Intraperitoneal Radioactive Phosphorus (32P) Versus Observation After Negative Second-Look Laparotomy for Stage III Ovarian Carcinoma: A Randomized Trial of the Gynecologic Oncology Group

2003 ◽  
Vol 21 (15) ◽  
pp. 2849-2855 ◽  
Author(s):  
Mahesh A. Varia ◽  
Frederick B. Stehman ◽  
Brian N. Bundy ◽  
Jo Ann Benda ◽  
Daniel L. Clarke-Pearson ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Relative Risk ◽  
Ovarian Carcinoma ◽  
Tumor Recurrence ◽  
Stage Iii ◽  
Gynecologic Oncology Group ◽  
Consolidation Therapy ◽  
Risk Of Death ◽  
Second Look ◽  
Significant Difference

Purpose: The objectives of this prospective randomized study of consolidation therapy were to evaluate recurrence-free survival (RFS), overall survival (OS), and the morbidity of intraperitoneal (IP) chromic phosphate suspension (32P) therapy in patients with stage III epithelial ovarian carcinoma who have no detectable evidence of disease at the second-look laparotomy (SLL) procedure after primary chemotherapy. Patients and Methods: In a multi-institution clinical cooperative trial, 202 eligible patients with a negative SLL were randomly selected to receive either 15 mCi IP 32P (n = 104) or no further therapy (NFT; n = 98). Results: With a median follow-up of 63 months in living patients, 68 patients in the IP 32P group (65%) and 63 patients in the NFT group (64%) have developed tumor recurrence. The relative risk of recurrence is 0.90 (IP 32P to NFT) (90% confidence interval [CI], 0.68 to 1.19). The 5-year RFS rate is 42% and 36% for the IP 32P and NFT groups, respectively; the difference is not statistically significant (log-rank test, P = .27). There was no statistically significant difference in OS (P = .19). The relative risk of death is 0.85 (IP 32P to NFT) (90% CI, 0.62 to 1.16). Sixteen patients (8%) experienced grade 3 or 4 adverse effects, with eight in each respective group. Conclusion: Intraperitoneal chromic phosphate did not decrease the risk of relapse or improve survival for patients with stage III epithelial ovarian cancer after a negative SLL. Despite complete pathologic remission at SLL after initial surgery and platinum-based chemotherapy, 61% of stage III ovarian cancer patients had tumor recurrence within 5 years of negative SLL. This indicates a need for more effective initial therapy and further studies of consolidation therapy.

Randomized trial of cyclophosphamide plus cisplatin with or without doxorubicin in ovarian carcinoma: a Gynecologic Oncology Group Study.

1989 ◽  
Vol 7 (4) ◽  
pp. 457-465 ◽  
Author(s):  
G A Omura ◽  
B N Bundy ◽  
J S Berek ◽  
S Curry ◽  
G Delgado ◽  
...  
Keyword(s):  
Ovarian Carcinoma ◽  
Residual Disease ◽  
Gynecologic Oncology ◽  
Dose Schedule ◽  
Stage Iii ◽  
Hematologic Toxicity ◽  
Gynecologic Oncology Group ◽  
Disease Category ◽  
Second Look ◽  
Significant Difference

A randomized clinical trial was conducted in women with stage III ovarian carcinoma (less than or equal to 1 cm residual lesions), using cyclophosphamide plus cisplatin (CP) with or without doxorubicin. There were 349 evaluable patients, of whom 176 received CP while 173 patients received CP plus doxorubicin (CAP). Hematologic toxicity was almost identical. There was no significant difference in progression-free interval (PFI) (median, 22.7 months and 24.6 months), frequency of negative second-look laparotomy (30.2% and 32.8%), or survival (median, 31.2 months and 38.9 months) between CP and CAP, respectively. Thus, doxorubicin in the dose schedule employed does not improve combination chemotherapy of optimal stage III ovarian carcinoma. Several other findings, independent of treatment arm, were of interest. There was a significant difference in PFI and survival by residual disease category (yes v no) and by grade of differentiation (1 v 2 + 3). In multivariate analysis, age, residual disease at entry, cell type (clear cell carcinoma), and time from surgery to initiation of chemotherapy were significant predictors of survival. There was no difference in outcome comparing those who refused second-look with those who had a second-look.

Second-look laparotomy in the patient with minimal residual stage III ovarian cancer (a Gynecologic Oncology Group study)

1989 ◽  
Vol 35 (3) ◽  
pp. 378-382 ◽  
Author(s):  
William T. Creasman ◽  
Stanley Gall ◽  
Brian N. Bundy ◽  
Jackson Beecham ◽  
Rodrigue Mortel ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Gynecologic Oncology ◽  
Stage Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Oncology Group Study ◽  
Second Look ◽  
Minimal Residual

Surgery and prognosis in stage III epithelial ovarian cancer

1995 ◽  
Vol 5 (6) ◽  
pp. 416-420 ◽  
Author(s):  
G. Ing ◽  
N. Semrad ◽  
S. Jordan ◽  
F. Latino ◽  
W. G. Watring
Keyword(s):  
Ovarian Cancer ◽  
Epithelial Ovarian Cancer ◽  
Tumor Grade ◽  
Stage Iii ◽  
Retrospective Case ◽  
Second Look ◽  
Significant Difference ◽  
Grade 3 ◽  
Retrospective Case Study

The results of this retrospective case study indicate that a composite of tumor grade, pattern of spread and substage at the time of opening affects the outcome most in the treatment of stage III epithelial tumors of the ovary. The poorest prognosis was associated with grade 3 histology, a pattern of spread requiring extensive and often difficult surgery for removal and a high substage. The best prognosis was usually associated with grade 1, with either very easily removed, isolated spread or low substage.The extent of tumor defined the degree of primary cytoreduction possible. If the tumor was minimally extensive, primary cytoreduction results were excellent. The same conclusions were reached in the case of secondary cytoreduction at the time of second-look procedure. There was no statistically significant difference (z= 1.481,P= 0.069) in 5-year survival between patients with microscopic only disease (59%) at second-look, and patients with gross disease not cytoreduced (36%).

Clinical Value of Radioimmunoscintigraphy in the follow-up of Ovarian Carcinoma: A Prospective Study

1990 ◽  
Vol 5 (3) ◽  
pp. 103-108 ◽  
Author(s):  
F. Crippa ◽  
M. Presti ◽  
A. Marini ◽  
B. D'Onofrio ◽  
G. Bolis ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Ovarian Carcinoma ◽  
Residual Tumor ◽  
Clinical Value ◽  
Second Look ◽  
Tumor Persistence ◽  
Upper Abdominal ◽  
Abdominal Lesions ◽  
A Prospective Study

Twenty-five patients treated with debulking surgery and chemotherapy for ovarian cancer were prospectively studied to evaluate the efficacy of radioimmunoscintigraphy (RIS) in detecting residual tumor before second-look surgery. RIS was performed with the monoclonal antibody OC125 F(ab')2 labelled with 1-131 without knowledge of clinical data and compared with subsequent surgical results. Second look showed tumor persistence in 12 patients, mostly characterized by small lesions. The overall diagnostic sensitivity of RIS was 50% and the specificity was 85%. In particular, RIS showed better sensitivity for pelvic tumor localizations than for abdominal sites (73% vs 33%); this was due to the inability of RIS to detect upper abdominal lesions. Therefore, our conclusion is that, at present, RIS cannot substitute surgical second-look in the management of ovarian cancer, however, considering that also ultrasonography, computer tomography and magnetic resonance are not always able to give definite diagnostic evidence in the follow-up of ovarian carcinoma, RIS could be added to these procedures to balance the limitations of each method. In this regard, the best application of RIS could be in the follow-up of patients with marker elevation without clinical evidence of disease, especially in the case of pelvic fibrosis or adhesions due to previous therapy, where the other non-invasive tools can give doubtful diagnostic results.

The second-look operation improves survival in suboptimally debulked stage III ovarian cancer patients

2005 ◽  
Vol 15 (1) ◽  
pp. 19-25 ◽  
Author(s):  
J. Rahaman ◽  
P. Dottino ◽  
T. S. Jennings ◽  
J. Holland ◽  
C. J. Cohen
Keyword(s):  
Ovarian Cancer ◽  
Residual Disease ◽  
Stage Iii ◽  
Single Institution ◽  
Primary Ovarian Cancer ◽  
Primary Surgery ◽  
Second Look ◽  
Survival Difference ◽  
Second Look Operation

In a single-institution retrospective cohort study, 230 patients were treated for stage III primary ovarian cancer and 175 became eligible for second-look operations by virtue of a complete clinical response after primary surgical cytoreduction and platinum-based combination chemotherapy. Of these, 109 underwent a second-look operation. Optimal primary cytoreduction was defined as residual disease ≤1 cm. Median follow-up was 68.3 months. Five-year survival for all the 230 stage III ovarian cancers was 43.4%. Among all eligible patients (n = 175), there was no survival difference (P = 0.67) in those having second look (57.3%, 5-year survival) versus no second look (48.7%). In those patients with optimal primary cytoreduction (n = 118), there was no survival advantage to second look (69% versus 61%, P = 0.7). However, in those with suboptimal primary cytoreduction (n = 47), 5-year survival was 36% in those having second look versus only 13% in those refusing second look (P < 0.05). Multivariate analysis identified second-look surgery as the only significant independent prognostic variable affecting survival (RR = 0.321, P < 0.04). Patients with suboptimal debulking at primary surgery for stage III ovarian cancer appear to achieve a survival benefit from second-look surgical procedures, presumably from the early identification and treatment of residual disease.

scholarly journals Cost Effectiveness of Intraperitoneal Compared With Intravenous Chemotherapy for Women With Optimally Resected Stage III Ovarian Cancer: A Gynecologic Oncology Group Study

2008 ◽  
Vol 26 (25) ◽  
pp. 4144-4150 ◽  
Author(s):  
Laura J. Havrilesky ◽  
Angeles Alvarez Secord ◽  
Kathleen M. Darcy ◽  
Deborah K. Armstrong ◽  
Shalini Kulasingam
Keyword(s):  
Ovarian Cancer ◽  
Cost Effectiveness ◽  
Time Horizon ◽  
Gynecologic Oncology ◽  
Cost Effective ◽  
Stage Iii ◽  
Gynecologic Oncology Group ◽  
Oncology Group ◽  
Resected Stage ◽  
The Cost

Purpose To determine the cost effectiveness of intraperitoneal versus intravenous regimens for adjuvant treatment of optimally resected stage III ovarian cancer. Patients and Methods A decision model was developed to compare the cost effectiveness at 7-, 11.5-, and 35-year horizons of intravenous carboplatin and paclitaxel (IV-CARBO/PAC), intravenous cisplatin and paclitaxel (IV-CIS/PAC), or intravenous paclitaxel followed by intraperitoneal cisplatin and paclitaxel (IP-CIS/PAC). Survival data were from women participating in representative Gynecologic Oncology Group (GOG) protocols. Medicare reimbursement rates and the Agency for Healthcare Research and Quality Database were used to estimate costs for treatment regimens and grade 3 to 4 adverse effects, respectively. Results Median predicted survival was 66, 57, 51, and 48 months for IP-CIS/PAC, IV-CARBO/PAC, IV-CIS/PAC (GOG 172), or IV-CIS/PAC (GOG 158), respectively. Across a range of analyses, IV-CIS/PAC was more costly and had lower life expectancy than IV-CARBO/PAC. Compared with IV-CARBO/PAC, IP-CIS/PAC had an incremental cost-effectiveness ratio (ICER) of $180,022 per quality-adjusted life year (QALY) saved at a 7-year time horizon, $71,835/QALY at 11.5 years, and $32,053/QALY over a lifetime. Extending the survival advantage of IP-CIS/PAC over 11.5 years and a lifetime results in ICERs of $26,249 and $23,973, respectively. Assuming IP-CIS/PAC and IV-CIS/PAC were equally effective when administered on an outpatient basis, the ICER of IP-CIS/PAC compared with IV-CARBO/PAC was $26,311. Conclusion Inpatient IP-CIS/PAC, while not cost effective compared with IV-CARBO/PAC at 7 years, becomes cost effective if a longer time horizon is modeled and/or a survival benefit can be assumed to persist longer than currently available data. Outpatient IP-CIS/PAC may also be cost effective compared with IV-CARBO/PAC if proven as effective as inpatient IP-CIS/PAC.

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