Clinical observation of gemcitabine plus tegafur, gimeracil and oteracil potassium in patients with metastatic castration-resistant prostate cancer after docetaxel failure_West China Medical Journal

Authors：

CAI Zhong , CHEN Ye , ZHOU Jitao , CHENG Ke , HE Jianping , LI Zhiping ,  LIU Jiyan

Department of Abdominal Oncology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, P. R. China;

Corresponding author：

LIU Jiyan, Email: liujiyan1972@163.com

Keywords：

Gemcitabine; Tegafur, gimeracil and oteracil potassium; Castration-resistant prostate cancer; Chemotherapy

DOI：

10.7507/1002-0179.201702056

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Objective To observe the early efficacy and toxicity of gemcitabine plus tegafur, gimeracil and oteracil potassium (S-1) regimen (GS regimen) in patients with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel failure. Methods From July 2013 to December 2015, sixteen mCRPC patients who failed in the treatment of docetaxel-based chemotherapy in West China Hospital of Sichuan University were collected. And the patients were treated with gemcitabine 1 000 mg/m² intravenously on Day 1 and S-1 40–60 mg/m² orally dividedly twice daily on Day 1–10, which repeated every two weeks. The main outcome measures were total prostate-specific antigen (T-PSA) decline rate and pain remission rate. Results Of the 13 evaluable patients, the T-PSA decline rate≥50% was observed in 4 patients (30.8%). Among the 11 patients with bone pain, remarkable pain relief was observed in 4 cases (36.4%). Myelosuppression, gastrointestinal reaction, rash and fatigue were the commonly observed adverse reactions and the toxicity of chemotherapy was tolerable. Conclusion The GS regimen is active and tolerable in patients with mCRPC after docetaxel failure.

Citation： CAI Zhong, CHEN Ye, ZHOU Jitao, CHENG Ke, HE Jianping, LI Zhiping, LIU Jiyan. Clinical observation of gemcitabine plus tegafur, gimeracil and oteracil potassium in patients with metastatic castration-resistant prostate cancer after docetaxel failure. West China Medical Journal, 2017, 32(11): 1730-1733. doi: 10.7507/1002-0179.201702056 Copy

1.	Sweeney C, Chen Y, Carducci M, et al. Chemohormonal therapy versus hormonal therapy for hormone naïve high volume newly metastatic prostate cancer (PrCa): ECOG led phase Ⅲ randomized. Ann Oncol, 2014, 25(4): iv255-iv279.
2.	Gravis G, Fizazi K, Joly F, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol, 2013, 14(2): 149-158.
3.	Tannock IF, De Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med, 2004, 351(15): 1502-1512.
4.	Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol, 2008, 26(2): 242-245.
5.	Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med, 2004, 351(15): 1513-1520.
6.	Yanagimoto H, Ishii H, Nakai Y, et al. Improved survival with combined gemcitabine and S-1 for locally advanced pancreatic cancer: pooled analysis of three randomized studies. J Hepatobiliary Pancreat Sci, 2014, 21(10): 761-766.
7.	中国抗癌协会泌尿肿瘤专业委员会. 中国去势抵抗性前列腺癌诊治专家共识. 中华外科杂志, 2016, 54(7): 481-484.
8.	Scher HI, Eisenberger M, D’amico AV, et al. Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol, 2004, 22(3): 537-556.
9.	Center MM, Jemal A, Lortet-Tieulent J, et al. International variation in prostate cancer incidence and mortality rates. Eur Urol, 2012, 61(6): 1079-1092.
10.	Hertel LW, Boder GB, Kroin JS, et al. Evaluation of the antitumor-activity of gemcitabine (2’,2’-difluoro-2’-deoxycytidine). Cancer Res, 1990, 50(14): 4417-4422.
11.	Cronauer MV, Klocker H, Talasz H, et al. Inhibitory effects of the nucleoside analogue gemcitabine on prostatic carcinoma cells. Prostate, 1996, 28(3): 172-181.
12.	Morant R, Bernhard J, Maibach R, et al. For the swiss group for clinical cancer R (2000) response and palliation in a phase Ⅱ trial of gemcitabine in hormone-refractory metastatic prostatic carcinoma. Ann Oncol, 2000, 11(2): 183-188.
13.	Di Lorenzo G, Autorino R, Giuliano M, et al. phase Ⅱ trial of gemcitabine, prednisone, and zoledronic acid in pretreated patients with hormone refractory prostate cancer. Urology, 2007, 69(2): 347-351.
14.	Shirasaka T, Shimamato Y, Ohshimo H, et al. Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs, 1996, 7(5): 548-557.
15.	Li Y, Mizutani Y, Shiraishi T, et al. The significance of the of dihydropyrimidine dehydrogenase in prostate cancer. BJU Int., 2007, 99(3): 663-668.
16.	De Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet, 2010, 376(9747): 1147-1154.
17.	De Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med, 2011, 364(21): 1995-2005.
18.	Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med, 2012, 367(13): 1187-1197.

1. Sweeney C, Chen Y, Carducci M, et al. Chemohormonal therapy versus hormonal therapy for hormone naïve high volume newly metastatic prostate cancer (PrCa): ECOG led phase Ⅲ randomized. Ann Oncol, 2014, 25(4): iv255-iv279.
2. Gravis G, Fizazi K, Joly F, et al. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol, 2013, 14(2): 149-158.
3. Tannock IF, De Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med, 2004, 351(15): 1502-1512.
4. Berthold DR, Pond GR, Soban F, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer: updated survival in the TAX 327 study. J Clin Oncol, 2008, 26(2): 242-245.
5. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med, 2004, 351(15): 1513-1520.
6. Yanagimoto H, Ishii H, Nakai Y, et al. Improved survival with combined gemcitabine and S-1 for locally advanced pancreatic cancer: pooled analysis of three randomized studies. J Hepatobiliary Pancreat Sci, 2014, 21(10): 761-766.
7. 中国抗癌协会泌尿肿瘤专业委员会. 中国去势抵抗性前列腺癌诊治专家共识. 中华外科杂志, 2016, 54(7): 481-484.
8. Scher HI, Eisenberger M, D’amico AV, et al. Eligibility and outcomes reporting guidelines for clinical trials for patients in the state of a rising prostate-specific antigen: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol, 2004, 22(3): 537-556.
9. Center MM, Jemal A, Lortet-Tieulent J, et al. International variation in prostate cancer incidence and mortality rates. Eur Urol, 2012, 61(6): 1079-1092.
10. Hertel LW, Boder GB, Kroin JS, et al. Evaluation of the antitumor-activity of gemcitabine (2’,2’-difluoro-2’-deoxycytidine). Cancer Res, 1990, 50(14): 4417-4422.
11. Cronauer MV, Klocker H, Talasz H, et al. Inhibitory effects of the nucleoside analogue gemcitabine on prostatic carcinoma cells. Prostate, 1996, 28(3): 172-181.
12. Morant R, Bernhard J, Maibach R, et al. For the swiss group for clinical cancer R (2000) response and palliation in a phase Ⅱ trial of gemcitabine in hormone-refractory metastatic prostatic carcinoma. Ann Oncol, 2000, 11(2): 183-188.
13. Di Lorenzo G, Autorino R, Giuliano M, et al. phase Ⅱ trial of gemcitabine, prednisone, and zoledronic acid in pretreated patients with hormone refractory prostate cancer. Urology, 2007, 69(2): 347-351.
14. Shirasaka T, Shimamato Y, Ohshimo H, et al. Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs, 1996, 7(5): 548-557.
15. Li Y, Mizutani Y, Shiraishi T, et al. The significance of the of dihydropyrimidine dehydrogenase in prostate cancer. BJU Int., 2007, 99(3): 663-668.
16. De Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet, 2010, 376(9747): 1147-1154.
17. De Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med, 2011, 364(21): 1995-2005.
18. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med, 2012, 367(13): 1187-1197.

West China Medical Journal

Clinical observation of gemcitabine plus tegafur, gimeracil and oteracil potassium in patients with metastatic castration-resistant prostate cancer after docetaxel failure

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