Biomedical subjects

P Pinnarò

Publications and source records attributed to P Pinnarò.

6 recordsLinked to original sources

PubMed1994

A randomized phase II study comparing sequential versus simultaneous chemo-radiotherapy in patients with unresectable locally advanced squamous cell cancer of the head and neck.

BACKGROUND: Single-modality radiotherapy is still considered standard treatment for patients with locally advanced unresectable cancer of the head and neck. As treatment outcome is poor, attempts to integrate chemotherapy into the overall management of these patients are ongoing. PATIENTS AND METHODS: A randomized study was undertaken to compare a sequential with a simultaneous chemoradiotherapy program. Between February 1986 and February 1991, 93 eligible patients with locally advanced unresectable cancer of the head and neck were stratified by WHO PS, T and N class and primary site and then randomized to receive either three courses of neoadjuvant chemotherapy with cisplatin (100 mg/m2 i.v. d 1) and 5-fluorouracil 1000 mg/m2/days 1-5 by continuous i.v. infusion every 3 weeks prior to definitive conventional radiotherapy of 65-70 Gy (sequential treatment), or cisplatin 100 mg/m2 on days 1, 22, 43 given simultaneously for the duration of the same conventional radiotherapy (simultaneous treatment). RESULTS: At the end of the entire treatment 18 complete responses (47%) in the sequential-treatment arm and 18 (41%) in the simultaneous treatment arm were obtained. No statistically significant differences in the 5-yr progression-free survival, in the median time to loco-regional and distant progression and in the 5-yr overall survival were observed. Leukopenia was more frequent in the simultaneous than in the sequential arm (p = 0.03), whereas alopecia (p = 0.008) and phlebitis (p < 0.0001) were more frequent in the sequential-treatment arm. A better compliance was associated with the concomitant treatment, with 87% of the patients completing the entire radiotherapy program versus 63% of those in the sequential arm (p = 0.01). CONCLUSIONS: In the present study, the two treatment arms showed similar activity (complete response, progression-free and overall survival rates). Compliance to treatment was better in the concomitant arm. These data suggest that concomitant chemo-radiation therapy might be considered an option in unresectable locally advanced cancer of the head and neck. Phase III studies are needed in order to establish the superiority of this combination of cisplatin and radiotherapy versus radiotherapy alone.

Adult↗

PubMed1988

Neoadjuvant chemotherapy in previously untreated patients with advanced head and neck squamous cell cancer.

Between May 1981 and January 1986, 130 consecutive patients with advanced untreated head and neck squamous cell cancer (HNSCC) received neoadjuvant chemotherapy (NAC) with two or three courses of the CABO combination (methotrexate 40 mg/m2 intravenously (IV) on days 1 and 15; CDDP 50 mg/m2 IV on day 4; bleomycin 10 mg IV on days 1, 8, and 15; and vincristine 2 mg IV on days 1, 8, and 15 every 3 weeks) prior to surgery and/or radiotherapy. Of the 123 patients evaluable for response to chemotherapy, 19 (15.4%) had a complete remission and 59 (48%) a partial response, yielding a 63.4% overall response rate. Response rate was significantly correlated with the performance status (PS) (P = 0.001), the stage (P = 0.005), and the T class (P = 0.02); 107 patients completed subsequent local treatment (87 with radiotherapy and 20 with surgery +/- radiotherapy). The median survival of the 124 patients evaluable for survival was 14.7 months and the overall survival rate at 3 years was 24%. The median survival and the overall survival at 3 years for the surgical subgroup were 24.7 months and 38% and for the radiotherapy subgroup were 14.3 months and 22%. These results were compared with those obtained in a historical control group of 79 patients treated in our institute with short courses of chemotherapy regimens, which did not include cisplatin, followed by radiotherapy (29 patients) or local treatments alone (26 patients with radiotherapy and 24 patients with surgery +/- radiotherapy) between January 1976 and December 1980. Most of the patient characteristics were evenly distributed (age, sex, and primary sites) except that more advanced lesions were included in the NAC group (Stage IV: 85% versus 62%; T4: 65% versus 42%; N2-3: 48% versus 29%). The overall survival was significantly higher in patients receiving NAC than in the historical control group, comparing both the groups taken as a whole (P less than 0.05) and the surgery +/- radiotherapy (P less than 0.05) and the radiotherapy (P less than 0.02) subgroups. This experience suggests a positive role of NAC on survival. However, this improvement in outcome compared with a historical control group cannot be regarded as definitive evidence for benefit to patients. Randomized studies using active regimens are required to confirm these data.

Aged↗

PubMed1987

Alternating regimens in recurrent and metastatic squamous cell carcinoma of the head and neck.

In the present pilot study, two courses of CF and CABO combination chemotherapy were administered in an alternating manner to 27 patients affected with recurrent and metastatic squamous cell carcinoma of the head and neck. Of the 23 evaluable patients, 5 complete responses and 5 partial responses were observed; the overall response rate was 43.5%. Two out of five complete responders are still free of disease 30 and 65 weeks after the administration of CR. The toxicity of this program was tolerable and was carried out on an out-patient basis in all cases. The median survival of the entire group was 41 weeks (range 8-98.+). We conclude that these alternating regimens are not likely to produce better responses than other conventional cisplatin-including combinations, but they seem to significantly increase the duration of the response.

Antineoplastic Agents↗

PubMed1986

Cumulative or delayed nephrotoxicity after cisplatin (DDP) treatment.

The present retrospective study reports data regarding renal toxicity in 115 patients (63 males, 52 females; median age, 56 years) who received cumulative doses of cisplatin (DDP) greater than or equal to 200 mg/m2. DDP was administered alone or in combination at a dose of 50-70 mg/m2 in 91 patients, and at a dose of 100 mg/m2 in 22 patients. Two patients after progression of ovarian carcinoma treated with conventional doses of DDP received 4 and 2 courses, respectively, of high-dose DDP (40 mg/m2 for 5 days) in hypertonic saline. The median number of DDP courses was 6 (range 2-14), and the median cumulative dose was 350 mg/m2 (range, 200-1200). Serum creatinine and urea nitrogen were determined before initiating the treatment and again 13-16 days after each administration. The incidence of azotemia (creatinina levels that exceeded 1.5 mg/dl) was similar before (7.8%) and after (6.1%) DDP doses of 200 mg/m2. Azotemia appears to be related to the association of DDP with other potentially nephrotoxic antineoplastic drugs (methotrexate) more than to the dose per course of DDP. Of 59 patients followed for 2 months or more after discontinuing the DDP treatment, 3 (5.1%) presented creatinine values higher than 1.5 mg/dl. The data deny that the incidence of nephrotoxicity is higher in patients receiving higher cumulative doses of DDP and confirm that increases in serum creatinine levels may occur some time after discontinuation of the drug.

Adolescent↗

PubMed1986

Maintenance of antiemetic effect of a metoclopramide-dexamethasone combination during subsequent cisplatin courses.

In two previous consecutive studies on antiemetic combination of metoclopramide and dexamethasone was found to be very active against nausea and vomiting induced by cisplatin (DDP; 50 mg/m2) alone or in combination with other cytotoxic emetogenic drugs. In the present study the activity of the same antiemetic combination has been followed in 18 patients during subsequent DDP courses. Twelve out of 18 patients (67%) had a complete control of the side effect after the first course of chemotherapy. No statistically significant differences were found as regards the intensity of nausea and vomiting, the patients' overall opinions and preference and the emesis duration. In conclusion this antiemetic combination can guarantee a high degree and long-term control of DDP-induced emesis at a dose of 50 mg/m2 given alone or in combination.

Adult↗

PubMed1984

Randomized open cross-over trial between metoclopramide (MCP) and dexamethazone (DXM) for the prevention of cisplatin-induced nausea and vomiting.

Thirty-five patients receiving chemotherapeutic regimens including cisplatin (CDDP) were entered into a randomized open cross-over trial. Sixteen patients had previously received chemotherapy. Metoclopramide (MCP) was given i.v. in 4 doses of 1 mg/kg over a period of 4 1/2 hr, dexamethazone (DXM) was administered i.m. in 4 doses of 8 mg over 24 hr and another 10 mg i.v. just prior to CDDP administration. Sixteen patients who expressed a positive opinion on both previous antiemetics were given placebo (PLC). No significant differences were found between MCP and DXM, considering the mean score of both emesis intensity and patient's opinion. The mean duration of the symptoms was significantly longer with MCP than with DXM (P less than 0.02). Both antiemetic agents were more effective than PLC. No significant side-effects were observed. The results of this study indicate that both MCP and DXM provide a similar protection against CDDP-induced nausea and vomiting.

Adult↗