Use of axillary ultrasonography in breast cancer: a useful tool to reduce sentinel node procedures.

AIM OF THE STUDY: The lymph node sentinel method is today used for staging the axillary lymph node stations. Ultrasonography is widely available and inexpensive method to study axillary status. METHODS: One hundred fourteen patients were studied consecutively using axillary ultrasonography and ultrasound guided fine needle aspiration of the lymph node. We used ATL Ultramark 9 with 5-7.5 MHz multiple frequency linear probe or Aloka SSDD-1400 with 7.5 MHz linear probe. RESULTS: One hundred fourteen patients were examined; six were excluded because of definitive histological diagnosis of non-infiltrating carcinoma. 106 had monofocal carcinomas, 2 had bifocal carcinoma in 104/108 ultrasonography was carried out successfully. The axillary cytological examination was positive in 18 cases (17.3%) who were subjected to axillary examination. 86 patients were subjected to sentinel lymph node biopsy: positive 13 cases (6 micrometastases). 31 cases/104 (29.8%) showed positive axilla. Sensitivity of ultrasonography was 58%, 100%specificity. Predictive positive value 100%, Negative value 84.9% for an accuracy of 87.5%. DISCUSSION: Ultrasonography is useful in all cases eligible to sentinel lymph node examination; the minimum cost of the procedure and of the human resources is amply rewarded by the direct indication for surgical axillary dissection in case of a positive result (17.3% in our experience).

Lomustine (chloroethylnitrosourea [CCNU]), ifosfamide, bleomycin, vincristine, and cisplatin (CIBO-P) is an effective regimen for patients with poor prognostic refractory or multiple disease recurrent aggressive non-Hodgkin lymphoma.

BACKGROUND: The current study was designed to assess the activity and safety of a novel combination therapy for patients with recurrent or refractory aggressive non-Hodgkin lymphoma (NHL). METHODS: Forty-three consecutive patients with recurrent or refractory aggressive NHL were treated with lomustine (chloroethylnitrosourea [CCNU]; 60 mg/m2 on Day 1), ifosfamide (1.5 g/m(2 on Days 1, 2 and 21, 22), bleomycin (5 mg/m2 on Days 1, 5 and 21, 25), vincristine (1.4 mg/m2 on Days 1, 8 and 21, 28), and cisplatin (25 mg/m2 on Days 3, 4, 5 and 23, 24, 25), every 42 days (CIBO-P regimen). RESULTS: Thirty-nine patients (91%) were evaluable for response. The median patient age was 63 years. Thirty-five percent of the patients had received > or = 2 lines of previous chemotherapy and 40% had elevated lactate dehydrogenase levels at the time of treatment initiation. The overall objective response rate was 77% (95% confidence interval [95% CI], 63-90%), including 19 (49%) complete (CR) and 11 (28%) partial responses. CIBO-P induced responses in primary refractory disease and in patients treated for second or subsequent disease recurrences. A CR with previous therapy was the most important factor associated with a significantly higher CR rate. The median duration of response was 6 months (95% CI, 4.4-7.7 months) and the median survival duration was 10.7 months (95% CI, 5.9-18.1 months). Five patients (11.6%) remained disease free for > or = 24 months. By multivariate analysis, a CR with previous therapy and average dose intensity of CIBO-P drugs were independent prognostic factors for time-to-treatment failure, whereas a CR with previous therapy and serum lactate dehydrogenase were independent predictors for survival. Myelosuppression was the most frequent serious complication of this regimen. However, none of the patients had hemorrhage with thrombocytopenia, and only 2 patients (5%) had febrile neutropenia. CONCLUSIONS: In the current study, CIBO-P was a novel, highly active, and safe combination therapy for patients with refractory disease with a poor prognosis or for patients with multiply recurrent aggressive NHL.

P-CHOP: cisplatin (P) added to the standard CHOP regimen as first-line treatment for aggressive non-Hodgkin lymphoma: a single-institution phase II study.

We designed the P-CHOP regimen, which involves the addition of cisplatin (P) to the standard CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) regimen, and investigated its activity and its toxicities in a single institution phase II study. Twenty-two consecutive patients with untreated, aggressive, stage I-IV non-Hodgkin lymphoma were enrolled in the study. Cisplatin was administered at a dose of 40 mg/m2 on days 1 and 2, every 3 weeks; the dose and schedule of the other agents were identical to those used in the standard CHOP regimen. The complete remission (CR) rate was 86% in eligible and 80% in all the treated patients, which compares favorably with the CR rates of two recent randomized studies of CHOP versus other regimens. P-CHOP is an innovative regimen for the front-line treatment of aggressive non-Hodgkin lymphoma. It is feasible and warrants further research, which would ideally take the form of a randomized comparison of P-CHOP and CHOP, possibly with the addition of rituximab in both arms.

Compliance and outcomes in locally advanced head and neck cancer patients treated with alternating chemo-radiotherapy in clinical practice.

BACKGROUND AND AIMS: To evaluate the feasibility in clinical practice of alternating chemo-radiotherapy in locally advanced head and neck cancer patients. PATIENTS AND METHODS: From August 1993 to April 1998 at the Division of Medical Oncology of Parma, 48 consecutive patients were observed, and 38 (79%) started the Merlano chemo-radiotherapy. The characteristics of the patients were: males (32, 84%); median age, 57 years; PS <2 (32, 84%). The primary sites were the oropharynx (18, 47%), oral cavity (8, 21%), hypopharynx (7, 19%), larynx (5, 13%); stage IV disease was present in 29 (76%) patients. Twenty-five (66%) patients were married, and 24 (63%) resided outside of the city. RESULTS: The compliance was very low: 21 patients (55%) performed all the programmed cycles of chemotherapy, whereas only 5 patients (13%) performed the chemo-radiotherapy at full doses without any delay. The objective responses were 3 (8%) complete and 21 (55%) complete plus partial responses. Failures were 2 (5%) stable disease and 2 (5%) progressive disease, and the response was not assessable in 10 (26%). The median duration of the response was 8 months. The median overall survival and the time to progression were 18 and 13 months, respectively; the 5-year overall and relapse-free survival were 36% and 26%, respectively. Nine (24%) patients were still alive as of August 30, 2001, 8 (21%) of them without progression. Twenty-six patients (68%) died with a local-regional relapse. One patient (3%) died for a second cancer. Grade 3-4 hematologic toxicity was leukopenia (n = 25, 66%) and thrombocytopenia (n = 9, 24%); grade 3-4 non-hematologic toxicity was diarrhea (n = 3, 8%) and mucositis (n = 2, 5%). Two patients (5%) died for intestinal infarction and perforation possibly related to treatment. CONCLUSIONS: Compliance to the chemo-radiotherapy was very poor. The response rate was lower than that reported in clinical trials, whereas overall survival was comparable. The alternating chemo-radiotherapy is a very complex treatment that cannot be easily applied in clinical practice; a careful selection of patients is mandatory not only considering oncologic and medical criteria, but also the level of awareness of the patient and his family.

Randomized trial comparing cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) with rotational CMF, epirubicin and vincristine as primary chemotherapy in operable breast carcinoma.

BACKGROUND: According to the overview of Early Breast Cancer Trialists' Collaborative Group, anthracycline containing regimens are superior to cyclophosphamide, methotrexate, and 5-fluorouracil (CMF) as adjuvant chemotherapy for breast carcinoma, but no comparative information is available in terms of primary chemotherapy. In the current randomized controlled trial, the authors compared CMF with a chemotherapy regimen including CMF, epirubicin, and vincristine (CMFEV). METHODS: Two hundred eleven patients with Stages I and II palpable breast carcinoma and tumor diameter > 2.5 cm or < or = 2.5 cm with cytologically proven axillary lymph node involvement were randomized to receive CMF (arm A) or CMFEV regimen (arm B) for four cycles before surgery. After surgery, patients in both arms received adjuvant CMF for three cycles; the postmenopausal patients also received tamoxifen for two years. RESULTS: There were no significant differences in the complete response (CR) and in the CR plus partial response (PR) rates between the two arms. In the subset analysis, among premenopausal patients, significantly higher rates of CR (26% vs 4%, P = 0.004) and of CR + PR rates (80% vs 54%, P = 0.007) were observed in the CMFEV, as compared to the CMF arm. Multivariate analysis confirmed the presence of a significant interaction between menopausal status and type of treatment on the probability of achieving CR (P = 0.02) or CR + PR (P = 0.01). There were no major differences in the side effects of the two treatments, with the exception of more frequent alopecia in the experimental arm. CONCLUSIONS: The results of the current study are in line with those of previous published randomized clinical trials comparing regimens without and with anthracycline as adjuvant treatment, indicating an agreement between the short term response to primary chemotherapy and the long term results observed in the adjuvant setting.