Can Radiation Therapy Quality Assurance Improve Nasopharyngeal Cancer Outcomes in Low- and Middle-Income Countries: Reporting the First Phase of a Prospective International Atomic Energy Agency Study.

PURPOSE: Most new nasopharyngeal cancer cases occur in low-income and middle-income countries, and these patients experience poorer overall survival than that of new nasopharyngeal cancer cases in high-income countries. The goal of this research project is to determine whether the introduction of a radiation therapy quality assurance program can ultimately improve outcomes for nasopharyngeal cancer patients in lower-income and middle-income countries. This study reports the results of the first phase of the International Atomic Energy Agency Coordinated Research Project (325-E3-TM-47712). METHODS AND MATERIALS: This prospective study has 2 phases. Phase 1 is a survey of radiation therapy resources, patient characteristics and treatment, and results of radiation therapy quality assurance performed by the expert panel. An educational workshop reviewing phase 1 results for each center was completed before accrual of patients for phase 2. The ultimate aim of the study is to compare the first and second cohort of patients to see if quality assurance can result in fewer major protocol deviations and a 15% improvement in patients' 3-year progression-free survival. RESULTS: Of 14 participating centers, 13 (93%) had computed tomography simulators and linear accelerators (LINAC) with intensity modulated radiation therapy (IMRT) capacity, median 3 LINAC (range, 1-13), and median 10 radiation oncologists (range, 5-51). The annual number of nasopharyngeal cancer cases irradiated was median 54 (range, 10-627). Five of 14 centers (36%) had no local radiation therapy quality assurance. For the current phase 1 study, 134 patients were evaluated, 82.1% had MRI staging, 99.3% had metastatic workup, 65.6% undifferentiated histology, 51% stage 3 and 49% stage 4. Radiation therapy quality assurance revealed 81 (60.4%) of 134 patients had major protocol violations in gross tumor volume and high dose planning target volume contours and/or dosimetry, 28.4% patients had borderline plans, 15 (11.2%) acceptable, and only 6 (4.2%) had inevitable compromise due to tumor extent. CONCLUSIONS: This is the first International Atomic Energy Agency study to address the fundamental issue of treatment quality rather than altered treatment regimens. The high rate of unacceptable radiation therapy plans is a major concern, and we hope phase 2 will show a significant reduction and improved patient outcomes.

Transanal total mesorectal excision for locally advanced middle-low rectal cancers.

BACKGROUND: This study investigated the results of transanal total mesorectal excision (TaTME) combined with laparoscopy for locally advanced mid-low rectal cancer. METHODS: Patients with mid-low locally advanced rectal cancer (T3 category or above and/or N+) who underwent rectal resection with TaTME technique were enrolled prospectively. Patients who had distant metastasis, multiple malignancies, intestinal obstruction or perforation, or a clinical complete response to chemoradiotherapy were excluded. Postoperative results, including morbidity, circumferential resection margin (CRM) assessment, short-term survival and functional outcomes, were analysed. RESULTS: Thirty-eight patients, with 25 mid and 13 low rectal tumours, who had elective resection by TaTME from March 2015 to September 2018 were included. There were 25 men and 13 women. Mean(s.d.) age was 58·2(16·4) years and mean(s.d.) BMI was 24·2(2·5) kg/m2 . Tumours were 3-9 cm from the anal verge. Mean(s.d.) duration of surgery was 210(42) min. All patients had hand-sewn anastomoses and protective ileostomies. There were no conversions, abdominal perineal resections or postoperative deaths. Four patients had a complication, including three presacral abscesses, all managed by transanastomotic drainage. At 3 months after ileostomy closure, all patients had perfect continence. Apart from a greater tumour diameter in patients with low rectal cancers (6·0 cm versus 4·6 cm in those with mid rectal tumours; P = 0·035), clinical features were similar in the two groups. CRM positivity was greater for low than for mid rectal tumours (3 of 13 versus 0 of 25 respectively; P = 0·034), and more patients with a low tumour had TME grade 2 (4 of 13 versus 1 of 25; P = 0·038). There was no difference in oncological outcomes at 17 months. CONCLUSION: Although this study cohort was small, special attention should be paid to bulky low rectal tumours to reduce the rate of CRM positivity.

ANTECEDENTES: La escisión total del mesorrecto transanal (transanal total mesorectal excision, TaTME) combinada con la laparoscopia convencional se ha descrito como un procedimiento prometedor para el tratamiento del cáncer de recto medio-inferior localmente avanzado. El objetivo de este estudio fue investigar los resultados de TaTME combinados con la laparoscopia para el cáncer de recto medio-inferior localmente avanzado. MÉTODOS: Se incluyeron de forma prospectiva los pacientes con cáncer de recto medio-inferior localmente avanzado (≥ T3 y/o N+) a los que se realizó una resección anterior de recto con la técnica TaTME. Se excluyeron aquellos pacientes con metástasis a distancia, neoplasias múltiples, obstrucción intestinal o perforación y aquellos que presentaron una respuesta clínica completa después de la quimiorradioterapia. Los pacientes recibieron tratamiento neoadyuvante de acuerdo con las guías de práctica clínica internacionales. Se analizaron los resultados postoperatorios entre los que se incluyen la morbilidad, la evaluación del margen de resección circunferencial (circumferential resection margin, CRM) y la supervivencia a corto plazo junto con los resultados funcionales. RESULTADOS: Se seleccionaron 38 pacientes, 25 con el tumor en el recto medio y 13 con el tumor en el recto inferior que se sometieron a una resección anterior de recto electiva por TaTME desde marzo de 2015 hasta septiembre de 2018. Las localizaciones de los tumores oscilaron entre 3 y 9 cm desde el margen anal. La relación varón/mujer fue de 1,93, la edad media fue de 58,2 ± 16,4 años y el IMC medio de 24,2 ± 2,5 kg/m2 . El tiempo medio operatorio fue de 210 ± 42 minutos. En la todos los pacientes se realizó una anastomosis manual y una ileostomía de protección. No se registró ninguna conversión, ninguna amputación abdomino-perineal y ninguna muerte postoperatoria en toda la cohorte. Cuatro pacientes (10,5%) presentaron alguna complicación, incluidos tres abscesos presacros (7,9%), todos tratados mediante drenaje a través de la anastomosis. La continencia a los 3 meses del cierre de la ileostomía fue grado I según la clasificación de Horgan en todos los pacientes. Las características clínicas fueron similares en los cánceres de recto medio e inferior, sin embargo, este último grupo presentó un diámetro tumoral medio mayor en la estadificación clínica (4,8 en el cáncer de recto medio versus 6,0 cm en el cáncer de recto inferior; P = 0,03). En comparación con los tumores del recto medio, aunque en una cohorte muy pequeña, los tumores del recto inferior presentaron una tasa de afectación del CRM significativamente mayor (3 casos de afectación del CRM versus ninguno, P = 0,02) y así como un mayor número con escisión completa del mesorrecto grado 2 (4 pacientes versus 1 paciente; P = 0,02). No se encontraron diferencias significativas en los resultados oncológicos después de una mediana de seguimiento de 17 meses. CONCLUSIÓN: Aunque este estudio es el resultado de una pequeña cohorte, se debe prestar especial atención a los tumores de recto inferior voluminosos para reducir la tasa de positividad de CRM.

Natural orifice transluminal endoscopic surgery for colorectal cancer.

BACKGROUND: Natural orifice transluminal endoscopic surgery (NOTES) has theoretical advantages over other approaches. METHODS: This was a prospective cohort study of colorectal cancers operated on by NOTES (transanally for rectal tumours, transvaginally for sigmoid tumours) between December 2013 and December 2015, with a minimum follow-up of 1 year. Eligibility criteria included ASA fitness grade I-III, BMI below 25 kg/m2 and TNM stage T3 N0 M0. Exclusion criteria included pregnancy or distant metastasis. The anastomosis was either handsewn or performed mechanically. RESULTS: Sixteen patients were operated on by a transanal and four by a transvaginal approach. There were ten men and ten women, with a mean(s.d.) age of 55·6(12·1) years. Mean BMI was 22·4(2·6) kg/m2. Four anterior, 11 low anterior and five intersphincteric resections were performed for 16 rectal and four low sigmoid tumours. The mean duration of surgery was 258(11) min. No conversion to laparotomy was needed, and there were no deaths. Five patients required additional ports, for intraoperative bleeding (1), suture of an intraoperative urethral injury with covering ileostomy (1) and difficulty in dissection (3). One patient had an anastomotic leak requiring transanal closure and ileostomy on day 7. Both ileostomies were closed after 2 months. The mean hospital stay was 6·4(1·8) days. All resections were R0. CONCLUSION: In carefully selected patients NOTES for colorectal cancer resection was feasible and effective.