Long-term results of a prospective phase II trial of medically inoperable stage I NSCLC treated with SBRT - the Nordic experience.

BACKGROUND: Presentation of long term results of a phase II multicenter Nordic trial of medically inoperable stage I non-small cell lung cancer (NSCLC) treated with stereotactic body radiotherapy (SBRT). MATERIAL AND METHODS: We report the extended outcome, focusing on long-term effects, of a prospective cohort of 57 evaluable patients with peripherally located T1N0M0 (72%) and T2N0M0 (28%) NSCLC, treated with SBRT 15 Gy × 3, prescribed to the 67% isodose line encompassing the PTV. The patients were inoperable due to chronic obstructive pulmonary disease (65%), cardiovascular disease (25%) or other illnesses (3%) or refused surgery (7%). Median Karnofsky score pre-treatment was 80% (70-100%). Late effects were defined as occurring > 36 months. RESULTS: Thirty-eight patients (67%) were relapse free during their entire follow-up. Local control rate at four and five years were 79% (CI 95% 64-95%) and local relapses occurred at 10-76 months post-treatment. Seven local failures were noted, four occurring ≤ 36 months (all T2a-tumors; two isolated and two in combination with out-of-field relapses) and three occurring > 36 months (T1b-tumors n = 3). Thirteen patients had out-of-field failure only as first presentation of recurrence. Overall survival rate and lung cancer-specific survival rate at five years were 30% and 74%, respectively. Toxicity throughout the entire observation period was acceptable without any grade 5 toxicities. Seventeen grade 3-4 toxicities were noted, three presenting > 36 months (rib fracture, dyspnea and ventricle tachycardia). Median follow-up was 41.5 months (3.4-113.0) for the entire cohort and 59.3 months (36.4-113.0) for the 34 patients (60%) with a follow-up of > 36 months. CONCLUSION: Throughout the observation period local control was excellent and toxicity limited with no increase in late presenting local relapses or late treatment-related morbidity. This further supports SBRT as an efficient local treatment modality even in a medically impaired patient cohort.

Late radiation effects to the rectum and anus after treatment for prostate cancer; validity of the LENT/SOMA score.

BACKGROUND: The Late Effects Normal Tissue/Subjective Objective Management Analytic (LENT/SOMA) system for grading of side effects after radiotherapy was proposed several years ago. Only a few studies have previously been performed on the validity of the LENT/SOMA. The aim of the present study was to validate the LENT/SOMA scoring system for recto-anal side effects after treatment for prostate cancer in a randomized trial. MATERIAL AND METHODS: A total of 875 patients with locally advanced prostate cancer were randomized to either hormonal treatment alone or hormonal treatment plus radiotherapy in the Scandinavian Prostate Cancer Group 7 (SPCG-7) study. At least three years after treatment was started, the 178 patients that were randomized at St. Olavs Hospital were approached. One hundred and three patients of these accepted inclusion. The side effects according to LENT/SOMA were graded by oncologist and nurse. In addition, side effects were graded according to the European Organisation for Research and Treatment of Cancer and the Radiation Therapy Oncology Group (EORTC/RTOG) toxicity scale and patient-reported health-related quality of life (HRQOL) questionnaires. Content/face validity, sensitivity and inter-rater reliability of the LENT/SOMA tables for rectum were analyzed. RESULTS: Content/face analysis of LENT/SOMA revealed serious problems. Significant correlations (Spearman's rho > 0.4) were found between three of 15 LENT/SOMA items and similar HRQOL items. LENT/SOMA score made it possible to detect significant differences between the two groups of patients (p < 0.001), EORTC/RTOG toxicity score did not (p = 0.138). Inter-rater reliability was acceptable. CONCLUSIONS: LENT/SOMA scoring system for recto-anal side effects after radiotherapy for prostate cancer displays serious difficulties in the present study. Replacement of LENT/SOMA tables for rectum by a combination of patient-reported HRQOL questionnaires, clinical examination and objective physiological measurements might be called for.

Anal carcinoma in mid-Norway 1970-2000.

The treatment of anal carcinoma changed from surgery to chemoradiotherapy 20-25 years ago. The aim of this observational study was to compare surgery with chemoradiotherapy with regard to side effects, local recurrence and survival during and after the implementation of a new treatment policy for anal carcinoma. The study includes all 111 patients with anal carcinoma diagnosed between 1970 and 2000 in mid-Norway. One hundred patients were treated with the intention to cure, and 11 patients received palliative treatment. Thirty-four patients were treated with surgery alone, and 57 patients with chemoradiotherapy. Among patients treated for cure, 17 patients (17%) developed local recurrence; ten patients (33%) in the surgically treated group and 4 (7%) in the chemoradiotherapy group (p = 0.15). Five year overall survival was 48% after surgery, compared to 78% after chemoradiotherapy (p = 0.004). Stage, age and treatment were all significant indicators of survival in uni- and multivariable analysis. Late side effects were moderate after combined therapy; only one patient preferred getting a stoma due to radiation damage of the anal sphincter. The change of strategy for anal cancer treatment from surgery to combined therapy has probably reduced local recurrence and improved survival. Side effects in this series of patients were minor after chemoradiotherapy compared to a permanent stoma after surgery.

Endoanal ultrasound is of little value in follow-up of anal carcinomas.

PURPOSE: The treatment of anal carcinoma has a vigorous follow-up regimen, and several authors have stated that endoanal ultrasound is a useful and necessary part of this regimen. This study was designed to evaluate the value of endoanal ultrasound in follow-up of anal carcinoma. METHODS: In this retrospective study, 82 patients were treated between 1983 and 1999. Main outcome measures were five-year survival and local recurrence rates, and in particular, it was focused on how local recurrences have been detected. RESULTS: Overall five-year survival was 68 percent. Fourteen patients (17 percent) developed local recurrence. Despite an estimated number of 780 scheduled endoanal ultrasound examinations, all the local recurrences were detected by digital and visual examination before the ultrasound procedures. CONCLUSIONS: In this study, all the local recurrences of anal carcinoma were detected by digital and visual examination. Thus, the addition of endoanal ultrasound was costly and unnecessary.