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Biomedical subjects

R Rosso

Publications and source records attributed to R Rosso.

At least 325 records · Page 18Linked to original sources

Etoposide v etoposide and cisplatin in the treatment of advanced non-small cell lung cancer: a FONICAP randomized study.

A multicenter Italian Cooperative Study Group (FONICAP) conducted a prospective, randomized trial comparing cisplatin and etoposide (VP-16) with single-agent etoposide. The national study accrued 216 patients with measurable or evaluable non-small cell lung cancer (NSCLC) with either unresectable stage III, or distant metastasis (stage IV). One hundred patients were evaluable for response in the single-agent arm, and 93 in the two-drug combination arm. The overall response rates for the etoposide group and cisplatin/etoposide (VP-16) group were 7% and 26%, respectively (P less than 0.005). Five patients (5.6%) in the combination arm and 1 (1%) in the single agent arm had a complete response. The overall median survival was 236 days for the two-drug arm and 178 days on the single-drug arm (P = 0.2). Treatment-related toxicity (nausea and vomiting, leukopenia, anemia, hearing-loss, peripheral neuropathy, serum creatinine elevation) was significantly more pronounced in the combined arm. The addition of cisplatin to etoposide gave a small non-statistically significant improvement in terms of performance status and thoracic symptoms.

Aged↗

[Sequential or alternate chemo-radiotherapy in the treatment of advanced head and neck tumors. Results of a randomized study].

Between 1983 and 1986, a multicenter randomized study was conducted to compare a sequential program of induction chemotherapy (CT) followed by radiotherapy (RT), Arm A, with an alternation of 4 cycles of CT with 3 courses of RT (20 Gy/10 fractions up to a total dose of 60 Gy), Arm B, in advanced head and neck cancer patients. The same CT (VBM: Vinblastine, Bleomycin, Methotrexate) was used on both arms; one hundred and sixteen patients (pts) entered the study, 55 in Arm A, 61 in Arm B. Fourty-five pts had stage III and 71 stage IV cancers. The two arms are fully comparable. Up to October 1987, 116 pts are evaluable for survival, while 112 are evaluable for toxicity and 105 for response. In 21 patients (10 in Arm A, 11 in B) the association CT-RT was followed by surgery. Response analysis shows 14 complete responses in Arm A and 30 in Arm B (p less than or equal to 0.03). The median disease-free survival and median overall survival are also statistically different, with an advantage for Arm B (33 vs 22 weeks, p less than or equal to 0.0007, and 59 vs 38 weeks, p less than 0.03 respectively). The actuarial overall survival of complete responders at 50 months is 43% (B) and 21% (A). Toxicity (mainly stage III-IV mucositis) is superior in Arm B (30% vs 4%). Our experience demonstrates the advantages of alternate over sequential CT-RT. A comparison of this cyclic association with RT alone is in progress.

Actuarial Analysis↗

Combination chemotherapy with methotrexate, bleomycin, and vincristine with or without cisplatin in advanced squamous cell carcinoma of the head and neck.

A total of 185 eligible patients with advanced inoperable squamous cell carcinoma of the head and neck were randomized into two groups; the cisplatin, methotrexate, bleomycin, and vincristine (CABO) group received cisplatin (50 mg/m2; day 4), methotrexate (40 mg/m2; days 1, 15), bleomycin (10 mg; days 1, 8, and 15), and vincristine (2 mg; days 1, 8, and 15) and the ABO group received methotrexate, bleomycin and vincristine in the same doses on days 1, 8, and 15. After three courses, patients in both arms received weekly methotrexate as maintenance therapy; those 34 patients with previously untreated locoregional disease went off the study because of subsequent locoregional treatment in form of radiotherapy +/- surgery. The complete response rate was 16% in patients receiving CABO, compared with 5% among patients given ABO. The corresponding overall response rates were 50% and 28%, respectively (P = 0.003). Among patients with recurrent or metastatic disease, progression was delayed in patients receiving CABO (median, 18 weeks) compared to those receiving ABO (median, 14 weeks) (P = 0.07), but there was no difference in survival time. Myelosuppression consisted mostly of leukopenia, which was seen in 67% of the CABO patients versus 47% in the other arm. Myelosuppression-associated infection and hemorrhage led to death in two patients in the CABO treatment group and six patients in the ABO treatment group. Nausea and vomiting, mostly of grades 1 or 2, occurred in 93% of the patients given CABO and 44% of those receiving ABO. Other toxic effects--neuropathy, alopecia, stomatitis, constipation, fever/chills, diarrhea, cutaneous alterations, and renal impairment--occurred equally in the two treatment groups. This study underlines the role of cisplatin in head and neck cancer, although no impact on survival could be demonstrated. It also supports indirectly the superiority of combination chemotherapy over single-agent treatment for this disease.

Adult↗

High-dose cisplatin in the outpatient clinic: a feasibility study.

A clinical trial was undertaken to assess the feasibility of treatment with high-dose cisplatin on an outpatient basis. Eleven patients entered the study: 9 patients with squamous cell carcinoma of the head and neck, 1 patient with malignant melanoma of the skin, and 1 patient with breast cancer. All patients were pretreated. The chemotherapy scheme consisted of cisplatin, 60 mg/m2 for 3 consecutive days, every 4 weeks. We observed 5 partial responses, 4 stable diseases, and 1 progression of disease; 1 patient failed due to toxicity. The overall response rate was 45.4%. This treatment was associated with severe toxicity including nausea and vomiting, myelosuppression, neurotoxicity, nephrotoxicity and electrolyte disorders. Two patients died and 2 discontinued the treatment due to toxicity. In light of the incidence and severity of toxicity, this treatment should not be used as routine practice.

Adult↗

Relapsing eruptive multiple Spitz nevi or metastatic spitzoid malignant melanoma?

An unusual case of multiple relapsing Spitz nevus (SN) in a patient with pseudohypoparathyroidism is described. It arose initially as a single lesion, and recurred twice as multiple agminated lesions that maintained the same histological pattern as the original SN. Nevertheless, the clinical behavior led to a diagnosis of metastasis from malignant melanoma at another medical institution. This case emphasizes the need for relying on accurate histopathological criteria to distinguish SN from malignant melanoma if inappropriate and detrimental therapeutic procedures are to be avoided.

Adolescent↗

Methylprednisolone for the control of CMF-induced emesis.

Sixty-eight breast cancer patients for outpatient adjuvant chemotherapy (CT) with cyclophosphamide, methotrexate, and fluorouracil (CMF) on a 1-day schedule entered a randomized trial comparing the antiemetic-efficacy of different doses of methylprednisolone (MPN). Treatment was administered concomitantly with the first course of CT and consisted of MPN in either 375 or 120-mg doses divided into 3 equal parts, the first administered i.v. just prior to CMF and then i.m. 6 and 12 h after CT. Overall, antiemetic protection was appreciable: complete emetic protection (no emetic episodes) was observed in 71 and 66% of patients receiving MPN 375 and 120 mg, respectively. In 43 and 54% of patients receiving MPN 375 and 120 mg, respectively, nausea did not occur. Efficacy of the two treatment arms was not statistically different for either emesis or nausea. Antiemetic protection with MPN was reproducible over time at subsequent courses: 60% of patients in either treatment arm experienced less than 5 emetic episodes at their 12th CMF course. Facial flush was the most frequently observed side effect (36% with MPN 120 mg vs. 68% with MPN 375 mg). Other acute untoward effects consisted of headache, pyrosis, and edema. However, the latter was observed only with the higher dose. In patients receiving CMF, MPN alone provides effective and reproducible emetic protection. No dose-response relationship was observed.

Adult↗

A phase II study with danazol in metastatic breast cancer.

Danazol is a synthetic steroid that inhibits the gonadotropin secretion. Its efficacy was tested in 27 patients with metastatic breast cancer at the dose of 200 mg three times daily. Characteristics of patients were as follows. The median age was 57 years (range, 44-85). All patients were postmenopausal, and all had previously received a median of two (range, 1-3) endocrine therapies. Estrogen receptor status was known in 12 (positive in five of 12; negative in seven of 12). Dominant sites of metastases were lung in seven, bone in ten, liver in three, and soft tissue in seven. Six of 27 patients were unevaluable for response (early death, four; lost to follow-up, two). Three of 21 patients showed an objective response, eight of 21 obtained stabilization of disease, and eight progressed. The therapy was well tolerated in the majority: gastric pain was observed in three and nausea in two. Danazol could have a role in the treatment of metastatic breast cancer as an alternative regimen when other treatment has failed.

Adult↗

Adjuvant immunochemotherapy in colorectal cancer Dukes C.

The initial aim of the present study was to verify in a randomized trial whether the addition of Levamisole, an immunomodulator, could increase the effectiveness of postoperative chemotherapy (MeCCNU + 5-FU) in Dukes C colorectal cancer patients. After entering 29 consecutive patients, the poor results of most studies of adjuvant therapy in colorectal cancer prompted an early end to patient accrual. After 8 years, the lack of significance in survival (48.9 versus 37.3%) and disease-free survival (50 versus 38.8%) between the two treatment arms rules out any improvement associated with Levamisole administration.

Adjuvants, Immunologic↗

Stage I-II melanoma: the value of metastatic work-up.

A total of 116 asymptomatic patients with malignant skin melanoma entered a multiple staging work-up including chest X-ray, multiple nuclear scans and abdominal ultrasonography. All 116 chest X-rays and 68 brain scans performed gave negative findings. Liver scans resulted in 1/66 false-positive findings. Out of 73 bone scans, 5 gave false-positive results. Only 2 out of 66 abdominal ultrasonographies showed abnormal findings and were found to be true-positive on surgical exploration. Due to the low yield in detecting silent metastases, such a multiple staging work-up would not be regarded as a routine staging program.

Adolescent↗

Multimodality treatment of locally advanced breast cancer.

From 1976 to 1985, 61 consecutive patients with locally advanced breast cancer were treated with multimodality therapy. Overall 5-year survival was 30% with a median survival of 36 months. 50% of patients relapsed within 13 months. Other factors such as menopausal status, side of illness (right or left breast), responses to systemic or to local treatment, survival and progression-free survival in responders and non-responders have been analyzed.

Adult↗

4-Demethoxydaunorubicin (IMI-30) in refractory epithelial ovarian cancer: a pilot study.

Fifteen patients with advanced epithelial ovarian cancer were treated with 4-demethoxydaunorubicin (IMI-30) after platinum failure. A total of 33 courses of IMI-30 15 mg/m2, per os, daily for 3 consecutive days every 3 weeks were performed. Three patients experienced severe hematologic toxicity (WHO grade greater than or equal to 3), while gastroenteric toxicity was acceptable and no cardiotoxicity was observed. One minor response, 4 stabilization of disease and 7 progression were observed in 12 evaluable patients. In conclusion, IMI-30, at this scheduling, is inactive in our small series of heavily pretreated epithelial ovarian cancer patients.

Aged↗

Metastatic malignant melanoma treated with procarbazine, vincristine and lomustine (POC).

Fourteen consecutive melanoma patients with evaluable metastatic disease were treated with combination chemotherapy including procarbazine, vincristine and lomustine (POC). All but two patients had been previously treated with single agent chemotherapy (dacarbazine 11 patients, melphalan plus hyperthermia 1 patient). One transient partial response and 4 stable disease were noted. Median overall survival was 5 months. In our experience POC seems unlikely to improve the response rate compared with other chemotherapy combinations. Patient characteristics can partially explain the contrasting results reported in the literature.

Adult↗

Hypercoagulable state induced by cytostatic drugs in stage II breast cancer patients.

An increased incidence of thromboembolic complications occurring in cancer patients during chemotherapy was recently reported. In view of this report, a study in 49 patients receiving adjuvant chemotherapy for Stage II breast cancer was begun in order to determine the effect of antineoplastic drugs on coagulation factors and platelet function. Among the coagulation factors, a significant decrease of thrombin time and partial prothrombin time was observed, whereas platelet function tests were unchanged. This finding suggests a trend towards hypercoagulability induced by chemotherapy. This effect should be considered when chemotherapy is employed in advanced cancer patients at high risk for thrombosis.

Adult↗