VITAL phase 2 study: Upfront 5-fluorouracil, mitomycin-C, panitumumab and radiotherapy treatment in nonmetastatic squamous cell carcinomas of the anal canal (GEMCAD 09-02).

AIM: VITAL, a phase II single-arm study, aimed to evaluate efficacy and safety of panitumumab addition to 5-fluorouracil (5-FU), mitomycin-C (MMC) and radiotherapy (RT) in patients with localized squamous cell carcinoma of the anal canal (SCCAC). METHODS: Adult, treatment-naïve SCCAC patients (Stage T2-T4, any N, M0) and ECOG-PS ≤2, received panitumumab (6 mg/kg, day 1 and Q2W; 8 weeks), 5-FU (1000 mg/m2 /d, days 1-4 and 29-32), MMC (10 mg/m2 , days 1 and 29) and RT 45 Gy (1.8 Gy/fraction) to the primary tumor and mesorectal, iliac and inguinal lymph nodes, plus 10-15 Gy boost dose to the primary tumor and affected lymph nodes. The primary objective was disease free survival rate (DFS) at 3-years (expected 3-year DFS rate: 73.7 ± 12%). RESULTS: Fifty-eight patients (31 women; median age: 59 years; ECOG-PS 0-1:98%; TNM II [29%] (T2 or T3/N0/M0)/IIIA (T1-T3/N1/M0 or T4/N0/M0) [21%]/IIIB (T4/N1/M0 or any T/N2 or N3/M0) [47%]/nonevaluable [4%]) were included. The median follow-up was 45 months. The 3-year DFS rate was 61.1% (95% CI: 47.1, 72.4). The 3-year overall survival rate was 78.4% (95% CI: 65.1, 87.1). Eighteen patients (31.0%) required a colostomy within 2 years posttreatment. Grade 3-4 toxicities were experienced by 53 (91%) patients. Most common grade 3-4 treatment-related events were radiation skin injury (40%) and neutropenia (24%). No toxic deaths occurred. Improved efficacy in colostomy-free survival and complete response rate was observed in human papilloma virus positive patients. CONCLUSIONS: Panitumumab addition to MMC-5FU regimen in SCCAC patients increases toxicity and does not improve patients' outcomes. RT plus MMC-5FU remains the standard of care for localized SCCAC patients.

Radiation therapy after sentinel lymph node biopsy for early stage breast cancer using a magnetic tracer: Results of a single institutional prospective study of tolerance.

PURPOSE: . The aim of the study was, through a single institutional analysis of a large population of breast cancer patients, to assess the feasibility of and the tolerance to radiotherapy after the use of magnetic detection method for sentinel lymph node biopsy. MATERIAL AND METHODS: The super paramagnetic iron oxide particles database was collected prospectively and identified 520 cases from October 2013 to December 2016 at our institution. All of them received super paramagnetic iron oxide particles injection 20minutes before the surgical procedure and some of them received also isotope technique. Injection site for super paramagnetic iron oxide particles and isotope was periareolar. Among them, 288 patients received adjuvant radiotherapy. In our study, we evaluated the tolerance of postoperative radiotherapy. RESULTS: The median age of the patients was 64 years. The median follow-up period was 16 months (range: 1-42 months). Double detection of sentinel lymph node was done in the first 30 patients (10.4%). The sentinel lymph node identification rate was 99.7% (287 out of 288). There were 34 axillary lymph node dissections, of which 58.8% were realized straightaway. The total radiation dose was 50Gy EQD2 (range: 28.5-66Gy). Regarding the occurrence of radiodermatitis, 95.8% of patients had grade 0-2 radiodermatitis and 1% had grade 3. During follow-up, 19.4% of patients developed grade 1-2 post-therapeutic fibrosis (of which 92.9% grade 1). CONCLUSION: The results of this large-scale study show that the radiotherapy after sentinel lymph node biopsy using super paramagnetic iron oxide particles is feasible, and that no increase of the toxicity was observed.

[Early-onset radiation complications and tissue damage in the treatment of head and neck tumors].

The report discusses the results of an evaluation of the effectiveness of combined radiotherapy in 1,192 cases of head and neck tumors divided into 4 groups: distant radiotherapy in standard fractions of 1.8-2.3 Gy, 5 times a week, TTD of 60 Gy (group 1 - 486 40.8%); radiotherapy + local UHF hyperthermia + regional intraarterial chemotherapy + hyper glycemia + administrations of regional intraarterial chemotherapy + hyperglycemia + local UHF hyperthermia (group 2 - 244 20.5%); accelerated superfractition radiotherapy with variable STD of 1 and 1.5/2 Gy, TTD of 60 Gy, plus neoadjuvant polychemotherapy with cisplatin 100 mg/lm2 + 5-fluorouracil, continuous intravenous infusion of 3,000 mg for 72 h (group 3 - 204 17%1); combined photon-neutron therapy (group 4 - 258 21.6%): neutron beam therapy - 36 (3%); interstitial neutron brachytherapy with 252 Cf sources in combination with external beam gamma-therapy and chemotherapy. Overall radiation injury incidence was 1,087 (91.2%); oral mucositis grade I (WHO) - 110 (9.2%), grade II - 166(13.9%), grade III - 811 (68%), radiation dermatitis - 279 (23.4%), grade I/II - 196 (16.4%), grade III/IV - 83 (7%). Grade III/IV side effects developed in 26.7% after gamma therapy and in 72.2% - in the photon-neutron group (p < or = 0.0001). Skin damage was rare, as expected, in the photon-brachytherapy group (1.8%) (p < or = 0.0001). Hence, Cf252 neutron brachytherapy and radiotherapy with concomitant chemotherapy appeared to produce the most sparing effects.

[The treatment of laryngeal cancer by using local hyperthermia]. / Lechenie raka gortani s ispol'zovaniem lokal'noi gipertemii.

Potentiation of the effect of radiation and combined treatment of laryngeal cancer by local hyperthermia was studied in 43 patients. In 51 cases of the control group (radiotherapy), conventionally-dynamic fractionation of dose was used. At 32 Gy, complete or partial regression of tumor was observed in 72.1% in the study group and 64.7% of controls. An increased frequency of radiation-induced damage of the oral mucosa was observed whereas radiation epidermitis did not occur. Three-year relapse-free survival following a course of radical thermoradiotherapy was as high as 76.5% compared to 40% in controls. Overall three-year survival (including the results of combined treatment and treatment for relapse) increased from 66.7 to 83.3%.