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PubMed1981

A randomized comparison of radiotherapy with a radiotherapy--chemotherapy combination in stage IV carcinoma of the head and neck.

Between 1975 and 1978, 23 patients with Stage IV, unresectable, squamous cell carcinoma of the head and neck were randomized to receive radiotherapy (RT, 11 patients), or radiotherapy-chemotherapy (RT & CT, 12 patients). The response rate for the 12 RT & CT patients was four complete remissions (CR) and four partial remissions (PR); the 11 RT patients had one CR and three PR. The presence of a responses (CR or PR) significantly enhanced the median survival (14 vs. 5 months; P = 0.005). The duration of objectives remission was longer among the RT & CT patients when compared with RT patients (6 vs. 2.3 months, P = 0.18). The median survival of the RT & CT group was 12 months compared with 5.6 months for the RT group (P = 0.13). One RT & CT patient remains alive with disease at 44 months, one RT patient remains alive without disease at 30 months. The present chemotherapy regimen did not modify the pattern of failure and only marginally increased patient survival. It did, however, increase the response rate. The authors plan to reactivate the trial with modification in the induction chemotherapy and the addition of postradiation maintenance CT consisting of sequential bleomycin and cis-platinum.

Aged↗
PubMed1977

The survival of inoperable breast cancer treated with radiotherapy and radiotherapy followed by mastectomy.

Forty-five patients with locally advanced breast carcinoma were treated by radiotherapy. Twelve of them became operable and were operated. After 3 and 4 years in comparable clinical stage the rate of metastases in the nonoperated group was 78.6% and in the operated 75%. The survival after 3 and 4 years in comparable clinical stages was similar. In more advanced stages the survival was worse. Considering the trauma of mastectomy and the similar survival obtained in our material, an international trial should be performed to decide whether inoperable breast cancer becoming operable after radiotherapy should be operated.

Breast Neoplasms↗
PubMed1999

Pilot study of concurrent cisplatin, 5-fluorouracil, and external beam radiotherapy prior to radical surgery +/- intraoperative electron beam radiotherapy in locally advanced cervical cancer.

PURPOSE: The purpose of this study was to describe the feasibility of a combined preoperative chemoradiation program followed by radical surgery in advanced cervical cancer. MATERIALS AND METHODS: From February 1988 to April 1997, 40 patients with carcinoma of the cervix were treated with preoperative external beam radiotherapy to 45 Gy in 5 weeks. Patients received concurrent continuous infusion cisplatin (20 mg/m2) and 5-fluorouracil (1500 mg) chemotherapy during the first (days 1-4) and fifth (days 22-25) weeks of the radiation course. Radical surgery was performed 4-6 weeks after the completion of the preoperative treatment. Intraoperative radiotherapy was given to 20 patients, based on intraoperative assessment. RESULTS: Toxicity associated with chemoradiation was usually mild except in two patients who presented WHO grade 4 bone marrow aplasia. Three patients developed postoperative ureterovaginal fistula, and five patients developed long-term hydronephrosis that needed ureteral stenting. Clinical response was observed in 95% of the patients (55% complete response). The analysis of the surgical specimens revealed complete pathological response in 67.5% of the cases and partial pathological response in 32.5%. As expected, the degree of pathological response was predicted by the degree of clinical response (P = 0.001). Nine-year local control, distant metastases-free survival, disease-free survival, and overall survival were 86, 84, 81, and 85%, respectively. Patients displaying a complete pathological response had statistically significant improved local control (P = 0.004), distant metastases-free survival (P = 0.009), disease-free survival (P = 0.002), and overall survival (P = 0.038). CONCLUSIONS: Cisplatin plus 5-fluorouracil preoperative chemoradiation is active and usually well tolerated in locally advanced carcinoma of cervix, inducing a high rate of clinical and pathological complete responses. When this therapy is followed by radical surgery, the local control rates are excellent, even in patients with advanced stages or poor response. These improved local control rates may be achievable only through extensive surgical resection, with a parallel increase in the complication rates.

Actuarial Analysis↗
PubMed1991

Study of treatment variation in the radiotherapy of head and neck tumors using a fiber-optic on-line radiotherapy imaging system.

On-line radiotherapy imaging systems allow convenient daily acquisition of portal images for treatment verification. The information can also be used to study treatment variability. Using a prototype fiber-optic imaging system, we have measured the treatment variation of 17 head and neck patients. Daily digital portal images were acquired for the on-cord left and right lateral fields. Treatment variations were quantified using the Cumulative Verification Image Analysis (CVIA) method developed at our institute. In the CVIA method, daily portal images were aligned according to three anatomical points predefined on a digitized simulation, or prescription, image. After each image alignment, the block position was cumulated in a bit-map and superimposed on the prescription image to give a cumulative verification summary image. Iso-frequency distributions, or contours, of the block overlap were calculated and examined with respect to the prescription treatment area. The range of the treatment variation was large for the 17 patients. On average, separation of the 0% to 100% block overlap contours was about 10 mm, and the 20% to 80%, 5 mm. The block overlap contours were also used to calculate the frequency with which the prescription area as defined on the simulation film had been treated. The fraction of the prescription area treated depended on the accuracy of the treatment setup and patient repositioning, as expected. At best, approximately 95% of the prescribed area was irradiated 100% of the time during the entire course of radiotherapy. At worst, approximately 70% of the prescribed area was irradiated 100% of the time. These results demonstrate that despite immobilization, large setup variation can still occur. Presenting treatment variation data as population averages does not reflect on the large variation that may be observed in the individual patient.

Adolescent↗
PubMed2004

Concomitant hydroxyurea plus radiotherapy versus radiotherapy for carcinoma of the uterine cervix: a systematic review.

We identified eight randomised control trials of hydroxyurea and radiation versus radiotherapy alone (six published in full and two abstracts). Most concluded that outcomes were improved by use of hydroxyurea. However, methodological problems associated with these trials included small sample size, a large number of patient exclusions post randomisation, differing outcome definitions, subgroup analyses of already small numbers of patients and questionable rules for censoring, particularly a failure to include treatment related deaths in the survival analysis. All but two studies were of less than 50 patients. Patients were excluded from some analyses for treatment related reasons. The exclusion of such patients undoubtedly altered the conclusions of the studies. Even if there was a survival advantage attributed to hydroxyurea, overall survival was somewhat poor. We found the evidence regarding the use of hydroxyurea and radiotherapy to be inadequate for assessing its role in the treatment of cervical cancer.

Antineoplastic Agents↗
PubMed1998

Pharmacokinetics of nicotinamide in cancer patients treated with accelerated radiotherapy: the experience of the Co-operative Group of Radiotherapy of the European Organization for Research and Treatment of Cancer.

BACKGROUND: The EORTC has initiated studies to combine nicotinamide with carbogen in accelerated fractionation schedules (ARCON), since for some tumour types, acute and chronic hypoxia as well as treatment protraction may prejudice the outcome of radiotherapy. The tolerable dose of nicotinamide and the optimal interval for administration need to be ascertained. AIM: Full pharmacokinetic profiles of nicotinamide concentrations in plasma were analyzed repeatedly in 15 patients to determine the inter- and intra-patient variability in peak plasma concentrations and the optimum times for administering nicotinamide as a radiosensitizer. METHODS: Nicotinamide (Nicobion) was administered in tablet form to patients with advanced head and neck and non-small cell lung carcinomas. A standard 6 g dose was given regardless of body weight after an overnight fast and at least 30 min before breakfast. In 15 patients, blood samples were taken prior to and 1, 2, 4, 6, 8, 12 and 24 h after administration of the drug. This full profile was determined on two to four occasions for the head and neck cancer patients and on two occasions for the lung cancer patients. For each profile, the maximum concentration of nicotinamide (Cmax), time to peak plasma concentration (Tmax), elimination half-lives (t1/2) and area under the curve (AUC) were determined. Compliance was recorded and nausea and vomiting were graded on a 0-3 scale. Complete profiles of the five major metabolites were also obtained. RESULTS: In the 48 complete sets of blood samples, peak plasma concentrations ranged from 787 to 2312 nmol/ml with a median value of 1166 nmol/ml. The peak plasma concentration was achieved at 1 h in only 54% of the pharmacokinetic profiles, but at this time 92% of the profiles had already exceeded the target concentration of 700 nmol/ml, the level required in the mouse for tumour radiosensitization. The median t1/2 for all 15 cases was 9.3 h, with minimum and maximum values of 4.2 and 26.8 h. The highest concentrations of nicotinamide metabolites were found to be the N-oxide, 2-pyridone and 1-methylnicotinamide. The toxicity (nausea and vomiting) was scored and found not to be correlated with any of the pharmacokinetic parameters. CONCLUSIONS: The plasma concentrations considered necessary to radiosensitize can easily be exceeded with a dose of 6 g taken as 12 x 500 mg in tablet form; 700 nmol/ml was achieved in all patients and apparently would have been achieved in most even with a considerable reduction in dose. An adequate time between administration and radiotherapy appeared to be 1 h with this drug formulation for 92% of the profiles.

Administration, Oral↗
PubMed2001

Prospective randomised study of split-course radiotherapy versus cisplatin plus split-course radiotherapy in inoperable squamous cell carcinoma of the oesophagus.

Between 1983 and 1989, 211 patients with inoperable squamous cell carcinoma of the oesophagus were randomised in a study comparing split-course irradiation (two courses of 20 Gy in five fractions of 4 Gy, separated by a rest of 2 weeks) (arm A) and the same split-course irradiation in combination with cisplatin (CDDP) (3-4 days before each of the two courses of radiotherapy, repeated every 3-4 weeks, for a total of six cycles) (arm B). The Cox's regression model with retrospective stratification was used to compare the two arms to correct for the imbalance at randomisation of the T classification. The median overall survival was 7.9 (95% confidence interval (CI) 7.3-9.4) months in arm A and 9.6 (95% CI 8-13.5) months in arm B. The difference in overall survival was only borderline significant (P=0.048) with a reduction of the instantaneous rate of death of 24%. The 1 and 2 year overall survival rate were respectively 29% (95% CI 21-37%) and 15% (95% CI 8-22%) in arm A and 45% (95% CI 36-54%) and 20% (95% CI 13-27%) in arm B; thereafter, the survival curves became similar. The median progression free survival (PFS) was 5.0 (95% CI 4.6-5.7) versus 6.9 (95% CI 5.3-8.7) months (P=0.028) and the median time to local progression was 6.2 (95% CI 5.1-7.6) months versus 10.9 (95% CI 8.1-15.5) months (P=0.018), respectively, in arms A and B. Haematological toxicities were slightly more commonly observed in the combined group (1% versus 6%). This study shows that split-course irradiation in combination with CDDP is very well tolerated and should be preferred to radiotherapy alone.

Adult↗
PubMed1992

Carcinoma of the maxillary antrum treated by pre-operative radiotherapy or radical radiotherapy alone.

The results of pre-operative radical radiotherapy and subsequent maxillary resection are reported in 54 consecutive patients with carcinoma of the maxillary antrum treated at The Royal London Hospital from 1965 to 1989. The actuarial two and five year survivals were 50.3 per cent and 38.5 per cent respectively. Patients with adenocarcinomas fared better when compared with squamous and undifferentiated carcinomas (log rank p = < 0.01). Undifferentiated carcinoma and involved regional lymph nodes were both very poor prognostic factors. In those patients who were either unfit for or refused maxillary resection, radical radiotherapy alone was still an effective treatment, with only a slight disadvantage in terms of local control and survival.

Adenocarcinoma↗
PubMed2001

The Leicester radiotherapy bite block: an aid to head and neck radiotherapy.

We describe the construction of a custom-made bite block to be used during external beam radiotherapy to the oral cavity. The bite block is made with standard maxillofacial prosthetic techniques and materials. The design allows accurate and reproducible positioning of the perioral tissues to aid planning of radiotherapy and treatment. The compressibility of this device improves comfort for the patient, while it is in use.

Cranial Irradiation↗
PubMed1994

Randomized study comparing chemotherapy plus radiotherapy versus radiotherapy alone in FIGO stage IIB-III cervical carcinoma. GONO (North-West Oncologic Cooperative Group).

Between January 1989 and December 1991, 64 patients with advanced cervical carcinoma FIGO stage IIb-III were randomized to receive radiotherapy (RT) alone or the sequential combination of chemotherapy (CT) and RT. RT consisted of external RT (40 Gy fractionated over 4 weeks)+brachy-therapy (40 Gy to point A)+an additional boost to the parameters (15-20 Gy) in arm RT; CT consisted of cisplatin 60 mg/m2 i.v. day 1 q 15 days administered for 2 cycles before the start of RT and for 4 cycles after the end of radiation treatment in CT+RT arm. Among the 58 evaluable patients objective response rate was as follows: in RT arm, CR in 40.7% of patients, PR in 40.7%, and SD in 18.6%; in CT+RT arm, CR in 42% of patients, PR in 35.5%, and SD in 22.5%. The median duration of response was 12 months (range: 3-38 + months). At a median follow-up of 36 months survival (S) and progression-free survival (PFS) were 83% and 72.4% in RT arm, 72% and 59.3% in CT+RT arm, respectively. No significant difference was observed between the 2 treatment arms, neither in terms of objective response nor in terms of S and PFS. Both treatments were generally well tolerated. In our experience the addition of chemotherapy to standard radiotherapy does not enhance morbidity and does not interfere with the correct delivery of the planned treatment. However, results of this combined modality regimen remain unsatisfactory, since no improvement in pelvic control and survival of patients with advanced cervical carcinoma was observed.

Adult↗
PubMed2003

Atypia in nonneoplastic prostate glands after radiotherapy for prostate cancer: duration of atypia and relation to type of radiotherapy.

It is unknown how long postradiation atypia of benign prostate glands persists and whether the type of radiation is a factor. Forty-four cases consisting of 37 needle biopsies and 7 transurethral resections of the prostate seen in consultation (January 1997 to September 2000) were studied. In two men (5%), the cases were initially sent without a history of radiotherapy. Thirteen patients had minimal cancer (one core) with the remaining showing no residual tumor. Twenty patients were treated with interstitial radiotherapy (brachytherapy) (IRT), 17 with external beam radiation (XRT), and 7 with a combination of both (CT). The time interval between the treatment and tissue sampling ranged from 8 to 72 months (mean 3 months). Slides were reviewed blindly to the type of radiation and the time interval. Radiation-induced atypia in nonneoplastic glands, stromal fibrosis, and vascular changes was scored separately 0-3, with 0 showing no radiation injury and grade 3 showing prominent nuclear atypia, stromal fibrosis, and vascular hyalinization. We derived a combined score for the epithelial atypia from 0 to 300 (% of glands x grade) for each biopsy. For each case, an overall grade from 0 to 3 was given separately for the stromal and vascular changes. Cases were divided into three groups based on time between treatment and biopsy: <24 months (n = 14), between 24 and 48 months (n = 19), and >48 months (n = 11). Because the scores for epithelial atypia with IRT and CT were the same, we combined them into one group. There was more atypia in cases treated with IRT/CT (mean score 190) than XRT (mean score 105) (p <0.00001). There was also a greater degree of stromal fibrosis with IRT/CT than XRT (p <0.04). There was no correlation between the type of treatment and the effect on vessels. There was no change over time in epithelial atypia in men treated with IRT/CT. With XRT, there was less epithelial atypia in cases biopsied >48 months after treatment (mean score 57) compared with those with a shorter interval between biopsy and treatment (mean score 132) (p = 0.02). Radiation atypia in benign prostate glands may persist for a long time after the initial treatment, resulting in a significant pitfall in evaluating prostate biopsies. Prominent radiation effect (100% of the glands showing grade 2 and 3 atypia) was detected up to 72 months in one of the patients treated with IRT. In some cases, the clinician may not be aware of a prior remote history of radiation or does not relay this history to the pathologist. The pathologist must recognize radiation atypia without relying on the clinician to provide this history. The type of radiation therapy (IRT/CT vs XRT) is a major factor in the degree and duration of postradiation epithelial atypia.

Adenocarcinoma↗
PubMed1981

Comparison of radiotherapy alone and radiotherapy with chemotherapy using adriamycin and 5-fluorouracil in bronchogenic carcinoma.

Eighty-two patients with histologically confirmed lung cancer were randomly allocated to receive either radiotherapy alone (2400-3200 rads, depending upon cell type) or the same dose of radiotherapy followed by four cycles of adriamycin and 5-fluorouracil. Eighty-one patients were evaluated and for the group as a whole survival was better in the undifferentiated group assigned to receive adjuvant chemotherapy but survival in the patients with squamous tumours was not significantly prolonged. The chemotherapy was not unduly toxic.

Carcinoma, Bronchogenic↗
PubMed2006

A meta-analysis of hyperfractionated and accelerated radiotherapy and combined chemotherapy and radiotherapy regimens in unresected locally advanced squamous cell carcinoma of the head and neck.

BACKGROUND: Former meta-analyses have shown a survival benefit for the addition of chemotherapy (CHX) to radiotherapy (RT) and to some extent also for the use of hyperfractionated radiation therapy (HFRT) and accelerated radiation therapy (AFRT) in locally advanced squamous cell carcinoma (SCC) of the head and neck. However, the publication of new studies and the fact that many older studies that were included in these former meta-analyses used obsolete radiation doses, CHX schedules or study designs prompted us to carry out a new analysis using strict inclusion criteria. METHODS: Randomised trials testing curatively intended RT (> or =60 Gy in >4 weeks/>50 Gy in <4 weeks) on SCC of the oral cavity, oropharynx, hypopharynx, and larynx published as full paper or in abstract form between 1975 and 2003 were eligible. Trials comparing RT alone with concurrent or alternating chemoradiation (5-fluorouracil (5-FU), cisplatin, carboplatin, mitomycin C) were analyzed according to the employed radiation schedule and the used CHX regimen. Studies comparing conventionally fractionated radiotherapy (CFRT) with either HFRT or AFRT without CHX were separately examined. End point of the meta-analysis was overall survival. RESULTS: Thirty-two trials with a total of 10 225 patients were included into the meta-analysis. An overall survival benefit of 12.0 months was observed for the addition of simultaneous CHX to either CFRT or HFRT/AFRT (p < 0.001). Separate analyses by cytostatic drug indicate a prolongation of survival of 24.0 months, 16.8 months, 6.7 months, and 4.0 months, respectively, for the simultaneous administration of 5-FU, cisplatin-based, carboplatin-based, and mitomycin C-based CHX to RT (each p < 0.01). Whereas no significant gain in overall survival was observed for AFRT in comparison to CFRT, a substantial prolongation of median survival (14.2 months, p < 0.001) was seen for HFRT compared to CFRT (both without CHX). CONCLUSION: RT combined with simultaneous 5-FU, cisplatin, carboplatin, and mitomycin C as single drug or combinations of 5-FU with one of the other drugs results in a large survival advantage irrespective the employed radiation schedule. If radiation therapy is used as single modality, hyperfractionation leads to a significant improvement of overall survival. Accelerated radiation therapy alone, especially when given as split course radiation schedule or extremely accelerated treatments with decreased total dose, does not increase overall survival.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma.

PURPOSE: We report the 5-year survival and late toxicity results of a randomized clinical trial, which showed a 3-year improvement in overall survival and locoregional control of stage III or IV oropharynx carcinoma, using concomitant radiochemotherapy (arm B), compared with standard radiotherapy (arm A). PATIENTS AND METHODS: A total of 226 patients were entered onto a phase III multicenter randomized trial comparing radiotherapy alone (70 Gy in 35 fractions; arm A) with concomitant radiochemotherapy (70 Gy in 35 fractions with three cycles of a 4-day regimen comprising carboplatin and fluorouracil; arm B). Prognostic factors were evaluated by univariate and multivariate analysis. Five-year late toxicity was evaluated using National Cancer Institute Common Toxicity Criteria for neurological toxicity, hearing, taste, mandibula, and teeth damage, and Radiation Therapy Oncology Group toxicity criteria for skin, salivary gland, and mucosa. RESULTS: Five-year overall survival, specific disease-free survival, and locoregional control rates were 22% and 16% (log-rank P =.05), 27% and 15% (P =.01), and 48% and 25% (P =.002), in arm B and arm A, respectively. Stage IV, hemoglobin level lower than 125 g/L, and standard treatment were independent prognostic factors of short survival and locoregional failure by univariate and multivariate analysis. One or more grade 3 to 4 complications occurred in 56% of the patients in arm B, compared with 30% in arm A (P was not significant). CONCLUSION: Concomitant radiochemotherapy improved overall survival and locoregional control rates and does not statistically increase severe late morbidity. Anemia was the most important prognostic factor for survival in both arms.

Adult↗
PubMed2005

Oral health needs of the head and neck radiotherapy patient: 1. Epidemiology, effects of radiotherapy and role of the GDP in diagnosis.

UNLABELLED: Head and neck cancer represents a heterogeneous group of neoplasms affecting a number of sites in the aerodigestive tract, histologically primarily epithelial in type. Most are sensitive to a treatment regime of ablative surgery followed by radiotherapy. The incidence in Ireland of head and neck cancers is approximately 11.8 per 100,000 population and is the 8th commonest cancer in males and the 16th in females. Many of these cancers will manifest with oral signs and symptoms thus placing the GDP in the unique position of being able to detect and positively influence outcomes: the GDP also has a vital, proactive role to play in supportive care before, during and following surgery and radiotherapy. CLINICAL RELEVANCE: The aim of this paper is to review the rationale for the different treatment modalities and the oral/dental side-effects of each.

Cranial Irradiation↗
PubMedDate not supplied

Combined modality (ABVD plus radiotherapy) versus radiotherapy in the management of early stage (IIA) Hodgkin's disease with mediastinal involvement.

The aim of this study was to establish whether combined modality treatment (ABVD plus radiotherapy) can reduce the risk of relapse in Hodgkin's disease patients with mediastinal involvement, as compared to radiotherapy alone. The results obtained suggest that one course of ABVD before irradiation can reduce the incidence of relapse. These findings, however, should be considered preliminary and need to be confirmed in larger studies.

Adult↗
PubMed2003

Quality of life in patients with oropharynx carcinomas: assessment after accelerated radiotherapy with or without chemotherapy versus radical surgery and postoperative radiotherapy.

BACKGROUND: In oropharyngeal carcinomas, it is assumed that the effectiveness of the different treatment approaches is roughly equivalent, whereas the functional outcome after radical radiotherapy (RT) is superior to that associated with primary surgery. The aim of this study is to assess quality of life (QoL) outcomes of patients after two treatment strategies: radical surgery with postoperative RT and accelerated concomitant boost RT with or without chemotherapy. METHODS: Sixty patients who were disease free at least 1 year after treatment of oropharynx carcinoma were studied. Forty had been treated with radical RT (median tumor dose, 69.9 Gy in 5.5 weeks), and 20 had been treated with primary surgery and postoperative monofractionated RT (median dose, 60.2 Gy). Seven of the former patients received chemotherapy concomitantly with, and one before, RT. Functional outcome was assessed by the subjective Performance Status Scale for Head and Neck cancer (PSSHN) and the general QoL by the European Organization for Research and Treatment of Cancer Core QoL questionnaire (EORTC QLQ-C30). The unpaired t test was used to assess for significant differences between means. RESULTS: By use of the PSSHN module, scores were generally higher in the RT group, with a significant difference in the speech subscale (p =.005), a trend for a significant difference for the eating in public subscale (p =.08), and an insignificant difference for the normalcy of diet subscale (p =.25). When analyzed by tumor stage, no significant differences were observed for T1-2 tumors, whereas for patients with T3-4 tumors highly significant differences favoring the RT group became evident for all three subscales. Although no significant differences were observed using the EORTC QLQ C-30 functional scales, patients treated with primary surgery reported significantly more dyspnea (28 vs 12, p =.04) and appetite loss (30 vs 13, p =.05). In patients with T3-4 tumors, trends toward better scores favoring the RT group were observed for physical, role, emotional, and social functions, as well as a significantly better score for pain symptoms. CONCLUSIONS: Although for early stages no clear advantage in QoL outcome was noted for the RT group compared with the surgery group, for advanced-stage disease an advantage favoring radical RT seemed apparent. For those patients, if an equivalency between the two treatment strategies could be assumed regarding oncologic results, then nonsurgical treatment should be considered the preferred option.

Activities of Daily Living↗
PubMed1994

Chemotherapy followed by radiotherapy versus radiotherapy alone in locally advanced cervical cancer: a randomized study.

Between August 1990 and January 1992, 184 patients with squamous cell carcinoma of the cervix, FIGO stage IIB-IVA, were randomized to receive either two cycles of bleomycin, ifosfamide-mesna, and cis-platinum (BIP) chemotherapy (CT) followed by radiotherapy (RT) ("CT-RT group," n = 94) or RT alone (RT group, n = 90). In the CT-RT group, of 89 evaluable patients, 64 responded: complete response (CR) 4 (4.5%) and partial response 60 (67.5%). Of the remaining 25 patients, 23 had stable disease and 2 progressed. Eighty of 89 patients completed RT as planned. Following RT 56 (70%) achieved CR, 19 (23.7%) had residual disease, and 5 (6.3%) had progressed. CT responders had a better response to RT: 83% (49/59) vs 33.3% (7/21), P < 0.01). The stage of disease, histologic grade, duration of symptoms, and history of smoking had no influence on the response to CT. Patients aged > 45 years and those with Hb > 10 g/dl had significantly better response. Nausea/vomiting, alopecia, grade I-II myelosuppression, diarrhea, and mucositis were the major side effects of CT. Two patients died of CT toxicity. In the RT group, 88 patients were evaluable: 61 (69.3%) patients achieved CR, 25 had residual disease, and 2 progressed. The side effects of RT were cystitis, proctitis, and local skin reaction. These were equally distributed between the two groups. There was no significant difference in overall and disease-free survival in the two groups.

Adult↗