Thirty five patients with metastatic RCC were observed over a 57 months period in our Division of Radiotherapy and Medical Oncology, and 30 are evaluable for this analysis. MPA was selected as ...primary treatment agent in 23 patients, VLB singly, in combination with MPA or in combination with CCNU was used in 1.4 and 2 patients. With MPA the TR rate was 3/23 (1 CR and 2 PR). Duration of response for the patient with CR was 6 months whereas for the patients with PR was 21 and 14 months respectively. 4 additional patients showed NC. With VLB-MPA the TR rate was 1/+ (1 PR). Duration of PR was 3 months. The median duration of survival for the 11 patients with CR, PR and NC was 14 months whereas for the 19 patients with NR was 7 months (p < 0.01). TES and TAM showed no or minimal activity as second treatment agents.
Summary Background After breast-conserving surgery, 90% of local recurrences occur within the index quadrant despite the presence of multicentric cancers elsewhere in the breast. Thus, restriction of ...radiation therapy to the tumour bed during surgery might be adequate for selected patients. We compared targeted intraoperative radiotherapy with the conventional policy of whole breast external beam radiotherapy. Methods Having safely piloted the new technique of single-dose targeted intraoperative radiotherapy with Intrabeam, we launched the TARGIT-A trial on March 24, 2000. In this prospective, randomised, non-inferiority trial, women aged 45 years or older with invasive ductal breast carcinoma undergoing breast-conserving surgery were enrolled from 28 centres in nine countries. Patients were randomly assigned in a 1:1 ratio to receive targeted intraoperative radiotherapy or whole breast external beam radiotherapy, with blocks stratified by centre and by timing of delivery of targeted intraoperative radiotherapy. Neither patients nor investigators or their teams were masked to treatment assignment. Postoperative discovery of predefined factors (eg, lobular carcinoma) could trigger addition of external beam radiotherapy to targeted intraoperative radiotherapy (in an expected 15% of patients). The primary outcome was local recurrence in the conserved breast. The predefined non-inferiority margin was an absolute difference of 2·5% in the primary endpoint. All randomised patients were included in the intention-to-treat analysis. This trial is registered with ClinicalTrials.gov , number NCT00983684. Findings 1113 patients were randomly allocated to targeted intraoperative radiotherapy and 1119 were allocated to external beam radiotherapy. Of 996 patients who received the allocated treatment in the targeted intraoperative radiotherapy group, 854 (86%) received targeted intraoperative radiotherapy only and 142 (14%) received targeted intraoperative radiotherapy plus external beam radiotherapy. 1025 (92%) patients in the external beam radiotherapy group received the allocated treatment. At 4 years, there were six local recurrences in the intraoperative radiotherapy group and five in the external beam radiotherapy group. The Kaplan-Meier estimate of local recurrence in the conserved breast at 4 years was 1·20% (95% CI 0·53–2·71) in the targeted intraoperative radiotherapy and 0·95% (0·39–2·31) in the external beam radiotherapy group (difference between groups 0·25%, −1·04 to 1·54; p=0·41). The frequency of any complications and major toxicity was similar in the two groups (for major toxicity, targeted intraoperative radiotherapy, 37 3·3% of 1113 vs external beam radiotherapy, 44 3·9% of 1119; p=0·44). Radiotherapy toxicity (Radiation Therapy Oncology Group grade 3) was lower in the targeted intraoperative radiotherapy group (six patients 0·5%) than in the external beam radiotherapy group (23 patients 2·1%; p=0·002). Interpretation For selected patients with early breast cancer, a single dose of radiotherapy delivered at the time of surgery by use of targeted intraoperative radiotherapy should be considered as an alternative to external beam radiotherapy delivered over several weeks. Funding University College London Hospitals (UCLH)/UCL Comprehensive Biomedical Research Centre, UCLH Charities, National Institute for Health Research Health Technology Assessment programme, Ninewells Cancer Campaign, National Health and Medical Research Council, and German Federal Ministry of Education and Research (BMBF).
To evaluate the quality of life (QL) in patients with ductal carcinoma in situ of the breast treated with conservative surgery and postoperative irradiation.
A self-completed questionnaire covering ...many disease-, symptom-, and treatment-specific issues was administered to 106 conservatively treated patients affected by non-infiltrating breast cancer. The questionnaire was based on a series of 34 items assessing five main fields of post-treatment adjustment: physical well being, sexual adaptation, aesthetic outcome, emotional/psychological well being, relational behaviour. Furthermore, the patients were requested to evaluate the degree of information provided by the medical staff concerning surgical procedures and radiation therapy, and to evaluate the effects of the treatment on their social and overall life.
The questionnaire was completed by 83 patients (78%), who had a median follow-up of 54.5 months. This final sample had a median age of 50 years (range 29-88) at the time of treatment and 54 years (range 32-94) at the time of study. The patients claimed to be in good physical condition. Data relating to sexual life were provided by 93% of the sample. Some limitations in sexuality, some interference with sexual desire, and some modifications during intercourse were reported by 5, 6, and 5 patients, respectively. The subjective evaluations of the cosmetic results of the therapies were generally good. Only 13 patients (16%) reported the perception of a worsened body image. Forty-six percent of the sample (38 patients) declared that they felt tense, 48% (39 patients) nervous, 29% (38 patients) lonely, 59% (41 patients) anxious, and 41% (34 patients) depressed. Only seven patients (8%) declared that the treatment had had a bad effect on their social life, and 15 (18%) thought that their current life had been affected by the treatment. The amount of information received concerning the disease and treatment (surgery and radiotherapy) was considered sufficient by 79%, 75%, and 79% of the sample, respectively.
This study revealed a good QL in patients treated with breast conservation and postoperative irradiation, with a preserved favourable body image and a lack of negative impact on sexuality. Radiation therapy did not lead to any significant additional problems capable of affecting the QL.
From January 1975 to March 1981, 97 consecutive patients with brain metastases from various tumors were treated with cobalt-radiotherapy. Two successive treatment schedules were employed: the first ...52 patients were treated according to a conventional schedule (30 or 40 Gy in 15 or 20 treatments over a 3 or 4 week period), while in the successive 45 patients a concentrated schedule was employed (2 series of 17 Gy in 2 sessions over a 3 day period, separated by an interval of 3 weeks). In the 87 evaluable patients, no significant difference was noted regarding the efficacy of radiotherapeutic treatment (25/47 and 20/40 partial remissions, respectively, with median survival of 4 and 3 months, respectively). Acute toxicity was more relevant with concentrated irradiation (approximately 20% of cases).
A controversy exists regarding whether it is safe to delay radiation therapy until the completion of chemotherapy following breast-conserving surgery for patients with node-positive breast cancer. ...Within the context of two concurrent randomized clinical trials we had the opportunity to evaluate outcomes for patients who received breast irradiation after completing different durations of chemotherapy.
From July 1986 to April 1993 the International Breast Cancer Study Group (IBCSG) Trial VI randomly assigned 1554 pre/perimenopausal node-positive breast cancer patients to receive cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) for either three consecutive courses on months 1-3, or six consecutive courses on months 1-6, both with or without reintroduction CMF. IBCSG Trial VII randomly assigned 1266 postmenopausal node-positive breast cancer patients to receive tamoxifen for 5 years, or tamoxifen for 5 years with three early cycles of CMF, both with or without three courses of delayed CMF. Both trials allowed a choice of mastectomy, or breast-conserving surgery plus radiation therapy, and both were stratified by type of surgery. Radiotherapy was delayed until the initial block of CMF was completed; 4 or 7 months after surgery for pre/perimenopausal patients, and 2 or 4 months after surgery for postmenopausal patients. Over both trials, 718 eligible patients elected to receive breast-conserving surgery plus radiation therapy: 433 on Trial VI, and 285 on Trial VII. Four-year actuarial total failure rates (failure at any site), risks of developing distant metastases (DM at any time during observation), and overall survival (OS) were estimated using the Kaplan-Meier method. To avoid potential bias due to competing causes of failure, only patients who could be followed for at least 4 years (enrolled prior to July 1, 1990) were used to evaluate the patterns of first relapse site. Crude percents of local failure with or without other sites (LF), distant metastases including regional nodal failure (DM/RNF), or other first events (second primaries/death without recurrence) were estimated for each treatment group. For this report, an intent to treat analysis was performed at a median follow-up of 48 months.
No differences were found in the 4-year actuarial total failure rates, risk of developing distant metastases, and overall survival among the two radiotherapy groups of each study. The cumulative incidence of types of first failure and the 4-year crude rates showed no treatment differences in the patterns of site of first event. Estimates for the 4-year crude percent of local failures were 8 and 9% for pre/perimenopausal patients who had radiation therapy at 4 or 7 months after surgery, and 3 and 6% for postmenopausal patients who had radiation therapy at 2 months or 4 months after surgery.
For node positive patients receiving breast-conserving surgery followed by radiation therapy, the incidence of breast recurrence in the conserved ipsilateral breast within 4 years was between 8 and 9% for pre/perimenopausal patients and between 3 and 6% for postmenopausal patients. After 48 months of median follow-up, administering radiation therapy after three or six cycles of CMF for pre/perimenopausal women, or after no cycles or three cycles of CMF for postmenopausal women does not influence overall efficacy or local control in this series.
Between June 1980 and December 1983, 111 patients with inoperable epidermoid bronchogenic carcinoma (limited disease) were entered into a randomized trial comparing radiotherapy alone versus ...radiotherapy and combination chemotherapy with cyclophosphamide, Adriamycin (doxorubicin), methotrexate, and procarbazine. Thirty‐five of 62 (56.4%) patients treated with 4500 rad in 15 fractions in 3 weeks and 19 of 49 (38.8%) patients treated with the same radiation treatment and chemotherapy had an objective response. The difference in response rate was not significant (P = 0.900). Median time to progression was 5.9 and 7.02 months, respectively, for the radiation treatment and the combined treatment. Median survival was 11.74 and 10.03 months, respectively, without statistically significant differences between the two groups of patients. The toxicity was acceptable and no treatment‐related death occurred in either treatment schedule. In this study no significant superiority of combined radiotherapy and chemotherapy treatment over radiation therapy alone was evidenced. Whether different chemotherapy regimens may prove more effective in this context should be clarified by further studies.
PDF
