Chemoradiotherapy versus chemotherapy: There were two randomized trials of chemoradiotherapy compared with chemotherapy alone (Table 1[B]). A study by the Eastern Cooperative Oncology Group (ECOG) suggested that 5-FU alone was as effective as combined therapy with 5-FU and radiation. 5-FU was given at a dose of 600 mg/m2 weekly until disease progression. Chemoradiotherapy consisted of 5-FU 600 mg/m2 IV on the first three days of radiation, which was administered to a total dose of 40 Gy. Patients receiving chemoradiotherapy were given maintenance 5-FU afterwards, as administered in the chemotherapy arm. The trial closed early due to poor accrual, with 91 pancreatic cancer patients enrolled (patients with gastric cancer were also included).
The median time to treatment failure for the patients with pancreatic cancer was 4.4 months with 5-FU versus 4.2 months with chemoradiotherapy (P-value not reported). There was more toxicity (leucopenia accompanied by sepsis) in patients receiving combined-modality treatment. There was no difference in local control between the arms. The results of this study have been questioned because of the poor survival seen in both arms, the less than optimal radiation planning and delivery in the radiation arm, the brevity of the course of chemotherapy in the combined-modality arm compared with other studies, and the possibility that the observed survival equivalence is a power issue due to poor accrual and early closure.
TABLE 1 Randomized trials in locally advanced pancreatic cancer
|Reference||Radiation(Gy)||Chemotherapy||Number of patients randomized (evaluable)||Median Survival (months)||Percentage one-year survival (estimate*)|
|B) Chemoradiotherapy versus chemotherapy alone|
|ECOG,||40||5-FU||NR (47)||8.3||NR (28)|
|1985||–||5-FU||NR (44)||8.2||NR (31)|
|GITSG 9283,||54||5-FU + SMF||24 (22)||9.7t||41t|
*Calculated from survival curve where data not provided in the text; Tp<0.05. 5-FU Bolus 5-fluorouracil; ECOG Eastern Cooperative Oncology Group; GITSG Gastrointestinal Tumor Study Group; Gy Gray; mCCNU Methyl lomustine; NR Not reported; RTOG; Radiation Therapy Oncology Group; SMF Streptozocin, mitomycin, 5-FU; SWOG Southwest Oncology Group
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