This study reported characteristics and predictive factors of early-onset diarrhoea in patients receiving pelvic irradiation. We retrospectively reviewed 229 patients undergoing radiotherapy alone for cervical or uterine cancer. Oral barium was taken 90 min before simulation. According to contrast medium within small intestine only or colon in simulation films, we categorised patients as normal and rapid transit groups. Small or large volume of small-bowel was also evaluated according to barium distribution of simulation films. Whole-pelvic irradiation (39.6-45 Gy/22-25 fractions) was delivered to all patients initially. We recorded the onset of diarrhoea during pelvic irradiation. The rates of early-onset diarrhoea (<10 Gy) were compared between these two groups. The incidence of diarrhoea before 10 Gy was 7% and 17% (p = 0.138) in patients with normal and rapid transit, respectively. In multivariate analysis, interaction among rapid transit, prior abdomen operation and large small-bowel volume (p = 0.019) were noted for early-onset diarrhoea. Further subgroup analysis revealed that rapid transit (p = 0.046) was a significant factor in patients with both prior abdominal operation and large small-bowel volume. The incidence of early-onset diarrhoea was as high as 40% in this particular group. Patients experiencing early-onset diarrhoea had a higher incidence of moderate to severe diarrhoea (65%) than those without early-onset diarrhoea (23%) (p<0.001). In multivariate analysis, early-onset diarrhoea was the only factor of moderate to severe diarrhoea (p = 0.001). In conclusion, rapid small-bowel transit may be predisposed to early-onset diarrhoea during pelvic radiotherapy in patients with both prior abdominal operations and large small-bowel volume. Early-onset diarrhoea is considered as a predictive factor of diarrhoea of a higher grade.

Background and purpose: Intracavitary brachytherapy (ICBT) is as important as external beam radiotherapy (EBRT) for the radical radiotherapy of uterine cervical cancer. The degree of urinary bladder distension during ICBT may affect the dose distribution in the bladder and rectum, to which an overdose may increase the chance of developing treatment-related complications. The purpose of this prospective study was to assess and quantify the impact of bladder distension on dosimetry in ICBT in patients with cervical cancer.Patients and methods: We recruited 20 patients with cervical cancer during a 12-month period. Inclusion criteria included pathological diagnosis of cervical cancer with IA to IIIB stages, and intact uterus. Patients were evaluated for brachytherapy after EBRT, and eligible individuals (cervical as could be identified clearly) were invited enter to this protocol to receive ICBT. In the first brachytherapy, bladder preparation (evacuation and distension by a Foley catheter) and CT scan were performed soon after the insertion of CT-compatible applicators. Then the bladder wall doses [median dose, maximum dose and dose-volume histograms (DVH)] were calculated via the PLATO computer planning system (Nucletron PLATO-RTS version 2.0). The individual data regarding doses and DVH were collected and compared. Bladder distension may shift the applicator position, and posterior displacement of the applicator system may increase the dose to the rectal wall, so this effect was also evaluated.Results: All the continuous variables of these 20 patients followed a normal distribution. By paired t-test and multiple linear regression analysis, we found that bladder distension statistically significantly decreased the median bladder wall dose with an average reduction of 48% of the dose of an empty bladder (P<0.001), and the maximum dose did not change; on the other hand, the bladder distension did not have any adverse effects on the rectal wait doses.Conclusions: Using CT-assisted three-dimensional techniques to assess the bladder and rectal wall doses is feasible. Bladder distension reduces the median dose in the bladder wait, which may reduce treatment-related complications. (C) 2005 Elsevier Ireland Ltd. All rights reserved.

We used a computer tomography (CT)-assisted three-dimensional (3D) technique to assess dose to the rectum and bladder in intracavitary brachytherapy (ICBT) for patients with cervical cancer, and compared this technique with the conventional method. The results revealed that the difference in dose to the rectal and bladder wall between these two methods were significant. The CT-assisted technique is a feasible method, and it gives different results than the conventional method.

The purpose of this study was to analyse the outcome and prognostic factors of non-small cell lung cancer (NSCLC) patients with nodal disease treated by complete tumour resection followed by radiotherapy alone. Between October 1990 and October 1999, 49 NSCLC patients with N1 or N2 stage were treated with complete resection of tumour followed by post-operative radiotherapy in our department. The radiation was delivered with 10 MV X-rays given 5 days per week at 1.8-2 Gy per fraction. Total doses ranged from 40 Gy to 64.8 Gy, with a median dose of 55.8 Gy. All patients had at least 30 months of follow-up. The 5 year overall survival rate (OS), local control rate (LC) and distant metastasis-free rate (DMF) were 34%, 52% and 29%, respectively. In multivariate analysis, stage and margin were found to influence OS. The total number of involved lymph nodes and positive margins were significant factors for LC. Only N stage was found to correlate with DMF. In conclusion, patients with multiple involved lymph nodes, advanced stage or positive surgical margins had a poor outcome even with post-operative radiotherapy. Based on these prognostic factors, new therapeutic regimens and modalities for NSCLC need to be further investigated.

Boron neutron capture therapy (BNCT) is particle radiotherapy with alpha (4He) particle and recoiled lithium nucleus (7Li) derived from a reaction of boron (10B) and thermal neutron. We investigated applying BNCT to malignant liver tumors. The purpose of the present study was to reveal the efficacy for administration of emulsion of a boron compound (sodium borocaptate; BSH) and lipiodol via a hepatic artery using a rat liver tumor model.Rat liver tumors were developed by direct injection of Walker 256 cells into the liver parenchyma. BSH (75 mg/kg)/lipiodol (0.3 mL/kg) emulsion was administered via the hepatic artery. Boron concentrations in the tumors, liver, and blood were measured at 1, 6, and 12 h after administration. Neutron capture radiography (NCR) was taken to confirm the selective accumulation of 10B in the liver tumors.Boron concentrations in the liver tumors and the tumor/liver (T/L) boron concentration ratio at 1, 6, and 12 h after administration of BSH/lipiodol emulsion (concentration: T/L ratio) were 479.2 ppm: 4.0, 197.3 ppm: 14.9, and 96.5 ppm: 6.6, respectively. Highly selective irradiation was clearly demonstrated by the NCR images.Intra-arterial administration of BSH/lipiodol emulsion is effective method for delivering high concentration of 10B selectively to the liver tumors.

This study evaluated the predictive factors associated with skin telangiectasia following post-mastectomy electron beam irradiation of the chest wall and regional lymph nodes in patients with breast cancer. From July 1987 to December 1994, 120 women with stages II and III breast cancer received electron beam irradiation following modified radical mastectomy. Doses of 50-50.4 Gy per 25-28 fractions were given to the chest wall (with bolus), the internal mammary nodes, the supraclavicular nodes and the axillary lymph nodes using a 12 MeV or 15 MeV single portal electron beam. 19 patients received an additional 10-16 Gy boost to the surgical scar using a 9 MeV electron beam. Univariate and multivariate analyses for the development of skin telangiectasia showed 5- and 7-year actuarial rates of telangiectasia to be 59% and 72%, respectively. In univariate analysis, an additional surgical scar boost (p=0.023) as well as no treatment interruption (p=0.028) were associated with a significantly increased risk of skin telangiectasia. In multivariate analysis, the only significant independent factor for the development of skin telangiectasia was surgical scar boost (p=0.026); no treatment interruption showed a trend but did not achieve significance (p=0.051). Thus, patients given an additional boost to the surgical scar are more likely to develop skin telangiectasia. Shorter treatment courses may result in a higher probability of skin telangiectasia following electron beam irradiation.

Purpose: To evaluate the health-related quality of life (HR-QOL) of nasopharyngeal cancer (NPC) patients with cancer-free survival after treatment and to investigate the factors correlated with their HR-QOL.Methods and Materials: One hundred eighty-two NPC patients with cancer-free survival of more than 2 years after treatment were enrolled in the study. Data from the same number of people without a history of cancer, who had come to the hospital for health checkups, were also collected for comparison. The Chinese SF-36 questionnaire and nine items about head-and-neck functional impairments (HNFI) were self-reported by all participants at the clinics. Data relating to sociodemograpbic factors, cancer stage, and treatment of NPC survivors were analyzed.Results: Psychometric tests revealed the excellent internal reliability (Cronbach's alpha: 0.87-0.96) and discriminative validity of the Chinese SF-36 used in Taiwan. Most functional domains of the Chinese SF-36 and all nine HNFI items were significantly worse in NPC survivors than in control subjects. No cancer or treatment-related variables significantly correlated with any functional domains of SF-36 or any items of HNFI for NPC survivors. Economic status, educational level, occupational status, and the number of comorbidities were the variables that significantly correlated with most functional domains of SF-36 for NPC survivors. Patients with more sufficient economic status, higher educational levels, with employment, or without comorbidity tended to enjoy better HR-QOL as detected by the SF-36. Salivation, hearing, and swallowing dysfunctions were the top three HNFI that disturbed NPC survivors. Economic status remained the most significant variable correlated with HNFI, including salivation, swallowing, neck stiffness, taste, and phonation. Survivors with better economic status reported less severe HNFI.Conclusions: NPC survivors had worse HR-QOL than healthy control subjects in the study. Socioeconomic status was the most significant variable that correlated with the HR-QOL of NPC survivors. This result might indicate that patients' superior individual characteristics and financial resources are important variables determining their ability to cope with cancer and treatment complications affecting their HR-QOL. (C) 2002 Elsevier Science Inc.

Purpose: To analyze the treatment results and prognostic factors of patients with primary thymic carcinoma treated by total or subtotal tumor resection followed by radiotherapy alone.Methods and Materials: Between October 1987 and October 1997, 26 patients with thymic carcinoma were treated with complete or incomplete surgical resection and postoperative adjuvant irradiation without chemotherapy. The radiation was delivered with 10-MV X-ray given 5 days per week at 1.8 to 2 Gy per fraction. Total doses ranged from 40 to 70 Gy. All patients had at least 40 months of follow-up.Results: The 5-year overall survival rate, local control rate, and distant metastasis-free rate were 77%, 91%, and 57%, respectively. Several prognostic factors, including sex, age, extent of resection (total resection vs. subtotal resection), Masaoka staging (early Stage I + II vs. advanced Stage III + IV), pathology (low-grade vs. high-grade), and postoperative radiation dose (greater than or equal to60 Gy vs. <60 Gy), were evaluated in univariate analysis. The Masaoka staging system was the only statistically significant predictor in overall survival rate (p = 0.0482) and distant metastasis-free rate (p = 0.0193).Conclusions: The Masaoka staging system is the most important prognostic factor in primary thymic carcinoma patients receiving postoperative radiotherapy alone. For resectable tumors, surgery and postoperative radiotherapy can achieve good local control, but the distant metastatic rate is still high. Further investigation of more effective chemotherapy is needed. (C) 2002 Elsevier Science Inc.

Purpose: Oligodendroglioma is a relatively rare central nervous system tumor. Currently, surgical intervention is the mainstay of treatment, and the role of postoperative radiotherapy (RT) remains a subject of controversy. The objective of this study was to investigate the prognostic factors, evaluate the treatment outcomes, and assess whether postoperative RT has a benefit on local control and overall survival rates.Methods and Materials: This was a retrospective review of 52 consecutive adult patients with supratentorial low-grade oligodendrogliomas diagnosed at our institution between September 1980 and September 1998. Thirty-two received postoperative RT. Data were analyzed retrospectively to survey the significant prognostic factors for local control and overall survival.Results: The 5-year overall and progression-free survival rate was 80% and 67%, respectively. Twenty-five patients experienced local disease progression during the follow-up period. In multivariate analysis, postoperative RT and age at diagnosis showed independent prognostic significance for overall survival. For progression-free survival, postoperative RT was the only independent prognostic factor.Conclusion: On the basis of the results of this study, we recommend considering postoperative RT as one of the standard adjuvant treatment modalities for patients with supratentorial low-grade oligodendroglioma, regardless of the extent of surgical resection. The optimal treatment strategy to maximize the treatment outcome should still be explored. (C) 2002 Elsevier Science Inc.

Gliomatosis cerebri (GC) is a rare disease loosely defined as a diffusely infiltrating glioma involving extensive areas of the brain. The prognosis is poor and no definite treatment has proven effective for GC. Little information exists regarding the role of radiation therapy (RT) for GC, but some researchers have suggested that it is a good choice of treatment from their limited experience. In this report, we present a case with imaging and histological diagnosis of GC and demonstrate the treatment results of RT. The patient was a 39-year-old woman with progressive symptoms of dizziness, unsteady gait, headache, vomiting, and consciousness disturbance for 6 months. She received a series of radiographic examinations and surgical interventions for diagnosis. The definite diagnosis of GC was made by a combination of magnetic resonance imaging (MRI) findings and histological examinations. Forty Gray (Gy) of whole brain irradiation followed by 14 Gy reduced-field boosts were given to her. The MRI, following treatment, showed regressive changes, and clinical symptoms were slightly improved. The patient survived 19 months after the diagnosis, which is longer than the average survival time of patients without treatment.

Background and purpose: To evaluate the factors associated with pulmonary fibrosis after postmastectomy electron beam irradiation of chest wall and regional lymphatics in patients with breast cancer.Materials and methods: From July 1987 through July 1994, 109 women with stage II and III breast cancer receiving modified radical mastectomies were managed by postoperative electron beam irradiation. Doses of 46 to 50.4 Gy were delivered to the chest wall covered with bolus, internal mammary nodes, supraclavicular nodes and axillary lymph nodes via 12 or 15 MeV single portal electron beam. Seventeen patients received additional 10-16 Gy surgical scar boost via 9 MeV electron beam. Comparison of pre-treatment and post-treatment chest X-ray films were used to monitor the development of pulmonary fibrosis.Results: Only Grade 1 radiation-induced late pulmonary toxicity was noted in 33 patients (29%). Twenty-six patients (24%) developed pulmonary fibrosis under unbolused chest wall. Lung fibrosis under bolused chest wall was noted in 11 patients (10%). Statistical difference (P < 0.01) was noted between the incidence of fibrosis in these two sites. In multivariate analysis of lung fibrosis under unbolus-covered chest wall, the independent prognostic factors, are low body mass index (BMI) (P < 0.01), tamoxifen taking (P = 0.03), and no treatment interruption (P = 0.03). No independent factor was associated with lung fibrosis under bolus-covered chest wall in multivariate analysis.Conclusions: In the analysis of pulmonary fibrosis induced by unbolused electron beam, BMI rather than body weight and body height is a strong prognostic factor. Tamoxifen and short overall time can predispose the development of lung fibrosis. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.

Background and purpose: This study evaluates the treatment results of patients with dermatofibrosarcoma protuberans.Patients and methods: Between August 1987 and July 1998, 35 consecutive patients with pathologically proved dermatofibrosarcoma protuberans received surgery with or without radiation therapy. Their treatment results were analyzed retrospectively.Results: The patient ages ranged from 5 to 67 years (median 37 years). There were 24 males and 11 females. The anatomic sites of tumor were: trunk in 21, extremity in eight, and head and neck region in six. The maximal dimension of tumor ranged from 1.5 to 25 cm. Surgery techniques included local excision and wide excision with or without graft or Rap. Adjuvant radiation therapy was given to 11 patients, with a dose ranging from 46 to 68 Gy (one pre-operative, ten post-operative). At a median follow-up of 50 months (range 11-131 months), there were 11 patients (nine patients without radiation therapy) who developed local failure. Salvage therapy (excision with or without radiation therapy) was given to all of them, and ten achieved disease control. Some patients had treatment-related moderate cosmetic or functional problems.Conclusions: Dermatofibrosarcoma protuberans is a malignancy of a high cure rate, and adjuvant radiation therapy can reliably decrease the local recurrence rate and prevent mutilation and functional deficit caused by repeated surgery. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.

PURPOSE:To evaluate the influence of oral glutamine on radiation-induced oral mucositis in the radiotherapy of head and neck cancer. METHODS AND MATERIALS:From July 1997 through June 1998, 17 patients with head and neck cancer receiving primary or adjuvant irradiation were randomized to either glutamine suspension (16 g in 240 ml normal saline) (n = 8) or placebo (normal saline) (n = 9) arm. Patients were instructed to swish the test solutions (30 ml) four times per day. All patients received half-mouth irradiation at least. Patients were treated 1.8 Gy per fraction daily, 5 days a week. We evaluated the grading of oral mucositis daily fraction at each day of treatment until 45 Gy/25 fractions. World Health Organization (WHO) step analgesic medication and body weight change were compared between the two arms. RESULTS:The duration of objective oral mucositis > or = Grade 1 (p = 0.0097), Grade 2 (p = 0.0232), and Grade 3 (p = 0.0168) was shorter in the glutamine arm. Mean maximum grade of objective oral mucositis was less severe in the glutamine arm (1.6 vs. 2.6) (p = 0.0058). Glutamine did not reduce the duration and severity of subjective oral mucositis except for duration > or = Grade 3 (p = 0.0386). In the analysis of mean maximum WHO step of analgesic medication, there was no statistical difference (p = 0.5374) between the two arms. Mean body weight change was also not significantly different (p = 0.8070). CONCLUSIONS:Oral glutamine may significantly reduce the duration and severity of objective oral mucositis during radiotherapy. It may shorten the duration of > or = Grade 3 subjective mucositis.

Purpose: The radiation therapy results for patients with inoperable non-small-cell lung cancer (NSCLC) have been disappointing. Tumor dose escalation using concomitant boost technique (CBT) has been shown to improve local control in a few prospective studies. This trial was carried out to prospectively assess the radiation response and acute toxicity of CBT in comparison to the conventional treatment technique (CTT).Methods and Materials: Ninety-seven consecutive eligible patients were entered in this prospective clinical trial between November 1994 and February 1998. Patients were randomized to receive either CBT (43 patients) or CTT (54 patients) radiation therapy. These patients either refused chemotherapy or were judged as unsuitable for chemotherapy. Patients in the CBT group received 46.8 Gy in 26 fractions using large fields that encompassed the gross and occult disease. A concomitant boost of 18.2 Gy (0.7 Gy per fraction) was delivered to the gross disease using small fields with 1.5-cm margins. The small fields were treated concurrently with the large fields and the total dose to the tumor area was 65 Gy in 26 fractions. Patients in the CTT group received 70.8 Gy in 38 fractions. The acute toxicity between each group was compared. The response rate was analyzed and compared by treatment group, gender, age, stage, histology, initial Karnofsky performance score (KPS), severity of acute toxicity, and maximum body weight loss (MBWL) during treatment course.Results: The demographic parameters such as sex, age, and stage were evenly distributed in each treatment group. The majority of these patients had Stage IIIA and IIIB disease. Overall median treatment times were 39 days for the CBT group of patients and 62 days for the CTT group. No treatment-related mortality was found. There were 2 patients in the CTT group with acute RTOG Grade 3 lung toxicity, and no Grade 3 lung or esophageal toxicity was observed in CBT group. The response rates, assessed by radiographic images, were 69.8% and 48.1% for the CBT and CTT patients, respectively. Univariate and multivariate analysis revealed that patients in the CBT group, patients with better KPS, and patients with more severe acute toxicity had a higher response rate.Conclusion: This study demonstrates that concomitant boost radiation therapy is tolerable, and produces a superior response rate than conventional radiation therapy for patients with inoperable NSCLC. The length of treatment was reduced from 38 to 26 treatment days, almost a 30% reduction. (C) 2000 Elsevier Science Inc.

BACKGROUND:Treatment of primary central nervous system lymphoma (PCNSL) in Chinese individuals has rarely been reported. Therefore, this article presents our experience in managing PCNSL with radiotherapy.METHODS:A thorough review was made of the medical records of 13 patients diagnosed with PCNSL at Kaohsiung Chang Gung Memorial Hospital from 1988 through 1997. The clinical characteristics, treatment modalities, and results were analyzed as well.RESULTS:Thirteen patients diagnosed with PCNSL were identified, of which 10 cases originated in the brain whereas three were of spinal origin. Seven of the patients were man and six were women, with a mean age of 54.9 +/- 13.1 years (range 29 to 74 years). Diffuse large cell lymphoma (11 cases) was the most common histology. Limb weakness (11 cases) and headache (7 cases) were the most common complaints at presentation. Nine patients received radiation therapy alone and four patients received radiation therapy plus chemotherapy after surgical resection or biopsy. Follow-up computed tomography (CT) scans 3 to 4 months after the completion of radiotherapy revealed that nine patients (69%) had a complete response and four (31%) had a partial response. Local recurrence occurred in five patients (56%) treated with radiation therapy alone and in one patient (25%) treated with combined modalities. The overall actuarial survival rate was 54% at 2 years and 27% at 5 years.CONCLUSION:Results in this study indicate that the initial response to radiotherapy is satisfactory. However, a local relapse frequently occurs. Future considerations should focus on new modes of treatment, such as three-dimensional conformal radiation therapy for dose escalation or a combination of chemotherapy and radiotherapy.

Purpose: To evaluate the response of bony destruction (BD) of the skull base following radiotherapy in nasopharyngeal carcinoma (NPC) and investigate the implications of bony regeneration (BR) on local control and its related factors.Methods and Materials: Ninety patients with NPC with skull base destruction clearly demonstrated on computed tomography (CT) were reviewed. These patients have completed the prescribed treatment and received regular CT follow-up. A total of 338 sets of CT images of the head and neck were reviewed. The tumor response and the appearance of BR in the previous destructive part of the skull base were recorded and analyzed. The tumor response was divided into complete, partial, or no response, BR was defined as recalcification or sclerotic change with partial or complete healing in the previous osteolytic bony defect. Local failure was confirmed either by pathological or merely by imaging studies showing progression of tumor in consecutive radiological pictures.Results: The distribution of specific sites of bony destruction (BD) in these patients included the sphenoid bone (68%), paracavernous sinus area (48%), petrous apes (47%), clivus (44%), pterygoid plates (20%), and others (7%). The CT showed 57 patients (63%) had BR. All were observed within 1 year after treatment. Sixty-two patients (69%) had complete tumor response after treatment, Analyzed by logistic regression method, tumor response after treatment was found to have a statistically significant correlation with BR (p = 0.0004). Most BR (55/57) was demonstrated in patients with complete tumor response, The 3-year actuarial local control rate was 54 % in these patients. The local control was quite different in the comparison of patients with BR versus those with persistent ED (77% vs, 21%,p < 0.0001), Multivariate analysis showed that patients with complete tumor response or with BR on imaging had statistically better local control than those without either of the two findings (p < 0.05),Conclusion: Appearance of BR at previous destructive skull base following radiotherapy for NPC patients could be clearly demonstrated on CT, Bony regeneration significantly correlated with treatment response and local control, Although the underlying significance of BR was unknown, to predict the outcome after treatment, the appearance of BR shown on CT may imply the complete eradication of tumor in this area. (C) 1999 Elsevier Science Inc.

Purpose: A scoring system is proposed to measure the extent of parametrial involvement and predict treatment outcome in patients with carcinoma of the uterine cervix.Methods and Materials: 244 patients with PICO Stage IIB (n = 146) or IIIB (n = 98) carcinoma of the uterine cervix were treated by radical radiotherapy from October 1987 to June 1992. Impact of the extent of parametrial involvement on outcome was studied. All patients were scored by the newly introduced scoring system described as follows: score 1, tumor extending <1/2 the distance to the pelvic side wall; score 2, tumor extending >1/2 the distance to the pelvic side wall but not to pelvic side wall; score 3, tumor extending to the pelvic side wall. The score in each patient was defined as the sum of the scores of both the left and right parametrial tumor extent.Results: There were 53, 47, 61, 34, 25, and 24 patients in score 1, 2, 3, 4, 5, and 6, respectively. All 244 patients were subdivided into three groups described as follows: score 1 and 2, group I; score 3 and 4, group n; score 5 and 6, group III. In univariate analysis, lower score groups had better overall survival rate (OS), disease-free survival rate (DFS), local control rate (LC), and distant metastasis-free rate (DMF) than higher score groups including groups I vs. II, II vs. III, or I vs. III. The differences were all statistically significant except for the difference of the DMF in group I vs. II. In multivariate analysis, score (range 1-6) was also statistically significant in OS (p < 0.0001), DFS (p = 0.0015), LC (p = 0.0032), and DMF (p = 0.0141).Conclusions: The data suggested that the new scoring system defined by pelvic examination is a convenient, simple, and reliable method of measuring the degree of parametrial extension and predicting the outcome of patients with parametrial disease. (C) 1998 Elsevier Science Inc.

Purpose: To correlate the acute toxicity during pelvic irradiation and the development of late rectal injury following radiation therapy for cervical carcinoma.Methods and Materials: Two hundred and twenty patients treated with curative-intent radiation therapy between November 1987 and January 1992 were analyzed. Patients were treated initially with external beam irradiation, 40-44 Gy/20-22 fractions to whole pelvis, followed by high dose rate intracavitary brachytherapy, 7.2 Gy to point A for 3 fractions. Severity of diarrhea during radiation therapy was scored according to six criteria: fecal characteristics, frequency, onset, prescription of antidiarrheal agents, body weight loss during irradiation, and extramedical care needed. Patients were categorized as group ND (no obvious diarrhea), group MD (moderate diarrhea), and group SD (severe diarrhea) for sum score 0-1, 2-5, and greater than or equal to 6, respectively. The rate of radiation proctitis was expressed, analyzed, and compared with actuarial proctitis-free rate and prevalence.Results: 1) According to the score, 76 (35%), 89 (40%), and 55 (25%) patients were categorized as group ND, group MD, and group SD, respectively. Distribution of patients and treatment characteristics among the three groups appeared similar. Patients treated with a larger field size, greater than or equal to 16.5 cm(2), tended to have increased severity of diarrhea. 2) Overall, 103 patients (47%, 103 of 220) developed radiation proctitis. Twenty-one patients were in group ND (28%, 21 of 76), 43 in group MD (48%, 43 of 89), and 39 in group SD (71%, 39 of 55). 3) The five-year actuarial proctitis-free rate was 72, 52, and 29% for group ND, MD, and SD, respectively (p < 0.005). 4) Taking time evolution and recoverability into account, the effect of diarrhea on the prevalence of radiation proctitis remained statistically significant at the first through the fourth year after irradiation. 5) Severity of radiation proctitis and severity of diarrhea were not correlated (Spearman's rank correlation coefficient r(s) = 0.229, p = 0.098). 6) Cox's multivariate analysis revealed that severity of diarrhea was the only factor that significantly correlated with the development of radiation proctitis.Conclusion: Patients with increased acute toxicity and diarrhea during radiation therapy of cervical carcinoma significantly increased the risk of late rectal injury. This result suggested that early excessive damage of acute-responding component of rectal wall may play an important role in the initiation of late rectal injury. Radiation proctitis can be accounted, in part, as a consequential late effect. (C) 1998 Elsevier Science Inc.

Purpose: To evaluate the clinical efficacy of local vaginal lidocaine application for pain relief during high-dose-rate (HDR) intracavitary brachytherapy for patients with cervical cancer, and to investigate sequential changes in serum levels of lidocaine during the procedures.Methods and Materials: This prospective study was designed to examine the analgesic effect, physical response, and side effects of local anesthesia during HDR intracavitary brachytherapy. Forty patients were enrolled. All patients received 10-15 MV X-rays to the pelvis with a total dose of 45-59.4 Gy 5-6 weeks before undergoing HDR intracavitary brachytherapy. All patients underwent first intracavitary brachytherapy under general anesthesia. These patients were randomly allocated to receive one of two different treatment protocols as follows: (1) treatment session - control session - treatment session - control session; or (2) control session - treatment session- control session - treatment session. In the treatment sessions, topical anesthesia was administered using 4 ml of 10% lidocaine solution sprayed liberally on the cervix and vagina during intracavitary brachytherapy. In the control sessions, a placebo was administered in the same manner during brachytherapy. The Hensche's applicators for brachytherapy were inserted into the cervix and vagina 5 min after lidocaine application. The visual analogue scale (VAS) was used to assess pain and discomfort during brachytherapy. Blood pressure and heart rates were measured to evaluate the physiological response. Another prospective study was then performed to investigate the sequential changes of serum lidocaine levels during the anesthetic procedure. Eleven additional patients with similar disease state and demographic characteristics were enrolled and blood samples were obtained before, and 5, 15, 30, and 45 min after the initiation of lidocaine application.Results: The mean VAS values recorded during the treatment sessions and control sessions were 49.9 +/- 24.1 versus 60.1 +/- 24.8, respectively. The value of VAS in the treatment session was significantly lower than that of the control session (p < 0.001). No statistically significant differences were found in the changes of blood pressure and heart rate and in the incidence of side effects during these two types of sessions (p > 0.05). In the drug-level study, serum levels of lidocaine reached a peak 5 min after the initiation of local anesthesia. The mean peak concentrations (Cmax) of lidocaine were 0.50 +/- 0.45 mu g/ml.Conclusion: Local vaginal anesthesia with 10% lidocaine solution can significantly decrease the degree of painful sensation during HDR intracavitary brachytherapy, and is safe to administer for the procedure for cervical cancer. (C) 1998 Elsevier Science Inc.