Combination of daily 4-h infusion of 5-fluorouracil and cisplatin in the treatment of advanced head and neck squamous-cell carcinoma: a South-East European Oncology Group study.

Between April 1986 and May 1989 a multicentre study was conducted to evaluate the efficacy of a 4-h intravenous infusion of 1000 mg/m2 5-fluorouracil (5-FU) followed by a 1-h infusion of 25 mg/m2 cisplatin (CDDP) given for 4 consecutive days every 4 weeks to patients with advanced squamous-cell carcinoma of the head and neck. A total of 189 consecutive patients entered the study, including 106 who had previously undergone chemotherapy and 83 who were chemotherapy-naive. Of the 165 evaluable patients, 96 (58%) responded to treatment, including 22 (13%) who achieved a complete remission (CR). In the group of previously untreated patients an objective response (CR+PR) was seen in 78% (CR, 14%) whereas in pretreated patients the response rate (CR+PR) was 40% (CR, 13%). The median survival period was 10 months. No significant difference in the duration of survival or of remission was found between the two groups in relation to previous therapy, tumour localisation, disease stage or performance status. Almost half of the patients (49%) experienced leucopenia but it was severe in only 11% of cases. Anemia (mainly WHO grades 1-2) occurred in 38% of the patients. Nausea and vomiting were common (84%). Nephrotoxicity (23%) was mild and of short duration. Moderate hair loss was seen in 42% of the patients, and phlebitis occurred in 8%. A few cases of cardiotoxicity and neurotoxicity were observed. This regimen is well tolerated and can be given even on an outpatient basis. The resultant response rate and side effects appear to be similar to those previously reported for combination chemotherapy with CDDP and continuous 5-FU infusion.

Combination chemotherapy with vincristine, epirubicin and cyclophosphamide in small cell lung carcinoma. Polish Lung Cancer Cooperative Group.

The aim of this prospective study was to assess the activity of a combination of vincristine, epirubicin and cyclosphosphamide (VEC) in previously untreated patients with limited small cell lung carcinoma (SCLC) and to delineate the feasibility of dose escalation for epirubicin in this regimen. The chemotherapy schedule included cyclophosphamide, 1000 mg/m2, vincristine, 1 mg/m2 and escalating doses of epirubicin: 50 mg/m2, 70 mg/m2 and 90 mg/m2; respectively in three consecutive groups of patients. Drug cycles were repeated every 3 weeks. 118 patients from eight institutions were enrolled in this study between February 1986 and March 1989. Objective tumour response was observed in 81 of 116 evaluable patients (70%) including 25 patients (22%) who achieved a complete remission. Responding patients received thoracic radiation after the fourth cycle of chemotherapy. The median duration of response was 30 weeks and the median duration of survival was 52 weeks. There were no significant differences in treatment results between the consecutive groups of patients. The regimen was well tolerated for all doses of epirubicin. The main toxicities included alopecia (96%), nausea and vomiting (81%) and leukopenia (44%). Grade 4 haematological toxicity was observed in 3 patients (2.6%). No significant epirubicin dose-dependent side effects, except for mucositis were observed.

[Long-term survival of patients with small cell lung cancer]. / Dlugotrwale przezycia chorych na drobnokomórkowego raka pluca.

The analysis of clinical determinants of long-term survival in small cell lung cancer was investigated in consecutive series of 469 patients included in prospective multicenter clinical trials from 1981 to 1985. Forty eight patients (19.2%) were alive after 2 years from initiation of therapy and among them 27 (5.8%) were disease free. The most important clinical determinants of long-term survival were: extent of disease, performance status and sex. 38 out of 243 patients with limited disease (15.6%) survived for 2 years or more as well as 10 out of 226 patients with extensive disease (4.4%, p less than 0.001), 33 out of 237 patients with WHO performance status 0 and 1 (13.9%), and 15 out of 232 patients with performance status from 2 to 4 (6.4%, p less than 0.01), 29 out of 229 (12.2%) with absence of weight loss before therapy and 19 out of 240 (7.9%) with weight loss (N.S.), 32 out of 392 males (8.2%) and 16 out of 77 females (20.7%, p less than 0.01). Out of 27 disease-free survivors 21 are alive with no sign of malignancy after 3.5 to 7 years from initiation of therapy. Ten patients out of 229 followed up for a minimum 5 years after inclusion to the studies survived this period with no signs of disease. This study confirms the possible curability of small cell lung cancer, especially in patients with favorable prognostic characteristic.