Neoadjuvant therapy for resectable pancreatic cancer

Table 3 Phase I and Phase II studies assessing the outcomes of patients with resectable pancreatic cancer treated with neoadjuvant therapies

Author (yr)/ journal/trial/institution	No. of patients	Clinical stage/ duration of neoadjuvant therapy	Study design	Chemotherapy/chemoradiation	Radiological response	Resection rate (%)	Negative resection margins (%)	Median overall survival (mo)
Hoffman (1998)/J Clin Oncol/ECOG	53	Resectable PC/2.8 mo	Phase II, prospective study, November 1991 to September 1993	5-FU (1000 mg/m2) per day + Mitomycin C (10 mg/m2) + RT (50 Gy)	Partial response 8%; Stable disease 78%; Progression 16%	45	67	15 with surgery; without surgery 8; 10.9 for the entire cohort
PistersPister (2002)/J Clin Oncol/MD Anderson Cancer Centre	35	Resectable PC/1.8 mo	Phase II, prospective study, timeframe not specified	Paclitaxel (60 mg/m2) weekly, RT (30 Gy)	Partial response 4%; Stable disease 23%; Progression 20%	57	68	12 for the entire cohort; 19 with surgery; 10 without surgery
Joensuu (2004)/Int J Radiat Oncol Biol Phys/Helsinki University	28	Resectable PC/3.5 mo	Phase I-II prospective study, November 1999 to December 2001	Gemcitabine (20 mg/m2vs 50 mg/m2vs 100 mg/m2) twice a week + RT (50 GY)	NA	71	NA	13.6 for the entire cohort
Talamonti (2006)/Ann Surg Oncol/Northwestern University	20	Resectable PC/3.8 mo	Phase II prospective, multi-institutional study, April 2002 to October 2003	Gemcitabine (1000 mg/m2 weekly) + RT (36 Gy)	Partial response 15%; Stable disease 80%; Progression 5%	85	94	26 mo with surgery
Palmer (2007)/Ann Surg Oncol/University of Birmingham	24	Resectable PC/4 mo	Phase II, prospective study, November 1999 to May 2003	Gemcitabine (1000 mg/m2 weekly)	Partial Response 0%; Stable Disease 29%; Progression 4%; Unable to measure 4%	38	75	28.4 with surgery; 9.9 for the entire cohort
Palmer (2007)/Ann Surg Oncol/University of Birmingham	26	Resectable PC/4 mo	Phase II, prospective study, November 1999 to May 2003	Gemcitabine (1000 mg/m2 weekly) + Cisplatin (25 mg/m2)	Partial Response 0%; Stable Disease 66%; Progression 21%; Unable to measure 4%	70	75	28.4 with surgery; 9.9 for the entire cohort
Le Scodan (2009)/Ann Oncol/SFRO-FFCD	41	Resectable PC/3 mo	Phase II, prospective study, January 1998 to March 2003	RT (50 Gy) + 5-FU (300 mg/m2 daily) + Cisplatin (20 mg/m2)	Partial response 10%; Stable Disease 65%; Progression 25%	63	81	11.7 with surgery; 9.4 for the entire cohort
Heinrich (2008)/Ann Surg/University Hospital of Zurich	28	Resectable PC/2 mo	Phase II, prospective study, August 2001 to April 2007	Gemcitabine (1000 mg/m2 twice weekly) + Cisplatin (50 mg/m2)	Partial response 4%; Stable Disease 61%; Progression 13%	89	80	19.1 mo with surgery
Evans (2008)/J Clin Oncol/MD Anderson Cancer Centre	80	Resectable PC/3 mo	Phase II, prospective study, July 1998 to October 2001	Gemcitabine (400 mg/m2 weekly) + RT (30 Gy)	NA	85	82	34 mo with surgery; 22.7 mo for the entire cohort; 7 mo without surgery
Varadhachari (2008)/J Clin Oncol/MD Anderson Cancer Centre	90	Resectable PC/4.3 mo	Phase II, prospective study, October 2002 to February 2006	Gemcitabine (750 mg/m2 weekly) + Cisplatin (30 mg/m2) every 2 wk + RT (30 Gy)	NA	58	96	31.0 mo with surgery; 17.4 mo for the entire cohort; 10.5 mo without surgery
Turrini (2009)/Oncology /University Mediterranean	34	Resectable PC/2.1 mo	Phase II, prospective study, May 2003 to July 2005	Docetazel (30 mg/m2) weekly + RT (45 GY)	Partial response 9%; Stable disease 59%; Progression 32%	68	100	32 mo with surgery; 15.5 mo for entire cohort; 11 mo without surgery
Landry (2010)/J Surg Oncol/Emory University/Multicenter ECOG	21	Resectable PC/3 mo	Phase II, prospective two-arm study, October 2013 to June 2015	Arm A: Gemcitabine (500 mg/m2) weekly + RT (50 Gy) Arm B: Gemcitabine (175 mg/m2) + Cisplatin (20 mg/m2) + 5-FU (600 mg/m2) + RT (50 Gy)	Arm A: Partial response 10%, Arm B: Partial response 18.2%	NA	NA	Arm A: Entire cohort 19.4 mo. Arm B: entire cohort 13.4 mo. 26.3 mo with surgery
Wo (2014)/Radiother Oncol/Multicentric	10	Resectable PC	Phase I, prospective study	Capecitabine (1650 mg/m2) over 10 d + RT (30 Gy)	NA	80	NA	NA
Shinoto (2013)/Cancer/Japan	26	Resetable PC	Phase I, prospective study, April 2003 to December 2010	RT (30 Gy)	Partial response 3.8%; Stable disease 96.1%	81	90	18.6 mo for entire cohort; NA for patients who underwent surgery
O'Reilly (2014)/Ann Surg/Memorial Sloan Kettering Cancer Centre	38	Resectable PC	Phase II, prospective study, July 2007 to December 2011	Gemcitabine (1000 mg/m2) + Oxaliplatin (80 mg/m2) every 2 wk	Partial response 10.5%; Stable disease 73.7%; Progression 7.9%; NA 7.9%	77	74	27.2 mo for the enire cohort; 22 mo progression free survival with surgery
Golcher (2015)/Strahlenther Onkol/Germany	66 (33 patients allocated to surgery + 33 patients allocated to chemoradiation followed by surgery)	Resectable PC	Phase II, prospective randomized trial with two arms: Primary surgery vs preoperative chemoradiation followed by surgery. June 2003 to December 2009	Gemcitabine (300 mg/m2) + Cisplatin (30 mg /m2) + RT (50.4 Gy) (Preoperative for patients enrolled in Arm A)	NA	Preoperative chemoradiation: 69% Surgery first: 57%	Arm A (preoperative chemoradition): 48. Arm B (surgery first): 51	Arm A (preoperative chemoradiation): 18.9 mo. Arm B (surgery first): 25.0 mo
Van Buren (2013)/Ann Surg Oncol/Multicenter/United States	59	Resectable PC	Phase II, prospective study, February 2007 to February 2011	Gemcitabine (1500 mg/m2) ever 2 wk + Bevacizumab (10 mg/kg) + RT (30 Gy)	Partial response 8.4%; Stable disease 73.7%; Progression 7.9%	74	88	19.7 mo with surgery; 16.8 mo for the entire cohort

NA: Not available.