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

Citation
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
Citations number
41
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Oncology
ISSN journal
0732-183X
Volume
15
Issue
3
Year of publication
1997
Pages
994 - 999
Database
ISI
SICI code
0732-183X(1997)15:3<994:S2LIO->2.0.ZU;2-2
Abstract
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.