. Ingeberg
Keyword(s):  
Oral Mucositis ◽  
Performance Status ◽  
Randomized Study ◽  
Artificial Nutrition ◽  
Chi Square ◽  
Double Blind ◽  
Oral Nutrition ◽  
Type 1 Error ◽  
Chi Square Test ◽  
Grade 3

8508 Background: Oral mucositis is a frequent complication to many chemotherapy agents in conventional doses. Chlorhexidine prophylaxis has been beneficial in some studies and suggested detrimental in others, but never compared to cryotherapy. Methods: Previously untreatedpatients (pts) with colon or gastic cancer receiving the first course of bolus 5-FU 425 mg/m2 with leucovorine 20 mg/m2 daily in five days were randomized, pending informed consent, to either chlorhexidine 0.1% 15 ml mouthrinse one minut TID for 3 wks. (regimen A), or to doubble blind placebo (normal saline with same taste additive as in A) with same dose and frequency (reg. B), or to cryotherapy with crushed ice tips from 10 min. before to 35 min. after start of chemotherapy (reg. C). Pts self-reported on severity (CTC-grading, main end-point) and duration of oral mucositis and side effects on a questionnaire. 75 pts were planned in each arm to detect a 15% difference in grade 3–4 mucositis with a 5% type 1 error and a 20% power. Chi-square test and Mann-Whitney test were used. Results: Among 225 pts randomized, 206 answered the questionnaire (70, 64, and 63 pts in reg.A, reg.B, and reg.C) There were no differences between the regimens with respect to diagnoses, stage, age, gender, smoking habits, or performance status. Mucositis grade 3–4 (impaired oral nutrition/need of artificial nutrition) occurred in 13%, 33%, and 11% in regimens A, B, and C, respectively. Reg. B was significantly worse than A (p<0.01) and C (p<0.005). Median mucositis durations were A: 3 days (0–17), B: 5 (0–20), and C: 1 (0–20). Duration was significantly longer in B than in both A (p=0.035) and C (p=0.003). Pts <40 years had grade 3–4 mucositis in 36% compared to 18% among older pts (p=0.14). Conclusions: Oral mucositis is common with bolus 5-FU,but frequency and duration may be significantly improved by either prophylactic chlorhexidine or by cryotherapy, giving similar results. The latter is an easy and inexpensive treatment which however is drug- and schedule-dependent as it can not be used with infusional 5-FU or with chemotherapy with substantially longer half-lifes than 5-FU. No significant financial relationships to disclose.

A double-blind comparative study of Trimethoprim-Polymyxin B versus Trimethoprim-Sulfacetamide-Polymyxin B otic solutions in the treatment of otorrhea

1981 ◽  
Vol 95 (3) ◽  
pp. 251-259 ◽  
Author(s):  
Maurice C. Gydé
Keyword(s):  
Comparative Study ◽  
Fungal Infection ◽  
Otitis Media ◽  
Randomized Study ◽  
Polymyxin B ◽  
Correction Method ◽  
Chi Square ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Recurrent Otitis Media

AbstractThis was a double-blind randomized study to compare the safety and efficacy of timethoprim-polymyxin B (TP) and trimethoprim-sulfacetamide-polymyxin B (TSP) drops in the treatment of otorrhea. The 68 cases treated suffered from external otitis, recurrent otitis, recurrent otitis media with tympanic membrance perforation, or infected mastoid cavities and post-operative tympanoplasties. The TP ototopical solution was successful in 60·6 per cent of cases compared to 88·6 per cent of cases with TSP. These rates were statistically different using the Chi Square with Yates' correction method.There were no sings of ototoxicity, fungal infection overgrowth or local sensitivity to either of the solutions.The study has shown that both drugs are equally safe and that TSP is significantly more effective in the treatment of otorrhea.

scholarly journals CONTROL OF POST-SURGICAL PAIN

2010 ◽  
Vol 17 (03) ◽  
pp. 400-404
Author(s):  
ALI MIR MANSOURI ◽  
FARNOUSH FARZI ◽  
SHIRIN KHALKHALIRAD ◽  
Katayoon Haryalchi ◽  
Abas Sediginejad
Keyword(s):  
Pain Relief ◽  
Cesarean Section ◽  
Pain Control ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Analgesic Effects ◽  
Emergency Cesarean ◽  
Surgical Pain ◽  
Chi Square Test

Introduction: There are many complications for patients with post cesarean section relative pain. So it delays in discharging or increasing in hospital stay. The objective of this study was a comparison between Tramadol and Meperidine according to pain relief or other possible complications in post cesarean section pain control. Materials and Methods: This study was a double blind clinical trial. It arranged for 240 parturients who scheduled for emergency cesarean section with pain after surgery in spite of spinal anesthesia. All patients were in ASA class I. They were divided randomly in two groups .Meperidine (M) and Tramadol (T) groups with 120 patients in each group. After beginning of pain in post anesthesia care unit (VAS> or = 4), in group (T) tramadol 1.5 mg/kg and in group (M) meperidine  .5 mg/kg were injected intravenously. Apart from pain, other drug complications such as shivering, blood pressure changes, itching, nausea and vomiting, drowsiness were recorded one and two hours after injection. Data were analyzed by chi-square test. Results: Relative frequency rate (RFR) of 50% decrease in pain score one hour after intravenous injection was 56.7% in group (T) and 69.2% in group (M) ( P = 0.054). RFR for respiratory depression after one hour was 5.8% in (M) group and 0 in (T) group (P = 0.007). RFR for nausea after one hour was 39.2% in (T) group and 23.3% in (M) group (P = 0.008). RFR for vomiting after one hour was 23.3% in (T) group and 13.3% in (M) group (P= 0.045). RFR for drowsiness after one hour was 25% in (M) group and 3.3% in (T) group (P=0.007). There was no statistically significant relationship after 2nd hour for pain relief, nausea, vomiting and drowsiness between two groups. There was no difference between two groups in RFR for shivering, blood pressurechanges and itching in both two groups. Conclusion: This study illustrates both remedies Meperidine and Tramadol which were effective for pain relief and shivering after cesarean section. But according to high incidence of nausea and vomiting with Tramadol and more analgesic effects of Meperidine than Tramadol, administration of Meperidine is better than Tramadol after cesarean section for pain control.

scholarly journals A double-blind randomized placebo-controlled study of low dose mirtazapine once daily in patients of major depressive disorders on escitalopram

2019 ◽  
Vol 8 (5) ◽  
pp. 1067
Author(s):  
Mallikarjuna Rao I. ◽  
Usha Kiran Prayaga ◽  
Dharma Rao Uppada ◽  
Ramachandra Rao E. ◽  
B. L. Kudagi
Keyword(s):  
Depressive Disorders ◽  
Low Dose ◽  
Rating Scale ◽  
Controlled Study ◽  
P Value ◽  
Chi Square ◽  
Double Blind ◽  
Increased Risk ◽  
Significant Difference ◽  
Chi Square Test

Background: The SSRIs being used as 1st line therapy in treatment of depression have delayed therapeutic effect which makes the patient vulnerable to an increased risk of suicide and decreased adherence to the treatment and will prematurely discontinue the therapy. The present study was conducted to evaluate if low dose mirtazapine-escitalopram combination therapy has any add on benefit over monotherapy with escitalopram.Methods: In a single-centered, comparative study involving patients with depression attending the out-patient after screening and exclusion, 60 eligible patients were randomly assigned to receive tablet mirtazapine 7.5 mg plus tablet escitalopram 10 mg intervention or tablet escitalopram 10 mg plus placebo intervention in a double-blind 6-week treatment phase. The primary outcome measure was the change in the 17-item Hamilton Depression Rating Scale (HDRS) and Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline. Participants were evaluated at baseline, 1st, 2nd,4th and 6th week. Results were analyzed using Chi-Square test for adverse effects and independent t-test analysis for efficacy parameter.Results: In the analysis of results at 6th week the numbers of patients achieved remission in mirtazapine group are more with a p-value of 0.018 which is significant and the numbers of responders in mirtazapine group are also more which is statistically significant on chi-square test. There is no significant difference was observed between the two groups with reference to occurrence of adverse effect.Conclusions: Adding low dose mirtazapine has an added benefit in terms of efficacy and getting remission early with more number of responders in the treatment of major depression.

Sequence decision making for cabazitaxel (Cbz) versus abiraterone (Abt) or enzalutamide (Enz) post-docetaxel (Dtx) in a publicly funded health care system.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 57-57
Author(s):  
Alexander Watson ◽  
Richard Gagnon ◽  
Eugene Batuyong ◽  
Nimira S. Alimohamed ◽  
Richard M. Lee-Ying
Keyword(s):  
Real World ◽  
Performance Status ◽  
Patient Choice ◽  
Rank Test ◽  
First Line ◽  
Chi Square ◽  
The Real ◽  
Therapeutic Decisions ◽  
Chi Square Test ◽  
Castrate Resistant

57 Background: The TROPIC trial demonstrated an overall survival (OS) benefit of Cbz after Dtx in metastatic castrate-resistant prostate cancer (mCRPC). However, the novel anti-androgens (NAA) Abi and Enz have demonstrated similar improvements post-Dtx. The recent CARD trial suggests Cbz may provide the greatest OS benefit in selected patients who were rapid progressors ( < 12 months, RP) on first NAA, however Cbz use and efficacy in the real-world is uncertain. We sought to quantify the real-world use of Cbz and evaluate outcomes post-Dtx. Methods: mCRPC patients who received Dtx at the two tertiary referral centres in the Canadian province of Alberta from October 2012 (Cbz funding approval) to December 31st 2017 were assessed. We examined Cbz eligibility per TROPIC and CARD trial criteria, tracked therapies received, and documented objective and subjective reasoning for therapeutic decisions. OS was measured using the Kaplan-Meier method and the log-rank test was used to compare outcomes. The Chi-Square test was used to compare relative therapy utilization. Results: 463 mCRPC patients received Dtx over the study period, including 83 (18%) for castrate sensitive disease. At Dtx progression, 262 patients (56%) were eligible for Cbz per TROPIC trial criteria, while only 162 (62%) of those were RP on first NAA. Post-Dtx OS was lower among TROPIC-eligible patients receiving Cbz compared to those receiving Abi or Enz (9.1 vs 14.2 months, p = 0.001). This OS difference was not demonstrated among RP patients (11.2 vs 12 months, p = 0.664). The most common reasons for TROPIC ineligibility were Dtx intolerance (13%), serious comorbidities (12%), unacceptable blood counts (11%), performance status (9%) or, for CARD ineligible patients, no progression within 12 months on first NAA (38%). The most common agent immediately post-Dtx was Abi (n = 180, 39%), followed by Enz (n = 129, 28%). Significantly fewer patients (n = 56, 12%) received Cbz immediately post-Dtx (p = 0.001), and 149 (32%) received Cbz overall. First line post-Dtx, 286 patients (62%) did not have a documented discussion about Cbz, and in 172 cases (38%) consideration of Cbz was never documented. Patient choice against Cbz chemotherapy was recorded in 15% of discussions. Conclusions: In a real-world cohort of mCRPC patients, Cbz was a significantly less common choice than Abi or Enz after progression on Dtx. In a majority of these cases, no first line discussion of Cbz was documented, and in documented discussions, patient choice was the driving factor in a minority. OS post-Dtx in patients who met TROPIC trial criteria was lower for those receiving Cbz, noting that, unlike in TROPIC, these patients also received NAAs. This OS difference was not seen in those who also progressed rapidly on first NAA. These data suggest ongoing hesitation towards Cbz use in mCRPC and support careful selection of patients who may obtain benefit.

scholarly journals Self-perception of side effects by adolescents in a chlorhexidine-fluoride-based preventive oral health program

2006 ◽  
Vol 14 (4) ◽  
pp. 291-296 ◽  
Author(s):  
Ana Rita Duarte Guimaraes ◽  
Marco Aurélio Peres ◽  
Ricardo de Sousa Vieira ◽  
Rodrigo Melin Ferreira ◽  
Maria Letícia Ramos-Jorge ◽  
...  
Keyword(s):  
Oral Health ◽  
Side Effects ◽  
Adverse Effects ◽  
Health Program ◽  
Double Blind Study ◽  
Chi Square ◽  
Double Blind ◽  
Chi Square Test ◽  
Plaque Control ◽  
Descriptive Scale

OBJECTIVE: The objective of this study was to evaluate the incidence of adverse effects reported by adolescents following 14 days of use of a mouthrinse containing 0.05% NaF+0.12% chlorhexidine. METHODS: This double-blind study was developed as part of a randomized clinical trial. The adolescents enrolled to the study were randomly divided into two groups to use either: 0.05% NaF+0.12% chlorhexidine (G1, n=85) or 0.05% NaF (G2, n=85). Both groups used a 10mL solution of the mouthwash during 1 minute daily for 2 weeks under supervision. After that period, the subject's acceptance of taste was measured using a verbal descriptive scale (Labeled Magnitude Scale - LMS)11. Participants were also interviewed regarding the occurrence of possible adverse effects during treatment (temporary palate disorders, tooth staining or unpleasant taste). The proportional differences between the groups were tested using the chi-square test. RESULTS: Palate changes were reported by 26% of participants of each group; 17.7% of G1 and 32% of G2 reported an unpleasant taste (p = 0.062), while staining was reported by 55% of G1 and 68.9% of G2 (p = 0.117). Absenteeism rates were similar in both groups (G1= 2.58 ± 2.69; G2=2.81 ± 2.39), p=0.362. CONCLUSION: adherence was high in both groups and side effects reported by subjects were not perceived by them as being important. Since subjects' acceptance and compliance is fundamental to the success of an oral health program, chlorhexidine-fluoride could be a useful resource in a program of plaque control.

A randomized, double-blind phase II study of the oral tyrosine kinase inhibitor (TKI) axitinib (AG-013736) in combination with docetaxel (DOC) compared to DOC plus placebo (PL) in metastatic breast cancer (MBC)

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 1003-1003 ◽  
Author(s):  
H. S. Rugo ◽  
A. Stopeck ◽  
A. A. Joy ◽  
S. Chan ◽  
S. Verma ◽  
...  
Keyword(s):  
Adverse Events ◽  
Kinase Inhibitor ◽  
Performance Status ◽  
Single Agent ◽  
Metastatic Breast ◽  
Primary Objective ◽  
Hazard Ratio ◽  
Ecog Performance Status ◽  
Double Blind ◽  
Grade 3

1003 Background: Single-agent DOC is commonly used to treat MBC. Axitinib (AG) is a potent TKI of VEGFRs. A phase I lead-in study identified 80 mg/m2 q3wks of DOC in combination with 5 mg BID of AG as the recommended phase 2 dose. The primary objective was to determine whether the time to progression (TTP) of AG+DOC arm is superior to DOC+PL. Methods: Pts with no prior chemotherapy for MBC and =12 mos from adjuvant chemotherapy (aCT), measurable disease, ECOG performance status (PS) of 0–2, and no uncontrolled brain metastases were randomly assigned (2:1) to receive treatment with either DOC+AG or DOC+PL without prophylactic growth factor in cycle 1. Tumor measurements were performed q9wks. Pts were stratified according to estrogen receptor (ER) status, prior aCT and PS (0–1 or 2). Results: A total of 168 pts were randomized. 92 pts had received prior aCT, 27 of whom received a prior taxane. Treatment arms were well balanced for prior adjuvant and taxane therapy. A median of 7 cycles of AG+DOC (range: 1–18) and 7 cycles of DOC+PL (range: 1–23) were administered. The most common non-hematologic adverse events observed in the AG+DOC arm included diarrhea (60%), nausea (53%), alopecia (51%), fatigue (49%), stomatitis (44%) and vomiting (40%). Grade 3/4 adverse events that were increased with AG+DOC vs DOC included febrile neutropenia (16 vs 7%), fatigue (13 vs 5%), stomatitis (13 vs 2%), diarrhea (11 vs 0%) and hypertension (5 vs 2%). Other grade 3/4 hematologic toxicities were similar in both arms. The median TTP (by RECIST) was 8.2 mo with AG+DOC arm and 7 mo with DOC+PL arm with a hazard ratio of 0.73 (prespecified, one-sided p=0.052). The overall response rate (ORR) was 40% for AG+DOC arm and 23% for DOC+PL arm (p=0.038). In a hypothesis-generating subgroup analysis, the median TTP in patients receiving prior aCT was 9.0 mo with AG+DOC arm and 6.3 mo with DOC+PL arm with a hazard ratio of 0.54 (p=0.012). Within this stratum, ORR was 45% for AG+DOC arm and 13% for DOC+PL arm (p=0.003). Conclusions: The anti-angiogenic TKI AG combined with DOC (80 mg/m2 q3wks) as first line therapy for MBC has an acceptable safety profile and promising anti-tumor activity. No significant financial relationships to disclose.

Updated results of BICC-C study comparing first-line irinotecan/fluoropymidine combinations with or without celecoxib in mCRC: Updated efficacy data

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4027-4027 ◽  
Author(s):  
C. Fuchs ◽  
J. Marshall ◽  
E. Mitchell ◽  
R. Wierzbicki ◽  
V. Ganju ◽  
...  
Keyword(s):  
Survival Rate ◽  
Randomized Study ◽  
Progression Free Survival ◽  
First Line ◽  
Double Blind ◽  
Period 2 ◽  
Common Grade ◽  
Grade 3 ◽  
One Year

4027 Background: This multicenter, randomized study assessed efficacy & safety for irinotecan/fluoropyrimidines combinations in previously untreated mCRC. Methods: Pts were randomized to: infusional FOLFIRI, modified bolus IFL (mIFL), or CapeIri; and concurrent celecoxib or placebo in a double-blind fashion. The protocol was amended in April 2004: bevacizumab (bev) was added to the FOLFIRI and mIFL arms, whereas CapeIri was discontinued. Period 1 (P1) and Period 2 (P2) designate subjects enrolled before or after the amendment. Initial efficacy & safety analyses were reported at ASCO ’06. We now report follow-up of 46 months for P1 and 31 months for P2. Results: 430 pts were treated in P1 and 117 pts in P2. Baseline characteristics and post-study treatment were balanced. P1 results: Median progression free survival (PFS) was 7.6 mos for FOLFIRI; 5.9 mos for mIFL (p=0.004); and 5.8 mos for CapeIri (p=0.015). Median overall survival (OS) was 23.1 mos for FOLFIRI; 17.6 mos for mIFL (p=0.087); and 18.9 mos for CapeIri (p=0.27). One-year survival rate favored FOLFIRI (75%) compared to either mIFL (65%) or CapeIri (66%). Overall Response Rate (ORR) was 47% in FOLFIRI, 43% in mIFL, 39% in CapeIri (not significantly different). P2 results: Median PFS was 11.2 mos for FOLFIRI+bev and 8.3 mos for mIFL+bev (p=0.28). Median OS was not reached for FOLFIRI+bev but was 19.2 mos for mIFL+bev (p=0.007). One-year survival rate favored FOLFIRI+bev (87%) when compared to mIFL+bev (61%). ORR was 58% for FOLFIRI+bev and 54% for mIFL+bev (p=0.73). Common grade = 3 AEs are listed below. Celecoxib did not impact safety or efficacy. Conclusions: First line FOLFIRI or FOLFIRI+bev were superior to their comparators and show favorable results in survival and tolerability in untreated mCRC. Median survival for FOLFIRI+bev has not been reached. [Table: see text] No significant financial relationships to disclose.

A randomized, double-blind phase II trial of docetaxel plus prednisone (DP) combined with either AT101 or placebo for the first-line therapy of metastatic castration-resistant prostate cancer (CRPC).

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 125-125
Author(s):  
G. Sonpavde ◽  
V. B. Matveev ◽  
J. M. Burke ◽  
J. R. Caton ◽  
M. T. Fleming ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Performance Status ◽  
Castration Resistant Prostate Cancer ◽  
Double Blind ◽  
First Line Therapy ◽  
Castration Resistant ◽  
Risk Patients ◽  
Grade 3 ◽  
And Performance

125 Background: AT-101 (A), a small molecule oral inhibitor of the Bcl-2 protein family has broad preclinical activity including synergy with docetaxel (D). AT-101 has demonstrated activity alone and in combination with D in D-refractory patients with metastatic CRPC. Methods: A randomized, double-blind, placebo-controlled phase II trial was conducted to compare the combination of DP with either A or placebo in chemo-naive men with progressive metastatic CRPC. A key requirement was progression (bone scan, RECIST or rising PSA ≥ 2 ng/mL) despite androgen deprivation. Stratification factors were pain and performance status. Patients received DP (75mg/m2 day 1; 5mg PO b.i.d.) Q 21 days (1 cycle) with either A (40 mg b.i.d.) or placebo PO on days 1–3. Radiological assessments were performed every 3 cycles. Primary endpoint was overall survival (OS) and 221 patients were planned for 110 events (80% power, HR 0.67, 1-sided alpha 0.1). Results: 221 patients were randomized to ADP or placebo-DP and baseline factors were balanced. Efficacy outcomes (OS, PFS, PSA declines, disease control) were not significantly different ( Table ). In a subgroup of patients with poor-risk CRPC (n=34), efficacy endpoints appeared to favor ADP with a median OS of 19 months vs.14 months for placebo-DP. Grade 3/4 AEs that occurred with higher incidence in the ADP arm compared to placebo-DP included cardiac AEs (5% vs. 2%), lymphopenia (23% vs. 16%), neutropenia (47% vs. 40%), ileus (2% vs. 0%) and pulmonary embolism (6% vs. 2%). Conclusions: The combination of AT-101 with DP in men with chemonaive metastatic CRPC was well tolerated but did not extend OS compared to placebo-DP. There was a potential benefit in a subset of high-risk patients. [Table: see text] [Table: see text]

A phase II, randomized, double blind comparison of calcium aluminosilicate clay (CASAD) versus placebo (dibasic calcium carbonate) for the prevention of diarrhea in patients (pts) with metastatic colorectal cancer (mCRC) treated with irinotecan (I).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3600-3600
Author(s):  
Bryan K. Kee ◽  
Rebecca Slack ◽  
Todd S. Crocenzi ◽  
Lucas Wong ◽  
Benjamin Esparaz ◽  
...  
Keyword(s):  
Phase Ii ◽  
Performance Status ◽  
Symptom Burden ◽  
Active Metabolites ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Significance Level ◽  
Significant Difference ◽  
Grade 3

3600 Background: CASAD is a naturally occurring calcium montmorrilonite clay that serves as a cation exchange absorbent. One of the active metabolites of Irinotecan is SN-38, which is adsorbed by CASAD in vitro. The study hypothesis was that oral CASAD would reduce the rate of grade 3/4 diarrhea in mCRC patients treated with irinotecan. Methods: The study is a multicenter, prospective, randomized, double blinded placebo-controlled phase II trial. One hundred patients receiving I-based chemotherapy were randomized equally between CASAD (1000 mg po 4x daily) and placebo in order to have 75% power to detect a difference in the proportions of patients with grade 3/4 diarrhea within 6 weeks at a 1-sided 5% significance level. We also compared symptom burden using the MDASI questionnaire summed over the 13 symptom items for weeks 0, 3, 5, and 6. Results: Between 5/2009 and 5/2012, 100 patients were randomized in a 1:1 ratio between study arms. Median age 57 yrs, 54% male, 74% Non-Hispanic White, 93% performance status 0 or 1. Serious diarrhea was less frequent than expected based upon prior studies with Irinotecan. In evaluable patients, no significant difference in the rate of G3/4 diarrhea was seen (the primary endpoint): CASAD arm: 7/43 pts (16%), Placebo arm: 3/32 pts (9%), p=0.70. The rate of any diarrhea among all pts was also similar: CASAD arm 64% vs. Placebo arm 70%. The rate of study dropout was 14% in CASAD and 38% for placebo (p=0.01; 2-sided). No differences were found in symptom burden or individual symptom items or serious adverse events. Conclusions: Compared with placebo, CASAD use was safe but ineffective in preventing diarrhea in mCRC patients treated with irinotecan-containing chemotherapy regimens. There were no favorable or unfavorable signals in terms of the patient experience related to symptoms, but there were significantly more dropouts in the placebo arm. Future CASAD trials are focused on active treatment of diarrhea. Clinical trial information: NCT00748215.

Pharmacogenetic biomarkers for predisposition to toxicity to adjuvant FOLFOX/XELOX in colorectal cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 390-390
Author(s):  
Pilar Garcia Alfonso ◽  
Andres J. Muñoz ◽  
Montse Blanco Codeisido ◽  
Daniel Lopez-Trabada Ataz ◽  
Lucia Cortejoso-Fernandez ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Multivariate Analysis ◽  
Adverse Reactions ◽  
Performance Status ◽  
Univariate Analysis ◽  
Chi Square ◽  
Hand Foot Syndrome ◽  
Chi Square Test ◽  
And Performance ◽  
Prior Application

390 Background: 5-fluorouracil and capecitabine are the gold standards in colorectal cancer (CRC) treatment and are often combined with oxaliplatin (FOLFOX and XELOX chemotherapy, respectively). Our purpose was to analyze associations between severe adverse reactions to these regimes and polymorphisms in genes related to these drugs Methods: Retrospective study with 47 adult CRC patients treated with adjuvant FOLFOX/XELOX. 20 polymorphisms in 14 genes were selected: 6 genes [XRCC1 (rs25487), ERCC2 (rs131181), ERCC1 (rs11615), GSTP1 (rs1695), EGFR (rs4559542) and GSTT1 (copy number variation)] related to the pharmacokinetics and dynamics of oxaliplatin and 8 related to fluoropyrimidines [MTHFR (rs1801131 and rs1801133), DPYD (rs2297595 and rs3918290), TYMS (rs34743033 and rs34489327), ABCB1 (rs1128503, rs2032582 and rs1045642), ABCC4 (rs4148551 and rs3742106), ABCC5 (rs3805114), CYP2A6 (rs3742106 ) and CDA (rs2072671)]. Linear by linear association chi-square test (SPSS v.18.0.) was used to study associations. A multivariate analysis including sex and performance status was also conducted. p< 0.05 was considered significant. Results: Mean age was 62 (SD: 12) years and 78.7% male. Univariate analysis: statistically significant associations were obtained between rs11615 (ERCC1), neutropenia and hand-foot syndrome; rs3742106 (CYP2A6) and neutropenia; rs34743033 and rs34489327 (TYMS) and nausea/vomiting; and CNV of GSTT1 and neutropenia. Multivariate analysis: statistically significant associations were obtained between rs3742106 (CYP2A6) and neutropenia (GT vs. TT: OR, 0.042, 95% CI, 0004-0499, p = 0.012); rs2297595 (DPYD) and nausea/vomiting (GA vs AA: OR, 0.051, 95% CI, 0003-0772, p = 0.032); and rs11615 (ERCC1) and neutropenia (CC vs CT / TT: OR, 0.099, 95% CI, 0016-0615, p = 0.013) Conclusions: These results could help oncologists reduce adverse reactions associated to FOLFOX and XELOX chemotherapy by giving patients the best possible option, thus, improving their quality of life. Bigger cohorts are needed to verify the polymorphisms in ERCC1, CYP2A6, TYMS, DPYD and GSTT1 prior application in clinical practice.

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