Login to MyKarger

New to MyKarger? Click here to sign up.



Login with Facebook

Forgot your password?

Authors, Editors, Reviewers

For Manuscript Submission, Check or Review Login please go to Submission Websites List.

Submission Websites List

Institutional Login
(Shibboleth or Open Athens)

For the academic login, please select your country in the dropdown list. You will be redirected to verify your credentials.

Clinical Study

Biweekly Docetaxel-Irinotecan Treatment with Filgrastim Support Is Highly Active in Antracycline-Paclitaxel-Refractory Breast Cancer Patients

Frasci G. · D’Aiuto G. · Thomas R. · Comella P. · Di Bonito M. · Lapenta L. · D’Aiuto M. · Botti G. · Vallone P. · De Rosa V. · D’Aniello R. · Giordano R. · Comella G.

Author affiliations

Division of Medical Oncology A, National Cancer Institute of Naples, Naples, and Department of Surgery, Pagani General Hospital, Salerno, Italy

Related Articles for ""

Oncology 2005;68:391–397

Do you have an account?

Login Information





Contact Information












By signing up for MyKarger you will automatically participate in our year-End raffle.
If you Then Do Not wish To participate, please uncheck the following box.

Yes, I wish To participate In the year-End raffle And Get the chance To win some Of our most interesting books, And other attractive prizes.


I have read the Karger Terms and Conditions and agree.



Login Information





Contact Information












By signing up for MyKarger you will automatically participate in our year-End raffle.
If you Then Do Not wish To participate, please uncheck the following box.

Yes, I wish To participate In the year-End raffle And Get the chance To win some Of our most interesting books, And other attractive prizes.


I have read the Karger Terms and Conditions and agree.



To view the fulltext, please log in

To view the pdf, please log in

Buy

  • FullText & PDF
  • Unlimited re-access via MyKarger
  • Unrestricted printing, no saving restrictions for personal use
read more

CHF 38.00 *
EUR 35.00 *
USD 39.00 *

Select

KAB

Buy a Karger Article Bundle (KAB) and profit from a discount!

If you would like to redeem your KAB credit, please log in.


Save over 20% compared to the individual article price.
Learn more

Rent/Cloud

  • Rent for 48h to view
  • Buy Cloud Access for unlimited viewing via different devices
  • Synchronizing in the ReadCube Cloud
  • Printing and saving restrictions apply

Rental: USD 8.50
Cloud: USD 20.00


Select

Subscribe

  • Access to all articles of the subscribed year(s) guaranteed for 5 years
  • Unlimited re-access via Subscriber Login or MyKarger
  • Unrestricted printing, no saving restrictions for personal use
read more

Subcription rates


Select

* The final prices may differ from the prices shown due to specifics of VAT rules.

Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: August 11, 2004
Accepted: November 28, 2004
Published online: August 17, 2005
Issue release date: August 2005

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 4

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: https://www.karger.com/OCL

Abstract

Purpose: To evaluate the feasibility and activity of combination treatment with docetaxel (DTX) and irinotecan (CPT-11), given together every other week, combined with filgrastim support, in anthracycline- and paclitaxel-pretreated breast cancer (BC) patients. Patients and Methods: Advanced BC patients pretreated with anthracycline- and paclitaxel-based chemotherapy were eligible. DTX (80 mg/m2) and CPT-11 (100 mg/m2) were given biweekly with filgrastim support (300 µg/day on days 4–7). Results: Fifty patients (48 with metastatic and 2 with locally advanced cancer) were enrolled, with a total of 318 cycles being delivered. Thirty-one patients had visceral localizations. All patients had received epirubicin plus paclitaxel, with or without cisplatin, as front-line treatment for advanced disease. Overall, fatigue and diarrhea were the main chemotherapy-related toxicities in this study, being severe in 10 (20%) and 4 (8%) patients. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 18 (36%) and 6 (12%) patients, respectively. Red blood cell transfusions were required in 4 patients. A total of 32 objective responses were registered (overall response rate, ORR = 64%, 95% confidence interval = 49–77%), including 8 complete responses (16%). An additional 8 patients showed stable disease. After a median follow-up of 18 (range 4–29) months, 30 patients were still alive, and 19 were progression free; median progression-free and overall survivals were 10 and 23 months, respectively. Conclusions: Biweekly DTX/CPT-11 with G-CSF support is a well-tolerated and highly effective approach in anthracycline-/paclitaxel-pretreated patients. The very promising ORR and survival outcome observed in this subset of patients with a poor prognosis suggest that this regimen might play a major role in the management of this disease.

© 2005 S. Karger AG, Basel


References

  1. Van Oosterom AT: Docetaxel (Taxotere): An effective agent in the management of second-line breast cancer. Semin Oncol 1995;22(suppl 13):22–28.
    External Resources
  2. Nabholtz JM, Senn HJ, Bezwoda WR, Melnychuk D, Deschenes L, Douma J, Vandenberg TA, Rapoport B, Rosso R, Trillet-Lenoir V, et al: Prospective randomised trial of docetaxel versus mitomycin plus vinblastine in patients with metastatic breast cancer progressing despite previous anthracycline-containing chemotherapy. 304 Study Group J Clin Oncol 1999;17:1413–1424.
  3. Valero V, Jones SE, Von Hoff DD, Booser DJ, Mennel RG, Ravdin PM, Holmes FA, Rahman Z, Schottstaedt MW, Erban JK, et al: A phase II study of docetaxel in patients with paclitaxel-resistant metastatic breast cancer. J Clin Oncol 1998;16:3362–3368.
  4. Fumoleau P, Chevallier B, Kerbrat P, Krakowski Y, Misset JL, Maugard-Louboutin C, Dieras V, Azli N, Bougon N, Riva A, et al: A multicentre phase II study of the efficacy and safety of docetaxel as first-line treatment of advanced breast cancer. Report of the Clinical Screening Group of the EORTC. Ann Oncol 1996;7:165–171.
  5. Taguchi T: A phase II study of CPT-11 in advanced breast cancer. Int J Oncol 1994;5:404–405.
  6. Shigeoka Y, Itoh K, Igarashi T, Ishizawa K, Saeki T, Fujii H, Minami H, Imoto S, Sasaki Y: Clinical effect of irinotecan in advanced and metastatic breast cancer patients previously treated with doxorubicin- and docetaxel-containing regimens. Jpn J Clin Oncol 2001;31:370–374.
  7. Ikeda H, Koshiba R: A pilot study of irinotecan hydrochloride for metastatic breast cancer – Efficacy as a salvage therapy. Gan To Kagaku Ryoho 2000;27:723–727.
  8. Cameron It, Hardman WE: Comparative efficacy of CPT-11, topotecan, doxorubicin and cisplatin against xenografts of colon, lung, and breast cancer cells in nude mice. Proc AACR 1999;40:109AB.
  9. Okishio K, Kudoh S, Hirata K, et al: Schedule dependent additive effects of docetaxel and irinotecan in vitro. Proc Jpn J Cancer Res 1995;86:619.
  10. Bissery MC, Couteau C, Oulid-Aissa D, Armand JP: Docetaxel in combination with irinotecan: Prediction of clinical maximum tolerated dose (abstr 773). Proc Am Soc Clin Oncol 1997;16:221a.
  11. Masuda N, Negoro S, Kudoh S, Sugiura T, Nakagawa K, Saka H, Takada M, Niitani H, Fukuoka M: Phase I and pharmacologic study of docetaxel and irinotecan in advanced non-small cell lung cancer. J Clin Oncol 2000;18:2996–3003.
  12. Couteau C, Risse ML, Ducreux M, Lefresne-Soulas F, Riva A, Lebecq A, Ruffie P, Rougier P, Lokiec F, Bruno R, Armand JP: Phase I and pharmacokinetic study of docetaxel and irinotecan in patients with advanced solid tumors. J Clin Oncol 2000;18:3545–3552.
  13. Knuuttila A, Ollikainen T, Halme M, Mali P, Kivisaari L, Linnainmaa K, Jekunen A, Mattson K: Docetaxel and irinotecan (CPT-11) in the treatment of malignant pleural mesothelioma. A feasibility study. Anticancer Drugs 2000;11:257–261.
  14. Adjei AA, Klein CE, Kastrissios H, Goldberg RM, Alberts SR, Pitot HC, Sloan JA, Reid JM, Hanson LJ, Atherton P, Rubin J, Erlichman C: Phase I and pharmacokinetic study of irinotecan and docetaxel in patients with advanced solid tumors: Preliminary evidence of clinical activity. J Clin Oncol 2000;18:1116–1123.
  15. Frasci G, Comella P, Thomas R, Di Bonito M, Lapenta L, Capasso I, Botti G, Vallone P, De Rosa V, D’Aiuto G, Comella G: Biweekly docetaxel-irinotecan with filgrastim support in pretreated breast and non-small cell lung cancer patients. A phase I study. Cancer Chemother Pharmacol 2004;53:25–32.
  16. Miller AB, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 1981;47:207–274.
  17. Kaplan ES, Meier P: Non parametric estimation for incomplete observations. J Am Stat Assoc 1958;53:557–580.
    External Resources
  18. Fujita A, Ohkubo T, Hoshino H, Takabatake H, Tagaki S, Sekine K: Phase I study of carboplatin, irinotecan and docetaxel on a divided schedule with recombinant human granulocyte colony stimulating factor support in patients with stage IIIB or IV non-small cell lung cancer. Anticancer Drugs 2002;13:505–509.
  19. Pectasides D, Visvikis A, Kouloubinis A, Glotsos J, Bountouroglou N, Karvounis N, Ziras N, Athanassiou A: Weekly chemotherapy with carboplatin, docetaxel and irinotecan in advanced non-small cell lung cancer: A phase II study. Eur J Cancer 2002;38:1194–1200.
  20. Font A, Sanchez JM, Taron M, Martinez-Balibrea E, Sanchez JJ, Manzano JL, Margeli M, Richardet M, Barnadas A, Abad A, Rosell R: Weekly regimen of irinotecan/docetaxel in previously treated non-small cell lung cancer patients and correlation with uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) polymorphism. Invest New Drugs 2003;21:435–443.
  21. Yamamoto N, Fukuoka M, Negoro SI, Nakagawa K, Saito H, Matsui K, Kawahara M, Senba H, Takada Y, Kudoh S, et al: Randomised phase II study of docetaxel/cisplatin vs. docetaxel/irinotecan in advanced non-small cell lung cancer: West Japan Thoracic Oncology Group Study (WJTOG9803). Br J Cancer 2004;90:87–92.
  22. Yoshioka T, Sakata Y, Terashima M, Sekikawa K, Gamoh M, Mitachi Y, Saitoh S, Kanamaru R: Biweekly administration regimen of docetaxel combined with CPT-11 in patients with inoperable or recurrent gastric cancer. Gastric Cancer 2003;6:153–158.
  23. Jatoi A, Tirona MT, Cha SS, Alberts SR, Rowland KM, Morton RF, Nair S, Kardinal CG, Stella PJ, Mailliard JA, Sargen D, Goldberg RM: A phase II trial of docetaxel and CPT-11 in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and gastric cardia. Int J Gastrointest Cancer 2002;32:115–123.
  24. Lordick F, von Schilling C, Bernhard H, Henning M, Bredenkamp R, Peschel C: Phase II trial of irinotecan plus docetaxel in cisplatin-pretreated relapsed or refractory oesophageal cancer. Br J Cancer 2003;89:630–633.
  25. Kurtz JE, Negrier S, Husseini F, Limacher JM, Borel C, Wagner JP, Prevot G, Bergerat JP, Dufour P: A phase II study of docetaxel-irinotecan combination in advanced pancreatic cancer. Hepatogastroenterology 2003;50:567–570.
  26. Seidman AD, Hochhauser D, Gollub M, Edelman B, Yao TJ, Hudis CA, Francis P, Fennelly D, Gilewski TA, Moynahan ME, et al: Ninety-six hour paclitaxel infusion after progression during short paclitaxel exposure: A phase II pharmacokinetic and pharmacodynamic study in metastatic breast cancer. J Clin Oncol 1996;14:1877–1884.
  27. Livingston RB, Ellis GK, Gralow JR, Williams MA, White R, McGuirt C, Adamkiewicz BB, Long CA: Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1997;15:1395–1400.
  28. Frasci G, Comella P, D’Aiuto G, Thomas R, Capasso I, Elmo M, Botti G, Cortino GR, Lapenta L, De Rosa V, Vallone P, Petrillo A, Comella G: Weekly docetaxel plus gemcitabine or vinorelbine in refractory advanced breast cancer patients: A parallel dose-finding study. Ann Oncol 2000;11:367–371.
  29. Comella G, Comella P, D’Aiuto G, Thomas R, Capasso I, Botti G, Cortino GR, Maiorino L, Lapenta L, Frasci G: Weekly cisplatin-epirubicin-paclitaxel with G-CSF support vs triweekly epirubicin-paclitaxel in advanced breast cancer. A SICOG phase III study (abstr 2823). Proc Am Soc Clin Oncol 2003;22:702.

Article / Publication Details

First-Page Preview
Abstract of Clinical Study

Received: August 11, 2004
Accepted: November 28, 2004
Published online: August 17, 2005
Issue release date: August 2005

Number of Print Pages: 7
Number of Figures: 1
Number of Tables: 4

ISSN: 0030-2414 (Print)
eISSN: 1423-0232 (Online)

For additional information: https://www.karger.com/OCL


Copyright / Drug Dosage / Disclaimer

Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher.
Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.