Efficacy of gabapentin for the prevention of paclitaxel induced peripheral neuropathy: A randomized placebo controlled clinical trial.

Neuropathy is a dose limiting side effect of taxanes which may impact the quality of life and treatment outcomes. This randomized placebo-controlled double-blinded clinical trial was carried out to assess the efficacy of gabapentin in preventing chemotherapy induced neuropathy. Women with breast cancer were randomized into two groups of paclitaxel chemotherapy with gabapentin 300 mg/three times a day orally or placebo for 2 weeks started at day 1 of each paclitaxel cycle. Two groups were compared based on the relative frequency of neuropathy and change in nerve conducting velocity (NCV). Twenty women were assigned to each study arm. The majority of the neuropathy in gabapentin group was grade 1 in all of the four cycles with no event of ≥grade 3 neuropathy in this group. Compared to the placebo, the rate of 2nd and 3rd grade neuropathy was significantly lower in the gabapentin group (P = 0.000). The change in NCV after four cycles of paclitaxel was significantly lower in the gabapentin group compared to the placebo group (17.7% vs 61.0% decline in NCV for sural and 21.9% vs 62.5% declines in NCV for peroneal nerve). Gabapentin given with paclitaxel is effective in the prevention of intermediate and high grade neuropathies both objectively and subjectively.

Preoperative short course radiotherapy with concurrent and consolidation chemotherapies followed by delayed surgery in locally advanced rectal cancer: preliminary results.

PURPOSE: This study aimed to assess complications and outcomes of a new approach, that is, combining short course radiotherapy (SRT), concurrent and consolidative chemotherapies, and delayed surgery. MATERIALS AND METHODS: In this single arm phase II prospective clinical trial, patients with T3-4 or N+ M0 rectal adenocarcinoma were enrolled. Patients who received induction chemotherapy or previous pelvic radiotherapy were excluded. Study protocol consisted of three-dimensional conformal SRT (25 Gy in 5 fractions in 1 week) with concurrent and consolidation chemotherapies including capecitabine and oxaliplatin. Total mesorectal excision was done at least 8 weeks after the last fraction of radiotherapy. Primary outcome was complete pathologic response and secondary outcomes were treatment related complications. RESULTS: Thirty-three patients completed the planned preoperative chemoradiation and 26 of them underwent surgery (24 low anterior resection and 2 abdominoperineal resection). Acute proctitis grades 2 and 3 were seen in 11 (33.3%) and 7 (21.2%) patients, respectively. There were no grades 3 and 4 subacute hematologic and non-hematologic (genitourinary and peripheral neuropathy) toxicities and perioperative morbidities such as anastomose leakage. Grade 2 or higher late toxicities were observed among 29.6% of the patients. Complete pathologic response was achieved in 8 (30.8%) patients who underwent surgery. The 3-year overall survival and local control rates were 65% and 94%, respectively. CONCLUSION: This study showed that SRT combined with concurrent and consolidation chemotherapies followed by delayed surgery is not only feasible and tolerable without significant toxicity but also, associated with promising complete pathologic response rates.

High-dose-rate brachytherapy in treatment of non-melanoma skin cancer of head and neck region: preliminary results of a prospective single institution study.

PURPOSE: Skin cancers are the most common human malignancy with increasing incidence. Currently, surgery is standard of care treatment for non-melanoma skin cancers. However, brachytherapy is a growing modality in the management of skin cancers. Therefore, we aimed to assess the outcome of patients with non-melanoma skin cancers treated by high-dose-rate (HDR) brachytherapy with surface mold technique. MATERIAL AND METHODS: In this prospective study, we recruited patients with basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) of the skin who were candidates for definitive or adjuvant brachytherapy during 2013-2014. Alginate was used for making the individualized surface molds for each patient. Patients were treated with afterloading radionuclide HDR brachytherapy machine, with a total dose of 30-52 Gy in 10-13 fractions. Participants were followed for 2 years for radiation toxicity, cosmetic results, and local failures. RESULTS: A total of 60 patients (66.7% male; median age, 71 years) were included, of which 42 (70.0%) underwent definitive radiotherapy. Seventy-five percent of lesions were BCC. The mean total dose was 39.6 ± 5.4 Gy. Of patients in definitive group, 40/42 (95.2%) experienced complete clinical response after 3 months. The recurrence rate was 2/18 (11.11%) and 1/42 (2.38%) in adjuvant and definitive groups, respectively. The percentage of grade 3-4 acute (3-month post-treatment) and late toxicities (2 years post-treatment) was 6.7% and 0%, respectively. The cosmetic results were good/excellent in 96.2% of patients after 2 years of follow-up. CONCLUSIONS: With appropriate patient selection and choosing as lowest dose per fraction as possible, HDR brachytherapy with customized surface molds yields good oncological and cosmetic results for the treatment of localized skin BCC and SCC.