Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases.

OBJECTIVE: To assess the effectiveness of a single dose of radio therapy (8 Gy vs. 6 Gy) plus zoledronic acid in cancer patients with bone metastases in treating pain; quality of life, time to onset of skeletal events and functional status. MATERIAL AND METHODS: A total of 139 patients from 22 Spanish hospitals were randomly assigned to: Group A, administered a single dose of 8 Gy+zoledronic acid (4 mg iv, in 15-min infusions), and Group B, administered a single dose of 6 Gy+zoledronic acid (4 mg iv, in 15-min infusions). The main variable was pain, which was assessed with the Visual Analogue Pain Scale (VAS) in supine, seated and standing positions. RESULTS: There was a total of 118 patients for intention to treat (n=67 in Group A and n=51 in Group B). The most frequent primary neoplasms were the lung (29.66%), prostate (22.03%) and breast (21.19%). Sixty patients were analysed per protocol, n=34 in group A and n=26 in group B. Improvements were observed in the VAS scores for pain in all three positions. The mean time to onset of the event was greater (p=0.0211) in Group A than in Group B (122 vs. 81.62 days). Functional status improved in Group A, and quality of life improved in both groups. CONCLUSION: The two groups achieved similar levels of pain control in supine, seated and standing positions. Quality of life also improved in both groups. However, the higher dose (8 Gy dose) in combination with zoledronic acid is associated with a longer period without skeletal events.

Randomised study of single dose (8 Gy vs. 6 Gy) of analgesic radiotherapy plus zoledronic acid in patients with bone metastases

OBJECTIVE: To assess the effectiveness of a single dose of radio therapy (8 Gy vs. 6 Gy) plus zoledronic acid in cancer patients with bone metastases in treating pain; quality of life, time to onset of skeletal events and functional status. MATERIAL AND METHODS: A total of 139 patients from 22 Spanish hospitals were randomly assigned to: Group A, administered a single dose of 8 Gy+zoledronic acid (4 mg iv, in 15-min infusions), and Group B, administered a single dose of 6 Gy+zoledronic acid (4 mg iv, in 15-min infusions). The main variable was pain, which was assessed with the Visual Analogue Pain Scale (VAS) in supine, seated and standing positions. RESULTS: There was a total of 118 patients for intention to treat (n=67 in Group A and n=51 in Group B). The most frequent primary neoplasms were the lung (29.66%), prostate (22.03%) and breast (21.19%). Sixty patients were analysed per protocol, n=34 in group A and n=26 in group B. Improvements were observed in the VAS scores for pain in all three positions. The mean time to onset of the event was greater (p=0.0211) in Group A than in Group B (122 vs. 81.62 days). Functional status improved in Group A, and quality of life improved in both groups. CONCLUSION: The two groups achieved similar levels of pain control in supine, seated and standing positions. Quality of life also improved in both groups. However, the higher dose (8 Gy dose) in combination with zoledronic acid is associated with a longer period without skeletal events (AU)

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Infrastructure of radiotherapy in Spain: a minimal standard of radiotherapy resources.

PURPOSE: To assess the state of our specialty, the Spanish Society of Radiotherapy and Oncology ordered a survey of all Spanish services of radiation oncology. METHODS AND MATERIALS: In June 1999, the Society ordered an analysis of the state of radiation oncology. It created a survey that was sent to all radiotherapy units in Spain. A database was created in which 230 variables were analyzed. RESULTS: Eighty-four centers were analyzed, and 157 external beam irradiation, megavoltage units were counted, of which 67 were cobalt units and 90 were linear accelerators. The cobalt units worked an average of 11.4 h daily and the linear accelerators 11.6 h. The number of patients/unit/y was 472 for the cobalt units and 442 for the linear accelerators. The number of patients by physician and year was 179. Each center received a mean of 958 new patients annually. The average between the reception and start of treatment was 25.52 days (maximum 60), and it was estimated that only 38.1% of cancers were irradiated. The number of radiation oncologists working was 392. Spain has a deficit of 297 radiation oncologists. CONCLUSION: There is a need for 44 MV units and for the replacement of 67 cobalt units. The present lack of units has had an impact on palliative treatment, which has resulted in pharmacy costs. As long as these instrumental deficiencies are not solved, waiting lists will continue to be inherent to the system. There are also important staff deficiencies, in that about 297 radiation oncologists would be needed to cover the needs.

[Radiotherapy in glottic T1 carcinoma. Local control and survival]. / Radioterapia en el carcinoma T1 glótico. Control local y supervivencia.

Between January 1980 and April 1995, 57 treatment-naive patients diagnosed as glottic epidermoid T1 carcinoma were treated in the ear, nose and throat department of Juan Canalejo Hospital of La Coruña, Spain. Seventy-nine percent (79%) (45/57) had T1a lesions and 21% (12/57) had T1b. All patients were treated by the radiotherapy department of the Regional Oncological Center with Co60 at doses ranging from 50 Gy to 70 Gy. Local control was achieved in 74.5% (43/57). Cause-specific survival was 96% at 3, 5, and 10 years. The larynx was preserved in 96.5% (55/57). The local recurrence rate was significantly lower for T1a (16.8%) than for T1b (57.8%) (p < 0.05). No significant differences were found in local control or survival with different dosing regimens.

Radioterapia en el carcinoma T1 glótico. Control local y supervivencia / Radiotherapy in glottic T1 carcinoma. Local control and survival

Entre Enero de 1980 y Abril de 1995, se trataron mediante radioterapia 57 pacientes diagnosticados de carcinoma epidermoide TI glótico, en el Servicio de Otorrinolaringología del Hospital Juan Canalejo de La Coruña. El 79 por ciento (45/57) correspondían a lesiones T1 y 21 por ciento (12/57) T1b. Todos los pacientes fueron tratados en el Servicio de Radioterapia del Centro Oncológico Regional mediante Co60, con dosis que oscilaron entre los 5.000 y los 7.000 cGy. El control local fue del 74,5 por ciento (43/57). La supervivencia causa-específica fue de 96 por ciento a los 3,5 y 10 años. El índice de preservación de la laringe fue del 96,5 por ciento (55/57). El índice de recidiva local fue significativamente inferior en los T1a (16,8 por ciento) frente a los T1b (57,8 por ciento) (p < 0,5). No se encontraron diferencias significativas ni en el control local ni en la supervivencia en función de la dosis empleada (AU)

Between January 1980 and April 1995, 57 treatment-naive patients diagnosed as glottic epidermoid T1 carcinoma were treated in the ear, nose and throat department of Juan Canalejo Hospital of La Coruña, Spain. Seventy-nine percent (79%) (45/57) had T1a lesions and 21% (12/57) had T1b. All patients were treated by the radiotherapy department of the Regional Oncological Center with Co60 at doses ranging from 50 Gy to 70 Gy. Local control was achieved in 74.5% (43/57). Cause-specific survival was 96% at 3, 5, and 10 years. The larynx was preserved in 96.5% (55/57). The local recurrence rate was significantly lower for T1a (16.8%) than for T1b (57.8%) (p < 0.05). No significant differences were found in local control or survival with different dosing regimens (AU)

Phase II study of radiochemotherapy with UFT and low-dose oral leucovorin in patients with unresectable rectal cancer.

PURPOSE: To determine the activity and evaluate the toxicity of uracil and tegafur in a 4:1 molar concentration (UFT) plus low-dose leucovorin administered concomitantly with pelvic irradiation in patients with unresectable or recurrent rectal cancer. METHODS AND MATERIALS: Thirty-five patients (22 with primary unresectable tumors and 13 with locally recurrent tumors) were enrolled in the trial. Thirty-five patients were evaluable for toxicity and 32 of these were evaluable for clinical response. Patients received 300 mg/m2/day UFT and 30 mg/day leucovorin on days 8-35 concomitantly with pelvic radiotherapy, to a total dose of 45 Gy. RESULTS: Eight of the 35 (23%) patients developed Grade 3 diarrhea and were treated with radiotherapy alone after this event. Of the 22 patients with unresectable primary tumors, 17 underwent surgery, and resection was feasible in 15 cases (88%). Of the 32 patients evaluable for clinical response, 4 (13%) had a complete clinical response (CR) and 22 (69%) a partial response (PR). A complete pathologic response was observed in 3 cases (18%) and, a PR in 11 cases (65%). CONCLUSION: The response rates achieved with this schedule seem comparable to those obtained with 5-FU and radiotherapy. These results warrant further evaluation of this combination in patients with unresectable or locally advanced tumors.

X-ray biological dosimetry performed by selective painting of human chromosomes 1 and 2.

Fluorescence in situ hybridization with a cocktail of whole-chromosome probes, specific for human chromosomes 1 and 2, was performed to analyze the induction of translocations and dicentrics in human peripheral blood lymphocytes exposed to 100 KVp X-rays and cultured for 48 h. The dose-response curves for both aberration types were linear-quadratic, with similar coefficients, and after correction for genome content were a little lower than the dose-response curve for dicentrics established by conventional analysis. Three doses were also assessed after 76-h culture. The dicentric yield at 76 h was reduced compared with that at 48 h because of the existence of second and third division metaphases. The translocation yield did not reduce except at 4 Gy. The frequency of cells containing both dicentrics and translocations suggested that their occurrence is not correlated. The importance of stating the scoring criteria and of specifying the different types of aberrations is stressed.

Persistence of DNA lesions and the cytological cancellation of sister chromatid exchanges.

The ability of UV light, mitomycin C and ionizing radiation to induce the formation of sister chromatid exchanges (SCEs) at the same locus in successive cell generations was investigated in human lymphocytes. Cells were exposed to the DNA damaging agents after they had completed their first round of DNA replication, and SCEs were examined at the third division in chromosomes that had been differentially stained three ways. Although some of these treatments induced long-lived lesions that increased the frequency of SCEs in successive cell generations, none of the lesions led to the formation of consecutive SCEs at the same locus in successive cell generations. This observation seriously challenges the hypothesis that SCE cancellation results as a consequence of persistence of the lesions induced by these agents.

[Enzymatic changes in cancer]. / Alteraciones enzimáticas en cáncer.

Several enzymes were estimated in different tumors. Ceruloplasmin, lactate dehydrogenase (LDH), and phosphohexose isomerase (PHI) showed a direct correlation with tumor growth and remission. The ratio LDH/PHI was low in solid tumors and high in lymphomas, suggesting a different metabolism.