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Background: We conducted a phase II randomized study to assess the efficacy, with response as the primary endpoint, and the toxicity of gemcitabine/cisplatin (GP) and gemcitabine/carboplatin (GC) in patients with advanced non-small cell lung cancer (NSCLC)., Methods: Patients were randomized to GP (gemcitabine 1200 mg/m(2), days 1 and 8 plus cisplatin 80 mg/m(2) day 2) or GC (gemcitabine 1200 mg/m(2), days 1 and 8 plus carboplatin AUC=5 day 2). Cycles were repeated every 3 weeks., Results: Sixty-two patients were randomized to GP and 58 to GC. A total of 533 cycles were delivered (264 GP, 269 GC), with a median of four cycles/patient. The objective response rate was 41.9% (95% C.I., 29.6-54.2%) for GP and 31.0% (95% C.I., 18.2-42.8%) for GC (P=0.29). No significant differences between arms were observed in median survival (10.4 months GP, 10.8 months GC) and median time to progression (5.4 months GP, 5.1 months GC). Both regimens were very well tolerated with no statistical differences between arms in grade 3/4 toxicities. When all toxicity grades were combined, emesis, neuropathy and renal toxicity occurred more frequently on the GP arm (P<0.005)., Conclusions: GC arm did not provide a significant difference in response rate compared with GP arm, with better overall tolerability. Carboplatin could be a valid alternative to cisplatin in the palliative setting.

Aims and Background: MVP chemotherapy (mitomycin C, vindesine or vinblastine, cisplatin) is one of the most commonly used regimens for advanced non-small cell lung cancer (NSLCLC). Experimental data suggest a synergistic cytotoxic activity of alpha-interferon (alpha-IFN) when combined with cisplatin, mitomycin C and vinca alkaloids. In an effort to improve MVP chemotherapy activity, we have combined this regimen with alpha-IFN., Patients and Methods: Thirty-five patients with advanced NSCLC (19 stage IV) were treated with the MVP regimen (mitomycin C, 8 mg/m2; vindesine, 3 mg/m2, cisplatin, 75 mg/m2, all on day 1) plus alpha-2a-IFN, 3x10(6) U from day 1 to 7. The cycles were repeated every 28 days., Results: There were no complete responses and 18 partial responses, for an overall response rate of 51%. Median time to treatment failure was 6 months (range, 1-18), and the median survival was 9.5 months (range, 1-32). WHO grade 3 toxicity was recorded in up to 8% of patients, flu-like syndrome was a common complaint; one toxic death occurred., Conclusions: The combination yielded a level of response comparable to that of other cisplatin-based regimens. Larger randomized trials are needed to assess the role of alpha-IFN combined with chemotherapy in advanced NSCLC.

Aims and Background: This study was conducted to investigate the activity and toxicity of 5fluorouracil folinic acid+mitomycin C combined with alpha 2b interferon in advanced colorectal cancer based upon recent studies suggesting a possible biochemical modulation of 5fluorouracil by interferon., Patients and Methods: Between June 1990 and April 1991 25 previously untreated patients with advanced colorectal carcinoma were treated with mitomycin C 10 mg/m2 iv bolus on day 1, 5fluorouracil 375 mg/m2 on days 1 to 4 and folinic acid 200 mg/m2 on days 1 to 4 every 4 weeks, combined with alpha 2b interferon 3 million U day continuously., Response: Of the 25 patients entered into the study, 20 were evaluable for response as 5 patients withdrew due to toxicity (grade 3-4 thrombocytopenia in 4 cases and fatigue in 1). No complete response was recorded, 6 patients had partial remission (30%; 95% confidence interval, 10% to 50%), 4 experienced no change and 10 showed progressive disease. The toxicity of this regimen was significant, particularly myelosuppression., Conclusions: This combination showed a significant toxicity and low response rate compared with other 5fluorouracil based regimens in advanced colorectal cancer.

It is not easy to weigh up therapeutic and toxic effects in the medical treatment of intestinal cancer. The number of drugs that have demonstrated certain activity in these forms is extremely limited, only 5 FU being definitely active and even this only in a small percentage of patients. 5 FU produces remission in some 20% of cases. It is highly probable that prophylactic treatment with 5 FU increases patient survival as reported by Regelson and other workers, but the resulting damage (hepatic, bone marrow, immunodepression, etc.) must also be assessed and the risk of a second neoplasia should not be forgotten. The personally used association of 5 FU and cyclophosphamide has proved active at least to the same extent as 5 FU alone, while toxic effects were not particularly important. Brilliant but unfortunately temporary results can be obtained by peritoneal PTC in peritoneal carcinomatosis. Good results with respect to the pain symptom have been obtained by associating 5 FU with radiotherapy in non-operable intestinal tumours.

5-FU i.v. and Ptc i.v. and intraperitoneally were used to treat 8 patients in the Ancona Oncology Centre suffering from metastatic peritoneal carcinosis. Tolerance was generally good and where side-effects were observed they were the same as those habitually encountered in patients treated with 5-FU and Ptc. Ascitic effusion disappeared or reduced by more than 50% in almost all cases. General condition thus improved.

Since November 1981, 90 cancer patients treated with cytotoxic chemotherapy (CMF, FAC, FAM) have been studied to evaluate whether the administration of Synchrodyn 1-17, 100 micrograms i.m. a day for 15 consecutive days, could reduce some side effects caused by the cytotoxic drugs. Nausea, vomiting and weakness which are the most frequent side effects generally found to be very upsetting to patients, were less pronounced in the treated patients than in patients treated with a placebo. The performance status was not modified by the treatment. Skin pigmentation was noted in the majority of cases and it appeared to be related to the sustained treatment with high dosages of the peptide. Some side effects were observed in the treated patients such as sodium retention and hypertension, hyperglycemia. Successively we have begun to study the circadian rhythm of the cortisol, which often changes during the advanced stages of the illness and which chemotherapy does not seem to alter.