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A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202

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Abstract

Purpose

Patients with gallbladder cancer or cholangiocarcinoma were treated with the combination of gemcitabine 1,000 mg/m2 IV over 100 min on days 1 and 8 and capecitabine 650 mg/m2 BID PO on days 1–14, administered every 21 days.

Methods

The primary objective of this study was to assess the response rate (confirmed complete and partial responses) of gemcitabine and capecitabine used in advanced/metastatic biliary neoplasms. Secondary objectives included overall survival and toxicities.

Results

The study accrued 57 patients from September 2003 to April 2005. Three patients were ineligible, and two others received no treatment. Characteristics of analyzable patients: 35 (67%) cholangiocarcinoma, 17 (33%) gallbladder cancer; PS 0 (18 pts), 1 (26 pts), 2 (8 pts); 26 (50%) men; median age 58.8 years (29.5–85.6). Among 51 patients evaluated for toxicity, 6 experienced grade 4 toxicities. Among 52 patients, there were 7 confirmed partial responses for a confirmed response probability of 13% (95% CI: 6–26%). Six patients had an unconfirmed partial response for an overall response probability of 25% (95% CI: 14–39%). Twelve patients (23%) demonstrated stable disease. The 6-month overall survival was 55% (95% CI: 41–69%), and median survival was 7 months (95% CI: 5–8 months).

Conclusions

The combination of gemcitabine and capecitabine is a well-tolerated regimen with activity in patients with advanced gallbladder cancer and cholangiocarcinoma.

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References

  1. American Cancer Society (2010). Cancer facts & figures. American Cancer Society, Atlanta

  2. Serra I, Calvo A, Baez S et al (1996) Risk factors for gallbladder cancer. An international collaborative case-control study. Cancer 78:1515–1517

    Google Scholar 

  3. Falkson G, MacIntyre JM, Moertel CG (1984) Eastern Cooperative Oncology Group experience with chemotherapy for inoperable gallbladder and bile duct cancer. Cancer 54:965–969

    Article  PubMed  CAS  Google Scholar 

  4. Takada T, Kato H, Matsushiro T et al (1996) Prospective randomized trial comparing 1/2 FAM (5-fluorouracil (5-FU) + adriamycin + mitomycin C) versus palliative therapy for the treatment of unresectable pancreatic and biliary tract carcinomas (the 2nd trial in non-resectable patients). Japanese Study Group of Surgical Adjuvant Therapy for Carcinomas of the Pancreas and Biliary Tract. Gan To Kagaku Ryoho 23:707–714

  5. Kajanti M, Pyrhonen S (1994) Epirubicin-sequential methotrexate-5-fluorouracil-leucovorin treatment in advanced cancer of the extrahepatic biliary system. A phase II study. Am J Clin Oncol 17:223–226

    Article  PubMed  CAS  Google Scholar 

  6. Patt YZ, Jones DV Jr, Hoque A et al (1996) Phase II trial of intravenous flourouracil and subcutaneous interferon alfa-2b for biliary tract cancer. J Clin Oncol 14:2311–2315

    Google Scholar 

  7. Sanz-Altamira PM, Ferrante K, Jenkins RL et al (1998) A phase II trial of 5-fluorouracil, leucovorin, and carboplatin in patients with unresectable biliary tree carcinoma. Cancer 82:2321–2325

    Google Scholar 

  8. Verderame F, Mandina P, Abruzzo F et al (2000) Biliary tract cancer: our experience with gemcitabine treatment. Anticancer Drugs 11:707–708

    Article  PubMed  CAS  Google Scholar 

  9. Castro MP (1998) Efficacy of gemcitabine in the treatment of patients with gallbladder carcinoma: a case report. Cancer 82:639–641

    Article  PubMed  CAS  Google Scholar 

  10. Eng C, Ramanathan RK, Wong MK et al (2004) A phase II trial of fixed dose rate gemcitabine in patients with advanced biliary tree carcinoma. Am J Clin Oncol 27:565–569

    Google Scholar 

  11. Valle J, Wasan H, Palmer DH et al (2010) Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer. N Engl J Med 362:1273–1281

    Google Scholar 

  12. Eckel F, Schmid RM (2007) Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials. Br J Cancer 96:896–902

    Article  PubMed  CAS  Google Scholar 

  13. Braakhuis BJ, Ruiz van Haperen VW, Boven E et al (1995) Schedule-dependent antitumor effect of gemcitabine in in vivo model system. Semin Oncol 22:42–46

  14. Tempero M, Plunkett W, Ruiz Van Haperen V et al (2003) Randomized phase II comparison of dose-intense gemcitabine: thirty-minute infusion and fixed dose rate infusion in patients with pancreatic adenocarcinoma. J Clin Oncol 21:3402–3408

    Article  PubMed  CAS  Google Scholar 

  15. Mandola MV, Stoehlmacher J, Zhang W et al (2004) A 6 bp polymorphism in the thymidylate synthase gene causes message instability and is associated with decreased intratumoral TS mRNA levels. Pharmacogenetics 14:319–327

    Article  PubMed  CAS  Google Scholar 

  16. Lurje G, Zhang W, Yang D et al (2008) Thymidylate synthase haplotype is associated with tumor recurrence in stage II and stage III colon cancer. Pharmacogenet Genomics 18:161–168

    Google Scholar 

  17. Riechelmann RP, Townsley CA, Chin SN et al (2007) Expanded phase II trial of gemcitabine and capecitabine for advanced biliary cancer. Cancer 110:1307–1312

    Article  PubMed  CAS  Google Scholar 

  18. Cho JY, Paik YH, Chang YS et al (2005) Capecitabine combined with gemcitabine (CapGem) as first-line treatment in patients with advanced/metastatic biliary tract carcinoma. Cancer 104:2753–2758

    Article  PubMed  CAS  Google Scholar 

  19. Iyer RV, Gibbs J, Kuvshinoff B et al (2007) A phase II study of gemcitabine and capecitabine in advanced cholangiocarcinoma and carcinoma of the gallbladder: a single-institution prospective study. Ann Surg Oncol 14:3202–3209

    Article  PubMed  Google Scholar 

  20. Santini D, Vincenzi B, Vasile E et al (2009) Fixed dose rate (FDR) gemcitabine (G) and capecitabine (C) in patients with metastatic biliary tract cancer (BTC): final results of phase II trial. Abstract # e15510. Proceedings of the American Society of Clinical Oncology

  21. Kim ST, Park JO, Lee J et al (2006) A phase II study of gemcitabine and cisplatin in advanced biliary tract cancer. Cancer 106:1339–1346

    Article  PubMed  CAS  Google Scholar 

  22. Julka PK, Puri T, Rath GK (2006) A phase II study of gemcitabine and carboplatin combination chemotherapy in gallbladder carcinoma. Hepatobiliary Pancreat Dis Int 5:110–114

    PubMed  CAS  Google Scholar 

  23. André T, Reyes-Vidal JM, Fartoux L et al (2006) An international multicenter phase II trial of gemcitabine and oxaliplatin (GEMOX) in patients with advanced biliary tract cancer. J Clin Oncol. ASCO annual meeting proceedings part I, vol 24, no. 18S (June 20 Supplement), p 4135

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Acknowledgments

Support: This investigation was supported in part by the following Public Health Service Cooperative Agreement grant numbers awarded by the National Cancer Institute, Department of Health and Human Services: CA32102, CA38926, CA20319, CA58882, CA45808, CA58723, CA35176, CA76132, CA46441, CA63844, CA35178, CA58658, CA67575, CA45560, CA11083, CA46113, CA35128, CA58861, CA46368, CA35261, CA58416, CA42777, and CA35431 and supported in part by Roche.

Conflict of interest

Dr. Charles Blanke has consultant/advisory role for Roche Pharmaceuticals; Dr. El-Khoueiry has a consultant/advisory role and funding from Genentech.

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Authors and Affiliations

  1. Norris Comprehensive Cancer Center, University of Southern California, 1441 Eastlake Ave., Rm. 3457, Los Angeles, CA, 90033, USA

    Syma Iqbal, Heinz-Josef Lenz & Anthony B. El-Khoueiry

  2. Southwest Oncology Group Statistical Center, 1100 Fairview Ave. N., M3-C102, P.O. Box 19024, Seattle, WA, 98109, USA

    Cathryn Rankin

  3. Swedish Cancer Institute, 1221 Madison St., Seattle, WA, 98104, USA

    Philip J. Gold

  4. Barrett Center, Department of Surgery, University of Cincinnati, 234 Goodman St., ML #0772, Cincinnati, OH, 45219, USA

    Syed A. Ahmad

  5. Southeast Cancer Control Consortium, Inc. CCOP, Cancer Care of WNC, 445 Biltmore Ave., Suite 100, Asheville, NC, 22801, USA

    Michael J. Messino

  6. University of California at Irvine, Chao Family CCC, 101 The City Dr., Bldg. 23, Rt. 81, Orange, CA, 92868, USA

    Randall F. Holcombe

  7. University of British Columbia, and British Columbia Cancer Agency, 600 W. 10th Ave., Vancouver, BC, V52 4E6, Canada

    Charles D. Blanke

Authors
  1. Syma Iqbal
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  2. Cathryn Rankin
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  3. Heinz-Josef Lenz
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  4. Philip J. Gold
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  5. Syed A. Ahmad
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  6. Anthony B. El-Khoueiry
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  7. Michael J. Messino
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  8. Randall F. Holcombe
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  9. Charles D. Blanke
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Corresponding author

Correspondence to Syma Iqbal.

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Iqbal, S., Rankin, C., Lenz, HJ. et al. A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202. Cancer Chemother Pharmacol 68, 1595–1602 (2011). https://doi.org/10.1007/s00280-011-1657-1

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  • DOI: https://doi.org/10.1007/s00280-011-1657-1

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