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Stage III Pancreatic Cancer

    Table 5. Randomized Studies in Stage III Pancreatic Cancer: Median Survival continued...

    As it became clear that radiation therapy alone was an inadequate treatment, investigators evaluated combined modality approaches versus chemotherapy alone. Investigators from the FFCD-SFRO randomly assigned 119 patients to induction chemoradiation therapy (60 Gy in 2 Gy fractions with 300 mg/m2 /day of continuous infusion 5-FU on days 1 through 5 for 6 weeks and 20 mg/m2 /day of cisplatin on days 1 through 5 during weeks 1 and 5) or induction gemcitabine (1,000 mg/m2 weekly for 7 weeks).[8][Level of evidence: 1iiA] Maintenance gemcitabine was administered to both groups until stopped by disease progression or treatment discontinuation as a result of toxicity. Median survival was superior in the gemcitabine arm (13 vs. 8.6 months, P = .03).

    Nonhematological grade 3 to 4 toxicities (primarily gastrointestinal) were significantly more common in the chemoradiation arm (44% vs. 18%, P = .004), and fewer patients completed at least 75% of induction therapy (42% vs. 73%). Nonetheless, the survival benefit persisted in a per-protocol analysis of patients receiving at least 75% of planned therapy. Notably, the dose intensity of maintenance gemcitabine was significantly less in the chemoradiation arm because of a greater incidence of grade 3 to 4 hematological toxicities (71% vs. 27%, P = .0001). As a result of this study, induction chemoradiation has fallen out of favor.

    The results of the FFCD study stand in contrast to the results of a study from ECOG where investigators randomly assigned 74 patients to either gemcitabine alone or gemcitabine with radiation followed by gemcitabine.[6] Of note, the study was closed early as the result of poor accrual. The primary endpoint was survival, which was 9.2 months (95% CI, 7.9–11.4 months) and 11.1 months (95% CI, 7.6–15.5 months) for chemotherapy and combined modality therapy, respectively (one-sided P = .017 by stratified log-rank test). Grade 4 and 5 toxicity was greater in the chemoradiation arm than in the chemotherapy arm (41% vs. 9%).

    Given the increased toxicity of chemoradiation and the early development of metastatic disease in a large percentage of patients with stage III pancreatic cancer, investigators are pursuing a strategy of selecting patients with localized disease for chemoradiation. With this strategy, the selected patients have an absence of progressive disease locally or systemically after several months of chemotherapy. A retrospective analysis of 181 patients enrolled in prospective phase II and III GERCOR studies revealed that 29% had metastatic disease after three months of gemcitabine-based chemotherapy. For the remaining 71%, median OS was significantly longer among patients treated with chemoradiation compared to additional chemotherapy (15.0 months vs. 11.7 months, P = .0009).[9][Level of evidence: 3iiiA] Taken together, the FFCD and GERCOR studies provide support for gemcitabine-based chemotherapy for at least 3 months, followed by chemoradiation in the absence of metastatic disease. This approach has yet to be validated in a prospective phase III trial.

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