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Patients with resectable gastric cancer have an improved survival chance, if they are treated with an adjuvant radiochemotherapy. This is the result of a landmark study, presented at the ASCO 2000,
New Orleans, USA.

Background

Patients with gastric cancer have a 5-year survival rate of 10-60% after surgical treatment, depending on the involvement of lymph nodes. Provided that there are no metastases in locoregional nodes, survival rate can be as high as 40-60%, while node-positive patients are facing a worse prognosis with a chance of being alive after 5 years ranging from 10 to 30%. Although surgical treatment of early stage gastric cancer is an established and widely used therapy, it has failed to show significant improvement of overall survival. Therefore, the combination of surgery and adjuvant radiochemotherapy was regarded to be an important treatment option that should be investigated in a controlled clinical trial.

Trial design

With respect to the need for an improved treatment strategy in resectable gastric cancer, an American study group has performed a randomized controlled trial comparing surgical treatment alone with the combination of surgery and adjuvant radiochemotherapy (5-FU/LV + radiation) in 556 patients. The trial included patients with adenocarcinomas in stage I-IV, provided that a complete removal of the primary tumour had been achieved. More than 50% of the patients had a < D1 resection, while 36% were staged as D1 and 10% as D2.

Results

After a median follow-up of 3,3 years the adjuvant radiochemotherapy showed significant superiority compared to surgery alone (table 1). There was not only a higher proportion of patients with disease free survival (49% versus 32%), but also a longer median duration without recurrent disease (30 versus 19 months) and an improved overall survival (35 versus 28 months). As to toxicity, there were some remarkable side effects in the RCT group like haematological toxicity (54%) and gastrointestinal com-plaints (33%), but they generally were acceptable and did not result in a significant drop-out rate.

Discussion

The results of the presented study are quite remarkable, because it is the first time that a significant improvement in overall survival has been shown in surgically treated patients with gastric cancer. Compared to prior studies, the present results in the surgery onlyarm are pretty similar, suggesting that the advantage of RCT was not due to a selection bias. What remains open for discussion is the potential role of RCT in patients with stage IB, because these patients have a rather good prognosis on surgery alone, but have been included only to a very small extent in the present study. Therefore, valid conclusions cannot be drawn from this study based on subgroup analyses. Another important issue is the superiority of RCT in patients with D1 resection. Compared to prior studies, the present results are not suggestive of an advantage of RCT compared to surgery alone and further analyses are necessary in order to get some more information. From the clinical point of view it should be emphasized that radiochemotherapy requires a careful planning in order to avoid severe side effects. According to the present
study more than 30% would have run into troubles, if there had not been a surveillance of the central planning committee.

ASCO meeting, May 2000,New Orleans, USA

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