Efficacy of prolonged intermittent therapy with combined 5-FU and methyl-CCNU following resection for gastric carcinoma. A veterans administration surgical oncology group report

Abstract

This prospective evaluation of 5‐fluorouracil (5‐FU) and methyl‐CCNU administered in combination to patients with surgery for histologically proved gastric adenocarcinoma is based upon 312 patients randomized between August 1974 and May 1980. Patients were stratified into three categories of resectability, (1) complete, (2) proven incomplete, and (3) nonresectable, prior to random treatment assignment to surgery alone or surgery followed by adjuvant chemotherapy. Drug therapy consisted of discrete 5‐day courses administered at 7‐week intervals. Toxic reactions were reported in association with 42% of the courses. Treatment was suspended or discontinued in 6% of the courses because of hematologic toxicity. Treated patients with curative resections experienced a more favorable survival than did controls, but the early advantage was lost by the end of the second follow‐up year. However, no statistically significant improvements in survival or reductions in risks of recurrence were observed. Similar proportions of treated and control deaths were attributable to residual or recurrent disease.

Gastric carcinoma in China: Current status and future perspectives (Review)

“…A smallscale randomized study found that adjuvant chemotherapy based on the semustine (Me-ccnU) and 5-FU regimen resulted in longer overall survival compared with surgery alone (22), although this result was not confirmed by a largescale phase III trial (23).…”

Adjuvant therapy for gastric cancer: A reality at last

“…One study done by the Gastrointestinal Tumor Study Group using these drugs found a survival advantage [18]. Unfortunately, trials by the Veterans Surgical Oncology Group [19] and Gastric cancer remains a significant healthcare problem throughout the world and is usually diagnosed at a fairly advanced stage in the West. Despite complete resection of the primary tumor, most patients eventually experience a relapse and die of recurrent disease.…”

Adjuvant therapy in resectable gastric cancer

“…In the reviewed papers important prognostic factors are not considered, like localisation of the primary tumour (Allum et al, 1989a;1989b;Harrisson et al, 1989;Nakajima et al, 1978;Koyama et al, 1986;Ochiai et al, 1983;Popiela et al, 1988;Allum et al, 1989c;GITSG, 1982), age (Coombes et al, 1990;Harrisson et al, 1989), and performance status or loss of weight (Higgins et al, 1983; Alcobendas et al, 1983; Coombes et al, 1990;Harrison et al, 1989;Tonnesen et al, 1988;Moertel et al, 1984;Hugier et al, 1980;Nakajima et al, 1980;Koyama et al, 1986;Maehara et al, 1990;Ochiai et al, 1983;Schlag, 1987;IGTSG, 1988).…”

“…The majority of them gives no details on the procedure (Harrisson et al, 1989;Tonnesen et al, 1988;Moertel et al, 1984;Engstrom et al, 1985;Hugier et al, 1980;Nakajima et al, 1978;Nakajima et al, 1980;Maehara et al, 1990;Schlag, 1987;Lise et al, 1989;Allum et al, 1989c;Koyama et al, 1986;Higgins et al, 1983;Popiela et al, 1988;GITSG, 1982;Blake et al, 1981;Alcobendas et al, 1983) some lay down guidelines for surgical procedure (Coombes et al, 1990;Ochiai et al, 1983;Serlin et al, 1969;GITSG, 1982;IGTSG, 1988) or recommend a specific type of resection (Allum et al, 1989b). None had organised a pathological review of all operative specimens (Coombes et al, 1990).…”

“…Forty-five per cent of the patients had severe hematological toxicities and 8.4% a severe episode of gastrointestinal symptoms. A similar schedule was evaluated in two other trials which did not confirm the results of the GITSG (Higgins et al, 1983;Engstrom et al, 1985).…”