Compliance to the prescribed dose and overall treatment time in five randomized clinical trials of altered fractionation in radiotherapy for head-and-neck carcinomas

2003 ◽  
Vol 55 (3) ◽  
pp. 568-575 ◽  
Author(s):  
Azza A. Khalil ◽  
Søren M. Bentzen ◽  
Jacques Bernier ◽  
Michele I. Saunders ◽  
Jean-Claude Horiot ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Head And Neck ◽  
Randomized Clinical Trials ◽  
Treatment Time ◽  
Overall Treatment Time ◽  
Head And Neck Carcinomas ◽  
Altered Fractionation

Altered Fractionation Schedules in Radiotherapy of Head and Neck Cancer. A Review

1992 ◽  
Vol 78 (5) ◽  
pp. 311-325 ◽  
Author(s):  
Carlo Fallai ◽  
Patrizia Olmi
Keyword(s):  
Total Dose ◽  
Head And Neck ◽  
Local Control ◽  
Randomized Trials ◽  
Treatment Time ◽  
Dose Intensity ◽  
Field Size ◽  
Overall Treatment Time ◽  
Altered Fractionation ◽  
Improvement In Survival

The authors review the main contributions of international literature to show the current status in clinical trials on unconventional fractionations of the dose in radiotherapy of head and neck cancers. Several clinical (but only a few randomized) trials have been conducted over the last 15 years using hyperfractionated (HF), accelerated (AF) or mixed (HF-AF) schedules. HF schedules have obtained promising results in terms of local control in comparison with conventional fractionation (CF) of the dose. Improvement in survival was also obtained by the random trials of Pinto and Sanchiz, whereas in EORTC trial no. 22791, the improvement in survival rate was only marginal. A significant increase in local control and, less frequently, in survival has been claimed in several studies using HF-AF. Such data still need to be confirmed by a random study, since EORTC trial 22811 showed superimposable results in comparison with CF. Selection of the most suitable cases for altered fractionation schemes is also being studied in ongoing trials of the EORTC (22851) and RTOG (90-03). As regards acute reactions during and after altered fractionation, they are more severe than after CF. Only pure HF with a dose intensity approximately comparable to CF seems to produce similar acute reactions. Several factors have been found to influence the severity of acute mucosal reactions: interfraction interval, overall treatment time, total dose, and field size. As regards late damage, genuine HF schemes seem to cause roughly equivalent late damage in comparison to CF, whereas high-dose intensity schedules have a higher rate of complications. Interfraction interval, overall treatment time, total dose, fraction size and field size can influence the risk of late sequelae. Before altered fractionations can be considered standard therapy, more data are needed, which should be provided by multicentric randomized trials, some of which are already in progress.

Altered Fractionation in Radiotherapy

1998 ◽  
Vol 84 (2) ◽  
pp. 155-159 ◽  
Author(s):  
Riccardo Valdagni
Keyword(s):  
Treatment Time ◽  
Clinical Results ◽  
Therapeutic Benefit ◽  
Phase Iii ◽  
Overall Treatment Time ◽  
Conventional Fractionation ◽  
Normal Tissues ◽  
Normal Tissue Damage ◽  
Altered Fractionation ◽  
Cell Repopulation

Differences between late-responding (slowly proliferating) normal tissues and early-responding (rapidly proliferating) normal tissues and tumor cells and the event of tumor cell repopulation occurring during treatment have essentially led to the development of altered fractionation schemes. Altered fractionation regimens mainly refer to schedules utilising two or more (small dose) fractions per day for part of or for the entire treatment course. It must be underlined that a true standard or conventional fractionation regimen does not exist: no schedule is universally recognised as the standard of reference to be compared with. However, continental European and U.S. conventional regimens are the considered control arm with which the new experimental regimens have to be compared. For this reason they are generally recognised as the standards. The basic rationale for hyperfractionated or accelerated regimens respectively lies in the possibility (a) to deliver higher total doses reducing late-responding normal tissue damage, (b) to deliver total doses in a reduced overall treatment time to defeat tumor clonogen repopulation. Multiple fractions per day should not be delivered with interfraction intervals smaller than 6 hours. Clinical results of phase I-II and limited but convincing phase III randomised trials suggest that a therapeutic benefit can be achieved with new altered regimens.

scholarly journals Research Frontiers in Oral Toxicities of Cancer Therapies: Osteoradionecrosis of the Jaws

2019 ◽  
Vol 2019 (53) ◽  
Author(s):  
Frederik K L Spijkervet ◽  
Michael T Brennan ◽  
Douglas E Peterson ◽  
Max J H Witjes ◽  
Arjan Vissink
Keyword(s):  
Clinical Trials ◽  
Cancer Treatment ◽  
Head And Neck ◽  
Conservative Therapy ◽  
Randomized Clinical Trials ◽  
Preventive Effect ◽  
Cure Rate ◽  
Dental Surgery ◽  
Large Numbers ◽  
Increased Risk

AbstractThe deleterious effects of head and neck radiation on bone, with osteoradionecrosis (ORN) as the major disabling side effect of head and neck cancer treatment, are difficult to prevent and hard to treat. This review focuses on the current state of the science regarding the pathobiology, clinical impact, and management of ORN. With regard to the pathobiology underlying ORN, it is not yet confirmed whether the current radiation schedules by 3-dimensional conformal radiotherapy and intensity modified radiotherapy result in an unchanged, decreased, or increased risk of developing ORN when compared with conventional radiation treatment, the main risk factor being the total radiation dose delivered on any clinically significant surface of the mandible.With regard to the prevention of ORN, a thorough, early pre-irradiation dental assessment is still considered the first step to reduce the hazard of developing ORN post-radiotherapy, and hyperbaric oxygen (HBO) treatment reduces the risk of developing ORN in case of dental surgery in an irradiated field.With regard to the treatment of ORN, the focus is bidirectional: elimination of the necrotic bone and improving the vascularity of the normal tissues that were included in the radiation portal. The cure rate of limited ORN by conservative therapy is approximately 50%, and the cure rate of surgical approaches when conservative therapy has failed is approximately 40%.Whether it is effective to support conservative or surgical treatment with HBO as an adjuvant is not set. HBO treatment is shown to increase the vascularity of hard and soft tissues and has been reported to be beneficial in selected cases. However, in randomized clinical trials comparing the preventive effect of HBO on developing ORN with, eg, antibiotic coverage in patients needing dental surgery, the preventive effect of HBO was not shown to surpass that of a more conservative approach.More recently, pharmacologic management was introduced in the treatment of ORN with success, but its efficacy has to be confirmed in randomized clinical trials. The major problem of performing well-designed randomized clinical trials in ORN is having access to large numbers of patients with well-defined, comparable cases of ORN. Because many institutions will not have large numbers of such ORN cases, national and international scientific societies must be approached to join multicenter trials. Fortunately, the interest of funding organizations and the number researchers with an interest in healthy aging is growing. Research aimed at prevention and reduction of the morbidity of cancer treatment fits well within these programs.

Treatment-related toxicities in patients with squamous cell carcinoma of the head and neck (SCCHN)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17041-e17041
Author(s):  
M. Ulcickas Yood ◽  
P. Feng Wang ◽  
S. Hensley Alford ◽  
S. Oliveria ◽  
K. Wells ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Health System ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Medical Record ◽  
Squamous Cell ◽  
Real World ◽  
Randomized Clinical Trials

e17041 Background: Although treatment effects and toxicities have been reported from randomized clinical trials of patients with squamous cell carcinoma of the head and neck (SCCHN), little information is available from real-world clinical practice where heterogeneous treatment patterns and patient populations may lead to different estimates than those observed in clinical trials. Methods: Using a population-based tumor registry at a large, Midwestern integrated health system, we identified all cases of stage III or IV SCCHN diagnosed 2000–2006. The incidence/severity of acute and late toxicities associated with SCCHN treatment was obtained from detailed medical record review of health system encounters, including physician notes. Grading of toxicities (using CTCAE3 criteria), distinction between acute and late toxicity, and analyses by treatment are ongoing. The incidence and severity of toxicities will be presented by treatment regimen, tumor location and tumor stage. We presented here an interim analysis. Results: Among the target population of 194 patients that will ultimately be included in this study, 137 medical record reviews have been completed to date. The percentages of patients with toxicities, including 95% confidence intervals are presented in the table , below. Conclusions: Toxicity in patients with advanced SCCHN is common. Data from clinical practice quantifying the incidence are lacking, these data from an observational real-world study provide important baseline information on the incidence of toxicities in patients with advanced SCCHN and also call for safer effective treatment for SCCHN. [Table: see text] [Table: see text]

Cetuximab versus cisplatin concurrent with IMRT in locally advanced head and neck cancer (LAHNC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17030-e17030 ◽  
Author(s):  
S. L. Galper ◽  
H. Deshpande ◽  
M. G. Rose ◽  
R. H. Decker
Keyword(s):  
Treatment Time ◽  
Randomized Study ◽  
Locally Advanced ◽  
Late Toxicity ◽  
Distant Metastases ◽  
Overall Treatment Time ◽  
Tumor Registry ◽  
Altered Fractionation ◽  
N Stage

e17030 Background: Concurrent chemoradiation of LAHNC with cetuximab or cisplatin improves survival. The purpose of this study is to compare cetuximab chemoradiation (ExRT) with cisplatin chemoradiation (ChRT) in patients treated with IMRT. Methods: Between January 2005 and August 2008, 24 patients with LAHNC were treated with definitive chemoradiation utilizing IMRT. ExRT was reserved for those whose age or comorbidities precluded ChRT. 15 patients were treated with ChRT and 9 patients were treated with ExRT. Patient charts and Tumor Registry data were reviewed for acute and late toxicity and for local/regional failure (LRF), distant metastases and death. Results: The ExRT cohort was significantly older (median age 71 vs 58, p=0.005) and had more larynx/hypopharynx primaries (44% vs 27%). The cohorts were otherwise balanced with respect to T- and N-stage. Median follow-up for the ExRT and ChRT cohorts was 11 and 12 months, respectively. Overall treatment time in compliant patients was lower in ExRT patients (46 vs 50 days, p=0.05), reflecting increased use of accelerated radiation fractionation (66% vs 40%). See Table for toxicity outcomes. There was a trend toward increased ≥G3 acute mucositis in the ExRT group (p=0.07). However, there was less weight loss (p=0.05). There were similar acute epidermitis and hospitalizations for malnutrition/hydration rates and a nonsignificant decrease in prolonged mucosal toxicity. 1 patient developed skin necrosis and another osteoradionecrosis in the ChRT group. 1-year freedom from LRF was 89% in the ChRT group vs 56% in the ExRT group (p=0.07). Overall survival (OS) at 1 year was 100% (ChRT) vs 88% (ExRT). Conclusions: ExRT showed a trend toward worse acute mucosal toxicity but not late toxicity despite increased rates of altered fractionation with a higher daily dose. ExRT was associated with worse LRC and OS. A randomized study would best compare outcomes and toxicity profiles. Until such analysis, cetuximab should be reserved for patients unable to tolerate ChRT. [Table: see text] No significant financial relationships to disclose.

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