Reduction in severity of radiation-induced dermatitis in head and neck cancer patients treated with topical aloe vera gel: A randomized multicenter double-blind placebo-controlled trial.

PURPOSE: To assess the efficacy of topical aloe vera gel on radiation induced dermatitis (RID) in head and neck cancer (HNC) patients. METHOD: In this multicenter randomized double-blind controlled study, HNC patients treated with concurrent chemoradiation (CCRT) received either aloe vera gel or placebo gel. Adverse skin toxicity levels were evaluated with the radiation-induced skin reaction assessment scale (RISRAS). RESULTS: One hundred-twenty patients were enrolled in this study. Analysis of the baseline characteristics did not reveal any differences between the groups. The median RISRAS values from the 1st to the 8th week of the CCRT course were not statistically different between the two groups. In the 5th and 6th weeks of treatment, moderate to severe grades of skin erythematous were observed at values of 13.6% and 24.1% versus 27.8 and 42.6% for members of the aloe vera gel group and the placebo group, respectively (p = 0.05 for the 5th week and p = 0.038 for the 6th week). In the 7th week, moderate to severe instances of moist desquamation were observed in eight patients (19.0%) in the placebo group (p = 0.001). Subjects experienced a burning sensation with RISRAS scores of 3-4 in the 7th week representing only 11.9% of patients in the placebo group (p = 0.016). CONCLUSION: Topical applications of aloe vera gel significantly reduced moderate to severe grades of skin erythematous and instances of moist desquamation in HNC patients receiving CCRT. In this study, there was no prophylactic efficacy for RID in the aloe vera gel group when compared to the placebo group.

Two-year outcome of concurrent chemoradiation with carboplatin with or without adjuvant carboplatin/fluorouracil in nasopharyngeal cancer: A multicenter randomized trial.

BACKGROUND: According to the noninferiority result of chemoradiation with carboplatin in our previous nasopharyngeal carcinoma (NPC) study along with the inconclusive data on the efficacy of adjuvant chemotherapy (AC) following concurrent chemoradiotherapy (CCRT), we designed to assess the role of adjuvant carboplatin/fluorouracil following CCRT with carboplatin in locoregionally advanced NPC. MATERIALS AND METHODS: A multicenter randomized trial was conducted at 5 cancer centers in Thailand. We enrolled in stage T2N0M0-T4N2M0 (American Joint Cancer Committee 7th edition) WHO Type 2 NPC patients. N3 or metastatic disease patients were excluded. Participants were randomized into 2 groups: CCRT plus AC group vs the CCRT alone group. Patients in both groups received weekly carboplatin 100 mg/m2 for 6 cycles concurrently with radiotherapy 69.96-70 Gy. Patients in the AC group subsequently received 3 cycles of carboplatin area under curve-5 plus 1000 mg/m2/day of fluorouracil infusion within 96 hours every 3 weeks. We report the 2-year overall survival (OS), disease-free survival (DFS), loco-regional recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS). Treatment-related toxicities and compliance were also explored. RESULTS: Of 175 patients, 82 (46.9%) were assigned to the AC group, and 93 (53.1%) to the CCRT group. The compliance rate during CCRT was 90% and 86% in the AC and CCRT group, whereas 81.7% during adjuvant treatment in the AC group. With a median follow-up time of 24.4 months (interquartile range 17.9-24.4), the 2-year OS rate was 89.6% in the AC group and 81.8% in the CCRT group (P= 0.167). The 2-year DFS rate was 86.8% in the AC group and 74.6% in the CCRT group (P = 0.042). The 2-year LRFS rate was 91.5% in the AC group and 88.2% in the CCRT group (P = 0.443). The 2-year DMFS rate was 85.4% in the AC group and 79.6% in the CCRT group (P = 0.294). The most frequent serious (grade 3/4) nonhematologic toxicity was acute mucositis, which occurred 5% in the AC group vs 4% in the CCRT group (P = 0.498). For hematologic toxicity, grade 3-4 leukopenia were found 10% and 5% in the adjuvant and CCRT groups, respectively (P = 0.003). Multivariate analyses determined stage N2 disease was an adverse prognostic factor associated with shorter OS, DFS, and DMFS. And the adjuvant treatment was a significant protective factor for only DFS. CONCLUSIONS: The addition of adjuvant carboplatin/fluorouracil following CCRT with carboplatin significantly improved 2-year DFS in stage T2N0M0-T4N2M0 NPC albeit there was a nonsignificant trend in favor of a higher 2-year OS, LRFS, and DMFS. Long-term efficacy and late toxicities of AC still require exploration.

Cost-utility analysis of 5-fluorouracil and capecitabine for adjuvant treatment in locally advanced rectal cancer.

BACKGROUND: Adjuvant chemotherapy at concurrent time with radiation therapy (RT) or at adjuvant time alone in locally advanced rectal cancer (LARC) is used with several regimens. The cost-utility analysis was conducted to compare administration of two 5-FU regimens and capecitabine in the aspect of provider and societal viewpoint. METHODS: Stage II or III rectal cancer patients who received pre-operative or post-operative concurrent chemoradiotherapy and adjuvant chemotherapy were compared by using decision tree model between (I) 5-FU plus leucovorin (LV) for 5 days per cycle (Mayo Clinic regimen); (II) 5-FU continuous infusion (CI) for 120-h per cycle (CAO/ARO/AIO-94 protocol); (III) standard regimen of capecitabine. All probability data were extracted from landmark study. Direct medical costs were the cost from database of Drug Medical Supply Information Center, while direct non-medical cost and utility were interviewed from stage II and III rectal cancer patients. The time horizon of this study was 5 years. Incremental cost-effectiveness ratio (ICER) was the final result in this study, which determined as the numerator of the difference of costs among three drug regimens, and the difference of quality-adjusted life years (QALYs) from each drug was the denominator. RESULTS: 5-FU plus LV was the cheapest and least efficacy for adjuvant treatment of LARC in both provider and societal viewpoint. In provider viewpoint, the ICERs of 5-FU CI and capecitabine were 334,550 THB/QALY (US $9,840/QALY) and 189,935 THB/QALY (US $5,586/QALY), respectively, with the corresponding societal viewpoint of 264,447 THB/QALY (US $7,778/QALY) and 119,120 THB/QALY (US $3,504/QALY) when 5-FU plus LV was used as comparator. The most influential parameter for value of treatment was acquisition cost of capecitabine. At the willingness to pay for one QALY gained in Thailand (160,000 THB or US $4,706), 5-FU plus LV, 5-FU CI and capecitabine had probabilities of cost-effectiveness of 63%, 2% and 35%, respectively. CONCLUSIONS: Capecitabine was the most expensive regimen but produced the higher effectiveness than 5-FU plus LV and 5-FU CI. The most influential parameter in the model was acquisition cost of capecitabine.

Randomized control trial of benzydamine HCl versus sodium bicarbonate for prophylaxis of concurrent chemoradiation-induced oral mucositis.

PURPOSE: The purpose of the study is to compare the efficacy of benzydamine HCl with sodium bicarbonate in the prevention of concurrent chemoradiation-induced oral mucositis in head and neck cancer patients. METHODS: Sixty locally advanced head and neck cancer patients treated with high-dose radiotherapy concurrently with platinum-based chemotherapy were randomly assigned to receive either benzydamine HCl or sodium bicarbonate from the first day of treatment to 2 weeks after the completion of treatment. The total score for mucositis, based on the Oral Mucositis Assessment Scale (OMAS), was used for the assessment, conducted weekly during the treatment period and at the fourth week of the follow-up. Pain score, all prescribed medications, and tube feeding needs were also recorded and compared. RESULTS: The median of total OMAS score was statistically significant lower in patients who received benzydamine HCl during concurrent chemo-radiotherapy (CCRT) than in those who received sodium bicarbonate, (p value < 0.001). There was no difference in median pain score, (p value = 0.52). Nineteen percent of patients in sodium bicarbonate arm needed oral antifungal agents whereas none in the benzydamine HCl arm required such medications, (p value = 0.06). Tube feeding needs and the compliance of CCRT were not different between the two study arms. CONCLUSIONS: For patients undergoing high-dose radiotherapy concurrently with platinum-based chemotherapy, using benzydamine HCl mouthwash as a preventive approach was superior to basic oral care using sodium bicarbonate mouthwash in terms of reducing the severity of oral mucositis and encouraging trend for the less need of oral antifungal drugs.