Electrochemical monitoring of the breast milk quality.

The electrochemical techniques were used to determine the total antioxidant capacity of breast milks and the results were compared with a commonly used spectrophotometric (2,2-diphenyl-1-picrylhydrazyl, DPPH) method. Breast milk from mothers of preterm infants was monitored in three lactation phases and after storage of expressed milk by monitoring changes in the total antioxidant capacity over a two year period. Statistical analysis showed there was no significant difference between the ability of the three methods to detect changes in breast milk after storage. Either of the electrochemical techniques studied could be successfully used to replace the time-consuming spectrophotometric method and can be applied to clinical trials.

The amplification of c-erb-B2 in cancer-free surgical margins is a predictor of poor outcome in oral squamous cell carcinoma.

The tumour subtype, TNM classification, and histopathological data are sometimes not sufficient for understanding and assessing the behaviour of oral cancers. In an attempt to find additional markers of tumour biology and behaviour, this study sought to determine the incidence and consequently the relevance of c-erb-B2, c-Myc, and H-ras gene alterations in tumour-free margins of oral squamous cell carcinoma (OSCC). Fifty samples of OSCC were analyzed for c-erb-B2 and c-Myc amplification by real-time polymerase chain reaction and for H-ras point mutations by sequencing. A relatively high incidence of genetic lesions was detected: 22% of cases had c-erb-B2 and 30% had c-Myc amplification, whilst only 12% harboured H-ras mutations. Kaplan-Meier analysis and the log-rank test showed statistically significant differences in 5-year survival rates and relapse between patients with tumour margins positive for c-erb-B2 amplification and those with margins that were negative (P=0.002). H-ras and c-Myc alterations could not be associated with tumour behaviour. Molecular analysis of margins, targeting cancer genes, could identify additional, independent predictors of risk and outcome in OSCC.

Detection of bacteria and analyses of Chlamydia trachomatis viability in patients with postvenereal reactive arthritis.

Postvenereal reactive arthritis is an inflammatory form of arthritis that commonly develops after urogenital infection, predominantly in human leucocyte antigen-B27-positive men in the third decade of life. In our hospital, patients underwent synovectomy before a 4-month course of antibiotics (ciprofloxacin, tetracycline and roxithromicin). The clinical remission was achieved in approximately 70% patients. At molecular level, the remission was associated with the negative polymerase chain reaction findings of bacteria.

A novel semi-quantitative method for measuring tissue bleeding.

In this study, we describe a new semi-quantitative method for measuring the extent of bleeding in pathohistological tissue samples. To test our novel method, we recruited 120 female patients in their first trimester of pregnancy and divided them into three groups of 40. Group I was the control group, in which no dilation was applied. Group II was an experimental group, in which dilation was performed using classical mechanical dilators. Group III was also an experimental group, in which dilation was performed using a hydraulic dilator. Tissue samples were taken from the patients' cervical canals using a Novak's probe via energetic single-step curettage prior to any dilation in Group I and after dilation in Groups II and III. After the tissue samples were prepared, light microscopy was used to obtain microphotographs at 100x magnification. The surfaces affected by bleeding were measured in the microphotographs using the Autodesk AutoCAD 2009 program and its "polylines" function. The lines were used to mark the area around the entire sample (marked A) and to create "polyline" areas around each bleeding area on the sample (marked B). The percentage of the total area affected by bleeding was calculated using the formula: N = Bt x 100 / At where N is the percentage (%) of the tissue sample surface affected by bleeding, At (A total) is the sum of the surfaces of all of the tissue samples and Bt (B total) is the sum of all the surfaces affected by bleeding in all of the tissue samples. This novel semi-quantitative method utilizes the Autodesk AutoCAD 2009 program, which is simple to use and widely available, thereby offering a new, objective and precise approach to estimate the extent of bleeding in tissue samples.

Radiotherapy alone versus radiochemotherapy in patients with stage IIIA adenocarcinoma (ADC) of the lung.

PURPOSE: To evaluate the outcome of radiotherapy (RT) versus radiochemotherapy (RT-CHT) in patients with locally advanced (stage III) inoperable adenocarcinoma of the lung. PATIENTS AND METHODS: 146 patients with these characteristics were among 600 patients enrolled into five prospective trials and were treated with either hyperfractionated (Hfx) RT (64.8 and 69.6 Gy using 1.2 Gy bid) alone (n = 33) or with Hfx RT (64.8 and 69.6 Gy using 1.2 Gy bid and 67.6 Gy using 1.3 Gy bid) and concurrent carboplatin-etoposide or paclitaxel-carboplatin (n = 113). RESULTS: The median times and 5-year overall survival (OS), local progression-free survival (LPFS) and the distant metastasis-free survival (DMFS) rates for all 146 patients were 17, 20 and 20 months, respectively, and 15, 26 and 33, respectively. RT-CHT was superior to RT alone in terms of both OS (MST 19 vs. 12 months, respectively, 5-year OS 18 vs. 6 %, respectively; p = 0.003) and LPFS (MTLP 21 vs. 15 months, respectively, 5-year LPFS 28 vs. 0 %; p = 0.06), but not the DMFS (p = 0.43). In all 146 patients, the most frequent acute high-grade toxicity was esophageal, bronchopulmonary and hematological (each 12 %), while the most frequent late high-grade toxicity was bronchopulmonary (4 %) and esophageal (3 %). RT-CHT caused significantly more frequent acute high-grade (>3) esophageal (15 %), and hematological (15 %), while late high-grade toxicity was similar between RT and RT-CHT groups of patients. CONCLUSION: RT-CHT achieved excellent results (MST 19 months, 5-year survival 18 %) in this patient population accompanied with low toxicity, comparing favorably to results of other similar studies.

Effects of conventional versus biocompatible peritoneal dialysis solutions on peritoneal and systemic inflammation, malnutrition and atherosclerosis in CAPD patients.

BACKGROUND: Chronic inflammation, malnutrition and atherosclerosis (MIA syndrome) are important predictors of high mortality in continuous ambulatory peritoneal dialysis (CAPD) patients. We aimed to evaluate the effects of PD solutions (standard vs. biocompatible) on some parameters of MIA syndrome in patients undergoing CAPD. METHODS: 42 stable patients who were on CAPD at least 2.5 years participated in this cross-sectional study. Patients who had severe anemia (Hb < 10 g/l), immunomodulatory therapy, peritonitis or any inflammatory conditions for at least 3 months before the analysis, malignant disease and acute exacerbation of heart failure, were excluded. 21 (50%) patients were treated with standard PD solutions (CAPDP-1), while the remaining 21 (50% of patients) were treated with biocompatible PD solutions (neutral solutions with lower level of glucose degradation products and lower concentration of calcium, CAPDP-2). All patients underwent echocardiography and B-mode ultrasonography of common carotid arteries together with assessments of nutrition status and parameters of systemic and local inflammation. RESULTS: There were no significant differences between the groups concerning age, gender, underlying disease, residual renal function, peritoneal transport characteristics, comorbidity or therapy applied. Patients from group CAPDP-2 had a significantly lower serum level of hs-CRP (3.7 ± 2.6 mg/l vs. 6.3 ± 4.5 mg/l; p = 0.023) and significantly better nutritional status confirmed by mid-arm circumference (p = 0.015), mid-arm muscle circumference (p = 0.002) and subjective global assessment (14.28% of patients in CAPDP-2 vs. 71% of patients in CAPDP-1 were malnourished; p = 0.000). Group CAPD-2 had less frequent left ventricular hypertrophy (p = 0.039), thinner intima-media thickness (p = 0.005), smaller carotid narrowing (p = 0.000) and fewer calcified plaques of common carotide arteries (p = 0.003). No significant difference between the CAPDP groups was observed in serum and effluent levels of inflammatory cytokines (IL-1, IL-6 and TNF-α) and CA-125 effluent level. Logistic regression analysis did not confirm that biocompatibility of PD solutions was an independent predictor of any parameter of MIA syndrome. CONCLUSIONS: According to the present study and logistic regression analysis, the effect of biocompatible CAPD solutions on parameters of malnutrition, inflammation and atherosclerosis have to be confirmed by well-designed and controlled studies in a higher number of patients.

[The influence of Helicobacter pylori eradication on appearance of gastro-oesophageal reflux disease].

UNLABELLED: Gastro-oesophageal reflux disease (GERD) includes wide spectrum of symptoms caused by gastric acid regurgitation through the incompetent lower oesophageal sphincter in oesophagus. Etiopathogenesis of GERD is multifactorial. AIM OF THIS STUDY: to establish the relationship between Helicobacter pylori eradication and appearance or aggravating of present GERD. If this relationship exist, the aim is to estimate its level and clinical consequences. MATERIAL AND METHODS: 50 Helicobacter pylori positive patients with different endoscopic findings (ulcer disease, gastritis and non-ulcer dyspepsia) to whom eradication of Helicobacter pylori was done, were following next 6 months. Questionnaire, uppear GI endoscopy with verification changes of oesophagus in accordance to LA classification, histopathological examination of gastric and oesophageal mucosal biopsy specimens, and oesophageal manometry have been done to all patients. These examinations have been done before Helicobacter pylori eradication and one, three. six and none months after that. RESULTS: non statistical significant difference was found among the appearance or aggravating of present GERD in all patients during the following period (Cochran Q test; p=0,408). Non statistical significant difference was found among the endoscopic types of oesophagitis (LA classification) in all patients during the following 6 months (Friedman test; p=0,058). Non statistical significant difference was found among the changes of histopathological findings on distal oesophagus, too (Friedman test; p=0,217). CONCLUSION: Eradication od Helicobacter pylori infection does not cause the appearance or aggravating of present GERD. The presence of mildly form of GERD, or aggravating of present GERD is transitory, and haven't the statistical signification.

The use of thoracodorsal nerve transfer in restoration of irreparable C5 and C6 spinal nerve lesions.

There are only a few reports on the use of thoracodorsal nerve (TDN) transfer to the musculocutaneous or axillary nerves in cases of directly irreparable brachial plexus injuries. In this study, we analysed outcome and time-course of recovery in correlation with recipient nerves and type of nerve transfer (isolated or in combination with other collateral branches) for 27 patients with transfer to the musculocutaneous or axillary nerves. Using this nerve as donor, we obtained useful functional recovery in all 12 cases for the musculocutaneous nerve, and in 14 (93.3%) of 15 nerve transfers for the axillary nerve. Although, we found no significant statistical difference between analysed patients according to the percentage of recoveries and mean values, we established a better quality and shorter time of recovery for the musculocutaneous nerve. According to obtained results, we consider that transfer may be a valuable method in reconstruction after directly irreparable C5 and C6 spinal nerve lesions.

Serum uric acid levels in multiple sclerosis patients correlate with activity of disease and blood-brain barrier dysfunction.

Several findings suggest lower levels of serum uric acid in multiple sclerosis (MS) patients. The aim of this study is to investigate relationships of uric acid serum levels in relapse-remitting (RR) MS patients with clinical activity of disease and blood-brain barrier (BBB) condition. Sixty-three definite RRMS patients and 40 controls divided into two groups: 20 healthy donors and 20 patients with other inflammatory neurological diseases (OINDs) were analysed. By using a quantitative enzymatic assay according to the manufacture's protocol and a commercial uric acid standard solution, serum uric acid levels were measured and the results were standardized. To investigate BBB function, magnetic resonance imaging after administration of gadolinium was used. MS patients were found to have significantly lower serum uric acid levels (193.89 +/- 49.05 micromol/l; mean value +/-SD) in comparison with healthy donors (292.7 +/- 58.65 micromol/l; P=0.000) and OIND patients (242.7 +/- 46.66 micromol/l; P=0.001). We found that MS patients with relapse had significantly lower serum uric acid levels (161.49 +/- 23.61 micromol/l) than MS patients with remission (234.39 +/- 41.96 micromol/l; P=0.000) and more over, MS patients with BBB disruption had significantly lower serum uric acid levels (163.95 +/- 26.07 micromol/l) than those with normal BBB (252.48 +/- 25.94 micromol/l; P=0.000). Further, we also found that serum uric acid level independently correlated with disease activity, BBB disruption, and gender. These results indicate that lower uric acid levels in MS patients are associated with relapse and suggest that uric acid might be beneficial in the treatment of MS.

Restoration of upper arm function in traction injuries to the brachial plexus.

BACKGROUND: Restoration of upper arm function presents the main priority in nerve repair of brachial plexus traction injuries. The results are predominantly influenced by the level and extent of injury, and the type of surgical procedure. The purpose of this study is to evaluate influence of these factors on final outcome. METHODS: Study included 91 surgically treated patients, including 71 patients with avulsions of one or more spinal nerve roots and 20 with peripheral traction injuries. We performed 120 nerve transfers, 25 nerve graftings and 29 neurolyses on different nerve elements depending on the type of nerve damage. Analysis of motor recovery for elbow flexion and arm abduction, isolated or in combination, was done. FINDINGS: Recovery of elbow flexion was obtained in 75% nerve transfers, and in 68,7% nerve graftings in peripheral traction injuries. Recovery of arm abduction was obtained in 78,5% nerve transfers, and in 44,4% nerve graftings in peripheral traction injuries. Neurolysis was successful in all cases. Generally, the quality of recovery was better for the musculocutaneous nerve. Useful global upper arm function was obtained in 49,3% of patients with avulsion of spinal nerve roots, and in 55% of patients with peripheral traction injuries. INTERPRETATION: Regarding upper arm function the prognosis of surgically treated patients with traction injuries to the brachial plexus is generally similar in cases with central or peripheral level of injury. However, nerve transfers of collateral branches seem to be superior to nerve grafting and may be another possibility for repair in cases with extensive nerve gaps.

Concurrent accelerated hyperfractionated radiation therapy and carboplatin/etoposide in patients with malignant glioma: long-term results of a phase II study.

PURPOSE: Feasibility, antitumor activity and toxicity of accelerated hyperfractionated radiation therapy (Acc Hfx RT) and concurrent carboplatin/etoposide (CBDCA/VP 16) chemotherapy were investigated in patients with malignant glioma. MATERIAL AND METHODS: Seventy-nine patients with either glioblastoma multiforme (GBM) (n = 61) or anaplastic astrocytome (AA) (n = 18) entered into a phase II study on the use of Acc Hfx RT with 60 Gy in 40 fractions in 20 treatment days over 4 weeks and concurrent CBDCA, 200 mg/m2, and VP 16, 200 mg/m2, both given once weekly during the RT course. RESULTS: The median survival time for all 79 patients was 14 months (11 and 44 months for GBM and AA patients, respectively), while the 2- and 4-year survival was respectively 33% and 11% for all patients, 13% and 1.6% for GBM patients, and 100% and 44% for AA patients (p < 0.0001). The median time to progression for all patients was 12 months (9 and 40 months for GBM and AA, respectively), while the 2- and 4-year progression-free survival (PFS) was respectively 28% and 10% (all patients), 10% and 1.7% (GBM) and 89% and 39% (AA) (p < 0.0001). Multivariate analysis showed that age, performance status, and preoperative size of tumor influenced survival in GBM. Only 5 (6%) patients experienced grade 3 leukopenia and 6 (8%) patients experienced grade 3 thrombocytopenia. No late RT-induced toxicity was observed to date. CONCLUSIONS: Although Acc Hfx RT/CBDCA + VP 16 was feasible and little toxic, it failed to improve survival/progression-free survival over that obtained with other currently used regimens. These results do not justify the investigation of this regimen in a phase III trial.

Influence of interfraction interval on the efficacy and toxicity of hyperfractionated radiotherapy in combination with concurrent daily chemotherapy in stage III non-small-cell lung cancer.

PURPOSE: To investigate the influence of the interfraction interval (IFI) on treatment outcome and toxicity in hyperfractionated (HF) radiotherapy (RT) for Stage III non-small-cell lung cancer. METHODS AND MATERIALS: Data for 301 patients treated with 1.2 Gy b.i.d. to a total of 69.6 Gy and concurrent chemotherapy in our 3 prospective studies were analyzed. The chemotherapy regimen was either (1) 50 mg each of carboplatin and etoposide (CE) given on RT days (163 patients) or (2) 30 mg of CE on RT days and 100 mg of CE on Saturdays and Sundays during the RT course (138 patients). An IFI of 4.5-5 h or 5.5-6 h had been nonrandomly assigned for each patient, and this interval was kept throughout the treatment. RESULTS: No difference was observed in treatment outcome due to the chemotherapy protocol, and the 2 groups were combined. Patients treated with the shorter IFI had a better local control rate (38% at 5 years) and survival rate (30% at 5 years) than those treated with the longer interval (23% and 14%, respectively; p < 0.001). However, female patients and those with a high Karnofsky performance status score (KPS), weight loss of < or =5% in the previous 6 months, or Stage IIIA disease had been more often treated with the shorter IFI, and these characteristics were associated with better treatment outcome. In multivariate analysis, only gender, KPS, and weight change proved to be significant prognostic factors influencing both local control and survival, and the effect of IFI was not significant. The incidence of Grade 4 acute esophagitis tended to be higher in the shorter interval group (p = 0.072), but there were no differences in the incidence of late or other acute RT-related toxicities between the 2 groups. CONCLUSIONS: The possible influence of the IFI on local control and survival could not be verified using multivariate analysis. To better understand the influence of the IFI, randomized studies with more patients and wider ranges of intervals (e.g., 5 h vs. 8 h) seem to be necessary.

Hyperfractionated radiation therapy and concurrent low-dose, daily carboplatin/etoposide with or without weekend carboplatin/etoposide chemotherapy in stage III non-small-cell lung cancer: a randomized trial.

PURPOSE: To investigate whether the addition of weekend chemotherapy consisting of carboplatin/etoposide to hyperfractionated radiation therapy (Hfx RT) and concurrent daily carboplatin/etoposide offers an advantage over the same Hfx RT/daily carboplatin/etoposide. METHODS AND MATERIALS: A total of 195 patients (Group I, 98; Group II, 97) were treated with either Hfx RT to a total tumor dose of 69.6 Gy via 1.2 Gy b.i.d. fractionation and daily 50 mg each of carboplatin and etoposide during the RT course (Group I) or the same Hfx RT with daily carboplatin/etoposide consisting of 30 mg each of carboplatin and etoposide and with weekend (Saturdays and Sundays) 100 mg each of carboplatin and etoposide during the RT course (Group II). RESULTS: No difference was found regarding median survival time and 5-year survival rates (20 vs. 22 months and 20% vs. 23%; p = 0.57). Median time to local progression was 20 and 19 months, respectively, while 5-year local progression-free survival rates were 28% and 27%, respectively (p = 0.66). Also, there was no difference regarding either median time to distant metastasis and 5-year distant metastasis-free survival (21 vs. 25 months and 29% vs. 34%, p = 0.29). There was no difference in the incidence of various nonhematologic toxicities between the two treatment groups, but patients treated with the weekend CHT had significantly more high-grade (> or = 3) hematologic toxicity (p = 0.0046). Late high-grade toxicity was not different between the two treatment groups. CONCLUSION: The addition of weekend carboplatin/etoposide did not improve results over those obtained with Hfx RT and concurrent low-dose, daily carboplatin/etoposide, but it led to a higher incidence of acute high-grade hematologic toxicity.

Elective ipsilateral neck irradiation of patients with locally advanced maxillary sinus carcinoma.

BACKGROUND: The current study was conducted to investigate retrospectively whether elective ipsilateral neck irradiation (EINI) is effective in controlling subclinical neck disease in patients with locally advanced (T3 and T4) nonmetastatic (N0, M0) squamous cell carcinoma (SCC) of the maxilla. METHODS: Between 1987 and 1993 a total of 44 patients were treated with EINI. The primary tumor bed was treated with 60 grays (Gy) in patients undergoing radical maxillectomy or with 66 Gy in patients undergoing partial maxillectomy. The ipsilateral upper and lower neck (down to the clavicle) was treated with either opposing anteroposterior-posteroanterior fields or appositional electron fields. The dose of elective neck radiotherapy was 50 Gy in 25 daily fractions. RESULTS: The 5-year and 10-year survival rates (with standard error [SE]) were 66% (SE 7%) and 60% (SE 8%), respectively, whereas the 5-year and 10-year recurrence free survival rates both were 64% (SE 7%). The 10-year local recurrence free survival rate was 69% (SE 7%), whereas the 10-year regional recurrence free survival rate was 94% (SE 4%). Of the 2 patients who developed a recurrence in the neck, 1 was salvaged successfully by surgery, producing an ultimate 10-year regional recurrence free survival rate of 97%. The 10-year distant metastasis free survival rate was 91% (SE 4%). CONCLUSIONS: The findings of the current study appear to suggest the potential efficacy of EINI in patients with locally advanced, nonmetastatic SCC of the maxilla and that the high rate of control of cervical lymph nodes may lead to better overall survival than that reported in the majority of the recent series.

Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: a prospective randomized trial.

PURPOSE: To investigate whether the addition of cisplatin (CDDP) to hyperfractionation (Hfx) radiation therapy (RT) offers an advantage over the same Hfx RT given alone in locally advanced (stages III and IV) squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: One hundred thirty patients were randomized to receive either Hfx RT alone to a tumor dose of 77 Gy in 70 fractions in 35 treatment days over 7 weeks (group I, n = 65) or the same Hfx RT and concurrent low-dose (6 mg/m(2)) daily CDDP (group II, n = 65). RESULTS: Hfx RT/chemotherapy offered significantly higher survival rates than Hfx RT alone (68% v 49% at 2 years and 46% v 25% at 5 years; P =.0075). It also offered higher progression-free survival (46% v 25% at 5 years; P =.0068), higher locoregional progression-free survival (LRPFS) (50% v 36% at 5 years; P =.041), and higher distant metastasis-free survival (DMFS) (86% v 57% at 5 years; P =.0013). However, there was no difference between the two treatment groups in the incidence of either acute or late high-grade RT-induced toxicity. Hematologic high-grade toxicity was more frequent in group II patients. CONCLUSION: As compared with Hfx RT alone, Hfx RT and concurrent low-dose daily CDDP offered a survival advantage, as well as improved LRPFS and DMFS.

Results of nerve transfers to the musculocutaneous and axillary nerves.

OBJECTIVE: Nerve transfers in cases of brachial plexus traction injuries with avulsion of spinal nerve roots or irreparable proximal lesions of spinal nerves have been attempted using a variety of donor nerves. The purpose of this study was to analyze the results of nerve transfers to the musculocutaneous and axillary nerves, using collateral branches of the brachial plexus, upper intercostal nerves, or the accessory nerve. METHODS: This study included 62 patients with brachial plexus traction injuries who were surgically treated using various nerve transfer techniques. The follow-up periods were at least 3 years. Analysis of motor recovery was performed according to the type of donor nerve, the age of the patient, and the timing of surgery. RESULTS: The rates of recovery for the musculocutaneous and axillary nerves were 50% and 63.2% with intercostal nerve transfers, 65% and 75% with accessory nerve transfers, and 90.4% and 86.9% with nerve transfers of collateral branches, respectively. Despite the obviously better outcomes with the latter technique, a significant difference was found only in comparison with intercostal nerve transfers for the musculocutaneous nerve (P = 0.007). With respect to the quality of recovery, we found a significant difference between the latter type and the other two types of nerve transfers only for the musculocutaneous nerve (P = 0.027 for intercostal nerve transfers and P = 0.05 for accessory nerve transfers). There was no significant difference in results obtained using the thoracodorsal and medial pectoral nerves as donors. CONCLUSION: Our findings suggest that nerve transfer of collateral branches when possible, such as in cases involving upper brachial plexus palsy, may be the method of choice, yielding better results.

Short-course radiotherapy in elderly and frail patients with glioblastoma multiforme. A phase II study.

PURPOSE: To evaluate efficacy of short-course radiotherapy (RT) in elderly (> or = 60 years) and frail [Karnofsky performance status (KPS) 50-70] patients with glioblastoma multiforme (GBM). MATERIALS AND METHODS: Between January 1987 and June 1993, a total of 47 elderly and frail patients with histological diagnosis of GBM entered into a phase II study. RT alone was administered with tumor dose of 45 Gy in 15 daily fractions in 15 treatment days in 3 weeks to a target volume described as tumor visible on CT scan and a 2-cm margin. RESULTS: Forty-four patients were evaluable for this analysis. There were 15 (34%) CR and 11 (25%) PR, making the overall response rate of 60%. Median duration of response was 9 months (range, 2-36 months). Improvement in pretreatment performance status was observed in 20/44 (45%) patients, 5 of which improved their KPS for 20%. Median survival time is 9 months, and 1-4 year survival rates are 39%, 6.8%, 4.5%, and 0, respectively, while median time to tumor progression is 8 months, and 1-4 year progression-free survival rates are 30%, 4.5%, 4.5%, and 0, respectively. Females did significantly better than males, patients with KPS 60-70 did significantly better than those with KPS 50, patients having tumors 4-5 cm did significantly better than those with tumors 6-8 cm as well as did those with more radical surgery when compared to those with biopsy only. On multivariate analysis, only tumor size and extent of surgery were found to independently influence survival. Acute toxicity was generally assessed as mild. One of the 12 (8%) autopsied patients had RT-induced brain necrosis. CONCLUSION: This shortened RT appears to be an effective tool in palliation of elderly and frail patients with GBM. Further studies with more patients are needed before testing it against more aggressive treatment approaches in this patient population.

Role of radiation therapy in the combined-modality treatment of patients with extensive disease small-cell lung cancer: A randomized study.

PURPOSE: To investigate the efficacy and toxicity of cisplatin/etoposide (PE) chemotherapy (CHT) with or without accelerated hyperfractionated radiation therapy (ACC HFX RT) and concurrent daily carboplatin/etoposide (CE) in patients with extensive-disease small-cell lung cancer. PATIENTS AND METHODS: A total of 210 patients were treated with three cycles of standard PE. Patients with a complete response (CR) at both the local and distant levels (CR/CR) or a partial response (PR) at the local level and CR at the distant level (PR/CR) received either thoracic ACC HFX RT with 54 Gy in 36 fractions over 18 treatment days in combination with CE followed by two cycles of PE (group 1, n = 55) or an additional four cycles of PE (group 2, n = 54). Patients who experienced less response were treated nonrandomly (groups 3, 4, and 5). All patients with a CR at the distant level received prophylactic cranial irradiation. RESULTS: For 206 assessable patients, the median survival time (MST) was 9 months and the 5-year survival rate was 3.4%. Patients in group 1 had significantly better survival rates than those in group 2 (MST, 17 v 11 months; 5-year survival rate, 9.1% v 3.7%, respectively; P =.041). Local control was also better in group 1, but the difference was only marginally not significant (P =.062). There was no difference in distant metastasis-free survival between groups 1 and 2. Acute high-grade toxicity was higher in group 2 than in group 1. CONCLUSION: The addition of ACC HFX RT to the treatment of the most favorable subset of patients led to improved survival over that obtained with CHT alone.

Prolonged oral versus high-dose intravenous etoposide in combination with carboplatin for stage IV non-small-cell lung cancer (NSCLC): a randomized trial.

In order to investigate whether dose-intensive intravenous (i.v.) etoposide offers an advantage over prolonged oral administration of etoposide when combined with carboplatin (CBDCA), between January, 1991 and December, 1994, 171 patients with metastatic (stage IV) non-small cell lung cancer were randomized to receive CBDCA, 400 mg/m2, day 1 with either oral etoposide, 50 mg/m2, days 1-21 (group I) or i.v. etoposide, 200 mg/m2, days 1-3 (group II), every 4 weeks for up to six cycles or until tumour progression. Of the patients 168 were fully assessable for response, survival and toxicity. There were three (4%) CR and 16 (19%) PR in group 1, and the overall response rate was 23%. There were four (5%) CR and 12 (14%) PR in group II, and the overall response rate was 19% (P = 0.82). The median survival time (MST) in group I was 8 months, and 1- and 2-year survival rates were 35 and 9.5%, respectively, while the corresponding figures for group II were 7 months, and 31 and 7.1%, respectively (P = 0.40). Both haematological and non-haematological toxicity was significantly more frequent in group II with six (7%) patients in that group dying of treatment-related infection. Intensive i.v. etoposide combined with CBDCA was similar in efficacy to but more toxic than prolonged oral etoposide plus carboplatin and we do not recommend it for further investigation.

Combined treatment modality for anaplastic oligodendroglioma: a phase II study.

PURPOSE: To investigate feasibility, toxicity and antitumor activity of combined surgery, postoperative radiation therapy (RT) and adjuvant chemotherapy (CHT) in adult patients with pure anaplastic oligodendroglioma (PAO) or mixed anaplastic oligoastrocytoma (MAO). METHODS: Between January 1988, and June 1993, 23 patients entered into a phase II study. After surgery, postoperative RT was administered with 60 Gy in 30 daily fractions in 30 treatment days in 6 weeks. Two weeks after RT, adjuvant 'modified' PCV (mPCV) (Procarbazine, 60 mg/m2, days 1-14; CCNU, 100 mg/m2, day 1; and vincristine, 1.4 mg/m2 (max. 2 mg), days 1 and 8) was administered every six weeks up to six cycles or until progression occurred. RESULTS: Median survival time is not attained yet, while 1-5 year survival rates are 100%, 100%, 78%, 61%, and 52%, respectively. Median time to tumor progression is not attained yet, while 1-5 year progression-free survival rates are 100%, 100%, 70%, 52%, and 52%, respectively. On univariate analysis of potential prognostic factors, sex, tumor location (frontal versus other), and histology (pure versus mixed anaplastic oligodendroglioma) were not found to influence survival. Age of < 50 years carried improved prognosis as well as Karnofsky performance status (KPS) 90-100 when compared to KPS of 70-80. Patients having tumors < or = 4 cm did better than those with tumors > 4 cm as well as those with total tumor resection when compared to those with subtotal tumor resection or biopsy only. Acute high-grade (> or = 3) CHT-related toxicity was mainly hematological with only 3 (13%) patients experiencing acute grade 4 toxicity. CONCLUSIONS: Combined treatment modality consisting of surgery, postoperative high-dose RT and mPCV chemotherapy for patients with anaplastic oligodendroglioma was effective with acceptable toxicity. Further studies are needed with more patients and longer follow-up to verify these results in this rare disease.