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Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients.

Publication ,  Journal Article
Lee, SJ; Lee, J; Lee, J; Park, SH; Park, JO; Park, YS; Lim, HY; Kim, K-M; Do, I-G; Jung, S-H; Yim, D-S; Kang, WK
Published in: Invest New Drugs
December 2013

BACKGROUND: The aim of this study was to assess the efficacy and safety of combination regimen of capecitabine plus everolimus in patients with refractory gastric cancer who have failed to at least two cytotoxic regimens. METHODS: Patients received capecitabine 650 mg/m(2) twice daily (D1-14) and everolimus 5 mg twice daily (D1-21) every 3 weeks until disease progression or unacceptable toxicity. The primary endpoint of the study was overall response (partial or complete response) and the secondary endpoints were progression-free survival (time between registration and disease progression or death) and overall survival. Pharmacokinetic analysis was also performed. Patients who have failed to at least two cytotoxic regimens were enrolled. RESULTS: Between March 2010 and June 2012, 47 patients were enrolled. 33 patients (70.2%) had received more than three previous regimens prior to enrolment. Among 43 evaluable patients for treatment response, 5 patients achieved confirmed partial response and 18 patients showed stable disease, resulting in an overall response rate (ORR) of 10.6% (95% C.I.: 1.8-19.4%) and disease control rate of 48.9% (95% C.I.:34.6-63.2%). At a median follow-up of 106 weeks (range, 21-141 weeks), the median progression-free survival and overall survival were 11.0 weeks (95% C.I.: 5.7-16.3 weeks) and 21.0 weeks (95% C.I.: 14.3-27.7 weeks), respectively. Grade 3 nausea, diarrhea and stomatitis occurred in two, three and three patients, respectively. Elevated liver enzyme was observed in 21 patients and no patient had pulmonary fibrosis. CONCLUSIONS: The combination of capecitabine 650 mg/m(2) twice daily and everolimus 5 mg twice daily was found to be effective in a small subset of GC patients who were heavily pre-treated.

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Published In

Invest New Drugs

DOI

EISSN

1573-0646

Publication Date

December 2013

Volume

31

Issue

6

Start / End Page

1580 / 1586

Location

United States

Related Subject Headings

  • Young Adult
  • Stomach Neoplasms
  • Sirolimus
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Fluorouracil
  • Female
  • Everolimus
 

Citation

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Lee, S. J., Lee, J., Park, S. H., Park, J. O., Park, Y. S., Lim, H. Y., … Kang, W. K. (2013). Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients. Invest New Drugs, 31(6), 1580–1586. https://doi.org/10.1007/s10637-013-0022-0
Lee, Su Jin, Jongtae Lee, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, et al. “Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients.Invest New Drugs 31, no. 6 (December 2013): 1580–86. https://doi.org/10.1007/s10637-013-0022-0.
Lee SJ, Lee J, Park SH, Park JO, Park YS, Lim HY, et al. Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients. Invest New Drugs. 2013 Dec;31(6):1580–6.
Lee, Su Jin, et al. “Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients.Invest New Drugs, vol. 31, no. 6, Dec. 2013, pp. 1580–86. Pubmed, doi:10.1007/s10637-013-0022-0.
Lee SJ, Lee J, Park SH, Park JO, Park YS, Lim HY, Kim K-M, Do I-G, Jung S-H, Yim D-S, Kang WK. Phase II trial of capecitabine and everolimus (RAD001) combination in refractory gastric cancer patients. Invest New Drugs. 2013 Dec;31(6):1580–1586.
Journal cover image

Published In

Invest New Drugs

DOI

EISSN

1573-0646

Publication Date

December 2013

Volume

31

Issue

6

Start / End Page

1580 / 1586

Location

United States

Related Subject Headings

  • Young Adult
  • Stomach Neoplasms
  • Sirolimus
  • Oncology & Carcinogenesis
  • Middle Aged
  • Male
  • Humans
  • Fluorouracil
  • Female
  • Everolimus