Journal of Clinical Oncology, Vol 15, 994-999, Copyright © 1997 by American Society of Clinical Oncology
Surgical second look in ovarian cancer: a randomized study in patients with laparoscopic complete remission--a Northeastern Oncology Cooperative Group-Ovarian Cancer Cooperative Group Study
MO Nicoletto, S Tumolo, R Talamini, L Salvagno, S Franceschi, E Visona, G Marin, F Angelini, G Brigato, C Scarabelli, A Carbone, A Cecchetto, A Prosperi, A Rosabian, M Giusto, GP Cima, S Morassut, O Nascimben, O Vinante and MV Fiorentino
Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.
PURPOSE: The usefulness of extensive and repetitive surgery for patients
with ovarian cancer still remains unproven (at least for some conditions).
We planned an accurate prospective test of the hypothesis that patients
with advanced-stage disease, after they had reached a clinical complete
remission (CR), may benefit from surgical second look (SSL). PATIENTS AND
METHODS: One hundred two patients in CR (as assessed by clinical findings,
markers, and visualization by computed tomographic [CT] scan and
laparoscopy), after initial debulking and first-line chemotherapy, were
randomized to two arms, which were well balanced for predictive criteria
such as age, stage at presentation, histology, grading, date of
randomization, and residua after first surgery. Forty-eight patients were
randomly assigned to receive follow- up evaluation only, while 54 were
assigned to receive second surgery (eight of them refused). Of 46 surgical
patients, 35 had negative and 11 positive surgical findings (24% clinically
false-negative). RESULTS: Despite the microscopic residua found at open
surgery, and the fact that the patients were then treated with second-line
chemotherapy, SSL did not increase the probability of survival in this
setting. In an analysis of the results according to the intention-to-treat
criteria, after a 60-month follow-up period, the overall survival rates in
the two groups of patients (SSL v no SSL) were 65% and 78%, respectively (P
= .14). Multivariate analysis according to predictive criteria confirmed
there was no significant difference between the two groups (P = .39).
CONCLUSION: Our study shows the following: (1) our second-line treatment is
scarcely effective; (2) SSL accurately defines complete responders to
first-line chemotherapy; (3) SSL per se does not prolong survival; and (4)
if confirmed, a less invasive procedure could replace SSL as a valuable
method in new first-line regimens in ovarian cancer patients with clinical
CR confirmed by laparoscopy.
