Implications of second-look laparotomy in the context of optimally resected stage III ovarian cancer: a non-randomized comparison using an explanatory analysis: a Gynecologic Oncology Group study.
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.


CONCLUSIONS
In the context of a non-randomized comparison, the performance of a SLL was not associated with longer survival.
Greer
Benjamin E
BE
Division of Gynecologic Oncology, University of Washington, Fred Hutchinson Cancer Research Center, Puget Sound Oncology Consortium LF-287, 1100 Fairview Avenue N., Seattle, WA 98109, USA. bengreer@u.washington.edu
Bundy
Brian N
BN
Ozols
Robert F
RF
Fowler
Jeffrey M
JM
Clarke-Pearson
Daniel
D
Burger
Robert A
RA
Mannel
Robert
R
DeGeest
Koen
K
Hartenbach
Ellen M
EM
Baergen
Rebecca N
RN
Copeland
Larry J
LJ
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007813:Laparotomy; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D017239:Paclitaxel / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D024162:Second-Look Surgery; D016896:Treatment Outcome
D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin