The Italian Oncology Group for Clinical Research (GOIRC) randomized 55 naive patients with advanced pancreatic cancer (APC) between intravenous fluorouracil (5FU) 400 mg/m2, days 1-5 and folinic acid (FA) 200 mg/m2, days 1-5 alone, using Machover's schedule, or with FU, FA, and ifosfamide (IFO) 5 g/m2, day 1 and Mesna. In both arms, treatment was repeated every 28 days. Fifty-one patients were evaluable for response. The overall response rate was 6% (3 out of 51), 1 out of 29 (3%) complete response (CR) in the arm with FU plus FA, and 2 out of 22 (9%) partial responses (PR) in the arm with IFO. The duration of response rate was 39, 55, and 74 weeks, respectively. Median survival time was 21 weeks (range, 4-83 weeks) for 5FU/FA and 16 weeks (range, 3-106 weeks) for the FU/FA/IFO arm. Diarrhea, mucositis, and vomiting occurred in the majority of patients. One patient died due to toxicity. The combination of 5FU plus FA failed to demonstrate therapeutic activity in patients with APC and was associated with moderate to severe toxicity that could lower the quality of life of these patients. Ifosfamide did not potentiate the activity of this combination. Neither of these combinations should be considered for treatment of patients with APC.

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The quality of diagnostic and therapeutic care was examined in a series of 380 consecutive newly diagnosed cases of primary lung cancer seen in 20 Italian general hospitals between January and June 1987. At diagnosis most patients (78%) had one or more symptoms related to the tumor, and in an additional 9 % symptoms were related to the presence of distant metastases. The median diagnostic time lag between first symptoms and final diagnosis was 50 days with a significantly longer delay in patients first seen by their general practitioner compared with those who sought first care in hospital outpatient departments. The diagnostic process was satisfactorily carried out in fewer than two-thirds of the patients leading to complete ascertainment of disease stage and histology in 58% cases with significantly better performance in more specialized institutions. Analysis of the first-line treatment profile indicated a rather aggressive therapeutic attitude In the case of patients with non-small cell lung cancer – 28% of them had chemotherapy despite the lack of any proof of efficacy in controlled clinical trials – and a failure to identify among the patients with small cell disease those amenable to more aggressive treatment. The lack of progress in the treatment of lung cancer over the last decades seems to have resulted in widely varying practice patterns where a mixture of aggressive and laissez-faire attitudes does not take into account that in the absence of effective therapies a more conservative attitude would at least have some advantage in terms of quality of remaining life for many patients.

In a phase II trial, 36 patients with advanced gastrointestinal cancer were treated with: folinic acid (FA) 500 mg/m2 in a 2-hr intravenous (IV) infusion, 5- fluorouracil (5-FU) 600 mg/m2 as an IV push injection 1 hr after FA, and hydroxyurea (HU) 35 mg/kg/day given p.o. in three administrations (every 8 hr) 6 hr after 5-FU. Cycles consisted of six weekly treatments for 6 weeks, followed by a 2-week rest period. Thirty-three patients were evaluable for response and 36 for toxicity; 73% had previous chemotherapy. The response rate was 30% (CR + PR), the median duration of response was 21 weeks (range 5-36), and time to failure was 17 weeks (range 3-51). The response in patients previously exposed to chemotherapy was 29% and 44% in chemotherapy-naïve patients. The median survival for all entered patients was 28 weeks (range 6-54). The most common toxicity was gastrointestinal: diarrhea 22/36 (61%), mucositis 15/36 (42%), and nausea and vomiting 15/36 (42%); hematological toxicity was mild. We conclude that HU can potentiate the activity of 5-FU plus FA in advanced gastrointestinal cancer; in particular, HU can restore the activity of 5-FU in patients previously exposed to chemotherapy.

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