Alexander B Olawaiye1, James J Java2, Thomas C Krivak3, Michael Friedlander4, David G Mutch5, Gretchen Glaser6, Melissa Geller7, David M O'Malley8, Robert M Wenham9, Roger B Lee10, Diane C Bodurka11, Thomas J Herzog12, Michael A Bookman13. 1. Division of Gynecologic Oncology, Magee-Womens Hospital of UPMC, Pittsburgh, PA, United States of America. Electronic address: olawaiyea@mail.magee.edu. 2. NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, United States of America. 3. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Western Pennsylvania Hospital, Pittsburgh, PA, United States of America. Electronic address: thomas.krivak@ahn.org. 4. Prince of Wales Clinical School UNSW, Department of Medical Oncology, The Prince of Wales Hospital, Sydney, Australia. Electronic address: michael.friedlander@sesiahs.health.nsw.gov.au. 5. Dept. of Obstetrics and Gynecology, Washington University School of Medicine, Saint Louis, MO 63110, United States of America. Electronic address: mutchd@wudosis.wustl.edu. 6. Gynecologic Oncology, Carilion Clinic Gynecological Oncology, Roanoke, VA 24016, United States of America. Electronic address: geglaser@carilionclinic.org. 7. Dept. of Obstetrics, Gynecology and Women's Health, University of Minnesota Medical Center-Fairview, Minneapolis, MN 55455, United States of America. Electronic address: gelle005@umn.edu. 8. Dept. of Obstetrics and Gynecology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, United States of America. Electronic address: omalley.46@osu.edu. 9. Department of Gynecologic Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL 33612, United States of America. Electronic address: robert.wenham@moffitt.org. 10. Tacoma General Hospital, Tacoma, WA, United States of America. 11. Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, United States of America. Electronic address: dcbodurka@mdanderson.org. 12. Dept. of Obstetrics & Gynecology, University of Cincinnati Cancer Institute, University of Cincinnati, Cincinnati, OH 45267, United States of America. Electronic address: herzogtj@ucmail.uc.edu. 13. The Permanente Medical Group, Inc. 2350 Geary Blvd, Room 115 San Francisco, CA 94115, United States of America. Electronic address: michael.bookman@usoncology.com.
Abstract
PURPOSE: To determine the relationship between chemotherapy dose modification (dose adjustment or treatment delay), overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma (PPC) who receivecarboplatin and paclitaxel. METHODS:Women with stages III and IV EOC and PPC treated on the Gynecologic Oncology Group phase III trial, protocol 182, who completed eight cycles ofcarboplatin with paclitaxel were evaluated in this study. The patients were grouped per dose modification and use of granulocyte colony stimulating factor (G-CSF). The primary end point was OS; Hazard ratios (HR) for PFS and OS were calculated for patients who completed eight cycles of chemotherapy. Patients without dose modification were the referent group. All statistical analyses were performed using the R programming language and environment. RESULTS:A total of 738 patients were included in this study; 229 (31%) required dose modification, 509 did not. The two groups were well-balanced for demographic and prognostic factors. The adjusted hazard ratios (HR) for disease progression and death among dose-modified patients were: 1.43 (95% CI, 1.19-1.72, P < 0.001) and 1.26 (95% CI, 1.04-1.54, P = 0.021), respectively. Use of G-CSF was more frequent in dose-modified patients with an odds ratio (OR) of 3.63 (95% CI: 2.51-5.26, P < 0.001) compared to dose-unmodified patients. CONCLUSION: Dose-modified patients were at a higher risk of disease progression and death. The need for chemotherapy dose modification may identify patients at greater risk for adverse outcomes in advanced stage EOC and PPC.
RCT Entities:
PURPOSE: To determine the relationship between chemotherapy dose modification (dose adjustment or treatment delay), overall survival (OS) and progression-free survival (PFS) for women with advanced-stage epithelial ovarian carcinoma (EOC) and primary peritoneal carcinoma (PPC) who receive carboplatin and paclitaxel. METHODS:Women with stages III and IV EOC and PPC treated on the Gynecologic Oncology Group phase III trial, protocol 182, who completed eight cycles of carboplatin with paclitaxel were evaluated in this study. The patients were grouped per dose modification and use of granulocyte colony stimulating factor (G-CSF). The primary end point was OS; Hazard ratios (HR) for PFS and OS were calculated for patients who completed eight cycles of chemotherapy. Patients without dose modification were the referent group. All statistical analyses were performed using the R programming language and environment. RESULTS: A total of 738 patients were included in this study; 229 (31%) required dose modification, 509 did not. The two groups were well-balanced for demographic and prognostic factors. The adjusted hazard ratios (HR) for disease progression and death among dose-modified patients were: 1.43 (95% CI, 1.19-1.72, P < 0.001) and 1.26 (95% CI, 1.04-1.54, P = 0.021), respectively. Use of G-CSF was more frequent in dose-modified patients with an odds ratio (OR) of 3.63 (95% CI: 2.51-5.26, P < 0.001) compared to dose-unmodified patients. CONCLUSION: Dose-modified patients were at a higher risk of disease progression and death. The need for chemotherapy dose modification may identify patients at greater risk for adverse outcomes in advanced stage EOC and PPC.
Authors: M Colleoni; K Price; M Castiglione-Gertsch; A Goldhirsch; A Coates; J Lindtner; J Collins; R D Gelber; B Thürlimann; C M Rudenstam Journal: Eur J Cancer Date: 1998-10 Impact factor: 9.162
Authors: F M Muggia; P S Braly; M F Brady; G Sutton; T H Niemann; S L Lentz; R D Alvarez; P R Kucera; J M Small Journal: J Clin Oncol Date: 2000-01 Impact factor: 44.544
Authors: M J Piccart; K Bertelsen; K James; J Cassidy; C Mangioni; E Simonsen; G Stuart; S Kaye; I Vergote; R Blom; R Grimshaw; R J Atkinson; K D Swenerton; C Trope; M Nardi; J Kaern; S Tumolo; P Timmers; J A Roy; F Lhoas; B Lindvall; M Bacon; A Birt; J E Andersen; B Zee; J Paul; B Baron; S Pecorelli Journal: J Natl Cancer Inst Date: 2000-05-03 Impact factor: 13.506
Authors: K Bertelsen; A Jakobsen; J Strøyer; K Nielsen; E Sandberg; J E Andersen; S Ahrons; M Nyland; P Hjortkjaer Pedersen; G Larsen Journal: Gynecol Oncol Date: 1993-04 Impact factor: 5.482