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PubMed2001

Hypothyroidism: a frequent event after radiotherapy and after radiotherapy with chemotherapy for patients with head and neck carcinoma.

BACKGROUND: The incidence of hypothyroidism was assessed retrospectively from a data base of 155 patients with head and neck carcinoma who were treated at the Cleveland Clinic Foundation between 1990 and 1997. METHODS: One hundred patients were randomized between radiotherapy (RT) (66-72 grays in single daily fractions) and RT with concurrent chemotherapy (CT) using 5-fluorouracil and cisplatin. An additional 55 patients received RT and CT without randomization. Primary site surgery was performed for tumor persistence or recurrence and included a thyroidectomy in nine patients. These nine patients, along with three patients who had hypothyroidism prior to treatment, were excluded from the analysis. At regular intervals after the completion of treatment, all patients were evaluated for the development of hypothyroidism, defined as a serum thyroid-stimulating hormone (TSH) level > 5.5 microU/mL. RESULTS: With a median follow-up for 143 evaluable patients of 4.4 years (range, 1.5-9.2 years), the 5-year Kaplan-Meier projected incidence rate of hypothyroidism was 48%, and the 8-year projected incidence rate was 67%. The median time to the development of hypothyroidism was 1.4 years (range, 0.3-7.2 years). The likelihood of developing hypothyroidism could not be predicted according to age, gender, primary site, tumor or lymph node status, overall stage, RT dosage to the primary site or to the neck, or inclusion of CT in the treatment plan. Only race proved predictive, with no African-American patients developing hypothyroidism (P = 0.02). CONCLUSIONS: The authors conclude that the incidence rate of hypothyroidism after patients undergo RT for head and neck carcinoma is higher than generally reported and that TSH screening after treatment appears justified.

Adult↗
PubMed1997

A comparative study of undifferentiated nasopharyngeal carcinoma treated with radiotherapy or combined treatment with zorubicin-cisplatin and radiotherapy.

Undifferentiated nasopharyngeal carcinoma has been related to the Epstein-Barr virus. These tumors are known to be radiosensitive and chemosensitive. While radiotherapy (RT) allows for a high rate of local control, 80% of all patients die from or with metastatic spread. This study analyzed 61 patients treated with RT alone and 28 treated with zorubicin (ZRB)-cisplatin (CDDP) and RT between 1977 and 1990. All patients treated with RT received 60-74 Gy in 6-7 weeks. Patients treated with combined therapy received ZRB 250 mg/m2 on the 1st day and CDDP 30 mg/m2 from the 2nd to 5th day. The interval between cycles was 4 weeks. Following treatment with chemotherapy patients were then given RT. The 5-year survival rate was 20% for patients with T1 and T2 tumors when treated with RT alone and 54% when treated with chemotherapy (CT). This was 25% for T3 and T4 lesions with RT only and 27% for RT with CT. Survival of patients with N0 and N1 lesions was 41% after RT and 60% after RT with CT. This decreased to 10% for N2 and N3 lesions treated with RT and 30% with RT and CT.

Adult↗
PubMed1999

[Radiotherapy of the elderly patient. Radiotherapy tolerance and results in older patients].

BACKGROUND: Despite a growing number of elderly patients receiving radiation therapy little is known about side effects and outcome of irradiation in this section of the population. METHODS: In a review article epidemiologic data, aspects of radiation-biology as well as side effects and outcome of radiation therapy of elderly patients are discussed. RESULTS: Cancer incidence rises with age (Figure 1) and is exceeding 3.5% for males older than 85 years. With a life expectancy of more than 4 years, curative therapy is indicated even at this age. Furthermore several retrospective studies indicate that local control and disease-Specific survival after radiation therapy of elderly patients is comparable with that of younger persons (Tables 3 and 4). The exception contains elderly patients with Grade-III to IV gliomas or with rectal carcinoma who show a reduced survival which is perhaps caused by less aggressive combined treatment (tumor resection). Although some biological and molecular data indicate a rise in radiation sensitivity with growing age like the reduction of the capacity of some DNA-repair enzymes, there is no convincing evidence in animal studies or in retrospective clinical studies that radiation therapy is generally less well tolerated by older individuals (Tables 1 and 2). Some age-depending differences in organ toxicities are described in 3 large studies, which evaluate the data of patients who were enrolled in different EORTC-trials: Older patients suffer more of functional mucositis in case of radiation therapy to the head and neck, they have an increased weight loss and a higher frequency of late esophageal damage when irradiated in the thorax, and they show a higher prevalence of sexual dysfunction when treated with radiation therapy to the pelvis. On the other hand younger patients suffer more from acute toxicity like skin damage, nausea, and deterioration of the performance status during pelvic radiotherapy. When discussing the dose intensity of radiation therapy concomitant disease which leads to extensive atherosclerotic vessel damage should be kept in mind. Old patients should be monitored closely during therapy, since the loss of electrolytes or fluid is often not very well tolerated. CONCLUSION: The indication to radiation therapy of elderly cancer patients should take into account their performance status as well as the extent and the severity of comorbidity. Age per se is seldom a contraindication for radiation therapy. Regarding the available data in literature there is no indication for a dose reduction in radiation therapy only because of age, especially in the curative setting.

Aged↗
PubMed2002

Dependence of the risk of encephalopathy on the radiotherapy volume after combined surgery and radiotherapy of invasive pituitary tumours.

The effectiveness of radiotherapy in reducing tumour recurrence of pituitary adenomas is well documented. On the other hand, the risk of side effects to the surrounding central nervous system normal tissue should not be underestimated. This retrospective study includes 58 patients with subtotally resected pituitary tumours. Photon from a 5,7 MV linear accelerator of a 60 cobalt unit with a source-isocenter distance of 80 cm were used throughout for treatment. The doses per fraction ranged from 45 Gy to 60 Gy. For a direct comparison of the different fractionation schedules, the biological effective total dose with 2 Gy per fraction was calculated for all the different application schemes with doses per fraction longer or smaller than 2 Gy. To do this, a fractionation sensitivity of the normal cerebral tissue by an square / square value of 2 Gy was assumed. Encephalopathy developed in 17 cases (28 percentage) after follow-up times of more than 5 years. Pathological CT- or MRI-findings were seen in 13 cases. Two factors were important for the genesis of radiogenic encephalopathy: 1. Multivariate analysis revealed that the risk of encephalopathy was associated with the radiation volume. 2. The location of the upper field border line was the strongest prognostic factor associated with the risk of encephalopathy (p<0.05).

Adolescent↗
PubMed1994

Personal computer-based small PACS for radiotherapy--analog image filing system for radiotherapy.

The purpose of this study is to evaluate the usefulness of a personal computer-based small PACS using analog video images. The analog video recorder, personal computer, and display monitor constitute our system. An analog video recorder is composed of a laser disk recorder for still images and a video cassette recorder for moving images. The acquired video images are managed by a personal computer and database software. The serial communication ports of the personal computer and a video recorder are connected with the reverse cable, and the video recorder is controlled by the personal computer using our program. This system enables filing of multi-modality images including moving images and is used for following up and treatment planning of the patients who received radiotherapy.

Aftercare↗
PubMed1989

A randomized clinical trial comparing systemic radiotherapy versus chemotherapy versus local radiotherapy in small cell lung cancer.

Between 1982 and 1987 a prospectively randomized trial of sequential hemibody irradiation (SHBI) (A), a non-cross-resistant chemotherapy drug combination (B) and local and/or locoregional radiotherapy (C) in small cell lung cancer (SCLC) was conducted. Previously untreated patients with extensive SCLC were randomized into three arms: A = 31 patients, B = 37, C = 31. In the chemotherapy combination, the following were used: etoposide, doxorubicin, methotrexate (VAM) and procarbacine, vincristine, cyclophosphamide, lomustine (POCC) and prophylactic cranial irradiation (30 Gy). The results show that the median survival was significantly (P less than 0.01) better in chemotherapy (44 weeks) compared with 17 and 20 weeks in arms A and C, respectively. One year and 2 year survival rates were better for the chemotherapy arm. No differences were found between groups A and C. In comparing the total hospitalization time expressed as a percentage of overall survival, an advantage for group B was shown. In conclusion, high dose SHBI cannot be recommended as a standard therapy for extensive SCLC.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1995

Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas.

PURPOSE: The objectives of this study were to determine the efficacy and toxicity of Etanidazole (ETA), a hypoxic cell sensitizer, when combined with conventional radiotherapy (RT) in the management of advanced head and neck carcinomas. METHODS AND MATERIALS: From March 1988 to September 1991, 521 patients who had Stage III or IV head and neck carcinomas were randomized to receive conventional RT alone (66 Gy in 33 fractions to 74 Gy in 37 fractions, 5 fractions per week) or RT+ETA (2.0 g/m2 thrice weekly for 17 doses), of whom 504 were eligible and analyzable. Treatment assignments were stratified before randomization according to the primary site (oral cavity + hypopharynx vs. supraglottic larynx + oropharynx + nasopharynx), T-stage (T1-3 vs. T4), and N-stage (N0-2 vs. N3). Pretreatment characteristics were balanced. In the RT-alone arm, 39% of patients had T3 and 34% had T4 disease, whereas in the RT+ETA arm, 42% of patients had T3 and 33% had T4 disease. Thirty-eight percent of the RT-alone patients and 37% of the RT+ETA patients had N3 disease. The median follow-up of surviving patients was 3.38 years, with a range between 0.96 and 5.63 years. RESULTS: One hundred and ninety-four of the 252 (77%) RT+ETA patients received at least 14 doses of the drug. Overall RT protocol compliance rate was 82% in the RT-alone arm and 86% in the RT+ETA arm. No Grade 3 or 4 central nervous system or peripheral neuropathy was observed in the RT+ETA arm. Eighteen percent of the patients developed Grade 1 and 5% developed Grade 2 peripheral neuropathy. Other drug related toxicities included nausea/vomiting (27%), low blood counts (15%), and allergy (9%). Most of these toxicities were Grade 1 and 2. The incidence of severe acute and late radiation effects were similar between the two arms. The 2-year actuarial local-regional control rate (LCR) was 40% for the RT-alone arm and 40% for the RT+ETA arm. Two-year actuarial survival was 41% for the RT-alone arm and 43% for the RT+ETA arm (p = 0.65). Multivariate analyses were performed to investigate the influence of covariates on treatment effects. A strong treatment interaction with N-stage was revealed: LCR (50% vs. 40% at 2 years), RT+ETA improved for patients with N0-2 disease but not for N3 patients (22% for RT+ETA and 40% for RT). Further analyses showed that RT+ETA was more advantageous in N0-1 patients, with a 2-year LCR of 55% for RT+ETA vs. 37% for RT only (p = 0.03). A similar phenomenon was observed when using survival as the end point. CONCLUSION: The results showed that adding Etanidazole to conventional RT produced no global benefit for patients who had advanced head and neck carcinomas. There was a suggested benefit for patients who had N0-1 disease, and that needs to be confirmed by another study.

Carcinoma, Squamous Cell↗
PubMed2006

[Air breath control radiotherapy in severe insufficiency respiratory patients with NSCL: application for deformable registration method in thoracic radiotherapy].

PURPOSE: Using deformable registration methods from a phase two clinical study of air breath control during radiotherapy in patients suffering from severe respiratory insufficiency and non-small cell lung carcinoma. PATIENTS AND METHODS: Between April 2002 and November 2005, 22 patients with severe respiratory insufficiency were treated with curative intent by conformal therapy combined with active breathing control. RESULTS: After a mean of follow-up of 22 months, the local control rate is 28% and the method is feasible despite the severe respiratory insufficiency. However the overall survival is still poor due to metastatic widespread. For the second part of the study, the clinical protocol was also used for two studies using deformable registration methods. In the first study, a deformable registration method has been developed in order to register several breath-hold 3D CT of the same patient acquired at several days of interval. It allowed quantifying the interfraction breath-hold reproducibility by analysing the resulting displacement field. For 6 patients, the breath-hold was effective, while for 2 patients, motion greater than 10 mm were detected. The second study aimed to simulate 4D images from 3D breath-hold images. Developing an ad-hoc methodology based on the interpolation of 3D dense deformation fields performed it. The approach has been validated with expert selected landmarks, with accuracy lower than 3 mm. CONCLUSION: ABC is feasible, even in case of severe insufficiency respiratory syndrome but metastatic widespread disease is still a major challenge even with an acceptable local control rate without serious side effects: regarding the deformable registration method. Such artificial 4D images could allow decreasing the dose need to acquire a full 4D image, to simulate irregular breathing pattern and to be used for 4D dosimetry planning.

Adenocarcinoma↗
PubMed2006

Mammographic and ultrasonographic comparison between intraoperative radiotherapy (IORT) and conventional external radiotherapy (RT) in limited-stage breast cancer, conservatively treated.

OBJECTIVE: Assess mammographic and echographic modifications in mild cases of breast cancer (suitable for conservative surgery) after intraoperatory radio treatment (IORT) as opposed to conventional post-operative radiotherapy (RT). MATERIALS AND METHODS: We report data from 45 patients in each group (IORT and RT). All patients were examined using the same mammographic and ecographic equipment at 6, 12 and 24 months after treatment. We focused on structural alterations, edema and others, and quantified them using pre-established (unbiased) protocols. Both patient examination and subsequent assessment of the results were performed by radiologists with exepertise in breast cancer evaluation. RESULTS: At 6 months, IORT patients showed slightly more pronounced structural distortions and oedema than RT patients; these differences became more apparent at 12 months, with the addition of fat necrosis and/or calcifications. These alterations were evident and consistent under both mammographic and ecographic examination, and became even more pronounced at 24 months. At this stage, RT patients showed minimal alterations of the tissue (apart from normal post-surgical scarring), whereas IORT patients showed virtually no improvement over the preceding 12-month period. CONCLUSION: We show radiological alterations in post-operative breast cancer are significantly more pronounced in patients treated with IORT as opposed to RT.

Aged↗
PubMed2004

Long-term results of a phase III trial comparing once-daily radiotherapy with twice-daily radiotherapy in limited-stage small-cell lung cancer.

PURPOSE: This Phase III study was performed to determine whether twice-daily (b.i.d.) radiotherapy (RT) resulted in better survival than once-daily (q.d.) RT for patients with limited-stage small-cell lung cancer (LD-SCLC). METHODS AND MATERIALS: A total of 310 patients with LD-SCLC initially received three cycles of etoposide and cisplatin. Subsequently, the 261 patients without significant progression were randomized to two cycles of etoposide and cisplatin plus either q.d. RT (50.4 Gy in 28 fractions) or split-course b.i.d. RT (24 Gy in 16 fractions, a 2.5-week break, and 24 Gy in 16 fractions) to the chest. Patients then received a sixth cycle of etoposide and cisplatin followed by prophylactic cranial RT. RESULTS: Follow-up ranged from 4.6 to 11.9 years (median, 7.4 years). The median survival and 5-year survival rate from randomization was 20.6 months and 21% for patients who received q.d. RT compared with 20.6 months and 22% for those who received b.i.d. RT (p = 0.68), respectively. No statistically significant differences were found in the rates of progression (p = 0.68), intrathoracic failure (p = 0.45), in-field failure (p = 0.62), or distant failure (p = 0.82) between the two treatment arms. No statistically significant difference was found in the overall rate of Grade 3 or worse (p = 0.83) or Grade 4 or worse toxicity (p = 0.95). Grade 3 or worse esophagitis (p = 0.05) was more common in the b.i.d. arm. Grade 5 toxicity occurred in 4 (3%) of 130 patients who received b.i.d. RT compared with 0 (0%) of 131 who received q.d. RT (p = 0.04). CONCLUSION: Although this study did not demonstrate an advantage to split-course b.i.d. RT, the long-term survival was favorable, likely reflecting the positive influences of concurrent combined modality therapy and prophylactic cranial RT.

Adult↗
PubMed2005

Matched case-control study of quality of life and xerostomia after intensity-modulated radiotherapy or standard radiotherapy for head-and-neck cancer: initial report.

PURPOSE: To compare quality of life (QOL) and xerostomia between head-and-neck cancer patients who received standard radiotherapy (RT) and patients matched by factors known to affect QOL who received intensity-modulated RT (IMRT). METHODS AND MATERIALS: This was a prospective, longitudinal study of patients with head-and-neck cancer requiring bilateral neck irradiation who received IMRT at the University of Michigan and patients who received standard RT at affiliated clinics. Each patient received a validated head-and-neck cancer-related QOL questionnaire (HNQOL) consisting of four multi-item domains--Eating, Communication, Pain, and Emotion--and a validated patient-reported xerostomia questionnaire (XQ). In both questionnaires, the answers were scored 0-100, with higher scores denoting worse QOL or xerostomia. The questionnaires were given before therapy and at 1, 3, 6, 12, 18, and 24 months after the completion of therapy. Each standard RT patient was matched with several IMRT patients according to tumor site, stage, RT status (postoperative or definitive), and age. A linear mixed-effects model was fit to compare outcomes between the two treatment groups and to model trends over time. To account for matching, the differences in scores between the matched sets of patients were fit as a random intercept. Also, matching was taken into account in the model by using the standard error of the within-paired-groups differences. RESULTS: Between 1997 and 2002, 10 patients who had received standard RT and answered the XQ and HNQOL through at least 1 year were included in the study. Each of these patients was matched with a subgroup of 2-5 patients (median, 3) who had received IMRT, had similar patient and tumor characteristics, and answered the same questionnaires. A total of 30 patients were included in the IMRT group. During the initial months after therapy, the XQ and HNQOL summary scores worsened significantly in both groups compared with the pretherapy scores. Starting at 6 months, improvements of both XQ and HNQOL scores were found over time in the IMRT patients (p = 0.01 and 0.04, respectively), compared with no trend of improvement in the standard RT patients (p = 0.5 and 0.9, respectively). The trend of improvement over time in QOL in the IMRT patients was noted in most of the HNQOL domains (Eating: p = 0.07, Pain: p = 0.05, Emotion: p = 0.04, and Communication: p = 0.13), compared with no trend of improvement in most of the domains in the standard RT patients. As the scores of the IMRT (but not the standard RT) patients improved over time, the differences between the groups in the mean XQ and HNQOL summary scores widened. At 12 months, median XQ and HNQOL scores were lower (better) in the IMRT compared with the standard RT patients by 19 and 20 points, respectively, adjusted for the pretherapy values (p = 0.2). In both groups, the pretherapy XQ and HNQOL summary scores were significantly related to the respective posttherapy scores (p = 0.02 and p < 0.01, respectively). CONCLUSIONS: After initial posttherapy declines in both groups, xerostomia and QOL improved over time after IMRT but not after standard RT. The potential benefits gained from IMRT in xerostomia or in QOL, compared with standard RT, are best reflected late (> or = 6 months) after therapy.

Adult↗
PubMed2005

Comparison of two dimensional and three dimensional radiotherapy treatment planning in locally advanced non-small cell lung cancer treated with continuous hyperfractionated accelerated radiotherapy weekend less.

BACKGROUND AND PURPOSE: Patients with inoperable non-small cell lung cancer being treated with continuous hyperfractionated accelerated radiotherapy weekend less (CHARTWEL) were planned and treated with a three dimensional (3D) conformal protocol and comparison made with two dimensional (2D) planning, as used previously, to compare past practice and methods. PATIENTS AND METHODS: Twenty-four patients were planned initially using 3D and then replanned using a 2D system. The 2D plans were transferred onto the 3D system and recalculated. Dose volume histograms could then be constructed of planning target volumes for phases 1 and 2 (PTV 1 and 2, respectively), lung and spinal cord for the 2D plans and compared with the 3D plans. RESULTS: There was a significantly lower absolute dose to the isocentre with 2D compared to 3D planning with dose reductions of 3.9% for phase 1, 4.4% for phase 2 and 4.7% for those treated with a single phase. Maximum dose to spinal cord was greater in 17 of the 24 2D plans with a median dose reduction of 0.82 Gy for 3D (P=0.04). The percentage volume of whole lung receiving > or =20 Gy (V20) was greater in 16 of the 24 2D plans with a median reduction in V20 of 2.4% for 3D (P=0.03). CONCLUSIONS: A lower dose to tumour was obtained using 2D planning due to the method of dose calculation and spinal cord and lung doses were significantly higher.

Aged↗
PubMed2000

Clinical and quality of life outcomes in the first United Kingdom randomized trial of endobronchial brachytherapy (intraluminal radiotherapy) vs. external beam radiotherapy in the palliative treatment of inoperable non-small cell lung cancer.

BACKGROUND AND PURPOSE: A randomized controlled trial was designed to evaluate the clinical and quality of life (QL) outcomes of patients receiving endobronchial brachytherapy (EBT) or external beam radiotherapy (XRT) as a primary palliative treatment in advanced lung cancer. MATERIALS AND METHODS: Ninety-nine patients presenting de novo with lung cancer were randomized to receive EBT or XRT. Eleven key symptoms or clinical signs were assessed by clinicians and patient ratings using self-assessment questionnaires were obtained at the same time. The primary endpoints were a comparison of EBT and XRT for symptom relief and acute and late side-effects (palliation) and their effect on patients' functional status and patient-rated QL outcomes. A secondary objective was a comparison of clinician assessments with patient self-reported symptoms. RESULTS: Both treatments produced good levels of symptom relief. They were better for XRT at the expense of more acute morbidity. Late side-effects were similar. The functional status of patients was well maintained and changed similarly with time in both groups. XRT gave a better duration of palliation. Twenty-eight percent of XRT patients required EBT (at a median time of 304 days) whereas 51% of EBT patients subsequently had XRT (at a median of 125 days). There was a significant modest gain in median survival with initial XRT (287 vs. 250 days). When clinician and patient assessments were compared, doctors were found to underestimate the severity of breathlessness, anorexia, tiredness and nausea. CONCLUSIONS: Fractionated XRT is preferred to EBT as an initial treatment in better performance patients because it provides better overall and more sustained palliation with fewer retreatments and a modest gain in survival time. QL assessment is required in the evaluation of palliative treatments because clinicians frequently underestimate the incidence and severity of key symptoms.

Adult↗
PubMed2001

Postoperative pelvic radiotherapy with or without elective irradiation of para-aortic nodes and liver in rectal cancer patients. A controlled clinical trial of the EORTC Radiotherapy Group.

OBJECTIVE: The purpose of this randomized multicenter study was to assess the impact on disease free and overall survival of low dose irradiation to para-aortic nodes and liver in patients with a locally advanced resected rectal cancer receiving a 50 Gy postoperative pelvic radiotherapy. PATIENTS AND METHODS: Main inclusion criteria were: a curative resection for a histologically proved carcinoma of the rectum, Gunderson-Sosin stages B2-B3, C1-C3, age <70 years. The patients were randomized between pelvic irradiation (Lim-XRT): 50 Gy in 25 fractions over 5 weeks and extended irradiation (Ext-XRT): same scheme/doses in the pelvis and extended fields on para-aortic nodes and liver, delivering 25 Gy in 19 fractions over 25 days. From 1983 to 1992, 484 patients were enrolled by 18 EORTC institutions and 29 patients were ineligible. The end-points were local and distant relapses, toxicity and survival. RESULTS: Compliance to treatment: 87.2% in Lim-XRT arm and 71.8% in Ext-XRT arm. Moderate acute hematological and hepatic toxicities were significantly increased in Ext-XRT arm. Among 325 patients at risk, 44 suffered a severe intestinal complication requiring surgery in 29. The 5- and 10-year estimates of disease free survival were respectively 42 and 31% in Lim-XRT arm and 47 and 31% in Ext-XRT arm (ns). The corresponding figures for overall survival were respectively 45 and 40% in Lim-XRT arm and 48 and 37% in Ext-arm (ns). The 10 years estimate of intra-pelvic failures was approximately 30% in both arms. Patients in Ext-arm appeared to have a slight shorter interval free of liver metastases (P=0.047). CONCLUSION: Low dose irradiation to the para-aortic nodes and liver did not improve survival for patients with resected adenocarcinoma of the rectum.

Aorta, Abdominal↗
PubMed2002

Radiotherapy or chemotherapy followed by radiotherapy with or without amifostine in locally advanced lung cancer.

Radiotherapy (RT) or radiochemotherapy is the treatment of choice for patients with medically or technically inoperable non-small cell lung cancer (NSCLC) localized to the primary site and regional lymph nodes. Radiation-induced damage has been recognized as a major complication in thoracic RT. The use of concurrent chemoradiation has been associated with an increase in acute and late toxicity. Amifostine (Ethyol) is an effective cytoprotective agent and also may have a role in protecting healthy lung tissue during radiation treatment. The purpose of these 2 clinical trials was to investigate whether daily pretreatment with amifostine could reduce the incidence of esophagitis, and acute and late lung toxicity without affecting the antitumor efficacy of the treatment. The first was a phase III randomized trial of 146 patients with locally advanced lung cancer. All patients received conventional RT to a total of 55 to 60 Gy, and they were assigned randomly to pretreatment with 340 mg/m(2) of amifostine (A). Acute and late toxicities were graded according to the Radiation Therapy Oncology Group (RTOG) grading system from grades 0 to 4. Ninety-seven patients were evaluated 2 months post-RT for the incidence of pneumonitis; 43% (23 of 53) of patients in the RT arm and 9% (9 of 44) in the A plus RT arm experienced grade > or = 2 pneumonitis (P <.001). Forty-nine percent (26 of 53) of patients in the RT arm and 16% (7/44) in the A plus RT arm showed changes that were representative of grade > or = 2 lung damage in the computed tomography (CT) scan. Fibrosis was present in 53% (19 of 36) of patients receiving RT versus 28% (9 of 32) in the A plus RT arm at 6 months (P < 0.05). The incidence of esophagitis grade > or = 2 during week 4 was 42% (31 of 73) in the RT arm versus 4% (3 of 73) in the A plus RT arm (P <.001). Among 97 patients evaluable for response 2 months after RT, complete or partial responses were present in 76% (40 of 53) of patients in the RT arm and 75% (33 of 44) in the A plus RT arm (P = 1.0). The second trial was a phase II randomized study of 45 patients with NSCLC. All patients had received platinum-based induction chemotherapy before being referred for conventional radiation treatment with or without A; a total dose of 55 to 60 Gy was administered at the primary site. Acute and late toxicities were evaluated and graded according the RTOG criteria from grades 0 to 4. Forty-five patients were evaluable for response 2 months after RT. Complete or partial responses were achieved in 78% (18 of 23) of patients in the RT arm and 82% (18 of 22) in the A plus RT arm (P =.278). By week 5, 74% (17 of 23) of patients in the RT group versus 36% (8 of 22) in the A plus RT group experienced grade > or = 2 esophagitis. (During the follow-up period, pulmonary toxicity was evaluated by CT scan.) Three months after RT, 65% (15/23) of patients in the RT group and 32% (7 of 22) in the A plus RT group presented with grade > or = 2 pneumonitis (P =.038). Amifostine reduces the incidence of acute and late radiation-induced toxicities.

Acute Disease↗
PubMed1992

Combined chemotherapy and radiotherapy compared with radiotherapy alone in patients with cancer of the esophagus.

BACKGROUND: The efficacy of conventional treatment with surgery and radiation for cancer of the esophagus is limited. The median survival is less than 10 months, and less than 10 percent of patients survive for 5 years. Recent studies have suggested that combined chemotherapy and radiation therapy may result in improved survival. METHODS: This phase III prospective, randomized, and stratified trial was undertaken to evaluate the efficacy of four courses of combined fluorouracil (1000 mg per square meter of body-surface area daily for four days) and cisplatin (75 mg per square meter on the first day) plus 5000 cGy of radiation therapy, as compared with 6400 cGy of radiation therapy alone, in patients with squamous-cell carcinoma or adenocarcinoma of the thoracic esophagus. The trial was stopped after the accumulated results in 121 patients demonstrated a significant advantage for survival in the patients who received chemotherapy and radiation therapy. RESULTS: The median survival was 8.9 months in the radiation-treated patients, as compared with 12.5 months in the patients treated with chemotherapy and radiation therapy. In the former group, the survival rates at 12 and 24 months were 33 percent and 10 percent, respectively, whereas they were 50 percent and 38 percent in the patients receiving combined therapy (P less than 0.001). Seven patients in the radiotherapy group and 25 in the combined-therapy group were alive at the time of the analysis. The patients who received combined treatment had fewer local (P less than 0.02) and fewer distant (P less than 0.01) recurrences. Severe and life-threatening side effects occurred in 44 percent and 20 percent, respectively, of the patients who received combined therapy, as compared with 25 percent and 3 percent of those treated with radiation alone. CONCLUSIONS: Concurrent therapy with cisplatin and fluorouracil and radiation is superior to radiation therapy alone in patients with localized carcinoma of the esophagus, as measured by control of local tumors, distant metastases, and survival, but at the cost of increased side effects.

Adenocarcinoma↗