We have located links that may give you full text access.
Clinical Trial, Phase II
Journal Article
Research Support, Non-U.S. Gov't
Long-Term Patient-Reported Outcomes After High-Dose Chemoradiation Therapy for Nonsurgical Management of Distal Rectal Cancer.
PURPOSE: Surgery is standard treatment for rectal cancer, but neoadjuvant chemoradiation therapy (CRT) may result in clinical complete response (cCR) in select patients, allowing for nonsurgical management (NSM). Prospective studies of NSM strategies are sparse, however, and long-term data on quality of life (QoL) are limited. We conducted a single-arm phase 2 trial of high-dose CRT for NSM of distal rectal cancer; we report secondary long-term patient-reported outcomes (PROs), local regrowth, and overall survival in patients managed nonsurgically.
METHODS AND MATERIALS: Fifty-one patients with resectable, T2 or T3, N0-N1, low adenocarcinoma received 65 Gy (intensity modulated radiation therapy, brachytherapy boost) and oral tegafur-uracil. Patients with cCR 6 weeks after treatment (clinical examination, magnetic resonance imaging, biopsy) were referred for observation and followed closely with clinical examination, endoscopy, positron emission tomography/computed tomography, and PROs for 5 years. Overall colorectal cancer-specific QoL and specific symptom scores were evaluated at baseline and in follow-up and compared between time points. Local regrowth was estimated using cumulative incidence and overall survival using Kaplan-Meier estimates.
RESULTS: Forty patients achieved cCR after treatment; 29 were in follow-up at 24 months, 21 at 36 months, and 20 at 60 months. PRO questionnaire completion rates were 90% at 24 months, 100% at 36 months, and 85% at 60 months for patients still in follow-up. Average QoL score did not differ between baseline (median 11.1) and 24 months (13.7), 48 months (11.1), or 60 months (6.9). Only rectal bleeding deteriorated from baseline, with bowel- and bladder-related symptom scores otherwise unchanged in follow-up. At median follow-up of 5.0 years, local regrowth rate and overall survival were 31% (95% confidence interval, 15%-47%) and 85% (95% confidence interval, 75%-97%), respectively.
CONCLUSIONS: Long-term follow-up after NSM of distal rectal cancer showed excellent general colorectal cancer QoL and local symptom scores. Our study results indicate that high-dose CRT followed by organ preservation might be an alternative to standard treatment.
METHODS AND MATERIALS: Fifty-one patients with resectable, T2 or T3, N0-N1, low adenocarcinoma received 65 Gy (intensity modulated radiation therapy, brachytherapy boost) and oral tegafur-uracil. Patients with cCR 6 weeks after treatment (clinical examination, magnetic resonance imaging, biopsy) were referred for observation and followed closely with clinical examination, endoscopy, positron emission tomography/computed tomography, and PROs for 5 years. Overall colorectal cancer-specific QoL and specific symptom scores were evaluated at baseline and in follow-up and compared between time points. Local regrowth was estimated using cumulative incidence and overall survival using Kaplan-Meier estimates.
RESULTS: Forty patients achieved cCR after treatment; 29 were in follow-up at 24 months, 21 at 36 months, and 20 at 60 months. PRO questionnaire completion rates were 90% at 24 months, 100% at 36 months, and 85% at 60 months for patients still in follow-up. Average QoL score did not differ between baseline (median 11.1) and 24 months (13.7), 48 months (11.1), or 60 months (6.9). Only rectal bleeding deteriorated from baseline, with bowel- and bladder-related symptom scores otherwise unchanged in follow-up. At median follow-up of 5.0 years, local regrowth rate and overall survival were 31% (95% confidence interval, 15%-47%) and 85% (95% confidence interval, 75%-97%), respectively.
CONCLUSIONS: Long-term follow-up after NSM of distal rectal cancer showed excellent general colorectal cancer QoL and local symptom scores. Our study results indicate that high-dose CRT followed by organ preservation might be an alternative to standard treatment.
Full text links
Related Resources
Trending Papers
Challenges in Septic Shock: From New Hemodynamics to Blood Purification Therapies.Journal of Personalized Medicine 2024 Februrary 4
Molecular Targets of Novel Therapeutics for Diabetic Kidney Disease: A New Era of Nephroprotection.International Journal of Molecular Sciences 2024 April 4
The 'Ten Commandments' for the 2023 European Society of Cardiology guidelines for the management of endocarditis.European Heart Journal 2024 April 18
A Guide to the Use of Vasopressors and Inotropes for Patients in Shock.Journal of Intensive Care Medicine 2024 April 14
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app
All material on this website is protected by copyright, Copyright © 1994-2024 by WebMD LLC.
This website also contains material copyrighted by 3rd parties.
By using this service, you agree to our terms of use and privacy policy.
Your Privacy Choices
You can now claim free CME credits for this literature searchClaim now
Get seemless 1-tap access through your institution/university
For the best experience, use the Read mobile app