Peter G Rose1, James J Java2, Mark A Morgan3, Angeles Alvarez-Secord4, Joshua P Kesterson5, Frederick B Stehman6, David P Warshal7, William T Creasman8, Parviz Hanjani9, Robert T Morris10, Larry J Copeland11. 1. Dept. of OB/GYN, Cleveland Clinic, Cleveland, OH 44109, United States. Electronic address: rosep@ccf.org. 2. NRG Oncology Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States. Electronic address: james.j.java@gmail.org. 3. Dept. of OB/GYN, University of Pennsylvania Hospital System, University of Pennsylvania, Philadelphia, PA 19104, United States. Electronic address: mark.a.morgan@uphs.upenn.edu. 4. Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology, Duke University Medical Center, Durham, NC 27710, United States. Electronic address: secor002@mc.duke.edu. 5. Dept. of GYN/Oncology, Hershey Medical Center, Hershey, PA 17033, United States. Electronic address: jkesterson@hmc.psu.edu. 6. Section of Gyn Onc, Simon Cancer Center, Indianapolis, IN 46202, United States. Electronic address: fstehman@iupui.edu. 7. Division of Gynecologic Oncology, Cooper Health, Camden, NJ 08103, United States. Electronic address: warshal-david@cooperhealth.edu. 8. Dept. of Obstetrics & Gynecology, Medical University of South Carolina, Charleston, SC 29425, United States. Electronic address: creasman@musc.edu. 9. Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA 19001, United States. Electronic address: phanjani@amh.org. 10. Dept. of Oncology, Wayne State University Medical Center, Detroit, MI 48201, United States. Electronic address: rmorris@med.wayne.edu. 11. Dept. of Gynecologic Oncology, Ohio State University Medical Center, Columbus, OH 43210, United States. Electronic address: larry.copeland@osumc.edu.
Abstract
PURPOSE: GOG 152 was a randomized trial of secondary cytoreductive surgery (SCS) in patients with suboptimal residual disease (residual tumor nodule >1cm in greatest diameter) following primary cytoreductive surgery for advanced stage ovarian cancer. The current analysis was undertaken to evaluate the impact of disease findings at SCS on progression-free survival (PFS) and overall survival (OS). METHODS: Among the 550 patients enrolled on GOG-152, two-hundred-sixteen patients were randomly assigned following 3cycles of cisplatin and paclitaxel to receive SCS. In 15 patients (7%) surgery was declined or contraindicated. In the remaining 201 patients the operative and pathology reports were utilized to classify their disease status at the beginning of SCS as; no gross disease/microscopically negative N=40 (19.9%), no gross disease/microscopically positive N=8 (4.0%), and gross disease N=153 (76.1%). RESULTS: The median PFS for patients with no gross disease/microscopically negative was 16.1months, no gross disease/microscopically positive was 13.5months and for gross disease was 11.7months, P=0.002. The median OS for patients with no gross disease/microscopically negative was 51.5months, no gross disease/microscopically positive was 42.6months and for gross disease was 34.9months, P=0.018. CONCLUSION: Although as previously reported SCS did not change PFS or OS, for those who underwent the procedure, their operative and pathologic findings were predictive of PFS and OS. Surgical/pathological residual disease is a biomarker of response to chemotherapy and predictive of PFS and OS.
RCT Entities:
PURPOSE:GOG 152 was a randomized trial of secondary cytoreductive surgery (SCS) in patients with suboptimal residual disease (residual tumor nodule >1cm in greatest diameter) following primary cytoreductive surgery for advanced stage ovarian cancer. The current analysis was undertaken to evaluate the impact of disease findings at SCS on progression-free survival (PFS) and overall survival (OS). METHODS: Among the 550 patients enrolled on GOG-152, two-hundred-sixteen patients were randomly assigned following 3cycles of cisplatin and paclitaxel to receive SCS. In 15 patients (7%) surgery was declined or contraindicated. In the remaining 201 patients the operative and pathology reports were utilized to classify their disease status at the beginning of SCS as; no gross disease/microscopically negative N=40 (19.9%), no gross disease/microscopically positive N=8 (4.0%), and gross disease N=153 (76.1%). RESULTS: The median PFS for patients with no gross disease/microscopically negative was 16.1months, no gross disease/microscopically positive was 13.5months and for gross disease was 11.7months, P=0.002. The median OS for patients with no gross disease/microscopically negative was 51.5months, no gross disease/microscopically positive was 42.6months and for gross disease was 34.9months, P=0.018. CONCLUSION: Although as previously reported SCS did not change PFS or OS, for those who underwent the procedure, their operative and pathologic findings were predictive of PFS and OS. Surgical/pathological residual disease is a biomarker of response to chemotherapy and predictive of PFS and OS.
Authors: Deborah K Armstrong; Brian Bundy; Lari Wenzel; Helen Q Huang; Rebecca Baergen; Shashikant Lele; Larry J Copeland; Joan L Walker; Robert A Burger Journal: N Engl J Med Date: 2006-01-05 Impact factor: 91.245
Authors: D S Alberts; P Y Liu; E V Hannigan; R O'Toole; S D Williams; J A Young; E W Franklin; D L Clarke-Pearson; V K Malviya; B DuBeshter Journal: N Engl J Med Date: 1996-12-26 Impact factor: 91.245
Authors: M E Randall; R J Barrett; N M Spirtos; E Chalas; H D Homesley; S L Lentz; M Hanna Journal: Int J Radiat Oncol Biol Phys Date: 1996-01-01 Impact factor: 7.038