Defining a Standard Set of Health Outcomes for Patients With Squamous Cell Carcinoma of the Head and Neck in Spain.

PURPOSE: A systematic, standardized collection of health outcomes during patient treatment and follow-up, relevant from the perspective of all stakeholders, is a crucial step toward effective and efficient disease management. This project aimed to define a standard set of health outcomes for patients with squamous cell carcinoma of the head and neck (SCCHN). METHODS: The project was led and coordinated by a scientific committee (SC). It comprised: (1) a literature review (to identify variables used during SCCHN management); (2) 1st-SC meeting (to select the variables for presentation during nominal groups-NG); (3) five NG (n=42 experts) and four interviews with patients (to reach consensus on the variables for inclusion); and (4) final-SC meeting (to review the results of NG ensuring consensus on the variables where consensus was not reached). RESULTS: Experts agreed to include the following variables in the standard set: treatment-related (treatment intent and type, response to treatment, treatment toxicity/complication, treatment completion), degree of health (performance status, patient-reported health status, pain, dysphonia, feeding and speech limitations, body image alteration, tracheotomy), survival (overall and progression-free survival, cause of death), nutritional (weight, nutritional intervention), other variables (smoking status, alcohol consumption, patient satisfaction with aftermath care, employment status), and case-mix variables (demographic, tumor-related, clinical and nutritional factors). CONCLUSIONS: This project may pave the way to standardizing the collection of health outcomes in SCCHN and promote the incorporation of patients' perspective in its management. The information provided through the systematic compilation of this standard set may define strategies to achieve high-quality, patient-centered care.

Quality of life of patients with metastatic pancreatic adenocarcinoma initiating first-line chemotherapy in routine practice.

BACKGROUND: Despite advances in surgery, radiotherapy, and chemotherapy, pancreatic adenocarcinoma often progresses rapidly and causes death. The physical decline of these patients is expected to impact their quality of life (QoL). Therefore, in addition to objective measures of effectiveness, the evaluation of health-related QoL should be considered a matter of major concern when assessing therapy outcomes. METHODS: Observational, prospective, multicenter study including patients with metastatic pancreatic adenocarcinoma who started first-line chemotherapy in 12 Spanish centers. Treatment and clinical characteristics were recorded at baseline. Patients' health-related quality of life, ECOG, and Karnofsky index were measured at baseline, at Days 15 and 30, and every four weeks up to 6 months of chemotherapy. Health-related quality of life was measured using the EORTC-QLQ-C30 and EQ-5D questionnaires. Other endpoints included overall survival and progression-free survival. RESULTS: The study sample included 116 patients (median age of 65 years). Mean (SD) scores for the QLQ-C30 global health status scale showed a significant increasing trend throughout the treatment (p = 0.005). Patients with either a Karnofsky index of 70-80 or ECOG 2 showed greater improvement in the QLQ-C30 global health status score than the corresponding groups with better performance status (p ≤ 0.010). Pain, appetite, sleep disturbance, nausea, and constipation significantly improved throughout the treatment (p < 0.005). Patients with QLQ-C30 global health status scores ≥50 at baseline had significantly greater overall survival and progression-free survival (p = 0.005 and p = 0.021, respectively). No significant associations were observed regarding the EQ-5D score. CONCLUSIONS: Most metastatic pancreatic adenocarcinoma patients receiving first-line chemotherapy showed an increase in health-related quality of life scores throughout the treatment. Patients with lower performance status and health-related quality of life at baseline tended to greater improvement. The EORTC QLQ-C30 scale allowed us to measure the health-related quality of life of metastatic pancreatic adenocarcinoma patients receiving first-line chemotherapy.

Braquiterapia de alta tasa en el carcinoma escamoso de labio en estadios iniciales / High dose rate brachytherapy in early stage squamous-cell carcinoma of the lip

Introducción y objetivos: Analizar los resultados obtenidos en el tratamiento del carcinoma escamoso de labio en estadios iniciales (T1-T2) con braquiterapia de alta tasa y evaluar la eficacia para el control local y regional de dicho tratamiento. Material y métodos: Análisis retrospectivo de los tratamientos realizados entre marzo de 1999 y marzo de 2013 con braquiterapia de alta tasa de dosis con agujas rígidas, a 68 pacientes, 63 varones y 5 mujeres. Treinta y siete pacientes (54,4%) presentaban un tumor igual o menor de 2cm (T1), y 31 (45,6%) de 2-4cm (T2). En todos se indicó braquiterapia radical con una dosis total mediana de 45Gy, con una dosis por fracción de 5Gy x 9 fracciones, dos veces al día, en un ingreso de cinco días. Resultados: Con 56,4 meses de seguimiento medio el control local fue 96,9%. En pacientes con tumores T1 el control local fue del 100%, mientras en T2 fue 93,2% (2 recidivas locales). El control regional a 5 años, en T1 fue 93,8% y en T2 80,8%. En once casos con profilaxis cervical no hubo recaídas. En cuanto a toxicidad, ningún paciente presentó necrosis de tejidos blandos ni ósea y en todos ellos se consiguieron resultados cosméticos y funcionales buenos o excelentes. Conclusiones: La braquiterapia de alta tasa permite realizar métodos seguros y efectivos para tratamiento del carcinoma escamoso de labio, con buenos resultados estéticos y funcionales y mínimas complicaciones y puede considerarse una alternativa válida al tratamiento quirúrgico en estadios iniciales (AU)

Introduction and goals: To analyze the results obtained after treatment of early stage (T1-T2) squamous cell carcinoma of the lip with high dose rate brachytherapy and evaluate the efficacy of this treatment in both local and regional control. Materials and methods: Retrospective analysis of the treatments performed at our department from March 1999 to March 2013 with high dose rate brachytherapy with rigid needles. We included 68 patients, 63 men and 5 women; 37 patients (54.4%) presented a T1 tumour, less than or equal to 2cm, while the other 31 (45.6%) were classified as T2. Median total dose was 45Gy, with a median dose per fraction of 5Gy x 9 fractions twice a day for 5 days. Results: With a mean follow-up of 56.4 months, local control was 96.9%. Stratifying by tumour size, local control of T1 cases was 100%, while T2 achieved 93.2% (2 local recurrences). Regional control at 5 years was 93.8% for T1, and 80.8% for T2. In 11 cases with elective cervical treatment, no regional failure happened. As for toxicity, no patient presented soft tissue, or bone, necrosis. All patients achieved good or excellent cosmetic and functional results. Conclusions: High dose rate brachytherapy allows effective, safe treatments for squamous cell carcinoma of the lip, with good aesthetic and functional results. It can be considered a valid alternative for surgery in early stage tumours (AU)

High dose rate brachytherapy in early stage squamous-cell carcinoma of the lip. / Braquiterapia de alta tasa en el carcinoma escamoso de labio en estadios iniciales.

INTRODUCTION AND GOALS: To analyze the results obtained after treatment of early stage (T1-T2) squamous cell carcinoma of the lip with high dose rate brachytherapy and evaluate the efficacy of this treatment in both local and regional control. MATERIALS AND METHODS: Retrospective analysis of the treatments performed at our department from March 1999 to March 2013 with high dose rate brachytherapy with rigid needles. We included 68 patients, 63 men and 5 women; 37 patients (54.4%) presented a T1 tumour, less than or equal to 2cm, while the other 31 (45.6%) were classified as T2. Median total dose was 45Gy, with a median dose per fraction of 5Gy x 9 fractions twice a day for 5 days. RESULTS: With a mean follow-up of 56.4 months, local control was 96.9%. Stratifying by tumour size, local control of T1 cases was 100%, while T2 achieved 93.2% (2 local recurrences). Regional control at 5 years was 93.8% for T1, and 80.8% for T2. In 11 cases with elective cervical treatment, no regional failure happened. As for toxicity, no patient presented soft tissue, or bone, necrosis. All patients achieved good or excellent cosmetic and functional results. CONCLUSIONS: High dose rate brachytherapy allows effective, safe treatments for squamous cell carcinoma of the lip, with good aesthetic and functional results. It can be considered a valid alternative for surgery in early stage tumours.

Tratamiento no quirúrgico del schwannoma vestibular / Non surgical treatment of vestibular schwannoma

Introducción y objetivos: Valorar los resultados de control local y complicaciones en el tratamiento del schwannoma vestibular tratado con radiaciones. Métodos: Estudio retrospectivo de 194 pacientes diagnosticados de schwannoma vestibular, tratados de manera consecutiva bien con observación o bien con radiaciones (bien radiocirugía o radioterapia esterotáctica fraccionada) de 1997 a 2012. Analizamos el control local de los tumores, así como de las complicaciones secundarias al tratamiento con radiocirugía. Resultados: El 68% (132 tumores) son inferiores a 2 cm es decir grado I-II de la clasificación de Koos, 22 pacientes (13%) con tumores grandes grado IV, el resto (40 pacientes) son grado III. Los tumores relacionados con la neurofibromatosis (NF2) representan el 3,6% (6 tumores en 4 pacientes). El control tumoral para los pacientes tratados con radiaciones es del 97% a 5 años, con un seguimiento mediano de 80,4 meses. Para los tumores grandes el control local es del 91% a 5 años. La supervivencia libre de complicaciones crónicas es del 89% a 5 años. De los 50 tumores a los que se realizó seguimiento, 28 (58%) continúan en seguimiento al no haberse objetivado crecimiento alguno. Conclusiones: La radiación y el seguimiento con RM, dentro de un enfoque multidisciplinar, es una alternativa a la cirugía en el tratamiento del schwannoma vestibular, con un bajo nivel de complicaciones (AU)

Introduction and objectives: To evaluate the results of local control and complications in the treatment of vestibular schwannoma treated with radiation. Methods: A retrospective study of 194 patients diagnosed with vestibular schwannoma, treated consecutively with radiation (either stereotactic radiosurgery or fractionated radiotherapy) from 1997 to 2012. We analyze the local control of tumors, as well as secondary complications to treatment with radiation. Results: A total of 132 (68%) tumors 68% are grade I-II tumors of the Koos classification, 40 (19%) are grade III, and 22 (13%) are grade IV. The tumors associated with neurofibromatosis (NF2), are 3.6% (6 tumors in 4 patients). The tumor control for the overall serie is 97% at 5 years, with a median follow-up of 80.4 months. For large tumors the local control is 91% at 5 years. Free survival of chronic complications is 89% at 5 years. Aditionally, 50 tumors were subjected to regular follow-up with MRI without treatment, and 28 (58%) did not experienced tumor growth. Conclusions: Radiation and follow up with MRI, are an alternative to surgery in the treatment of vestibular schwannoma, with a low level of complications inside of multidisciplinary approach (AU)

High-dose-rate brachytherapy boost effect on local tumor control in young women with breast cancer.

PURPOSE: To evaluate the local control rate and complications of a single fraction of high-dose-rate brachytherapy (HDR BT) boost in women aged 45 yeas and younger after breast-conserving therapy. METHODS AND MATERIALS: Between 1999 and 2007, 167 patients between the ages of 26 and 45 years old (72 were 40 years old or younger), with stages T1 to T2 invasive breast cancer with disease-free margin status of at least 5 mm after breast-conserving surgery received 46 to 50 Gy whole-breast irradiation plus a 7-Gy HDR-BT boost ("fast boost"). An axillary dissection was performed in 72.5% of the patients and sentinel lymph node biopsy in 27.5%. A supraclavicular area was irradiated in 19% of the patients. Chemotherapy was used in 86% of the patients and hormone treatment in 77%. Clinical nodes were present in 18% and pathological nodes in 29%. The pathological stage was pT0: 5%, pTis: 3%, pT1: 69% and pT2: 23%. Intraductal component was present in 40% and 28% were G3. RESULTS: At a median follow-up of 92 months, 9 patients relapsed on the margin of the implant, and 1 patient in another quadrant, resulting in a 10-year local relapse rate of 4.3% and a breast relapse rate of 4.9%, with breast preservation in 93.4%; no case of mastectomy due to poor cosmesis arose. Actuarial 5- and 10-year disease-free, cause-specific, and overall survival rates were 87.9% and 85.8%, and 92.1% and 88.4%, and 92.1% and 87.3%, respectively. In a univariate analysis, triple-negative cases and negative hormone receptors did worse, but in a multivariate analysis, only the last factor was significant for local and breast control. Asymptomatic fibrosis G2 was recorded in 3 cases, and there were no other late complications. Cosmetic results were good to excellent in 97% of cases. CONCLUSIONS: A single dose of 7 Gy using the fast-boost technique is well tolerated, with a low rate of late complications and improved local tumor control in women aged 45 and younger, compared to published data. This approach is recommended in breast-preserving treatment.

Non surgical treatment of vestibular schwannoma.

INTRODUCTION AND OBJECTIVES: To evaluate the results of local control and complications in the treatment of vestibular schwannoma treated with radiation. METHODS: A retrospective study of 194 patients diagnosed with vestibular schwannoma, treated consecutively with radiation (either stereotactic radiosurgery or fractionated radiotherapy) from 1997 to 2012. We analyze the local control of tumors, as well as secondary complications to treatment with radiation. RESULTS: A total of 132 (68%) tumors 68% are grade I-II tumors of the Koos classification, 40 (19%) are grade III, and 22 (13%) are grade IV. The tumors associated with neurofibromatosis (NF2), are 3.6% (6 tumors in 4 patients). The tumor control for the overall serie is 97% at 5 years, with a median follow-up of 80.4 months. For large tumors the local control is 91% at 5 years. Free survival of chronic complications is 89% at 5 years. Additionally, 50 tumors were subjected to regular follow-up with MRI without treatment, and 28 (58%) did not experienced tumor growth. CONCLUSIONS: Radiation and follow up with MRI, are an alternative to surgery in the treatment of vestibular schwannoma, with a low level of complications inside of multidisciplinary approach.

Mejora en el control local en mujeres jóvenes con cáncer de mama precoz añadiendo una sola fracción de braquiterapia de alta tasa de dosis / Improved local control in young women with early-stage breast cancer by adding a single fraction of high-dose-rate brachytherapy

Objetivo. Evaluar la eficacia de la braquiterapia con iridio-192 de alta tasa de dosis con una sola fracción como sobreimpresión después de irradiar la mama en mujeres de hasta 45 años. Pacientes y métodos. Se estudiaron 167 pacientes consecutivas con tumores T1-2, entre 26-45 años, sometidas a cirugía conservadora con bordes libres y radioterapia (46-50 Gy) por carcinoma de mama infiltrante entre 1999 y 2008. Se realizó implante con agujas metálicas paralelas bajo anestesia local y sedación de forma ambulatoria. La quimioterapia se utilizó en el 85% (66% adyuvante, 19% neoadyuvante) y la hormonoterapia en el 77%. Se administró una dosis única de 7 Gy con braquiterapia de alta tasa de dosis (fast-boost). Resultados. El seguimiento mediano fue de 69 meses. Ocho pacientes recayeron en el lecho o en el margen tumoral con un control actuarial local de 95,6% a 10 años (tasa de recaída 4,4%). Hubo una recaída en otro cuadrante, por tanto, el control local en la mama fue de 94,1%. Las pacientes hasta 40 años recayeron en la mama en un 6,9% a los 10 años. Ventidós pacientes desarrollaron metástasis. La supervivencia libre de enfermedad y global fue de 85,5 y 92%, respectivamente. Los resultados cosméticos fueron buenos/excelentes en el 97%. La toxicidad aguda y tardía fueron mínimas. Conclusiones. El fast-boost con una sola fracción es una técnica rápida, sencilla y eficaz cuando los márgenes quirúrgicos están libres. El control local en las mujeres jóvenes se ha mejorado respecto a la literatura, por lo que se recomienda la preservación de la mama con este esquema

Objective. To evaluate the effectiveness of a single fraction of high-dose-rate iridium-192 brachytherapy as a boost after irradiation of the breast in women aged 45 or less. Patients and methods. We studied 167 consecutive patients with T1-2 tumors, aged between 26 and 45 years undergoing conservative surgery with free margins and radiotherapy (46-50 Gy) for invasive breast carcinoma between 1999 and 2008. Parallel metal needles were implanted under local anesthesia and sedation on an outpatient basis. Chemotherapy was used in 85% (66% adjuvant and 19% neoadjuvant) and hormonal therapy in 77%. A single 7 Gy-dose of high-dose rate brachytherapy ("fast boost") was administered. Results. The median follow-up was 69 months. In 8 patients, recurrences occurred in the tumor bed or in the margin with an actuarial local control of 95.6% at 10 years (relapse rate 4.4%). There was a relapse in another quadrant and therefore breast control was 94.1%. In patients aged up to 40 years, the breast failure rate was 6.9% at 10 years. Metastases developed in 22 patients. Disease-free survival was 85.5% and overall survival was 92%. Cosmetic results were good or excellent in 97% and acute and late toxicity was minimal. Conclusions. The fast boost technique with a single fraction is fast, simple, and effective when surgical margins are free. Local control in young women has improved compared with prior reports in the literature. Therefore, this technique can be recommended for breast preservation

Prognostic factors in squamous cell lip carcinoma treated with high-dose-rate brachytherapy.

BACKGROUND: The purpose of this study was for us to present our analysis of the results and prognostic factors in squamous lip carcinoma treated with high-dose-rate (HDR) brachytherapy. METHODS: From 1999 to 2010, 102 patients were treated with HDR-brachytherapy, 54 with T1, 33 with T2, and 15 with T4. Eight cases were N+. Twenty-one patients were treated with surgery plus brachytherapy because of close/positive margins. Nine fractions of 5 Gy were given over 5 days in 67% of the patients. Elective neck treatment was performed in 23 cases. RESULTS: The 10-year actuarial local control was 94.6%, nodal regional control was 88.6%, disease-free survival was 84.6%, and cause-specific survival was 93.2%. In the univariate analysis, T4 tumors had higher risk of local failure and T2 of regional relapse. In the multivariate analysis, skin involvement was the only significant factor for tumor progression. CONCLUSION: HDR-brachytherapy yields excellent local control rates. Skin involvement increases the risk of local and cervical recurrence. Elective neck treatment should be done in T2 to T4 tumors or with skin or commissure involvement.

From low-dose-rate to high-dose-rate brachytherapy in lip carcinoma: Equivalent results but fewer complications.

PURPOSE: To compare the use of high-dose-rate (HDR) brachytherapy (BT) in patients with lip carcinoma with a former series previously treated with low-dose-rate (LDR) BT. METHODS AND MATERIALS: Ninety-nine patients treated with LDR-BT were compared with 104 patients treated with HDR-BT. Distribution by stage was 53.5% T1, 15.1% T2, 3.1% T3, and 28.3% T4 for LDR and 52.9% T1, 32.7% T2, 0% T3, and 14.4% T4 for HDR. Some cases with positive or close margins received BT after surgery (34.3% with LDR vs. 16.3% with HDR). Parallel metallic needles were used in 100% of HDR cases and in 76% of LDR cases. Most HDR patients were treated with HDR-BT to a dose of 4.5-5 Gy per fraction prescribed to a 90% isodose, in nine fractions delivered twice daily for 5 days. RESULTS: Median followup was 63 months for LDR-BT and 51 months for HDR-BT. Overall local control for LDR- vs. HDR-BT was 94.9% vs. 95.2%; and 100% vs. 100%, 86.6% vs. 94.1%, and 89.3% vs. 80%, for T1, T2, and T4 stage tumors, respectively. Disease-free survival for LDR vs. HDR was 95.9% vs. 94.2%. Soft tissue necrosis, bone necrosis, and fair-bad cosmesis for LDR vs. HDR was 15.1% vs. 0%, 1% vs. 0%, and 11.1% vs. 0%, respectively. CONCLUSIONS: Treatment with HDR-BT using rigid needles is a simple technique that provides good long-term results with minimal complications. LDR- and HDR-BT are regarded as equally effective in local control and disease-free survival, but fewer complications arise when using HDR-BT.