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Biomedical subjects

N Nikolic

Publications and source records attributed to N Nikolic.

At least 19 recordsLinked to original sources

Subjective assessments of safety, exposure to chemicals and use of personal protection equipment in seafaring.

BACKGROUND: Most of the scientific publications from the maritime area are studies about the mortality and morbidity, while studies about the present hazards of potentially dangerous exposures are relatively rare. AIMS: To describe the seafarers' assessments of the occupational safety on board, their exposure to chemicals and the use of personal protection equipment and to identify the areas for further risk assessment and preventive measures. METHODS: A questionnaire study was carried out in 11 countries among seafarers who attended a regular health examination. RESULTS: The total number of seafarers who participated in the study was 6461 (response rate 93.7%). The occupational safety on board was assessed to be very good or good in 82%. Multivariate analyses showed that the safety was assessed as lowest among ratings, seafarers<30 years of age, work in the engine rooms and on dry cargo ships. It was highest on crude oil tankers and supply ships. Fifty-five per cent of seafarers were exposed to chemicals. Personal protection equipment to chemicals was used 'always/almost always' in 93% of the exposed. Multivariate analysis showed that the use of personal protection was highest on deck, on the largest ships, on roll-on roll-off ships and on crude oil tankers. CONCLUSION: The occupational safety and the use of personal protective equipment was assessed to be significantly different in some strata of the population and in specific working areas and types and sizes of ships.

Adolescent↗

Non-fatal occupational injuries related to slips, trips and falls in seafaring.

BACKGROUND: Merchant seafaring often involves hazardous occupational operations and several studies have shown increased overall injury mortality. The aim of this study was to describe the risks involved in slip, trip and fall (STF) injuries in merchant seafaring, in order to point out areas for prevention. METHODS: A questionnaire study was carried out in 11 countries with 6,461 participants. The seafarers gave information on whether they were injured during their latest tour of duty, and whether STF preceded the injury. RESULTS: Of the total reported injuries 43% (n=467) were STF related. Fractures and sprains accounted for 42% of the STF injuries compared with 17% for non-STF injuries. The proportions of STF injuries for different types of ships and areas of the ships varied from < 30% to >60%, particularly work on passenger ship decks, where STF injuries were >60%. The proportions of STF injuries increased by age and by severity of the injury. CONCLUSIONS: Injuries related to STF on merchant ships were more frequent than previous estimates. There is a need for improvements in defining, reporting, and preventing STF injuries in merchant seafaring.

Accidental Falls↗

Incidence of self-reported occupational injuries in seafaring--an international study.

AIMS: Seafaring is known as a high-risk industry. The aims were to describe the incidence of non-fatal injuries among seafarers, including testing the hypothesis that long working hours might result in higher injury rates. METHODS: A questionnaire study of injury on the latest tour of duty was carried out among seafarers in 11 countries with 6461 participants. The seafarers were asked if they were injured during the latest tour of duty and what was the number of hours worked. RESULTS: During the latest tour of duty, 9.1% of all seafarers were injured and 4.3% had an injury with at least 1 day of incapacity. The injury incidence rates for cargo ships and tankers: 39.5 per 1 million work hours and 37.6 per 100,000 days. Multivariate analyses: incidence rate ratios (IRR) for >70 working hours per week compared with <57 h: 0.90 [95% confidence interval (95% CI) = 0.61-1.32]; non-officers compared with officers: IRR = 1.57 (95% CI = 1.14-2.15); seafarers <35 years compared with > or =35 years of age: IRR = 2.11 (1.57-2.86); tour lengths > or =117 days compared with <117 days: IRR = 0.27 (0.19-0.39). Main work area on the deck and in the service area compared with work in the engine room: IRR = 0.37 (0.27-0.52) and IRR = 0.49 (0.26-0.91), respectively. CONCLUSIONS: There was no evidence that long working hours alone resulted in higher injury rates. Low self-perceived health, lack of use of personal protection and lack of occupational safety on board were significantly related to an increase in the injury risk.

Accidents, Occupational↗

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.

Antineoplastic Combined Chemotherapy Protocols↗

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.

Adult↗

Second cancers occurring in patients with early stage non-small-cell lung cancer treated with chest radiation therapy alone.

PURPOSE: To investigate the incidence of second cancers occurring in patients with early stage (I/II) non-small-cell lung cancer (NSCLC) treated with radiation therapy (RT) alone. PATIENTS AND METHODS: Seventy-eight patients had been treated with conventionally fractionated (CF) RT (1982 to 1987), and 116 patients had been treated with hyperfractionated (Hfx) RT (1988 to 1993). Tumor doses were 60 Gy for CF and 69.6 Gy (1.2 Gy bid) for Hfx. RESULTS: A total of 26 patients developed second cancers. The cumulative incidence of second cancer was 21.8% (SE, 4.7%) at 5 years and 34.8% (SE, 6.7%) at 10 years. For second lung cancers, it was 6.0% (SE, 2.8%) at 5 years and 14.2% (SE, 5.2%) at 10 years, and for second nonlung cancers, it was 16.3% (SE, 4.2%) at 5 years and 22.2% (SE, 5.7%) at 10 years. The rate of developing second cancer per patient per year was 4.3% (95% confidence intervals [CI], 2.7% to 5.9%), with the rates being 1.4% (CI, 0.5% to 2.3%) for the second lung cancers and 2.8% (CI, 1.5% to 4.1%) for second nonlung cancers. The rate of developing second cancers during the first and second 5-year period after RT (0 to 5 and 5 to 10 years) was 4.3% (CI, 2.4% to 6.2%) and 4.2% (CI, 0.6% to 7.8%), respectively, for all cancers. These rates were 1.0% (CI, 0.1% to 1.9%) and 2.2% (CI, 0% to 4.6%), respectively, for second lung cancers, and 3.2% (CI, 1.6% to 4.8%) and 1.5% (CI, 0% to 3.6%), respectively, for second nonlung cancers. CONCLUSION: Long-term survivors after RT alone for early stage NSCLC carry the same risk of developing second cancer, either lung or nonlung, as their counterparts treated surgically when the results of this study are compared with those of the published literature.

Aged↗

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.

Adult↗

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.

Carcinoma, Squamous Cell↗

A solution to the cyclic aldol problem

[formula: see text] A protocol for achieving stereoselective aldol reactions with cyclic ketones is presented. In terms of yield, the process is particularly effective when a quaternary center at the alpha-carbon of the beta-hydroxy ketone product is created. The stereochemical outcome, anti or syn, is achieved by the Lewis acid-mediated ring expansion of stereochemically homogeneous epoxides in a reaction related to the pinacol rearrangement.

Journal Article↗

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.

Adult↗

A phase II study of concurrent accelerated hyperfractionated radiotherapy and carboplatin/oral etoposide for elderly patients with stage III non-small-cell lung cancer.

PURPOSE: To investigate feasibility, toxicity, and efficacy of accelerated hyperfractionated radiation therapy and concurrent carboplastin/oral etoposide in elderly (> 70 years) patients with stage III non-small-cell lung cancer. METHODS AND MATERIALS: Between January 1988 and June 1993, a total of 58 patients entered a phase II study. Carboplatin (400 mg/m(2)) was given intravenously on days 1 and 29, and etoposide (50 mg/m(2)) was given orally on days 1-21 and 29-42. Accelerated hyperfractionated radiotherapy was administered starting on day 1, with a total dose of 51 Gy in 34 fractions over 3.5 weeks. RESULTS: In 55 evaluable patients, the complete response rate was 27% and the overall response rate was 65%. For the 55 patients, the median survival time was 10 months, and the 1-, 2-, and 5-year survival rates were 45%, 24%, and 9.1%, respectively. The median time until relapse was 8 months and the 1-, 2-, and 5-year relapse-free survival rates were 45%, 20%, and 9.1%, respectively. The median time to local recurrence was 14 months and the 5-year local control rate was 13%; the median time to distant metastasis was 18 months and the 5-year distant metastasis-free rate was 15%. Hematological, esophageal, and bronchopulmonary acute grade 3 or 4 toxicities were observed in 22%, 7%, and 4% of the patients, respectively. There was no grade 5 toxicity or late grade > or = 3 toxicity. CONCLUSION: Concurrent accelerated hyperfractionated radiotherapy and carboplatin/oral etoposide produced relatively low and acceptable toxicity. The survival results appeared to be comparable to those obtained in nonelderly patients with stage III non-small-cell lung cancer treated by full-dose radiation.

Administration, Oral↗

Pre-irradiation carboplatin and etoposide and accelerated hyperfractionated radiation therapy in patients with high-grade astrocytomas: a phase II study.

PURPOSE: To investigate feasibility, activity and toxicity of pre-irradiation chemotherapy (CHT) in patients with newly diagnosed high-grade astrocytoma. MATERIAL AND METHODS: Thirty-five patients with glioblastoma multiform (GBM) and ten patients with anaplastic astrocytoma (AA) entered into this study. Three weeks after surgery patients started their CHT consisting of two cycles of carboplatin (CBDCA) (C) 400 mg/m2, day 1 and etoposide (VP 16) (E) 120 mg/m2, days 1-3, given in a 3-week interval. One week after the second cycle of CE, accelerated hyperfractionated radiation therapy (ACC HFX RT) was introduced with tumor dose of 60 Gy in 40 fractions in 20 treatment days in 4 weeks, 1.5 Gy b.i.d. fractionation. RESULTS: Responses to two cycles of CE could be evaluated in 29 (67%) of 43 patients who received it. Fourteen patients were found impossible to determine radiographic response due to an absence of post-operative contrast enhancement because they were all grossly totally resected. There were 7, 24% (95% confidence intervals - CI, 9-40%), PR (2 AA and 5 GBM), 19 SD, and 3 PD. After RT, of those 29 patients, there were 3 CR and 11 PR (overall objective response rate was 48% (95% CI, 30-67%)), 12 SD, and 3 PD. Median survival time (MST) for all 45 patients is 14 months (95% CI, 11-20 months, while median time to progression (MTP) for all patients is 12 months (95% CI, 8-16 months). Toxicities of this combined modality approach were mild to moderate, with the incidences of CHT-induced grade 3 leukopenia, being 5% (95% CI, 0-11%), and grade 3 thrombocytopenia being 7% (95% CI, 0-15%). Of RT-induced toxicity, grade 1 external otitis was observed in 26% (95% CI, 13-39%), while nausea, vomiting and somnolence were each observed in 5% (95% CI, 0-11%) patients. CONCLUSION: Pre-irradiation CE and ACC HFX RT was a feasible treatment regimen with mild to moderate toxicity, but failed to improve results over what usually would be obtained with 'standard' approach in this patient population.

Antineoplastic Combined Chemotherapy Protocols↗

External beam radiation therapy alone for loco-regional recurrence of non-small-cell lung cancer after complete resection.

Between January 1982 and June 1993, a total of 61 patients with post-surgical loco-regional recurrence only were treated with external beam radiation therapy only at our institution. Patients were treated with either curative intent [tumor dose (TD) 55-60 Gy in 26-30 fractions] or palliative intent (TD 30 Gy in ten fractions). Median survival time (MST) for all 61 patients is 13 months, and 1-5-year survival rates are 61, 28, 16, 9.8 and 9.8%, respectively. There was a significant difference between high-dose and low-dose RT groups regarding both MST (18 vs. 7 months, respectively) and 1-5-year survival rates (74, 36, 24, 14 and 14% vs. 32, 11, 0, 0 and 0%, respectively) (P = 0.0000). Age, extent of initial surgery, time from initial surgery to documented recurrence were not found to influence survival in the high-dose group and influence of performance status, weight loss and histology were only marginally insignificant. Females did better than males and patients with bronchial stump recurrence only did better than those with non-stump recurrence only. Initial and recurrent staging significantly influenced survival, with patients in early stages doing better than those in advanced stages. External beam RT is an effective tool in the treatment of loco-regional recurrent NSCLC after curative resection. Identification of a favorable subset of patients that may fare better may help optimize treatment in the future by using high-dose, curative RT. Otherwise, unfavorable patients may appropriately be treated with palliative RT.

Adult↗

Short-term chemotherapy and palliative radiotherapy for elderly patients with stage IV non-small cell lung cancer: a phase II study.

Optimal treatment in elderly (> 70 years) with stage IV non-small cell lung cancer (NSCLC) is not known. In order to define it, concurrent short-term chemotherapy (CHT) and palliative radiotherapy (RT) was evaluated in this patient population. Between January 1988 and June 1993, a total of 50 patients entered into a study that used two cycles of carboplatin (CBDCA), 300 mg/m2, days 1 and 29 and oral etoposide, 50 mg/m2, days 1-21 and 29-42. RT was administered with dose of 14 Gy in two fractions given with 1 week split, days 1 and 8. Of 47 patients evaluable for the response, there were three (6%) complete response (CR), and ten (21%) partial response (PR), making the overall response rate of 13 (28%). Response duration ranged 2-8 months (median, 5 months; mean, 5 months). Median survival time (MST) for all 50 patients was 7 months and 1-3 year survival rates were 31, 4.1, and 2%, respectively. There were only nine (19%) patients experiencing hematological grade 3 toxicity, all other CHT-induced toxicity being grade 1 or 2. Of RT-induced high-grade toxicity, grade 3 esophageal was observed in nine (19%) patients while only four (9%) patients experienced grade 3 bronchopulmonary toxicity. No grade 4 or 5 toxicity occurred during this study. Short-course CHT and palliative RT in elderly patients with stage IV NSCLC was well tolerated with mild to moderate toxicity. Together with results obtained this way, they warrant further studies evaluating the effectiveness of this approach and possible CHT- and/or RT-dose escalation in elderly patients with stage IV NSCLC.

Aged↗

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.

Administration, Oral↗

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.

Adult↗

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.

Aged↗

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.

Adult↗