Table 4.
Selective neoadjuvant therapy trials in borderline-resectable pancreatic cancer.
Trial | Regimen | Significance/Outcome | Comments |
---|---|---|---|
Lee, J. et al. [53] (n = 18) | 3–6 cycles of gemcitabine (GEM) + capecitabine every 3 weeks | Eleven (61%) had surgical resection; 82% had R0 resection. Median OS in surgery group: 23.1 months Median OS in no-surgery group: 13.2 months (p = 0.017) |
43-month follow-up: Median progression-free survival of 10.0 months |
Kim, E.J. et al. [55] (n = 39) | Two 28-day cycles of GEM (1 g/m2 over 30 min on days 1, 8, and 15) and oxaliplatin (85 mg/m2 on days 1 and 15) with RT during cycle 1 (30 Gray (Gy) in 2-Gy fractions) | Twenty-eight had surgical resection; 70% had R0 resection Median survival of borderline resectable: 18.4 months (95% CI, 11–27.1); resectable disease: 26.5 months (95% CI, 11.8–44.7) |
28 had surgical resection with median survival of 25.4 months. |
Motoi, F. et al. [60] (n = 16) | GEM + S-1 | Two-year survival: 31.5% Median OS in surgery group: 34.7 months. Surgery group had better survival (p = 0.0017) |
Neutropenia in treatment group. |
Tahahashi. H. [56] (n = 80) | GEM-Radiotherapy | Forty-three (54%) had surgical resection; Forty-two (98%) had R0 resection. Five-year cumulative incidence of peritoneal and distant recurrence higher in borderline resectable group compared to resectable group |
5-year survival: 34% (less than resectable group-57%) (p = 0.02) |
Katz, M. et al. [59] (n = 22) | FOLFIRINOX * then chemoradiotherapy | Fifteen (68%) had surgical resection; 14 (93%) had R0 resection. | Median OS: 21.7 months |
GEM: Gemcitabine; * (85 mg/m2 of oxaliplatin, 180 mg/m2 of irinotecan hydrochloride, 400 mg/m2 of leucovorin calcium, and then 2400 mg/m2 of 5-fluorouracil for 4 cycles) followed by 5.5 weeks of external-beam radiation (50.4 Gy delivered in 28 daily fractions) with capecitabine (825 mg/m2 orally twice daily).