The evaluation of efficacy and tolerability of gemcitabine vs. capecitabine therapy in the second-line setting for metastatic pancreatic cancer patients with poor performance status
Received Date : 26 Apr 2019
Accepted Date : 24 Aug 2019
Available Online : 30 Aug 2019
Doi: 10.1016/j.jons.2019.08.003 - Article's Language: EN
J Oncol Sci 5 (2019) 85-89
This is an open access article under the CC BY-NC-ND license
Aim: The aim of this study was to evaluate the efficacy and tolerability of single-agent gemcitabine vs. capecitabine therapy in the second-line setting for metastatic Pancreatic Cancer (mPC) patients with poor performance status. Material and methods: A total of 48 patients with mPC, who were followed and treated in oncology center between 2012 and 2017, were included. After a failure of first-line therapy, patients with an ECOGPS 2 treated with capecitabine or gemcitabine monotherapy in the secondline setting were retrospectively analyzed. Results: Of the 48 patients, 26(54.2%) were males and 22(45.8%) were females. The median age of the patients was 62 years(range, 31-82). Treatment regimens in the first-line setting were as follows; gemcitabine+cisplatin in 24(50%) patients, gemcitabine+nub-paclitaxel in 4(8.3%) patients, FOLFIRINOX in 8(16.7%) patients, FOLFOX in 8(16.7%) patients, and gemcitabine+oxaliplatine in 4(8.3%) patients. After progression on first-line therapy, 29(60.5%) patients were treated with capecitabine in the second-line setting, while 19(39.5%) patients were given gemcitabine. Median progression-free survival was found to be 4 months(95% CI,1.9-6.0) in patients receiving capecitabine compared to 2 months(95% CI, 0.5-3.4) in those treated with gemcitabine (p¼0.271). Median overall survival was 6.0 months(95% CI, 2.0-9.9) in patients receiving capecitabine therapy versus 5.0 months (95% CI, 1.0-8.9) in those treated with gemcitabine monotherapy (p¼0.353). Conclusions: Optimal second-line treatment for mPC has not yet been established. In the present study, capecitabine monotherapy was compared to gemcitabine and it was found that they both had similar efficacy in the second-line treatment for mPC patients who were not eligible for combination chemotherapy regimen.
  1. Siegel RL, Miller KD, Jemal A. Cancer statistics. CA A Cancer J Clin. 2019;69:7e34, 2019. [Crossref]  [PubMed] 
  2. Bilimoria KY, Bentrem DJ, Ko CY, Stewart AK, Winchester DP, Talamonti MS. National failure to operate on early stage pancreatic cancer. Ann Surg. 2007;246:173e180. [Crossref]  [PubMed]  [PMC] 
  3. Burris 3rd HA, Moore MJ, Andersen J, et al. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 1997;15: 2403e2413. [Crossref]  [PubMed] 
  4. Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364:1817e1825. [Crossref]  [PubMed] 
  5. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369:1691e1703.
  6. Sohal DPS, Kennedy EB, Khorana A, et al. Metastatic pancreatic cancer: ASCO clinical practice guideline update. J Clin Oncol. 2018;36:2545e2556. [Crossref]  [PubMed] 
  7. Passero Jr FC, Saif MW. Second line treatment options for pancreatic cancer. Expert Opin Pharmacother. 2017;18:1607e1617. [Crossref]  [PubMed] 
  8. Cunningham D, Chau I, Stocken DD, et al. Phase III randomized comparison of gemcitabine versus gemcitabine plus capecitabine in patients with advanced pancreatic cancer. J Clin Oncol. 2009;27:5513e5518.
  9. Pelzer U, Schwaner I, Stieler J, et al. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011;47:1676e1681. [Crossref]  [PubMed] 
  10. Oettle H, Riess H, Stieler JM, et al. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabinerefractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014;32:2423e2429. [Crossref]  [PubMed] 
  11. Gill S, Ko YJ, Cripps C, et al. PANCREOX: a randomized phase III study of fluorouracil/leucovorin with or without oxaliplatin for second-line advanced pancreatic cancer in patients who have received gemcitabine-based chemotherapy. J Clin Oncol. 2016;34:3914e3920. [Crossref]  [PubMed] 
  12. Chung MJ, Kang H, Kim HG, et al. Multicenter phase II trial of modified FOLFIRINOX in gemcitabine-refractory pancreatic cancer. World J Gastrointest Oncol. 2018;10:505e515. [Crossref]  [PubMed]  [PMC] 
  13. Girardi DM, Faria L, Teixeira MC, Costa FP, Hoff PMG, Fernandes GS. Second-line treatment for advanced pancreatic adenocarcinoma: is there a role for gemcitabine? J Gastrointest Cancer. 2018. [Crossref]  [PubMed] 
  14. de Jesus VHF, Camandaroba MPG, Donadio MDS, et al. Retrospective analysis of efficacy and safety of Gemcitabine-based chemotherapy in patients with metastatic pancreatic adenocarcinoma experiencing disease progression on FOLFIRINOX. J Gastrointest Oncol. 2018;9:806e819. [Crossref]  [PubMed]  [PMC] 
  15. Bayoglu IV, Varol U, Yildiz I, et al. Second-line capecitabine and oxaliplatin combination for gemcitabine-resistant advanced pancreatic cancer. Asian Pac J Cancer Prev APJCP. 2014;15:7119e7123. [Crossref]  [PubMed] 
  16. Chung KH, Ryu JK, Son JH, et al. Efficacy of capecitabine plus oxaliplatin combination chemotherapy for advanced pancreatic cancer after failure of first-line gemcitabine-based therapy. Gut Liver. 2017;11:298e305. [Crossref]  [PubMed]  [PMC] 
  17. Bodoky G, Timcheva C, Spigel DR, et al. A phase II open-label randomized study to assess the efficacy and safety of selumetinib (AZD6244 [ARRY-142886]) versus capecitabine in patients with advanced or metastatic pancreatic cancer who have failed first-line gemcitabine therapy. Investig New Drugs. 2012;30:1216e1223. [Crossref]  [PubMed]