The role of UGT1A1 polymorphisms (*28 and *6) in Japanese cancer patients.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 570-570
Author(s):  
S. Morimoto ◽  
M. Shimada ◽  
N. Kurita ◽  
T. Iwata ◽  
M. Nishioka ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Prospective Trial ◽  
Optimal Dose ◽  
Japanese Patients ◽  
Dose Finding ◽  
Severe Toxicity ◽  
Severe Diarrhea ◽  
First Line Therapy ◽  
Grade 3

570 Background: Combination protocol using FU-LV with irinotecan (FOLFIRI) is currently regarded as standard first-line therapy in advanced colorectal cancer (CRC). Although irinotecan prolongs survival, it causes severe diarrhea and neutropenia. Recent pharmacogenetic studies on irinotecan have revealed significant associations of UDP-glucuronosyltransferase 1A1 (UGT1A1) polymorphisms *28 and *6, the latter being specifically detected in East Asians resulting in severe toxicity. It is necessary that the dose-finding trial that decided the optimal dose according to the gene polymorphism to draw out the maximum therapeutic effect while evading the side effect. Here we present the result of prospective trial of the safety about FOLFIRI therapy according to each gene type of UGT1A1 for Japanese patients with advanced CRC. Methods: From 2008, 250 Japanese patients in TOKUSHIMA University were enrolled in this study. Homo group (*6/*6 and *28/*28 or a both hetero types), hetero group (It was *28 and either *6 was hetero type), and wild group (*28 and *6 were wild types) were defined. On the 23 patients with advanced CRC treated with FOLFIRI after standard chemotherapy, wild and homo groups were administered 150mg/m2 irinotecan, and homo group was 100mg/m2. Results: On the 23 patients, the genotypes of UGT1A1 *28 were homozygous in 1 (0.5%) and heterozygous in 5 (28%), *6 were homozygous in 0 and heterozygous in 6 (26%). In *6 heterozygous patients, severe toxicities (grade 3 or more) were found (33%), but in *28 heterozygous patients were not (0%). There was no decrease of irinotecan doses in each group. In Japanese people, UGT1A1 *6 polymorphisms were higher than *28 (*6 homo 3%, hetero 27% vs *28 homo 0.5%, hetero 13%). Conclusions: When the dosage of irinotecan is decided, it is necessary to consider the UGT1A1 *6 heterozygous in Japanese cancer patients. [Table: see text]

Feasibility study of irinotecan based on UGT1A1 polymorphisms for metastatic colorectal cancer: Interim report.

2012 ◽  
Vol 30 (4_suppl) ◽  
pp. 505-505 ◽  
Author(s):  
Hideya Kashihara ◽  
Mitsuo Shimada ◽  
Nobuhiro Kurita ◽  
Masanori Nishioka ◽  
Takashi Iwata ◽  
...  
Keyword(s):  
Response Rate ◽  
Prospective Trial ◽  
Optimal Dose ◽  
Japanese Patients ◽  
Dose Finding ◽  
Severe Toxicity ◽  
Interim Report ◽  
Severe Diarrhea ◽  
Gene Type ◽  
Grade 3

505 Background: Although Irinotecan prolongs survival, it causes severe diarrhea and neutropenia. Recent pharmacogenetic studies on irinotecan have revealed significant associations of UDP-glucuronosyltransferase 1A1 (UGT1A1) polymorphisms *28 and *6, the latter being specifically detected in East Asians resulting in severe toxicity. It is necessary that the dose-finding trial that decided the optimal dose according to the gene polymorphism to draw out the maximum therapeutic effect while evading the side effect. Previously, we showed UGT1A1 polymorphisms in Japanese patients (2011 ASCO-GI). Here, we present the interim report of prospective trial of the safety about FOLFIRI therapy according to each gene type of UGT1A1 for Japanese patients with advanced CRC. Methods: From 2008, 250 Japanese patients in TOKUSHIMA University were enrolled in this study. Homo group (*6/*6 and *28/*28 or a both hetero types), hetero group (It was *28 and either *6 was hetero type), and wild group (*28 and *6 were wild types) were defined. On the 30 patients with advanced CRC treated with FOLFIRI after standard chemotherapy, wild and homo groups were administered 150mg/m2 irinotecan, and homo group was 100mg/m2. The incidences of severe toxicities in each gene type of UGT1A1 and the response rate in FOLFIRI therapy were investigated. Results: In Japanese people, UGT1A1*6 polymorphisms were higher than *28 (*6 homo 3%, hetero 27% vs *28 homo 0.5%, hetero 13%). On the 30 patients with advanced CRC treated with FOLFIRI, the genotypes of UGT1A1*28 were homozygous in 1 (3%) and heterozygous in 6 (20%), *6 were homozygous in 0 and heterozygous in 8 (27%). In *6 heterozygous patients, severe toxicities (grade 3 or more) were found (38%). In *28 heterozygous patients, 1 patient (17%) showed severe toxicities. There was no decrease of irinotecan doses in each group. The number of course to PD was 7.6 (1-23). Regarding the response rate, PR, SD, PD was observed in 2 (7%), 6 (20%) and 18 patients (60%), respectively. Conclusions: In our interim report, the dosages of irinotecan based on UGT1A1 polymorphisms are safety in FOLFIRI therapy.

Oral (po) and Intravenous (iv) Clofarabine for Patients (pts) with Myelodysplastic Syndrome (MDS)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 222-222 ◽  
Author(s):  
Stefan Faderl ◽  
Guillermo Garcia-Manero ◽  
Farhad Ravandi ◽  
Gautam Borthakur ◽  
Zeev Estrov ◽  
...  
Keyword(s):  
High Risk ◽  
Optimal Dose ◽  
Infectious Complications ◽  
Dose Finding ◽  
Two Phase ◽  
Phase Ii Studies ◽  
Starting Dose ◽  
Grade 3 ◽  
Secondary Mds

Abstract Clofarabine (CLO) is a second generation deoxyadenosine nucleoside analog with activity in pts with acute myeloid leukemia (AML). Early reports also suggested activity in MDS, but the role of CLO in MDS has not been defined. To evaluate the activity and safety of CLO in MDS we designed two phase II studies of IV CLO and PO CLO, respectively. Pts were eligible with MDS and ≥5% blasts or IPSS intermediate-2 and high-risk, CMML, and RAEB-t by FAB. Hematopoietic growth factor support prior to and during the study was permitted. In the IV study pts were adaptively randomized (based on response) to receive CLO 15 or 30 mg/m2 IV over 1 hr. daily × 5 every 4–6 weeks. For the PO study, the starting dose of CLO was 40 mg/m2 orally daily × 5 every 4–6 weeks (oral bioavailability assumed ~ 50%, based on preclinical data), which was decreased to 30 mg/m2 orally daily × 5 after 6 pts had been treated on the higher dose. Sixty-one pts (6 RA/RARS/RCMD, 17 RAEB-1, 16 RAEB-2, 11 CMML, 11 RAEB-t) were treated. Forty-two pts (69%) had high- or intermediate-2 risk disease by IPSS. Thirty-six pts received IV CLO and 25 PO CLO. Median age was 67 yrs (range 25–89) (IV) and 70 yrs (54–86) (PO). Overall, > 80% of pts were older than 60 yrs. Approximately 1/3 of pts had secondary MDS: 13 (36%) (IV) and 8 (32%) (PO), respectively. Seventeen (47%) (IV) and 10 (40%) (PO) of pts had unfavorable cytogenetics (by IPSS definition). Thirty-nine (64%) pts failed prior hypomethylator therapy with either decitabine or azacitidine (22 [61%] pts on IV and 17 [68%] pts on PO CLO). Responses of 60 evaluable pts (one pt refused continuation of therapy on D4 of first course) are summarized in the Table: Response (%) Route Dose (mg/m2) N CR CRp HI PO 40/30 24 7 (29) 2 (8) 3 (13) IV 15 20 7 (35) 3 (15) - 30 16 4 (25) 2 (13) - Total - 60 18 (30) 7 (12) 3 (5) Six pts (10%) died on study (all IV CLO; most commonly related to infectious complications). All pts were evaluable for toxicities. Common AEs were nausea, vomiting, skin rash, hyperbilirubinemia and transaminase elevations. Toxicities ≥ grade 3 were rare. Acute renal failure occurred in 7 pts (2 IV [15 mg/m2], 3 IV [30 mg/m2], 2 PO). Myelosuppression and hospitalizations for neutropenic fever were common, but prolonged myelosuppression (> 42 days) was rare. In conclusion, CLO has activity in pts with higher-risk MDS. Optimal dose and schedule for PO and IV CLO remain to be defined. Lower doses of CLO are also associated with responses. Additional dose finding trials are underway to define the MTD and DLT of IV and PO CLO in high-risk MDS.

The role of nutritional assessment for predicting Radiotherapy-induced adverse events in patients with gastric cancer

2021 ◽  
Author(s):  
Wenjie Sun ◽  
Guichao Li ◽  
Jing Zhang ◽  
Ji Zhu ◽  
Zhen Zhang
Keyword(s):  
Gastric Cancer ◽  
Body Weight ◽  
Adverse Events ◽  
Cancer Patients ◽  
Body Weight Loss ◽  
Nutritional Factors ◽  
Nrs 2002 ◽  
Grade 3 ◽  
Gastric Cancer Patients

Objectives: The aim of this study was to investigate the role of nutritional factors in predicting radiotherapy-associated toxicities for gastric cancer patients. Methods: A total of 285 gastric cancer patients who underwent radiotherapy in our hospital between 2010 and 2017 were included in this retrospective study. Nutritional status assessment included body weight loss (BWL), body mass index (BMI), serum albumin, nutrition risk screening 2002(NRS-2002), patient-generated subjective global assessment(PG-SGA) and nutritional risk index (NRI). Results: Of all patients, 19.6% were underweight (BMI <18.5 kg/m2), 25.6% were hypoalbuminemia (<35 g l−1) and 48.8% lost ≥10% of body weight in the 6 month interval before radiotherapy(BWL). Meanwhile, 73.3%, 78.6 and 47.2% of the patients were diagnosed as malnutrition based on NRS-2002, PG-SGA and NRI, respectively. Hematological adverse events were present in 91.2% (≥Grade 1) and 20.4% (≥Grade 3) of the patients. Non-hematological adverse events occurred in 89.8% (≥Grade1) and 14.4% (≥Grade 3) of the patients. Multivariate analyses indicated that only hypoalbuminemia(<35 g l−1) was independent predictor for Grade 3/4 hematological and non-hematological adverse events. Meanwhile, higher BWL(≥10%) was also independent predictor for Grade 3/4 non-hematological adverse events. NRS-2002, PG-SGA and NRI score were not associated with treatment-induced adverse events. Conclusions: Body weight loss and serum albumin are useful factors for predicting severe adverse events in gastric cancer patients who undergo radiotherapy. Advances in knowledge: The use of nutritional factors in predicting severe adverse events enables implementation of individualized treatment strategies for early and intensive nutritional interventions in high-risk patients.

Reversal of Resistance to Doxifluridine and Fluorouracil in Metastatic Colorectal Cancer: The Role of High-Dose Folinic Acid

1992 ◽  
Vol 78 (4) ◽  
pp. 258-261 ◽  
Author(s):  
Marco Colleoni ◽  
Emilio Bajetta ◽  
Filippo de Braud ◽  
Nicoletta Zilembo ◽  
Franco Noiè ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Folinic Acid ◽  
Performance Status ◽  
Objective Response ◽  
High Dose ◽  
Severe Toxicity ◽  
First Line ◽  
First Line Therapy ◽  
Colon And Rectum

The benefits from medical treatment in colorectal cancer are limited. Fluorouracil remains the only recognized drug, and how to treat unresponsive patients is still debated. To evaluate the role of folinic acid (FA) in circumvence resistance in colorectal cancer, 28 patients pretreated with fluoropyrimidine were candidated to receive one of the following schedules: fluorouracil (600 mg/m2) associated with FA (500 mg/m2) weekly for 6 weeks (Regimen A: 21 cases), or fluorouracil (370 mg/m2) plus FA (200 mg/m2) dally for 5 days every 4 weeks (Regimen B: 7 cases). Fourteen patients were pretreated with doxifluridlne, a new fluoropyrimldine derivative with a peculiar mechanism of action, and the remaining 14 patients with fluorouracil. All but 2 patients were unresponsive to first-line treatments. When the treatment began, the median age of the patients was 60 years (range, 30-68). The performance status (ECOG) was 0/1 in 25 of them, and the primary tumor was in the colon and rectum in 19 and 9 patients, respectively. Sites of disease were liver (64 %), lung (35 %), local recurrence (10 %) and peritoneum (10 %). A median of 3 cycles (range, 1-7) was delivered, and no objective response was observed in the group of patients pretreated with doxlfluridine or in the group pretreated with fluorouracil. In 5 cases a significant decrease in baseline CEA values was observed. Therapy was well tolerated, and no grade 4 toxicity was encountered. Severe toxicity was limited and included diarrhea (7 patients), stomatitis (1 patient) and nausea/vomiting (1 patient). High-dose FA has no role in reversing resistance to fluoropyrimidine, and other mechanisms of refractoriness are surely involved. FA should be associated with fluoropyrimidine as first-line therapy together with other biochemical modulators. Further rescue therapies need to be developed.

A multicenter dose-finding study of irinotecan (CPT-11) based on UGT1A1 polymorphisms for metastatic colorectal cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14572-e14572
Author(s):  
Hirohiko Sato ◽  
Mitsuo Shimada ◽  
Nobuhiro Kurita ◽  
Takashi Iwata ◽  
Kozo Yoshikawa ◽  
...  
Keyword(s):  
Response Rate ◽  
Prospective Trial ◽  
Progression Free Survival ◽  
Dose Finding ◽  
Final Report ◽  
Severe Toxicity ◽  
Second Line ◽  
Free Survival ◽  
Gene Type ◽  
Wild Group

e14572 Background: Recent pharmacogenetic studies on irinotecan have revealed significant associations of UDP-glucuronosyltransferase 1A1 (UGT1A1) polymorphisms *28 and *6, the latter being specifically detected in East Asians resulting in severe toxicity such as severe diarrhea and neutropenia. It is necessary that the dose-finding trial that decided the optimal dose according to the gene polymorphism to draw out the maximum therapeutic effect while evading the side effect. Here, we present the final report of prospective trial of safety and efficacy about FOLFIRI ± bevacizumab (Bev) therapy according to each gene type of UGT1A1for Japanese patients with advanced CRC in second-line setting. Methods: Between September 2008 and March 2012, 59 patients were enrolled in this study. Grouping was defined as follows: wild group; both *28 and *6 were wild types, hetero group; *28 and either *6 was hetero type, and homo group; 28/*28 and *6/*6* or a both hetero types. In the 59 patients with advanced CRC treated with FOLFIRI ± Bev as a second line, wild and hetero groups were administered 150mg/m2 irinotecan, and homo group was 100mg/m2. The incidences of severe toxicities according to gene type of UGT1A1, the response rate and progression-free survival were investigated. Results: In the 59 patients, wild group was 28 (47%), hetero group was 26 (44.1%) and homo group was 5 (8.5%). 8 patients (29%) showed severe toxicities (grade 3 or more) in wild group, 5 patients (19%) in hetero group, 1 patient (20%) in homo group (P=0.71). Regarding the response rate, CR, PR, SD, PD was observed in 1 (4.0%), 1 (4.0%), 5 (20.0%) and 18 patients (72.0%), respectively in wild group, 0 (0.0%), 2 (8.3%), 5 (20.8%) and 17 patients (70.8%), in hetero group, 0 (0.0%), 0 (0.0%), 1 (20.0%) and 4 patients (80.0%), in homo group. The overall response rate (CR+PR) was 8.0% in wild group, 8.3% in hetero group, 0% in homo group (P=0.80). As for progression-free survival, the number of cycle to PD was 12.1 cycles (2-35 cycles) in wild group, 8.3 (2-20) in hetero group, 9.8 (6-14) in homo group (P=0.15). Conclusions: The dosages of 150mg/m2 irinotecan in hetero group, 100mg/m2 in homo group are safe and effective in FOLFIRI ± Bev therapy in the second line. Clinical trial information: UMIN000004773.

A phase II study on the efficacy and toxicity of cabozantinib in recurrent/metastatic salivary gland cancer patients.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6529-6529
Author(s):  
Wim van Boxtel ◽  
Maike Uijen ◽  
Chantal Driessen ◽  
Sjoert Pegge ◽  
Stefan M. Willems ◽  
...  
Keyword(s):  
Salivary Gland ◽  
Cancer Patients ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Objective Response ◽  
Salivary Gland Cancer ◽  
Severe Toxicity ◽  
Duct Carcinoma ◽  
Systemic Treatments ◽  
Grade 3

6529 A phase II study on the efficacy and toxicity of cabozantinib in recurrent/metastatic salivary gland cancer patients. Background: Because c-MET and VEGFR are often overexpressed in salivary gland cancer (SGC), this study evaluated the efficacy and safety of cabozantinib in recurrent/metastatic (R/M) SGC pts. Methods: A single center, single arm, phase II study was conducted. Immunohistochemical c-MET positive (H-score ≥10) R/M SGC pts were included in 3 cohorts: adenoid cystic carcinoma (ACC), salivary duct carcinoma (SDC), and other SGCs. Objective growth or complaints due to the disease were required before inclusion in the ACC and other SGC cohort. No prior systemic treatments were required. Pts started 60 mg cabozantinib tablets OD. Primary endpoint was the objective response rate (ORR). A Simon two-stage design was used. In case of ≥1 objective response in the first 9 pts/cohort, 8 additional pts would be included in the cohort. Results: In total 25 pts were included from Sep. 2018 until premature closure due to severe toxicity in Nov. 2019. Median age was 56 years (range 49-72), prior treatments included: primary tumor resection ( n=19), radiotherapy ≥50Gy ( n=24), systemic therapy ( n=10; adjuvant in 2 pts, palliative in 8 pts). Six pts had grade 3 ( n=4), grade 4 ( n=1), or grade 5 ( n=1) wound/fistula complications, occurring at a median of 7.2 mths on cabozantinib (range 2.1-12.8). This resulted in a severe wound complication rate of 32% in 19 pts on treatment for ≥2 mths. Remarkably, 4 out of 6 pts developed this complication in the area exposed to high-dose Rx; 2/4 had a pre-existing fistula in this area. Median interval between Rx and start of cabozantinib was 71.3 mths (range 10.6-94.7). Other grade ≥3 adverse events in >1 pt were: hypertension (5 pts), diarrhoea (2 pts) and dehydration (2 pts). Current median follow-up is 6.8 mths. The ORR was 6% (1/17 pts) in the ACC cohort, 20% (1/5 pts) in the SDC cohort, and 0% (0/3 pts) in other SGC pts; median PFS is 12.6 mths (95% CI 6.8 – 18.4 mths), 9.0 mths (insufficient events for 95% CI), and 6.9 mths (95% CI 0 – 15.2 mths), respectively. Median OS is not reached in any cohort. Conclusions: This phase II study on cabozantinib in R/M SGC pts demonstrated severe wound and fistula complications in 32% of pts on treatment for ≥2 mths, mostly (4/6 pts) within the radiotherapy field. Because of this toxicity the study was closed prematurely. Furthermore, cabozantinib showed minimal clinical activity in SGC pts. Research funding: Ipsen Pharmaceuticals Clinical trial information: NCT03729297 .

scholarly journals Tegafur–uracil is a safe alternative for the treatment of colorectal cancer in patients with partial dihydropyrimidine dehydrogenase deficiency: a proof of principle

2012 ◽  
Vol 4 (4) ◽  
pp. 167-172 ◽  
Author(s):  
Daniel I.G. Cubero ◽  
Felipe Melo Cruz ◽  
Patrícia Santi ◽  
Ismael Dale C.G. Silva ◽  
Auro del Giglio
Keyword(s):  
Colorectal Cancer ◽  
Cancer Patients ◽  
Dehydrogenase Deficiency ◽  
Dihydropyrimidine Dehydrogenase ◽  
Gene Sequencing ◽  
Severe Toxicity ◽  
Safe Alternative ◽  
Grade 3 ◽  
Colorectal Cancer Patients ◽  
Proof Of Principle

Objective: The objective of this study was to evaluate the safety of using tegafur–uracil (UFT) in colorectal cancer patients with partial dihydropyrimidine dehydrogenase (DPD) deficiency. Patients and Methods: The study included five colorectal cancer patients who presented with acute toxicity (grades 3 and 4) after being given the first cycle of chemotherapy using 5-fluorouracil. The DPD deficiency was confirmed by gene sequencing. After a full recovery from all side effects, we changed the regimen to UFT (300 mg/m2/day) associated with leucovorin (90 mg/day) for 21 days, with an empirical dose reduction of at least 10% in the first cycle. Results: We prospectively analysed 22 UFT cycles in 5 patients. We did not observe any episodes of grade 3 or 4 toxicity. The predominant toxicities were of grades 1 and 2 (nausea, vomiting and diarrhoea). Conclusion: Here, we demonstrate a complete absence of severe toxicity in all patients and cycles analysed. We believe that UFT is a safe alternative for the treatment of patients with partial DPD deficiency.

Genetic polymorphisms of the adenosine triphosphate-binding cassette transporters (ABCC2, ABCG2) and irinotecan toxicity in cancer patients

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13096-13096
Author(s):  
M. Usui ◽  
M. Ando ◽  
C. Kitagawa ◽  
Y. Ando ◽  
Y. Sekido ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Adenosine Triphosphate ◽  
Interindividual Variability ◽  
Antitumor Drugs ◽  
Severe Toxicity ◽  
Reference Allele ◽  
Reference Type ◽  
Grade 3 ◽  
Altered Sensitivity

13096 Background: Irinotecan is subject to substantial interindividual variability in pharmacokinetic and the occurrence of unpredictably severe toxicities of leukopenia or diarrhea. These toxicities have been reported to be associated with increased levels of SN-38, the active metabolite of irinotecan. ABCC2 and ABCG2, members of adenosine triphosphate-binding cassette transporters, are involved in mediating the elimination of anionic antitumor drugs, such as SN-38 and SN-38G. Recently, Innocenti et al. reported SN-38G AUC and SN-38G/SN-38 AUC ratios were correlated with ABCC2 3972T>C. The variant ABCG2 421C>A was associated with low ABCG2 expression levels and altered sensitivity to several drugs, including SN-38, in vitro as compared with the reference-type protein. Methods: We assessed whether the variants ABCC2 3972T>C and ABCG2 421C>A would be associated with severe toxicity (leucopenia of grade 4 and/or diarrhea of grade 3 or worse) in 120 Japanese cancer patients in which 27 patients experienced severe toxicity. Results: 74 patients (62%) were homozygotes for the reference allele of ABCC2 3972T>C, 39 heterozygous (33%), and 7 homozygous (6%) for the variant, whereas 62 patients (52%) were homozygous for the reference allele of ABCG2 421C>A, 48 heterozygous (40%) and 10 homozygous (8%) for the variant. Logistic regression analysis did not show any significant associations between the occurrence of severe toxicity and carrying these variants (see Table ). Conclusions: It suggests that genotyping of ABCC2 3972T>C and ABCG2 421C>A would not be useful for predicting severe toxicity caused by irinotecan. [Table: see text] No significant financial relationships to disclose.

Prophylactic fluconazole treatment of mucositis in radiotherapy of head and neck cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6062-6062
Author(s):  
C. Demiroz ◽  
L. Ozkan ◽  
O. Karadag
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Cancer Patients ◽  
Neck Cancer ◽  
Late Toxicity ◽  
Group A ◽  
Fluconazole Prophylaxis ◽  
Grade 3 ◽  
Group B

6062 Background: The aim of the study is to evaluate the preventive role of antifungal fluconazole prophylaxis on mucositis in head and neck cancer patients treated with radiotherapy. Methods: We evaluated 43 head and neck cancer patients treated with radiotherapy with/without chemotherapy. The patients were randomized to two groups: twenty patients (group A) received fluconazole when micotic infections appeared; 23 patients (group B) received fluconazole 200 mg once a week starting from the sixth irradiation session throughout the treatment.The two groups were similar in terms of patients and radiotherapy characteristics. Oral mucositis was recorded according to EORTC/RTOG criteria. Results: The usage of fluconazole 200 mg once a week was well tolerated and no early and late toxicity was observed. Mucositis was appeared in both groups on the third week of radiotherapy. Grade 3 mucositis developed at eight of the patients in group A (40%), three of the patients in group B (13%) and the result was statistically significant (p = 0.044). While grade 3 mucositis was observed the second/third week in group A, it was also observed in group B on third/fourth week in group B (p = 0.043). Conclusions: Weekly fluconazole prophylaxis showed a significant effect on the grade 3 mucositis and improved radiotherapy results. No significant financial relationships to disclose.

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