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Objective: To find the optimal dose of immunomodulator Z-100 in patients with stage IIIB squamous cell carcinoma of the cervix in combination with radiation therapy., Methods: The patients were randomly assigned to the dosage levels of 2, 20 or 40 mug of Z-100. Z-100 was subcutaneously injected twice a week during radiotherapy and once in two weeks during the maintenance period. The response rate after radiotherapy was evaluated, and the optimal clinical dosage was then determined. Safety of Z-100 was evaluated during the radiation therapy and maintenance therapy. Survival was also evaluated., Results: A total of 116 patients were entered. The adverse reactions were not dose-dependent and no serious toxicities were observed. The response rates were 72.2% (26/36) in the 2 microg group, 84.6% (33/39) in the 20 microg group and 94.3% (33/35) in the 40 microg group (P = 0.006). However, the survival was not significantly different., Conclusions: The optimal dose of Z-100 was determined to be 40 mug in combination with radiation therapy for stage IIIB cervical cancer. However, impact of Z-100 on survival must be determined by the placebo controlled randomized trial, because survival benefit was not observed in this small population study.

Background: The previous trials of radiotherapy conducted for primary central nervous system lymphoma (PCNSL) have not been successful. Therefore, we have investigated the clinical outcomes and the role of radiation therapy in the treatment of PCNSL., Methods: Thirty-three consecutive patients with PCNSL treated with cranial radiotherapy (30-40 Gy whole brain plus 10-20 Gy boost) without administration of high-dose methotrexate were retrospectively analyzed. Nine patients received whole spinal irradiation (WSI) as an additional therapy. The median age of patients was 58 years (range: 28-78 years), and 70% showed a poor performance status (PS)., Results: The median survival time (MST) was 13 months, and the 5-year overall survival rate was 35%. The initial response and the number of tumors were significant prognostic factors, and WSI tended toward significance in a multivariate analysis. Four of five patients, who received prophylactic WSI, were 4-year survivors without a tumor relapse and none of them had tumor involvement in the vertebral canal. One patient developed radiation-induced brain necrosis, however, WSI did not seem to affect the late complications., Conclusions: We consider it important to reduce severe acute and late complications in patients qualified for receiving an aggressive therapy, and to explore the possible tolerable and curative treatment methods that can be used in order to improve the prognosis for PCNSL. Further modifications, including the application of WSI seem to be necessary in the management of PCNSL.

We report a case of small cell lung cancer whose initial presentation was a solitary brain metastasis. On chest radiography the primary tumor was unclear and only detected by bronchofiberscopy. A small single pulmonary metastasis was noted in the right lower lobe. Subtotal resection and external irradiation were applied to the brain tumor and external irradiation was applied to the lung. Concurrently one course of systemic chemotherapy was administered. The tumors in the brain and lung had disappeared by the end of the treatment. The patient has been alive and well for 5 years without recurrence.

Background: As the human society grows more aged, it is considered important to elucidate factors essential in applying radical radiotherapy (RT) to the elderly, with ages as high as 90 years and greater., Methods: A retrospective survey was conducted for patients 90 years of age or older who received radiotherapy with radical intent in eight leading institutions in Japan from 1990 through 1995., Results: Fifty-seven nonagenarian patients were studied. Their ages ranged up to 98 (median 91) and there was a strong female preponderance (M/F: 16/41). The distribution by site was as follows: head and neck, 16; skin and adnexae, 11; uterine cervix, 7; esophagus, 6. The prevailing histopathological diagnosis was squamous cell carcinoma (34), followed by adenocarcinomas (8). The highest age at RT was 98 years [female, skin cancer, died of senility 2.5 years after treatment, with no evidence of disease (NED)] and the longest survivor is 102 years old (female, glottic cancer T2, age at RT 93, alive NED for 8 years, uses wheel-chair). The rate of completion of treatment was 75% (43/57), if the treatment field was limited to the gross primary tumor volume only and if the cumulative dose was above 80% of the tolerable adult dose. Familial escort was necessary for most of the patients in completing the day-to-day RT., Conclusion: Radiotherapy is feasible with radical intent even in the elderly, if the treatment field is limited to the gross primary tumor volume only, if the cumulative dose is above 80% of the tolerable adult dose and if familial support is adequate.

We report a patient with nasopharyngeal cancer with long-term follow-up of more than 16 years after the first course of radiotherapy in 1981. He developed a lung metastasis in 1996 after having a second course of radiotherapy for neck recurrence in 1989. The patient was a 42-year-old man with a nasopharyngeal tumor and a fixed upper neck metastasis (T1N1M0), which was treated with definitive radiotherapy. He manifested regional recurrence, at the margin of the radiation portal, with an 8 year disease-free interval, which was treated successfully by definitive re-irradiation. He developed a solitary lung metastasis, which was treated by video-assisted thoracoscopic lung resection, 7 years disease-free after the second course of radiotherapy. For 20 months after the removal of the lung metastasis he has been generally well without any signs of recurrence of sequelae. This case indicates the efficacy of definitive re-irradiation for regional recurrence and the necessity for long-term observation after radiation therapy for nasopharyngeal cancer.

Background: To improve the quality of radiation therapy in Japan, Patterns of Care Study (PCS), a widely known QA program in the USA, was introduced in Japan. The feasibility was tested by collecting nationwide data by extramural audit for esophageal cancer., Methods: From July 1996 through February 1997, PCS audits were performed for 29 institutions. Based on the facility survey by Tsunemoto, 13 institutes were classified as A1 (university hospital/cancer center treating > 300 patients/year), 10 as B1 (other institutes > 120 patients/year) and six as B2 (other institutes < 120 patients/year). Medical charts for 455 patients with thoracic esophageal cancer between 1992 and 1994 were reviewed based on the data format of PCS in the USA., Results: Concerning external beam equipment, linear accelerators of > or = 10 MV were used for 73% of patients in A1, whereas in B1-2, 60Co machines were still used for 13% of patients (P < 0.0001). The median number of full-time equivalent (FTE) radiation oncologists was 2.7 in A1, 0.65 in B1 and 0.2 in B2. Forty-five percent of patients had received surgery in A1 and 34% in B1-2 (P = 0.0068). In the non-surgery group, a higher radiation dose of > 60 Gy was delivered in A1 than in B1-2 (P = 0.0008). Chemotherapy was administered to 51% of the patients in A1 and to 30% in B1-2 (P < 0.0001). Brachytherapy was utilized for 17% in A1 and only for 5% in B1-2 (P = 0.0001)., Conclusion: Institutional stratification, including equipment and personnel, significantly affected the patterns of care for esophageal cancer. Therefore, to improve the quality of radiation therapy nationwide, improvement of equipment and supply of FTE personnel is extremely important. PCS was found to have great potential for the practical evaluation of how much will be required in Japan.

Background: As age-related infirmity often influences treatment options and outcome of esophageal cancer, the optimization of treatment for the elderly, especially in octogenarians, has been the subject of considerable debate., Methods: We performed a retrospective, multi-institutional survey to assess the effect of age on the outcome of definitive radiotherapy for esophageal cancer by a questionnaire sent to eight institutions in Japan., Results: There were 362 evaluable replies. The patients included 317 males and 45 females, with a median age of 72 years (range 35-93 years), and 96% had squamous cell carcinoma. There were 30 clinical stage 1, 71 stage IIA, 17 stage IIB, 113 stage III and 116 stage IV cases. The stage was not specified in 16 cases. Multiple co-morbidities existed in 40% of the patients who were 70 years of age or older. There was no statistically significant age-related difference in the incidence of adverse reactions to radiotherapy (P > 0.05). Overall survival was more significantly affected by Karnofsky Performance Status than by the patient's age. The influence of performance status on cumulative survival for stage I and II disease was more pronounced in patients in their 80s., Conclusion: The safety of radiotherapy for esophageal carcinoma is not influenced by the patient's age. Because the performance status strongly influenced survival, the multi-disciplinary assessment of functional status is mandatory for optimizing the choice of treatment for patients in their 80s with esophageal cancer.

We analyzed 52 patients with stage III and IV head and neck cancer who were given split-course accelerated hyperfractionated radiotherapy with curative intent, focusing particularly on the influence of split-time on local control. An initial complete response was achieved in 16 patients (31%), and the rate of persistent local control at 3 years was 23%. The cause specific survival rate at 3 years was 29%. Univariate analysis of local control according to the split-time duration and overall treatment time showed that shorter duration (< or = 14 days or < or = 45 days, respectively) had a significantly positive impact on local control (P < 0.05). Multivariate analysis using local control as an endpoint also demonstrated that gender (women showing a better outcome than men) and split-time (< or = 14 days was better than > 14 days) were statistically significant factors for local control. These results suggest that shortening the split-time during radiotherapy might improve local control in accelerated hyperfractionation.

The results of treatment of 141 patients with stage III non-small cell lung cancer (NSCLC) who received definitive radiation therapy at Gunma University Hospital between 1976 and 1989 were retrospectively analyzed. Radiation was given with standard fractionation for a planned prophylactic dose of 40 Gy over 4 weeks and a definitive dose of 60 Gy over 6 weeks or more. The two- and five-year survival rates were 27% and 12% for stage IIIA, and 18% and 8% for stage IIIB, respectively (P = 0.052). By univariate analysis, a primary tumor less than 5 cm in diameter was also an important predictor of survival (P = 0.008). As for tumor location, the patients with primary tumors in the upper lobes or the superior segment of the lower lobes of the lung lived longer than those with primary tumors at any other site (P = 0.032). Patients with epidermoid carcinoma had a higher survival rate at 5 years than those with other histologic types (14% vs 3%, P = 0.074). Multivariate analysis showed that among tumor characteristics, the site of the primary tumor, the pattern of tumor spread and N stage were significantly associated with overall survival. Among the patients with stage III NSCLC, those with stage IIIA epidermoid carcinoma in the upper lobe or the superior segment of the lower lobe of the lung were considered to be the most favorable candidates for definitive radiation therapy.

We reviewed the results of treatment in 52 patients with hypopharyngeal carcinoma who underwent radical radiation therapy using a two-fractionation scheme--conventional fractionation (CF) and accelerated hyperfractionation (AHF)--in order to evaluate the impact of the fractionation scheme on prognosis. The 5-year survival rate for the 52 patients was 19.5%, and a significantly better rate was obtained with AHF (44.4%) than with CF (12.4%). Of 27 patients who showed a complete response (CR), a higher CR rate (61%) was achieved with AHF than with CF (47%). A similar trend was also observed for T3 and T4 tumors (55% with AHF vs. 36% with CF). Multivariate analysis demonstrated that neck node status was a significant factor related to local control, and that local response and the fractionation scheme employed were significant prognostic factors for survival. The recurrence rate and recurrence within the radiation field in the AHF group was lower than in the CF group (27% vs. 50%), although the time to recurrence in the two groups did not differ greatly. Voice preservation was achieved in 20% of the patients. Considering the better survival and local control rate compared with conventional fractionation, accelerated hyperfractionation seems a preferable treatment for hypopharyngeal carcinoma.

Between 1976 and 1992, 32 patients aged 75 and older with stage I-II non-small cell lung cancer (NSCLC) were given definitive radiation therapy. These patients did not undergo surgery because of old age, poor cardiac/pulmonary condition, or refusal to give consent. The mean age was 79 years, and 11 patients were over 80 years old. The histologic type was squamous cell carcinoma in 25 patients and adenocarcinoma in 7. The clinical T and N stage was T1N0 in 4 patients, T2N0 in 9, and T2N1 in 19. The total dose of radiation therapy given to each patient exceeded 60 Gy using 10-MV X-rays. The treatment was completed in all 32 patients without treatment-related complications. The 2- and 5-year overall actuarial survival rates wer 40% and 16%, respectively. Eleven intercurrent deaths occurred, including 7 patients who died of heart disease. The 2- and 5-year cause-specific survival rates were 57% and 36% respectively. None of the patients developed severe pneumonitis requiring hospitalization. All but three patients received radiation therapy on an inpatient basis. The mean duration of the hospital stay for initial treatment was 56 days, and mean ratio to total survival period (mean 739 days) was 8%. Although many elderly patients have concurrent medical complications such as heart disease and chronic pulmonary disease, the present study showed that elderly patients with clinical stage I-II NSCLC can expect a realistic probability of long-term survival with definitive radiation therapy.

Retrospective analysis was performed with intent to evaluate prognostic factors in radiation therapy for 72 patients with histologically confirmed poorly-differentiated squamous cell carcinoma of the nasopharynx. The 10-year overall actuarial and cause specific survival rates were 36 and 40%, respectively. The median survival time was 43 months. Sixteen patients survived for more than 10 years (maximum 297 months). The five- and 10-year cause specific survival rates for Stages I, II, III and IV disease were 100 and 100%, 80 and 27%, 83 and 83%, and 38 and 31%, respectively. Two patients with Stage II disease died of a re-recurrent tumor more than seven years after their initial treatment. There was a significant difference between the survival curve for Stage I or III disease and that for Stage IV disease (P < 0.05). The patients with a T1-3 tumor had a statistically better survival rate than those with a T4 tumor (T1:T4, P < 0.001, T2 or T3:T4, P < 0.05). The patients with N0 had statistically better survival rates than those with N3 (P < 0.01). Twenty-eight patients developed loco-regional recurrence. Twenty-one patients developed distant bone metastases, most of which occurred within a year of the initiation of radiation therapy. The survival for the patients with loco-regional recurrence was nearly the same as that for the patients without loco-regional recurrence. The 10-year survival rates for patients with and without distant bone metastases were 0 and 48%, respectively (P < 0.001). Multivariate analysis revealed that the parameters influencing cause specific survival were stage categories of T and N, and adjuvant chemotherapy, whereas those influencing loco-regional recurrence were only stage categories of T and N. The only parameter to influence distant bone metastases was sex. We concluded the most important cause of failure for the patients with poorly-differentiated squamous cell carcinoma of the nasopharynx to be distant bone metastases.