SURGICAL 2ND 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 et al., SURGICAL 2ND LOOK IN OVARIAN-CANCER - A RANDOMIZED STUDY IN PATIENTS WITH LAPAROSCOPIC COMPLETE REMISSION - A NORTHEASTERN ONCOLOGY COOPERATIVE GROUP OVARIAN-CANCER COOPERATIVE GROUP-STUDY, Journal of clinical oncology, 15(3), 1997, pp. 994-999
Purpose: The usefulness of extensive and repetitive surgery for patien
ts with ovarian cancer still remains unproven (at least for some condi
tions). We planned an accurate prospective test of the hypothesis that
patients with advanced-stage disease, after they had reached a clinic
al complete remission (CR), may benefit from surgical second look (SSL
). Patients and Methods: One hundred two patients in CR (as assessed b
y clinical findings, markers, and visualization by computed tomographi
c [CT] scan and laparoscopy), after initial debulking and first-line c
hemotherapy, were randomized to two arms, which were well balanced for
predictive criteria such as age, stage at presentation, histology, gr
ading, date of randomization, and residua after first surgery. Forty-e
ight patients were randomly assigned to receive follow-up evaluation o
nly, while 54 were assigned to receive second surgery (eight of them r
efused). Of 46 surgical patients, 35 had negative and 11 positive surg
ical findings (24% clinically false-negative). Results: Despite the mi
croscopic residua found at open surgery, and the fact that the patient
s were then treated with second-line chemotherapy, SSL did not increas
e the probability of survival in this setting. In on analysis of the r
esults according to the intention-to-treat criteria, after a 60-month
follow-vp period, the overall survival rates in the two groups of pati
ents (SSL v no SSL) were 65% and 78%, respectively (P = .14). Multivar
iate analysis according to predictive criteria confirmed there was no
significant difference between the two groups (P = .39). Conclusion: O
ur study shows the following: (1) our second-line treatment is scarcel
y effective; (2) SSL accurately defines complete responders to first-l
ine 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 clin
ical CR confirmed by laparoscopy. (C) 1997 by American Society of Clin
ical Oncology.