OBJECTIVE: A non-randomized comparison of outcome in women undergoing second-look laparotomy (SLL) or clinical follow-up, after receiving six cycles of combination chemotherapy with paclitaxel plus either cisplatin or carboplatin, for optimally resected stage III ovarian cancer. METHODS: Prior to chemotherapy randomization, patients chose whether or not to undergo SLL; this was a stratification factor to insure balance of treatment assignment. Any subsequent therapy was physician-directed. Explanatory analysis replaced intent-to-treat because of a higher likelihood of detecting SLL effect in the presence of noncompliance. RESULTS: There were 393 patients (median age: 54) who Elected SLL and 399 (median age: 59) who Elected No SLL. The former group was more likely to have gross residual disease at initial surgery than the latter group (69% versus 60%, respectively). In the Elected SLL group, 59 (15%) patients subsequently refused surgery, in nine (2%) surgery was contraindicated, and 31 (8%) relapsed or died prior to the procedure. Cancer was found in 46% of 294 (75%) patients undergoing SLL. Since early failures (prior to SLL) do not address benefit, such patients (SLL: 32; No SLL: 33), defined as progression-free survival (PFS) < 6 months, were excluded from analysis. The adjusted relative risk of progression is 0.89 (95% confidence interval: 0.75, 1.07); the difference in median PFS is 1.0 month (SLL: 23.9 months; No SLL: 22.9 months). The survival rate curves are superimposable. CONCLUSION: In the context of a non-randomized comparison, the performance of a SLL was not associated with longer survival.
OBJECTIVE: A non-randomized comparison of outcome in women undergoing second-look laparotomy (SLL) or clinical follow-up, after receiving six cycles of combination chemotherapy with paclitaxel plus either cisplatin or carboplatin, for optimally resected stage III ovarian cancer. METHODS: Prior to chemotherapy randomization, patients chose whether or not to undergo SLL; this was a stratification factor to insure balance of treatment assignment. Any subsequent therapy was physician-directed. Explanatory analysis replaced intent-to-treat because of a higher likelihood of detecting SLL effect in the presence of noncompliance. RESULTS: There were 393 patients (median age: 54) who Elected SLL and 399 (median age: 59) who Elected No SLL. The former group was more likely to have gross residual disease at initial surgery than the latter group (69% versus 60%, respectively). In the Elected SLL group, 59 (15%) patients subsequently refused surgery, in nine (2%) surgery was contraindicated, and 31 (8%) relapsed or died prior to the procedure. Cancer was found in 46% of 294 (75%) patients undergoing SLL. Since early failures (prior to SLL) do not address benefit, such patients (SLL: 32; No SLL: 33), defined as progression-free survival (PFS) < 6 months, were excluded from analysis. The adjusted relative risk of progression is 0.89 (95% confidence interval: 0.75, 1.07); the difference in median PFS is 1.0 month (SLL: 23.9 months; No SLL: 22.9 months). The survival rate curves are superimposable. CONCLUSION: In the context of a non-randomized comparison, the performance of a SLL was not associated with longer survival.
Authors: Peter G Rose; James J Java; Mark A Morgan; Angeles Alvarez-Secord; Joshua P Kesterson; Frederick B Stehman; David P Warshal; William T Creasman; Parviz Hanjani; Robert T Morris; Larry J Copeland Journal: Gynecol Oncol Date: 2016-09-28 Impact factor: 5.482
Authors: Michael A Bookman; Mark F Brady; William P McGuire; Peter G Harper; David S Alberts; Michael Friedlander; Nicoletta Colombo; Jeffrey M Fowler; Peter A Argenta; Koen De Geest; David G Mutch; Robert A Burger; Ann Marie Swart; Edward L Trimble; Chrisann Accario-Winslow; Lawrence M Roth Journal: J Clin Oncol Date: 2009-02-17 Impact factor: 44.544
Authors: F C Muñoz-Casares; S Rufián; M J Rubio; E Lizárraga; C Díaz-Iglesias; E Aranda; R Ciria; J Muntané; P Barrios; J Torres-Melero; S González-Moreno; L González-Bayón; B Camps; P Bretcha; J Farré; G Ortega-Pérez; A Gómez-Portilla Journal: Clin Transl Oncol Date: 2007-10 Impact factor: 3.405