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Biomedical subjects

Adam S Garden

Publications and source records attributed to Adam S Garden.

At least 19 recordsLinked to original sources
PubMed2006

Disease-control rates following intensity-modulated radiation therapy for small primary oropharyngeal carcinoma.

BACKGROUND: The purpose of this study was to assess the ability of intensity-modulated radiation therapy (IMRT) to achieve favorable disease-control rates while minimizing parotid gland doses in patients treated for small primary tumors of the oropharynx. METHODS AND MATERIALS: We retrospectively identified all patients who received IMRT as treatment for a small (<4 cm) primary tumor of the oropharynx between October 2000 and June 2002. Tumor characteristics, IMRT parameters, and patient outcomes were assessed. RESULTS: Fifty-one patients met the criteria for our study. All patients had treatment to gross disease with margin (CTV1), and all but 1 had treatment to the bilateral necks. The most common treatment schedule (39 patients) was a once-daily fractionation of prescribed doses of 63-66 Gy to the CTV1 and 54 Gy to subclinical sites, delivered in 30 fractions. Twenty-one patients (40%) had gastrostomy tubes placed during therapy; in 4 patients, the tube remained in place for more than 6 months after completion of IMRT. The median follow-up was 45 months. The 2-year actuarial locoregional control, recurrence-free, and overall survival rates were 94%, 88%, and 94%, respectively. CONCLUSIONS: These preliminary data suggest that treatment with IMRT results in favorable locoregional control of small primary oropharynx tumors. IMRT did not appear to have a more favorable acute toxicity profile in this group with respect to the use of a feeding tube; however, the mean dose of radiation delivered to the parotid gland by IMRT was decreased, because 95% of patients had a mean dose of <30 Gy to at least one gland.

Adult↗
PubMed2006

Phase I/II study of docetaxel, cisplatin, and concomitant boost radiation for locally advanced squamous cell cancer of the head and neck.

PURPOSE: To investigate the feasibility of combining concomitant boost accelerated radiation with docetaxel and cisplatin and assess the regimen's toxicity, locoregional control rate, and survival in patients with locally advanced head and neck cancer (HNSCC). PATIENTS AND METHODS: Patients with stage III-IV HNSCC were eligible. Phase I included two schedules of docetaxel and cisplatin: arm 1, once per week during weeks 1 to 4; arm 2, every 21 days for weeks 1 and 4. Radiation consisted of 72 Gy in 42 fractions over 6 weeks (concomitant boost). RESULTS: Twenty patients were enrolled in phase I. The arm 1 maximum-tolerated dose (MTD) was defined at docetaxel 15 mg/m2 and cisplatin 20 mg/m2 based on prolonged mucositis in 29% of patients. The initial dose level in arm 2 was above the MTD. In total, 52 patients were treated using the arm 1 regimen in phase II. Acute toxicity included grade 3 mucositis and dermatitis in 81% and 44% of patients. The 2-year locoregional control rate was 71%. The 2-year progression-free and overall survival rates were 61% and 65%. Median survival was 37.8 months. Late effects included feeding tube dependence in 17% of patients alive and free of disease. CONCLUSION: Locoregional control, survival, and acute toxicity with this regimen were comparable with other trials utilizing taxanes and/or platins and concomitant conventional or altered fractionation radiation. Our data suggest that chemotherapy added to concomitant boost fractionation may increase rates of long-term feeding tube dependence. Phase III trials are needed to assess the contribution of concomitant boost fractionation to chemoradiotherapy.

Adult↗
PubMed2006

Clinical evaluation of the intraoral fluoride releasing system in radiation-induced xerostomic subjects. Part 1: Fluorides.

Radiation-induced xerostomia results in significant changes in the oral cavity particularly oral microbial changes, which include a marked increase in the number of cariogenic organisms, notably Streptococcus mutans and lactobacillus species. This loss of the capacity to secrete saliva creates or promotes the rapid onset and progression of rampant dental caries. In this 2-part series, the benefit of fluoride in reducing caries activity is presented. Part 1 discusses the historical and currently available fluoride preparations and Part 2 presents data of a recently completed trial investigating the benefit of an intraoral sodium fluoride releasing system.

Anti-Bacterial Agents↗
PubMed2006

Two-field versus three-field irradiation technique in the postoperative treatment of head-and-neck cancer.

PURPOSE: We have increasingly used a two-field noncoplanar "caudal tilt" technique (CTT) for irradiating postlaryngectomy and pharyngectomy patients to avoid matchline problems that can be encountered with the classic three-field head-and-neck radiation technique (3FT). This report compares the clinical outcomes of patients treated with postoperative radiation (PORT) using either 3FT or CTT. METHODS AND MATERIALS: We conducted a retrospective review of the medical records of all patients with laryngeal or hypopharyngeal cancers consecutively treated with PORT between 1997 and 2002. Three-dimensional dosimetric planning was carried out for all patients. RESULTS: Of 91 patients, 39 were treated with 3FT and 52 with CTT. The median follow-up was 34 months. Estimated rates of 2-year locoregional control, disease-free survival, and overall survival for patients treated with 3FT and CTT were, respectively, 92% and 85% (p=0.241), 62% and 55% (p=0.497), and 77% and 72% (p=0.616). There were no significant differences in the incidence of acute or late side effects in the two groups. CONCLUSIONS: "Caudal tilt" technique is often used as an alternative to 3FT for postoperative radiotherapy in cases of greater medical and technical complexity. Despite its use in more challenging cases, CTT provides similar long-term clinical outcomes compared with standard 3FT, when computerized three-dimensional dosimetry is used to assure adequate dosimetry throughout the treated volume.

Adult↗
PubMed2006

Clinical evaluation of the intraoral fluoride releasing system in radiation-induced xerostomic subjects. Part 2: Phase I study.

Radiation-induced xerostomia can result in the rapid onset and progression of dental caries in head and neck cancer patients. Topically applied fluorides have been successfully used to inhibit the formation of dental caries in this population. However, because intensive daily self-application is required, compliance is an issue. The intraoral fluoride-releasing system (IFRS) containing a sodium fluoride core is a newly developed, sustained-release, passive drug delivery system that does not require patient involvement except for periodic replacement, thus reducing the effect of patient compliance on its effectiveness in dental caries prevention. Twenty-two head and neck cancer patients from U. T. M. D. Anderson Cancer Center, with radiation-induced xerostomia, were entered into a pilot study to contrast the daily home use of a 0.4% stannous fluoride-gel-containing tray (control group) to IFRS (study group) with respect to tolerability and adherence, and to obtain information on relative caries preventive efficacy. Participants were stratified on the basis of radiation exposure and randomly assigned to treatment with either IFRS or stannous fluoride gel. Patients in both groups were fitted with two IFRS retainers and also were instructed to use a 1100-ppm fluoride conventional sodium fluoride dentifrice twice daily. The study was conducted as a single-blinded, parallel-cell trial. Pre-existing carious lesions were restored prior to the beginning of the study. The efficacy variable was determined by the mean number of new or recurrent decayed surfaces. Patients were examined for caries 4, 8, 12, 24, 36, and 48 weeks after initiation of treatment. Reports of adverse reactions were based on information volunteered by patients and that were elicited during interviews. At baseline, the resting and stimulated salivary flow rates (g/5min) were significantly greater in the control group than in the study group (p<0.05). Patients in the control group had received significantly more radiation than those in the test group (68Gy vs. 60Gy; p=0.047). No marked differences in follow-up new and recurrent caries were found between the stannous fluoride gel control and IFRS groups during the study period. The rate of new or recurrent carious lesions in the group treated with the fluoride gel was slightly lower than in the IFRS group, based on carious lesions at the baseline examination (Poisson mean number of new or recurrent carious lesions for the control group=0.55 per year vs. 0.83 per year for the study group, p=0.705; odds ratio of the occurrence of any new or recurrent caries during follow-up for control group vs. the study group=0.80; p=0.781). This pilot study revealed that the IFRS was well-tolerated and safe in this study population associated with minimal complications during the duration of this study and was comparable in efficacy to a SnF(2) gel in preventing caries development. The IFRS provided similar rates of control for caries formation to a fluoride-gel-containing tray. The IFRS is designed to release a daily dose of 0.12mg of sodium fluoride, which can be evenly distributed throughout the oral cavity for a single application of 4 months. It would be more convenient than the daily home application of a tray of 0.4% stannous fluoride or 1.1% sodium fluoride gel, and avoids the problem of variable patient compliance.

Administration, Topical↗
PubMed2006

Impact of changes to the American Joint Committee on Cancer T classification on outcome prediction in patients with oropharyngeal cancer.

BACKGROUND: The efficacy of the current 6th edition of the American Joint Committee on Cancer (AJCC) tumor staging criteria in improving outcome prediction for patients with oropharyngeal cancer was analyzed. METHODS: From the database of the Department of Radiation Oncology at the University of Texas M. D. Anderson Cancer Center the authors identified 875 patients irradiated at the study institution for oropharyngeal cancer between January 1975 and December 1998. The tumors were restaged based on the 6th edition of AJCC tumor staging criteria to reassess the original outcome predictions, specifically overall survival (OS) and local control (LC). RESULTS: Applying the new 6th edition staging system resulted in the following T classification distributions: T2, 301 tumors (34%); T3, 248 tumors (28%); T4a, 224 tumors (26%), and T4b, 102 tumors (12%). The 5-year and 10-year OS rates based on the new system were: T2, 65% and 45%; T3, 44% and 28%; T4a, 30% and 23%; and T4b, 26% and 12%, respectively. The 5-year and 10-year actuarial local LC rates based on the new system were: T2, 85% and 83%; T3, 73% and 71%; T4a, 61% and 58%; and T4b, 42% and 42%, respectively. Differences in OS and LC rates stratified by stage were found to be statistically significant both for the overall distribution of survival and pairwise comparisons of the 4 tumor stage groups. CONCLUSIONS: The modifications established in the 6th edition of the AJCC tumor staging system for oropharyngeal tumors appear to be useful to distinguish prognostic groups for both LC and OS based on tumor stage.

Adult↗
PubMed2006

Phase III Trial of an emulsion containing trolamine for the prevention of radiation dermatitis in patients with advanced squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Trial 99-13.

PURPOSE: This multicentered phase III trial was designed to compare an emulsion containing trolamine against the usual supportive care within each participating institution for patients with head and neck cancer undergoing radiation therapy. PATIENTS AND METHODS: Patients with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to one of the following treatments: prophylactic trolamine emulsion, interventional trolamine emulsion, or declared institutional preference. The primary outcome was the reduction in grade 2 or higher skin toxicity, as per National Cancer Institute Common Toxicity Criteria version 2.0. Secondary outcomes included patient-reported quality of life (QOL). RESULTS: From October 2000 to April 2002, 547 patients from 51 institutions were entered onto the trial. The average age was 59 years. Patients were predominately male (79%) and most continued to use tobacco products (52%). The rates of grade 2 or higher radiation dermatitis were 79%, 77%, and 79% in the prophylactic, interventional, and institutional preference arms of the study, respectively. No significant differences in QOL were found. CONCLUSION: The results of this trial demonstrate no advantage for the use of trolamine in reducing the incidence of grade 2 or higher radiation dermatitis or improving patient-reported QOL. The use of 15 different local standards of care highlights the need to continue research that will result in evidence-based recommendations to reduce the burden of radiation dermatitis.

Carcinoma, Squamous Cell↗
PubMed2006

Multiple regions-of-interest analysis of setup uncertainties for head-and-neck cancer radiotherapy.

PURPOSE: To analyze three-dimensional setup uncertainties for multiple regions of interest (ROIs) in head-and-neck region. METHODS AND MATERIALS: In-room computed tomography (CT) scans were acquired using a CT-on-rails system for 14 patients. Three separate bony ROIs were defined: C2 and C6 vertebral bodies and the palatine process of the maxilla. Translational shifts of 3 ROIs were calculated relative to the marked isocenter on the immobilization mask. RESULTS: The shifts for all 3 ROIs were highly correlated. However, noticeable differences on the order of 2-6 mm existed between any 2 ROIs, indicating the flexibility and/or rotational effect in the head-and-neck region. The palatine process of the maxilla had the smallest right-left shifts because of the tight lateral fit in the face mask, but the largest superior-inferior movement because of in-plane rotation and variations in jaw positions. The neck region (C6) had the largest right-left shifts. The positioning mouthpiece was found effective in reducing variations in the superior-inferior direction. There was no statistically significant improvement for using the S-board (8 out of 14 patients) vs. the short face mask. CONCLUSIONS: We found variability in setup corrections for different regions of head-and-neck anatomy. These relative positional variations should be considered when making setup corrections or designing treatment margins.

Algorithms↗
PubMed2006

Importance of patient examination to clinical quality assurance in head and neck radiation oncology.

BACKGROUND: When quality assurance programs in clinical radiation oncology focus mainly on the technical aspects of treatment, they tend to underplay questions of therapeutic process and outcome. We determined the value of clinical peer review in radiation therapy for head and neck cancer that involved head and neck examination. METHODS: Data were collected prospectively on 134 consecutive patients with preliminary radiation therapy (RT) plans. Peer review was performed that included head and neck examination and imaging review to confirm target localization. RESULTS: Peer review led to changes in treatment plans for 66% of patients. Most changes were minor, but 11% of changes were major and thought to be of a magnitude that could potentially affect therapeutic outcome or normal tissue toxicity. Most changes involved target delineation based on physical findings CONCLUSIONS: Peer review of radiation target localization in RT plans led to changes that could potentially affect rates of cancer control or complication in about 10% of patients. We suggest that the accuracy of head and neck radiation oncology treatment plans might be increased by co-examination by another head and neck cancer specialist, typically a radiation oncologist or head and neck surgeon, to confirm RT target volumes.

Clinical Competence↗
PubMed2006

How to reduce radiation-related toxicity in patients with cancer of the head and neck.

Radiation for head and neck cancers is often curative, but high doses are used. Normal tissues, including mucosa, salivary glands, and muscles, are exposed to these high doses, resulting in severe mucositis, xerostomia, and dysphagia. Efforts to minimize toxicity have involved advances in radiation physics and development of pharmacologic agents. Radiation techniques include conformal and intensity-modulated therapy, which minimizes dose to normal tissues while delivering high doses to tumor targets. Drugs used to prevent mucositis have targeted infection, but recently interest has been shown in the use of growth factors. Cholinergic agonists and cytoprotective agents, specifically amifostine, can address xerostomia. Involvement of speech pathologists in evaluation and treatment of patients with dysphagia can minimize swallowing difficulties and identify the tissues most responsible for swallowing. Minimizing radiation dose to these tissues may lower the incidence of radiation-induced dysphagia.

Amifostine↗
PubMed2006

Intensity-modulated radiation therapy and xerostomia.

Conformal radiation with intensity-modulated radiation therapy, IMRT, is a radiation technique that potentially can minimize the dose to salivary glands and thereby decrease the incidence of xerostomia. Precise target determination and delineation is most important when using salivary gland-sparing techniques of IMRT. The reduction of xerostomia may be achieved by sparing the salivary glands on the noninvolved oral cavity and keeping the mean parotid gland dose of < 26-30 Gy if the treatment of disease is not compromised and parotid function preservation is desired.

Head and Neck Neoplasms↗
PubMed2005

A phase I/II study of neoadjuvant chemotherapy followed by radiation with boost chemotherapy for advanced T-stage nasopharyngeal carcinoma.

PURPOSE: Local recurrence is the most common site of failure for locally advanced nasopharyngeal carcinoma (NPC) treated with neoadjuvant cisplatin/5-fluorouracil (PF) and definitive radiation at our center. Based on this, we studied the addition of chemotherapy during the boost phase of radiation after neoadjuvant PF for advanced T-stage (T3-T4) NPC. This strategy was based on theoretical radiosensitization with chemotherapy during accelerated repopulation of the tumor with relatively radioresistant clonogens. METHODS AND MATERIALS: Three cycles of neoadjuvant PF was followed by conventionally fractionated radiation with additional PF during the boost portion of the radiation course. An initial Phase I study was done to establish the maximum tolerated dose of concurrent PF. RESULTS: Forty-four patients were enrolled. Six patients in Phase I defined the MTD for concurrent PF as: cisplatin 10 mg/m2/day and PF 320 mg/m2/day, on Days 1-5 during Weeks 6 and 7 of radiation therapy based on dose-limiting toxicities of mucositis, neutropenia, and thrombocytopenia. Forty-one patients were treated with concurrent therapy per protocol: complete, partial, and minor responses were seen in 23, 16, and 2 patients, respectively. Progression-free and overall survival rates at 5 years were 55% (95% CI, 41-75%) and 66% (95% CI, 52-85%), respectively. Seven of 11 tumor-related deaths were due to local recurrence. Nine of 10 patients with local recurrence had T4-stage disease at presentation. Local control of T4 disease was achieved in 74% of patients overall, and in 25% (1/4) with World Health Organization (WHO) type 1, 76% (16/21) with WHO type 2, and 90% (9/10) with WHO type 3 histology. Common toxicities included mucositis, dermatitis, fatigue, vomiting, and weight loss. CONCLUSIONS: This regimen was feasible and associated with promising overall survival. Local recurrence remains the major reason for treatment failure in advanced T-stage NPC, especially WHO types 1 and 2. Other strategies to improve local control in these patients should be investigated.

Adolescent↗
PubMed2005

Determining optimal clinical target volume margins in head-and-neck cancer based on microscopic extracapsular extension of metastatic neck nodes.

PURPOSE: To determine the optimal clinical target volume margins around the gross nodal tumor volume in head-and-neck cancer by assessing microscopic tumor extension beyond cervical lymph node capsules. METHODS AND MATERIALS: Histologic sections of 96 dissected cervical lymph nodes with extracapsular extension (ECE) from 48 patients with head-and-neck squamous cell carcinoma were examined. The maximum linear distance from the external capsule border to the farthest extent of the tumor or tumoral reaction was measured. The trends of ECE as a function of the distance from the capsule and lymph node size were analyzed. RESULTS: The median diameter of all lymph nodes was 11.0 mm (range: 3.0-30.0 mm). The mean and median ECE extent was 2.2 mm and 1.6 mm, respectively (range: 0.4-9.0 mm). The ECE was <5 mm from the capsule in 96% of the nodes. As the distance from the capsule increased, the probability of tumor extension declined. No significant difference between the extent of ECE and lymph node size was observed. CONCLUSION: For N1 nodes that are at high risk for ECE but not grossly infiltrating musculature, 1 cm clinical target volume margins around the nodal gross tumor volume are recommended to cover microscopic nodal extension in head-and-neck cancer.

Adult↗
PubMed2005

Gastrostomy in oropharyngeal cancer patients with ERCC4 (XPF) germline variants.

PURPOSE: ERCC4 (XPF) plays a role in both recombinant DNA repair and nucleotide excision repair, which involve repairing radiation-induced genetic damage. We hypothesized that two ERCC4 single-nucleotide polymorphisms are associated with normal-tissue toxicity in patients treated with radiotherapy for oropharyngeal squamous cell carcinoma (OPSCC). METHODS AND MATERIALS: A retrospective review of the medical records of 130 patients with OPSCC who were prospectively recruited into a molecular epidemiologic study was performed to determine whether a long-term percutaneous feeding gastrostomy (LPFG) tube (a tube required for more than 180 days) had been used during and after definitive radiotherapy. We determined the genotype of the ERCC4 G1244A and T2505C polymorphisms using standard polymerase chain reaction-restriction fragment-length polymorphism techniques on DNA extracted from peripheral blood lymphocytes. RESULTS: Of 130 patients, 100 (77%) were evaluable for the ERCC4 G1244A polymorphism in exon 8, and 122 (94%) were evaluable for the ERCC4 T2505C polymorphism in exon 11. The ERCC4 G1244A polymorphism was associated with a decreased need for LPFG, but this was not statistically significant (adjusted odds ratio = 0.53; 95% confidence interval, 0.10-2.78). Sixteen (32%), 9 (14%), and 1 (10%) of patients with the wild-type homozygous TT genotype of ERCC4 T2505C, the heterozygous TC genotype, and the homozygous CC polymorphic genotype, respectively, required LPFG. These results suggest that the ERCC4 2505C allele was associated with a reduced need for LPFG (adjusted odds ratio = 0.20; 95% confidence interval, 0.06-0.67). Furthermore, the need for LPFG was reduced by having more than 1 ERCC4 2505C allele and further for having both the ERCC4 1244A and 2505C polymorphic alleles, but this was not statistically significant. In addition, the actual time of gastrostomy dependence was associated with the T2505C polymorphism based on the Kaplan-Meier method (p = 0.03). CONCLUSIONS: Our findings suggest that the ERCC4 T2505C polymorphism may be associated with improved recovery from radiation treatment toxicity in patients with OPSCC. Further study with larger sample sizes and prospective measure of radiotherapy-induced toxicity is warranted.

Adult↗
PubMed2005

Intensity-modulated radiation therapy (IMRT) of cancers of the head and neck: comparison of split-field and whole-field techniques.

BACKGROUND: Oropharynx cancers treated with intensity-modulated radiation (IMRT) are often treated with a monoisocentric or half-beam technique (HB). IMRT is delivered to the primary tumor and upper neck alone, while the lower neck is treated with a matching anterior beam. Because IMRT can treat the entire volume or whole field (WF), the primary aim of the study was to test the ability to plan cases using WF-IMRT while obtaining an optimal plan and acceptable dose distribution and also respecting normal critical structures. METHODS AND MATERIALS: Thirteen patients with early-stage oropharynx cancers had treatment plans created with HB-IMRT and WF-IMRT techniques. Plans were deemed acceptable if they met the planning guidelines (as defined or with minor violations) of the Radiation Therapy Oncology Group protocol H0022. Comparisons included coverage to the planning target volume (PTV) of the primary (PTV66) and subclinical disease (PTV54). We also compared the ability of both techniques to respect the tolerance of critical structures. RESULTS: The volume of PTV66 treated to >110% was less in 9 of the 13 patients in the WF-IMRT plan as compared to the HB-IMRT plan. The calculated mean volume receiving >110% for all patients planned with WF-IMRT was 9.3% (0.8%-25%) compared to 13.7% (2.7%-23.7%) with HB-IMRT (p = 0.09). The PTV54 volume receiving >110% of dose was less in 10 of the 13 patients planned with WF-IMRT compared to HB-IMRT. The mean doses to all critical structures except the larynx were comparable with each plan. The mean dose to the larynx was significantly less (p = 0.001), 18.7 Gy, with HB-IMRT compared to 47 Gy with WF-IMRT. CONCLUSIONS: Regarding target volumes, acceptable plans can be generated with either WF-IMRT or HB-IMRT. WF-IMRT has an advantage if uncertainty at the match line is a concern, whereas HB-IMRT, particularly in cases not involving the base of tongue, can achieve much lower doses to the larynx.

Clinical Trials, Phase I as Topic↗
PubMed2005

Validation of an accelerated 'demons' algorithm for deformable image registration in radiation therapy.

A greyscale-based fully automatic deformable image registration algorithm, originally known as the 'demons' algorithm, was implemented for CT image-guided radiotherapy. We accelerated the algorithm by introducing an 'active force' along with an adaptive force strength adjustment during the iterative process. These improvements led to a 40% speed improvement over the original algorithm and a high tolerance of large organ deformations. We used three methods to evaluate the accuracy of the algorithm. First, we created a set of mathematical transformations for a series of patient's CT images. This provides a 'ground truth' solution for quantitatively validating the deformable image registration algorithm. Second, we used a physically deformable pelvic phantom, which can measure deformed objects under different conditions. The results of these two tests allowed us to quantify the accuracy of the deformable registration. Validation results showed that more than 96% of the voxels were within 2 mm of their intended shifts for a prostate and a head-and-neck patient case. The mean errors and standard deviations were 0.5 mm+/-1.5 mm and 0.2 mm+/-0.6 mm, respectively. Using the deformable pelvis phantom, the result showed a tracking accuracy of better than 1.5 mm for 23 seeds implanted in a phantom prostate that was deformed by inflation of a rectal balloon. Third, physician-drawn contours outlining the tumour volumes and certain anatomical structures in the original CT images were deformed along with the CT images acquired during subsequent treatments or during a different respiratory phase for a lung cancer case. Visual inspection of the positions and shapes of these deformed contours agreed well with human judgment. Together, these results suggest that the accelerated demons algorithm has significant potential for delineating and tracking doses in targets and critical structures during CT-guided radiotherapy.

Algorithms↗
PubMed2005

Concomitant boost radiation plus concurrent cisplatin for advanced head and neck carcinomas: radiation therapy oncology group phase II trial 99-14.

PURPOSE: To investigate the feasibility of combining concomitant boost accelerated radiation regimen (AFX-C) with cisplatin and to assess its toxicity and the relapse pattern and survival in patients with advanced head and neck carcinoma (HNC). PATIENTS AND METHODS: Between April and November of 2000, 84 patients with stage III to IV HNC who met the eligibility criteria were enrolled; 76 of these patients were analyzable. Radiation consisted of 72 Gy in 42 fractions over 6 weeks (daily for 3.5 weeks, then twice a day for 2.5 weeks). Cisplatin dose was 100 mg/m(2) on days 1 and 22. Tumor and clinical status were assessed, and acute late toxicities were graded. RESULTS: Sixty-five patients (86%) received both radiation and chemotherapy per protocol or with minor variations. The estimated 2-year locoregional relapse and distant metastasis rates were 34.7% and 16.1%, respectively. The estimated 2-year overall survival and disease-free survival rates were 71.6% and 53.5%, respectively. Three patients (4%) died of complications, 19 patients (25%) had acute grade 4 toxicity, and 49 patients (64%) had acute grade 3 toxicity. The 2-year cumulative incidence of late grade 3 to 5 toxicities was 51.3%. CONCLUSION: These data showed that it was feasible to combine AFX-C with cisplatin. The compliance to therapy was high, and the locoregional control and survival rates achieved compared favorably with AFX-C alone or other concurrent chemoradiation regimens tested by the Radiation Therapy Oncology Group. A phase III trial comparing AFX-C plus cisplatin against standard radiation plus cisplatin is ongoing to determine whether the use of AFX-C in the concurrent chemoradiation setting further improves outcome.

Adult↗