Population-based sentinel lymph node biopsy in early invasive breast cancer.

INTRODUCTION: Sentinel lymph node biopsy (SLNB) has been proposed as a reliable method for staging of early invasive breast cancer (EIBC). In the present study we analyse the impact of this procedure when systematically applied to all unselected women of a community-based Breast Cancer Unit (BCU). METHODS: All consecutive women with unifocal cT1-2 (

Outcome assessment of age group-specific (+/- 50 years) post-remission consolidation with high-dose cytarabine or bone marrow autograft for adult acute myelogenous leukemia.

BACKGROUND AND OBJECTIVE: To assess outcome of an age-adapted post-remission strategy for adult patients with acute myelogenous leukemia (AML, FAB-M3 excluded), including autologous bone marrow transplantation (ABMT) or high-dose cytarabine (HIDAC) consolidation. DESIGN AND METHODS: AML patients in first complete remission (CR) after doxorubicin-cytarabine-thioguanine (DoxAT) chemotherapy were scheduled to receive two identical early consolidation courses followed by HIDAC (1 g/m2/bd for 6 days), if aged > 50 years, or HiDAC plus total body irradiation (TBI) plus ABMT if aged < 50 years, the bone marrow being harvested prior to the HiDAC/TBI regimen and unpurged. Results were examined by treatment intention and in actual treatment groups, by selected pretreatment and therapy-related variables, and compared with age and disease matched historical patients treated with DoxAT consolidation without additional HIDAC or ABMT. RESULTS: One-hundred and eight (70%) of 153 patients achieved a response and were evaluable after a follow-up of 3.3-8.8 years. According to treatment intention, long-term relapse-free survival (RFS) was significantly improved in both age groups compared with controls (< 50 years: 41% vs 15%, p < 0.05; > 50 years: 33% vs 22%, p < 0.005). Actually, 41 patients proceeded to ABMT and 24 to the HIDAC cycle (including 5 aged < 50 years), 23 had early consolidation only (1: refusal; 1: inadequate marrow harvest; 21: complications), 10 relapsed and 2 died very early into remission, 7 were submitted to an allogeneic BMT, and one denied any post-remission therapy. The long-term RFS rates for ABMT and HIDAC groups were 53% and 54% (47% for 19 patients aged > 50), respectively, significantly better than for historical patients or those unable to go beyond early consolidation (p < 0.005, adjusted for early adverse events). Overall 5-year survival rate was 40% (p < 0.0001), 54% for CR patients, 60% after ABMT, and 65% after HIDAC. Relative to the ABMT and HIDAC intensive treatment groups, only the presence of hepatosplenomegaly at diagnosis was associated with a significantly worse outcome like that of the control study. INTERPRETATION AND CONCLUSIONS: This age-adapted double post-remission consolidation strategy with ABMT (allo-BMT) or HIDAC was applicable to only about two thirds of responders and was effective in about half these cases, regardless of patient age or specific treatment modality. While the loss of CR patients from treatment realization was unrelated to the study design and depended mainly on recurrence of AML and toxic complication, the exact place of ABMT vs HIDAC consolidation remains unsettled, calling for a new study in comparable patient and risk groups.

Autologous bone marrow transplantation for acute myeloid leukaemia in children using total body irradiation and melphalan as conditioning regimen.

We conducted a phase II study on 19 children with AML in first (10 patients) or second (nine patients) complete remission (CR) treated with ABMT, evaluating the combination of total body irradiation (TBI, 12 Gy in six divided fractions) and high-dose melphalan (140 mg/m2 in single dose) in an attempt to improve antitumour efficacy of conditioning regimen. All patients received cryopreserved and in vitro purged (mafosfamide at a dose of 100 micrograms/ml) bone marrow. The median time from first CR to ABMT was 5 months compared with a median time of 3 months for patients in second remission. One of the 19 patients, transplanted in second CR, died of transplant-related complication 10 days after transplant and another second CR patient relapsed on day +28, before engraftment. Three further patients in second CR relapsed at 6, 6 and 18 months after marrow transplant, respectively, and this determined a relapse rate of 43% in children given ABMT in second CR and 0% for patients transplanted in first remission (P < 0.05). Seventy-two per cent of all patients are projected to be alive and disease-free at 6 years, whereas the event-free survival of patients in first and in second CR is 100 and 44%, respectively (P < 0.05). Although the number of patients does not allow us to draw any firm conclusion, our results are encouraging and suggest that the association of TBI and high-dose melphalan appears to be safe and valuable.

[Radiotherapy plus a combination of cisplatin and 5-fluorouracil for locally advanced head and neck neoplasms. Study of feasibility and preliminary results]. / Radioterapia più cisplatino e 5-fluorouracile concomitante nei tumori della testa e del collo localmente avanzati. Studio di fattibilità e risultati preliminari.

In March 1989 we started a feasibility study of combined radio-chemotherapy in patients with locally-advanced head and neck cancer. The first phase of treatment consisted of conventional radiotherapy (2 Gy/day, 5 days/week for a total dose of 70 Gy to primary tumor and +/- 50 Gy to nodes) and cisplatinum (20 mg/m2, i.v., for 4 days) +5FU (200 mg/m2, i.v., for 4 days) every 4th week, during radiant sessions. The second phase of treatment was started about one month after the end of simultaneous chemotherapy and radiotherapy: patients in complete remission received 1 more cycle of chemotherapy, as consolidation, while patients in partial remission received two more cycles of chemotherapy. Non-responding patients received no more chemotherapy. During the second phase the days of cisplatinum and 5FU were 5. Up to April 1990, 17 patients have been included in the study. They were stage III (64%) and IV (36%). The mean administered dose of radiotherapy was 66 Gy (range: 60-70 Gy) to primary tumor and 60 Gy (range: 40-70 Gy) to nodes. The total number of chemotherapy cycles administered during radiant sessions was 37, the mean number of cycles was 2 (range: 1-3), with 100% dose percentage. The interval between cycles was 3 weeks in 84% of patients. The relationship between number of cycles administered and planned cycle was 37/39 (feasibility: 95%). Acceptability was 100% (no patient refused the treatment). Feasibility of the second phase was 77% and acceptability 90% (1 patient refused the treatment). Toxicity was moderate during the first and the second phases. After the first phase 14/15 evaluable patients (92%) had major response (complete remission: 46%). After the second phase 10/10 evaluable patients had a complete remission. In conclusion, this combined treatment is very easy to administer, and very well accepted. Moreover, it yields a high number of objective responses.

[Neoadjuvant chemotherapy of infiltrating carcinoma of the bladder: our experience]. / Chemioterapia neoadiuvante nel carcinoma vescicale infiltrante: nostra esperienza.

From January 1987 until October 1989, 96 patients have been treated with radical cystectomy for locally advanced bladder cancer. Nineteen, out of 96 underwent chemotherapy (either M-VAC or M-VEC) before cystectomy. Five had T1G3 bladder tumor. After chemotherapy the results had been the following: 5 complete responses (CR) 26%, 7 partial responses (PR) (37%) and no changes in 7 patients (37%). During the first two courses of chemotherapy, 36 administrations out of 152 scheduled should have not been done because of drug toxicity. The seven patients who had no changes had a drug administration reduced of 41% with respect of a rate of reduction of 12% in the group of patients who had complete response. The urinary diversion after cystectomy were performed with a neobladder according to Reddy in 4 patients, with a colon conduit in 1 patient and with an ileal conduit in 12 patients. All the patients survived the surgery. We did not notice any difference in the follow up after surgery in those patients treated before cystectomy with chemotherapy with respect to the patients who underwent cystectomy without chemotherapy. Despite the fact that by now we can not state any conclusion about the efficacy of neoadiuvant chemotherapy, due both to the short follow up and to the small number of patients treated, we should however perform cystectomy in all the patients after chemotherapy because up to now we have no evidence that a conservative treatment of the bladder after chemotherapy could be safe.

[Quadrantectomy and tumorectomy followed by radiotherapy in early tumors of the breast]. / Quadrantectomia e tumorectomia seguita da radioterapia nei tumori iniziali della mammella.

The authors examined 235 patients with early breast cancer treated by radiotherapy after conservative surgery during a 10-year period (1974-1984). Disease-free survival and incidence of local recurrences, in agreement with the data reported in literature, did not differ from those of patients with early breast cancer treated with radical surgery. As for local recurrences in the breast only (7/235), a slightly significant difference was observed in favor of quadrantectomy (3/62 for tumorectomy versus 4/173 for quadrantectomy). On the contrary, a significant difference was observed in the breast recurrence rate of premenopausal (5/7) and postmenopausal women (2/7). Complications occurred in 7.2% of the cases. Satisfactory esthetic results were generally obtained, with 78% good and excellent results. Doses greater than 50 Gy to the whole breast and irradiation of the axilla both worsened the esthetic results and increased complication rate. Chemotherapy does not worsen the esthetic results, while that is often the case when the removed volume is excessive in comparison to the whole breast volume.

[Definitive radical radiotherapy in tumors of the prostate. Analysis of statistics]. / La radioterapia a finalità radicale nel tumore della prostata. Analisi di una statistica.

The records were analyzed of 50 patients treated by definitive external beam irradiation for carcinoma of the prostate in the Oncologic Radiotherapy Department of the "Ospedali Riuniti" of Bergamo, Italy, from January 1981 to December 1985. Our series of patients included 22 cases of stage B and 28 cases of stage C tumors. The actuarial 5-year survival rates, according to the Kaplan-Meier method, were for the whole group 69.9%; 79.5% and 54.9% for stage B and stage C tumors respectively. Relationships were also analyzed of tumor control and survival to stage, grading, and total dose of radiations. The recent increasing interest is explained in the use of radiation therapy in the treatment of this kind of patients. A special emphasis is put on the role of CT in determining both field size and dose distribution, and on the use of high-voltage energy in order to make treatment more technically reliable and reduce its morbidity.