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Biomedical subjects

M Merlano

Publications and source records attributed to M Merlano.

At least 37 records · Page 2Linked to original sources
PubMed1993

Concomitant alpha-interferon and chemotherapy in advanced squamous cell carcinoma of the head and neck.

The combination of chemotherapy and interferons has been tested in several human tumors but, until now, no clinical data have been reported in head and neck cancer. At the Istituto Nazionale per la Ricerca sul Cancro of Genoa, 14 patients with previously treated SCC-HN underwent the following regimen: cisplatin, 20 mg/m2/day, 5-fluorouracil, 200 mg/m2/day i.v. bolus and recombinant interferon-alpha-2b (r-IFN-alpha-2b) (Intron-A, Shering-Plough), 3 MIU/day i.m., for 5 consecutive days. Recombinant IFN-alpha-2b was also administered, at the same dosage, 3 times per week during the 2 weeks interval among cycles. Grade III-IV hematological toxicity was recorded in 43% of patients. Increasing fatigue, anorexia, and flu-like symptoms were experienced by most patients. For these reasons 9 of 14 patients needed a chemotherapy delay and a r-IFN-alpha-2b discontinuation. Therefore, due to the heavy toxicity observed, accural was terminated early. The overall response rate was 54% (31% CR, 23% PR). Among the 5 patients who never delayed chemotherapy and discontinued r-IFN-alpha-2b, all but one responded. In conclusion, a synergistic activity between chemotherapy and r-IFN-alpha-2b in head and neck cancer cannot be excluded, but, in our opinion, further investigations should consider less aggressive regimens and/or more selected patients.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1992

Treatment of advanced squamous-cell carcinoma of the head and neck with alternating chemotherapy and radiotherapy.

BACKGROUND: For patients with advanced, unresectable squamous-cell carcinoma of the head and neck, radiotherapy is the standard treatment but has poor results. We therefore designed a randomized trial to determine whether alternating chemotherapy with radiotherapy would improve the survival of such patients. METHODS: Patients in the trial had biopsy-confirmed unresectable, previously untreated Stage III or IV, squamous-cell carcinoma of the oral cavity, pharynx, or larynx. They were randomly assigned to chemotherapy consisting of four cycles of intravenous cisplatin (20 mg per square meter of body-surface area per day for five consecutive days) and fluorouracil (200 mg per square meter per day for five consecutive days) alternating with radiotherapy in three two-week courses (20 Gy per course; 2 Gy per day, five days per week), or to radiotherapy alone (up to 70 Gy; 2 Gy per day, five days per week). RESULTS: The 80 patients given chemotherapy alternating with radiotherapy and the 77 given radiotherapy alone were comparable in terms of age, sex, performance status, disease stage, and site of the primary tumor. Complete responses were obtained in 42 percent of the patients in the combined-therapy group and 22 percent of those in the radiotherapy group (P = 0.037). The median survival was 16.5 months in the combined-therapy group and 11.7 months in the radiotherapy group (P less than 0.05); the 3-year survival was 41 percent and 23 percent, respectively. Severe mucositis occurred in 19 percent of the patients in the combined-therapy group and 18 percent of those in the radiotherapy group. CONCLUSIONS: In patients with advanced unresectable squamous-cell carcinoma of the head and neck, chemotherapy alternating with radiotherapy increases the median survival and doubles the probability of survival for three years as compared with radiotherapy alone. However, since local disease cannot be controlled in over half the patients who receive the combined treatment and since almost two thirds die within three years, further improvements in management are necessary.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1991

Combined chemotherapy and radiation therapy in advanced inoperable squamous cell carcinoma of the head and neck. The final report of a randomized trial.

Between 1983 and 1986, the National Institute for Cancer Research in Genoa and affiliated institutions conducted a randomized study to compare two different ways of combining chemotherapy (CT) and radiation therapy (RT). One hundred sixteen patients were randomized to receive neoadjuvant CT followed by definitive RT (treatment arm A) or alternating CT and RT. In treatment arm A, RT consisted of 70 Gy to the involved areas and 50 Gy to the uninvolved neck at 2 Gy/fraction, five fractions per week. In treatment arm B, RT consisted of 60 Gy to involved areas and 50 Gy to the uninvolved neck in three courses of 20 Gy each, 2 Gy/fraction, ten fractions/2 weeks alternated with four courses of CT. CT consisted of vinblastine 6 mg/m2 intravenously followed 6 hours later by bleomycin 30 IU intramuscularly, day 1; methotrexate 200 mg intravenously, day 2; leucovorin rescue, day 3. CT was repeated every 2 weeks up to four courses. The same CT was used in both treatment arms of the study. Fifty-five patients were entered in treatment arm A and 61 in treatment arm B. Complete responses were 7/48 and 19/57 in treatment arms A and B, respectively (P less than 0.03). Four-year progression-free survival was 4% in treatment arm A and 12% in treatment arm B (P less than 0.02), and four-year survival was 10% in A and 22% in B (P less than 0.02). Mucosal tolerance was significantly worse in treatment arm B (P less than 0.00004). The subgroup analysis shows the major improvement of alternating CT and RT in patients with the worst prognostic characteristics.

Adult↗
PubMed1990

5-Fluorouracil and high-dose folinic acid as second-line chemotherapy in head and neck cancer.

Experimental and clinical data support the concomitant use of 5-fluorouracil (5-FU) and high-dose folinic acid (HDFA). To verify the role of such a combination in far advanced head and neck cancer, we performed a phase II study employing weekly HDFA, 500 mg/m2 in 2-h infusions, and 5-FU, 600 mg/m2 bolus injection. Twenty-seven evaluable patients with recurrent disease entered the study. One complete response, seven partial responses, 10 stable disease, and nine progressions were observed: the overall response rate was 29.6%. Oral mucositis and diarrhea were major side effects; five patients discontinued the treatment due to toxicity; no deaths correlated to the treatment were detected. Considering the characteristics of our patients, the 5-FU/HDFA combination has shown a satisfactory antitumoral activity, but toxicity was similar to other chemotherapy regimens.

Aged↗
PubMed1990

Randomized comparison of two chemotherapy, radiotherapy schemes for stage III and IV unresectable squamous cell carcinoma of the head and neck.

Between August 1983 and December 1986, 116 previously untreated patients with squamous cell carcinoma of the head and neck were randomized to receive induction chemotherapy followed by radiotherapy given in conventional fractions (55 patients, arm A) or an alternating chemotherapy and radiotherapy (3 courses of 20 Gy, 10 daily fractions each; 61 patients, arm B). The same chemotherapy was used in both arms: 6 mg/m2 vinblastine sulfate, hour 0; 30 mg bleomycin, hour 6; 200 mg methotrexate, hours 24 to 26; 45 mg leucovorin, hour 48. Forty-five patients had stage III disease and 71 had stage IV disease. All patients were evaluated for survival, 112 for toxicity, and 105 for analyses of response and time from the start of treatment until progression of disease. At the end of the combined treatment, we observed an overall response rate of 52% in arm A and an overall response rate of 64.9% in arm B. The incidence of mucositis was more relevant in arm B compared to arm A (P less than .00004). The difference in complete response, progression-free survival, and survival was statistically significant, with an advantage for arm B (P less than .03, P less than .02, and P less than .03, respectively). The analysis at a median follow-up of 36 months (range = 19 to 59) demonstrates a higher effectiveness for the alternating program.

Adult↗
PubMed1990

[Biological aspects and perspectives applicable to the chemoprevention of cancer of the upper respiratory-digestive tract].

After defining chemoprevention a description is given of the phases of differentiation in normal epithelial cells and the features of proliferation in neoplasias developing in this epithelium. The latest studies on carcinogenesis indicate various types of prevention with which one can alter this transformation process. Epidemiological studies have shown that subjects with low serum levels of Vit-A or Beta carotenoids are at high risk of developing epithelial cancer. Three main categories of agents inducing cell transformation are described: a) physiological induction agents; b) non physiological induction agents; c) cytotoxic drugs. In regard to clinical use, some studies have focussed on the importance of Vit-A in chemoprevention of risk conditions (pre-cancerous lesions) and in prevention of cancer recurrence. The authors point out the increasing interest in the use of retinoids in the chemoprevention of head and neck cancer and report some personal clinical experience.

Adult↗
PubMed1990

[Epidemiology and natural history of cancer of the upper respiratory-digestive tract].

Squamous cell carcinoma of the upper aero-digestive tract represents 86% of all malignant neoplasms developing in the head and neck. In Italy a comparison of the standardized incidence data shows that such cancer is more frequent in the northern than in the central and southern parts of the country. Males are more often affected than females. After considering the most important risk factors the authors analyze the epidemiology and natural history of cancer of each organ of the head and neck.

Carcinoma, Squamous Cell↗
PubMed1989

Analysis of 16 patients with metastatic squamous cell carcinoma of the head and neck: implications for treatment.

The present paper reports a retrospective analysis of 16 patients with distant metastases from squamous cell carcinoma of the head and neck observed in our Institute in the last 10 years. Nine patients out of 16 underwent chemotherapy (7 patients), chemotherapy and radiotherapy (1 patient), or an alternating chemo-radiotherapy regimen (1 patient). The remaining 7 patients were not considered for a palliative treatment because of a poor performance status. Two complete responses, 2 partial responses, 2 stable diseases and 3 progressions were observed, with an overall response rate of 44%. Chemotherapy, when administrable, showed a temporary effectiveness, at least in patients with lung metastases. The combination of cisplatin and 5-fluorouracil seems to maintain the efficacy already shown in patients with locally relapsed disease.

Adult↗
PubMed1989

Neoadjuvant or definitive alternating chemotherapy and radiotherapy for infiltrating bladder cancer.

Thirty-two patients with infiltrating bladder cancer were treated with transurethral resection followed by one course of alternating chemoradiotherapy before radical cystectomy (group A, 20 patients) or two courses as definitive procedure (group B, 12 patients). One course consisted of: cisplatin 20 mg/m2 i.v. and 5-fluorouracil 200 mg/m2 i.v. for 5 consecutive days, the first and the fourth weeks; radiotherapy 20 Gy in 10 fractions in the second and third weeks. At the seventh week the same integrated therapy was restarted in group B. All 32 patients were evaluable for toxicity after the first course: no grade IV toxicity was observed. Significant increase in hematological toxicity was observed in 12 patients who received the second course of chemoradiotherapy: two patients had grade IV toxicity, and five patients had grade III. Fifteen patients of group A underwent radical cystectomy: 40% had a pathological (p) complete response (CR) and 13.3% a partial response Five patients in group A did not receive either the second course of therapy or cystectomy because of age (three patients), vascular obliteration (one patient) and enteritis (one patient). Actuarial disease-free survival in group A is 78% at 21 months. All patients of group B obtained clinical (c) CR and all but one have no evidence of disease at a median follow-up of 10 months (range 6-13). The high pCR and cCR obtained in patients of group A and group B, respectively, appears promising. A longer follow-up and a larger number of patients is required to determine the role of this integrated treatment.

Adjuvants, Pharmaceutic↗
PubMed1988

Cisplatin and 5-fluorouracil in refractory breast cancer patients: a phase II study.

24 patients with a median of 3 prior chemotherapy regimens were treated in our department with cisplatin 20 mg/m2 (with pre- and posthydration) and 5-fluorouracil 200 mg/m2 i.v. on day 1-5, every three weeks. 23 patients are evaluable; one had early death. 4 patients (17%) achieved a partial response, 8 had stable disease, and 11 progressed. Toxicity observed was moderate and no renal toxicity was noted. This study therefore shows tolerable toxicity but limited usefulness of adding cisplatin to 5-fluorouracil according to this schedule in these highly pretreated patients.

Adult↗
PubMed1988

Alternating cisplatin-5-fluorouracil and radiotherapy in head and neck cancer.

Thirty-four patients with advanced (stage IV) or relapsing squamous cell carcinoma of the head and neck (SCC-HN) were treated alternately with chemotherapy (CT) and radiotherapy (RT). Patients' characteristics were as follows: male: female ratio, 27:7; median age, 55 (34-76), median P.S., 1 (ECOG scale) (range 0-2). Patients studied had no renal, hepatic, or cardiac impairments, a life expectancy of greater than or equal to 3 months, and no previous treatment with RT or CT. Seventeen patients were previously untreated, and 17 had a relapse after radical surgery. The CT regimen consisted of 20 mg/m2 cisplatin, with 2 h forced diuresis, from day 1 to 5, and 200 mg/m2 i.v., from day 1 to 5, every 3 weeks, administered four times. The RT was performed after the first, second, and third CT course, and consisted of three courses of 20 Gy each, 2 Gy daily, 5 days per week. Weekend intervals were planned between CT and RT treatments. The 17 previously untreated patients showed an overall response rate of 88.2% [eight complete response (CR), seven partial response (PR), one stable disease (SD), one progression disease (PD)]; the 17 patients treated at relapse after radical surgery reached an overall response rate of 64.7% (six CR, five PR, six PD). Actuarial median survival is 47 weeks: 51 weeks in untreated patients, and 42 weeks in previously treated patients. Toxicity was mild, and only 10 patients suffered from grade III (WHO scale) gastrointestinal (2 patients), hematological (5 patients), mucosal (2 patients), and neurological (1 patient) toxicity. Neither grade IV toxicity nor treatment-related deaths have been observed. In our study, cisplatin and 5-FU alternating with RT has shown an interesting antitumor activity and moderate side effects.

Adult↗
PubMed1988

Sequential versus alternating chemotherapy and radiotherapy in stage III-IV squamous cell carcinoma of the head and neck: a phase III study.

A cooperative randomized study was begun in August 1983 to compare a sequential program of induction chemotherapy followed by definitive treatment, arm A, with an alternation of chemotherapy and radiotherapy (three courses of 20 Gy in ten daily fractions), arm B. The same chemotherapy was used in both arms: 6 mg/m2, vinblastine, hour 0; 30 mg, bleomycin, hour 6; 200 mg, methotrexate, hours 24 to 26; 45 mg, leucovorin, hour 48. One hundred sixteen patients entered the study, 55 in arm A and 61 in arm B. The patients all had previously untreated squamous cell carcinoma of the head and neck (SCCHN). Forty-five patients had stage III and 71 had stage IV disease. The two arms were fully comparable. As of April 1986, 116 patients were evaluable for survival, while 112 were evaluable for toxicity and 105 for response. Response analysis shows that there were 14 complete responses (CR) and 11 partial responses (PR), for an overall response rate (ORR) of 52% in arm A, and 30 CRs and seven PRs, for an ORR of 64.9% in arm B. The difference in terms of CR between the two arms was statistically significant (P less than .03). Progression-free survival (PFS) was also statistically different, with an advantage for arm B (P less than .05), but without differences in overall survival. Arm B correlates with a significant increase in mucositis compared with arm A (P less than .001).

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

[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↗
PubMed1987

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↗
PubMed1987

Simultaneous cisplatin and 5-fluorouracil as second-line treatment of head and neck cancer.

Between November 1983 and January 1986, 70 patients with recurrent squamous cell carcinoma of the head and neck were treated with simultaneous cisplatin (20 mg/m2 for 5 consecutive days) and 5-fluorouracil (400-200 mg/m2 by iv push for 5 consecutive days) every 3 weeks. Sixty-seven patients were fully evaluable. The major toxic effect was myelosuppression, and two patients died from septic or hemorrhagic complications. Other toxic effects were moderate and quite rare, including nausea and vomiting. All of the patients were treated in the outpatient clinic. The overall response rate was 52.2% (14 complete responses +21 partial responses). The worst prognostic factor in the present series was the persistence of disease after front-line therapy. This treatment has shown an acceptable toxicity and its antitumoral activity seems to be in the range of the higher activity reported by literature in these kind of patients.

Adult↗