PJ Online | News: Pancreatic cancer patients get no survival benefit from adjuvant chemoradiotherapy

The Pharmaceutical Journal Vol 267 No 7174 p701-706
17 November 2001

Pancreatic cancer patients get no survival benefit from adjuvant chemoradiotherapy

There is no survival benefit for patients with pancreatic cancer who receive adjuvant chemoradiotherapy, say European researchers. However, adjuvant treatment with chemotherapy is likely to prolong survival.

Professor John Neoptolemos, department of surgery, Liverpool University, and colleagues from the European Study Group for Pancreatic Cancer, say that previous studies have shown that adjuvant chemoradiotherapy seems to provide survival benefit, but because the trials were inadequately powered definitive conclusions are not possible.

Therefore, they conducted a randomised trial to assess the roles of both chemoradiotherapy and chemotherapy as adjuvant treatments for the disease.

A total of 541 patients with resected pancreatic cancer were randomised to receive no additional therapy after surgery, chemoradiotherapy alone, chemotherapy alone, or both chemoradiotherapy and chemotherapy (see below).

Treatment regimens

Chemoradiotherapy consisted of a 20 Gy (Gray) tumour dose in 10 daily fractions over two weeks with 500mg/m2 intravenous fluorouracil on days one to three, repeated after two weeks.

Chemotherapy consisted of 425mg/m2 intravenous fluorouracil and 20mg/m2 folinic acid daily for five days, monthly for six months.

Combination therapy consisted of chemoradiotherapy followed by chemotherapy.

The researchers found that overall there was no survival benefit for adjuvant chemoradiotherapy (median survival 15.5 months in 175 patients given chemoradiotherapy versus 16.1 months in 178 patients not given this treatment, P=0.24). However, they say that there was evidence of a survival benefit for adjuvant chemotherapy (median survival 19.7 months in 238 patients given chemotherapy versus 14.0 months in 235 patients not given this treatment, P=0.0005). They also report that chemoradiotherapy had a confounding negative effect on the benefit of chemotherapy.

The researchers conclude that the results "clear the way for focusing on chemotherapy as the principal adjuvant modality in pancreatic cancer". A final analysis of the study results will be done when all patients have been followed up for at least two years (Lancet 2001;358:1576).

In an accompanying commentary, Dr Ross Abrams, Johns Hopkins Hospital and School of Medicine, Baltimore, Maryland, pointed out that the trial was essentially three parallel studies and that it was underpowered to detect interactions among the therapies given. Dr Abrams welcomed the study but warned that its major conclusions should be viewed tentatively (ibid p1565).