ESPAC-4: A randomized controlled phase III trial of adjuvant gemcitabine (GEM) and capecitabine (CAP) versus gemcitabine in resected pancreatic ductal adenocarcinoma: five year follow up.

Pancreatology ◽  
2020 ◽  
Vol 20 ◽  
pp. S17-S18
Author(s):  
J. Neoptolemos ◽  
D. Palmer ◽  
P. Gahneh ◽  
J. Valle ◽  
D. Cunningham ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Phase Iii Trial ◽  
Randomized Controlled

ESPAC-3(v2): A multicenter, international, open-label, randomized controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. LBA4505-LBA4505
Author(s):  
J. Neoptolemos ◽  
M. Büchler ◽  
D. D. Stocken ◽  
P. Ghaneh ◽  
D. Smith ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Folinic Acid ◽  
Annual Meeting ◽  
Clinical Oncology ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Open Label ◽  
Phase Iii Trial ◽  
Randomized Controlled ◽  
Final Text

LBA4505 The full, final text of this abstract will be available in Part II of the 2009 ASCO Annual Meeting Proceedings, distributed onsite at the Meeting on May 30, 2009, and as a supplement to the June 20, 2009, issue of the Journal of Clinical Oncology. [Table: see text]

ESPAC-3(v2): A multicenter, international, open-label, randomized, controlled phase III trial of adjuvant 5-fluorouracil/folinic acid (5-FU/FA) versus gemcitabine (GEM) in patients with resected pancreatic ductal adenocarcinoma

2009 ◽  
Vol 27 (18_suppl) ◽  
pp. LBA4505-LBA4505 ◽  
Author(s):  
J. Neoptolemos ◽  
M. Büchler ◽  
D. D. Stocken ◽  
P. Ghaneh ◽  
D. Smith ◽  
...  
Keyword(s):  
Pancreatic Ductal Adenocarcinoma ◽  
Bolus Injection ◽  
Survival Rates ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Open Label ◽  
Treatment Groups ◽  
Significant Difference

LBA4505 Background: Adjuvant 5-FU/FA (ESPAC-1 trial) and GEM (CONKO-001 trial) provide improved survival for patients with resected pancreatic cancer compared to no chemotherapy. The aim of the ESPAC-3 (v2) trial was to compare 5FU/FA vs GEM to identify if either adjuvant chemotherapy was associated with a significantly better survival. Methods: Patients with an R0/R1 resection for pancreatic ductal adenocarcinoma were randomized (stratified for resection margin status and country) <8 weeks of surgery to receive either 5FU/FA (FA, 20 mg/m2, iv bolus injection followed by 5-FU, 425 mg/m2, iv bolus injection given 1–5d every 28 days) or GEM (1,000mg/m2 iv infusion 1d, 8d and 15d every 4 weeks) for 6 months. The primary outcome measure was overall survival; the secondary measures were toxicity, progression free survival and quality of life. 1,030 patients were needed to detect a 10% difference in 2-year survival rates with 90% power. Results: 1,088 patients from 16 countries were randomized from July 2000 to Jan 2007 (5FU/FA = 551, GEM = 537). Median (range) age was 63 (31–85) years; 598 (55%) were men. Median tumor size was 30 (20–350) mm; 384 (35%) were R1 resections; 777 (72%) were node positive; and 263 (25%) were poorly differentiated tumors. Final analysis was carried out on an intention to treat basis with a minimum of 2 years follow-up after 753 (69%) patients had died. Median (IQR) follow-up of 335 alive patients was 34.2 (27.1–43.4) months, equal across treatment groups. Median survival from resection of patients treated with 5FU/FA was 23.0 (95% CI: 21.1, 25.0) months and for patients treated with GEM this was 23.6 (95%CI: 21.4, 26.4) months. Log-rank analysis revealed no statistically significant difference in survival estimates between the treatment groups (c2LR=0.7, p=0.39, HRGEM=0.94 (95%CI: 0.81, 1.08)). There was no significant difference in the effect of treatment across subgroups according to R status (test of heterogeneity c21=0.3, p=0.56). Conclusions: This is the largest adjuvant trial ever conducted for pancreatic ductal adenocarcinoma and showed no significant difference in survival between adjuvant 5FU/FA and adjuvant GEM. [Table: see text]

ESPAC-4: A multicenter, international, open-label randomized controlled phase III trial of adjuvant combination chemotherapy of gemcitabine (GEM) and capecitabine (CAP) versus monotherapy gemcitabine in patients with resected pancreatic ductal adenocarcinoma: Five year follow-up.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4516-4516
Author(s):  
John P. Neoptolemos ◽  
Daniel H. Palmer ◽  
Paula Ghaneh ◽  
Juan W. Valle ◽  
David Cunningham ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Adverse Events ◽  
Pancreatic Ductal Adenocarcinoma ◽  
Survival Rates ◽  
Phase Iii ◽  
Ductal Adenocarcinoma ◽  
Rank Test ◽  
Serious Adverse Events ◽  
Grade 3

4516 Background: The ESPAC-4 trial demonstrated that adjuvant GEM/CAP for pancreatic cancer significantly improved survival compared to GEM monotherapy. The aim of this study is to evaluate the long-term outcomes in the ESPAC-4 trial. Methods: Patients with pancreatic ductal adenocarcinoma were randomized within 12 weeks of surgery (stratified for R0/R1 resection margin status and country) to have either six 4-week cycles of IV GEM alone or GEM with oral CAP. The primary endpoint was five-year survival; secondary endpoints were toxicity and relapse free survival. 722 patients (480 expected events), 361 in each arm, were needed to detect a 10% difference in 2-year survival rates with 90% power (log-rank test with 5% two-sided alpha). Results: Between Nov 10 2008 and Sep 11 2014, 732 patients were randomized with 730 included in the full analysis set (366 GEM, 364 GEM/CAP). Median age was 65 years, 57% were men. WHO performance status was 0, 1 or 2 in 42% 55% and 3% respectively. Postoperative median CA19-9 was 19 kU/L. Median maximum tumor size was 30 mm, 61% were R1 resections, 80% were node positive and 40% were poorly differentiated. The data freeze was on 24 February 2020; median follow up was 60 months with 531 overall deaths, 280 in GEM, and 251 in GEM/CAP. Median (95% CI) survival (months) for patients treated with GEM/CAP was 27.7 23.3 – 31.2) and 26.0 (22.7 – 28.4) for GEM. Five-year (95% CI) survival rates were 20 (16 – 25) % for GEM and 28 (23 – 33) % for GEM/CAP. Stratified log-rank analysis revealed an HR=0.84 [95% CI, 0.70 – 0.99]; χ2 (1) = 3.87, P=0.049. 70 out of 366 GEM patients in the safety set reported 101 grade 3/4 serious adverse events, while 65 out of 359 GEM/CAP patients reported 97 grade 3/4 serious adverse events ( P=0.724). Conclusions: Adjuvant GEM/CAP for pancreatic cancer had a statistically significant improvement in survival compared to GEM monotherapy. Clinical trial information: 96397434 .

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